Who Essential Drugs

Managing Drug Supply 2–13Benefits of Thailand’s collective

bargaining system for drugprocurement

Drug supply choices: what works best?A primary distributor system for drugs

in South AfricaGuatemala’s strategies for improving

drug supply and accessAnd more...

National Drug Policy 13–14Meeting promotes African consumers’

involvement in drug policyPlus articles on Belarus and Zimbabwe

Research 15–20Reviving the popularity of commune

health stations in a Vietnameseprovince

Public education in rational drug use:research study shows the value andreveals the problems

Training 20–21Students taught how to develop a

personal formulary

Newsdesk 21–25Change at WHOUK study shows patients don’t get the

information they needAnd more...

Drug Information 26–27Communicating drug safety

information effectively

Meetings & Courses 27

Netscan 28

Letters to the Editor 28

Published Lately 29–30

Rational Use 31–36How the Netherland’s

pharmacotherapy discussion groupshave evolved

Essential drugs concept needs betterimplementation

DOUBLE ISSUE – No 25 & 26 (1998)

The Essential Drugs Monitor is producedand distributed by the WHO Action Pro-gramme on Essential Drugs. It is pub-lished in English, French, Spanish andRussian, and has a global readership ofsome 200,000 to whom it is free of charge.The Monitor carries news of develop-ments in national drug policies, therapeu-tic guidelines, current pharmaceuticalissues, educational strategies and opera-tional research.WHO’s Action Programme on EssentialDrugs was established in 1981 to provideoperational support to countries in the de-velopment of national drug policies and towork towards the rational use of drugs.The Programme seeks to ensure that allpeople, wherever they may be, are able toobtain the drugs they need at the lowestpossible price; that these drugs are safeand effective; and that they are prescribedand used rationally.

All correspondenceshould be addressed to:The EditorEssential Drugs MonitorWorld Health OrganizationCH-1211 Geneva 27, SwitzerlandFax: +41 22-791-4167e-mail: [email protected]

Essential Drugs Monitor

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I N T H I S I S S U E :

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mid 1970s basic drug managementconcepts began to evolve in countries asdiverse as Cuba, Norway, Papua NewGuinea, Peru and Sri Lanka.

Over the last 20 years countries haveacquired considerable experience inmanaging drug supply. Broad lessonsthat have emerged from this experienceinclude: that national drug policy pro-vides a sound foundation for managingdrug supply; that wise drug selectionunderlies all other improvements; thateffective management saves money andimproves performance; that rational druguse requires more than drug information;and that systematic assessment andmonitoring are essential.

Over the years the Monitor has aimedto share both positive and negative expe-riences in this critical field. This issuereports on the strengths and constraintsof some national, provincial and localinitiatives to rationalise drug supply anduse. It also draws on material publishedin the comprehensive second edition ofManaging Drug Supply, issued in col-laboration with the Action Programme onEssential Drugs. This publication, whichhas long been a fundamental tool in manycountries, now compiles state of the art

knowledge, experience andguidance on every aspect ofthe drug management cycle.Watch out in future issuesof the Monitor for a new“how to” section drawn fromManaging Drug Supply andfrom accompanying trainingmaterials currently beingdeveloped.

What works best in drugsupply has no simple answer.As the article posing this ques-tion on p.7 concludes, it willnever be possible to state thatone particular system is “thebest”. Each country bringsunique political, economicand geographical factors tothe equation. And to weigh thepros and cons of one drug sup-ply system against anothercannot be properly done froma global perspective withoutdetailed study. The Action

Photo: WHO/E. Lauridsen

OST leading causes of deathand disability in developingcountries can be prevented,treated or at least alleviatedwith cost-effective essential

drugs. Despite this fact hundreds ofmillions of people do not have access toessential drugs.

Although the relative frequencies ofspecific illnesses vary among countries,health services throughout the world arepresented with a fairly common set ofhealth problems for which essential drugshave an important role. Mortality figuresacross developing regions reflect a hugeburden of illness that can be substantiallyreduced if carefully selected, low-cost pharmaceuticals are available andappropriately used. And even in indus-trialised countries escalating costs ofhealth care have placed evidence-basedand efficient drug supply managementhigh on the agenda. Good drug supplymanagement is an essential componentof effective and affordable health careservices globally.

Within a decade after the first modernpharmaceuticals became available,efforts began to ensure their widespreadavailability. From the mid 1950s to the

Programme is embarking on just such amulticountry study to examine in depthat the country level the outcomes of thedrug supply systems in use. This studywill look at the advantages and dis-advantages of the systems and thefactors which influence the level ofsuccess or failure.

However, what the experiences ofcountless countries and programmes dodemonstrate is that substantive and sus-tainable improvements in the supply anduse of drugs are possible. But an equalor greater number of negative experi-ences show that success is by no meansassured. Clear goals, sound plans, effec-tive implementation and monitoring ofperformance are essential ingredients inpharmaceutical sector development. Andwe can be sure that if changes in a drugsupply system are not based on a carefulanalysis of the underlying causes for theweaknesses of the existing system thenthey are unlikely to produce the desiredoutcome. Systems chosen, for example,because they function in a “successful”market economy may not prove thesolution to the drug supply problemsfaced in the context of a developingcountry. ❏

E S S E N T I A L D R U G S M O N I T O R2

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Health reformand drug financing

a number of reasons, including limitedformal employment and weak statemechanisms.

There are benefits in providing phar-maceutical coverage together with healthcoverage although challenges, such asdifficulties in tracking prescriptions,exist. Policy makers and managers needto be fully informed about the value ofinsurance coverage, alternative mecha-nisms for providing pharmaceuticalbenefits, and methods to ensure qualityof care, while controlling costs.

User chargesUser charges are increasingly being

implemented by governments and localcommunities in countries at all levels ofdevelopment, both to supplement generalgovernment revenues or insurance pre-miums, and to help control use (see Box1). Often, however, such programmeshave not learned from past experiences,are not well managed, and, as a result,access shows no improvement, revenuereplaces rather than supplementsgovernment funding, and drugs areoverprescribed.

User fees can complement govern-ment allocations for pharmaceuticals,but should not replace them. Futureefforts need to ensure that the lessonsfrom existing research and actual ex-perience are applied to the design,implementation and monitoring of userfee programmes to ensure that access todrugs does improve, and that rational usedoes not suffer. When fee mechanisms areinstituted at a national level, a top-downapproach, starting with major nationaland local hospitals, may have advantagesin terms of equity, reinforcement ofthe referral system, revenue potential,administrative capacity and impactevaluation.

Donor financing and drug donationsDonor financing includes bilateral and

M A N A G I N G D R U G S U P P L Y

HEALTH sector reform is a processaimed at improving equity,quality and efficiency in thehealth sector through changes in

the organization and financing of healthservices. In this context, the role of WHOtoday is to explore and promote ways oforganizing health services which respondbetter to the objectives of equity, qualityand efficiency.

Nearly every aspect of national drugpolicy and pharmaceutical sector devel-opment is directly or indirectly affectedby health reform initiatives. An additionto DAP’s Health Economics and DrugsSeries1, which is summarised here,focuses primarily on certain financialaspects of health reform.

DRUG FINANCING REFORMS

Governments have the responsibilityto ensure that drug financing mechanismsare managed in such a way as to achieveequity of access to essential drugs. Fi-nancing mechanisms include publicfinancing, health insurance, user fees,donor financing and development loans.

Public financingSome public spending will always be

needed to ensure access to drugs by thepoorest in society; to ensure provision ofdrugs for tuberculosis, sexually transmit-ted diseases and other communicablediseases; and to ensure care for targetgroups, such as mothers and children. Asa share of national economic output(GNP), public spending on health indeveloping countries is one-quarter toone-half that of industrialised countries.Health financing reform should improvethe use of public resources, but it shouldnot be aimed to further reduce publicspending on health.

The level of public commitment forfinancing health care and drugs shouldbe a matter of explicit public policy,based on an analysis of health care needsand financing options. Policy makers,managers responsible for health carefinancing, and essential drugs managersshould be familiar with the methods foranalysing public financing for drugs andfor planning public expenditures fordrugs.

Health insuranceFormal health insurance and various

informal community insurance pro-grammes represent a growing source ofhealth and drug financing in transitionaland developing countries. The experienceof many countries has shown that com-pulsory social insurance can be the criticalstep to a more equitable health care sys-tem. It must be recognised, however, thatsome developing countries will havedifficulties in implementing widespreadinsurance coverage in the short-term for

multilateral grants. For somecountries, internal financingmechanisms for drugs mayprove insufficient, even afterreforms, and thereforeexternal funding canprove invaluable torelieving immediatehuman sufferingand can allowcountries to developlong-term solutions.

The challengewith all externalfinancing, but par-ticularly when itinvolves the financingof recurrent costs, is to notallow this to substitute for effortsby countries to develop sustainablefinancing mechanisms. Transitionsfrom external mechanisms to internalmechanisms need to be incorporatedin assistance plans from their concep-tion. But it should be recognised thatsustainability may require relativelylong-term commitments by donors.

To promote beneficial drug donationsand to minimise unintended problemswith drug donations, interagency guide-lines2 have been published which set outcore principles and 12 specific guidelineswhich should be followed in all drugdonations.

Development loansDevelopment loans through the World

Bank and regional development banksmay contribute to long-term developmentof the human and physical infrastructurefor the health sector. However, loans gen-erally should not be used for financingof the cost of drug supplies, as these re-present recurrent expenses. There can becertain exceptions to this which may jus-tify the use of loans for procurement (e.g.seeding of revolving drug funds). As withdonor financing, conditions associatedwith development loans should not dis-tort national drug policies defined bygovernments.

AFFORDABILITY ANDEFFICIENCY

The appropriate choice and use ofdrugs is the key to the achievement ofpharmaceutical policy objectives andshould lead to greater economic effi-ciency in the health sector. A variety ofcost-control measures have been appliedat different levels within public andprivate drug supply systems. Theappropriateness of different measuresvaries with the particular health system.

Affordability of drugs for consumersis a public health concern. Private expen-ditures for pharmaceuticals in developingcountries typically account for 50 to 90%of all spending on drugs. Even for rural

populations and the urban poor, the mostcommon source of drugs is direct out-of-pocket purchase from the private market.

Use of generic drugs and price con-trols are the two most commonly pursuedmechanisms to promote affordability.Generic competition with price informa-tion is effective in this regard. But genericdrug markets have grown very slowly inmost countries. The strength of publicpolicy commitment to generic drugs is amajor determinant of the growth of ge-neric markets. Four essential factors forsuccess appear to be supportive legisla-tion and regulation, reliable qualityassurance, professional and publicacceptance, and economic incentives(see Box 2).

Various mechanisms exist to controlproducer prices and distribution margins.Wholesale and dispensing marginsbased on cost plus a fixed professionalfee provide a better incentive for rationaldispensing than margins based only on apercentage. The effects of pharmaceuti-cal price controls have been mixed.Paradoxically, a number of developingcountries are relaxing price controls ondrugs, while governments in indus-trialised countries are becomingincreasingly concerned with pharma-ceutical prices. With or without pricecontrols, price transparancy should be acentral objective.

ORGANIZATIONALREFORMS

Reforms to financing systems cannotbe made without organizational reformsthat should match the structure ofthe public and private sectors to theirresponsabilities in fulfilling policy objec-tives. Changes may include incorporationof competitive mechanisms within thepublic sector, decentralisation of healthservice provision, and a greater role forNGOs and other non commercial “thirdsector” entities.

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Competitive mechanismsin public drug supply

Alternative drug supply strategies forpublic drug supply include the traditionalcentral medical stores system, autono-mous supply agencies, the direct deliverysystem, the prime vendor system and fullyprivate supply. Several of these systemsinvolve different public-private roles andrely on greater competition to improveefficiency.

The practical results of differentmechanisms for public drug supply haveyet to be clearly documented. Govern-ments seeking to improve efficiency inpublic drug supply should do so with theknowledge that a number of options ex-ist and that success depends not onlyon choosing an appropriate option, butalso on the way in which the option isimplemented.

Decentralisation and integrationin drug supply systems

Control and decision making in healthsystems is increasingly being decentral-ised. For drugs, decentralisation mayimprove quantification of drug require-ments, inventory control, prescribing and

Recently some governments have ex-plored ways of carrying out “public”functions such as standard-setting or qual-ity control testing through innovativearrangements with third sector institu-tions. The various roles played by thethird sector should be clearly acknow-ledged by policy makers, and ways to bestsupport and involve the sector should beexplored. ❏

Health Reform and Drug Financing: SelectedTopics is available, free of charge, from:

dispensing. But some degree of centrali-sation may still be required for functionssuch as drug registration, developmentof essential drugs lists and standardtreatments, quality assurance and bulktendering.

Efforts are also being made in somecountries to integrate supply systemsfor family planning, tuberculosis control,and other “vertical” programmes intoessential drugs programmes. Resource-intensive functions such as procurement,quality assurance, storage and physicaldistribution may be integrated underthe essential drugs programme, whilefinancing, quantification of needs andmonitoring may remain under themanagement of the national controlprogramme.

Role of the “third sector”Discussions of public and private

roles in the pharmaceutical sectorshould not ignore the vital role of the“third sector”. This includes NGOs’health services, not-for-profit essentialdrugs supply agencies, professionalassociations, consumer groups, and spe-cialised NGOs such as some nationalpharmacopoeial organizations.

Box 1

Observations fromuser fee experiences in Africa

Revenue generationIn 34 countries with user charges (out of 39 surveyed), the revenue generated bythese fees was generally a very small share of public recurrent health expenditures(almost always less than 10%). However, for some of the systems which haveremained in place over several years, modest improvements in this percentage havebeen observed.

Recovery of fundsOf the community drug funds operating in 17 Sub-Saharan African countries (Benin,Chad, Niger, Sierra Leone, and Zaire are some examples), the success rate for therecovery of funds was about 50% with positive margins ranging from 49–83%(depending on the margin type).

Experiences of the Central African Republic indicate that public health centres whichwere self-managed, controlled their own drug sales, and had fees for all services,had higher cost-recovery rates than centres which did not exert as much control overdrug sales and offered a range of free services.

Utilisation of facilities and quality of careDemand for community health services which have user fees does seem to increaseif quality, as measured by the availability of drugs, also increases. This is particularlytrue if accessing the next best care alternative involves significant time and travelcosts.

However, because user fees do not always succeed in making drugs more available,and other factors are also involved in utilisation, decreases in use of health facilitiesare also frequently observed. Utilisation of community health centres, after theadoption of revolving drug funds, was noted to have increased in seven countries,and to have decreased in four.

Equity and affordabilityStudies of health care use following the charging of fees show that the poor are morelikely than other segments of the population to treat price increases as deterrents toaccessing services.

Of 25 Sub-Saharan countries with cost recovery programmes, it appears that onlyone (Zimbabwe) had an official policy specifying national income ceiling criteriawhich would allow exemptions for the poor. Fourteen other countries indicatedthat exemptions for the indigent are permitted but did not provide criteria. Theremaining 10 countries relied primarily on local and ad hoc measures for providingexemptions.

Exemptions based on income are difficult to formulate and implement where formalemployment is limited. In some countries, the fairness of certain exemption policiesremains questionable. Therefore, equity remains a critical issue. Easy-to-use, reliablemethods for determining exemptions in mechanisms charging user-fees are notreadily available.

Box 2

Mechanisms for promotinggeneric drug use

Supportive legislationand regulation• abbreviated registration procedures

(focus on drug quality)• product development and

authorisation during patent process• provisions which permit, encourage,

or require generic prescription andsubstitution

• requirement that labels and druginformation contain generic names

Reliable quality assurancecapacity• development of substitution, non

substitution lists• procedures to demonstrate

bioequivalence• national quality assurance capability• national drug manufacturer and drug

outlet inspection capability

Professional andpublic acceptance• involvement of professional

associations in policy development• phased implementation, beginning

with permission to substitute

• required use of generic names in alleducation and training of healthprofessionals

• brand-generic and generic-brandname indexes available to healthprofessionals

• required use of generic names inclinical manuals, drug bulletins, andother publications

• widespread promotional campaignstargeting consumers andprofessionals

Economic incentives• public and professional price

information• reference pricing for reimbursement

programmes• retail price controls that favour

generic dispensing• support by social and private health

insurance organizations• incentives for generic drug industry• trade-offs with industry (reduced

price regulation, increased patentprotection)

Action Programme on Essential Drugs, WorldHealth Organization, 1211 Geneva 27,Switzerland.

References

1. WHO/DAP. Health reform and drug financing: selectedtopics. Health Economics and Drugs Series No.6.Geneva: World Health Organization; 1998. WHO/DAP/98.3.

2. WHO/DAP. Guidelines for drug donations. Geneva:World Health Organization; 1996. WHO/DAP/96.2.

Table 1

Public health and drug expendituresfor selected countries

Total public health Total public drugexpenditures expenditures

as % GNP per capita as % health per capita(US$) budget (US$)

Bulgaria 3.8% 44.76 18.4% 8.24Chad 0.6% 1.06 4.5% 0.05Colombia 1.6% 20.03 18.0% 3.61Guinea 0.4% 1.73 15.8% 0.27India (Andhra Pradesh) 3.2% 1.93 6.8% 0.13Mali 0.4% 0.74 18.8% 0.14Philippines 0.5% 4.53 13.3% 0.60Sri Lanka 1.5% 8.58 15.6% 1.34Thailand 2.0% 33.65 5.6% 1.89Viet Nam 1.1% 2.32 20.0% 0.46Zimbabwe 2.8% 12.43 36.1% 4.49

Sources: Shaw PR, Ainsworth M. Financing health services through user fees and insurance. World Bankdiscussion paper No. 294, 1996.WHO/SHS. Experience with organizational and financing reform in the health sector. Geneva: WorldHealth Organization; 1995. WHO/SHS/CC/94.3.

Source: WHO/DAP. Public–private roles in the pharmaceutical sector. Geneva: World HealthOrganization; 1997. Data are from the most recent year available, generally in the early 1990s. Figuresfrom Chad, Colombia, Sri Lanka and Viet Nam are still considered preliminary.

◆ ◆ ◆

Source: WHO/DAP. Public-private roles in the pharmaceutical sector. Geneva: World Health Organiza-tion; 1997. WHO/DAP97.12.


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The top-up systemWith the top-up system total responsibility for supply is given to the supplier. It is akind of imprest system that has proved effective for drug distribution within hospitals.As with other imprest systems, the maximum (imprest) level of stocks is agreed withthe ward/department in charge.

The content of the list of stocks to be held is based on the regularly used drugs, andthe final list is an agreement between the “user” and the pharmacy (store). The stocklevel of each drug is based on the known average use of the drug and the intervalbetween stock replacements.

In the top-up system it is the pharmacy staff who visit the ward/department on agreeddays and note how much of each drug is needed to make the stock up to the imprestlevel. The pharmacy staff then deliver the noted items to the ward/department.

In this system there is no need for ward or department staff to order, the stock is auto-matically renewed by the pharmacy. The system depends on good communicationand trust between user and supplier.

Pharmacy technician, Margaret Fianko-Sakyi (right), discussing apoint with Nurse Stella Opoku during one of the weekly meetingsat the Bank of Ghana Clinic. These meetings are vital to thesuccess of the Clinic’s drug management system

Sample weekly replenishment form

Item Maximum Stock Top-up Expirydescription allowed level quantity date

quantity as at:

Sign 1 DateSign 2

Remarks:

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How “topping-up”improved drug managementat a small clinic in Ghana

DANIEL SEKYERE MARFO*

HE adoption of the top-up systemof drug supply has led to animprovement in drug supplymanagement at the Bank of

Ghana Clinic in Accra. As a result a smallproject that started with injectables hasnow been extended to other items withequal success.

The Bank of Ghana Clinic is a fairlysmall quasi-Government outpatient healthfacility. It was established in June 1988,mainly to provide quality health care (interms of economy, efficiency, effective-ness and equity) for the Bank’s staff andtheir dependants. It is also open to a smallgroup of non entitled but authorisedpaying patients – mostly expatriates andtourists. The clinic’s professional staff ismade up of two doctors, one pharmacist,three pharmacy technicians, 10 nurses,one medical laboratory technologist, threemedical laboratory technicians and apart-time physiotherapist.

The clinic is organized on a “func-tional unit” basis with medical consulting,nursing, pharmacy, medical laboratoryand support units. It is funded entirely byannual budgetary allocations from theBank of Ghana. Treatment, includingdrugs, is free for all members of staff andtheir dependants. Patients receive drugsof proven efficacy, purchased from reli-able sources. They are counselled againstabuse and misuse, and possible or ex-pected adverse effects of drug therapy.They are also encouraged to complete thefull course of treatment, to follow instruc-tions correctly and to refrain from sharingdrugs with colleagues, relations orfriends. Additional written instructionsand labels are provided to ensure adher-ence to treatment, successful outcome andpatient safety. The pharmacy unit, whichdispenses about 17,000 prescriptions perannum, is also responsible for managingmedical stocks at the health facility, in-cluding selection, sourcing, procurement,storage and distribution through thesystem.

With the exception of injectables,all other dosage forms are supplied topatients directly on prescription from thepharmacy, as described earlier. Injectablesare first supplied to the injection room,where they are managed by the nursingstaff.

PROBLEMS OFRATIONAL SUPPLY AND USE

The rational use of drugs is a pre-requisite for good health delivery. Theimpact of drug use on the health of apopulation does not only depend on avail-ability, affordability or accessibility, buteven more importantly on the rationaluse of drugs at clinic level. This is

particularly true in situations of relativeplenty, in other words where pharmaceu-ticals are generally available, affordable(at no cost at all to users) and accessible.Sometimes health workers in such situa-tions are overwhelmed by the variety andquantity of drugs available, and theresult is excessive and unnecessaryexpenditure on drug supply.

IMPLEMENTING A TOP-UPSYSTEM OF INJECTABLES

Essentially a top-up system is basedon real need and involves the replenish-ment of running stock with quantitiesequal to those used (see Box). Meetingsare held between the pharmacy unit andthe nursing unit to discuss the issuesinvolved in the supply of injectables.

➤ Initially a survey was carried out todetermine the actual weekly consump-tion pattern of all injectable itemssupplied to the nursing unit. Record-ings in the nursing books wereextracted and analysed, with a safetymargin of 10%.

➤ This information was used to agree onmaximum weekly stockholdings.Review meetings were also planned.

➤ New weekly injection supply formswere designed to provide data onquantity used, top-up quantity andexpiry dates.

➤ Since September 1996, at the begin-ning of each working week, thedifference between the current stockand the maximum agreed stocks hasbeen provided as replenishment. Thenursing staff fill in the current stocklevels and send the forms to the phar-macy. A pharmacy technician sendsthe week’s supply to the injectionroom where he or she assists in up-dating records of stock levels andexpiry dates.

MEASURING SUCCESS

A comparative study of the value ofstock requests before and after the insti-tution of the top-up system (changed inSeptember 1996) was carried out. The 13most commonly used drugs were selectedfor study. Stock requests for the 13 drugsover a period of four months before andafter September 1996 were recorded andanalysed. The results indicated a generaltrend of over-stocking before the top-upsystem was introduced illustrated by anaverage 46.8% reduction in nursing re-quests after it began. The other obviousadvantage is a notable reduction in inven-tory value. The success of the initial trialled to the extension of the new system tothe supply of dressings and other sundries,followed by drug procurement. Currently

procurement is largely ona replenishment basis.

Over-stocking is pre-valent in most governmentfunded medical stores. Itis our belief that a maincause lies in structuresand procedures; the suc-cess achieved with thetop-up system has sub-stantiated our conviction.However, the outcome ofthe trial could have beendifferent if the pharmacyunit had decided to “goit alone” in the effort tochange the old style ofsupplying injections tothe nursing unit. The in-volvement of the nursingunit, as the major in-house customers ofpharmacy services, was crucial. The top-up system of drug supply has proved tobe very useful if well managed. The phar-macy can have better control over runningstock. Drug needs’ estimation can be moreaccurate and thus funds and needs can bebetter matched for greater efficiency.

Drug budgets and therefore real expendi-ture can be reduced by the adoption ofthe top-up system of drug supply on aneven wider scale. ❏

* Daniel Sekyere Marfo is Chief Pharma-cist, Bank of Ghana Clinic, Accra, Ghana.

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Good drugs at low cost:Thailand’s provincial collectivebargaining system for drug procurement

MONGKOL NA SONGKHLA, SUWIT WIBULPOLPRASERT,PHUSIT PRAKONGSAI*

RUG expenditure constitutes approximately 35% of total healthexpenses in Thailand. Attempts to procure good quality drugs ata lower price are therefore important to improve health serviceefficiency, particularly in the current economic crisis. This article

describes one such attempt at increasing bargaining power throughcollective provincial bargaining by all district hospitals in one province.The system not only brings down drug prices but also improves thequality of drugs, the efficiency of the drug management system and thestrength of the referral system. In 1994 the Ministry of Public Healthfinally took up the model, and applied it to all 75 provinces. Successwas limited to only three provinces during the first three years (1995–1997). However, after the economic crisis, with the reduced drug budgetand increase in drug prices, the mechanism was implemented morevigorously and successfully on a wider scale. Currently 67 (out of 75)provinces implement the system and they have achieved a 25%reduction in drug expenditure.

hospitals and health centres, under thePublic Health Ministry in each province,report to the Provincial Chief MedicalOfficer.

Drug expenditure in 1993 was US$34per capita (retail value) and constitutedroughly 35% of total health expenditure2.Drugs are distributed through all publicand private facilities, including more than10,000 private pharmacies.

Services in public facilities are not freeof charge. Unless patients are covered bysome kind of insurance, they have to paya subsidised level of user fees. The pub-lic hospitals thus receive financial supportthrough government budget (tax rev-enues), insurance premiums and user fees.Each hospital is authorised to use thesefunds to purchase drugs. According togovernment regulations, public hospitalshave to purchase 60%–80% of their drugbudget based on items in the essentialdrugs list.

Drugs are produced locally by 176private factories and a few publicenterprises, the biggest one being theGovernment Pharmaceutical Organi-zation. Locally produced drugs havea 50%–60% market share. There arealso 460 drug importers. Most publichospitals purchase drugs from both theGovernment Pharmaceutical Organiza-tion and private companies. Only thoseprivate drug factories with GoodManufacturing Practice (GMP) Certifi-cates from the Thai Food and DrugAdministration are allowed to sell drugsto public hospitals.

The prices of drugs from the Govern-ment Pharmaceutical Organization arefixed, and quality control is carried out

Thailand is a lower middle incomecountry in South-East Asia with a popu-lation of 60 million in 1997. It consistsof 75 provinces, 774 districts, 81 sub-districts, 7,255 Tambons (communes) and66,974 villages. The health care deliverysystem is composed of both public andprivate facilities. The public facilitieshave a 75% share of resources while pri-vate facilities have 25%. Approximately80% of all public health resources arelocated within the Ministry of PublicHealth, with its extensive network of pro-vincial general hospitals, district hospitalsand commune health centres. In 1997there were 89 general hospitals, 703 dis-trict hospitals and 9,132 commune healthcentres1. Administratively all public

by the Organization itself. On the otherhand, prices of drugs from private com-panies depend on direct bargainingwithout a good quality control system onthe buyer’s side.

Thus drugs are purchased, based ondifferent hospital drug lists, at varyingprices and quality levels in different hos-pitals. Bigger provincial hospitals usuallyhave more bargaining power and moreaccess to better quality drugs. Under thissystem, different drugs are used by dif-ferent health facilities in the sameprovinces.

THE PROVINCIALBARGAINING SYSTEM

In 1990, in order to solve the problemsof inefficient drug procurement – highprices and questionable quality– acollective provincial bargaining systemwas developed in one of the biggest prov-inces in Thailand, Nakorn Ratchasima.The system aims at procuring good qual-ity drugs at lower prices, and ensuring anadequate supply of the same essentialdrugs to all district hospitals and healthcentres. The rationale of the system issummarised in Figure 1. This systemconsists of six sub-systems3:

1. Establishment of a commonhospital drug list

Representatives of doctors andpharmacists in all 23 district hospitalscollectively developed the commondrug list of Nakorn Ratchasimadistrict hospitals, under the ProvincialPharmaceutical and Therapeutic Com-mittee. Since the first list was drawn up

in 1990 it has been reviewed annually, andin 1997 contained 356 drugs. This is theessential initial step to reduce unneces-sary drug items and establish a commonlist for collective bargaining. Thiscommon drug list is also used in theprocurement of drugs for the communehealth centres.

2. Drug procurement systemA drug procurement committee,

comprising pharmacists from all districthospitals, invited private drug companiesto join the provincial bargaining system.A short-list of companies was preparedthrough an extensive survey of drug fac-tories by the committee members, relyingon their previous experiences as a furtherdeterminant. In 1994, 78 companies (45local, 27 imported) declared their inten-tion to join the system. However, only 39(50% – 25 local, 14 imported) of thesewere short-listed.

Each hospital prepares an annualdrug requirement plan according to itspast utilisation experience. The plans areaggregated into the provincial plan, andthe short-listed companies are requestedto submit offers. The companies with thelowest price for each item are selected toprovide drugs to the system. The pricesoffered stand for a year.

Each hospital then places orders dur-ing the year, according to need, directlywith the winning drug companies. Afterreceiving the orders, the companies sendtheir drugs and the bills directly to thehospitals. There is no central provincialstock, no need for provincial financial

Figure 1Rationale of the provincial bargaining system


Commondrug list with

purchasing plan

Collectivebargaining

Centralisedcold chain

GMP factoriesFactory visits

Post delivery Q.C.

Districtdrug management

system

Different drugs indifferent hospitalsand health centres

Inefficient, costly,and maybe harmfuldistrict health services

Inefficientreferral system andno continuity of care

Different hospitaldrug list

No districtdrug management

Individualbargaining

Many inessentialdrugs

Continuity ofsupply

Dead stock/overstock

Drugexpenditure

No purchasingQ.C.

Ineffectivecold chain

Supplyproblems

High commission

Low bargainingpower

Quality

Price

New collective bargaining Previous system of individual purchasing

A young Thai woman being examined at aprimary health care centre

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management and no provincialbureaucratic steps to follow.

Through increasing bargaining power,this collective bargaining system hasresulted in 12%–20% reduction in drugprices. For example, in 1989, before thesystem was implemented, ampicillininjection (1 gm.) was purchased at a priceof between 13–26 Baht/vial. In 1994, af-ter establishing the new system, the pricewas 11.75 Baht/vial (less expensive evenafter five years of inflation), due to thepower of collective bargaining. In 1991,19.5 million Baht of drugs were pur-chased, saving 5.3 million Baht. In 1993,20.4 million Baht of drugs were pur-chased, with a saving of 2.8 million Baht.

3. Drug quality control systemThe quality of drugs purchased

was controlled through the process ofshort-listing the companies and postprocurement sampling for quality testing.

Only drug factories with GMPCertificates from the Food and DrugAdministration were short-listed. Drugsfrom factories with GMP Certificates arethree times less substandard than thosefrom factories without GMP (8% as com-pared to 25%)2. In 1998, 127 of the 175private drug factories (72.1%) receivedGMP Certificates. Short-listed factorieswere then visited by representatives ofpharmacists from the district hospitals.During visits to the factories the qualityof raw materials, the manufacturing proc-esses, the drug quality control processes,and the external quality control systemwere thoroughly checked. Only approvedfactories were allowed to join thecollective bargaining system.

After the drugs were received at thedistrict hospitals, samples were system-atically collected according to thesampling plans, and sent to the RegionalMedical Science Centre for analysis. Thesampling plans usually focus on anti-biotics, commonly used drugs, drugs forspecific diseases and life saving drugs.

With this system, the proportion ofsubstandard drugs was reduced from30% before, to under 15% after imple-mentation of the system (see Table 1).

4. Low temperature drugmanagement system

Supplying low temperature drugs torural health facilities requires a good coldchain system. Private drug companiesusually hesitate to send low temperaturedrugs to individual district hospitals be-cause of the difficulty with the cold chainsystem. Thus the provincial health office

Table 1Quality of drugs before and after implementation of the systemin 1990.

Year Samples Number of Percentanalysed substandard drugs substandard

1988 207 62 29.951990 32 4 12.501991 65 2 3.081992 66 2 3.031993 46 2 4.341994 70 5 7.141995 143 17 11.881996 31 3 9.681997 57 8 14.04

Source: Provincial Health Office, Nakorn Ratchasima Province.

was designated by the committee toprocure and stock these drugs to supplyto all district hospitals. This sub-systemnot only reduces the drug price and im-proves quality, but also guarantees theavailability of good quality low tempera-ture drugs. In 1991, 22 such drugs wereincluded in the sub-system.

5. Drug supply system tocommune health centres

There are 287 commune health cen-tres in the Province. Previously theirdrugs were supplied through the Provin-cial Health Office. There were problemsof expired stock, overstock and shortagesof some drugs due to unresponsivenessof the Provincial Health Office to meetthe demand of various health centres.

Under this new system, the districthospitals maintain the district stock ofdrugs to be supplied to the lower levelcommune health centres according totheir demand and allocated budget. Thissystem gives more flexibility and reducesunnecessary expired stock. Most impor-tant of all it allows the same type of drugsto be used in the district health systems,which strengthens the referral system inthe districts.

6. Monitoring the districts’drug management system

The ordering and sampling of drugsby district hospitals is monitored closelyby the Provincial Health Office’spharmacists.

The district level drug managementsystem is monitored through indicatorscovering the development and implemen-tation of the drug management plan,continuous supply of drugs, drug utilisa-tion, overstock and the expired stock.Forty-one specific indicators in 10 sub-groups under three main groups weredeveloped. The scores of all 41 indica-tors amounted to 200. The districts wereclassified by grades A to F according totheir level of management achievement.There was much improvement after theimplementation of the system (see Table2). Satisfaction levels of the district hos-pitals and commune health centres werealso surveyed and it was found that thesystem was highly accepted.

FACTORS BEHINDTHE SUCCESS

Several factors contributed to thesuccess of this system:

Strong leadershipDrug procurement often involves

many vested interests and much

Table 2

Improvement in the district drug management system

% of the districts in each level of drug management *

Year A B C D F

1992 28.29 27.51 27.90 12.40 3.871993 59.77 23.31 11.28 3.01 2.631994 58.33 24.24 12.88 3.03 1.521995 86.06 9.84 3.28 0.00 0.821996 85.14 9.90 2.97 1.48 0.501997 80.79 15.25 2.26 1.12 0.56

* Scoring for each level of drug management:A = 181–200 B = 161–180 C = 141–160 D = 121–140 F = < 120

Source: Provincial Health Office, Nakorn Ratchasima Province.

inefficiency. In many cases 20%–30%commission is requested or paid to thehospital authority. Thus some hospitalsdid not want to participate in the system,and some were hesitant. Strong leader-ship both from the Provincial ChiefMedical Officer and peer influenceamong district hospital directors was es-sential to the initiation and the successof the preliminary phase of development.

In the case of Nakorn Ratchasima, theProvincial Chief Medical Officer, whoinitiated this system in 1990, used hisstrong leadership and perseverance toovercome the vested interests. He wasstrongly supported by a few leading dis-trict hospital directors and pharmacistswho dedicated their time and wisdom to

together with information on corruptionin drug procurement, also prompted theAnticorruption Committee of the PrimeMinister’s Office to demand the Minis-try of Public Health to implement thesystem on a nationwide basis.

THE WAY FORWARD:OPPORTUNITIES FOR CHANGE

The success in Nakorn RatchasimaProvince prompted others to follow. In1992 Ayuthaya Province started the sys-tem, to cover not only the district hospitalsand health centres but also the main pro-vincial hospital. The number of drugs forcommon bargaining increased from five

design, develop and managethis system.

Sound justificationThe system was able to

show the expected outcomes– better quality drugs atlower prices, a better drugmanagement system, andbetter support to the districtreferral systems. Only suchevidence can satisfy allpartners and guaranteecontinuity of the system.

PartnershipActive involvement of all

district hospitals created anenvironment to support ac-countability, transparency and acceptanceof the system, without increasing anybureaucratic steps or any vested interests,at the provincial level. This, backed bystrong leadership and sound justification,was essential to the sustainability ofthe system. The system in NakornRatchasima Province has been on-goingup to present (eight years) despite thechange of four Provincial Chief MedicalOfficers.

Publicity and strong civil societyPublicising the results created public

awareness, strengthened civic movementsand supported the sustainability of thesystem. It was also a strong advocacy toolto get policy support for wider implemen-tation. The Thailand Health ResearchInstitute evaluated the system in 19934.Its report was widely publicised and fi-nally, in 1994, discussed in the NationalDrug Committee chaired by the Ministerof Public Health. The Minister thenbrought the issue into further discussionin the ministerial committee, and a Min-istry policy was developed. The report,

in 1992 to 23 in 1995. They were able tosave from 0.33 million Baht in 1992 to4.7 million Baht in 1995. Other provinces,such as Burirum, Surin and Lumpoon,started to follow.

In November 1994, three years afterthe system was launched and the successstory was publicised, the Ministry of Pub-lic Health put forward a policy to establishsuch a system in all provinces. However,during an era of high economic growthwith a high drug budget (1995–1997), theresponse was rather weak. Evaluation ofthe implementation in 1996, by the Na-tional Health Foundation, found that onlythree provinces implemented the systemas intensively as Nakorn Ratchasima.Another 30 provinces did it weakly tomoderately and the rest did not implementit at all5.

The current severe economic crisis,which began in July 1997, is a good op-portunity for further development. Thesystem was promptly included in a com-prehensive “Good Health at Low Cost”policy package. Inspector Generals of the

A pharmacy in Thailand, where collective bargaining ishelping to keep Government drug expenditure down


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Drug supply choices:what works best?

mechanisms be used to improve publicsector efficiency and, thereby, improveaccess to essential drugs through govern-ment health services? It is important toremember that one element which stimu-lates efficiency in the private sector is theexistence of competition.

Various strategies have been tried inorder to provide access to pharma-ceuticals and, in particular, to essential

ised, non CMS approach in whichdrugs are delivered directly bysuppliers to districts and majorfacilities. The government drug pro-curement office tenders to establishthe supplier and price for each item,but the government does not storeand distribute drugs from a centrallocation;

➤ Primary distributor system: another

Stores (CMS) approach, in which drugsare financed, procured and distributed bythe government, which is the owner,funder and manager of the entire supplysystem. Selection, procurement anddistribution are all handled by the centralgovernment, often by a unit within theministry of health. Financing is usuallyfrom central treasury allocations and/ordonors, though a CMS can function as arevolving drug fund.

This is a demanding approach in termsof human resources, physical infra-structure, management systems andcommunication systems, requiring thestate to manage and fund every aspect ofthe system. It has been a logical approachin situations where the vast majority ofitems were imported through onechannel; the demand was predictable;finance and administration were highlycentralised; and a developed and profes-sional private sector did not exist.Traditional CMS structures continue tobe used in a number of countries includ-ing Ghana, Oman and Zimbabwe.However the distribution and financingmechanisms in use vary.

Using the traditional CMS system theavailability of drugs in the public sectorhas deteriorated in many (but not all)countries as the nature of medicalpractice has changed and real financialresources have diminished. At the sametime the demand for, and cost of, healthservice provision has increased.

The causes are many. The drug sup-ply environment has changed drasticallyfrom a range of chemicals and galenicalsto a multiplicity of manufactured finishedproducts. CMSs have experiencedproblems with financial management,quantification of requirements, manage-ment of tenders, warehouse management,transport and security of drugs. Theseproblems have also been exacerbated bypolitical or administrative influences and


Effective supply of essential drugs includes rational selection,quality assurance, good procurement and storage practices,and timely distribution

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Ministry of Public Health have been sentinto each province to ensure its intensiveimplementation. Nine months later, thesituation has improved with 67 provincesnow actively implementing the system,although in other provinces the old sys-tem of individual purchasing prevails orimplementation of the new system is stillweak. The impact has been clear in the67 provinces where collective bargainingis used: drug costs were lowered by24.7%, from 622.05 million Baht (ifpurchased under the regular individualpurchasing system) to 468.03 million

Baht, a very significant saving6. Never-theless, this 622.05 million Baht accountsfor only about 10% of the Ministry ofPublic Health’s drug budget. Most of thedrug budget is still spent on individualpurchasing and procurement throughGPO.

With the economic crisis, politicalreform, public sector reform, strongercivil society and decentralisation, atransparent and efficient public manage-ment system is essential. This will enablethe provincial bargaining system todig deeper roots and gain widerimplementation in the near future. ❏

* Dr Mongkol Na Songkhla is SecretaryGeneral, Food and Drug Administration,Thailand, Dr Suwit Wibulpolprasert is Assist-ant Permanent Secretary, Ministry of PublicHealth, Thailand and Dr Phusit Prakongsaiis Director, Kao Sukim Hospital, Chuntaburi,Thailand.

Update: In December 1998 the Ministry ofPublic Health announced a policy aiming touse the collective bargaining system for 50%of its hospital drug expenses. This wouldmean that at least 5,000 million Baht worthof drugs would be purchased under the sys-tem, a possible saving of 1,250 million Baht.Improved drug quality would also be en-sured, thus achieving greater efficiency andquality in the midst of economic crisis.

References1. Bureau of Health Policy and Planning, MoPH. Health in

Thailand 1995–1996. Bangkok: The Veteran Press; 1997;p 110, 124.

2. Wibulpolprasert S. (ed.). Thai drug system: a situationanalysis for further development. Bangkok: Desire Co.Ltd., 1995; p 21, 29.

3. Prakongsai P. Summary of provincial bargaining systemfor drug procurement in Nakorn Ratchasima Province1990–1994; 1996 (mimeograph in Thai).

4. Tangcharernsathien V. Evaluation of the provincialbargaining system for drug procurement in NakornRatchasima Province. Bangkok: Thailand HealthResearch Institute; 1994 (mimeograph in Thai).

5. Thailand Health Research Institute. Evaluation of thepolicy for provincial bargaining drug procurement sys-tem of the MoPH, 1995–1996. Bangkok: Thailand HealthResearch Institute; 1998 (mimeograph in Thai).

6. Rural Hospital Division, MoPH. Progress report on thedrug management under the Good Health at Low CostPolicy Package. Report to the Permanent Secretary.


drugs. At least five alternatives exist forsupplying drugs to governmental andnongovernmental health services.

ALTERNATIVE SYSTEMSOF DRUG SUPPLY

➤ Central medical stores (CMS):conventional drug supply system, inwhich drugs are procured and distrib-uted by a centralised government unit;

➤ Autonomous supply agency: acentralised supply system in whichthe management responsibility isdevolved to an autonomous orsemi-autonomous Board;

➤ Direct delivery system: a decentral-

non CMS system, inwhich the governmentdrug procurement officeestablishes a contractwith a single primarydistributor , as well asseparate contracts withdrug suppliers. Theprimary distributor iscontracted to managedrug distribution byreceiving from thesuppliers, storing, anddistributing all drugsto districts and majorfacilities;

➤ Fully private supply:in some countries,drugs are provided byprivate pharmacies inor near government

health facilities.

It is possible to identify some advan-tages and disadvantages for each of theabove systems and to make some theo-retical comparisons, but true comparisonsof cost-effectiveness have not been made.In part this is because other issues havemade such comparisons very complex.The introduction of policies on usercharges, decentralisation, contracting-outand privatisation all have an impact onthe drug supply system.

The Central MedicalStores system

The historical approach to publicsector drug supply is the Central Medical

Thailand... cont’d from pg. 6

PERSPECTIVES on the role ofgovernment in health vary froma social welfare approach (thestate should provide all health and

other social services except where it isunable to do so) to a self-help or marketeconomy approach (the private marketshould provide most health services). Inthe past many governments (in both de-veloping and developed countries) havesubscribed to the social welfare approach,particularly when health technology waslimited in scope and cost and was there-fore affordable. Increasing complexityand technology has taken the cost ofhealth care provision beyond the reach ofmost developing country governments,and there is a growing emphasis on theresponsibility of the individual to providefor their own health care.

In fulfilling the goals of a nationaldrug policy government has a central rolein ensuring that drugs distributed throughthe public and private sectors are of ac-ceptable quality, safe and effective. Alsogovernment has a responsibility to pro-mote the rational use of drugs. In addition,it is necessary to actively promote drugavailability (geographic access) andaffordability (economic access) if a largeshare of low income and remotepopulations depend on private sector drugsupply.

Among the decisions which govern-ments have to face in the pharmaceuticalsector the most complex and the mostcostly often concern the financing andsupply of drugs for government healthservices. In some countries public sectordrug supply is well financed and admin-istratively efficient. In other countries thedrug supply system is unreliable andshortages are common. Such systemssuffer from inadequate funding, outdatedprocedures, inefficiency or a mixture ofthese and other problems.

In a situation of diminishing resourcesone response is to maximise them byincreasing efficiency. Can private sector


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weak staff discipline proce-dures in an atmosphere ofdiminishing incentives. Wherepublic financing is adequatethen the public sector CMSsystem can be effective in pro-viding a supply of drugs as hasbeen demonstrated in the pastin many countries and is stillseen in some.

The inability of the CMSsystem to achieve its purposesin the current economic andcommercial climate in manycountries indicates a need toconsider alternative mecha-nisms for the procurement anddistribution of drugs.

Autonomous supplyagency system

The problems which havebeen experienced with CMSsystems have led some govern-

in the context of a public sector revolv-ing drug fund, where fees are used topurchase drugs on a cash-and-carrybasis as in Benin, or in a system wheregovernment institutions purchase drugswith centrally allocated treasury fundsas in Uganda, or where budgets arestill centrally controlled as in Tanzania.Whatever the financing mechanism, au-tonomous agencies can only function ifthere is a market for their products and ifthe client(s) has funds to purchase theproducts.

Autonomous agencies are likely toimprove drug supply only if structured toovercome the constraints of the CMSapproach. Experience to date, thoughlimited, suggests that features whichshould be sought in establishingautonomous supply agencies, include:

◆ supervision by an independent

are political appointees rather thanprofessional managers appointed byan independent management board.Similarly if the government retains theauthority to require distribution of drugswithout charge or on a credit basis (with-out ensuring payment). Again, if specialinterests outside the agency influencedrug procurement, or if the agency isrequired to retain staff members regard-less of their ability or performance, thesefactors will be counter-productive.

Countries considering an autonomoussupply agency should recognise that thisapproach will not solve problems relatedto lack of funding for drugs.

Direct delivery systemIn general, CMS and autonomous sup-

ply services involve bulk procurementinto, and distribution from, a central ware-house. The costs and logistical problemsassociated with central storage and dis-tribution are substantial. An alternative isthe direct delivery system.

In this non CMS model, a governmentprocurement office tenders to establishprices and suppliers for each essentialdrug, but drugs are then delivered directlyby the suppliers to individual regionalstores, district stores or major healthfacilities. Variations of direct deliverycontracts have been implemented in manycountries, including Chile, Colombia, theEastern Caribbean, Indonesia, Mexico,South Africa, Thailand, UK and Peru. InIndonesia annual allocations for drugsare made on a per capita basis to eachdistrict. Using their budget and theMinistry’s current price list for essentialdrugs, each district determines its owndrug order.

Contracts for direct delivery mayspecify fixed quantities with scheduleddeliveries (generally the approach in In-donesia) or estimated quantity tenderswith orders placed by the local store orhealth facilities as needed. Financing ar-rangements can be a sensitive issue. Debtscan quickly accumulate if drug suppliesare not balanced against available funds.This means maintaining separate ac-counts for each supply point (if funding

is from central allocations)or ensuring that all suppliesare paid for at the time ofdelivery.

Like most procurementsystems, direct delivery con-tracts require a sole-sourcecommitment, that is, for thetender drugs the local ware-houses and facilities will orderfrom the supplier who holdsthe tender contract. The localpurchasers are free to orderdrugs that were not on thetender from any supplier.

Direct delivery supplyagreements depend on and en-courage further developmentof an effective private sectordistribution system. In princi-ple, they reduce storage andtransport requirements andrisks for the government byspecifying in the procurementcontracts that drugs are to bedelivered directly to districtstores and major health facili-ties. The government then has

ments to establish systems which placethe responsibility for bulk procurement,quality assurance, storage, distributionand financial management in the handsof an autonomous or semi-autonomoussupply agency. This model has been triedin several countries, particularly in Africaand Latin America.

Autonomous supply agencies are of-ten constituted as parastatals, either underthe ministry of health or as independentorganizations, with a board of directorsincluding representation from other (thanhealth) government ministries. Their pri-mary and priority client is governmenthealth services and they may or may notoperate on a non profit basis. Examplesof such supply agencies have been func-tioning in Benin, Haiti, Sudan, Tanzania,Uganda and Zambia.

A commonly seen Ministry of Healthorganigram is as follows:

only to store drugs at the regional or dis-trict level and deliver them to healthcentres and peripheral health units.

Direct delivery contracts preserve thebenefits of centralised selection (theessential drugs list), bulk procurement(suppliers offer favourable prices to getall the business for the products they areawarded), and centralised quality control(only reputable suppliers are invited totender). Hospitals and/or districts benefitfrom being able to manage their ownfunds and determine the exact quantitiesneeded. Also, the problems of security,central storage and transport are shiftedfrom the ministry to the privatesuppliers.

With a direct delivery system,however, district level and facility leveldrug management responsibilities aremuch greater, since the quantities andquality of drug deliveries must be con-firmed. Success will depend on the abilityand willingness of staff to manage theincreased responsibilities. Finally, directdelivery in itself cannot solve problemsof inadequate financing.

Primary distributor systemThe primary distributor system is a

variation of direct delivery in which thepublic procurement agency tenders andestablishes two types of contracts. Thepublic procurement agency contracts withany number of suppliers to establish thesource and price for each drug. But thedrugs are not delivered by the suppliersdirectly to health facilities; instead, aseparate contract is negotiated (throughtender if feasible) with a single privatesector distributor, the primary distributor.Two provinces in South Africa use theprimary distributor system for delivery ofdrugs and medical supplies to hospitals(see p.10). Contracts for the procurementof drugs are negotiated nationally usingcompetitive tenders.

The suppliers deliver tender drugs tothe primary distributor, who is responsi-ble for maintaining sufficient stocks to fillorders from regional warehouses, districtstores and/or health facilities. Primary dis-tributors may maintain their own vehicle

management board;

◆ professional pharmaceuticalsupply managers;

◆ good personnel manage-ment;

◆ adequate financing;

◆ public accountability andsound financial management;

◆ focus on essential drugs (rather than“profitable” alternatives);

◆ focus on quality assurance, both interms of products and of servicesprovided.

The intention is that an autonomoussupply agency will achieve greater valuefor money and improved drug availabil-ity through more efficient management.Three important characteristics that areneeded to promote efficiency are flexibil-ity, incentive and competition. Theexistence of competition will encourageefficiency, but in the majority of situa-tions the monopoly of the CMS continuesto apply to the autonomous agency, withno pressure to improve the quality ofservices and products or aim for thelowest prices.

A whole series of difficulties mayoccur, for example, if senior managers

where the board is autonomous inrunning the agency but reports to the min-ister of health, who may be involved inthe appointment of the chairman of theboard and/or the executive officer.

The goals of establishing an auto-nomous supply agency are to achieve theefficiency and flexibility associated withprivate management and private sectoremployment conditions. At the same timesufficient public sector supervision ismaintained to ensure that the servicesprovide a range of essential drugs, atreasonable prices, with adequate controlof quality.

The basic concept is that, under theright conditions, a well-constitutedmanagement board or board of directorswill have the freedom to appoint quali-fied senior managers, who will in turnensure an efficient, accountable supplyagency.

Supply agencies may be established

Drug supply choices...cont’d from pg. 7

Graphic: Zimbabwe Essential Drugs Action Programme

Director ofMedical Services

“Medical Stores”Board of Directors

Ministry of Health

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fleet or subcontract transportation.Like other direct delivery contracts,

this system depends on sole-sourcecommitment for the essential drugs list,though districts and health facilities maybe allowed to purchase non-tender drugsfrom any source. The system also requiresthe same level of good information andmonitoring.

The primary distributor is paid a feeor commission for storage and deliveryservices. The primary distributor mayappear to add an extra middleman andextra costs, but the expectation is that thecost of the primary distributor will be lessthan the cost to the government of run-ning the warehouse and distributionsystem itself. Competitive bidding for theprimary distributor contract is importantto achieve this efficiency.

Fully private supply systemFinally, national policy, insufficient

financing or management problems haveled some countries to avoid responsibil-ity for providing hospitals and health

equipment maintenance, laundry and foodservices. Contracting out services is com-mon within the private sector. Oftencompanies find that outside contractorswho specialise in specific services suchas managing staff cafeterias or repairingcomputers can provide those services atlower cost and higher quality thanproviding the service in house. Thephilosophy prevails in industrialisedeconomies that if you can find someoneelse to do a specific task then pay them todo it rather than committing the capitalresources to do it yourself; for example,distribution is usually contracted out bylarge supermarket firms.

Primary distributor systems, transportcontracts, port-clearing services andrelated approaches to private sectorinvolvement require contracting forservices in contrast to contracting forproducts (drugs, for example). Howeverto contract out activities requires the skillsof writing, negotiating and monitoringcontracts. Contracting functions mosteffectively where there is competition aswith any tendering process. Contracting-out also demands a commitment to paythe contractors according to the terms ofthe contract.

Privatisation in health is properly de-fined as transfer of ownership from thepublic to the private sector. But the termis also applied, less precisely, to contract-ing government services to the privatesector (as with direct delivery contracts)or introducing private sector features intothe public sector (as with governmentowned but semi autonomous supplyagencies). The full privatisation ofdrug supply would have implicationsfor equitable access to drugs in an

access for the poor, children, patientswith communicable diseases and othervulnerable groups.

IMPLICATIONS OF DECEN-TRALIZATION, CONTRACTING

OUT AND PRIVATISATION

These health reform strategies areamong many being tried in developed anddeveloping countries to improve theefficiency and outcomes of health caredelivery. They have often been initiatedin response to the situation in developedcountries and are being proposed as po-tential answers to the problems faced inthe delivery of health care in developingcountries. These strategies have signifi-cant implications for drug supply systemsin developing countries which may nothave been factors in their implementationin developed countries.

Decentralisation either as delegationor devolution is intended to improve theresponsiveness, quality and efficiencyof health services. Decentralisation

Some experiences with competitivemechanisms for public drug supply

Autonomous supply agency in Tamil Nadu, India

The Tamil Nadu Medical Services Corporation (TNMSC) was created in 1995 tocontain drug costs and reduce shortages by purchasing and supplying drugs togovernment health care facilities. TNMSC is set up as a government company, with aBoard chaired by the Secretary of Health, which is accountable to the Minister ofHealth. The TNMSC created a list of 267 essential drugs from the previous state druglist of 900 items.

Drugs are procured through tender and delivered directly to district level stores.Quality assurance procedures are in place, including sampling of products frommanufacturers and district stores. Testing is contracted to reputable private laborato-ries through tenders. TNMSC adds a 5% charge to fund its own operations. Eachfacility is given a budget target and issued a “pass book” in which to record thevalue of drugs it has received. Through prompt payment and other administrativeefficiencies, TNMSC has considerably reduced drug costs, while maintaining reliablesupply.

Combined supply strategies in ZimbabweThe Zimbabwe Essential Drugs Action Programme (ZEDAP) uses different systems fordifferent categories of drugs. High-usage drugs on the essential drugs list are pro-cured, stocked and distributed in bulk through the central medical stores. Forhigh-cost, slow-moving specialist items, direct delivery contracts are used. For mostspecialist items an annual tender is conducted to fix the price for the year. Drugs arethen ordered as needed by the roughly two dozen national hospitals and NGOhospitals which require them. Orders are delivered directly to the hospitals. Finally,for cancer agents and some other highly specialised drugs, no contract exists.Instead, drugs are purchased by the Ministry’s pharmaceutical division by individualorder, with permission from the Secretary of Health.

Sometimes Central Medical Stores leave a lot to be desired, ascan be seen here in a country in Sub-Saharan Africa

aims to achieve thesebenefits through greaterlocal involvement, moredirect public accountabil-ity, increased flexibilityto adjust to local circum-stances, more rapid andmore accurate commu-nication, and quickeradaptation to changingconditions.

Problems that haveoccurred when attemptshave been made to decen-tralise drug managementfunctions include thefollowing:

◆ Lack of capacity:drug management re-sponsibility may bedecentralised withoutensuring there aresufficient local staffand management ca-pacity to sustain suchservices.

◆ Lack of financial re-sources: responsibilityis sometimes decen-tralised for all drugsupply without pro-viding an adequatebudget. In this case

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centres with even essential drugs. Wherethis is the case, retail pharmacies becomethe source of supply, especially in urbanenvironments. Often the pharmacies arelocated very close to the hospital, and maybe located inside the hospital. Suchpharmacies may be part of a parastatalpharmaceutical enterprise (Sudan), orthey might be an institutional enterprise(Ghana), or they may be independententerprises. In some countries, patientsreceiving health care through the publicsector are left to buy virtually all drugson their own from the private sector. Thissituation usually results from completelack of government funds, rather thanas part of an official drug managementplan.

As with revolving drug funds operatedby the government, the greatest concernwith fully private supply is equity of

decentralisation simply becomesabandonment of responsibility.

◆ Increased corruption: because of themoney involved, interference for per-sonal gain is common in drug supplysystems. While decentralisationis meant to improve accountability,it makes it easier for local officialsor other special interests to profitfraudulently.

◆ Increased cost: decentralisation ofprocurement usually means smallerorder quantities. It can result in higherprices for essential drugs, althoughthis problem can be overcomewith central contracts coupled withdecentralised ordering.

Contracting-out or resourcing inhealth care has most commonly beentried for non clinical services such as

environment where profit will become themotive for supply.

CONCLUSIONS

If a different drug supply system is notchosen as a result of a careful analysis ofthe underlying causes for the weaknessesof the existing system in a particular coun-try, the change may not produce thedesired outcome. Systems chosen becausethey function in the climate of a “success-ful” market economy may not prove tobe the solution to the problems faced inthe supply of drugs in the context of adeveloping country.

To weigh the pros and cons of onedrug supply system against another can-not properly be done from a globalperspective without detailed study. Eachcountry brings unique political, economicand geographical factors to the equation.It will never be possible to state that oneparticular system is “the best”. Howeversome basic factors will point in the di-rection of certain systems, for example,the existence of an effective privatesector is necessary for either directdelivery or prime distributor systems tofunction.

The Action Programme on EssentialDrugs has initiated a multicountry studyto examine in depth at country level theoutcomes of the drug supply systems inuse. This study will look at the advan-tages and disadvantages of the systems,and the factors which influence the levelof success in correcting problems andmeeting needs. ❏

This article has been adapted from DrugSupply Strategies, Chapter 6 of ManagingDrug Supply (see reference below).

Source: Bennett S, Muraleedharan VR. Personal communication on Tamil Nadu Medical ServicesCorporation. 1997.

MSH/WHO/DAP. Managing Drug Supply, 2nd ed. Hartford, CT: Kumarian Press; 1997.


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specifications are essential elements forsuccess. Tender specifications mayneed to vary according to the needs ofdifferent provinces. In Province A, sevenyears’ experience – one of the formerhomelands had already used contractingout services prior to 1995 – haveshown the following requirements to benecessary for a successful system:

◆ Procurement: The province mustmanage the procurement databaseand have the final say on orders,including prices.

◆ Warehousing and inventory manage-ment: At least one senior pharmacymanager should be on the provincialpayroll for this task. The public sec-tor should own the warehouse andequipment. This ensures independ-ence so that if the contractor does notperform to specifications, the provincehas the facilities to continue opera-tions. However, the contractor isresponsible for the maintenance andinsurance of the facilities and stocks.

The Department, in negotiationwith the contractor, determines stocklevels. This precaution ensures thatadequate levels of stocks are kept in asituation where the contractor paysinsurance coverage.

The contract should include theinstallation of adequate computerhardware and software for inventorymanagement at hospital pharmacies,and for on-going staff training.

◆ Distribution: The contractor’s owntransport is to be used; courier andsimilar services are not acceptable.When other transport is used, medi-cines are not always regarded aspriority by the transport contractor anddeliveries may not be according to aschedule.

◆ Management information: Thecontractor is required to supply com-prehensive management informationreports at agreed intervals.

◆ Billing: As the contractor is paid acommission on items delivered tohospitals the billing structure mustseparate these costs from the cost ofpurchasing stocks into the warehouse.In an earlier South African experiencewith limited contracting out the com-pany received a commission on stockpurchased into the warehouse and noton stock delivered to clients. This ar-rangement left many opportunities topurchase inappropriate medicines andquantities.

◆ Human resource development: Theentire contract must be seen as a part-nership between the Department and

“Contracting-out” drug procurement anddistribution: experience with a primarydistributor system in South Africa

rational, with around 2600 items on thenational pharmaceuticals tender list. (Thissituation is currently being changed: theNational Essential Drug List Committee,as part of the process of drafting stand-ard treatment guidelines, has establisheda database of conditions and relatedmedicines, which will lead to drug ration-alisation in the public sector. The EDLcurrently comprises just over 900 items,and is being further streamlined.)

After the 1994 elections, the newlyconsolidated provinces had to integratethe various pharmaceutical services, incommon with health and other services.Provinces generally had their own ware-houses and sent estimates of theirrequirements to the Coordinating Com-mittee for Medical Supplies (COMED),which coordinates the national tender.Payment is made by the provinces directlyto the suppliers.

The government of the newly consti-tuted Province A sought to integrate thedrug supply systems of four authoritiesas part of its efforts to establish a singlehealth authority. Following recommen-dations of a 1994 evaluation, ProvinceA, (which has high unemployment, lowaverage individual income and a pre-dominantly rural population), decided in1995 to contract out the procurement,warehousing and distribution of pharma-ceutical supplies. These functions werecontracted out to a private company at acommission of 8.05% of the value of theproducts. The contract also included a2.2% commission for computerisation ofhospital pharmacies and computer train-ing of provincial pharmaceutical staff.From January 1996, medicinal supplieshave been distributed from a single de-pot in the centrally situated provincialcapital.

In Province B, an essentially rural areawith less infrastructure than Province A,

a similar contract was awarded early in1997. A provincial warehouse was builton the western border of the province, inMarch 1997. A more central site wouldhave facilitated distribution.

Contracting-out is one of the optionsdescribed for public sector/private sectorcooperation in drug supply1.

In South Africa all of these factorsneeded to be tackled:

➤ The public sector does not insure stockagainst theft, fire or natural disasters,so all losses occur at government ex-pense, if services are not contractedout. Theft is a major problem inpharmaceutical warehouses in SouthAfrica.

➤ Strikes have become increasinglycommon since the 1994 elections astrade unions are trying to negotiatenew equitable rules and remunerationin the labour sector.

➤ Vehicle maintenance, cost-effectivestaffing and management informationare areas where the public sector hasnot always been efficient in the past.Government departments have beennotoriously overstaffed, but employ-ees were poorly paid and oftenunderqualified. Many motivatedworkers found work more rewardingin the private sector. With limited fi-nancial and logistic resources, servicesin remote areas were not easy tomanage.

The decision of two provinces to “con-tract-out” procurement and distribution tohospital level provided experience fromwhich important lessons can be drawn.

TENDER SPECIFICATIONS

Against this background, clearstructure, process and performance

Some advantages of “Contracting-Out”1. All losses by fire, theft or natural disasters are the responsibility of the contractor.2. The staff required to run a warehouse efficiently and effectively is expensive. Cost-

effectiveness of this component will be monitored closely by the contractor,because of the effect of poor performance on profitability.

3. Strikes and industrial disputes can be a major threat to the health services in asituation where all medicines are distributed from one depot. The service providerwill be responsible for ensuring continuity of services.

4. Transport is a major cost component in the distribution cycle. Adequate vehiclemaintenance and efficient scheduling of deliveries become the responsibility ofthe contractor.

5. Management information on drug availability and use can be improved withoutmajor investment by the public sector.

See Chapter l7 of Managing Drug Supply6 for a more detailed description of issues involved incontracting out pharmaceutical services.


P

R.S. SUMMERS1, H. MÖLLER2,D. MEYER3, R. BOTHA4

UBLIC/private sector relationshipshave been suggested as a meansof achieving some of the goals ofnational drug policies and essen-

tial drugs programmes1. Because of workwhich showed that “contracting-out” theprocurement and distribution of drugs canoffer advantages and improve perform-ance, two of the country’s nine provinceshave opted for this approach. SouthAfrican provinces have a considerabledegree of autonomy.

In this method, structure, process andoutcome specifications are established bya public sector authority and offered toprospective providers on “tender”. Theauthority, usually through a bidding proc-ess administered by a tender board, willthen select and establish a formal contractwith a provider.

Experience and some critical lessonslearned in using this approach in SouthAfrica are described here, providingvaluable insight into one of the few docu-mented primary distributor systemsoutside the USA.

BACKGROUND

South Africa, with a total populationof just over 40 million2, had a pharma-ceuticals’ expenditure of some 4.8 billionRand in the private sector and 1.8 billionRand in the public sector in 1996 (whenR1 was approximately US$0.22)3. Annualper capita expenditure on drugs for the85% of the population who rely on publicsector health services was approximatelyR52 (US$11). For the remaining 15%served by the private sector the equiva-lent figure was around R792 (US$174).To place this figure in context, the WorldBank quotes an average drug expenditureof US$2.1 for nine African Countries inthe mid-1980s4. While in 23 Sub-SaharanAfrican countries drug consumption wasvalued at less than US$5 per capita in 19905.

The procurement and distribution ofpharmaceuticals in the public sector iscentrally coordinated; the provinces pro-vide estimated quantities to the NationalTender Board, which then calls for andawards supply tenders. The provincespurchase their requirements from the suc-cessful tenderer through a provincialdepot.

This system has encountered somemajor difficulties over the years. Thesemainly revolved around stock losses andinexplicable variations between recordedpurchases and actual stock-on-hand.There was also a general lack of infor-mation, and the selection process was not

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the contractor. The Department mustalso ensure that the contract is carriedout according to the specifications.This necessitates the active involve-ment of provincial staff members inthe entire process from database man-agement, and procurement to receiptand distribution.

CURRENT CHALLENGES

Sufficient data are available to enablean evaluation of how the first two ele-ments listed above have contributed togoal of improved drug supply 6.

Procurement andfinancial control

Procurement was initially effective inProvince A. Towards the end of 1997,however, and for approximately the firstquarter of 1998, the situation deteriorated.This situation arose because of financialdifficulties within the Province which ledto the transfer of funds from Health toEducation to offset overexpenditure onthe Education budget.

In Province B, the situation mani-fested major difficulties from the start.Initially, accurate demand data had notbeen given to the contractor. Hence, or-der quantities did not match requirements.Cash flow problems surfaced as a resultof a backlog in payments during 1997/1998. More recently, the health budgetwas decentralised to district management,which caused major difficulties with cashflow at the depot. Suppliers who had notbeen paid suspended deliveries.

Warehousing andinventory management

As described earlier there weresignificant differences in the location andavailable space of the two depots.

In addition to the poor siting and in-adequate space at the depot of ProvinceB, attracting (and retaining) professionalstaff to the area has been a majorproblem. These factors significantlyinfluenced the performance of the depotwhich was, reflected in a relatively highnumber of out-of-stock items. BetweenMarch and June 1998, the percentage of132 essential items listed as out of stockby Province B increased from 23% to35%. Twelve critically important drugswere listed for virtually the entire period.We have rated procurement and stockcontrol systems as ineffective when morethan 15% of items are always out of stock.

(Contractor)(Province/contractor)

(Contractor)

(Contractor)

(Contractor)

(Province/contractor)

(Facility)

(Province)(Province)

ProcurementConsumptionreports

Collect consumptioninformation

Deliveryand payment Ordering/

requisitioningby facility

Storage(at depot)

Receiptand inspection

(Contractor)

(Province monitorcontractor)

(Contractor)

(Contractor)

(Contractor)

(Contractor/province)

(Provincepays contractor –Contractorpays suppliers)

(Province)

(Province)

Set orderparameters(e.g. stocklevel of6 weeks)

Determinequantitiesneeded Reconcile

needs andfunds

Chooseprocurementmethod

Select supplies

Specifycontract terms

Monitororder status

Receiveand check

Paysuppliers

Distribute

Set format ofreported information

Collect consumptioninformation

Reviewprocess

(Province)

(Province)

(Province)

(Province)

distribution from the depot to facilities.It meets this responsibility by checkingthe performance of the contractor throughthe data in the management informationsystem, without being involved inday-to-day procedures.

Here the contractor plays the main rolebut is supported by important inputs fromthe province. In both provinces, the con-tractor’s responsibility extends only to thehospital level. Thereafter, to the clinics,the responsibility for effective deliveryand inventory control becomes that of theprovince. Transport and management

A health centre in a rural area of South Africa

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Figure 1 Procurement cycle

The situation at the depotof Province B is thereforevery poor.

Over the first sixmonths of 1998, ProvinceA, which operates a simi-lar system but has aprovincial chief pharmacistat its depot at all times, hada stock-out rate between7% and 22%. This perform-ance was also far from idealbut better than Province B.

The reasons for thestockouts included poorselection of supplier, whomay have overtendered andtherefore could not deliver;

ably, in some cases the contrac-tor paid suppliers of critical stockout of its own funds in order tomaintain services to patients.

For a project like this to suc-ceed both parties need to haveinsight into, and understandingof, the functioning of a depart-ment of health. This will then bemanifested in the acceptanceand support of the service by itsusers. Here too there was a sig-nificant difference between thetwo provinces.

In conclusion we have at-tempted to identify critical issues,lessons and key success factorsfrom these two cases, which had

payment difficulties (see above)and poor depot management. Prov-ince A faced mainly the first twoproblems, whereas all three appliedto Province B from time to time.

RELATIONSHIPSBETWEEN THE PLAYERS

To obtain a perspective of theactual difficulties involved we ex-amined the components of theprocurement and distribution cy-cles in terms of the relationshipsbetween, and responsibilities of,the two role players (see Figures1 and 2).

The provincial authority is involvedin every element except receipt andchecking of goods at the depot and

information at this level have often beenproblematic.

LESSONS LEARNED

Perhaps the core lesson learned is thatwhat occurs in contracting-out is a part-nership. If either partner does not deliver,and there are weak links in the chain, theprocess will fail!

There were differences in perform-ance between the two provinces. Theselay in the partnerships and inputs in eachcase. In the early stages of the process inProvince A, there was extensive prepara-tion by both parties. Facilities hadadequate stock in place. Stock at differ-ent depots was checked and consolidated.This was not the case in Province B. Thedepot there had been newly set up andhad encountered difficulties in establish-ing its own management informationsystem. In addition the depot was toosmall for the Province B’s needs. It lackedadequate senior provincial supervision,which is essential for proper control ofpublic sector resources and funds. Toomany items were listed at the variouslevels of pharmaceuticals distribution inthis province.

Towards the end of the financial year,both provinces faced payment difficultieswhich inhibited procurement. In ProvinceA, where the budget was centralised,budget over-runs in departments otherthan Health and Welfare led to the with-drawal of funds from Health. In ProvinceB, decentralisation of budgets and res-ponsibility for payment to district levelmanagement, continued to cause majorcash flow difficulties with consequentdifficulty in paying suppliers. These dif-ficulties were the main reason for the highnumber of out-of-stock items. Commend-

the common factor of the samesupplier, but which differedmarkedly in performance.

➤ An integrated approachand planning by the publicsector provider and thecontractor is essential.

➤ The provincial drug list,which must have the sup-port of its users, should bestrictly applied and thereshould be a provincial vetoon non list items.

➤ The storage depot needs tobe carefully sized and cen-trally located.

➤ Appropriate facilities and systemsneed to be established for current andfuture requirements.

➤ A management information system isneeded to monitor order and deliverystatus.

➤ Contractor selection should be basedon previous performance and capac-ity to undertake the work, and includequality assurance for service delivery.

➤ Contractual terms and specificationsmust be fully detailed.

➤ Purchasing and payment methodsneed to be spelt out.

➤ Finally, and perhaps most critically,there has to be a sustained cash flowfrom recipient to contractor tosupplier. ❏

* Professor Rob Summers, School of Phar-macy, MEDUNSA, Helene Möller, SouthAfrican Drug Action Programme, Departmentof Health, Pretoria, Danie Meyer, Pharma-ceutical Services, Northern Province,Pietersburg, Rainier Botha, Vuna Health CareLogistics, Johannesburg.

For further information contact: ProfessorSummers, Head, School of Pharmacy, POBox 218, Medunsa 0204, South Africa.

■ ■ ■

References

1. Bennett S, Quick JD, Velasquez G. Public-private rolesin the pharmaceutical sector. Geneva: World HealthOrganization; 1997. WHO/DAP97.12

2. Central Statistical Services. Census ’96: Preliminaryestimates of the size of the population of South Africa.Central Statistics, Pretoria, 1997.

3. Summers RS, Suleman F. Chapter 8: Drug policy andpharmaceuticals. Chapter 8. In: South African HealthReview 1996. Durban: Health Systems Trusts and Cali-fornia: Henry J Kaiser Family Foundation; 1996.

4. World Bank. Better Health in Africa. Washington: WorldBank; 1994

5. Balance R, Pogany J, Forstner H. The world’s pharma-ceutical industry. Aldershot, UK: Edward Elgar; 1992.

6. Contracting for drugs and services. In: Quick JD, RankinJR, Laing RO, O’Connor RW, Hogerzeil HV, DukesMNG, Garnett A, editors. Managing drug supply, 2nded. West Hartford, CT: Kumarian Press; 1997. p. 256–269.

Figure 2 Distribution cycle


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Improving the supply, quality control andaccess to essential drugs in Guatemala

➤ revision of the legal framework;

➤ new guidelines for the purchase ofdrugs;

➤ an improved system of logistics for theprovision of supplies;

➤ establishment of a drug vigilanceprogramme.

Reform of the drug regulatoryauthorities and the official quality con-trol laboratory was achieved throughstrengthening the management structure,decentralisation of finance, staff trainingprogrammes and a review of salaries.Other measures included: the establish-ment of new administrative proceduresfor the register of authorised drug sales;better quality control of medicines; thecreation of a standardised system for drugregistration; better inspection of GoodManufacturing Practices; the purchase oflaboratory equipment; and the develop-ment of a computerized data system fordrugs.

Elsewhere, the Quality StandardsWorking Group studied the list of 1,400drugs purchased by the Government –which contained many duplicate products– and recommended the use of the 13thedition of the US Pharmacopeia andthe US Pharmacopiea Dispensing Infor-mation, to define the specifications ofproducts purchased by the Government.Other products on the list had to beratified from alternative sources, suchas the British, French and JapanesePharmacopoeias.

The Working Group also estimatedsupply needs on the basis of figures pro-vided by different health units. The aimwas to establish quantities that would beattractive to suppliers and ensure savingsthrough bulk purchase orders. Medicalsurgical materials and medical equipmentwere handled in a similar way, usinginternational standards such as those ofthe US Food and Drug Administration,as well as alternative standards. At every

stage, both consumers and suppliers wereinvolved in defining the quality of theproduct. A second working group wasestablished to review the legal aspects ofGovernment purchases of medicines andmedical surgical materials2.

As part of the modernisation process,the law was updated and a new HealthCode issued3. The regulation4 that this lawimplements facilitates Guatemala’s par-ticipation in the globalisation process, andestablishes responsibilities for all person-nel involved in the supply of medicines.

A computerized system has beendeveloped for this.

Resources must be used rationally toallow for extended coverage. Meanwhile,quality must be in conformity with theUS Pharmacopeia, and all medicinesreferred to by their International Non-proprietary Name. Norms have beenestablished for the qualification andawarding of suppliers and products,together with a procedure and paymentguarantee to ensure successful relation-ships. This agreement provides for


Meanwhile, overall controlremains within the Ministryof Health.

The legal framework pro-vides for the development ofa Programme of Ease of Ac-cess to Medicines5 throughalready established state andmunicipal pharmacies6, andthe establishment of a Salesof Medicines for CommunityBenefit scheme7 run by civil-ian groups to ensure theyare self-financing and sus-tainable. The proposal forthe Purchase of Medicinesystem, which came intooperation in early 1997,adopted the open contractsystem already in force for Governmentpurchases. This is an administrative toolwith centralised negotiation and decen-tralised execution – designed to guaranteethe quality of the product, purchased atprices previously determined at centrallevel.

ENSURING TRANSPARENCYIN SUPPLY

The new drug purchasing system wasmodified to include an open tenderingsystem, with control over those who makethe offers, and clear rules to ensure trans-parency and bring an end to corruption.

payment within a maximum of 30 daysafter receiving the product, compensationin the event of fluctuations in the ex-change rate and payment of interest ondelayed invoices. Sanctions can now beimposed for the supply of poor qualityproducts and for failure to deliver withinthe agreed timeframe (with a maximumpenalty of five years’ suspension as aGovernment supplier).

The new system allows for a maxi-mum of 3% deviation in the minimumprice offered by a maximum of eight sup-pliers. Meanwhile, an inter-institutionalcommission has been established to over-see the operation of the open contractsystem and apply sanctions for non-fulfilment. The private sector participatesas an observer in this commission. TheProcess of Public Awarding provides forthe participation of personnel from the ad-ministrative units and executing officersfrom the public health sector as well asobservers from private sector organiza-tions and professional colleagues (doctorsand pharmacists).

FOCUS ON QUALITY

The establishment of administrativeand technical norms was also necessaryto guarantee that the item gets to the userin perfect condition, in the correct quan-tity and on time. These included adefinition of the role of the professionalpharmacist to ensure that drugs are usedand administered correctly. Norms wereDispensing drugs to a patient at Panajachel Health Centre, Guatemala

The central drug warehouse in Solola District. The Guatema-lan Government is implementing measures to improve drugsupply

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OMANUEL ENRIQUE LEZANA*

VER the past 15 years, Guatemalahas followed through its commit-ment to the concept of essentialdrugs by developing a range of

strategies and actions designed to improvethe supply of drugs and ensure wideraccess to them1. More recently, theGuatemalan Ministry of Health has drawnup a blueprint for overall health policiesto the year 2000. The proposals include:the modernisation of state health servicesthrough decentralisation of finance andadministration; strengthening the capac-ity of governing bodies; improvingsectorial and intersectorial coordination;and making better use of existing re-sources for health. The Ministry ofHealth is also committed to improving thequality of health services and ensuringwider access as well as improving themanagement of health services.

Within the Health Ministry’s budget,the largest items of expenditure are medi-cines (10%), surgical materials (5%) andmedical equipment, including mainte-nance and replacement equipmentpurchases (6%–7%). However, over time,the administration of this budget haslacked transparency in the selection, pur-chase and distribution of these products.The quality of the product purchased wasneither defined in advance nor checkedon receipt. Meanwhile, suppliers had noguarantee of payment – resulting in pricespeculation of up to 400% of the originalprice.

One of the first steps taken was to forma group of national consultants to workwith the WHO Regional Office for theAmericas and the Pan American HealthOrganization. The group was to draw upa strategy to resolve existing problemsand capitalise on the then current employ-ment of an international company withexpertise in drug purchasing systems.

SWEEPING POLICY CHANGES

A Multisectorial Commission forPolicies on Medicines was formed withinthe Public Health Ministry with represen-tation from both the private and publicsector as well as international health or-ganizations. The Commission’s remit wasto advise the Ministry on new policies forthe quality control and supply of drugs.Because of the seriousness of theproblems encountered, it was decided toimplement new policies across the board.These included:

➤ strengthening the drug regulatoryauthorities and the official qualitycontrol laboratory;

➤ setting up working groups to developquality standards and new proceduresfor administration, purchasing anddistribution;

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Belarus: progress in thepharmaceutical sector

Important steps on theroad to pharmaceuticalsector reform in Belarus

◆ ◆ ◆

In April 1991 the first version ofthe essential drugs list was adopted.It has been reviewed annually sincethen and is widely used. The list is thebasis for procurement at all levels ofthe health care system and ensuresguaranteed coverage of the popula-tion’s pharmaceutical requirements.

In September 1992 the PrincipalDepartment of Pharmacy, MedicalEquipment and Regulation wasestablished. Within this frameworkthe process of developing a nationaldrug policy started.

In December 1992 licensing ofthe pharmaceutical market wasinitiated. This allowed the Govern-ment to preserve its control of thepharmaceutical sector and to regu-late newly established pharmacies,regardless of their ownership.

In November 1993 the Pharmaco-logical Commission was reorganizedinto the Pharmacological andPharmacopoeia Committees. Require-ments for drug registration in Belaruswere defined and legally approved.

ln November 1993 the nationalprogramme for pharmaceuticalindustry development was adopted.The list of drugs produced in Belarusincreased from 150 to 300 items.

In October 1997 the RepublicanCentre of Expertise and Trials inHealth Care was established. Thisfacilitated reorganization of drugregistration and pharmaceuticallicensing procedures to meetinternational standards.

MAJOR CHANGES AHEAD

Step by step over the next five years,Belarus will introduce international stand-ards for good manufacturing practice. Itwill modernise and increase the capacityof existing production plants, build newplants, widen the list of drugs produced,and strengthen the State’s role in drugproduction to better satisfy national drugrequirements.

The Ministry foresees the further de-velopment of the network of newlyestablished private pharmacies and im-proved regulations that will ensureincreased access to drugs for the ruralpopulation. There are plans to review ex-isting pharmacy regulations and tointroduce a list of compulsory medicines

that should be available in every phar-macy at all times.

Plans are also underway to: encour-age the more rational use of drugs,especially within the drug reimburse-ment scheme; increase the role of theessential drugs list; introduce drugtreatment guidelines; improve doctors’access to drug information; encourage theprocurement of drugs in the hospitalpackage; and review the price regulationsystem.

FRUITS OF COLLABORATION

International contacts, especiallythose established during 1993/1994, haveplayed a significant role in allowingBelarus to make more rational decisionson how to organize its drug regulation andsupply systems.

Agreements on collaboration in thepharmaceutical sector have been signedwith the Health Ministries of Latvia andUkraine, as well as with the French Medi-cines Agency, and the US Food and DrugAdministration. This allows Belarus toreceive much needed drug informationmore efficiently, and to organize trainingfor its experts at these institutions.Contacts and cooperation with thePharmaceuticals Programme at WHO’sRegional Office for Europe has alsobroadened knowledge on all aspects ofthe pharmaceutical sector.

Belarus has also benefitted from anInterstate Commission for standardisationand quality control of pharmaceuticalsand medical equipment established underthe Commonwealth of Independent StatesCouncil for Cooperation in Health. It hasallowed better harmonisation of pharma-ceutical standards and requirements forproducts manufactured in these countries,and the simplification of their circula-tion within the Commonwealth’s internalmarkets. ❏

This article is based on an interview withGennady Godovalnikov, Head, Pharma-ceutical Department of the Ministry of Healthof Belarus, which first appeared in:Pharmacuetical Reforms, WHO News forNewly Independent States, No.3, June 1998.

N A T I O N A L D R U G P O L I C Y

also established for selection, purchase,reception, storage and distribution in or-der to ensure the punctual delivery of thecorrect medicines. A system was put intoplace to deal with complaints about theefficacy or safety of products, and takeappropriate action wherever needed.

In late 1997 doubts about the qualityof medicines purchased through prescrip-tion prompted the launch of clinicalstudies of some products. The finding thatsome products were lacking in efficacyled to the establishment of the DrugVigilance Programme – designed toassess complaints about therapeuticfailure and/or adverse reactions to medi-cines purchased through the open contractsystem.

The new policies have met with op-position from some groups – includingprescribers and suppliers who failed towin contracts – each preferring to main-tain the status quo on drug supplies.Other problems have included inadequatesupply forecasting – leading to drugshortages – and budgetary restrictions onefforts to ensure vigilance and control.However, failure by some suppliers toprovide the correct amount and qualityof drugs has led to the imposition of sanc-tions, including five-year exclusion fromthe Government supply system.

Among the major achievements of thenew system are the savings on drug budg-ets and the extended coverage with lowcost, high quality medicines. The Minis-try of Health has saved 65% of its budgetand the Guatemalan Institute of SocialSecurity – the country’s other publichealth service provider – saved 23% ofits drugs budget. Meanwhile, throughthe Access to Medicine Programme –which benefits from decentralisedprice negotiations – medicines are nowbeing made available to underservedcommunities.

Elsewhere, quality standards havebeen established for the purchase of medi-cines and sanctions put in place to deterthe supply of poor quality medicines orlate deliveries.

Multidisciplinary teams now partici-pate in negotiations for the purchaseof drugs and other medical items, andthe decentralisation of health budgetsfacilitates the prompt payment ofsuppliers. ❏

* Ing. Manuel Enrique Lezana is Chief of theDrug Coordination Office, Ministry of Health,Guatemala.

References

1. Working together, learning together. Essential DrugsMonitor [editorial] 1992; 13.

2. Governmental Agreement 472–96, dated 4 November1996, related to the quality of medicines and medicalsurgical materials in which the purchasing standards areestablished.

3. Legislative Agreement 90–97 in force from February1998.

4. This regulation is awaiting final Presidential approval.

5. Governmental Agreement 714–97 dated 8 July 1997.

6. Ministerial Agreement 161–98 dated 26 May 1998.

7. Ministerial Agreement 162–98 dated 26 May 1998.

THE Ministry of Health in Belarushas set out its plans for healthsector development, which in-clude changes in the pharmaceu-

tical sector. Among proposals are that anetwork of state and private pharmacieswill develop in parallel, with their activi-ties strictly regulated. At the same time,state control of drug pricing will continue.Drugs will be supplied to the populationthrough both centralised and decentral-ised procurement, using the country’slist of essential drugs. Other importantinitiatives include a campaign to pro-mote the rational use of drugs, and plansto hold a national conference to adopta new approach for developing thepharmaceutical education system. It ishoped the Government will adopt thepublic health development package by theend of 1998.

The country plans two main ap-proaches for the pharmaceutical industry:the production of generics included inthe essential drugs list for centraliseddrug supply, in accordance with statedirectives; and the modernisation andupgrading of existing pharmaceu-tical manufacturing enterprises. Threenew factories have already begunpharmaceutical production.

Over the next five years it is plannedto develop and introduce up-to-daterequirements for clinical trials andstandards for drug quality and production,and to review other regulations coveringpharmaceutical issues.

INCREASED ROLE FORREGULATORS

The drug regulatory authority isexpected to have a stronger role andindependent status. Recently, the Minis-try of Health established the RepublicanCentre of Expertise and Trials in HealthCare. The aim is to help solve currentproblems in the drug supply system, andto improve the drug registration process,authorisation of products for medical useand industrial production, licensing ofpharmaceutical activities, and controlover drug imports to Belarus. The Minis-try intends to implement national drugpolicy through the Centre, and throughall these measures to exercise effectivecontrol over the pharmaceutical sector.

ENSURING ACCESS

Centralised procurement of certainimportant medicines will continue,among them those for treating diabetes,cancer and tuberculosis. Such procure-ment is done on a large scale, in bulk andexclusively on a tender basis. This sys-tem allows the purchase of needed drugsto be more cost-effective, and ensuresaccess to these vital drugs for the popu-lation. All pharmaceuticals supplied inthis way are free of charge to patients.


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Zimbabwe launchesNational Drug Policy

Drug Policy was not new to Zimbabweand that work on it started soon after thecountry gained its independence in 1980.At the same time promotion of the rationaluse of drugs and production of standardtreatment guidelines and essential drugslists had also begun.

The launch of the policy is “theGovernment’s commitment to the goalsdescribed” said Minister Stamps, whilsturging everyone to familiarise themselveswith its contents and to identify theirindividual roles in its implementation.

Also speaking at the launch wasthe Consumer Council of Zimbabwe’srepresentative, Mrs Keretia Chikowe. Sheexplained that access to correct drug

Involving African consumersin drug policy

the people at an affordable price, ensur-ing safety, efficacy, good dispensingpractices and patient education.

Obstacles to overcomeHowever, discussions revealed that

the national drug policies adopted byother countries in the region are less clear.Other problems also emerged. In manySouthern African countries there is anacute shortage of public sector health careproviders, especially pharmacists. Thishas a serious impact on the success ofnational drug policies. Key positionsremain vacant and trained workers oftenleave for better-paid jobs in the privatesector. Inadequate budgets, major localcurrency devaluations, drug shortages andemergency procurement damage the

N A T I O N A L D R U G P O L I C Y

national drug policy’s possible impact.Rising drug prices make drugs inaccessi-ble to many consumers in the region. Dueto economic liberalisation, drug pricingis not effectively controlled by legislationand instead relies on market forces. Pricesfor the same drugs vary widely depend-ing on where they are bought. Rationaldrug use goals are further upset by manycountries’ dependence on donations –which are often sent in an uncoordinatedway.

Yet there have been encouraging de-velopments which will help to solve theseproblems. In Malawi and Lesotho, forexample, donors have begun to contactchurch groups to ask if certain drugsare needed and they then send them inusable quantities. In Zimbabwe the Con-sumer Council is lobbying for legislation

to control drug prices, and a number ofgroups attending the workshop haveinitiated a regional drug pricing surveyto address unacceptable price variations.

Spreading the wordDespite so many constraints groups in

the region are active in making consum-ers more aware of the issues involved innational drug policies. For example, themeeting heard that in Mozambique a newconsumers’ organization has campaignedfor rational use of drugs. The group,ProConsumers, has publicised the dan-gers of using expired drugs and broadcastradio programmes informing peopleabout the dangers of buying drugs fromthe informal sector. Health Action Cen-tre in Nigeria has relied on creativemeans to educate consumers, includingtraditional storytelling and drama presen-tations to point out drug hawkers’ tricks,such as changing expiry dates, copyinglabels and substituting ingredients. TheGroup makes any location a potentiallearning place, by meeting with consum-ers in their homes, at schools, in churchesand market places, during women’sorganizations’ meetings or on buses.

Before the meeting closed, partici-pants discussed the next phase inHAI’s three-year project, Networking forRational Drug Use in Africa. Plans arealready well advanced for a third regionalworkshop, this time in francophoneAfrica. ❏

A report of the workshop is available from:HAI-Europe, Jacob van Lennepkade 334T,1053 NJ Amsterdam, the Netherlands.

Source: HAI News, August 1998.

information was a funda-mental consumer right, andthat increased literacy levelsin Zimbabwe had increasedconsumer’s critical aware-ness. Presenting a copy of thePatients Charter to the Min-ister, she impressed on himthe need for Parliamentariansto have a clear understand-ing of the National DrugPolicy, so that legislation tosupport the Policy would beput in place.

WHO Representative,Dr Levon Arevshatian,stressed the importancethat WHO attaches to thedevelopment and imple-mentation of national drug

Consumer groups in many African countries are realising the value of health education. Here inThe Gambia women gather to listen to health messages on the radio

Aidan Chadirikere (right), Director of Pharmacy Services andNorman Nyazema (left), Professor of Pharmacology at theUniversity of Zimbabwe celebrate the launch of Zimbabwe’snew national drug policy document

choir from the Harare Central HospitalSchool of Nursing was on hand to singthe Zimbabwe National Drug Policyinto life. ❏

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WHILE many countries in Africahave adopted national drugpolicies these policies do nothingfor the public they are meant to

serve if they remain only written plans.Consumer involvement in implementingsuch policies is crucial in order to addressthe public’s real needs regarding healthand medicines. In many cases countrieshave done little to make sure nationalpolicies address consumer’s health needsin a participatory and attainable way. Thereasons behind these successes and fail-ures, and strategies for ensuring consumerinvolvement in various aspects of thesepolicies were the focus of HAI’s secondregional workshop for Africa. EntitledNetworking for Rational Drug Use inSouthern Africa: Consumer Involvementin National Drug Policies, the meetingwas held from 30 May to 5 June 1998.It brought 34 participants – includingconsumer activists, NGO representatives,drug information experts, journalists,pharmacists and clinical pharma-cologists from 11 African countries –to Johannesburg, South Africa.

In his introductory remarks to theworkshop, Dr Harm Pretorious, DeputyDirector-General of South Africa’sDepartment of Health, spoke about thiscritical period for his country’s drugpolicy. After South Africa’s first demo-cratic elections in 1994, the Departmentof Health had revised its policy in orderto remove all of the health sector’s pastinequalities. The new policy was devel-oped through broad consultation andincluded many stakeholders because ofits far-reaching impact on all groups insociety. The policy’s main objective is tosupply essential drugs to the majority of

ZIMBABWE’S National Drug Policywas formally launched in March1998 by the Minister of Health,Dr Timothy Stamps, at a colour-

ful ceremony at the Harare CentralHospital. Simultaneously the Policywas launched in four other centresthroughout the country. The launch is aculmination of the efforts of all sectorsof the health system – including healthservice providers, the pharmaceuticalindustry, various ministries and otherstakeholders.

A five-year work plan underlies thePolicy, and has been in operation evenbefore the formal launch. Dr Stampsstressed that the concept of a National

policies. Other speakers underscoredthe need for a concerted multidis-ciplinary approach for successfulpolicy implementation. Finally, the

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Improving quality of carein Hai Phong Province

at the CHSs and altering the public’sawareness of issues surrounding the ra-tional use of drugs. It was assumed thatthis would increase the standing of theCHSs and therefore improve the chanceof the commune investing in them,

considerable period. We hypothesised thatif good prescribing habits could be estab-lished for more than half a year then therewas every hope that they would continue.We therefore used other aspects of im-proving quality of care as both carrots and

R E S E A R C H


stick towards changing prescribinghabits.

We reasoned as follows:

1. CarrotResearch: if all work was based on

locally found research results, the “topdown” image would be broken and wewould be seen to be basing our work onthe real situation.

Treatment guidelines: if simpleguidelines were developed, then it wouldbe easy to judge the quality of treatment.If these guidelines concentrated on themost frequently seen conditions in all dis-tricts covering more than 80% of patients,then only some 10 conditions would needto be covered.

Limited drug list: by looking at theguidelines and adding a few more foremergency situations, an agreed list ofdrugs could be determined.

Participation: if the health workersparticipated in forming these treatmentguidelines and drug list, they would bemore likely to have a sense of ownershipof the results.

Retraining: by concentrating on themanagement of these 10 basic conditionsand the limited list of drugs, retrainingcould be feasible and effective.

Supervision: regular supervision ofquality of prescribing from the districthealth centre would be a vital aspect ofin-service training, morale building anddeveloping a unified system.

Drug fund: if the CHS had a suffi-cient drug fund to stock the needed drugsfrom the limited list, it could purchasethese drugs locally and sell them at a com-petitive price to the private market. This

preserving the preventivecare that they offered.

We hypothesised that ifthe commune health stationsoffered a good service,where common diseaseswere well managed; wherenecessary drugs at affordableprices were supplied in theright doses at the right times;where people with more se-rious problems were referredin a timely way to hospitals;where they had the basicdrugs as a well managed re-volving fund; and where thenecessary basic equipmentwas present, then several

Participants at one of the district workshops which drew upstandard treatment guidelines

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JOHN CHALKER*

BACKGROUND

N 1993/94 the system of communehealth stations (CHSs) in HaiPhong Province, Viet Nam, wasin danger of collapse. This was a

system that had provided a health stationin every commune in Hai Phong with astaff of four to six para-medics, trainedfor three to four years at the secondarymedical school (these schools exist inmost provinces to train nurses, midwivesand medical, pharmacy and laboratory as-sistants). The health stations were a focusfor all preventive and curative activity.They were mainly financed by the com-mune, but carried out Health Ministryvertical control programmes as well asproviding obstetric and curative care.Each commune has an average popula-tion of around 6,000 people, and fewpeople are more than 10 or 15 minutesfrom their nearest station.

It was this extensive infrastructure thatwas a large contributory factor to VietNam’s excellent health statistics on infantmortality and life expectancy, which arecomparable to countries with a muchhigher gross national product.

Since 1989, under theGovernment’s policy of “DoiMoi” or renewal, privatepractice in the health sectorwas legitimised. This new ap-proach, coupled with inflation,meant that in practice invest-ment in the stations virtuallyceased. At the same time manyprivate drug sellers (both licensedand unlicensed) appeared. Salariesfor health workers reduced to nonliving wages in real terms (aboutUS$6 a month). The stations fellinto poor states of disrepair andequipment was not replaced.

In pre project research in early1995, we found that the average valueof drug stocks in a selection of HaiPhong CHSs was about US$20 perstation. Drugs were bought locallyby the health staff, and were sold andreplaced frequently via user fees. Thestaff had very little retraining. Districtsupervision of quality of treatment didnot exist, and treatment standards weredeteriorating.

At the same time attendance fellby more than half from 1989 to 1993.People had access to drugs from theproliferating number of drug sellers. Infact more than 70% went to these drugsellers as a first recourse when sick. Atthe drug sellers they would very oftenreceive the wrong, frequently poor qual-ity drug, in the wrong dose for the wronglength of time. Important and dangerous

This poster, used in the project, gives two pieces of advice

on antibiotic use: if you think you need antibiotics go to your

doctor; and if you need antibiotics take the full course of

treatment otherwise they will not be as effective next time

symptoms would be missed so that timelyreferral to hospital would be delayed.

The spiral of decline in the communehealth workers’ morale: the decreasingrespect of the public; the reduction of dis-trict supervision; and the lack of a livingwage which led to increasing numbers ofhealth workers starting a private practiceor taking up other income generatingactivities; all illustrated a breakdown ofthe health services.

The consequence had seriousimplications for preventive care. Withthe reduced esteem of the CHSs due todeclining curative activity, there was aconcomitant reduction in motivationto finance the CHS by the communes.This threatened the very existence of theinstitutions that delivered the preventivecare.

It was the project’s goal to break thiscycle of decline.

THE PROJECT

The project was a co-operationbetween Save the Children Fund UK, andthe Hai Phong Provincial HealthBureau,

supported by theMinistry of Health and partly financed bythe European Union.

Its objectives grew directly out of theprevious analysis. They were all aimedat improving the quality of curative care

consequences would follow.The first would be that more people

would use the CHS. If this were the case,then the small profit made on drug saleswould increase. These together wouldimprove the health workers’ moraleand financial situation. The second con-sequence would be that the commune,district and provincial people’s commit-tees would realise what an excellentresource they had in the CHSs andwould mobilise more funds to main-tain them. In this way the institutionsof preventive care would be preservedand the spiral of decline would bebroken.

StrategyWe aimed to affect several as-

pects of quality of care. We wouldimprove the basic medical equip-ment, drug availability and thelevel of staff training. In additionwe would help them construct asustainable accounting systemfor ongoing drug supply, de-velop standard treatmentguidelines, create district su-pervision of the quality ofprescribing and accounting,and improve the rational use

of drugs. Changing people’s

prescribing habits has been shown worldwide to be extraordinarily difficult. Thesehabits are not just formed from a rationalknowledge base, but are affected by manyfinancial, social and cultural factors. Pre-scribing (both bad and good) is a habit.To break the bad habits and establish goodhabits a combination of “carrot” and“stick” need to be employed over a


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would please health worker and publicalike.

Accounting system: developing anaccessible, transparent book keeping sys-tem kept by the CHS would help to ensurethe existence of an ongoing revolvingfund.

Equipment: the possibility for theCHS to choose basic equipment from anagreed list every three months for ninemonths would act as a real incentive tochange prescribing habits.

Patient load: with an increasing pa-tient load, income would increase.

2. StickWithholding of equipment: if the

agreed treatment guidelines and bookkeeping system were not followed, thenthe equipment would not be forthcoming.

Peer pressure: the withholding ofequipment would be public knowledge.

Supervision: the regular supervisionwould also be a form of inspection.

Public expectation: if, through a se-ries of television and radio programmes,leaflets and posters, the public wereinformed about key aspects of drug useand CHS service, then their demand forirrational treatment would decrease.

PHASEDIMPLEMENTATION

The project was implemented, districtby district, in all 12 districts in 217 com-munes in Hai Phong covering apopulation of 1.6 million people. In eachdistrict the whole process took up to oneyear. We started with the rural areas andended with the urban and island districts.Work started in the first district in June1994 and the last in January 1996. Itcovered a series of activities aimed atimproving aspects of quality of care.

Pre implementationin each district

Baseline research on key drug useindicators and which diagnoses werebeing made at CHSs was carried out inall CHSs of the district. This was eitherdone by retrospective examination of outpatient books or if these were absent, byprospectively giving prescription padsand examining them after one month.

As a pre-condition for joining theproject, each district health office had toagree to set up and run a team of supervi-sors to monitor the quality of treatmentand of book keeping in each communeeach month. This information was to befed back to the provincial health officeand project office every month, establish-ing a record of key indicators for eachCHS and aggregated for each district. Itwas mainly on the basis of these recordsthat the decision was made whether todonate or not, money for equipment toeach CHS each three months. The keyindicators used were those that had beenshown to be most problematical duringbaseline research (see Table1).

PreparationIn each of the 12 districts, a series of

workshops was carried out – normallytwo in each district but this varied withthe number of staff needing to attend. Theworkshops were with:

➤ Key commune and CHS leaders, toagree the plan of activity of theproject. This was basically to enlisttheir support and explain the ap-proach. It included them approvingregular supervision by district staff,the formalising of the selling of drugs,instigating an accounting system andagreeing that the CHS drug sellercould purchase drugs from the agreedlist from any registered drug seller.They would also understand thatequipment donation was dependent ongood prescribing.

➤ CHS curative staff, to create a stand-ard treatment guideline based on themost frequent diagnoses and to agreea drug list. A senior staff member fromthe Ministry of Health’s Educationand Science Department facilitatedthese workshops. The standard treat-ment guidelines were based oncommune prescribing patterns over

previous months and on the diagnosesmade. This information was foundeither by looking at records or ifthese did not exist, by supplyingduplicate prescription pads to allstaff, collecting them after one monthand analysing the data. Treatmentguidelines were made for the 10 mostcommon conditions that covered morethan 80% of patients seen in eachparticular district. While the processwas participatory, the final say restedwith the facilitator, who was familiarwith national and WHO policies fortreating the most prevalent diseases.

Compilation of the drug list wasthen relatively easy, as usually eightor nine drugs had been used in thetreatment guidelines and then, extradrugs were discussed and agreed, us-ing the same facilitator. Each district’sdrugs list was slightly different,containing between 29 and 31 drugs.When the programme ended theywere combined into one list of some32 drugs.

➤ CHS book keepers, to develop anappropriate book keeping system.

Box 1

The Information, Education andCommunication (IEC) campaign in Hai

Phong to promote the rational use of drugsIEC campaign principles

Messages were agreed and prioritised on the basis of research. These messagesaddressed the same problems found with CHS prescribing. They were repeated asoften as possible, using a variety of media channels.

Main problems identified

• Antibiotics are used too often.• When antibiotics are used they are used in too small a dose.• Injections are often preferred to tablets.• The majority of sick people are not using CHSs.

Agreed messages

• Never use injections if tablets will do. Injections can be dangerous and are usuallynot necessary.

• If you need antibiotics, you must use a full dose. Not finishing the dose means thatnext time you need them they may be less effective.

• When you are ill do not self prescribe, ask your local expert. Use your CommuneHealth Station.

• Save the Children Fund from the UK is here to help upgrade your local CommuneHealth Stations. Using your local CHS when you are ill is beneficial for your healthand the station.

Media used

These were variously applied from June 1994 to November 1995.

Two posters were designed in Hai Phong for the first two messages and every CHSwas given four or five of each.

Four radio programmes (short plays of five minutes starting and finishing with themessage) were written and recorded first by a district radio and secondly by provin-cial radio. They were transcribed onto cassette and distributed to every CHS tobroadcast on the commune public address system.

Four radio spots each 30 seconds long were treated the same way.

TV programmes. Provincial TV recorded four programmes, each approximately fiveminutes long, with a respected person talking about one of the messages. These wereshown several times over several months.

TV spots of one minute were treated in the same way.

Newspaper advertisements were taken out for each of the messages on the provincialnewspaper’s back page.

Leaflets. A simple leaflet was designed and given to each houshold in five communes.

Meetings. A key physician from each district was trained on the messages, but thishas not yet been taken any further.

Cost. All these inputs came to a total of US$2,200.

➤ District supervisors, to develop andlearn methods to monitor the agreedkey drug use indicators that were seento be a problem on the basis of theresearch findings.

At the conclusion of the workshops aceremony was held, where each actor(from the Provincial Health Bureau, Dis-trict Health Office, Commune PeoplesCommittee and CHS) signed a contractto agree their role in the plan of activi-ties. A week of retraining for all curativestaff was organized through the second-ary medical school, to reinforce basicdiagnosis and treatment for commonconditions.

With this done, Save the ChildrenFund UK transferred an average ofUS$300 to each CHS for them to set up arevolving drug fund. It also suppliedbooks and calculators for book keeping.This took around two months in eachdistrict.

In addition an information campaignon key drug use issues was launchedusing television, radio, newspapers,posters and leaflets. The messages werebased on survey results (see Boxes 1and 2).

Ongoing workWith satisfactory results from the

regular supervision of the district teams,at three monthly intervals, each CHS wasallowed to choose around US$250 worthof basic medical equipment from anagreed list. This equipment was condi-tional on following the treatmentguidelines and book keeping system.

Initially some CHS staff found itdifficult to understand and adhere to thenew accounting and prescribing proce-dures. However, the district health team’ssupervisory visits and at least one earlyvisit from a Save the Children team mem-ber helped to resolve problems. After thisvisit, when processing the monthly infor-mation for the district, the project wroteto the district health officer highlightingany unsatisfactory practices withinparticular CHSs, (such as overuse ofantibiotics or injections). If, after warn-ings, bad practices went unchanged, therequested equipment was refused untilimprovements had been made.

The supervisors’ motivation andabilities were another concern. If highlyqualified the supervisors were reluctantto travel around to the CHSs. If theywere less highly qualified they weremore willing to travel but did not havethe authority to advise the medicalassistants on their practice. This problemwas tackled differently in each dis-trict, but on the whole the supervisorsmanaged to collect the necessaryinformation. The head of the districthealth office reviewed the supervisors’progress each month when they came into collect their salaries. The review wasbased on the information that had beencollected. When information had notbeen collected for the month because thesupervisors had not done their work,equipment distribution was stoppedin the whole district. We also stoppeddelivery if the information seemed unre-liable, for example if everything wasscored at 100%. The reliability of the

HAI Phong... cont’d from pg. 15

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Box 2

The InformationEducation andCommunication

campaign evaluation

◆ ◆ ◆

Evaluation

Two hundred households from fivecommunes were randomly selectedand interviewed.

The results showed that the IECcampaign had been memorable:• 89% of households could report

some IEC messages.• Only 25% claimed no change in

knowledge. The other 75%claimed a change in knowledge,practice or both.

The most effective means of commu-nication was the commune publicaddress system. 67% of respondentsremembered at least one messagefrom these.

52% of all households rememberedsomething from TV (51% of thehouseholds owned a TV).

53% remembered something thattheir CHS staff had told them.

Newspapers and posters were lesseffective with only 7.5% and 15%remembering something from these.

The leaflet was not remembered veryoften (37%), but in the communeswhere the leaflet was not distributedto each house, respondents weretwice as likely not to remember anymessage.

Conclusions

IEC campaigns based on locallymade programmes and research-based messages can be veryeffective and inexpensive in VietNam. Commune public addresssystems are still effective in ruralareas. This is based on the decentral-ised media system of province,district and commune. This hasprofound implications for futurecampaigns on, for example,nutrition, weaning practices or HIV.

(A full report of the IEC evaluation isavailable from the address at the endof the article).

baseline research was carried out. Thestudies involved randomly choosing 40CHSs and looking at the out patient book,the accounting books, the drug cabinetand performing some interviews. Fromthe out patient book, the last 30 treatmentswere looked at in each CHS for the pre-scribing indicators.

A major impactAs the project was started district by

district over an 18-month period, the base-line research in new districts acted as arolling control to the results shown. Eachnew district showed broadly the samepattern of results as the original baseline,thus showing that most of the impactcould be attributed to the project activi-ties.

The most significant finding was thelarge improvement in the prescribing pa-rameters as can be seen in Table 1. In eachdistrict these improvements took place inthe first month after the workshops, andthen went on improving over the next fewmonths to reach a plateau which wasmaintained to six months beyond the endof the project (see Table 1). This showsthat good prescribing becomes a habitwhen maintained due to incentives overa considerable period.

The treatment guidelines and agreedlimited list of drugs were successfullydeveloped in each district. The week ofretraining concentrated on these. Eachdistrict guidelines covered around 10 con-ditions that covered more than 80% ofpatients. The 12 district guidelines wereeventually combined into one book forthe Province. As shown in Table 1, theguidelines were followed in a large per-centage of cases. The CHSs stocked anaverage of 27 of the 29 or 30 recom-mended drugs, but continued to stock anaverage of 23 other drugs, and 55% ofCHSs stocked specifically non regulationdrugs such as steroids, gentamycin andlincomycin. When asked they said thatthey sold these profitably over the coun-ter, from their drug store, and thereforeliked to stock them. Anecdotally this isan improvement on the pre-existing situ-

Table 1

Hai Phong baseline, Hai Phong researchand Hai Phong latest supervisors’ reports

Hai Research Latest Research LatestPhong RESULTS Super- RESULTS Super-Baseline vision vision

Reports Reportsn = 690 n = 1,200 n = 4,050 n = 1,200 n = 6,510

MONTH August December 1995 September 19961994

Patient numbers per CHS per month 76 115 120 114 137

ITEM/PT 2.3 1.4 1.5 1.5 1.4

% patients given VITAMINS 75% 8% 8% 6% 6%

% patients given INJECTIONS 33% 7% 7% 6% 6%

% patients given ANTIBIOTICS 69% 46% 45% 48% 43%

% antibiotic DOSES OK 29% 91% 98% 93% 98%

% treatments following the STG 92% 93% 86% 95%

to buy drugs, presumably because therewas a consensus that this purchasedenough of the products on the drug list tohave a sufficient store. This has impor-tant implications for funding of projectsin the future. The excess money was keptsafely in reserve, and may help the drugfund’s sustainability. The accounting sys-tem was only fully operated in around65% of the CHSs. Profit was not one ofthe things we asked to be recorded, as thisis a sensitive issue with potential tax con-sequences. However the average monthlypurchasing of drugs was around US$150,so assuming a 10% mark up, an extraUS$15 a month served to supplementsalaries which were only $6 a month. Thiswas not a fortune, but was a significantaddition.

All 217 CHSs eventually received theequipment they requested, although somewas delayed because the station did notfulfil the criteria of good prescribing.Using the equipment donation in this wayprovided a much-needed leverage to give

overall profit from selling drugs shouldhave increased due to the number ofpatients being seen.

The quality of care given to patientsimproved in the form of better drug andequipment supplies, better staff know-ledge in diagnosis and treatment, andabove all better prescribing.

It should be emphasised that thiswas first and foremost a practical projectto improve the deteriorating health caresituation, and only secondly a researchproject. The Hai Phong authorities had nointerest in research as such, but wantedbenefit for their people as soon as possi-ble. The whole project was run onoperational research lines. The justifica-tion was that all information usedshould be locally derived to increasethe relevance, and that supervision datawere a useful management tool and anecessary way of assessing whetherequipment should be donated or not.

The project itself was multi-faceted,using innovative together with well-triedtechniques that had been shown to workin other situations. This means that wecannot say which part of the project wasresponsible for its success. However thiswas never the intention. It is the verymultiplicity of approaches that has nowbeen shown to be effective. The innova-tion is the combination of the factorsinvolved, with particular focus on the con-ditional donation of chosen equipmentdepending on good prescribing and theeffective setting up of district widesupervision. ❏

* Dr John Chalker was Project Manager forthe Hai Phong Project, from December 1993to March 1996, for Save the ChildrenFund UK.

■ ■ ■

For further information on the Programmecontact: The Field Director, Save the ChildrenFund UK, 218 Doi Can Street, Ba DinhDistrict, Hanoi, Viet Nam. Reports on theProgramme evaluations, including thepublic information campaign, are availablefrom this address. Other publications arepending.

supervisors’ information was checkedthrough evaluation exercises and wasfound to be very good. Supervisionresults showed a large improvement inprescribing habits and book keeping overthe first five months of activity for eachdistrict (see Table 1).

EvaluationSupervisors’data were checked by

quantitative evaluations in December1995, before the project had finished andthen again in September 1996, six monthsafter the end of the external inputs.

These were retrospective studies, inthe eight rural districts which the origi-nal project covered, and where the

ation when all CHSs stockedsuch drugs.

The supervision systemeventually functioned well inall districts. The informationproduced in this way wasshown as reliable whencompared to the evaluationresearch (see Table 1). In twodistricts, after three months,when the equipment wasdue, we refused to release theequipment to any of theCHSs, as we felt the super-vision results were unreliableor they had not been pro-duced. After this thingsimproved. The conditionalityof equipment donation on

At the end of a series of training workshops John Chalkerpresents a participant with a set of posters, a cash box pluspadlock and a calculator. Inside the box are all the accountsand record keeping books necessary for one year. Allcommune health stations received these

reliable and regular supervision provedan effective incentive.

CONCLUSIONSA drug fund was supplied to each

CHS, tracked by an accounting system.Interestingly only an average of US$150(out of the US$300 supplied) was used

an incentive towards rational drug use.Patient attendance increased during

the project and maintained that level forsix months after the project’s end (seeTable 1). This may have been in part dueto the IEC campaign (see Boxes 1 and2). This means that although each patientmay be treated more rationally, andtherefore be given fewer drugs, the

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Survey highlights failings in publiceducation in rational drug use

A surprise finding was that there werefewer differences than expected betweenthe types of programmes in developingand developed countries. The mostsignificant was the different media used.While education programmes in devel-oped countries relied more on the printedword to get their message across,programmes in developing countries re-ported more frequent use of the massmedia, especially radio. In developingcountries, the most popular channel ofcommunication was the mass media (76%of projects) followed by workshops(70%) and the distribution or display ofprinted materials (26%). Developed coun-tries focused mainly on printed materials(61% of projects) and the mass media(56%).

Reaching out toschoolchildren and theelderly

School projects accounted for a largenumber of education programmes, espe-cially in developed countries, but onlySweden had launched a nationwide

programme targeting all schools. Projectsranged from a novel “pill-box” informa-tion campaign in secondary schools inBelgium (see Box 1), to projects foryounger children in the United States,involving the use of pharmacy studentsto teach drug safety and compliance, andencourage children to take responsibilityfor their own health.

Many of the sample school kitssubmitted had been developed incollaboration with the pharmaceuticalindustry or pharmacy organizations. Mostfailed to highlight the risk/benefit equa-tion of drug use, or even that the sameactive substance may be marketed underdifferent brand names and at differentprices. In addition, little effort was madeto encourage children to develop amore objective view of the commercialpromotion of drugs.

A variety of innovative approaches arebeing used by groups in both developedand developing countries to get themessage across. In Germany, the BUKOPharma-Kampagne uses street theatrepresentations to raise public awarenessabout rational drug use, while in Australia,the Medicine Information Project makesuse of trained elderly volunteers as peereducators to promote rational drug useamong the elderly population. Volunteersreceive an initial five days’ training,updated four times a year. The topics

R E S E A R C H

The report by the Action Programmeon Essential Drugs is based on the firstever global survey of public educationin rational drug use. The study set out toestablish who and what is being targetedby rational use programmes; who isdoing the work, how and why; what arethe needs and lessons learned; and whatfuture action needs to be taken. The sur-vey included data from about 100questionnaires and educational mate-rial gathered from 38 countries (25developing and 13 developed countries).

Critical need forpublic education

The report points out that in manyparts of the world up to 80% of illnessepisodes are self-treated with modernpharmaceuticals. And even where formalhealth care channels are used, it is theconsumer – not the prescriber – who de-termines whether and how the drugs areused. These decisions are based on theshared beliefs of family, friends or thewider community; information from pre-scribers and dispensers; and promotionalmaterial. As a result, consumers need ac-cess to accurate and understandableinformation about the potential benefitsand risks of medicines in general, includ-ing possible side effects; how they actwithin the body; and the limitations ofpharmacotherapy and other treatmentoptions.

“With the exception of Australia,no country – developed or developing –has undertaken a structured publiceducational programme, targeting allmembers of the community and devel-oped by a coalition of stakeholders,” saysthe report. The authors point out that indeveloping countries it is not surprisingthat, in view of the wide range of othercompeting areas of drug policy, publiceducation in rational drug use is oftengiven low priority. But its neglect bydeveloped countries is more difficult tounderstand.

“It is more difficult to explain the lackof commitment by developed countriesto systematic and structured public edu-cation in rational drug use, given thepotential economic and public healthbenefits,” the report states.

Until now few public education inrational drug use interventions have beendocumented or evaluated. As a result,experience cannot be shared or built on.The DAP survey was intended to helpclose this gap.

Box 1“Far-Well” and “Medi-Studt”.The best medicine for students – Belgium

Students are “open” to new information; learning is their job. Students are also proneto using medications, especially in order to study well during examination time.

Knowing this, the higher-educational institutions (non university) in Belgium requestedProjekt Farmaka, a non profit independent organization, to assist. The result, de-signed and developed by a planning group consisting of a pharmacist, prescribersand students, was an innovative “pill-box” of information destined for distribution inschools and student clubs. The choice of subject matter in these “pill-boxes” wasbased on the most common illnesses and complaints, and on the most commonly usedmedicines by students. The main message? “Use a medicine ONLY WHEN IT ISNEEDED.”

But activities went far beyond the simple distribution of the “pill-boxes”. Informationstands were set up during school breaks and at lunchtime, with displays and posters.In order to get a “pill-box”, a student had to complete a quiz form with five pertinentquestions. Workshops were held with the students to discuss the information. Massmedia also participated, with radio interviews and television announcements.

The campaign was well-timed. It was held during the examination period, whenstudents are prone to taking vitamins and “pep pills”, and to having sleep-relatedproblems. The students were particularly open to discussions about medications, andwanted to learn more. Some schools have established a “medicines panel” todisseminate additional information about problem drugs, and to discuss issues likesports and diet. Other schools are organizing question-answer sessions focusing onmedications.

The “pill-box” concept was innovative and sparked people’s curiosity. The materialscould be improved, to be sure, and future campaigns will take into considerationmore of the students’ views on content, in addition to design.

Box 2Michoacan, Mexico holds acampaign: Towards theRational Use of Drugs

Given evidence of an overabundantuse of medications by the generalpopulation, of an over-prescription ofmedications by medical doctors, andof unethical drug promotion, anongovernmental organization in onestate of Mexico embarked on a shortbut intense educational campaign.Participants in the planning wereprescribers, government officials,community members, students, themedia, and communication experts.

The campaign targeted the generalpublic, but also prescribers andmedical students. Materials devel-oped included posters, leaflets, pressarticles, slides, radio and televisionprogrammes, and posters for doctors.Many of the printed materials weredisplayed at points of prescription;others were used during 3-dayseminars held at the local medicalschool. The mass-media broadcastslasted for three months, with increas-ing intensity just prior to the medicalschool conferences.

Feedback after the campaign wasvery positive. Medical professionalsand students expressed increasedawareness of the problems. Thepharmacology curriculum of the localuniversity was revised. Articlespublished in the local and nationalpress suggested a significant changein general knowledge about rationaldrug use.

No words are necessary to convey thismessage on the dangers of becomingdependent on tranquilisers

AIS

Peru

Aglobal survey of public education in rational drug use1 has revealed thatefforts in both developing and developed countries are being severelyhampered by under-funding, lack of support and a shortage ofexpertise. The outcome, says the report, is a vicious circle in which projects

are poorly planned, weakly implemented, and not evaluated rigorously enough.

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covered include consumer rights andresponsibilities, use of specific medica-tions, assertiveness, problem-solving, aswell as presentational and listening skills.

developed countries.The report highlights the failure of

most projects to evaluate the impact oftheir activities. As a result, cost/benefit

to have been a failure.The main problems faced

by projects included:

➤ shortage of funds;

➤ inadequate external col-laboration and support;

➤ poor coordination;

➤ shortage of time andpersonnel;

➤ opposition from vestedinterests (both commer-cial and professional);

➤ unsupportive legislation.

Of these, the lack offunds was the major problemfor developing countries,while for developed coun-tries, the principal constraintwas a shortage of time andpersonnel. On sources offunding, the survey foundthat developing countryprojects were most likely tobe funded by internationalorganizations or inter-national NGOs, whileministries of health andprofessional associationswere the major source for developedcountries.

Tackling the problemsThe report notes that if public educa-

tion is to be properly researched, backedby the necessary tools and knowledge,and be effective and sustainable, it mustbe adequately resourced – ideally from avariety of funding sources. It says new,more creative and sustainable sources offunding are needed, possibly including:

➤ a tax on commercial drug informationbudgets to provide independent infor-mation to consumers and to supportcommunity projects;

➤ incentives to dispensers to developcommunity education projects orextend individual counselling –particularly in countries wheredispensing is covered by socialinsurance schemes;

➤ independent consumer information forsale at a price that covers recurrentcosts.

The report also highlights the need forgreater advocacy at international, nationaland regional levels to promote the impor-tance and rationale of public educationin rational drug use. It says there is a needfor greater understanding of its potentialcontribution to public health and savingsin health expenditure. Better advocacy,say the authors, would help “avoid sim-plistic, unsustainable, and tokenapproaches that contribute little to realcommunity empowerment and under-standing, but simply pay lip service to thevery real information and educationalneeds of the community in this importantarea.”

Also needed are opportunities forshort-term training and access to simple,practical tools essential for researchand development activities, especiallyfor small-scale community-based pro-grammes. The authors point out that nocourses exist in the area of public educa-tion in rational drug use, and call for the

This Kenyan health education poster warns against one ofthe most common dangers in many developing countries –untrained drug vendors whose products are often substandardor counterfeit

development of an international trainingcourse through which educators couldstrengthen their communication skillsand, in turn, train national colleaguesthrough in-country training programmes.

“Organizations or people who intendto carry out public education projectsneed clear, usable guidelines to help thembetter plan and structure their activities,including better definitions of thetheme(s), the desired outcomes of theproject, and the target audience.”

The report also calls for the develop-ment of supportive coalitions andpartnerships which could help strengthenthe work and long-term sustainabilityof many organizations, especially thoseworking in relative isolation. But it alsowarns that organizations need to ensurethey are not hijacked by powerful inter-ests “less interested in the community’sown perception of needs and empower-ment, and more concerned with‘marketing’ behaviour considereddesirable by the dominant group.”

The most encouraging finding of thesurvey was, despite its current failings,at its best, public education on rationaldrug use can and does work. Among de-veloping countries this was the secondmost important lesson learned and fordeveloped countries the third most impor-tant. In Bolivia, a primary health careproject declared that it was possible to getthe community to take responsibility fortheir health, while rational use of drugscampaigners in Bangladesh reported thateffective lobbying had shown that “con-tinuous, logical insistence to producers onrational/ethical production works.”Elsewhere, in Australia, the MedicineInformation Project noted that, “empow-ering consumers can drive change at alllevels of the health system.” ❏

Reference

1. WHO/DAP. Public education in rational drug use: aglobal survey. DAP Research Series No.24. Geneva:World Health Organization; 1997. WHO/DAP/97.5.

Both health professionals and the generalpublic need better information and educationabout when and how to use drugs

Elsewhere, telephone services in Peru andthe Netherlands have been forced toexpand the service after being swampedwith calls on medicine-related healthissues.

Weaknesses identifiedThe authors warn that the use of

a wide range of different materials insome developing country projects –inadvertently promoted by funding andsupporting agencies – may lower theireffectiveness by diluting the message. Thereport highlights the difficult balanceneeded between having a few, well-developed and well-used complementarymaterials and a large number of relativelyunconnected ones.

The report reveals that almost halfthe projects used educational materialthat had never been pre-tested. Of thosethat did pre-test materials, most reportedthat the materials needed subsequent revision. Although the survey did notextend to the quality of pre-testing, theauthors warn that the methodology forthis is often lax. Common weaknessesin the material submitted included aproliferation of messages and the over-use of scare tactics, while some requiredconsiderable training before they couldbe used effectively. The report recom-mends the development of relativelysimple methodologies to ensure that allmaterials can be thoroughly pre-testedand, where necessary, revised beforeuse.

Another weak spot identified in thereport is the lack of structured planning.Most projects selected fairly generalthemes on the basis of “perceived need”and their target groups and expected out-comes were also very broad. However,significantly more developing countries(43%) than developed countries (27%)had based their projects on research find-ings (including consumer and practitionersurveys, focus-group discussions, andpatterns of drug sales).

Of the specific drug problemstargeted, developing countries mostfrequently cited antidiarrhoeals andantibiotics, while developed countriesfocused more often on benzodiazepinesand other sedatives. The illnesses mostoften targeted were diarrhoea and malariain developing countries and asthma in the

analysis is impossible –deterring many potentialdonors. Very few projectswere able to provide evalua-tion reports. And, with theexception of rational use ofdrugs projects in Australiaand Viet Nam, most focusedon activity monitoring ratherthan impact assessment.

“This is unfortunate,” theauthors point out, “for pub-lic education programmesare often accused of a lackof rigour in their work, lead-ing to a questioning of theirvalue and consequent diffi-culties in obtaining supportfor such programmes.”

However, the report also warns thatthe impact of public education strategiesis often incremental – moving graduallyfrom initial awareness raising, to knowl-edge creation, community empowermentand behavioural change. “This may bedifficult to evaluate in the short-term –particularly using classical methodolo-gies,” say the authors,” and care is neededthat we do not ‘throw out the baby withthe bath water’ in an attempt to evaluateimpact with scientific rigour.”

In the absence of systematic evalua-tion studies, many projects gave estimatesof the impact of their activities. In devel-oping countries, 40% of projects judgedthat their project had met its objectives,compared to 66% in developed countries.Meanwhile, 60% of developing countriesand 30% of developed countries said theproject objectives had been partially met.No developing country and only 4% ofdeveloped countries deemed their project

Disseminating the survey results is essential to promoteeffective public education. Here the global survey ispublicised at a pharmacists’ association meeting in theNetherlands

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Advantages of pre-packaged antimalarialsSustainability – cheap, readily

available materials.

Acceptability – to both staff and pa-tients.

Because of the clear advantages ofpre-packaged antimalarials, Ghana’sdistrict medical officers are eager toextend the practice to other commonlyused drugs.

The Ghanaian study adds to theevidence from similar research onpre packaging in South-East Asia. Forexample, in China, blister packaging ofantimalarials produced 97% adherence totreatment compared to 83% in the con-trol group, whose drugs were handed outin envelopes (which are often lost or dis-integrate in the rainy season associatedwith malaria).

Why patients needinformation

Other Ghanaian studies have shownhow much greater the effect of pre-packaging antimalarials is when betterinformation is provided to patients by pre-scribers and dispensers. These studieswere part of the series being carried outby district medical teams in collaborationwith the Health Ministry’s HealthResearch Unit, in the context of Ghana’shealth sector reforms. A Phase 1 study hadindicated that many patients who receivechloroquine are not given any informa-tion about how many tablets to take or

how often to take them. They may alsobe given either more or less chloroquinethan they need. This is important becausefailure to comply with the full course oftreatment affects both the patient’s cureand the drug resistance of parasites.

number of patients strictly complyingwith these instructions. The proportion ofpeople obtaining at least enough chloro-quine on each of the three days oftreatment increased from 29% to 54%.The proportion of children who obtained

R E S E A R C H

T R A I N I N G

Course offers flexible approach tocommunity-based health education

workplace for a diploma, based onimplementation of a project that theydesigned at Leeds.

The aims of the course are to provideskills in research, planning, managementand evaluation of health education, andprovide opportunities to apply these skillsto a problem from the participant’s ownwork setting. Applicants should be expe-rienced managers and staff within fieldprojects who require a short course toimprove their capacity to plan, implementand manage the health promotion com-ponents of projects.

Module on medicines andessential drugs…

Among topics covered in this modulewill be:

➤ Appropriate use of medicines, includ-ing an introduction to: the essential

drugs concept and appropriate use ofmedicines; the work of WHO’s Ac-tion Programme on Essential Drugs,international pressure groups and con-sumer movements; and problemsarising from inappropriate use ofmedicines.

➤ Health seeeking behaviours: self-medication, informal market sectorsfor medicines and problems ofimplementing essential/rational drugpolicies.

➤ Assessment of needs for healtheducation/health promotion supportfor appropriate use of medicines.

➤ Community, social and economicinfluences on use of medicines and therole of multinational companies.

➤ Health education and health promo-tion methods in various settings:national campaigns, mass media,

patient education, community selfhelp groups, community pressuregroups, training of pharmacists, andtraining in the informal sector.

➤ Planning for programmes to promoteappropriate use of medicines: selec-tion of indicators for monitoring andevaluation.

The course is expected to cost £3,000for academic tuition and field visits, withsubsistence/accomodation expenses ofapproximately £2,500. ❏

For further details contact: Overseas Admis-sions Tutor, Health Education, Room F505,Leeds Metropolitan University, CalverleyStreet, Leeds LS1 3HE, UK. Tel: + 44 11328322600, fax: + 44 113 2835921,e-mail: [email protected]

Diseases, 1211 Geneva 27, Switzerland.

Source: TDR Newsletter No. 54, October1997.

Reference

1. The study was part of a project to improve malariacontrol in Ghana, co-sponsored by the UK’s Departmentfor International Health, Liverpool School of TropicalMedicine (UK), the Ministry of Health in Ghana andWHO’s Special Programme for Research and Trainingin Tropical Diseases (TDR).

The follow-up intervention ensuredthat prescribers and dispensers providedfull information to patients about theduration of therapy and the quantity ofchloroquine to take each day. As wellas verbal instructions patients weregiven a diagrammatic explanation to takehome.

Following the intervention there wasa significant increase in adherence totreatment – from 25% to 50% – in the

The packaging process for antimalarials, seen here at theNational Institute of Medical Research, Lagos, Nigeria. Pillsare bagged, heat sealed and labelled with dosageinstructions

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at least the recommendedminimum dose of chloro-quine syrup on each of thethree days increased from59% to 85%. Sample sizesused in the study werebetween 55 and 75 patients.

This work shows that alittle time invested in provid-ing appropriate informationto the user at primary healthcare facilities will, in the longrun, pay dividends in terms ofincreased patient adherenceto treatment. ❏

For further information contact:World Health Organization,Special Programme for Re-search and Training in Tropical

AGhanaian study1 has shown thattreatment of malaria is more cost-effective, in terms of both timeand money when antimalarials

are pre-packed in daily doses. Preliminaryobservations in six districts indicated thatsome of the major problems in malariacontrol programmes are: high cost oftreatment; high chloroquine consumption(in syrup form); long waiting times atdispensaries; and a large number ofuntrained/unqualified dispensers who areunable to give advice.

Two types of pre-packaging were usedin the study – plastic bottles for chloro-quine syrup and sealed plastic bags forchloroquine tablets. The advantages ofpre-packaged antimalarials were found toinclude:

Reduced cost because of: reduction inthe number of drugs prescribed; smallervolumes of syrup consumed; reduction inthe number of injections given; reductionin excess chloroquine consumption.

Improved drug management – easierto balance books; easier to monitor drugsissued; reduced contamination; lesswastage.

Improved case management – dosesgiven according to weight.

Improved compliance – easy tounderstand and easy to rememberinstructions; more effective counselling.

Reduced waiting times in dis-pensaries.

IN publicising one of its newestcourses, Leeds MetropolitanUniversity in the UK sets outclearly the benefits of health edu-

cation: the awareness it creates amongthe community, policy makers and healthcare providers of the advantages of arational drugs programme and the properuse of medicines; the increase in the skillsof health care providers in the deliveryof sensitive, appropriate and effective pa-tient education; and the encouragementit gives for community and politicalaction to prevent the misuse of drugs andmedicines.

The University is offering a 10-weekcourse in community-based healtheducation and health promotion withspecialist options, including one on medi-cines and essential drugs. Participantseither finish after 10 weeks and receive acertificate of attendance or study furtherby distance learning within their own

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Personal formulary system helpsuniversity students

Guide to Good Prescribing).One side of the page contains the

information needed to check not onlywhether a specific drug is indicated forthe disease but also whether the drug issuitable for the individual patient (seeFigure). If the doctor or student has de-cided that the drug can be prescribed,they then turn to the other side of thepage. Here a prescription can be made outtogether with the necessary informationand instructions for the patient, as wellthe date of the next appointment, whereappropriate (see Figure). Informationabout monitoring the drug treatment canalso be inserted here. With the loose-leafsystem, the content of the personalformulary can be easily changed.

The simplest way is to write or typethe information about each P-drug. Acomputer programme has been developedfor this with technical support from theWHO Collaborating Centre for Pharma-cotherapy Teaching and Training atGroningen University. Using thisprogramme, the data can be typed, andprinted in a standard format as shownin the Figure. Students can also add andremove drugs, and revise any of the in-formation about an individual drug. Inthis way students build up their ownpersonal formulary. To help make itmore personalised, each printout includesthe name of the student. The programmecan be installed on a computer network –a university network, for example – or on

a personal computer.In the computer network of the Free

University of Amsterdam, information onover 90 drugs has been included in thereference database. Clinical expertswithin the university consider these drugsappropriate for the treatment of 129 dis-eases and symptoms. At the end of thesix-year undergraduate course medicalstudents must be able to treat correctly,within 10 minutes, a real patient suffer-ing from any one of these diseases. At thestart of the second year, students receivea personal formulary with a printed ver-sion of the basic information on the fullrange of over 90 drugs and can copy thisinformation to their personal database.Next they are trained in developing andusing their personal formulary. Up to thefourth year they practice in small groupsby treating both textbook and simulatedpatients. A syllabus has been developedfor this which includes about 200 text-book cases together with treatment planforms (following the sequential approachof the Guide to Good Prescribing) andsuggestions for patient role-playing ex-ercises. During the internships in the fifthand sixth year, the students practice withreal patients. Students can buy a personal

formulary and the syllabus for US$20.They also receive the Dutch Drug Com-pendium free of charge from the NationalSick Fund.

Initial results so far from the personalformulary system have been promising.During a realistic training session, involv-ing three simulated patients, the secondyear students taught in this way pre-scribed drugs more rationally andcorrectly than graduates who had fol-lowed the traditional curriculum. ❏

* Theo P.G.M. de Vries is Professor ofPharmacotherapy at the Free University ofAmsterdam, Van der Boechorststraat 7,1081 BT Amsterdam, the Netherlands. Fax:+ 31 20 444 8100.

Guide to Good Prescribingavailable in more languages

To add to the list of locally producedversions of Guide to Good Prescrib-ing, editions have now beenpublished in Brazil (Portuguese), inIndia (in Bengali), Iraq, Italy, Japanand Pakistan. A Spanish edition willfollow by the end of 1998.

The personal formulary is a practicalelaboration of the P(ersonal)-drugconcept, which is outlined in Part 2 of theWHO Guide to Good Prescribing. It con-sists of a sequential approach for selectinga personal set of drugs for the treatmentof specific diseases. By using a loose-leafnotebook and a small manual, practicalinformation about the selected diseasesand P-drugs can be inserted, changed ordeleted. In this way a personal formularycan be developed.

The personal formulary is dividedinto sections. The first section is usedto list selected diseases. For each disease,a chosen standard drug and non-drugtreatment can be described extensivelyor merely summarised. For example,(Dutch Standard Guidelines):

Essential hypertension: start withweight, salt, and stress reduction. If noresult:1. atenolol or hydrochlorothiazide; if no

result:2. atenolol + hydrochlorothiazide; if no

result:3. captopril; if no result:4. consider calcium antagonist, alpha

1-blocker, or referral.The second section contains practical

information for prescribing the drugslisted in the previous section. Each pagehas information on a single drug, and theinformation is organized along the linesof the sequential approach to treatingpatients (outlined in Part 3 of the

Addressing supply issuesin the Eastern Caribbean

quantification of needs, drug donations,medical store management and inventorycontrol and drug utilisation reviews. Par-ticipants discussed their own experiencesand worked hard to complete realisticwork plans and timelines for improve-ment projects to be implemented upontheir return to work. These plans wereshared with the Ministries of Health andwill receive support and follow up fromthe Eastern Caribbean Drug Service. ❏

Source: INRUD News, February 1998.

ANAGEMENT Sciences for Healthand the Eastern Caribbean DrugService offered a special eight-day course on managing drug

supply, held in Dominica from 19–28January 1998. The 18 participants in-cluded central medical stores’ managersand hospital drug supply managers fromall nine countries in the Organization ofEastern Caribbean States.

The course was specially designed toaddress the specific drug supply issues ofthe island countries, including: lack ofnational drug policies; lack of current

M

TTHEO P.G.M. DE VRIES*

HE development of a personal formulary system by university teachers inthe Netherlands is proving to be a valuable tool for students in learninghow to prescribe drugs rationally. The personalised compendium of drugsnot only helps students learn about the drugs they prescribe, it also helps

them choose alternatives in case one drug is unsuitable for a particular patient.

Betty H. O. Student 12-06-98 Pharmac 95 Page 1

tablet 25,50,100 mg Beta blocker atenololAtenolol is a selective beta blocker without intrinsic sympathicomimetic activity. It depresses myocardialcontractility and reduces the heart rate. This initially causes a fall in blood pressure. With continuedtreatment the cardiac output returns to normal but blood pressure remains low because the peripheralvascular resistance is ‘reset’ at a lower level. In addition it may also increase the perfusion of theischaemic area. It has very limited solubility in lipids (limited capacity to pass Blood Brain Barrier).

Check indication

Indication Angina pectoris, HypertensionAlternatives Hydrochlorothiazide, Captopril

Check suitability of the patient

Side effects Hardly any in normal dosages. Sometimes slight sedation, reduced exercisetolerance, or bronchospasm.

Contra-indic. Sinusbradycardia, AV block, hypotension, cardiogenic shock, heartfailure, asthma.Interactions Some calcium antagonists, some anaesthetics.

Betty H. O. Student 12-06-98 Pharmac 95 Page 2

tablet 25,50,100 mg Beta blocker atenolol

Dosage

Adjust to each patient individually, start as low as possible. Raise the dose after 2 weeks if needed.Higher dosages do not increase therapeutic effect, but may increase side effects.Hypertension Start with 50 mg in the morning; average 50–100 mg per dayAngina pectoris 100 mg per day in 1–2 doses

Give patient information

Information Hypertension: drug decreases blood pressure. You will usually not notice any effectbut the drug is needed: it will prevent complications of high blood pressure (angina,heart attack, stroke).Angina pectoris: decreases blood pressure, prevents heart from working too hard,preventing chest pain.Hardly any side effects; sometimes slight sedation. In some cases shortness of breath;in that case phone me.

Instructions Take the drug … times per day, for … days;Warnings Angina pectoris: do not suddenly stop taking the drugAppointment Hypertension: one week

Angina pectoris: within one month, earlier if attacks occur more frequently, orbecome more severe.

Follow-up Hypertension: first few months check BP and pulse weekly; try to decrease dosageafter three months, and to stop after one year.Angina pectoris: in case frequency or severity of the attacks increase, more diagnos-tic tests or other treatment are needed. Try to stop drug treatment from time to time.


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Change at WHOHE Fifty-first session of the WorldHealth Assembly, meeting inGeneva in May 1998, electedDr Gro Harlem Brundtland of

Norway to be Director-General of WHOfor a five-year term which started on 21July 1998. Dr Brundtland had been nomi-nated to the position by the 101st Sessionof the WHO Executive Board in January1998. Former Prime Minister of Norway,

Dr Gro Harlem Brundtland, Director-General of WHO

the world one step closer to that goal isour call for action”.

On her first day in office Dr Brundtlandannounced her new management team. Ofthe 10 cabinet members, eight come fromoutside WHO, and six are women. Mem-bers are evenly split between the Northand the South, and all WHO regions arerepresented.

Governments pledge supportfor WHO campaign

The week that Dr Brundtland waselected Director-General and announcedthat one of her goals was to “Roll backmalaria”, good news came from the G8summit meeting of the world’s foremostindustrialised nations. Leaders attendingthe UK summit in May 1998 agreed tosupport WHO’s campaign against infec-tious and parasitic diseases, particularlymalaria. ❏

Rational use conferencein Palestine

health policy that meets the needs of allPalestinians.

Held at Beir Zeit University in Octo-ber 1998, the conference was organizedby the Union of Palestinian MedicalRelief Committees with the support ofthe French Government and the UnitedNations Development Programme. ❏

For further information, contact: NadineKamal, Head Pharmacist, Union of Palestin-ian Medical Relief Committees, P.O.Box51483, Jerusalem. Tel: + 972 2 5834 021,fax: + 972 2 5830 679, e-mail:[email protected]

Executive Board acts onRevised Drug Strategy

each region (of which at least onewould be currently entitled to designatea person to serve on the ExecutiveBoard).

As directed by the Board, WHO’sRegional Committees discussed theRevised Drug Strategy at their autumnmeetings, and nominated their representa-tives for the sub-group. The group metfor the first time in Geneva in October1998, and fulfilled its main objectiveof drafting a new resolution on drugstrategy. A total of 59 Member Statesparticipated in the meeting. As part of thesub-group’s deliberations a one-day paneldiscussion was held, which included pres-entations from interested internationaland nongovernmental organizations. TheExecutive Board will discuss the draftresolution at its 103rd session in January1999. ❏

African countries shareinformation on drug prices

regular tender information received frompublic drug procurement agencies, suchas central medical stores, in 16 Africancountries. The information covers drugdesignation, package size, unit, price,supplier, currency used and exchangerate in US$. A comparison of pricesfrom international suppliers, compiledby Management Sciences for Health,is also included to provide a globalperspective. ❏

Copies of the AFRO Essential Drugs PriceIndicator are available, free of charge,from: Essential Drugs Programme, WHORegional Office for Africa, P.O. Box BE 773,Belvedere, Harare, Zimbabwe, or fromAction Programme on Essential Drugs, WorldHealth Organization, 1211 Geneva 27,Switzerland.

The Essential Drugs Monitorencourages the reproduction ofarticles for non profit uses.

Please clearly credit WHO’sEssential Drugs Monitor as thesource, and send us a copy ofthe reprinted article to the ad-dress given on page 1.

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ALTHOUGH the availability ofessential drugs in Africa has im-proved during the last decade, itis estimated that one-third to a

half of the 700 million people in the re-gion still do not have regular access tothe drugs they need. Over 40% of deathsin Africa are due to infectious diseasesfor which effective medicines exist,but which are not available to those whoare ill.

Drug shortages remain chronic inmost African countries due to such fac-tors as inadequate national supply systemsand weak implementation of nationaldrug policies. Poor knowledge of the in-ternational drug market and the lack ofeffective national quality assurance sys-tems can lead to excessive prices and lowquality products. Appropriate and objec-tive information on drug prices andquality standards is therefore essential fordrug procurement agencies.

In order to help countries in theregion to address these issues, WHO’s Re-gional Office for Africa, in collaborationwith the Action Programme on EssentialDrugs, has developed the AFRO Intensi-fied Essential Drugs Programme. Thenew programme will focus on capacitybuilding, strengthened drug supplysystems, including quality assurance, andthe rational use of drugs.

One priority activity is the AFROEssential Drugs Price Indicator. This newpublication shares information on currentdrug procurement prices in Africa withthe aim of providing purchasing bodieswith a better negotiating position. Datain the first edition are based on the latest

T

EETING on 19 May 1998, WHO’sExecutive Board decided toestablish a two-tier method ofworking to explore the complex

issues, (including those related toglobalisation and trade), raised byReslolution 24 on the Revised Drug Strat-egy, passed by the Board in 1997. An adhoc working group would be open to allMember States wishing to participate; anda sub-group would be created to assistWHO in its contacts with relevant part-ners. These include the World TradeOrganization, the World Intellectual Prop-erty Organization, the pharmaceuticalindustry and NGOs. The Board decidedthat the sub-group would comprise theChair of the drafting group on theRevised Drug Strategy, establishedduring the 51st World Health Assemblyin 1998, and two Member States from

HE first Palestinian conference onrational use of drugs broughttogether an enthusiastic group ofhealth workers, nurses, pharma-

cists and doctors from throughout thehealth sector. Speakers from internationaland local NGOs, Palestinian universities,and physicians’ and pharmacists’ associa-tions helped to raise awareness of rationaluse issues. Discussions ranged from theimpact of inappropriate drug use to stand-ard treatment guidelines, essential drugspolicy, drug information, continuing edu-cation for pharmacists, quality assuranceand drug donations. The event is seen asan important step in moves to design a

and the first woman to become Director-General of WHO, Dr Brundtland studiedmedicine at the University of Oslo andhas a Masters degree in Public Healthfrom Harvard University, USA.

After taking the oath of office, DrBrundtland addressed the World HealthAssembly. She immediately affirmed herconviction that societies can be changedand that poverty can be fought. “The chal-lenge goes to all of us. WHO can and mustchange. It must become more effective,more accountable, more transparent andmore receptive to a changing world”.Referring to the complex processes oftransition that WHO must cope with, thenew Director-General said: “The transi-tion from one century to another seeschanges which will be faster and moredramatic from an economic, social andhealth perspective…Still we are facedwith daunting challenges. Above all they

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are linked to the persistence of poverty.The imbalances are striking. People indeveloping countries carry over 90% ofthe disease burden, yet have access toonly10% of the resources used for health.As regards the transition from the com-municable to the noncommunicablediseases, Dr Brundtland noted:“We need to fight both. Theburden of disease is the burden of unful-

filled human development”.Dr Brundtland concluded

her speech saying: “My mo-tivation will be this: makinga difference – being able tomake an effort – being oneof many dedicated peopleworking together for whatwe believe in. I envisage aworld where solidarity bindsthe fortunate with those lessfavoured. Where our collec-tive efforts will help roll backall the diseases of the poor.Where our collective effortswill assure universal accessto compassionate and com-petent health care. Bringing

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First national formulary for AustraliaHE first edition of the AustralianMedicines Handbook is the cul-mination of seven years’ planningand hard work. The need for an

independent and up-to-date source ofdrug information to foster rationalprescribing in Australia has long been dis-cussed. In February 1991, the ConsumerHealth Forum and the Australasian So-ciety of Clinical and ExperimentalPharmacologists and Toxicologists con-vened a meeting to discuss how drugprescribing in Australia might be im-proved. Representatives of prescribersand pharmacists, teachers of pharmacol-ogy and therapeutics, government andconsumer groups attended the meeting.There was unanimous agreement thatAustralia should develop a nationalformulary, like the British NationalFormulary, which since 1981 hasachieved a reputation as an indis-pensable and widely used source ofindependent drug information.

The task of developing a nationalformulary, to be called the AustralianMedicines Handbook, was ultimatelytaken by three organizations: theAustralasian Society of Clinical andExperimental Pharmacologists andToxicologists, the Pharmaceutical Soci-ety of Australia and the Royal AustralianCollege of General Practitioners. Theseorganizations obtained a grant from theCommonwealth Department of Healthand Human Services in 1995 to producea hard copy of the first edition of theHandbook. Work began on the content in1996. Whilst modelled on the conceptof the British National Formulary, theHandbook was to be totally Australian

and its contents were to reflect contem-porary Australian clinical practice. To thisend, the editors recruited a large numberof expert reviewers from all disciplinesand all parts of the country.

SERVING READERS’ NEEDS

The philosophy of the AustralianMedicines Handbook is to use the bestavailable evidence to support prescribingand dispensing recommendations, andthus the publication actively discouragesthe use of drugs where the evidence fortheir efficacy is lacking or poor. The pur-pose of the Handbook is two-fold: firstly,to provide a readily accessible, concise,up-to-date source of independent druginformation to facilitate effective, ra-tional, safe and economical prescribingand dispensing; secondly, to provide aneducational tool for practitioners andstudents. Readers are likely to use theformulary in different ways. Studentsmight want to read a whole chapter tolearn about a drug class, whilst prescrib-ers might want to focus only on specificinformation, such as the dosage or thecommon adverse effects of a drug.

The first 20 chapters contain in-formation which provides, in part, atheoretical framework for the reader touse the individual drug monographs.These monographs are organized withinchapters, each of which represents anorgan system, and the major therapeuticdrug classes within the system. Compara-tive information about different drugswithin the same class, or for other drugsfor the same indication, is highlighted sothat the reader can make an informed

choice about the most appropriate drugto use. Since a book of this size cannotbe exhaustive, the writers and membersof the editorial advisory panels have in-cluded only that material which theyconsider to be the most relevant anduseful for rapid reference by the busyhealth professional. The Handbook shouldbe supplemented, where necessary, by

more comprehensive texts and by themanufacturer’s product information. Itwill complement existing publications,such as the journal, Australian Prescriber,and the Therapeutic Guidelines series (seeEDM-24 Published Lately).

Future editions of the AustralianMedicines Handbook will be publishedannually and all relevant material up-dated. The next edition will be expandedto contain information on fluids, electro-lytes and nutritional agents; anti cancerdrugs; and emergency drugs; and willprovide more expansive information onanaesthetics and psychiatric drugs. Anelectronic version will be available laterin 1998.

The three organizations participatingin this project have high expectations ofthe Handbook. Firstly, the independentevidence-based material it containsshould enable practitioners to make in-formed choices for their patients, whichwill improve outcomes, reduce unwanteddrug effects and provide value for money.Secondly, students should be able to usethe formulary to acquire a strong ground-ing in therapeutics as undergraduates andto continue to use it when they becomepractitioners. Finally, the Handbook canbecome an important vehicle for enhanc-ing the quality use of medicines inAustralia to the benefit of all. ❏

Australian Medicines Handbook Pty Ltd,PO Box 240, Rundle Mall, AdelaideSA 5000 Australia. Tel: + 61 8 82225861,fax + 61 8 82225863, e-mail: [email protected] and homepage: http://www.amh.net.au Price: AUS$125 andAUS$85 for students.

UK study says patients not receivinginformation they need

choices about treatments and are ineffect excluded from the decisionmaking process.

The report details a study in which 62patients and 28 clinical experts revieweda wide range of leaflets, videos andaudiotapes in current use. It concludesthat the information they contained wasoften out-of-date and inaccurate, andsometimes seriously misleading. It did notinclude full details of treatment options,information about outcomes and treat-ment effectiveness was often omitted orwas unreliable, and patients’ questionswere left unanswered.

Change necessary

The patients involved in the study feltthat many of the leaflets were patronis-ing and failed to recognise their right tobe actively involved in decisions abouttheir care. The report recommends thatabove all, information should start by

answering the questions and concernsraised by patients. The language usedshould be simple without being patronis-ing. It should be honest about benefits andrisks of treatment. So far, the NationalHealth Service Executive has failed totake the initiative on patient information,the report states. Informing Patientsrecommends that they should funddevelopment and evaluation of materialsabout common clinical conditions. Thesecould be used alongside the clinical guide-lines to be commissioned by the NationalInstitute for Clinical Excellence. Thereshould also be a system for accreditingwritten and computerized materials, theFund believes.

A patient participating in one of thefocus groups for the research, said:“When they measured my cholesterol lev-els, I tried to find out what the numbersmeant, what the safe levels were and therole of triglycerides. I also asked whetherthe tamoxifen I am taking for breast

cancer would have an effect on mycholesterol and on my heart. “I was com-pletely brushed aside; they ignored theknowledge I had acquired from my ownresearch and I was told not to read toomuch! They also said no one else hadcomplained about lack of information.I’m still none the wiser about the factsand my own condition.”

The King’s Fund is urging theGovernment, the National HealthService Executive and health authoritiesto support good quality information, toenable patients to participate in decisionsabout their treatment and to improve theeffectiveness of clinical care. ❏

Informing Patients: An Assessment of the Qual-ity of Patient Information Materials is availablefrom the King’s Fund Bookshop, 11–13Cavendish Square, London, W1M OAN,UK. Tel: + 171 307 2591. Price: £16.95.

Reference

1. Materials were studied about the following conditions:back pain, cataract, depression, glue ear, high choles-terol, hip replacement, infertility, menorrhagia, prostateand stroke.

PATIENTS in the UK are beingdenied access to reliable informa-tion about treatment options,according to a new study1 from

the King’s Fund, an independent Britishhealth charity. Health professionals eitherdo not know the answers to questions,withhold the information or simply failto present the whole picture about ben-efits and risks. Despite endless surveysdemonstrating that patients want good,clear information, the study concludesthat it is not forthcoming. Yet it is highlylikely that good information would savethe health service money in the long run,the Fund believes, since it would helppatients to look after themselves in termsof prevention and self-treatment.

The study report, Informing Patients:An Assessment of the Quality of PatientInformation Materials1, demonstrates thatgood quality information can improve theeffectiveness of patient care. Without it,patients are unable to make informed

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IDA celebrates and looks tothe future

Availability of Essential Drugs”. Theystressed the need to ensure that genericdrugs of assured quality were trusted andaccepted both by prescribers and patients.They argued that all countries need todevelop and maintain a national drugpolicy to ensure continuing progress inthe pharmaceutical sector.

A representative from DAP discussedWHO’s role, stressing that it would con-tinue to be complementary to that ofbilateral organizations, industry and nonprofit suppliers in moving from assistancein acute relief situations to the stage ofprogressive development.

The time reserved for discussions andquestions saw a lively interaction betweenthe audience and speakers. Debate rangedover many topics, including the impor-tance of national drug policies andrational drug use; the need to control drugdonations; the harmonisation of registra-tion rules; the role of national qualitycontrol laboratories; and the need to fur-ther develop the WHO CertificationScheme on the Quality of Pharmaceuti-cal Products moving in InternationalCommerce.

On this memorable occasion IDA hadsought to provide a forum for the ex-change of facts and ideas – to look at whathas been achieved in the area of essentialdrugs and what remains to be done.Guests left the symposium with a muchbetter understanding of the problems andthe opportunities in this critical area. ❏

Controlling research data and updating for the Internet:journal editors revise guidelines

Opinions differ on how editors ofmedical journals should handle the ques-tion of commercial influences on researchthat they report. After reflecting at lengthon this complex issue, the InternationalCommittee of Medical Journal Editors(still commonly known as the VancouverGroup) altered its guidelines when it metin Boston, USA, in May 1997.

On the issue of controlling researchdata, the Vancouver Group agreed that:“Scientists have an ethical obligation tosubmit creditable research results for pub-lication, and should expect to do so. Asthe persons directly responsible for theirwork, the authors as individuals shouldnot enter into agreements that interferewith their control over the decision topublish.”

On the precise influences that a spon-sor might have in a research setting, theGroup wrote that: “Editors should requireauthors to describe the role of thesesources, if any, in study design, collec-tion, analysis and interpretation of data,and writing of the report. If the support-ing source had no such involvement, theauthors should so state. Because the bi-ases potentially introduced by the directinvolvement of supporting agencies inresearch are analogous to methodolo-gical biases of other types (e.g. studydesign, statistical and psychologicalfactors etc.), the type and degree of in-volvement of the supporting agencyshould be described in the methodssection. Editors should also requiredisclosure of whether or not the support-ing agency controlled or influenced the

decision to submit the final manuscriptfor publication.”

The second issue that the Grouptackled was the standards for postingmedical and health information on theInternet. The principles that apply to ad-vertising in journals must now be adaptedfor the Internet. The Vancouver Grouptackled this rapidly changing area withthe expectation that their statement willneed to be revised as web technologydevelops. The Group agreed that: “Elec-tronic publishing (which includes theInternet) is publishing. Authors, editorsand publishers of biomedical journalswho post medical and health informationon the Internet connected to these publi-cations should follow the policiesestablished by the International Commit-tee of Medical Journal Editors as theUniform Requirements for Authors Sub-mitting Articles to Biomedical Journalsand related statements.

The nature of the Internet requiressome special considerations within thesewell established and accepted policies. Asa minimum, sites should indicate thenames of editors, authors, and contribu-tors and their affiliations, relevantcredentials, and relevant conflicts of in-terest; documentation and attribution ofreferences and sources of all contents;information about copyright; disclosureof site ownership; and disclosure ofsponsorship and commercial funding.

Linking from one health or medicalInternet site to another may be perceivedas recommendation of the quality of thesecond site. Journals thus should exercise

caution in linking to other sites. If linksto other sites are posted as a result of fi-nancial considerations, such should beclearly indicated. All dates of contentposting and updating should be indicated.In electronic, as in print layout, advertis-ing and promotional messages shouldnot be juxtaposed with editorial content.Any commercial content should be

clearly identified as such.”In practice this guidance means

that advertising banners for drugs shouldnot appear on the same screen as edito-rial content. Also all links from onewebsite to another should be carefullyreviewed. ❏

Source: The Lancet, vol. 349, 17 May 1997.

Professor Graham Dukes, opening IDA’s symposium

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Agroup of editors of general medical journals met informally inVancouver, Canada, in 1978 to establish guidelines for the formatof manuscripts submitted to their journals. The group became knownas the Vancouver Group, which expanded, evolved into the Interna-

tional Committee of Medical Journal Editors, and has gradually broadenedits areas of concern.

HE International DispensaryAssociation (IDA) celebrated its25th anniversary in November1997 with a symposium entitled

“25 years of Essential Drugs: theChallenge Remains”. Over 100 peoplegathered at the Royal Tropical Institute,Amsterdam, to hear seven speakers rep-resenting international governmentalorganizations, national authorities fromrecipient countries, researchers and phar-maceutical suppliers. The symposiumwas chaired by Professor Graham Dukesof Oslo’s Institute of Pharmacotherapy.

The opening paper set the currentscene, arguing that the money availablefor drug treatment of populations is in-sufficient and often not used optimally.Sometimes the wrong drugs are pur-chased, often they are poorly distributedand very commonly they are usedunwisely, the audience was told.

IDA’s emphasis on qualityQuality assurance issues were high-

lighted in papers from representatives ofthe International Federation of Pharma-ceutical Manufacturers Associations andIDA. The latter explained how IDA hasintegrated a full quality assurance systemin its operations. In this way it hasovercome one obstacle to the wideruse of generic drugs in countries whereresources are limited. Speakers fromSudan and Uganda presented theirviews on “Acceptance, Acceptability and

Primary health care systems forthe 21st Century – the need forvision and values

AKING stock of the challenges to health that will confront the world in thecoming century and assessing their implications for future health systems is adaunting task. Yet this was the remit of the Seventh Consultative Committeeon Organization of Health Systems Based on Primary Health Care. The Com-

mittee met in Geneva in February 1997, and, in view of the far-reaching implicationsof its findings for WHO’s future agenda, it was decided to issue a short Statementsummarising its conclusions. ❏

Copies of the Statement and the full report of the Seventh Consultative Committee on Organi-zation of Health Systems based on Primary Health Care are available, free of charge, from:World Health Organization, Division of Analysis, Research and Assessment, Health SystemsDevelopment Programme, 1211 Geneva 27, Switzerland.

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Drugs sold onInternet: WHA acts

measures for enforcement.The Assembly appealed to industry

and consumer organizations to “encour-age their members to promote theformulation and use of good informationpractices, where applicable, consistentwith the principles embodied in the WHOEthical Criteria for Medicinal DrugPromotion”. Delegates also urged thedevelopment of a model guide for gov-ernments to “educate people using theInternet on how best to obtain reliable,independent and compatible informationon medical products”.

Fears for the futureConsumer groups were critical of the

current lack of controls on companies,with HAI issuing a report at the Assem-bly calling for new internationalagreements to regulate product promotionand sales on the Internet. The group wantscommercial or educational informationfrom commercial sources to have thecompany name clearly and prominentlystated on the screen. HAI argues that alladvertisements should have to meet thesame regulatory standards for content asadvertisements in other media, and directlinks to a company’s home page shouldbe regulated as if they originated from thecompany. ❏

Source: Scrip No. 2336, 1998.

Increased local production of essentialdrugs on agenda in Africa

Development Organisation, the WestAfrican Pharmaceutical Federationand WHO.

In his opening speech, the PrimeMinister of Cape Verde insisted on theneed to promote the development of aviable local pharmaceutical industry.The industry should be capable of pro-ducing good quality drugs at affordablecost, within an appropriate regulatoryenvironment, in order to improve thepopulation’s accessibility to essentialdrugs.

Participants held in depth plenary

and group discussions on five majorthemes:

➤ information exchange on the localproduction of pharmaceuticals;

➤ mechanisms to improve manage-ment and increase local production;

➤ bulk purchasing mechanisms atnational, intercountry and regionallevels;

➤ strategies for improving quality as-surance and regulatory mechanisms;

➤ industrial production of traditionalmedicines and their use in the healthcare delivery system.

Moving forward

After discussions a series of recom-mendations were made for each of the fiveareas, to move the initiative forward in apractical and concerted way. The WHORegional Director for Africa expressedhis wish to see the meeting becoming an

Brazil’s doctors turn on toevidence-based medicine

Goodbye AHRTAG, welcomeHealthlink Worldwide

annual event, in order to evaluate progressmade on local production and relatedissues. He also confirmed WHO’s readi-ness to assist Member States in theirpharmaceutical sectors.

Delegates concluded that the meetinghad proved a good opportunity to ex-change experiences related to localproduction of essential drugs in the Re-gion. It was also the first step towards thedevelopment of the existing potential ofthe pharmaceutical industry in Africa. Forthis potential to be realised, participantsagreed that there is a need for greaterpolitical commitment, development ofnational drug policies supportive oflocal production, improved management,and human resources and technologydevelopment. ❏

A report of the meeting is available from:Essential Drugs Programme, WHO RegionalOffice for Africa, P.O. Box BE 773,Belvedere, Harare, Zimbabwe.attracts an audience of some two mil-

lion, to watch the presenter, a doctortrained in evidence-based medicine,interview experts on medical topics.The show’s message is spreading be-yond Brazil’s borders, via satellite toviewers in Argentina, Paraguay andUruguay. ❏

Source: The Lancet, 8 August 1998.

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THE first meeting on the localproduction of essential drugs inthe African Region was held inPraia, Cape Verde, from 14 to

18 September 1998. Organized by theWHO Regional Office for Africa, it wasattended by 44 participants from 19countries in the Region. They includeddirectors of pharmaceutical services andnational supply agencies, national drugregulatory authorities, local drugmanufacturers and specialists in localproduction, as well as representativesof the United Nations Industrial

WENTY thousand Braziliandoctors, approximately 10% ofthe country’s total, regularlywatch a primetime television

show dedicated to promoting the prac-tice of evidence-based medicine. TheBrazilian Cochrane Centre and the SaoPaolo Medical Association created theprogramme, Medicina Baseada emEvidencias, three years ago. It regularly

ELEGATES at the Fifty-first WorldHealth Assembly (WHA), in May1998, expressed concern at theadvertising, promotion and un-

controlled sale of medical products byelectronic communication. There are fearsthat this rapidly developing phenomenonmay present a hazard for public health aswell as a risk for the individual patient –particularly with regard to fraudulentproduct information and lack of indi-vidual counselling for consumers. At the1997 Assembly delegates had already ex-pressed the view that advertising,promotion and sale through the Internetmight result in uncontrolled cross bordertrade of medical products or fraudulentimitations that may be unevaluated,unapproved, unsafe, ineffective, or usedinappropriately.

The Fifty-first WHA adopted a planfor tackling these concerns. While theplan leaves it up to individual govern-ments to decide their own course ofaction it urges them to: review their ex-isting legislation, regulations andguidelines; take regulatory action whereappropriate against violation of theirnational laws; and set up and/orstrengthen mechanisms to monitor prob-lems. Delegates also urged governmentsto collaborate on a range of issues, espe-cially the exchange of information on“difficult cases”, and specific national

EALTHLINK Worldwide is the new name for Appropriate Health Resourcesand Technologies Action Group (AHRTAG) which has been active in thefield of health information since 1977. The new name reflects theorganization’s focus on health and describes its way of working globally –

linking information and health workers, linking partners, linking policy andpractice.

Healthlink Worldwide continues AHRTAG’s aim of improving the health ofpoor and vulnerable communities by strengthening the provision, use and impactof information. Working with more than 30 partner organizations in developingcountries, Healthlink Worldwide runs programmes to support particular healthneeds. These include continuing education and training for health workers inAfrica and the Middle East, and programmes on AIDS and sexual health, childhealth and disability.

Healthlink Worldwide’s practical training and education materials in printedand electronic forms reach nearly two million health and development workers allover the world. The organization provides technical support to partner organiza-tions and others in setting up and developing resource centres and informationservices. This work draws on the organization’s extensive collection of healthlearning materials from developing countries. ❏

For further information contact: Healthlink Worldwide, Farringdon Point, 29–35 FarringdonRoad, London EC1M 3JB, UK. Tel: + 44 171 242 0606, fax: +41 171 242 0041, e-mail:[email protected], website: http://www.healthlink.org.uk


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Improving drug informationin Moldova

Getting the message across:communications and pharmacovigilance

Use” from 13–17 April 1998. Thirty-sixpostgraduate students and residents fromthe Pharmaceutical Faculty of the StateMedical and Pharmaceutical Universityof Moldova joined other faculty members,and staff from the State Quality ControlLaboratory on the course.

The five days passed quickly, with anatmosphere of trust rapidly developingbetween all involved, as discussions,working groups and business gamesbroke down any initial barriers. Studentswho had only intended participating in afew sessions found themselves reorgan-izing their schedules to remain on thecourse. Among the topics discussed were:the essential drugs concept, national es-sential drugs lists; guidelines for drugdonations; the role of independentdrug information centres; systematicapproaches to information searches;analysis of major references, (such asMartindale, the US PharmacopeiaDrug Index and the British National

Formulary); structures for disseminatinginformation on medicines; the creationof hospital formulary lists and formularycommittees; drug information forpatients; and the role of advertising indrug promotion. Course training materi-als were drawn from WHO, HAI,University of Arizona, USA, the US Phar-macopeia, and the US Food and DrugAdministration.

The post course questionnairerevealed that the participants’ high levelof motivation can partly be explainedby the fact that for the majority (76%)the information they received was new(31%) or new in many aspects (45%).The course ended with participantspresenting their own ideas for a structureto facilitate the flow of drug information.All participants were convinced of thebenefit of introducing such a structure atevery level of Moldova’s health system,but stressed the need for state support toachieve this. ❏

D R U G I N F O R M A T I O N

IN the Republic of Moldova thecollapse of the Soviet system hasbrought a flood of medicines onto the market which are virtually

unknown to doctors and pharmacists.The sale of medicines by prescription hasalmost ceased, with doctors’ recommen-dations often ignored as patients are luredby drug store offers. Collaboration be-tween doctors and pharmacists hasdiminished dramatically. The risk of pa-tients purchasing unsafe medicines isincreasing as some drug store staff, drivenby the profit motive, advise patients tobuy the most expensive rather than themost appropriate drugs.

A modern information system formedicines is seen as a priority to improvethe situation, and a prerequisite is to trainpersonnel. Therefore Moldova’s Asso-ciation “DRUGS”, a pharmacologyinformation centre, organized a trainingcourse entitled “A Model of a ModernInformation Network on Rational Drug

TBRUCE HUGMAN*

HE difficulty of balancing benefitand risk in drug therapy, drugscares, patient non adherence totreatment, anxiety and uncer-

tainty about the risks of drugs, and secrecyand suspicion in pharmaceutical matters,were among the pressing concerns whichgave rise to an international conferenceon Effective Communications inPharmacovigilance, held in Erice, Sicily,in September 1997.

Over 70 professionals from 30 coun-tries, representing patients, doctors,nurses, pharmacists, pharmaceutical com-panies, lawyers, academics, regulators,journalists and communications expertsput their collective brain power to thequestion of how drug safety informationcould be better communicated betweenall interested parties in the ultimateinterest of patient welfare.

It was acknowledged that even thebest scientists and clinicians may lack thespecialised skills of effective moderncommunications, and that insufficienttime and priority had been given to dis-cussion and training in this area. Muchmore attention needed to be paid not onlyto the content of communications, but alsoto their form, production quality and themedia chosen for their dissemination.

The danger of secrecy

The climate or context in whichcommunication takes place was also seenas a critical variable: in a climate of se-crecy, suspicion and uncertainty wouldflourish, and leaks of information andmedia scares would be all the more likely.These, in their turn, would lead to an un-dermining of public confidence inmedicine, in the judgement of doctors,and in the integrity of clinicians andpharmaceutical companies in general.

Participants from developed anddeveloping countries alike agreed that aclimate of openness and trust, particularlyin relation to the activities of regulatorsand pharmaceutical companies, was anessential prerequisite to a better under-standing of benefit-risk issues and toincreasingly rational therapy. Accessibil-ity of information was a core requirement.Practitioners needed to be encouragedto see feedback of information from prac-tice, especially adverse drug reactions,as a major professional responsibility.

The value of partnership

The concept of partnership was seenas the ideal to be pursued in the wholearea: partnership especially between cli-nician and patient (the notion of informedchoice by patients was seen as a highpriority); between professionals and themedia (so often at apparent variance witheach other); and between professionals in

this field with professionals in otherareas where significant influence can beexercised (with teachers and schools, forexample, where children’s attitudes andknowledge are established).

Conflicts between public health pri-orities and the needs of individual patientswere noted among the dilemmas to befaced. This was one of the many aspects,which could be resolved only by

multidisciplinary partnership in whichthe varying objectives and wishes of allthe players were negotiated as betweenequals. Patients and consumers, espe-cially, need a stronger voice indetermining not only the risks acceptableto them individually, but also to societyas a whole. For this, more and muchbetter communication was essential.

The conference produced a declara-tion of principles, the Erice Declaration,which is available on the Internet1 andfrom the Uppsala Monitoring Centre (seeaddress below). A full report of theconference proceedings is currently inpreparation.

The work of the conference will formthe basis of a working group of theCouncil of International Organizationsof Medical Science (CIOMS) which willpublish its findings and recommendationsin late 1998. The work will be continuedin a series of CIOMS meetings, leadingto guidelines for good practice in1998. ❏

* Bruce Hugman is Managing Director,EQUUS Communications, London, UK.

For further information contact: The UppsalaMonitoring Centre, Collaborating Centre forInternational Drug Monitoring, Stora Torget3, S-753 20 Uppsala, Sweden. Tel: + 46 18656060, fax: + 46 18 656080, e-mail:[email protected]

Reference

1. www.who.pharmasoft.se

Quality of care starts with communication

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WHO information on the move:introducing the blue trunk library

Providing much needed publications is only onepart of the blue trunk library project. Another ele-ment concentrates on raising the awareness of healthworkers about the importance of information, and ofstrengthening documentation services in ministriesof health. The aim is to set up a network capable ofsharing medical and health information in MemberStates.

The price of the mini-library, containing around100 books and four journals is US$2,000, includingadministrative, transport and training costs. ❏

For further information contact: World Health Organiza-tion, Office of Library and Health Literature Services,World Health Organization, 1211 Geneva 27,Switzerland.

United and committed: Asia-Pacific’sdrug bulletin editors meet

M E E T I N G S & C O U R S E S

International Congress onClinical Pharmacy

To help commemorate the 20thanniversaries of the founding of both theEuropean Society of Clinical Pharmacyand the American College of Clinical Phar-macy, the two organizations are holdingan International Congress. Scheduled for11–14 April 1999 in Orlando, Florida,the main theme of the Congress willbe Documenting the Value of ClinicalPharmacy Services.

For fur ther information contact: ThedaMansholtstraat 5b, 2331 JE Leiden, theNetherlands. Tel: + 31 71 572 24 30, fax: + 3171 572 24 31, e-mail: [email protected]

◆ ◆ ◆

The Pharmaceutical Societyof Australia

With the theme of “Practice Excellencethrough Technology”, the CommonwealthPharmaceutical Association Conferenceand the Pharmacy Australia Congresswill be held from 11–15 March 1999. Theoccasion will provide an opportunity tohear a variety of speakers on the applica-tion of technology in all areas of pharmacy

practice, and to network with colleaguesfrom around the world.

For further information contact the Secretariat at:ICMS Pty Ltd, 84 Queenbridge Street, Southbank,3006 Victoria, Australia. Tel: + 61 3 9682 0244,fax: + 61 3 9682 0288, e-mail: [email protected]

◆ ◆ ◆

Efficient drug managementThe Robert Gordon University’s tenth

postgraduate certificate course, “EfficientDrug Management and Rational DrugUse”, will be held from 17 May to 16July 1999. Run in collaboration with theAction Programme on Essential Drugs, thecourse is intended for health care profes-sionals, especially pharmacists, who areinvolved in the management and controlof pharmaceuticals at national, institutionaland programme levels. Fees are £3,300,including course books/materials andaccommodation.

For further information contact: Marthe Everard,Course Tutor, School of Pharmacy, The RobertGordon University, Schoolhill, Aberdeen AB101FR, Scotland, UK. Tel: + 44 1224 626559, fax:+ 44 1224 262555, e-mail: [email protected]

◆ ◆ ◆

Problem-basedpharmacotherapy teachingcourse

This course introduces a logical, step-by-step approach to patient problems:setting therapeutic objectives, selectingappropriate (pharmaco)therapy, andmonitoring the response to therapy. Italso emphasises the importance of correctprescribing and good patient-doctorcommunication. Intended for teachers ofpharmacology and therapeutics, the course(developed at the University of Groningenin the Netherlands) is now available in agrowing number of countries.

The next course based at the Univer-sity of Cape Town, South Africa, will beheld from 29 November to 8 December1999. For further information contact:Department of Pharmacology, MedicalSchool, University of Cape Town, Observa-tory 7925, South Africa. Tel: + 27 21 4066355, fax: + 27 21 448 0886.

And make a note…Course dates for the University of

Groningen course are 19 to 30 July 1999.For further information contact: Dr Wessel

Sloof, WHO Collaborating Centre forPharmacotherapy Teaching and Training,Department of Clinical Pharmacology, Uni-versity of Groningen, A. Deusinglaan 1,9713 AV Groningen, the Netherlands. Tel:+ 31 50 363 2810, fax : + 31 50 3632812, e-mail: [email protected], web site: http://www.indepth.org/courses

The problem-based pharmacotherapyteaching course will be held in the Philip-pines, in 1999. For further informationcontact: Professor Tony Smith, WHO Col-laborating Centre on PharmacotherapyTeaching and Training, University of New-castle, University Drive, Callaghan NSW2308, Australia. Fax: + 61 6 289 8846,e-mail: [email protected]

La Plata, Argentina, will be the venuefor the first South American course (this willbe held in Spanish), in either July or No-vember 1999. For further informationcontact: Professor Hector Buschiazzo,School of Medicine, National Universityof La Plata, 60 & 120 (1900) La Plata,Argentina. Tel/fax: + 54 21 820117.

D R U G I N F O R M A T I O N

The number of drug bulletins in the Asia-Pacific Region isincreasing

countries bulletins were compet-ing for doctors’ reading timeagainst the profusion of pharma-ceutical company literature.

Working together

The meeting, which receivedDAP support, was highlyinteractive with numerousworkshops on offer. Lengthy de-bate followed the sessions whichfocused on criteria for produc-ing useful, quality bulletins. Theneed to marry scientific informa-tion with practical implicationswas discussed, as were read-ability, author credibility,referencing and peer review.Participants developed an actionplan covering issues such as col-laboration*, improving accessand use of technology, andestablishing an evaluation meth-odology for bulletins.

The willingness of editors toshare, learn and commit to

providing quality drug information in theAsia-Pacific Region was evident through-out the meeting. The challenge is to putinto practice the many ideas and conceptsthat were discussed before the nextmeeting, which is planned for 1999. ❏

A report of the meeting is available from:International Society of Drug Bulletins,PO Box 459, 75527 Paris Cedex 11,

France. Tel : + 31 1 47003320, fax: + 31 147002864, e-mail: [email protected]

* Editors at the meeting decided to createan e-mail network to facilitate exchange ofinformation. The network offers the possibil-ity to post short announcements and news ofcommon interest, and initiate discussion ontopics of mutual interest. To participate in thisexchange contact: [email protected]

WH

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INFORMATION is a vital component in ensuring the efficacy and safety ofmedicine, and commitment to providing such information is evident in theincreased number and quality of drug bulletins in the Asia-Pacific Region.Thirty editors, representing countries extending from Pakistan to New Zea-

land, attended the first Asia-Pacific Regional Meeting of the International Society ofDrug Bulletins (ISDB). Held from 6–7 October 1997 at the Universiti Sains in Penang,Malaysia, the meeting showed that, despite their diversity, bulletins in the region sharecommon issues, opportunities and challenges. These include the need to provide in-formation on safe and effective drug use to consumers. This is especially true in countrieswhere consumers can access prescription medicines with little or no advice from healthprofessionals. The need for bulletins to be reader-friendly was highlighted, as in many

READY-TO-USE “mini-libraries” have been compiled by WHO Library Services,to help to ensure that district health teams in English- and French-speakingAfrican countries receive the medical and health information they need. Theselected books are contained in blue metal trunks for their protection and

easy transportation. Priority is given to practical manuals edited by WHO. Moduleson essential drugs, general medicine and nursing, maternal and child health, diarrhoealdiseases and primary health care are among those available. As well as choosing thebooks, WHO Library staff index and package them, and have created an electronicdatabase to go with the mini-library.


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Website on WHO health-trade related issues

For information on health care, tradedisputes and WHO see: http://www.cptech.org/ip/health/who/

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Evidence-based medicinelist in Spanish

EVIMED provides a new electronicforum in Spanish for those wanting todiscuss new ideas, research, education orpractice of evidence-based health care.Primarily dedicated to the Spanish healthcare community, non Spanish, particularlyLatin American, views are also welcome.

To subscribe contact: [email protected]

Two new web sitesThe Medical Lobby for Appropriate Marketing (MaLAM) is up and running with its

new web site at http://www.camtech.net.au/malamSo too is the International Society of Drug Bulletins at http://prn.usm.my/sites/

isdbdrul.html

DAP’s homepageThe Action Programme on Essential

Drugs’ homepage on World-Wide-Webintroduces users to the essential drugsconcept, national drug policies, and thework of WHO and the Action Programme.The information, which is frequently up-dated, is being made even more userfriendly.

The titles of selected WHO, DAP andother pharmaceutical publications areavailable on the homepage. The completeEnglish, French and Spanish versions ofthe Monitor (from number 22 onwards) canbe found in PDF format. In addition, textfrom other selected DAP publications canbe viewed and downloaded. For exam-ple, users can print out the Guidelines forDrug Donations and Guide to GoodPrescribing.

You can find DAP’s homepage at:http://www.who.ch/dap

Working for change in Ghana

Dear Editor,By chance I recently came across a

copy of your journal, the Essential DrugsMonitor, and although it was a 1993issue it was very educative. Since com-pleting my pharmacy studies in Ukraineand returning to Ghana I have found mis-use of drugs (particularly antibiotics andsedatives) on a massive scale. I have cometo the conclusion that irrational drug useis mainly due to the lack of effectivesources of information for patients, phar-macists and doctors. At my communitypharmacy I have tried in my own smallway to educate people, but their insultsand the potential loss of revenue for mybusiness sometimes overwhelm me.

The Monitor gave me the idea ofcreating an effective, independent druginformation service, where informationwill be given free of charge, or, when nec-essary, for a token fee. While I work onturning this idea into reality, I would ap-preciate it if you could continue to sendme your journal and also help me to con-tact organizations that already have a druginformation unit. We can then liaise and Ican benefit from their experience to cre-ate a substantive, effective, independentinformation unit for my people.

—Justice Dogbey, Pharmacist,P.O. Box KB516, Korle-Bu, Accra, Ghana.

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Drug donations in Rwanda

Dear Editor,Drug donations to developing coun-

tries have become a key factor ofinternational humanitarian assistance inthe field of health. People respond enthu-siastically to each emergency appealmade by NGOs, out of a desire to helpthose most in need. Nevertheless, the well

intentioned but misinformed individualsand institutions that wish to make theirmodest contribution can hardly imaginethe harmful consequences that result fromlarge-scale donations for the recipientcountries. Lack of training in the man-agement of essential drugs often meansthat part of the donations are useless.

In almost two years experience inZaire and Rwanda, during the refugeecrisis of 1994–1996, I witnessed the ar-rival of tons of drugs that nobody hadrequested. Many of them are still storedthere – either they have expired or thelocal population does not know how touse them – pending a means of eliminat-ing them without risk either to health orto the environment.

At the time, any form of assistancewas welcome, but attempting to make useof the unclassified drugs arriving fromSpain took away valuable time from anessential task: distributing drugs to phar-macies and health centres, and advisinglocal workers on their correct use.

For more than three months, four ofus, pharmacists responsible for manag-ing drugs provided by Spanish assistance,had to spend on average four hours eachday sorting out those that were suited toimmediate needs. Those we threw awayincluded drugs that had expired, othersthat were unsuited to the diseases preva-lent in the area, others in amounts whichwere insufficient to treat a patient, manynot included in WHO’s Model List ofEssential Drugs and many others.

Despite all these drawbacks I mustemphasise that many of the drugs wereused and helped to treat thousands ofpatients, thereby saving considerableexpenditure. Nevertheless it might havebeen preferable to load one of the humani-tarian assistance aircraft sent from Spainwith urgently needed drugs which hadbeen purchased directly from specialistfirms. Alternatively the drugs might havebeen sorted more systematically in Spainbefore they were sent, so that the work of

the hundreds of volunteers taking part inthe campaigns and of the pharmacistsworking in the field could be trulyeffective.

Since self sufficiency in drugs for allcountries is a long way off, we have to berealistic and work in more than one di-rection at once. As donations will still beneeded in the future, we should direct ourefforts towards ensuring that 100% of thedonations made are actually of use to therecipient. To this end society must beinformed and educated.

Knowledge of the problems, of itscauses and possible solutions, the reali-sation that the situation can be changedand a commitment to put change intopractice is the main challenge facinghealth professionals in general and healthcooperation NGOs in particular1.

—Natalia Herce,Pharmacist and Medicus Mundi’s

Project Manager in Rukoma, Rwanda.

1. For further information on improving drug donations see:Guidelines for Drug Donations. Geneva: World HealthOrganization; 1996. WHO/DAP/96.2.

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Indian survey reveals doctors’misgivings on training in RUD

Dear Editor,Criticism about the lack of input on

rational therapeutics in India’s under-graduate medical curricula was voiced bya number of participants at a national con-sultative meeting on the rational useof drugs (RUD) held in Calcutta in 1995.Delegates called for an increased focuson needs-based clinical pharmacologyteaching at undergraduate level, and forthe gap between students’ knowledgeabout drugs and knowledge of theiroptimal use to be narrowed.

Concerns expressed at the Calcuttameeting prompted a survey of 2,200

junior doctors in India. This has shownthat most received no information on theessential drugs concept during their train-ing. Carried out by the Calcutta-basedNGO, Foundation for Health Action, thepilot survey aimed to discover what re-cently qualified doctors thought about theadequacy of their undergraduate trainingin rational use of drugs. It also sought theiropinion on the feasibility of initiating acompulsory refresher course on rationaluse towards the end of medical training.

A structured multiple-choice question-naire was given to the doctors, whoworked in various disciplines at seventraining institutions in four regions of thecountry. Analysis of responses showedthat most participants wanted standardtherapeutic guidelines to be produced forcommonly occurring ailments. Almost allwere in favour of a compulsory refreshercourse on rational drug use for internsduring the internship period. It is antici-pated that such a course would be heldfor two hours weekly over four weeks,and run collaboratively by staff from de-partments of pharmacology and clinicalmedicine. The emphasis would be oncauses and consequences of therapeuticfailures, assessment of therapeuticoutcomes, alternative drug therapy,adverse drug reaction monitoring,drug interactions, and risk-benefit andcost-effectiveness of drug therapy.

The study concludes that there is anundoubted need for reinforcement ofknowledge. In particular it demonstratesa need for further inputs on prescribingguidelines in the later stages of theundergraduate curriculum.

—Krishnangshu Ray,Assistant Professor of Pharmacology,

Department of Pharmacology, CalcuttaNational Medical College, 32 Gorachand

Road, Calcutta-700014, India,and Pijush Kant Sarkar,

Professor of Pharmacology and Director,School of Tropical Medicine,

Calcutta, India.

WHO’s Model List of Essential Drugs available on InternetThe 10th WHO Model List of Essential Drugs is now available on the web site of the

WHO Division of Drug Management and Policy: http://www.who.ch/dmp/edl-10.htmThe List of Essential Drugs is a model guide to countries and health services in devel-

oping their own national and local lists. Such lists should be evidence-based, consideringprevalent diseases, treatment facilities, training and experience of health personnel,financial resources, and genetic and demographic factors. Over the last 20 yearsthe WHO Model List of Essential Drugs has been an invaluable tool for saving livesand improving health through more rational use of drugs, wider access to drugs andimproved drug quality.

One important advance in the new Model List is the addition of a new drug,triclabendazole, for the treatment of liver and lung flukes. This illustrates the way the Listcan be used to highlight a therapeutic need and speed up availability of new drugtreatment.

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ImportantThe Action Programme on Essential Drugs cannotsupply the publications reviewed on these pages

unless stated otherwise.Please write to the address given at the endof each item.

Understanding Rational Therapeutics, M. Hasnain, 1997, 234 p.

Sub-titled “Therapeutics is somethingmore than prescribing drugs”, this publicationadvises doctors on how to work effectively,rationally and ethically. Looking in depth atsome of the major problems they face, it willbe of value to doctors in Pakistan andelsewhere who wish to improve their skills.In three sections, the book first providesguidance on the fundamentals of rationaltherapeutics – how a patient should beapproached, and factors involved in makingan optimal therapeutic decision. Effectivecommunication skills are a prerequisite for asuccessful doctor-patient relationship. Theauthor calls them the “backbone of rationalprescribing”, and looks in detail at thecommunication process. The followingchapters examine the factors to consider whenplanning therapeutic interventions, how toremain up-to-date about drugs, and bestpractice in prescription writing.

The book’s second section analyses whatinfluences doctors’ judgement and decisionmaking. There is a discussion of what theauthor views as some of the shortcomings ofmedical education, including: too littleattention given to applied aspects ofpharmacology and therapeutics; and too littleemphasis on teaching problem-solvingtechniques, critical evaluation of druginformation, and preventive aspects ofmedicine.

During clinical and internship training,

time, equipment and guidance are rarely inshort supply. In contrast, once they havequalified, many doctors have to workunsupervised with too many patients andlimited facilities. As a result new graduateshave to adapt their training to their workingsituation. The book warns against someirrational methods of patient evaluation andmanagement doctors may learn during theadaptation process. In view of the difficultyin obtaining objective information on drugsit discusses the influence the pharmaceuticalindustry may have on doctors’ choice oftreatment. In the complex interaction betweendoctor, patient and family members all bringtheir own set of values and cultural beliefs,social and financial pressures, personal likesand dislikes, and family and professionalpriorities. The publication looks at how thesefactors can influence a doctor’s therapeuticapproach and prescribing behaviour.

In conclusion the book highlights theirrational use of some common drugs andprovides guidelines on using them optimally.Antibiotics, psychotropics, nonsteroidalanti-inflammatory drugs, antiepileptics andvitamins are among the drug categoriescovered.

Available from: The Network, Association for Rational Use of Medication in Pakistan,H No. 60-A, Str. 39, F-10/4, P.O. Box 2563,Islamabad, Pakistan. Price US$6.

Health Conditions in the Caribbean, Pan American Health Organization,1997, 326 p.

The publication presents an overview of the challenges and conditions faced by healthsystems in the Caribbean Community (CARICOM) member countries. It highlights the generalhealth status of the Caribbean people, as well as policies and legislation that impact healthprogrammes. The publication then describes those health programme areas which correspondto the major causes of morbidity and mortality in the Caribbean.

Available from: PAHO Sales and Distribution Centre, PO Box 27, Annapolis Junction,MD 20701-0027, USA. Price: US$36, US$26 in Latin America and the Caribbean.

Internet, Telematics and Health, M. Sosa-Iudicissa, M. Oliveri,C.A. Gamboa, J. Roberts, (eds.), Pan American Health Organization, 1997,530 p.

This publication offers academic, political and professional viewpoints on the healthrelated impact of informatics, from first-hand experiences around the world. It gives practicalguidance on how to begin using the Internet or to enhance its use in the health care field. Thebook also presents a range of informatics and telematics information currently availableto medicine, and includes a CD-Rom, containing a directory of health-related sites on theWorld-Wide-Web.

Available from: PAHO Sales and Distribution Centre, PO Box 27, Annapolis Junction, MD20701-0027, USA. Price: US$79.

Regulatory Situation of HerbalMedicines. A Worldwide Review,WHO, WHO/TRM/98.1, 1998,45 p.

Population growth in the developingworld and increasing interest in theindustrialised nations have greatly expandedthe demand for medicinal plants and theproducts derived from them. The evaluationof traditional medicinal products, and ensuringtheir safety and efficacy through regulationand registration present important challenges.This document describes experiences from 52countries in formulating policies on traditionalmedicinal products, and in introducingmeasures for their regulation and registration.Regular updates are planned as contributionsbecome available from more countries.

Available free of charge from: World HealthOrganization, Traditional MedicineProgramme, 1211 Geneva 27, Switzerland.

Blurring the Boundaries: New Trends in Drug Promotion, B. Mintzes,HAI-Europe, 1998, 64 p.

International Strategies for Tropical Diseases Treatment: Experiences withPraziquantel, WHO, DAP Research Series No. 26, WHO/DAP/CTD/98.5,1998, 94 p.

This report identifies national and international policies that have facilitated or hindered theavailability of praziquantel, especially in the world’s poorest countries in Africa, whereschistosomiasis is endemic. Analysis of praziquantel’s production and pricing illustrates moregeneral problems in the design of national and international policies for tropical disease products,and suggests strategies for future research and action.

The report raises questions about the international systems that affect the availability ofnew drugs in poor countries. It looks at how these systems could be improved for each of thefour major actors discussed in the report: national governments, the pharmaceutical industry,international agencies and nongovernmental organizations.

Available, free of charge, from: Action Programme on Essential Drugs, World HealthOrganization, 1211 Geneva 27, Switzerland.

Pharmaceuticals as Commodities in Public Health: the Implications of the

HAI’s latest publication describes newtrends in the way medicines are marketed,adding to the long-standing debate on methodsused by the pharmaceutical industry to sellits products. A large part of the publication isdedicated to direct-to-consumer drugpromotion, with other sections addressingsponsorship of patient groups, Internet

promotion, promotion targeted at prescribersand pharmacists, and industry sponsoredresearch. The author believes that the questionis not whether consumers should obtaininformation about treatment options, butwhether drug promotion – which aims tosell a product – can provide the type ofinformation that consumers need. She arguesthat there is a deliberate and disturbingblurring of the boundaries between drugpromotion and objective information. Mintzesbelieves this is all the more dangerous at atime when shrinking public health budgetshave created a new climate of partnershipbetween the public sector and industry,without the necessary examination of whatsuch partnerships might mean.

Blurring the Boundaries explores theimplications this situation has on consumerhealth, access to appropriate health servicesand the information on which treatmentdecisions are based. It also sets out a series ofrecommendations on how various playersinvolved in drug regulation can work tocontrol drug promotion effectively, in orderto encourage rational use of drugs.

Available from: HAI-Europe, Jacob vanLennepkade 334T, 1053 NJ Amsterdam, TheNetherlands. Price: NLG25 plus postage andhandling.

TRIPS Agreement from the Perspective ofDeveloping Countries, Pharmaceutical AdvisoryGroup, World Council of Churches, 1998, 18 p.

Why is the TRIPS Agreement important for thepharmaceutical sector? Are patents the right way to stimulateresearch and development? What are the implications of TRIPSon local drug production?. These are some of the questionsaddressed by speakers at the World Council of Churches,Pharmaceutical Advisory Group meeting held in Geneva inOctober 1997. The meeting report is now available andprovides a useful insight into the complex issue of TradeRelated Aspects of Intellectual Property Rights.

Available from: The Bookshop, CMC World Council ofChurches, P.O.Box 2100, 1211 Geneva 2, Switzerland. Price:Sw.fr.3.


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Update on new formularies, treatment guidelines,essential drugs lists, drug bulletins and newsletters

The Action Programme on Essential Drugs has a new publication, Progress of WHOMember States in developing national drug policies and in revising essential drugs lists,1998, (WHO/DAP/98.7). This comprehensive global listing also includes details of whichcountries have produced national formularies and standard treatment guidelines, and ofprogress made in providing access to essential drugs. The publication is available, free ofcharge, from the Action Programme.

Listed below are some recent additions to DAP’s global index. (Please note that weare unable to supply copies of the publications themselves. Requests should be madedirect to the countries concerned).

◆ Chad: Guide de Diagnostic et de Traitment des affections courantes au Tchad, 1998.Ministère de la Santé Publique. Intended to increase rational prescribing among doc-tors and paramedics at the first and second health care levels. The publication coversthe main illnesses found in Chad and includes advice on information, education andcommunication interventions.

◆ Gabon: Liste nationale des Médicaments Essentiels, 1997. Ministère de la SantéPublique et de la Population. The Essential Drugs List by generic name in 24therapeutic groups. The List will be updated every two years.

◆ Mali: Formulaire Thérapeutique National, 1998. Ministère de la Santé, des PersonnesAgées et de la Solidarité. The Formulary begins with advice on good prescribing andstorage practices, and then presents drug monographs, organized in alphabeticalorder by generic name for three levels of care.

◆ Nepal: Hospital Formulary, 1997. Tribhuvan Teaching Hospital, Institute of Medi-cine. This teaching hospital’s formulary includes 371 drugs and 16 non drug items.The drug list is based on the WHO Model List of Essential Drugs.

◆ Spain: Manuel del Medicamento, 1998. Farmacéuticos sin Fronteras de España. Adrug manual which includes donation guidelines and WHO’s Model List of EssentialDrugs.

◆ The Gambia: The Standard Drug Treatment Guidelines, 1998. Department of Statefor Health, Social Welfare and Women’s Affairs. Covers diagnosis and treatment ofthe country’s main health problems to achieve more rational and cost-effective use ofdrugs in hospitals, health centres and dispensaries.

◆ Uzbekistan: National Drug Formulary, 1998. Ministry of Health. The country’s firstnational formulary, which includes the Essential Drugs List.

Drug bulletins and newsletters◆ The WHO Regional Office for Africa’s Essential Drugs Programme has produced the

first in a series of monthly newsletters. The AFRO Pharmaceuticals Newsletter willreport on what the Regional Office is doing in the pharmaceutical field in collabora-tion with Member States, and on developments in the Region’s pharmaceutical sector.For further information contact: Dr Moses Chisale, WHO Regional Office for Africa(Attention EDP/AFRO), P.O. Box BE 773, Belvedere, Harare, Zimbabwe.

◆ A change of name for Drugs Today, the newsletter of the Christian MedicalAssociation of India, which is now called Rational Drugs.

European Pharmacopoeia Supplement, 3rd ed., 1998.

District Health Care, 2nd ed., R. Amonoo-Lartson, G.J. Ebrahim, H.J. Lovel,J.P. Ranken, 1996, 296 p.

Antimicrobial and Support Therapy for Bacterial Meningitis in Children.Report of the Meeting of 18–20 June 1997, WHO, WHO/CHD/98.6, 1998,25 p.

Globalization and Access to Drugs, WHO, Health Economics and Drugs,DAP Series No. 7, WHO/DAP/98.9, Nov. 1997, 58 p.

Evaluacion de la Situacion de los Medicamentos en el Peru, Ministerio deSalud, Direccion General de Medicamentos, Insumos y Drogas, 1997,136 p.

Pharmaceuticals and Health Sector Reform in the Americas: An EconomicPerspective, I. Madrid, G. Velasquez, E. Fefer, WHO/PAHO, 1998, 93 p.

The publication gives practical advice andsupport to district medical officers and districthealth teams in planning, organizing,

many of the evolving principles ofmanagement which have been adapted forapplication to health care, and which will be

Do health services work proactively or reactively? Why are pharmaceuticals important?What is health sector reform? What is the scope of pharmaceutical reform? What can be done toensure that reform leads to progress and not simply change? These key questions, addressed bythis publication, are particularly important when increasing pressures on health systems andeconomic changes in many Latin American and Caribbean countries make health sector reformimperative. Directed particularly to decision makers in health and finance, the publication helps

them to evaluate and put into operation necessary changes.The authors argue that the fundamental principle of

optimal health sector reform is that access to quality healthservices is a universal right. Each country must shape healthsector reform in accordance with its priorities and social andeconomic conditions. Pharmaceutical sector reform must beincorporated within health sector reform and should seek toensure that all individuals have access to essential drugs andto quality health services. The publication focuses on fiveareas central to reform strategy: the roles of the public andprivate sectors; drug financing alternatives; pricing policies;generics strategies; and rational use of drugs.

Available, free of charge, from: Action Programme onEssential Drugs, World Health Organization, 1211 Geneva27, Switzerland.

managing and evaluatinghealth services. Since the firstedition in 1984 health carecosts have escalated, even inricher countries. There isincreasing emphasis on pre-ventive and promotive care– the fundamental principleson which primary health careis based, the authors argue.They believe that as countrieshave oriented their servicestowards primary health care,the need for planning,managing and evaluatingservice programmes is greaterthan ever.

The new edition includes

of use in restructuring healthservices. Drawing on theirexperience in a number ofdeveloping countries, theauthors have produced avaluable aid for medical,health and nursing personnelinvolved in the planning,organization and running ofdistrict health services.

Available from: MacmillanEducation Ltd, Houndmills,Basingstoke, HampshireRG21 6XS, UK. Price:£10.50.

the choice of antimicrobial therapy and theimplications of antimicrobial resistance;the pharmacokinetics and current use ofchloramphenicol; the role of dexamethasone;and fluid management in bacterial meningitis.

Available, free of charge from: World HealthOrganization, Division of Child Health andDevelopment, 1211 Geneva 27, Switzerland.

Bacterial meningitis is an important causeof childhood morbidity and mortality, and anumber of differences exist in its managementfrom one region to another. This is a report ofa WHO meeting to review current treatmentand make recommendations for futurepractice. Chapters cover four issuesconcerning the management of bacterialmeningitis in children in developing countries:

This overview of the drug situation in Peruis intended for all those working in the public

programmes should be systematicallyevaluated to determine if the programmes’

The updated 3rd edition of the European Pharmacopoiea provides a single regulatoryreference for the quality of medicines in 25 European countries, including those of the EuropeanEconomic Area. The supplement contains 120 new standards or “monographs” and 130 revisedmonographs that incorporate the latest scientific advances. These 250 new harmonised Europeanmonographs became obligatory in 25 European countries on 1 January 1998, superseding thenational standard where one existed on the same subject.

In total the Pharmacopoeia contains approximately 1,300 European standards on subjectsranging from synthetic molecules to biologicals to vaccines for human or veterinary use toherbal preparations; 250 general methods of analysis and 800 reagents; and a specific chapteron dosage forms.

The publication is available in English and French. For further information contact: Councilof Europe, 226 Avenue de Colmar, BP 907-F67029, Strasbourg, France. Tel: + 33 3 88 41 2036, fax: +33 3 88 41 27 71.

health sector, but principallyin drug authorities. Thepublication aims to helpreaders to analyse problems inthe pharmaceutical field andto facilitate planning andinterventions.

The authors state thatdrugs should be available to allPeruvians, adequately selectedin terms of efficiency, safety,cost and need, be of guaranteedquality and be used rationally.They recommend that drug

objectives are being met.The publication includes

information on the NationalFormulary, the Health Ministrybudget, and drug purchasingpolicies. It also providesstatistical information onpatient’s access to drugs indifferent areas of the country.

Available from: Ministry ofHealth, Avda Salaverry, Lima,Peru.

The latest in DAP’s series on healtheconomics and drugs informs people in thehealth sector with no particular legalbackground about the impact of globalizationon access to drugs. In particular it focuses onthe World Trade Organization agreement onintellectual property (the TRIPS Agreement)that may have repercussions in thepharmaceutical field. The first part of thedocument gives an introduction to theinternational commercial system from the

General Agreement on Tariffs and Trade tothe advent of the World Trade Organization.The second part analyses the section onpatents of the TRIPS Agreement in relationto access to drugs.

Available, free of charge, in English, Frenchand Spanish from: Action Programme onEssential Drugs, World Health Organization,1211 Geneva 27, Switzerland.

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Pharmacotherapy discussion groupsin the Netherlands under the spotlight

offers a good opportunity for improvingintermediate pharmaceutical care.

The study identified a major shiftin the objectives of discussion group con-sultations since the previous survey.While information exchange and discus-sion on prescribing practices are still highon the agenda, there is an increasing em-phasis on the need to reach agreement onstandards, policies and guidelines. The

Prescriptions watchdog…

The survey showed that 68% ofgroups were using relevant prescriptiondata, due in part to efforts by the DutchPharmacological Society, health insur-ance companies and the Dutch Institutefor Effective Use of Medication to ensurethe availability and proper use of relevantdata. At present, the figures are usedmainly to gain an insight into existingprescribing patterns. For just over half thegroups these data serve as a tool in policydevelopment, while 44% of groups usingthe data do so to check adherence to thepolicies and guidelines agreed within thediscussion group.

One of the conclusions of the 1992survey was that regular monitoring ofprescription data was essential in orderto bring about effective change in pre-scribing practices. However, only aminority of groups currently monitor GPs’prescription practices for compliance withagreed group guidelines and policies.More widespread monitoring of datawould offer a way of comparing prescrib-ing practices among colleagues, and ofverifying compliance with agreed stand-ards, policies and guidelines.

What GPs and pharmaciststhink…

Over 80% of GPs and pharmacists ratethe pharmacotherapy discussion groupprocess as “useful” or “very useful”,while two-thirds of them also said it wasefficient. However, 8% of groups are lesssatisfied, complaining that the results arenot specific enough.

The GPs said they had gained a betterunderstanding of the scope of their pre-scription practices, partly as a result ofparticipation in a group. In addition theyreport improved relations with other GPsand pharmacists. Meanwhile, the discus-sion group system has helped define thepharmacist’s role as an adviser to the GP.Pharmacists are now paying more atten-tion to supervising medication schemesand giving advice to GPs, due in part totheir participation in pharmacotherapydiscussion groups. Pharmacists also saythey are now more inclined to contact aGP when they have a query. Anotherimprovement, noted by both GPs andpharmacists, is that both parties have aclearer understanding of how tasks shouldbe shared between them.

On ways of improving the discussiongroup system, almost a third of the groupsmaintained that consultations need to be-come more efficient, while over 40% saidthe agreements reached should becomeless voluntary – a view expressed morefrequently by pharmacists than GPs.Greater use of prescription data would notonly help develop and clarify policies but,more importantly, also enable groups tomore effectively monitor compliance withagreed policies and guidelines.

The way ahead…

Regular assessments of the effective-ness of the pharmacotherapy discussiongroup network remain essential in orderto modify goals and develop fresh ap-proaches, methods and content. Otherchallenges include the development andimplementation of regional formularies –exploiting the full potential of computer-ized data – and an increase in internationalcooperation. In Eastern Europe, the DutchInstitute for Effective Use of Medicationrecently responded to a request fromWHO to give presentations on rationaldrug use strategies. Elsewhere, collabo-ration is already underway, with similardiscussion networks in Belgium, Canada,Germany and the UK. In November 1998the Institute collaborated with theWHO Regional Office for Europe inorganizing a consultative meeting toshare problems experienced with guide-line implementation and to discusspharmacotherapeutic committees.

Meanwhile, Institute advisers areworking on new programmes – genericprescribing, polypharmacy among theelderly, pharmaceutical care and transmu-ral pharmacotherapy (where people are

R A T I O N A L U S E

A patient information leaflet from the genericprescribing project. It says that you can havethe same medicine in a different coat –generic drugs are just as good but cheaper

These folders are used for preparing discussions at thelocal groups of doctors and pharmacists

The study, carried out by theDutch Institute for Effective Useof Medication, reveals that thenumber of discussion groups hasincreased by a third to more than800 over the past five years, andthat up to 95% of the country’sGPs and pharmacists are nowinvolved.

The nationwide network oflocal pharmacotherapy discus-sion groups was launched bythe Institute in early 1992 (seeEDM-20). The idea was to pro-mote rational drug use bybringing together GPs and phar-macists to exchange informationabout pharmacotherapy anddevelop local guidelines.

Since then a team of 16advisers (communications con-sultants) have helped establishregional networks as well as pro-viding support to individualgroups of GPs and local phar-macists which meet regularly.The aim is to draw on the ex-pertise available within thesetwo professions in order toimprove the prescribing practice ofindividual GPs.

Latest findings…

The new survey was initiated in 1997to update information about the organi-zation and operation of pharmacotherapydiscussion groups and to find out whetherany changes had occurred since the 1992study. The number of groups had in-creased from 629 in 1992 to 827 in 1997,and 83% of these took part in the latestsurvey.

The study found that an increasingnumber of both GPs and pharmacistsplayed an active role in organizinggroup activities (up from 78% in 1992 to88% in 1997). Most groups meet sixtimes a year and about two-thirds of themare assisted by an adviser recognisedby the Dutch Association of GeneralPractitioners.

Contacts with specialists in hospitals– a need highlighted in the earlierstudy – have become more frequent(41% compared with 27% in 1992). TheInstitute for Effective Use of Medicationis currently trying to improve commu-nication between pharmacotherapydiscussion groups and hospitals at the in-terface between primary and secondarycare. The discussion group infrastructure

survey found that 72% of groups weremaking efforts to draw up policies andguidelines, while 27% planned to moni-tor compliance with them (compared with49% and 9% respectively in 1992).

In preparing activities groups relyheavily on the use of specially developedworking materials. Most groups (82%)have, at some time, used the series of pre-parative booklets issued by the Institutefor Effective Use of Medication. BothGPs and pharmacists were very positiveabout the booklets and the case studies.During 1995–96, the most frequently dis-cussed topics were asthma, hypertension,the use of antibiotics in the treatment ofrespiratory infections, the use of anti-microbial drugs to treat urinary tractinfections and the use of antidepressants(50%–60% of groups).

Although the Institute advises groupsnot to discuss new medicines untilthese have been assessed by autho-ritative publications, such as theDutch Pharmacotherapy Compendium(Farmacotherapeutisch Kompas), theDutch Society of General Practice Stand-ards, and the Dutch Drug Bulletin(Geneesmiddelenbulletin), 70% of groupsreported having done so. Indeed, manygroups have agreed not to prescribe newmedicines before consultations within thepharmacotherapy discussion group.

referred from hospital to have theirprescription dispensed in a communitypharmacy) – to ensure that all GPs, phar-macists and specialists have expertise inauditing and cost-effective use of medi-cation. In addition, the Institute continuesto offer a range of new working materi-als and support to pharmacotherapydiscussion groups to boost their effective-ness. This can involve evaluationexercises, help in solving cooperationproblems or in starting up compliancemonitoring, or efforts to revitalise the dis-cussion group process whenever it getsbogged down. ❏

* Geert Kocken is a health consultant atStichting Doelmatige GeneesmiddelenVoorzieninq (DGV) Dutch Institute forEffective Use of Medication, Postbus 3089,3502 GB Utrecht, the Netherlands. Tel. +31 24 360 6200, fax: + 31 24 360 6644,e-mail: [email protected]

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AGEERT KOCKEN*

FACT-FINDING study of pharmaco-therapy discussion groups in theNetherlands has highlighted amajor shift towards establishing

standards and guidelines for prescribing,coupled with a growing determina-tion to monitor compliance by generalpractitioners (GPs).


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Essential drugs concept needsbetter implementation

by doctors working in the private sector,who had a larger range of drugs to choosefrom than those employed in the publicsector. However, this opposition has less-ened, over time.

Another frequent criticism is that theessential drugs list is a “second class” list,determined on the basis of financial strin-gency rather than the effectiveness of thedrugs. However, the belief that countrieswill abandon the list, once the economicsituation improves, and switch to betterdrugs is based on a misconception. Thelist does not include less effective drugssimply because they are cheaper. The aimis to include more cost-effective drugsthat can be used by the majority of thepopulation. For example, among the H2receptor blockers, ranitidine has an ad-vantage over the much less expensivedrug cimetidine, in that it can be used bythe elderly and has fewer interactions withother drugs. However, cimetidine waschosen for the model list not only becauseit was cheaper but because it has similar

efficacy to ranitidine, andbecause the majority ofpatients using it wouldbe neither elderly nor

receiving drugs which could interactwith cimetidine. While a particularhealth technology may be superior in afew situations, another cheaper onemay be equally effective in the majorityof situations – making it more cost-effective.

The essential drugs list is also criti-cised for failing to include a drug for aparticular disease. However, the list wasnever meant to cover all diseases. The aimwas to ensure the availability of drugs totreat the majority of diseases that occurredin a specific country. The exclusion of adrug from the list does not prevent it frombeing purchased if needed. The factthat the essential drugs concept accom-modates this should be seen as itsstrength.

IMPACT IN DEVELOPINGCOUNTRIES

Over 120 developing countries havenow adopted the essential drugs conceptand developed a national essential drugslist based on the WHO Model List2. Theexclusive use of generic drugs in the listhas contributed to increasing awarenessof generic names. While some countrieshave closely followed the criteria for se-lection of drugs, others have lists thatinclude over 350 products (Pakistan) ortwo or more similar drugs rather than therecommended single drug (Tanzania)

from each therapeutic category. Some ofthese deviations may be due to attemptsby doctors to get a particular drugincluded in the national essential drugslist – thereby enabling hospitals to buythe drug and ensuring its inclusion inreimbursement schemes.

As countries have increasingly recog-nised the need for a national drug policy,the national list has provided the corner-stone for this policy development.Meanwhile, the knowledge that a limitedlist of drugs can meet the majority ofhealth care needs has also created anawareness that “more is not necessarilybetter” and that “newer is not necessarilybetter”. The list has also enabled healthadministrators to assess whether appro-priate drugs are being supplied.

Although the essential drugs concepthas consistently focused on the impor-tance not only of the selection but alsothe proper use of the drugs, progress inencouraging the rational use of drugs hasbeen slow. Even where essential drugs areavailable, their full potential is not beingrealised. This is mainly due to the failureto provide unbiased drug information forprescribers. Whereas suppliers of otherforms of goods routinely spend a propor-tion of sales revenue on evaluating howthe goods are used, very few developingcountries have access to independent druginformation – let alone the capacity tospend a proportion of their drugs budget


The idea – providing priority drugs tomeet the health care needs of the major-ity of the population – was simple,socially just, and both technically andeconomically sound. By having a care-fully designed, scientifically sound list ofa limited number of drugs, procurementcould be made easy, the drug storageproblem simplified, prescribers wouldhave safe and effective drugs, and costscould be reduced.

The system entailed no reductions inhealth services, and health administratorsdid not have to make difficult choicesbetween the competing needs of differ-ent groups or assess the social and healthimplications of different strategies. Themoney allocated for pharmaceuticals –20%–40% of limited health care budgets– could now be spent on less expensive,essential drugs, facilitating wider accessto drugs without any increase in costs.Rarely had administrators been offeredsuch a clear, simple solution to so manyproblems. The essential drugs conceptwas an idea whose time had come.

But the simplicity was beguiling.Although the concept was wellaccepted by most countries, its im-plementation has proved a dauntingtask. More than two decades afterit was conceived, the essentialdrugs concept has still to make thefull impact that was anticipated –demonstrating that technicalsoundness and economic ra-tionality do not necessarilyensure political viability1.

ESSENTIAL DRUGSCONCEPT UNDER FIRE

At the outset, direct opposi-tion to the essential drugs conceptcame mainly from the pharmaceuticalindustry – unconvinced by the argumentthat lost sales on more expensive drugswould be offset by the enlarged marketfor essential drugs. However, initialoutright rejection of the concept was fol-lowed by grudging acceptance that itmight be appropriate for poorer countriesthat cannot afford to have an unrestrictedamount of pharmaceuticals available onthe market. And with the increasing popu-larity of the essential drugs list, manymanufacturers have seen its potentialand sought to have their drugsincluded in the list.

Many doctors were also opposedat first – viewing the list as an unnec-essary restriction on their freedom toprescribe. Concern was voiced mainly

on providing information on therational use of drugs. It is esti-mated that both developing anddeveloped countries currentlyspend less than 1% of theirdrugs budget on rational druguse. However, the essentialdrugs concept has been influen-tial in preventing the import ofineffective drugs.

In some developing coun-tries, the implementation of theessential drugs concept has beenhampered by efforts to industri-alise. Many governments hopedthat a vigorous and profitablepharmaceutical industry, pro-ducing drugs that were mainlyoutside the essential drugs list,would contribute to a general in-crease in both living standardsand improved health. As a re-sult, essential drugs wereignored and sometimes difficultto obtain, while more expensive,non essential drugs were freelyavailable. Now, after findingthat the impact on living stand-ards is less than anticipated,some countries are rethinkingtheir policy and are likely toplace greater emphasis in futureon essential drugs. This devel-opment should help increase the

TKRIS WEERASURIYA, PASCALE BRUDON*

HE concept of essential drugs – first launched over 20 years ago – hasbeen widely adopted today by countries throughout the world. But itsimplementation is proving a lot more difficult than envisaged.

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accessibility and affordability of essen-tial drugs.

Although the essential drugs conceptwas designed to meet the health careneeds of the majority of the population,the private sector has tended to drag itsfeet in implementing the concept. This islargely due to fears that the resulting

evaluated for quality, safety and efficacy4.Once registered, a drug is then assessedfor possible inclusion in the reimburse-ment scheme. Approval at this stagedepends on evidence of cost-effective-ness. This two-stage process has resultedin the registration of drugs, such asfinasteride, that are expensive but

UNICEF’s activities involvingpharmaceuticals have been guided by theessential drugs concept in order to ensureequity, and donor countries/institutionshave focused on national lists when sup-plying drugs. Meanwhile, the guidelinesfor drug donations developed by WHOand other agencies have also stressed the

in this way it is taken for granted and notseen as a major advance. Because of this,it is a difficult concept to promote.

Another problem is the wide rangeof objectives involved: equity in theprovision of basic health care needs, effi-cient use of available resources, andresponsiveness to societies rather thanto market forces. While this elicitswidespread support, the involvement ofnumerous players with different strengthsand objectives can hamper the concept’simplementation.

In developed countries, the weakimplementation of the essential drugsconcept has been driven by fears that theinternational pharmaceutical industrywould suffer – a prospect that generatedstrong opposition from powerful groupsand governments. Meanwhile, in somecountries, implementation strategies havenot been carefully thought through.Effective implementation of the conceptrequires careful planning, backed up bystrong political commitment at countrylevel, together with a clearer understand-ing of the role of the different playersinvolved. Better implementation of theessential drugs concept could make allthe difference between success andfailure. ❏

* Kris Weerasuriya is Professor, Departmentof Pharmacology, Faculty of Medicine, Uni-versity of Colombo, Sri Lanka, and PascaleBrudon is Chief, Development of ProgrammeEvaluation, WHO and was formerly a Sci-entist in the Action Programme on EssentialDrugs.

References

1. WHO/DAP. Comparative analysis of national drug poli-cies. Second workshop, June 1996. Geneva: World HealthOrganization; 1997. DAP Research Series No.25. WHO/DAP/97.6.

2. WHO/DAP. WHO essential drugs strategy: objectives,priorities for action, approaches. Geneva: World HealthOrganization;1997. DAP/MAC(9)/97.4.

3. Reich MR. The politics of health sector reform in devel-oping countries: three cases of pharmaceutical policy.Health Policy. 1995; 32:47–77.

4. Murray M. Australian National Drug Policies: facilitat-ing or fragmenting health? Dev. Dialogue.1995;1:148–192.

5. World Bank. World development report 1993: Investingin Health. New York: Oxford University Press;1993.

6. World Bank. Better health in Africa. Experience and les-sons learned. (Report No.12577–AFR). Washington DC:The World Bank; 1994.

7. WHO/DAP. Guidelines for drug donations. Geneva:World Health Organization; 1996. WHO/DAP/96.2.

changes in the pharmaceu-tical sector might have anadverse effect on multi-national corporations, theurban elite, and, to a lesserextent, physicians. In orderto succeed, the conceptshould have broadly-basedsupport which reaches to thehighest political levels.However, with the excep-tion of the Philippines andSri Lanka, this has rarelyoccurred3.

The lack of acceptanceof the essential drugs con-cept within the privatesector is also due to the frag-mented nature of health carein this sector in developingcountries. Patients pay fortheir drugs “out of pocket”and are individual buyerswho purchase what thedoctor prescribes. However,large health care providerssuch as insurance schemes,which are common in thedeveloped world, can per-suade prescribers to use arestricted list of drugs knownto be effective. When suchschemes are established inthe developing world thesame trend towards usingknown effective drugs woulddevelop.

A RESPONSE TO RISING PRICES

Acceptance of the essential drugs con-cept and the essential drugs list faceddifferent hurdles in developed countries,due to the different socioeconomic andindustrial circumstances. In the developedcountries, governments saw the pharma-ceutical industry as a vibrant one,providing useful products as well as con-tributing to the economy through theemployment of skilled labour, the produc-tion of substantial export earnings, and acontribution to scientific and industrialresearch. Money was usually available tobuy more expensive pharmaceutical prod-ucts and it was believed that restrictingaccess to these products would be coun-terproductive in the long run. Unlike thedeveloping countries, health care provid-ers in developed countries (either the stateor state-sponsored social insuranceschemes) had immense buying power andcould negotiate a reduction in prices.However, these products are becomingincreasingly expensive and are often be-yond the reach of cash-strapped healthservice providers. As a result, both gov-ernments and health service providers inthe private sector have now adopted theessential drugs concept – albeit by anothername.

Most countries have adopted a two-step procedure for introducing a newproduct into the health system. InAustralia a new drug is scientifically

minimally effective – without theirapproval for reimbursement.

Elsewhere, in the UK, where 17benzodiazepines are available, the Na-tional Health Service supplies only fiveof these, each a generic drug. Althoughthe other 12 benzodiazepines are equallyeffective, they are more expensive and notreimbursable. Although this is not a strictinterpretation of the essential drugs con-cept (which allows only one drug from atherapeutic class) a focus exclusively ondrugs that are known to be safe, effec-tive, and cost-effective is in keeping withthe spirit of the concept. However, bothcountries promote the export of thesedrugs – a clear example of industrialpriorities overtaking health ones outsidethe country’s own borders.

INTERNATIONAL ORGANIZATIONSPROMOTE THE CONCEPT

Although, initially, a number of inter-national organizations failed to appreciatethe relevance or importance of the essen-tial drugs concept, today most accept andpromote it as a good tool for organizingthe pharmaceutical sector and improvinghealth care. The World Bank, which playsan increasing role in the health sector inthe developing world, has based most ofits activities in pharmaceuticals on theconcept and national drug lists – mainlyto facilitate managerial efficiency 5,6.

importance of donating onlydrugs that are included innational lists7.

The Model List is re-vised regularly by WHOwith the latest revision in1997. The number of itemsincluded has risen from208 in 1977 to 306 today –as new products are addedand older, less effectiveproducts removed. Pro-grammes covering malariaand cancer control havehelped refine the selectionof drugs included in the List.Meanwhile, the participa-tion of the pharmaceuticalindustry associations pro-vide an opportunity forthem to discuss the List aswell as propose products forinclusion. On several occa-sions, inclusion of a drugin the Model List hasencouraged pharmaceu-tical companies to eithercontinue manufacturingthe drug or to start manu-facturing it.

BETTERIMPLEMENTATION

NEEDED

The essential drugsconcept is today a key issueon the international health

agenda. Together with the concept ofprimary health care, it is one of the majorachievements of WHO over the last twodecades, and its most durable pharma-ceutical initiative. Other initiatives, suchas promoting the local production ofpharmaceuticals, have achieved neitherthe sustainability nor the prominence ofthe essential drugs concept.

Yet, while the concept’s scientificvalidity remains unchallenged, it has stillto be implemented to its full potential.One of the problems is that it is a publichealth concept and not a curative inter-vention. When drugs are made available

Essential drugs are not a poor man’s medicine, and the essential drugsconcept is as important today as it was 20 years ago

Photo: WHO/Zafar

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New Belgian committee promotesrational prescribing

HE Belgian Minister for Public Health, Dr Marcel Colla, has set up ascientific committee aimed at encouraging rational and cost-effectiveprescribing. The committee, which will implement a project for “independ-ent information on medicines” will be made up of representatives from the

Belgian pharmaceutical information centre, the transparency commission, theHealth Ministry, the pharmaceuticals inspectorate and general practitioners’ asso-ciations, Le Journal du Médecin reports. Other health professionals, such asspecialists and pharmacists, may also be asked to participate. A number of productcategories have already been put forward for examination, including anti-ulcers,antidepressants and antibiotics for upper respiratory tract infections. ❏

Source: Scrip, No. 2312, 25 February 1998.


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Pakistan’s largest Provincefocuses on drug sector reform

to review the Drug Act of 1976 and the1988 Drug Rules, the second to screenthe Province’s medical stores in the lightof existing licensing policy and to takesteps against those violating the law; andthe third to suggest measures, includingfurther legislation, against unqualifiedpeople practising medicine. ❏

Reference

1. The News on Sunday, 9 August 1998, p.28–29.

MSF Research Group on Essential Drugs:fighting for the underprivileged

existed for a long time, and people oftenwait in vain for new drugs. Pharmaceuti-cal research and development havefrequently been abandoned because therewould be no return on the required invest-ment. The same market economy logichas resulted in drugs that are obsolete indeveloped countries no longer beingmade – even when the drugs are still use-ful in developing countries (where priceaffects both access and adherence totreatment).

Action: The Research Group on Es-sential Drugs will make a detailedanalysis of the problems arising from nonavailability of essential drugs in devel-oping countries. Disease by disease anddrug by drug, the objective will be to findsolutions involving “orphan” tropicaldrugs.

Need to guarantee qualityIn developing or recently industrial-

ised countries, the technology and thelegal framework needed to guarantee drugquality are often missing. Local suppliescan therefore include good quality

drugs and unacceptable oreven dangerous drugs, withadverse consequences bothon occupational health (inef-fective treatment) and publichealth (development ofresistance).

Action: In collaborationwith organizations involvedin supplying quality essentialdrugs, the MSF ResearchGroup will set up a networkfor drug quality monitoringthat will identify countries,manufacturers and distri-butors with good controlprocedures. The networkwill also draw attention todubious or definitely danger-ous production lines or anyillegal distribution circuitsthat are discovered.

Making all essentialdrugs affordable

Cost and the lack offrequently found in countries wherecontrol of information, when it exists, haslittle effect.

Action: Through collaboration withother parties that are equally concernedwith the correct use of drugs and withprescriber training, the Research Groupon Essential Drugs will help improve thequality and distribution of reliable infor-mation on drugs. The Group will alsoprovide the appropriate managerial toolsfor underprivileged environments.

Cooperating on researchSome therapeutic regimens can be

modified to ensure greater efficacy, toreduce secondary effects, costs and drugresistance, and to improve adherence totreatment. Assessment of the efficacy ofshort courses of treatment, or study ofthe appropriate galenic forms are areasof operational research that have beenselected to improve the therapeuticeffectiveness of existing drugs.

Action: The Research Group on Es-sential Drugs will encourage independentresearch institutes to conduct studies orclinical trials. Networking with the MSF/EPICENTRE teams1 on cooperation inlocal studies is necessary.

The Research Group on EssentialDrugs, in collaboration with existingnetworks, hopes to become a source ofinformation for both decision makers andfield workers, and a force for ideas andaction to improve health, particularlyin countries which are currentlydisadvantaged. ❏

* Jacques Pinel is Coordinator of the Re-search Group on Essential Drugs, Médecinssans Frontières, 8 rue Saint-Sabin, ParisCedex 11, France.

Reference

1. The EPICENTRE teams are responsible for epidemio-logical programmes and data collection.


a moratorium on issuing any newlicences for setting up retail phar-macy outlets.

No compromise onquality

The Government is publicisingits campaign in front-page articlesin all the main local and Englishlanguage newspapers, which invitesuggestions from the public onhow to improve the situation in thepharmaceutical sector. The cam-paign received a major boost witha special report on a range of drugquality and rational use issueswhich appeared in a Sunday news-paper1.

Although the issue of spurious/substandard medicines is central,in the Task Force’s first meetingthe authorities made it clear thatthey are very serious about chang-ing the whole system. Threesub-committees were formed: one

A clear message from the Punjab Government, whichappreared in several popular newspapers

coverage for the poor restrict access totreatment in developing countries. Over-all, the price of essential drugs, which isusually presented as the primary cause oftheir inaccessibility, has come down,thanks to the development of generic es-sential drugs policies, initiated mainly byWHO and UNICEF. But it is importantto remember that not all essential drugsare old: recent drugs, which are thereforeprotected by patent, remain beyond thereach of developing countries.

Action: By making contact with themanufacturers and international organi-zations concerned, ad hoc agreements canbe made to take account of both the com-mercial constraints of pharmaceuticalcompanies and the resources of poorpopulations. However, more lasting so-lutions must be sought to match the pricesof vital modern drugs with the resourcesof poor countries. The current debate onAIDS treatment illustrates the urgency ofthe problem. With other organizationsworking on the same question, theResearch Group on Essential Drugs willhelp to promote the idea of internationalsolidarity in access to drugs.

Promoting rational useAchieving the rational use of essen-

tial drugs remains a constant struggle: itbecomes imperative in times of shortage.There is still much work to do in promot-ing the essential drugs concept, in viewof the number of useless or dangerousdrugs that are still used in most countries.At the same time, a considerable propor-tion of available essential drugs is badlymanaged. In terms of information, inde-pendent medical journals and guides canprovide prescribers and other healthprofessionals with reliable advice, but inmost countries, most pharmacothera-peutic information is distributed bydrug companies. Dubious promotionalactivities and misleading advertising are

Reaching out to the people: an MSF worker in Palala,Liberia, during a vaccination campaign

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LJACQUES PINEL*

IKE other medical aid organiza-tions, Médecins sans Frontières(MSF) is facing new problems asinternational pharmaceutical

trade is reorganized to the detriment ofthe world’s poor. In a new initiative MSFhas set up a “Research Group on Essen-tial Drugs”, which will benefit from theknowledge and experience of MSF’smedical teams in 50 countries. The teamsnot only work with national decisionmakers and prescribers but are in contactwith a wide range of people, and can pro-vide valuable insight into the currentproblems. In seeking solutions the Groupwill also use MSF’s influence in industr-ialised countries. In collaboration withother specialists, members will initiateactivities to defend the health of peoplewho are underprivileged in terms of theiraccess to drugs.

Vital drugs may disappearThe therapeutic options available for

treating tropical diseases have generally

THE Chief Minister of the Punjab,Pakistan’s largest Province, hasinitiated a major campaign to reform the pharmaceutical sector.

Disturbed by increasing news of spuri-ous/substandard drugs and aware of thenon implementation of the 1988 DrugRules, the Chief Minister, MuhammadShahbaz Sharif, has set up a Task Forceto try to find a long-term solution to theproblems. As a start he has suspended allof the Province’s drug inspectors and put

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Making injections safe

initiatives which aim to improve thesafety of injections; these include theintroduction of steam sterilisers,development of auto-destruct syringes,and development of training materialsand courses.

As part of an overall strategy to fur-ther improve the safety of immunizationinjections and emphasise the need for“one sterile syringe and one sterile nee-dle for each injection”, it is essential toprevent the reuse (within or outside thehealth sector), of large numbers of thesyringes introduced into countries formass campaigns.

WHO and UNICEF have agreed toimplement a strategy to assure thatspecial attention is paid to the safe ad-ministration of vaccines during massimmunization campaigns. They haveissued the following policy statementwhich defines their position.

WHO-UNICEF policystatement for massimmunization campaigns

“The reuse of standard single-use

administration of the vaccines by plan-ning and implementing the “bundling”strategy as well as supporting trainingand supervision of the process during thecampaigns.

WHO and UNICEF recommend thatauto-destruct syringes and safety boxesare used in all elective and emergencymass immunization campaigns. Donorsare requested to “bundle” the supplies:vaccine, auto-destruct syringes andsafety boxes.

What is “bundling”?

The term “bundling” has been chosento define the concept of a theoretical“bundle” which must comprise eachof the following items:

◆ Good quality vaccines◆ Auto-destruct syringes◆ Safety boxes.

The implication is that none of thecomponent items can be consideredalone; each component must beconsidered as part of a “bundle”which contains the other two.“Bundling” has no physical connota-tion and does not imply that itemsmust be “packaged” together.

CostsIndicative costs for the safe adminis-

tration of vaccines most commonly usedin immunization campaigns are listedbelow. Each estimate includes the costof one dose of vaccine (in 20 or 50 dosevials), one auto-destruct syringe (about10US cents), and a fraction of the cost ofthe safety box (less than US$1.00 for 100syringes).” ❏

For copies of the policy statement (ref. WHO/EPI/LHIS/97.04) and further informationcontact: World Health Organization, GlobalProgramme for Vaccines and Immunization,20 Avenue Appia, 1211 Geneva 27,Switzerland. Tel: + 41 22 791 4373, fax:+ 41 22 791 4193, e-mail: [email protected]

■ ■ ■

1. Designed to give a single standard dose of vaccine afterwhich the syringe blocks permanently, preventing fur-

ther use of contaminated syringes. The needles are either

fixed or standard, but non-detachable, to prevent reuse(WHO/EPI Standard Performance Specification E8/

DS1).

2. Designed to collect and transport syringes and needles

(without caps) safely, to minimise the risk of accidental

needle-stick. The safety boxes are supplied flat-packedfor simple, one-step local assembly and should be incin-

erated with the load of contaminated syringes and needles(WHO Standard Performance Specification E10/IC.1 or

E10/IC.2).

Vaccine Cost of a safe administration (US$)

TT 0.16Measles 0.26DTP 0.19Td or DT 0.18Yellow fever1 0.27–0.31Meningitis1 0.31–0.41Hepatitis B2 0.65– 0.85

1. Price range calculated from lowest and highest bids to UNICEF.

2. The WHO/Expanded Programme on Immunization does not recommend campaigns with hepatitis B,but some countries may decide to do catch-up campaigns for a target-age group after the introductionof the vaccine in the routine immunization programme.

CDMU’s new leadership trainingon rational use of drugs


During 1996, in the developing world,routine immunization of children underone year and immunization of women ofchildbearing age with tetanus toxoid (TT)accounted for nearly 800 million injec-tions. In addition to routine immunization,emergency disease-outbreak control op-erations delivered more than 240 millioninjections in the same year.

As part of the drive to eliminateneonatal tetanus as a public healthproblem, 74 million women are being tar-geted in high risk areas of developingcountries. By 1999 this will generate anestimated 220 million injections inspecial immunization activities.

By the turn of the century, hepatitis Bvaccine should be in use worldwide, andnew vaccines should be in the processof being introduced into immunizationprogrammes. Acceleration of specialactivities aiming at better measles con-trol will be in progress, with elective massimmunization potentially targeting about3.1 billion children under 15 years of ageby 2005.

These increases in immunizationservices, including elimination and

eradication campaigns, offer an opportu-nity for improvement and make itimperative that injections are made safefor people. Over the past years, WHO andUNICEF have launched a number of

syringes and safety boxes as a “bundle”(see below).

All donors supporting immunizationcampaigns are requested to financenot only the vaccines but the safe

Immunization for a young Bolivian in the competent hands ofa community health worker

disposable syringes andneedles places the generalpublic at high risk of diseaseand death.

The auto-destruct sy-ringe1 presents the lowestrisk of person-to-persontransmission of blood-borne pathogens because itcannot be reused. The auto-destruct syringe is (a) thepreferred type of disposableequipment for adminis-tering vaccines; and (b) theequipment of choice for con-ducting mass immunizationcampaigns.

“Safety boxes2”, punc-ture-resistant containers forcollecting and disposing ofused disposable and auto-destruct syringes, needlesand other injection materialsreduce the risk posed tohealth staff and the generalpublic by contaminatedneedles and syringes.

For all elective and emer-gency mass campaigns,vaccines must, as a rule, besystematically supplied to-gether with auto-destruct

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INFORMATION reaching WHO and UNICEF consistently highlights thewidespread occurrence of unsterile injection practices, and points toinsufficient supplies of syringes and needles as a major cause. Unsafeinjections can result in the transmission of bloodborne pathogens from

patient-to-patient, patient-to-health worker and, more rarely, health worker-to-patient. The community at large is also at risk when injection equipment is usedand then not safely disposed of. In many instances, used equipment is reused,sold or recycled because of its commercial value.

THE first in a series of leadership training courses on rational use of drugsattracted doctors and senior health workers to the Udayani Jesuit Institute,Calcutta, in February 1998. The course was organized by the CommunityDevelopment Medicinal Unit, Calcutta, a non profit voluntary organiza-

tion which maintains a drug distribution network for NGOs in India’s eastern region.While many CDMU courses provide information on essential drugs and ra-

tional therapeutics, on this occasion the aim was specifically to train leaders whocould disseminate this information, and assume a major role in putting theory intopractice. The five main modules generated lively debate and covered: the essentialdrugs concept and its implications; drug formularies; treatment guidelines for com-mon diseases; drug control, drug policy (including patents) and drug promotion inIndia; and inventory management. ❏


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Stepping beyond withCommunity-Directed Treatment

ADICAL ”, “a kind of mini-revolution”; Professor OladeleKale* is excited by the prospectsfor Community-Directed Treat-

ment (ComDT). “It’s not so much a brandnew approach to primary health care, butmore a logical extension of the concept.It is primary health care at a more basicand practical level – not only is it healthof the people, and for the people, but it isalso by the people.”

Dissatisfaction with the old primaryhealth care system, with its inefficienciesand diversions, led a group of scientistsand researchers in Bamako, Mali, in June1994 to the idea of Community-Directed

together covered a total population of some1.5–2 million. Study findings showedthat, in all respects (effectiveness, accept-ance, coverage), community-designedsystems were better than programme-designed systems. Community-directeddistributors adhered well to treatment pro-cedures, and were able to differentiatebetween those who should and should notreceive the drug; they gave the correctdose, to within half a tablet, in over 90%of cases; and they were able to identifysevere adverse reactions and refer suchcases to the nearest health facility. Thestudy was successful to the extent thatCommunity-Directed Treatment has now

The main difficulties encounteredduring the study were poor reporting (aproblem which was actually more appar-ent in programme-designed systems) andfailure in supply (which depends onsupport from the health system). Less ofa problem was the resistance of somehealth workers, who felt apprehensiveabout Community-Directed Treatment –that they were being displaced and theirstatus threatened.

Assessing informationneeds

What remains to be done, therefore,

Here lots of people without signs andsymptoms of the disease, who may notperceive the need for treatment, have tobe reached.

The next phaseThese are some of the issues that will

be looked at in the next multicountrystudy planned for 10 onchocerciasis sitesin Africa. The challenge now is to see ifCommunity-Directed Treatment works in“real life”, as opposed to the experimen-tal conditions of the multicountry study.The challenge is to persuade governmentsand control programmes to accept thephilosophy – to accept that people can beempowered and that they have theintelligence, willingness and ability tolook after themselves.

But can the concept of Community-Directed Treatment be extended anyfurther? It is only suitable for mass treat-ment, where a single drug is to be givenin a single distribution (no more thantwice per year). It must be easy to deter-mine who should and who should notreceive treatment. And, preferably, thereshould be no need for laboratory diagno-sis. Some obvious candidates, therefore,might be lymphatic filariasis, schisto-somiasis and intestinal parasites. A studyof Community-Directed Treatment inlymphatic filariasis is already planned foreight sites in Africa and Asia. With time,communities may be able to take on re-sponsibilities of a different nature, suchas disease surveillance. The guineawormprogramme has shown that villagers canbe used as village-based health workersfor control programmes and this approachhas not been fully exploited. And whatabout the Expanded Programme on Im-munization? The health care system mustbe persuaded to think of programmesother than drugs that could benefit fromthe Community-Directed Treatmentapproach.

All in all, Community-Directed Treat-ment could be a technically importantmeans of health delivery. At the very least,it promises to be the most cost-effectiveand sustainable variant of community-based mass delivery/distribution systemsfor chemotherapy-based disease controlprogrammes. ❏

* Professor Oladele Kale is Professor of Pre-ventive and Social Medicine, University ofIbadan, College of Medicine, Department ofPreventive and Social Medicine, PMB 5116,Ibadan, Oyo State, Nigeria. Tel. and fax:+ 234 2 8103563, e-mail: [email protected] (mark message for the at-tention of Professor Kale). This article is basedon an interview with Professor Kale, whichwas first published in TDR Newsletter, No.54, October 1997.

Reference1. WHO. Community directed treatment with ivermectin.

Geneva: World Health Organization; 1996.


Treatment, which goes a stepbeyond most communityinvolvement. It goes beyondmerely asking the commu-nity about its wants andneeds, beyond mere partner-ship between the client andthe care provider, to owner-ship by, and empowermentof, the community. Not onlyis the community consultedabout its wants and needs,as in community-basedtreatment, but afterwardsthe community designs andimplements the delivery oftreatment too (whereas incommunity-based treatmentthe control programme de-signs and implements thedelivery of treatment; inother words, the control pro-gramme tells the community what to do).In 1994 it was not known whether theconcept was at all practical; there wasonly a lack of satisfaction with commu-nity-based treatment as it was thenpractised and some anecdotal evidence(from Mali in particular) that Community-Directed Treatment might be better.Many people felt that communities wouldnot be able to handle the responsibilityfor drug distribution; and even thecommunities were sceptical.

Ivermectin studyshows the benefits

The mass distribution of ivermectin topopulations at risk from onchocerciasiswas used to test the concept of Commu-nity-Directed Treatment in a study whichwas completed in 19961. Althoughivermectin had been donated to the coun-tries, the primary health care systemswere not efficient at delivering it in theright quantities to the right people. There-fore a multicountry study was conceivedin which ivermectin-delivery systemsdesigned and implemented by communi-ties themselves were compared with thosedesigned and implemented by controlprogrammes. The study involved eightsites in five African countries, which

been adopted by the African Programmeon Onchocerciasis Control and 19 coun-tries are committed to making it work.

The value of “ownership”What are the reasons for the success

of Community-Directed Treatment?Primarily, success rests in the philosophyof ownership and empowerment. Duringthe study, and as the communities becamemore confident, the part played by “own-ership” became quite clear. Givingcommunities the freedom to designtheir own system, to select the distribu-tors they want, and to change the systemwhen necessary, means flexibility.Programme-designed systems, incontrast, are relatively inflexible.

Benefits that can be expected fromCommunity-Directed Treatment includeless diversion of drugs (the possibilitiesfor diversion are less when the people arein charge themselves); better indicatorsfor sustainability (less dependenceon health care from outside); and leastdistraction of village life (having a dis-tributor in the village means that drugscan be distributed at night, when it isconvenient to the villagers, and not in thedaytime, when it is convenient to thehealth workers).

is to fine-tune Community-Directed Treatment, inparticular to define moreclearly how it fits into theorthodox health service.The main points of contactbetween the two occurwhen dealing with cases ofadverse reaction and withivermectin supply to com-munities. Consequently, oneof the next steps will be tolook at what information isneeded – by both controlprogrammes and communi-ties. The communities willnot only be asked what in-formation they want, butalso how they are going togo about getting it – thustaking the concept of Com-munity-Directed Treatment

a step further (usually the health servicetells the community what information itwants and then gets it). Other points ofcontact between the health service andCommunity-Directed Treatment includesupervision and training. In themulticountry study, some basic supervi-sion by local health service staff wasassociated with better performance interms of treatment coverage than no su-pervision at all. And the “open” training(when the community could look on) notonly reinforced acceptance by the com-munity but also resulted in indirectmonitoring of the trainees’ performanceby the communities themselves. Involv-ing health workers at the interface rightfrom the start, in meetings with the com-munity, in the training of distributorsand in supervision, helped overcomeresistance.

Another issue to be addressed con-cerns cost sharing and cost recovery. Inthe multicountry study, ivermectin wasmostly provided free of charge. But inCameroon, where a programme of costrecovery was in place, coverage was less.We need to know, therefore, how payingfor a drug affects performance, sincedrugs are not always free of charge andCommunity-Directed Treatment is appli-cable only in mass treatment programmes.

Community-Directed Treatment with ivermectin, near Kita in Mali. The house-to-house distributor fills in the paperwork, while his colleague holds themeasuring stick used to determine dosage by height

Photo: WHO/TDR/A. Crump

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