ARV SUPPLY CHAIN MANAGEMENT AND HIV DRUG RESISTANCE

Transcription

1 ARV SUPPLY CHAIN MANAGEMENT AND HIV DRUG RESISTANCE Dr Cissy Kityo Mutuluuza INTEREST Meeting 5-9 th May 2014

2 Background ART programmes in Africa have been nurtured with donor funding largely from PEPFAR, The Global fund and other agencies e.g. The Clinton Foundation. As these ART in-country programmes mature, they will increasingly face new challenges that require careful planning with a smart balance between short and long term goals and consequences.

3 The Primary Challenge: The enormous need for HIV care and treatment in the setting of under-resourced health care systems that urgently need: Sustainability of funding for ART continuity Maintaining efficient ARV logistics systems Prevention of emerging resistance to ARVs Overcoming Structural barriers to Universal ART access

4 The Logistics Cycle

5 ARV Drug Pipeline Program Management (MOH) Quarterly Revised Quantification External Supplier Monthly Reports from Resource Center: - Stock position at Central level - Pipeline analysis - Delivery performance - Reporting rate Monthly Reports from Supplier: - Stock position - Deliveries/Issues CENTRAL SUPPLIER/ DISTRIBUTOR Quarterly shipments from external supplier - 3 month minimum stock - 6 month maximum stock At central level storage facility LMIS Forms at Supplier: - Stock Cards - Transaction Records Resource Data Processing Center At Central Level Bi-monthly Report of ARV patients and stock Flow of drugs Feedback Reports Flow of information Flow of returned drugs Monthly Allocation Order for Facilities ART Service Delivery Point ART Patients Bi-monthly re-supply from supplier to service point by dedicated delivery Inventory System: Forced ordering max-min: - 1 month minimum stock - 3 month maximum stock LMIS Forms at SDP: - Dispensing Log - Stock cards - Monthly Report - Transaction Records - Returning Unusable Drugs

6 Global Fund- Voluntary Pooled Purchasing Process Key Principles; Efficient, timely and reliable procurement Stringent quality standards for procured products Attractive pricing for key health products

7 PEPFAR Procurement Process Transitioned from drug purchases by individual implementing partners One procurement system by a contractor Provision of buffer stock for public sector/global fund supported sites

8 ARV Supply Chain Management; Why do we care? ARV drug supply discontinuity/drug stock outs lead to treatment interruptions and is a major risk for virologic failure and resistance development

9 Relation adherence resistance Catherine Orrell, personal communication, 2014

10 WHO-HIVDR prevention and assessment approach 1. Monitoring of HIVDR early warning indicators 2. Acquired HIV-DR Surveys 3. Transmitted HIVDR surveys 4. Supporting a network of accredited HIVDR genotyping laboratories for HIV-DR surveillance.

11 The Purpose of EWI 1. Assess the extent to which ART programmes are functioning to optimize prevention of HIVDR. ART site factors known to be associated with good programme functioning and the prevention of the emergence of HIVDR. Strengthening specific aspects of ART programme delivery at the site level to 1. minimize preventable HIVDR 2. promote the long-term efficacy and durability of available first- and second-line regimens.

12 WHY EWIs 1. EWIs evaluate factors associated with HIVDR prevention without requiring laboratory testing for drug resistance. 2. EWIs are monitored either at all ART sites in the country or at representative sites. 3. ART site profiles, completed annually, inform the interpretation of EWI results, and guide corrective public health interventions 4. EWI monitoring provides the evidence base for public health action to prevent and address HIVDR

13 Proportion of Clinics Achieving WHO-Recommended Targets for EWI Jordan M, IAS Conference 2012

14 100 EWI from 2107 ART clinics in Africa, Asia, Latin America& Caribbean( ) 90 Africa Asia LAC Prescribing practices Loss to follow up Retention on first line On time ART pickup On timeclinic appointment ART supply continuity Viral load suppression Bennett et al, Clinical Infectious Diseases 2012;54(S4):S280 9

15 WHO HIVDR Early Warning Indicators in 13 PASER-M sites at 12 months of follow-up Averag e % % % PASER sites perform above average 7/13 sites failed at least 1 EWI 17 % 65 % 85 % Sigaloff et al. CID 2012

16 WHO EWI for ARV Resistance-Uganda EWI 1 EWI 2 EWI 3 EWI 4 EWI 5 EWI 6 % of patients starting on appropriate first-line ART % of patients lost to follow-up during the first 12 months of ART % of patients on appropriate first-line ART 12 months after ART start On-time ARV drug pick-up Keeping ART clinic appointment % of ART stops, substitutions, switches due to ARV drug shortages at site

17 Wilford Kirungi et al, 2011

18 Summary of the National Level Performance on the six HIVDR EWI EWI 1 EWI 2 EWI 3 EWI 4 EWI 5 EWI

19 Performance of Facilities according to HIVDR EWI Targets met Six Five Four Three Two One None Targets Met

20 Distribution of ART Facilities meeting the Targets Characteristic N EWI1 EWI2 EWI3 EWI4 EWI5 EWI6 Geographical Region Central 36 (37.9) Eastern 16 (16.8) Northern 13 (13.7) Western 30 (31.6) Level of Facility Health Centre III 21 (22.1) Health Centre IV 27 (28.4) General Hospital 29 (30.5) Regional Referral 5 (5.3) Hospitals Special ART Clinics 10 (10.5) Private Clinic 3 (3.2)

21 Lablite: Baseline mapping survey of decentralized ART service provision in Uganda Describe and compare national and intercountry delivery of training, clinical care, use of laboratory & monitoring in HCs in National ART roll-out

22 Methods A baseline survey was conducted in 39 health facilities in 22 districts of Uganda 21 centres in Malawi and 20 centres in Zimbabwe Health facilities selected to represent facility levels, location and stages of ART provision 22 6th Nat Paed HIV Conf

23 Results: Facility types 6th Nat Paed HIV Conf 23

24 Low level facility Overview 6th Nat Paed HIV Conf 24

25 stock-outs of HIV test kits and drugs 6th Nat Paed HIV Conf. 25

26 Procurement and Supply Chain Management: Challenges Affecting Implementation Need for increased coordination in procurement and delivery of commodities between all partners. Delays in the release of funds for the procurement mechanisms. Delays in delivery of drugs from the Global Fund VPP system Weak commodity tracking system at the facility level. Staffing levels, training and staff attrition at facility level

27 Way forward Uninterrupted ART supply is a key aspect of the ART programmes that urgently needs to be addressed to minimize preventable HIVDR Use routine programme data to monitor EWI for HIVDR Structure existing program data to allow for collection of EWI data without additional data collection tools.

28 Way forward Facilitate increased use of data for evidencebased planning and decision making at all health system levels. Additional Health Systems Strengthening Support in Procurement and Supply Chain Management and Strategic Information ARV supply chain rationalized successfully; new systems in place for warehouse transfers, webbased ARV reporting and ordering quality assurance and tracking

29 Way forward Strengthen Quantification and Procurement Planning Unit (QPPU) and MOH Integrated Commodity Group for coordinated supply planning and information sharing Support public sites through central buffering Strengthen health commodities management in the districts/facilities