1. Abstract Impact of the Essential Drugs Programme at the Primary Health Care Level in South Africa Hela M, Zeeman H, Department of Health South Africa; Auton MS, South Africa Drug Action Programme, World Health; Organisation; Sallet J-P, Management Sciences for Health; Summers R, School of Pharmacy, Medunsa; Eagles P, School of Pharmacy, University of Western Cape Problem Statement: Prior to the establishment of a democratically elected and internationally recognized government in 1994, drugs were not available to all South Africans due to the structured inequalities and inaccessibility caused by apartheid. Objectives: To determine the impact of the Essential Drugs Programme (EDP) at the primary health care (PHC) level in South Africa. Design: Synchronized cross-sectional surveys in the 9 provinces and 6 metropolitan areas using prospective and retrospective sampling methods combined into a national data set and compared with baseline results. Intervention: The comprehensive EDP was established to support the implementation of the 1996 National Drug Policy, which has the goal of ensuring an adequate and reliable supply of safe, cost effective drugs of acceptable quality for all citizens of South Africa as well as rational use of drugs by prescribers, dispensers, and consumers. Outcome Measures: 202 indicators covering facility infrastructure, human resources, inventory management, financial management; drug use, patient knowledge, and patient care. Conclusions: The EDP was found to be widely implemented, although there are areas identified for improvement. The national report highlights recommendations for action at the national level and for individual provinces and metropolitan areas.

2. Introduction/background 80% of the population depends on public sector health care services Great inter-provincial and intra-provincial inequities. Equitable distribution of public health care resources and increased provision of primary health care, particularly for currently disadvantaged groups represent major challenges The goal of the 1996 National Drug Policy is to ensure an adequate and reliable supply of safe, cost effective drugs of acceptable quality to all citizens of South Africa and rational use of drugs by prescribers, dispensers and consumers. Provincial baseline surveys were carried out between 1996 and 1998 Follow up surveys in all 9 provinces and 6 metros were carried out simultaneously in 2003

3. Objective The aim of these surveys was to determine the impact of the Essential Drugs Programme at Primary Health Care level in South Africa, as a follow up to previous provincial baseline studies

4. Methodology Between February and April 2003, 15 surveys were carried out in the 9 provinces and 6 metropolitan areas - a total of 239 primary health care facilities and outpatient departments of district hospitals Methodology, sample size determination and Data Collection Instruments were based and adapted from the WHO publication: “How to investigate drug use in health facilities” Sample selection was performed as follows: 20 primary health care facilities from each province, and 10 from each metro, stratified by districts were randomly selected. The aim was for the sample to consist of 20% out patients (gateway) at district hospitals or community health centres and 80% primary health care clinics Data were verified at the provincial/metro level and then combined into a national data set Where possible, these findings were compared with the findings of provincial baseline surveys that were carried out between 1996 and 1998

5. Results: Availability of key drugs An average 82% of the basket of key drugs were found to be available at facilities; there is no notable change since the baseline survey 69% of facilities were found to have greater than 75% of the key drugs available, however 6% of the facilities had half or less of the key drugs available Recommendation Investigate why 6% of the facilities had half or less of the key drugs available and develop interventions

6. Prescribing according to the National EDL 90% of all prescribed items were found to be in accordance with the National EDL, a substantial improvement from the baseline surveys (65%) Recommendation As part of the launch of the 3rd PHC EDL in 2004, provinces and metros reflecting sub-optimal compliance with aspects of the EDP should be targeted for more intensive prescriber education initiatives.

7. Injection prescribing 5% patients were prescribed an injection, which is a marked decrease from 11% in the baseline surveys The proportion of patients receiving injections ranged from 1% to 11% between provinces/metros: a difference factor of 11 Recommendation Investigate the reasons for the marked differences in the proportion of injection prescribing and develop interventions

8. Patient knowledge 88% of patients knew how to take all of their drugs (i.e. how many tablets and when to take them) In 7% of facilities, half or fewer of the patients knew how to take their drugs Recommendations Investigate why in 7% of facilities 50% or fewer of the patients knew how to take their drugs and develop interventions; the list of facilities for the investigation can be obtained from the source data Counselling at dispensing point to be strengthened

9. Inventory compliance with provincial formularies 96% of drugs found on the shelves were found to be from the applicable provincial formulary Recommendation - Investigate which drugs are from provincial formularies but not from the National EDL and whether there are commonalities between provinces/metros, so that these drugs can be considered for inclusion in the EDL. Accuracy of stock records In 50% of cases, the physical stock count was found not to match with the stock records; there has been no notable change since the baseline surveys (48%) Recommendation - Investigate why interventions to improve inventory management are not effective. Ensure that Drug Supply Management Norms and Standards and SOPs for Stock Control are used in all facilities. Cold chain indicators 75% of facilities were found to be recording the vaccine fridge temperature twice a day; this is a considerable improvement from the baseline surveys (25%) Recommendation - Cold chain training and supervision needs to be continued and further improved to capitalise on progress made. Security Inadequate security and adherence to key policies Recommendation - Security measures should be improved at facilities.

10. Conclusions The EDP was found to be widely implemented, although there are areas identified for improvement. There are recommendations for action at the national level and for individual provinces and metropolitan areas. Summary of key recommendations Inventory Management Investigate which drugs are on provincial formularies but not on the National EDL so that they can be considered for inclusion in the EDL Investigate why 6% facilities had poor availability of key drugs and develop interventions. Investigate new interventions to address poor inventory management The Drug Supply Management Norms and Standards and SOPs should be implemented and supervision strengthened. ·

11. Prescribing Practice, drug use and patient satisfaction Investigate reasons for the marked differences between provinces/metros in the average number of items prescribed, proportion of antibiotics prescribed, proportion of injections prescribed and develop interventions. Target facilities where patient counselling on how to take medication was weak. Investigate why labelling in 80% of facilities did not comply with the minimum legal requirements and take remedial action. Human resource management Strengthen pharmaceutical supervision by district pharmacists. Ensure ongoing training is provided to staff responsible for drug supply management and prescribing.

12. Financial management Strengthen mechanisms to improve the financial management and accountability at facilities. Additional recommendations to those in the previous sections Provincial and metro PTCs should investigate the marked differences between provinces/metros on drug use and supply management identified in this report. PTCs should continue coordinating monitoring and evaluation of rational drug use and contributing to the EDL selection process. The training of pharmacist assistants should be prioritised. Attention should be given to recruitment and retention of personnel.