1. MONITORING THE PHARMACEUTICAL SECTOR IN A DEVELOPING COUNTRY - THE GHANA EXAMPLE Gyansa-Lutterodt M. 1,7, Andrews E 2, Arhinful D 3,7, Addo-Atuah J 4,7, Osei I 5, Ofori-Adjei D 3,7, Asiamah D 1,7, Dodoo A 6,7, 1 Ghana National Drugs Programme, Ministry of Health, 2 WHO/Ghana, 3 Noguchi Memorial Institute for Medical Research, University of Ghana, 4 University of Memphis, Tennessee, USA, 5 Ghana Health Service, 6 Centre for Tropical Clinical Pharmacology and Therapeutics, University of Ghana Medical School, University of Ghana, 7 INRUD-Ghana

2. Monitoring the Pharmaceutical Sector 2 Abstract Abstract ID: 553 Monitoring the Pharmaceutical Sector in the Developing World: The Ghana Example Gyansa-Lutterodt M, Andrews E, Arhinful D, Addo-Atuah J, Osei, I, Ofori-Adjei D, Asiama D, Dodoo A Ghana National Drugs Programme (Ministry of Health), World Health Organization/Accra, INRUD-Ghana Core Group, Email: gndp@ighmail.comgndp@ighmail.com Problem Statement: The Ghana National Drugs Programme was introduced in 1997 as part of a first Five-Year Medium-Term Strategic Framework (1997–2001) for health development in Ghana. The aim of the program is to improve access to essential medicines and ensure that medicines are used rationally. Although monitoring of the sector is ongoing, it was necessary to evaluate the interventions after several years of implementation to determine the current situation and measure any gains. Objectives: To define the current status of the pharmaceutical sector in Ghana in relation to rational use of medicines and drug management (including storage facilities and access to medicines), and to compare the findings with baseline data gathered in 1998. Design: Cross-sectional descriptive study. Setting and Study Population: Public and private health facilities at regional, district, and sub-district levels. A household survey was also carried out. Four regions of the country were purposively selected based on their socioeconomic profile. The study units comprised primary care facilities, pharmacies in the public and private sectors, public drug warehouses, and households within five kilometers of a public health facility. Interventions: Training of dispensers and prescribers; feedback about prescribing habits; provision of Standard Treatment Guidelines (STGs) and the Essential Medicines List (EML) to health professionals and institutions. Outcome Measures: Percentage outcomes of prescribing indicators, patient care indicators, facility indicators, and access to medicines (including availability and affordability). Results: Improvements were noted in average number of drugs prescribed (4.6–3.5), percentage of antibiotic use (56–42.5%), and percentage of injection use (42–33.5%). The Ghana STGs and EML were available in 90% of facilities, but adherence is far from satisfactory; for example, antibiotic use in acute respiratory infection was high at 76.1%. Of the medicines prescribed to outpatients, 91.23% were dispensed to them. Although adequacy of labeling is poor, 58.13% of patients had adequate knowledge of drugs dispensed to them. The average number of stock-out days in public facilities was 60.5 days, compared to 0 days in private outlets. Many households (66.7%) seek medication from health facilities, but private drug outlets are also popular sources, being utilized by 32.4% of households with ill members. Self-medication was observed in 8.1% of households. Conclusions: The drug use situation appears to have improved since 1998, but there is room for further improvement. Attention must be focused on reducing high injection and antibiotic use by prescribers. Greater efforts should be directed at drug management practices in public drug outlets to improve their efficiency. More research is necessary to assess the outcomes comprehensively. Study Funding: WHO, Royal Netherlands Government, Ministry of Health

3. Monitoring the Pharmaceutical Sector 3 Introduction The Ghana National Drugs Programme – (GNDP) was implemented as a 5-year comprehensive pharmaceutical sector development programme from 1997 onwards. It is part of Ghana’s first Five-Year Medium Term Strategic Framework (1997- 2001). The goal of the programme is to ensure that all people in Ghana have access to effective safe and affordable drugs of good quality in both the public and the private sector, and that these are rationally used.

4. Monitoring the Pharmaceutical Sector 4 Background The Ghana National Drugs Programme (GNDP) was established in 1997 to coordinate a fully comprehensive pharmaceutical sector development programme in several areas including: The development, implementation and monitoring of pharmaceutical policy Improving access to medicines by improving –The financing mechanism for pharmaceuticals and –Supply of pharmaceuticals & allied products Strengthening quality assurance systems in pharmaceuticals to deliver quality products and services and Promoting rational use of medicines by health professionals and consumers through drug regulation initiatives, pharmacy practice, capacity building, drug procurement and improvements in the practice of traditional medicine

5. Monitoring the Pharmaceutical Sector 5 Study Objective To define current status of the pharmaceutical sector in Ghana in relation to 1. Rational drug use –Describe prescribing patterns and dispensing practices 2. Drug management and medicines storage –Describe drug expiry, stock outs periods and storage conditions of the medicines 3. Access to medicines –Determine the availability and affordability of key drugs  To compare findings with 1998 baseline results To evaluate the impact of planned regular monitoring on achievement of programme objectives

6. Monitoring the Pharmaceutical Sector 6 Methodology Public and private health facilities were studied at regional, district, and sub-district levels. The study units comprised public health facilities, community pharmacies, public drug warehouses and households within five kilometers of a public health facility The design was cross sectional & descriptive –Rational use of medicines in public facilities –Drug availability and affordability in both public and private sectors –Household surveys Data collection methods used comprised: - Interviews, Observations and Review of existing records and registers

7. Monitoring the Pharmaceutical Sector 7 Interventions 1 Interventions carried out to date include: Rational Use of Medicines  Selection, training and monitoring of Regional Focal Persons;  Training of dispensers and prescribers in all regions;  Provision of Standard Treatment Guidelines (STGs) & Essential Medicines List (EML) to health professionals and institutions;  Monitoring by regional focal persons and activity-linked disbursement of funds and  Regular monitoring, feedback and visits by/from GNDP Coordinating Unit;

8. Monitoring the Pharmaceutical Sector 8 Interventions 2 Quality and Safety of Medicines –The Food and Drugs Board has been strengthened through the installation and training in SIAMED and competence development in evaluating dossiers of generic medicines including ARV’s; –Standards for pharmacy premises and practice developed and published awaiting dissemination –National Centre for Pharmacovigilance established and fully functional Access –A fully functional procurement unit, –Quantification of drugs/procurement audit; –Process of local production of ARV’s being considered Policy –Review of National Drug Policy completed –Collaboration with MSH/ SEAM Initiative to ensure access –Traditional and Alternative Medicine Directorate Training manual completed

9. Monitoring the Pharmaceutical Sector 9 Outcome Measures This focused on Rational use of medicines and access and comprised :-  Percentage outcomes of prescribing indicators,  Patient care indicators,  Facility indicators and  Access to medicines (including availability and affordability

10. Monitoring the Pharmaceutical Sector 10 Results I – The Indicators Indicator19982002 Av. No Drugs/encounter 4.63.5 % Antibiotic56.042.5 % Injection4233.5 % Drugs on EDL9594.3 % Availability of STG59.290 Availability of medicines 83.391.23 Compared to 1998 improvements were noted in the Prescribing and Facility Care Indicators

11. Monitoring the Pharmaceutical Sector 11 Results II Average number of stock-out days in public facilities was 60.5 days, compared to 0 days in private outlets Adequacy of labeling– <1% Patients knowledge of dispensed drugs 58.13% Household utilization of health facilities - 66.7% public and 32.4% private

12. Monitoring the Pharmaceutical Sector 12 Recommendations Appropriate and dynamic interventions are required to improve rational use of medicines in developing countries Activity linked disbursement of funds promotes adherence to set targets Regular monitoring and surveys are essential to evaluate gains to guide future interventions

13. Monitoring the Pharmaceutical Sector 13 Conclusions The implementation of the GNDP in 1997 has led to improvements in some drug use indicators in Ghana The decentralized implementation systems with feedback to central coordinating unit has facilitated some of the achievements Both centralized and decentralized systems of monitoring were key to success