Atieno Ojoo, Technical Specialist, HIV/AIDs and malaria

Atieno Ojoo, Technical Specialist, HIV/AIDs and malaria

WHO/UNICEF Technical Briefing Seminaron Essential Medicines PoliciesGeneva, 8-12 October 2007

UNICEFs mandate:advocate for childrens rightshelp meet their basic needs.

Equitable ACCESS to essential supplies is fundamental to childrens rights to good health, basic education and protection from harm.

Presentation outlineContextualize the access framework

Discuss Current Concerns

Outline how to bridge the need/access gap

The access frameworkAccess to essential Medicines is a Human right (Alma Ata 1978, MDG)Rational SelectionStandards for medicine qualityAffordable pricesSustainable financingReliable supply systemsGeographical access

The story so farIt all started in 1977Flash back, 22nd April 2002"The long-sought inclusion of ARVs in WHOs EML will encourage governments in hard-hit countries to further expand the distribution of these vital drugs to those who need them. Currently, fewer than 5% of those who require treatment in developing countries can access these medicines.Source:E-drug:WHO Press Release on ARVs and the Essential Drugs ListFast forward, 17th Jan 2007A shortage of paediatric testing kits (PCR) and specialised medical staff in Zambia is causing delays in rolling out antiretroviral (ARV) drugs for children infected with HIV/AIDS. Despite the National AIDS Council (NAC) having enough ARV medication to treat about 19,000 children, only about 5,000 (~25%)are able to access the drugs. Source: IRIN

UNICEFs priorities in response to the Millennium Development GoalsHIV / AIDSTech. support Antiretrovirals Essential Medicines Test kits1. Eradicate extreme poverty and hunger2. Achieve universal primary education3. Promote gender equality and empower women4. Reduce child mortality5. Improve maternal health6. Combat HIV/AIDS, malaria and other diseases8. Develop a global partnership for development7. Ensure environmental sustainability

Current concerns

At current rates of progress, the MDG on reducing U5MR goal will be reached 30 years later than planned-WHY??

Source: The Status of the Worlds Children 2006Current progress on U5MRWhen goal should be metIf trends in the 90s roughly continue, the goal will not be met until 2045

Lack of access can be as simple as

or as complex as

Sheet1

ARV table according to Thai National Guideline (PATC) 2003

AZTAZT3TC3TCddIddId4TEFVNVPRTVGPO-vir

Dosage100-120100-1204 mg/kg4 mg/kg100-120100-1201 mg/kg120-200200-400

mg/m2mg/m2mg/m2mg/m2mg/m2mg/m2

Preparation10 mg/ml100 mg caps10 mg/ml150 mg tab25 mg sach100 mg sach30 mg tab50, 200 mg caps10 mg/ml80 mg/ml30/150/200 mg tab

DosingQ 12Q 12Q 12Q 12Q 12Q 12Q 12ODQ 12Q 12Q 12

3-4 kg4 ml1/21. 5 ml1/10 tab11/41/82.5 - 4 ml0.6-1.2 ml-

>4-5 kg4.5 ml1/22 ml1/8 tab11/41/83 - 5 ml0.7 - 1.4 ml1/4

>5-6 kg5 ml1/22.5 ml1/6 tab1 1/21/21/43.5 - 6 ml0.8 -1.6 ml1/4

>6-7 kg5 ml1/22.5 ml1/6 tab1 1/21/21/44 - 6.5 ml0.8 -1.7 ml1/4

>7-8 kg6 ml3/43 ml1/4 tab1 1/21/21/44.5 - 7 ml0.9 -1.8 ml1/4

>8-97 ml3/43.5 ml1/4 tab21/21/25 - 8ml1 - 2 ml1/4

>9-108 ml3/44 ml1/4 tab21/21/2200 mg5.5 - 9ml1.2 - 2.3 ml1/2

>10-129 ml3/44.5 ml1/3 tab21/21/2200 mg6 - 10 ml1.3 - 2.7 ml1/2

>12-14 kg9 ml15 ml1/3 tab21/21/2200 mg6.5 - 11 ml1.4 -2.4 ml1/2

>14-16 kg10 ml16 ml1/2 tab2 1/23/41/2250 mg7 -12 ml1.5 - 3 ml1/2

>16-18 kg10 ml17 ml1/2 tab2 1/23/41/2250 mg8 -14 ml1.7 - 3.5 ml1/2

>18-20 kg12 ml1 1/28 ml1/2 tab33/43/4250 mg9 - 15 ml1.8 - 4 ml3/4

>20-25 kg14 ml1 1/29 ml3/4 tab3 1/213/4300 mg10 - 17ml2.1 -4.5 ml3/4

>25-30 kg15 ml1 1/210ml3/4 tab411350 mg11 -18 ml2.5 - 5 ml3/4

>30-35 kg-2-1-1 1/21400 mg12 - 20 ml-1

Sheet2

Sheet3

or as elaborate as

SPECIAL STORAGE CONDITIONSWH SPACE AND EQUIPMENT

or as thorny asNo safety, efficacy data, no suitable formulations

Bridging the need/access gap

CREATING THE ENABLING ENVIRONMENTNEEDACCESS

EMBODIMENT OF THE WHO ACCESS FRAMEWORK FOR COLLECTIVE ACTION Millennium Development Goal 8, TARGET 17 In cooperation with pharmaceutical companies, provide access to affordable essential drugs in developing countries

QUALITYSPEEDPRICE

Expanded Commodity management cycleRegistration, Marketing, patents, pricingDemandCreationSupplierAgreementsFinancingReceipt, Storage,DistributionForecastingQualityAssuranceEffectiveUseProductProcurementProductSelectionMonitoringCalculating the quantities we should/can buy Must be done

The PSM process

LOGISTICSMedicines must get to the end userInventory MgmtWarehousingGlobalShippingProcurement

Importance of inventory managementThe recent Viracept (Nelfinavir) recallGood pointsAbility to track batch records to in country & programme delivery pointsProviding options for Rx changeChallengesNot able to track product up to patient levelRe-export for destruction-countries without ability to safely destroy pharmaceuticalsWeak Pharmacovigilance mechanisms

ConclusionAccess to medicines is part of an intervention : Always understand the big picture

PSM requires systematic/co-ordinated organisation: Define system in detail, assign responsibilities and accountabilities, routinely monitor

Financing is critical: Secure & manage funds effectively, efficiently. Remember administrative costs

Human resource capacity: Recruit, motivate, train competent and trustworthy personnel

Principles: Follow tried and tested good practices

Conclusion contdLegislative, regulatory and commercial context: understand and ensure full compliance in advance.

Supplier integrity: pre-qualify suppliers, manage tender process transparently, monitor performance.

Product and process quality: monitor and evaluate and take action.

Information system: maintain information integrity and flow for action.

www.unicef.org/supply

THANK YOU aojoo@unicef.org, tel: +45 35 27 31 03

SOME USEFUL REFERENCESManaging Drug Supply (Second edition) , Management Sciences for Health in collaboration with WHO, 1997, 832 pages ISBN 1-56549-047-9

Operational Principles for Good Pharmaceutical Procurement Interagency guidelines, 2000, 24 pages Ref. no. WHO/EDM/PAR/99.5

Management of Drugs at Health Centre Level, Training Manual (AFRO 2004) http://www.who.int/medicines/library/general/ManagementDrugsHealthCenterLevel_whoafredp04_3.pdf

SOME USEFUL REFERENCES CONTD.

Guidelines for the Storage of Essential Medicines and Other Health Commodities (JSI/DELIVER/WHO/UNICEF 2003) http://www.who.int/medicines/library/theme/theme_sup.shtml#1Inter-agency Guidelines on Drug Donations (1999) http://www.who.int/medicines/library/par/who-edm-par-1999-4/who-edm-par-99-4.shtmlInter-agency guidelines on safe disposal of unwanted pharmaceuticals in and after emergencies (1999) http://www.who.int/medicines/library/par/who-edm-par-1999-2/who-edm-par-99-2.shtmlUNICEF Supply Catalogue - http://www.supply.unicef.dk/catalogue/