PROCURING AND DISTRIBUTING ARVs AND OTHER A.R.T COMMODITIES IN MALAWI

1. PROCURING AND DISTRIBUTING ARVs AND OTHER A.R.T COMMODITIES IN MALAWI Technical Briefing for Consultants in Procurement and Supply Management for HIV, TB and Malaria Caesar Mudondo, Project Officer HIV/AIDS Health and Nutrition Section UNICEF Malawi

2. Outline • HIV/AIDS situation in Malawi • Structure of the healthcare system • Background to ART program in Malawi • Guidelines for management of HIV/AIDS • Estimating needs (quantification) • Procurement system for ARVs and drugs for OIs • Distribution system for ARVs and other ART commodities • Challenges • Successes

3. HIV/AIDS situation in Malawi • Population of Malawi 10.5 million • 900,000 living with HIV/AIDS • HIV prevalence 14.4% (15-49 year), 2003 • New infections (15-24 year olds) 46% • New infections overall 10,000 per year • 80,000 <15 year olds estimated with HIV/AIDS • 86,000 deaths due to HIV/AIDS per annum

4. Structure of the healthcare system • Ministry of Health and Population (MOHP)- policy formulation and implementation of healthcare programs • National AIDS Commission- coordinating HIV/AIDS activities and programs • Central Medical Stores-storage and distribution of medicines and other medical supplies to government and CHAM facilities • Pharmacy, Medicines and Poisons Board- medicines regulatory authority

5. Background to ART program in Malawi • National HIV/AIDS policy adopted by GOM in 2003 • MOHP adopted policy to adopt ART country-wide (July 2004 launch of ART) • GFATM approved US$ 196m for HIV/AIDS • ART implemented in phases • 170,000 people estimated to need HAART • 4,000 on ART in Jan 04. 37,500+ in Dec 05 (i.e. 20% of patients requiring ART) • 1,024 health workers trained in ART in public sector and 240 in private sector • 83 facilities (23 in private sector) implementing ART • ART free in public sector

6. Guidelines for management of HIV/AIDS • Guidelines for management of HIV/AIDS developed • Health workers trained on guidelines • First line regimen: [2 NRTI + 1 NNRTI] d4T+3TC+NVP (Fixed-dose combination) “Triomune” Alternative first line regimens: AZT+3TC+NVP d4T+3TC+EFV Second line regimen: AZT+3TC+TDF+LPv/RTv • OIs managed as per recognised protocols

7. Estimating needs (quantification) • No sound historical data as basis for quantification available • Initial estimates of ARV needs based on case load of TB and clinicians’ experience • 20 years TB experience-no o/s for first line drugs • Use of standardised first line treatment important • 54 facilities categorised as low (25 patients/ month), medium (50 patients) and high (150+ patients) burden. • 24 low, 26 medium and 4 high burden • ARVs packaged into starter and continuation packs (kits)

8. Estimating needs (contd) • Starter pack for use during first 15 days • Continuation pack for next 30 days • Starter pack contains d4T/3TC/NVP+d4T/3TC • Continuation pack contains d4T/3TC/NVP • Kits produced containing starter and continuation packs • Quantities of each drug per pack worked out for low, medium and high burden

9. Procurement system for ARVs and drugs for OIs • ART largely funded by GFATM • Procurement of medicines and other medical supplies generally responsibility of CMS • Procurement responsibility for ARVs and other ART commodities contracted out to UNICEF • Includes ARVs, diagnostic agents (HIV test kits), OI drugs and other medical supplies (lancets etc) • UNICEF closely liaises with NAC and MOHP re-procurement of commodities • Needs originate from MOHP and UNICEF provides TA and procures

10. Distribution system for ARVs and other ART commodities • UNICEF responsible for clearing all ARVs and other ART commodities • Other ART commodities are delivered by UNICEF (in agreed proportions) to regional medical stores for further distribution to user facilities • ARVs are delivered by UNICEF (in agreed proportions) direct to service delivery points • Push for first line ARVs • 2nd line treatment for referral facilities • Based on consumption adjustments to quantities supplied to facilities can be made. Shift categories

11. Challenges • Funding limitations and lengthy procurement formalities • Lengthy lead times and effect on ability to react to urgent needs • Estimating needs accurately in light of lack of reliable historical data • Limited sources of supply for ARVs • Developing adequate capacity for supply management Developing local capacity for procurement in shortest possible time • Moving from “push” to “pull” for ARVs and other ART commodities • M&E to ensure ability to react timely

12. Successes • Scaled up ART from 3,700 patients at 9 sites in 2003 to 35,000 patients at 83 sites Dec 2005 • Kit concept assisted in minimising problems related to quantification at facility level • Procurement and distribution arrangement has worked satisfactorily to date (approx US$14m to date) • No stock outs of ARVs at national or facility level • Increase in demand of ART services since launch of ART (e.g. demand for HIV testing has increased 4-fold) • Quarterly supervisory visits to sites very useful

13. Malawi Design and Plan for ART../5 A B A = Starter drugs for patients weighing 59Kg or less B = Starter drugs for patients weighing 60 Kg or above

14. Malawi Design and Plan for ART../6 Continuation drugs: 60 tablets in a tin Patients 60 Kg+ Patients 59 Kg-

15. Delivery and Distribution

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