STUDY OF ADMINISTRATION ON PHARMACUTICALAn Internship
ReportSubmitted in partial fulfillment of therequirements for the
award of the degree of MASTER OF COMPUTER APPLICATIONSSubmitted
bySUGANYA.TREG NO : 20118129
Under the Supervision ofDr. JOTHI VENKATESVARAN, M.Sc., M.Phil.,
PhDHead of the DepartmentDEPARTMENT OF COMPUTER SCIENCEPRESIDENCY
COLLGE (AUTONOMOUS)(Nationally reaccredited at the A+ Level by
NAAC)CHENNAI-600 005
With deep sense of gratitude I acknowledged the encouragement
and guidance received from my Project Guide Mr.Dr. JOTHI
VENKATESVARAN, M.Sc., M.Phil., PhD, Head of the Department of
Computer Science, Presidency College (Autonomous), Chennai who was
very generous in giving me this opportunity to work under in his
valuable guidance. He has been a constant guiding force and source
of illumination for me. It entirely goes to his credit that this
project has attained its final shape. I would like to thank his for
his valuable advice and guidance.
Further I would thank all the staff members of computer science
department who have been very courteous in providing all other
information about academic subjects.
SUGANYA.T
STUDY OF ADMINISTRATION ON PHARMACEUTICAL
ABSTRACT "The Indian pharmaceutical industry is a success story
providing employment for millions and ensuring that essential drugs
at affordable prices are available to the vast population of this
sub-continent".
ABOUT COMPANY Medinews Pharma India limited is one of the
growing company in pharmaceutical Industry. At present we are
growing well in Tamilnadu.
Medinews Pharma India limited is a public limited company
registered at Register of companies (ROC) with 12 Directors out of
11 Doctor Directors. Medinews Pharma had backbone of 57 leading
Doctors in various part of Tamil Nadu as Share Holders. Medinews
Pharma India Limited is a kind of Pharmaceutical marketing company
like the most of the companies doing in Indian sub continent
Medinews Pharma India Limited market its own pharmaceutical
products in the market Medinews Pharma have strong enough Marketing
team to fight in the market
PRODUCT RANGE Medinews Pharma have both ranges of Generic
products WHO SAYSThe national health and drug regulatory
authorities should ensure that all pharmaceutical products subject
to their control are in conformity with acceptable standards of
safety, efficacy and quality, and that all premises and practices
employed in the manufacture, storage and distribution of these
products comply with Good Manufacturing Practice (GMP) standards so
as to ensure the continued conformity of the products with these
requirements until such time as they are delivered to the end user.
All pharmaceutical products, including multisource products, should
be used in a country only after approval by the local authority.
Regulatory authorities should require the documentation of a
multisource (Generic) pharmaceutical product to meet (i) GMP, (ii)
quality control specifications, and (iii) pharmaceutical product
inter changeability. Multisource pharmaceutical products need to
conform to the same appropriate standards of quality, efficacy and
safety required of the originator's (comparator) product.A generic
product is a multisource pharmaceutical product which is intended
to be interchangeable with the comparator product. It is usually
manufactured without a licence from the innovator company and
marketed after the expiry of patent or other exclusivity
rights.
Speciality productsEvery specialty pharmaceutical product should
have its own go-to-market strategy.The variety of services, prices,
contracting, and reimbursement is infinite. Manufacturers are the
channel captain, but payers can influence them by designating their
own preferences. Because here, one of the major pharmaceutical
player like India, people have lot of choices to choose. Because,
Pharmaceutical companies are in hot pursuit of specialty products
through their own R&D as well as looking to purchase.
For both ranges Medinews have 44 registered brands as its own
Medinews pharma products have scope to cover all the speciality
divisions in the pharma industry Medinews pharma products avail in
various forms of medications like tablet, capsule, suppositories,
suspension, ointment, Dry syrup, cream, syrup, gel, etc.. In India
only very few companies are marketing suppositories, Medinews
pharma proud to be a part of it.
Product coverageOur products are cover various speciality
divisions in pharmaceutical industry. Below are few important
divisions, Cardiology Paediatric ENT Dental Gynaecology Diabetology
Orthopedic Neurology Opthamologist Surgeon Dermatologist
Physician
Process
The procedures and structures of eight functions of the
pharmaceutical sector, namely:1. Registration of medicines2.
Licensing of pharmaceutical business3. Inspection of
establishments4. Medicine promotion5. Clinical trials6. Selection
of essential medicines17. Procurement of medicines8. Distribution
of medicines
Product line design involves design of various product variants
under a product line which aims to satisfy the needs of various
market segments. In the development of product lines, it is quite
common for companies to adopt sourcing strategy nowadays for
reducing product cost and development time, and improving product
quality. One major issue of the sourcing is supplier
selection.These are the important factors consider, while selecting
a product,Product selection SurveyAnalysisBrand registration
Product ManufacturingMarket the product as Brand
Choosing a product In Pharmaceutical industry the virginal
products are came every day, every minute, so to select a product,
we should care much and careful in pricing. Now a day's Indian
Government, NPPA (National Pharmaceutical Pricing Authority) fixes
the Maximum Retail Price (MRP) for many pharmacological molecules.
So, in pricing a product should be careful.
The choices are limitless and the task may be overwhelming at
first. Not only should there be a demand for our product, but it
must be profitable and something we enjoy selling Some companies
having their own Research and Development division. That products
took more time to reach market due to its procedures of using
human.
For other products well consider the following
Marketability Profit Margin Consumable (or) Need Competition and
Private Label Quality Diversity
Survey Take product survey with specialist people or by our
Marketing Field force Based on the survey reports well proceed
further If the reports shows negative impact, product will not go
to next level
Analysis Product analysis enable us to understand the
requirements before manufacturing Analyse the complete Life cycle
of the product Supply chain Marketing statergies
Brand registration & manufacturing Select a Brand name for
our product On the Brand name we Manufacture the product The
excellence of manufacturing a product is certified by several ways,
by commonly industry choose GMP and WHO for good manufacturer. Good
Manufacturing Practice (GMP) certificates are distributed by the
State government of India and WHO certification meant World Health
Organization certified unit can export pharmaceutical product all
over the world.
Market our brand Proceed to market our brand
COMPANY PRODUCT RANGE
S. NoBrand NameCompositionPack
1ALLERBEST-MLEVOCETRIZINE 5mg + MONTELUKAST 10mg10s
2BUGPOD 100 DTCEFPODOXIME PROXETIL 100mg10s
3BUGPOD 200 DTCEFPODOXIME PROXETIL 200mg10s
4BUGPOD-DRY SYRUPCEFPODOXIME PROXETIL 50 mg18g/30ml
5CALCIFORTCALCIUM CITRATE MALEATE 250mg + VIT D3 100IU10s
6CEFINU 100 DTCEFIXIME 100mg10s
7CEFINU 200 DTCEFIXIME 200mg10s
8CEFINU DRY SYRUPCEFIXIME 50MG15g/30ml
9CLAVBID A375CLAVULANATE POTASSIUM 125mg + AMOXYCILLIN
TRIHYTRATE 250 mg6's
10CLAVBID A625CLAVULANATE POTASSIUM 125mg + AMOXYCILLIN
TRIHYTRATE 500 mg6's
11CLAVBID-A DRY SYRUPAMOXYCILLIN 200MG + CLAVULANATE POTASSIUM
28.5 MG3.3g/30ml
12DEXCOFDMR 10mg PHENYEPHRINE 5mg CPM 2mg MENTHOL 1mg60ml
13DEZOARTDEFLAZACORT 6mg6s
14D-GRELCLOPIDOGREL 75mg10s
15EARLYSTATATROVASTATIN 10mg10s
16FOLFERRITIN ZFERROUS ASCOR BATE 100mg + FOLIC ACID 1.5mg +
ZINC 22.5mg10s
17GERD 20RABEPRAZOLE 20 + DOMPERIDONE 30 SR10s
18GI-40PANTOPRAZOLE 40mg10s
19MECORICHMETHYLCOBALAMIN 500mcg + ALPHA LIPOIC ACID 100mg+FOLIC
ACID 1.5mg + VITAMIN B6 10mg10s
20MEDIFENAC GELDICLOFENAC 1% w/w + METHYLSALICYLATE 10% w/w
LINSEEDOIL 3% MENTHOL30gm
21MEDIFENAC SUPPOS.DICLOFENAC SODIUM I.P 100mg5's
22MEDIFENAC-APACECLOFENAC 100mg + PARACETAMOL 325 mg10s
23MEDIFORMIN SR 1 gmMETFORMIN 1000mg SR10s
24MEDIFORMIN SR 500METFORMIN 500mg SR10s
25MEDIFORMIN G1METFORMIN 500mg + GLIMEPIRIDE 1mg10s
26MEDIFORMIN G2METFORMIN 500mg + GLIMEPIRIDE 2mg10s
27MEDIMETRO 25mg XLMETOPROLOL 25mg10s
28MEDIMETRO 50mg XLMETAPROLOL 50mg10s
29MEDIPM-125PARACETAMOL 125mg60ml
30MEDIPM170 SUPPOS.PARACETAMOL I.P 170 mg5's
31MEDIPM-250PARACETAMOL 250mg60ml
32PM-500PARACETAMOL 500mg10s
33MEDIPM-650PARACETAMOL 650mg10s
34MEDIPM80 SUPPOS.PARACETAMOL I.P 80 mg5's
35MEDITEL-40TELMISARTAN 40mg10s
36MEDITEL-40HTELMISARTAN 40mg + HYDROCHLOROTHIAZIDE
12.5mg10's
37MEDORNI OOFLOXACIN 200mg + ORNIDAZOLE 500mg10s
38MEGANUMETHYLCOBALAMIN 750mg + PREGABALIN 75mg + FOLIC ACID
0.75mg + VITAMIN B12 15mg10s
39MUCUS-ATERBUTALINE SULPHATE 1.25mg AMBROXOL HCL 15mg
GUAIPHENESIN 50mg MENTHOL 0.5mg (SORBITOL BASE)100ml
40M-VERT 16BETAHISTINE 16mg10s
41M-VERT 8BETAHISTINE 8mg10s
42PEPGELDRIED ALU HYDROXIDE 250mg MAGNESIUM HYDROXIDE 250mg
ACTIVATED DIMEEHICONE 50mg170ml
43POWIN-ZPOVIDONE-IODINE I.P 5%w/w +ALOES I.P 1.5% w/w+
ETRONIOAZOLE I.P 1% w/w + WATER SOLUBLE OINMENT BASE QS15mg
44TM PLUSTRAMADOL 37.5mg + PARACETAMOL 325mg10s
Company structure
DIRECTORS
COO
FINANCIALMARKETINGPRODUCTIONADMINISTRATION
PRO
COOMARKETING
MARKETING MANAGER
FIELD SALES OFFICERFIELD SALES OFFICERAREA MANAGERAREA
MANAGERAREA MANAGER REGIONAL MANAGER REGIONAL MANAGER
Administration & Finance
Essential medicines in India by WHO 2013Median availability of
selected generic medicinesf(%)Median consumer price ratio of
selected generic medicinesg
22.176.81.9
Infrastructures and technologiesHospital Hospital
bedsPsychiatric BedsComputed tomography unitsRadiotherapy Units
per 100000 populationper 10000 populationper million
population
2010200520122005-201220102010
...90.2...0.4
WHY I TOOK THIS INDUSTRY STUDYMedicines: rational use of
medicines
Key facts More than 50% of all medicines are prescribed,
dispensed or sold inappropriately, and half of all patients fail to
take medicines correctly.
The overuse, underuse or misuse of medicines harms people and
wastes resources.
More than 50% of all countries do not implement basic policies
to promote rational use of medicines.
In developing countries, less than 40% of patients in the public
sector and 30% in the private sector are treated according to
clinical guidelines.
A combination of health-care provider education and supervision,
consumer education, and an adequate medicines supply is effective
in improving the use of medicines, while any of these interventions
alone has limited impact.
Rational use of medicines refers to the correct, proper and
appropriate use of medicines. Rational use requires that patients
receive the appropriate medicine, in the proper dose, for an
adequate period of time, and at the lowest cost to them and their
community.
Incorrect use of medicines WHO estimates that more than half of
all medicines are prescribed, dispensed or sold inappropriately,
and that half of all patients fail to take them correctly. This
incorrect use may take the form of overuse, underuse and misuse of
prescription or non-prescription medicines.
Common problems include: Poly pharmacy (use of too many
medicines); overuse of antibiotics and injections; failure to
prescribe in accordance with clinical guidelines; Inappropriate
self-medication.
In developing countries, the proportion of patients treated
according to clinical guidelines for common diseases in primary
care is less than 40% in the public sector and 30% in the private
sector. For example:
less than 60% of children with acute diarrhoea receive necessary
oral rehydration therapy yet more than 40% receive unnecessary
antibiotics;
only 50% of people with malaria receive the recommended
first-line antimalarial;
only 5070% of people with pneumonia are treated with appropriate
antibiotics, yet up to 60% of people with viral upper respiratory
tract infection receive antibiotics inappropriately.
What are the consequences of incorrect use of medicines?
Incorrect use of medicines occurs in all countries, causing harm to
people and wasting resources. Consequences include:
Antimicrobial resistance. Overuse of antibiotics increases
antimicrobial resistance and the number of medicines that are no
longer effective against infectious disease. Many surgical
procedures and cancer therapies are not possible without
antibiotics to fight infection. Resistance prolongs illnesses and
hospital stays, and can even cause death, leading to costs of US$
45 billion per year in the United States of America1and 9 billion
per year in Europe2.
Adverse drug reactions and medication errors.
Harmful reactions to medicines caused by wrong use, or allergic
reactions to medicines can lead to increased illness, suffering and
death. Adverse drug reactions have been estimated to cost millions
of dollars each year3,4.
Lost resources.
Between 1040% of national health budgets are spent on medicines.
Out-of-pocket purchases of medicines can cause severe financial
hardship to individuals and their families. If medicines are not
prescribed and used properly, billions of dollars of public and
personal funds are wasted.
Eroded patient confidence.
Exacerbated by the overuse of limited medicines, drugs may be
often out of stock or at unaffordable prices and as result erode
patient confidence. Poor or negative health outcomes due to
inappropriate use of medicines may also reduce confidence.
What factors contribute to incorrect use of medicines?
Lack of skills and knowledge.
Diagnostic uncertainty, lack of prescriber knowledge of optimal
diagnostic approaches, lack of independent information such as
clinical guidelines, lack of opportunity for patient follow-up, or
fear of possible litigation, lead to improper prescription and
dispensing of medicines.
Inappropriate unethical promotion of medicines by pharmaceutical
companies.
Most prescribers get medicine information from pharmaceutical
companies rather than independent sources such as clinical
guidelines. This can often lead to overuse. Some countries allow
direct-to-consumer advertising of prescription medicines, which may
lead to patients pressuring doctors for unnecessary medicines.
Profits from selling medicines.
In many countries, drug retailers prescribe and sell medicines
over-the-counter. The more they sell the more income they generate,
leading to overuse of medicines, particularly the more expensive
medicines.
Unrestricted availability of medicines.
In many countries, prescription medicines such as antibiotics,
are freely available over-the-counter. This leads to overuse,
inappropriate self-medication and non-adherence to dosing
regimes.
Overworked health personnel.
Many prescribers have too little time with each patient, which
can result in poor diagnosis and treatment. In such circumstances
prescribers rely on prescribing habit as they do not have the time
to update their knowledge of medicines.
Unaffordable medicines.
Where medicines are unaffordable, people may not purchase a full
course of treatment or may not purchase the medicines at all.
Instead they may seek alternatives, such as medicines of
non-assured quality from the Internet or other sources, or
medicines prescribed to family or friends.
Lack of coordinated national pharmaceutical policy.
Less than half of all countries implement the basic policies
recommended by WHO to ensure the appropriate use of medicines.
These include appropriate measures and infrastructure for
monitoring and regulation of medicines use, and training and
supervision for prescribing health workers.
What can be done to improve rational use of medicines? WHO
advises countries to implement national programmes to promote
rational use of medicines through policies, structures, information
and education. These include:
a national body to coordinate policies on medicine use and
monitor their impact;
evidence-based clinical guidelines for training, supervision and
supporting decision-making about medicines;
lists of essential medicines used for medicine procurement and
insurance reimbursement;
drug (medicines) and therapeutics committees in districts and
hospitals to monitor and implement interventions to improve the use
of medicines;
problem-based training in pharmacotherapy and prescribing in
undergraduate curricula;
continuing medical education as a requirement of licensure;
publicly available independent and unbiased information about
medicines for health personnel and consumers;
public education about medicines;
elimination of financial incentives that lead to improper
prescribing, such as prescribers selling medicines for profit to
supplement their income;
regulations to ensure that promotional activities meet ethical
criteria; and
adequate funding to ensure availability of medicines and health
personnel.
The most effective approach to improving medicines use in
primary care in developing countries is a combination of education
and supervision of health personnel, consumer education, and
ensuring an adequate supply of appropriate medicines. Any of these
alone have limited impact.
WHO response
To improve rational medicine use, WHO:
monitors global medicines use and pharmaceutical policy;
provides policy guidance and support to countries to monitor
medicines use and to develop, implement and evaluate national
strategies to promote rational use of medicines;
develops and delivers training programmes to national health
professionals on how to monitor and improve medicines use at all
levels of the health system.
Medicines: medicines for children
Key facts
Nearly nine million children under five years old die every
year, many of them from conditions that could be treated with safe,
effective medicines.
Children are not small adults, their bodies respond to medicines
differently. They need medicines tailored to their age, body weight
and physiological condition.
Few medicines exist in formulations developed specifically for
children.
Worldwide many medicines for children are used "off-label", that
is their effects on children have not been studied and they are not
licensed for use in children.
Flexible solid oral dosage forms of medicines are ideal for
children.
The ideal children's medicine is one that suits the age,
physiological condition and body weight of the child taking them
and is available in a flexible solid oral dosage form that can be
taken whole, dissolved in a variety of liquids, or sprinkled on
foods, making it easier for children to take.
Global situation and challenges Nearly nine million children
under the age of five die every year, many of them from conditions
that could be treated with safe, effective medicines. Access to
appropriate medicines for children is essential for achieving the
child health goals including Millennium Development Goals (MDG) 4
(Reduce child mortality by two thirds) and MDG 6 (Combat HIV/AIDS,
malaria, and other major diseases).
Lack of medicines for children is a global problem, which most
acutely affects developing countries. Worldwide many medicines for
children are used "off-label", that is their effects on children
have not been studied and they are not licensed for use in
children.
Very few medicines exist in formulations developed specifically
for children and those that do often do not reach the children that
need them most. For example, nearly three million children under
five die each year from diarrhoea and pneumonia. In the case of
diarrhoea, reliable treatment exists in the form of oral
rehydration salts and zinc. Yet, studies show that this treatment
is frequently unavailable in pharmacies and clinics in countries
where these diseases are most common. Improved access to this
medicine could save millions of lives. When child specific
medicines are not available, healthcare workers and parents often
use fractions of adult dosage forms or prepare doses of medicines
for children by crushing tablets or dissolving portions of capsules
in water. This practice is difficult for the parent or care-giver,
can be hard for the child to take and can result in inaccurate
administration of the medicine with either under or over dosing the
child, leading to possible adverse reactions or unsuccessful
treatment.
Children with chronic conditions, such as HIV/AIDS, may have to
take several medicines daily. For them, fixed-dose combination
productsseveral medicines in one pillare best. However, very few
fixed-dose combinations for children exist.
Some regional and national regulatory authorities including the
European Medicines Agency and the United States' Food and Drug
Administration have undertaken initiatives to improve the
availability, safety and efficacy of medicines for children.
Ongoing global effort is needed to improve the situation.
Areas where more work is needed
Research
Many essential medicines do not exist in child-size dosage
forms. As well, for many medicines there is not enough information
about their efficacy and safety to allow them to be licensed for
use in children. In order to address the research needs for
children's medicines, strengthening the quality and quantity of
paediatric clinical trials research is essential. Clinical trials
involving children require careful ethical review and approval.
Access
Promoting the need for flexible solid oral dosage forms and
fixed-dose combinations for children is required. Pharmaceutical
companies interested in manufacturing of children's dosage forms
need to be identified and encouraged to produce medicines for
priority conditions e.g. fixed dose combinations for malaria,
HIV/AIDS and tuberculosis, as well as antibiotics for neonatal
infections. Health care workers and carers of children need to
expect 'preferred dosage forms'. A first step in promoting access
is to assess the current situation concerning the availability and
costs of essential medicines for children. Once an assessment has
been made it will be possible to advocate for changes that will
benefit children and their families and lead to measurable
improvements in health outcomes.
WHO response
Launching the 'Make medicines child size' initiative in December
2007 raised awareness and stimulated action to improve the
availability of safe, effective, quality medicines for children
including regulatory measures, government policy, procurement
agency purchasing decisions, research from academia and private
sector, and production from the pharmaceutical industry.
Providing the healthcare, procurement and pharmaceutical
communities with information on dosage and treatment guidelines
through the development of the WHO Model Formulary for Children
containing independent prescriber information on over 240 medicines
based on the WHO Model List of Essential Medicines for Children,
first developed in 2007 and reviewed and updated every two
years.
Advising countries on issues of quality, safety, efficacy,
supply management and promoting access to essential medicines for
children in countries. This is done by encouraging the inclusion of
medicines for children in national essential medicines lists,
treatment guidelines and procurement schemes and working with
national drug regulatory authorities to expedite regulatory
assessment of essential medicines for children.
Creating an online clinical trial registry for clinical trials
involving children and developing guidelines for conducting
clinical trials in children in resource-limited settings.
Establishing the Paediatric medicines Regulatory Network (PmRN),
a network of regulatory authorities to work on how best to license
medicines for children.
Medicines: safety of medicines adverse drug reactionsKey
facts
Unintended, harmful reactions to medicines (known as adverse
drug reactions) are among the leading causes of death in many
countries.
The majority of adverse drug reactions (ADR) are
preventable.
People in every country of the world are affected by ADRs.
In some countries ADR-related costs, such as hospitalization,
surgery and lost productivity, exceed the cost of the
medications.
No medicine is risk free. Vigilant assessment of the risks and
benefits of medicines promotes patient safety.
The safety of medicines is an essential part of patient safety.
Global drug safety depends on strong national systems that monitor
the development and quality of medicines, report their harmful
effects, and provide accurate information for their safe use.
Harmful, unintended reactions to medicines that occur at doses
normally used for treatment are called adverse drug reactions
(ADRs). ADRs are among the leading causes of death in many
countries.
Preventing and detecting adverse effects from medicines is
termed pharma covigilance. Vigilant assessment of the risks and
benefits of medicines applies throughout the life cycle of a
medicine - from the pre-approval stage to use by patients.
Global information-sharing on adverse effects strengthens drug
safety in countries, and can translate into timely policy decisions
that safeguard patient safety when problems emerge.
Examples of ADRs include:
MedicinesReactions
Amidopyrine (for inflammation)white blood cell disorder
Clioquinol (for skin infections)visual impairment
Erythromycin estolate (antibacterial)hepatitis (liver
disorder)
Oral contraceptivesthromboembolism (blood clots)
Statins (for controlling cholesterol)muscle degeneration
Thalidomide (for managing morning sickness)phocomelia
(disfigured infants)
Risks No drug is without risk and all medicines have side
effects, some of which can be fatal. People in every country of the
world are affected by ADRs. In some countries ADR-related costs,
such as hospitalization, surgery and lost productivity, exceed the
cost of the medications. At least 60% of ADRs are preventable, and
can be due to:
wrong diagnosis of the patients condition;
prescription of the wrong drug or wrong dosage of the right
drug;
an undetected medical, genetic or allergic condition that might
cause a patient reaction;
self-medication with prescription medicines;
not following the instructions for taking the medication;
reactions with other drugs (including traditional medicines) and
certain foods;
use of a sub-standard medication whose composition and
ingredients do not meet the correct scientific requirements, and
can be ineffective and often dangerous;
use of counterfeit medicines with no active ingredients or the
wrong ingredients, which can be dangerous or fatal.
Even when the above situations are avoided, all medicines have
side effects and some can be damaging. The effects of any treatment
with a medicine cannot be predicted with absolute certainty. All
medicines have both benefits and the potential for harm. The risk
of harm can be minimized by ensuring that prescribed medicines are
of good quality, safe, effective and used by the right patient in
the right dose at the right time.
Safety measures
Pharmaceutical companies, or drug-makers, are required by law in
all countries to test their drugs on healthy and patient volunteers
before making them widely available. These clinical trials show how
well a drug works for a defined disease and what potential harm it
can cause. However they provide no information for larger, untested
populations with different characteristics from the trial group,
such as age, gender, state of health, and ethnic origin. For many
medicines, and particularly complex products, safety monitoring
does not stop at the manufacturing stage. Medicine safety must be
followed by careful patient monitoring and further scientific data
collection. This aspect of drug monitoring is called post-marketing
surveillance. The effectiveness of national post-marketing
surveillance is directly dependent on the active participation of
health professionals.
Health professionals (physicians, pharmacists, nurses, dentists
and others) are in the best position to report suspected ADRs as
part of their daily patient care. Health professionals should
report ADRs even if they are doubtful about the precise
relationship between the given medicine and reaction.
WHO Response
WHO promotes global drug safety through its International Drug
Monitoring Programme, which began in the 1960s. Through the
cooperative effort, Member States and WHO work together to identify
possible relationships between the use of a drug and adverse
effects. Nearly 100 countries now have national systems in place to
report ADRs to the database managed by the WHO Collaborating
Centre, the Uppsala Monitoring Centre. When signals of drug safety
problems emerge, WHO shares the results with all Member
Countries.
In addition, WHO:
facilitates regular information exchanges among Member States on
the safety and effectiveness of medicines, involving a network of
national information officers;
promptly informs national health authorities about new
information on serious adverse effects of pharmaceutical
products;
provides guidelines to help countries set up national drug
monitoring centres;
assists countries as they work to strengthen drug regulatory
authorities and reporting systems;
trains health professionals on safety monitoring for new and
complex medicines (e.g. antiretrovirals to treat HIV);
draws together regulatory authorities, police, customs officials
and others to combat counterfeit medicines worldwide.
REFERENCES:
For more information contact:WHO Media centre