The National Department of Health (NDoH) is not aware of pervasive poor quality in pharmacies and clinics in South Africa. Where sporadic problems occur, they are attended to. Yes, the Minister has powers through the measures outlined below to improve quality in (a) Pharmacies and (b) Clinics:
a)Pharmacies
- All pharmacies in provinces, whether in the public or private sector, may operate only if a license has been issued in terms of the Pharmacy Act 53 of 1974, on the conditions as prescribed by the Director-General: Health. The conditions for the issue of the pharmacy premises licenses include compliance with the relevant legislation, including compliance with Good Pharmacy Practice (GPP) Rules.
- The South African Pharmacy Council (SAPC) is a statutory body mandated in terms of the Pharmacy Act, 1974 (Act 53 of 1974) to regulate the pharmacy profession in the country with powers to register pharmacy professionals and pharmacies, control of pharmaceutical education, and ensuring good pharmacy practice.
- The Good Pharmacy Practice (GPP) Rules, published by the SAPC in terms of Regulation 35A(b) of the Pharmacy Act provides for the quality which pharmacies must strive to achieve and adhere to.
- The SAPC requires the responsible pharmacists to conduct self-inspections of their pharmacies annually. Self-inspections are used to monitor compliance with GPP Rules and to identify gaps and implement corrective measures on shortcomings identified. The SAPC also provides a guide to compliance to help prepare for an inspection.
- Furthermore, the SAPC conducts different types of inspections to monitor the operations and quality of pharmaceutical services. Reports are generated from the inspections, which pharmacies should use to improve on the quality of services they provide.
b) Primary Health Care facilities (Clinics and Community Health Centres)
- Section 25(1)(n) of the Health Act, 2003 (Act 61 of 2003) mandates provincial departments to control the quality of all health services and facilities while section 47(1) requires all health establishments to comply with the quality requirements and standards prescribed by the Minister.
- To this end the National Health Council adopted an Ideal Clinic Realisation and Maintenance (ICRM) framework in the public sector that addresses the gaps in the primary health services delivery platform. The ICRM Framework is used to identify quality gaps, generate quality improvement plans for each gap identified, assign timelines for corrective actions and to assign responsible persons for every area who should report progress on the interventions undertaken.
- Patients are provided with an opportunity to lodge complaints, compliments and suggestions in writing and in person to the facility manager. Patients are at liberty to escalate their complaints to higher levels of authority in case they do not get a response or a satisfactory response.
- The Office of Health Standards Compliance, established in terms of section 78 of the Health Act, is mandated to conduct quality assurance inspections of all health establishments, to provide reports of outcomes, and the facilities are expected to develop quality improvement plans to correct non-compliance.
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