WHO/UNICEF Technical Briefing Seminar on Essential Medicines Policies Geneva, 8-12 October 2007 Atieno Ojoo, Technical Specialist, HIV/AIDs and malaria
Jan 13, 2016
WHO/UNICEF Technical Briefing Seminaron Essential Medicines Policies
Geneva, 8-12 October 2007
Atieno Ojoo,
Technical Specialist, HIV/AIDs and malaria
UNICEF’s mandate:advocate for children’s rightshelp meet their basic needs.
Equitable ACCESS to essential supplies is fundamental to children’s rights to good health, basic education and protection from harm.
Presentation outline
• Contextualize the access framework
• Discuss Current Concerns
• Outline how to bridge the need/access gap
The access framework
• Access to essential Medicines is a Human right (Alma Ata 1978, MDG)– Rational Selection– Standards for medicine quality– Affordable prices– Sustainable financing– Reliable supply systems– Geographical access
The story so far…It all started in 1977
Flash back, 22nd April 2002"The long-sought inclusion of
ARVs in WHO’s 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 List
Fast forward, 17th Jan 2007“A 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
UNICEF’s priorities in response to the Millennium Development Goals
HIV / AIDSHIV / AIDS• Tech. support• Antiretrovirals• Essential Medicines• Test kits
GIRLS' GIRLS'
EDUCATIONEDUCATION • School-in-a-box Kit• Water & sanitation• Education supplies
IMMUNIZATION +IMMUNIZATION +
• Vaccines• Immunization
devices• Vitamin A• Cold Chain Equip.
EARLY CHILDHOOD EARLY CHILDHOOD DEVELOPMENTDEVELOPMENT
• Mosquito nets• Essential medicines• Micronutrients• Medical Equip.• Water & Sanitation Equip.
CHILD CHILD PROTECTIONPROTECTION
• Emergency kits• Water & Sanitation• Health & Nutrition• Education & Recreation
1. Eradicate extreme poverty and hunger
2. Achieve universal primary education
3. Promote gender equality and empower women
4. Reduce child mortality
5. Improve maternal health
6. Combat HIV/AIDS, malaria and other diseases
8. Develop a global partnership for development
7. Ensure environmental sustainability
Current concerns
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20
40
60
80
100
120
1990 2004 2015 2030 2045 2055
De
ath
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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 World’s Children 2006
Current progress on U5MR
When goal should be met
If 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…
AZT AZT 3TC 3TC d4T NVP GPO-virDosage 100-120 100-120 4 mg/kg 4 mg/kg 1 mg/kg 120-200
mg/m2 mg/m2 mg/m2
Preparation 10 mg/ml 100 mg caps 10 mg/ml 150 mg tab 30 mg tab 10 mg/ml 30/150/200 mg tab
Dosing Q 12 Q 12 Q 12 Q 12 Q 12 Q 12 Q 12
3-4 kg 4 ml 1/2 1. 5 ml 1/10 tab 1/8 2.5 - 4 ml -
>4-5 kg 4.5 ml 1/2 2 ml 1/8 tab 1/8 3 - 5 ml 1/4
>5-6 kg 5 ml 1/2 2.5 ml 1/6 tab 1/4 3.5 - 6 ml 1/4
>6-7 kg 5 ml 1/2 2.5 ml 1/6 tab 1/4 4 - 6.5 ml 1/4
>7-8 kg 6 ml 3/4 3 ml 1/4 tab 1/4 4.5 - 7 ml 1/4
>8-9 7 ml 3/4 3.5 ml 1/4 tab 1/2 5 - 8ml 1/4
>9-10 8 ml 3/4 4 ml 1/4 tab 1/2 5.5 - 9ml 1/2
>10-12 9 ml 3/4 4.5 ml 1/3 tab 1/2 6 - 10 ml 1/2
>12-14 kg 9 ml 1 5 ml 1/3 tab 1/2 6.5 - 11 ml 1/2
>14-16 kg 10 ml 1 6 ml 1/2 tab 1/2 7 -12 ml 1/2
>16-18 kg 10 ml 1 7 ml 1/2 tab 1/2 8 -14 ml 1/2
>18-20 kg 12 ml 1 1/2 8 ml 1/2 tab 3/4 9 - 15 ml 3/4
>20-25 kg 14 ml 1 1/2 9 ml 3/4 tab 3/4 10 - 17ml 3/4
>25-30 kg 15 ml 1 1/2 10ml 3/4 tab 1 11 -18 ml 3/4
>30-35 kg - 2 - 1 1 12 - 20 ml 1
or as elaborate as…
SPECIAL STORAGE CONDITIONS
WH SPACE AND EQUIPMENT
or as thorny as…
No safety, efficacy data, no suitable formulations
Bridging the “need/access” gap
CREATING THE ENABLING ENVIRONMENT
NEED ACCESS
QUALITY
SPEED
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”
PRICE
Registration, Marketing, patents,
pricing
Expanded Commodity management cycle
DemandCreation
SupplierAgreements
FinancingReceipt, Storage,
Distribution
Forecasting
QualityAssurance
EffectiveUse
ProductProcurement
ProductSelection
Monitoring
Calculating the
quantities we should/can buy …
Must be done
The PSM process
Def
initi
on o
f N
eed
(spe
c, t
imin
g, q
ty)
Bud
getin
g an
d P
lann
ing
Pro
cure
men
t
Del
iver
y to
Nat
iona
l Lev
el
Insp
ectio
n
In-c
ount
ry
Dis
trib
utio
n
Util
izat
ion
by B
enef
icia
ry
Monitoring and EvaluationAssessing supply performance and efficiencyAssessing supply (programme-input) effectivenessMonitoring overall supply & demand of market
Capacity BuildingGovernment training and development
Programme
Supply
Government
Logistics & DeliveryProcurementPlanning
MDG MTSPrights
LOGISTICSMedicines must get to the end user
Inventory Mgmt WarehousingGlobal
Shipping
Procurement
Importance of inventory management
The recent Viracept (Nelfinavir) recall• Good points
– Ability to track batch records to in country & programme delivery points
– Providing options for Rx change
• Challenges– Not able to track product up to patient level– Re-export for destruction-countries without ability to
safely destroy pharmaceuticals– Weak Pharmacovigilance mechanisms
Conclusion• Access 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 contd
• Legislative, 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 [email protected], tel: +45 35 27 31 03
SOME USEFUL REFERENCES
Managing 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#1
Inter-agency Guidelines on Drug Donations (1999) http://www.who.int/medicines/library/par/who-edm-par-1999-4/who-edm-par-99-4.shtml
Inter-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.shtml
UNICEF Supply Catalogue - http://www.supply.unicef.dk/catalogue/