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WHO/UNICEF Technical Briefing Seminar on Essential Medicines Policies Geneva, 8-12 October 2007 Atieno Ojoo, Technical Specialist, HIV/AIDs and malaria
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Atieno Ojoo, Technical Specialist, HIV/AIDs and malaria

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WHO/UNICEF Technical Briefing Seminar on Essential Medicines Policies Geneva, 8-12 October 2007. Atieno Ojoo, Technical Specialist, HIV/AIDs and malaria. - PowerPoint PPT Presentation
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Page 1: Atieno Ojoo,  Technical Specialist, HIV/AIDs and malaria

WHO/UNICEF Technical Briefing Seminaron Essential Medicines Policies

Geneva, 8-12 October 2007

Atieno Ojoo,

Technical Specialist, HIV/AIDs and malaria

Page 2: 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.

Page 3: Atieno Ojoo,  Technical Specialist, HIV/AIDs and malaria

Presentation outline

• Contextualize the access framework

• Discuss Current Concerns

• Outline how to bridge the need/access gap

Page 4: Atieno Ojoo,  Technical Specialist, HIV/AIDs and malaria

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

Page 5: Atieno Ojoo,  Technical Specialist, HIV/AIDs and malaria

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

Page 6: Atieno Ojoo,  Technical Specialist, HIV/AIDs and malaria

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

Page 7: Atieno Ojoo,  Technical Specialist, HIV/AIDs and malaria

Current concerns

Page 8: Atieno Ojoo,  Technical Specialist, HIV/AIDs and malaria

0

20

40

60

80

100

120

1990 2004 2015 2030 2045 2055

De

ath

s p

er

1,0

00

liv

e b

irth

s

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

Page 9: Atieno Ojoo,  Technical Specialist, HIV/AIDs and malaria

Lack of access can be as simple as…

Page 10: Atieno Ojoo,  Technical Specialist, HIV/AIDs and malaria

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

Page 11: Atieno Ojoo,  Technical Specialist, HIV/AIDs and malaria

or as elaborate as…

SPECIAL STORAGE CONDITIONS

WH SPACE AND EQUIPMENT

Page 12: Atieno Ojoo,  Technical Specialist, HIV/AIDs and malaria

or as thorny as…

No safety, efficacy data, no suitable formulations

Page 13: Atieno Ojoo,  Technical Specialist, HIV/AIDs and malaria

Bridging the “need/access” gap

CREATING THE ENABLING ENVIRONMENT

NEED ACCESS

Page 14: Atieno Ojoo,  Technical Specialist, HIV/AIDs and malaria

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

Page 15: Atieno Ojoo,  Technical Specialist, HIV/AIDs and malaria

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

Page 16: Atieno Ojoo,  Technical Specialist, HIV/AIDs and malaria

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

Page 17: Atieno Ojoo,  Technical Specialist, HIV/AIDs and malaria

LOGISTICSMedicines must get to the end user

Inventory Mgmt WarehousingGlobal

Shipping

Procurement

Page 18: Atieno Ojoo,  Technical Specialist, HIV/AIDs and malaria

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

Page 19: Atieno Ojoo,  Technical Specialist, HIV/AIDs and malaria

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

Page 20: Atieno Ojoo,  Technical Specialist, HIV/AIDs and malaria

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.

Page 21: Atieno Ojoo,  Technical Specialist, HIV/AIDs and malaria

www.unicef.org/supply

Page 22: Atieno Ojoo,  Technical Specialist, HIV/AIDs and malaria

THANK YOU [email protected], tel: +45 35 27 31 03

Page 23: Atieno Ojoo,  Technical Specialist, HIV/AIDs and malaria

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

Page 24: Atieno Ojoo,  Technical Specialist, HIV/AIDs and malaria

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/