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Overview of Ethiopia ARVs and other Medicines Supply Management Issues WHO Meeting October 2005 MSH/RPM Plus in Ethiopia • Started operation in September 2003 • Funded by USAID/E under PEPFAR • Registered by Ministry of Justice as US-PVO in June 2004 • Set up a modest office in Addis • Current staff of 17 (all Ethiopian) Qualitative and Quantitative Assessment Human resources – staffing levels & training needs Infrastructure – structural & equipment System/Procedure – components of the pharmaceutical management system Availability LEVELS The Pharmaceutical Supply System: ETHIOPIA PUBLIC SECTOR International WB GF EPI/TBL FP/PMTCT PARTNERS Other Donors (USAID, JICA, etc) & Procurement Agencies PRIVATE SECTOR Multinational Suppliers National Local Manufacturers (12) HAPCO PASS/MOH/MOD PHARMID Parastatal Regional Local Regional Stores (14) Community PHARMID Branches (8) District Stores Hospitals, Health Centers Local Importers/Wholesalers Distributors (70) Private Pharmacies, Druggist Shops, RDVs(2450) NGOs, CBOs, FBOs, Special Pharmacies Target Population Drug Import/Distribution: Public Sector Major Players: • Pharmacy Administration and Supply Service – PASS/MoH • Pharmaceuticals and Medical Supplies Import and Wholesale Share Company - PHARMID • Armed Forces and Ethiopian Red Cross • NGOs, Donors including the UN • Private Commercial Sector – There are 51 importers and wholesale distributors Public & Private Sector Pharmacies (i) Public/NGO Non-profit Pharmacies: • Special Pharmacies (USAID/Irish supported pharmacies managed by public health facilities) - 260 • KENEMA Pharmacies (City Council) - 35 • Red Cross Pharmacies/Drug Shops/RDVs - 41 • Hospital/HC Pharmacies (DRF/IPP/OPP) (ii) Private for-profit Pharmacies: • Pharmacies/Drug Shops/Rural Drug Vendors Drug Outlets in Ethiopia SECTOR Ownership Public Health Facilities Drug Outlets Supply Source Service Private Public / Quasi-Private (Non-Profit) Special Pharmacy 260 Out -Patient Pharmacy In-Patient Pharmacy PHARMID Private Donation Hosp Rx, otc Red Cross Pharmacy 25 Drug Shop/RDV 16 City Council KENEMA Pharmacy 24 Druggist Shop 7 Rural drug Vendor 4 PHARMID Red Cross PHARMID Private OTC, Rx ARVs OTC, Rx Private Pharmacy 304 Drug Shop 270 Rural Drug Vendor Private PHARMID OTC, Rx ARVs RPM Plus/MSH 2003 Drug Supply Management Cycle Approach M&E Selection & Quantification Use Management Support M&E Procurement M&E M&E Distribution Policy and Legal Framework Main areas of investigation for site assessments • Information management ~ What record keeping and reporting procedures are in place to build upon? ~ What transaction forms are used between facilities and suppliers (RHBs, PHARMID etc.)? ~ What methods of communication and information exchange are used? ~ What basic MIS system can be put in place to improve accountability and stock status and patient tracking? Main areas of investigation for site assessments • Human resources ~ What is the current status of pharmacy and lab man power in the target facilities? ~ How can the number of pharmaceutical personnel be increased to cope with increasing workload? ~ What other methods are there to tackle the manpower problem? • Infrastructure ~ How adequate and appropriate are the infrastructure and storage conditions of pharmaceutical and laboratory facilities in the target sites? ~ What infrastructure improvements can be initiated and at which target facilities (working space, shelving, security, privacy, record keeping, etc)? Findings - Staffing & Training • Shortage and high attrition rate of professional staff (There are 26 pharmacists -46% in HF, 36 Druggists -75% in HF, 30 Pharm Technicians 83% in HF, 14 Pharmacy Assistants -100% in HF, and 4 clerks) • Limited management capacity at regional, district and health facility levels • Inadequate training on rational drug use and drug supply management • Lack of standard operating procedures, current reference materials or manuals PMTCT/ART Program Assessment RPM Plus Nov/Dec 2003 Pharmacy Personnel in Health Centers 2 1 Druggist Pharm Tech Pharm Asst Adet Woreta Wukro Marai Axum Mojo Bole Tekle Haymanot Addis ketema Lideta 0 Clerk PMTCT/ART Program Assessment RPM Plus Nov/Dec 2003 5 4.5 4 3.5 3 2.5 2 1.5 1 0.5 0 Z ditu w e ur Tik Pharmacist A ss a n ba Druggist am Ad a um Ax e Fel Pharm Tech ge o Hiw t Pharm Asst K ma ar a ra Clerk PMTCT/ART Program Assessment RPM Plus Nov/Dec 2003 Pharmacy Personnel in Hospitals 25 24 23 22 21 20 19 18 17 16 15 14 13 12 11 10 9 8 7 6 5 4 3 2 1 0 Zewdit u T ikur Anbassa Lab Technologist Adama Axum Lab Technician Felege Hiwot Lab Asst Karamara M&E and Inventory Control • Inventory control systems (bin cards, stock cards etc.) not adequate [only 64% of PMTCT facilities have bin/stock card] • Weak monitoring and evaluation system • Limited quality assurance of drugs due to shortage of human resources, weak information system, and lack of quality assurance management system. Preliminary Findings from 15 ART Sites Indicator Percentage (n=15) Pharmacist available and trained Two pharm. personnel available (not pharmacists) 47% 87% Monthly collection of ARV drugs feasible 53% Stock record cards used SOP available for ARV management 80% 0% Stock status regularly recorded Stock status regularly reported 53% 47% Space for confidential patient counseling 7% Lockable storage space (cabinets) available Lockable filing cabinet suitable for ART Sufficient cold storage space available 43% 29% 79% Kardex filing Computer Patient registration book for out-patients 0% 22% 29% Additional Findings from the Assessment of 15 ART Target Sites • 80% of the sites receive supplies from PHARMID • 80% of sites use stock cards but only 53% of sites regularly update and 47% report stock status • Only 60% use bin cards but only 40% update them • 33% of the facilities realized that there is loss due to damage, expiry and pilferage but only 1 facility had a system of recording such losses • Only 67% reported some kind of supervisory visits • 88% of the sites had stock of essential drugs on the day of the visit • 67% use past consumption data for quantification Appropriate Tools • • • • • • • • • Patient profile card Daily drug dispensing register Monthly activity reports Periodic supervisory tools and feedback mechanism Expiry date tracking chart Adherence follow-up chart Temperature monitoring chart for commodities Facility supervisory checklists Inventory management stock cards, bin cards, requisition slips, ADR reporting formats etc. • Simple locally sustainable computer software where applicable Sample Monitoring Indicators ~ % patients who could correctly describe how the prescribed medication should be used ~ % ART sites that had ARV drug by type was out of stock for more than 5 days during the last quarter ~ % of ARV drugs expired during the last quarter ~ Cost of loss due to expiry of ARV drugs ~ % of defaulters of ART program Demonstration of Computer System in the Making…… Drug supply management PHARMID / PASS LEVEL PHARMID BRANCHES/RHB LEVEL Drug stock management, client care and dispensing HEALTH FACILITY LEVEL Collaborative Vision for HIV/AIDS Patient Monitoring System HMIS Clinical System Pharmacy System Patient Profile Diagnostic System (Laboratory, Rad. etc.) Care & Support System Management System Supply Chain of ARV Drugs PASS / PHARMID HQ/ DACA / HMIS Information Flow •Information for International Community and National Publications •Consolidated information for ARV quantification and scaling up • Report on the supervisory visits and directives to the branches •Information based on periodic surveys of ART centers or Patients PASS/ PHARMID BRANCHES / DACA/ HMIS •Consolidated information based on data from the health facilities •Report on the supervisory visits and directives to the ART centers •Information based on periodic surveys of ART centers or Patients ART Service Centers ART Patients •New patient enrollment (by gender and age) in different programs (ART, PEP, PMTCT), revisiting patients, defaulters, change in regimen, drug substitution, and total drug consumption, current stock position, drug requirements, patient satisfaction and quality of care information ARV Drug Inventory Management at the Facility Level Drug Main Store •Stock cards, Bin cards, Temperature recording chart, Expiry date tracking charts Requisition slips ARV drugs Stock and consumption report Drug Dispensing Pharmacy •Individual patients cards •Drug dispensing register •Bin cards •Stock status and daily drug consumption report •Temperature recording chart for commodities •Expiry and adherence tracking charts Supply Chain of ARV Drugs PASS/ PHARMID HQ RPM Plus MIS Support Areas Strengthen •Procurement •Storage, inventory and distribution system PHARMID BRANCHES/ RHBs •Simple MS Access based computer system* + training on the use of information + Supervisory tools and procedures Strengthen •Storage, inventory and distribution system •Simple MS Access based computer system* + training on the use of information+ Supervisory tools and procedures HEALTH FACILITIES Strengthen •Quantification, storage, Inventory ,expiry tracking, adherence tracking and follow-up system •ADR monitoring and reporting system •Individual patient counseling and drug history recording system (computerized or manual)** ART Patients Current Challenges I. Difficulty in meeting minimum requirements by the new sites: ~ GF money earmarked for site renovation has not been put to use ~ Pharmacies at new sites have no confidential counseling rooms and/or booths ~ Many sites have no lockable cupboards, filing cabinets, shelves Challenges (contd …) II. “Integration” of ETAEP and GF ART drugs and services - the technical details of the integration need to be worked out urgently (eg. Distribution outlets, flow of information) lll. Need to revise Regimen and Dosage Forms List of ARV drugs permitted for importation – list does not include: > Tenofovir > Triple combinations > Pediatric solid and liquid formulations are limited > 2nd line regimen is incomplete Challenges (contd …) IV. Unreliability of suppliers due to manufacturing constraints (e.g. Stavudine; new orders for GSK’s AZT-containing drugs now need > 5 months to be processed) Good news: many generic manufacturers are coming on the market (partial shipment within 3 weeks!) V. Significant difference in the pattern of ARV prescribing by clinicians (next slide) Number of Doses Dispensed Comparison of the use of Efavirenz & Neverapine at Zewditu Hospital 25000 20000 15000 Efavirenz 600mg Neverapine 200mg 10000 5000 0 March April May June Number of doses Dispensed Comparison of the Use of EFV & NVP at Black Lion Hospital 70 60 50 40 EFV 30 NVP 20 10 0 March April May Challenges (contd …) VI. Acute Shortage of Pharmacy Staff – one pharmacist serving > 1200 patients at Zewditu ~ The need for training mid-level pharmacy personnel to handle ARVs and fully participate in ART ~ Unavailability of data clerks There is a need for pharmacy data clerks to record drug movement, track expiry and monitor patient profile. Computerized ARV Drug Use and Stock Management Tool at Zewditu Hospital – data is being maintained by RPM Plus staff, because the facility could not assign a data clerk. Data clerks are urgently required at all facilities! Thank You !