PSMO-13 - Risk-based approach to compliance: Ensuring quality and safety in healthcare services
Chair(s)
Ms Jackie Maimin, Independent Community Pharmacy Association, South AfricaIntroduction
The pharmaceutical value chain operates under various sets of quality and regulatory standards that apply from manufacturing until medicines are dispensed. Adherence to these standards is further monitored by various regulatory stakeholders. Compliance is ensured at the point of licensing and periodically by the South African Department of Health, the South African Pharmacy Council, and the South African Health Products Regulatory Authority. Where non-compliance is observed, professional disciplinary action may be taken or licenses may be denied or withdrawn.
Programme
| 14:30 – 14:35 | Introduction by the chair |
| 14:35 – 14:50 |
Licensing of pharmacies in South Africa |
| 14:50 – 15:05 | Ensuring quality and safety of medicines — Codeine Care Initiative Dr Boitumelo Semete-Makototlela, CEO South African Health Products Regulatory Authority (SAHPRA), South Africa |
| 15:05 – 15:20 |
Risk-based pharmacy inspections |
| 15:20 – 15:35 | Regulatory aspects for pharmacy inspections Mr Brett Simmonds, Chair FIP Regulators Advisory Group, Australia |
| 15:35 – 15:55 | Q&A |
| 15:55 – 16:00 | Summary and closing |
Learning objectives
- To understand the role and responsibilities of registration with the regulatory authorities with reference to pharmacy owners, responsible pharmacists and their joint relationship within the context of South African healthcare regulations.
- To understand the importance of pharmacy inspections in ensuring quality healthcare services with a focus on initiatives such as the Codeine Care Initiative.
Take home messages
Compliance with regulatory standards in the pharmaceutical value chain is crucial for ensuring the safety, quality and efficacy of the healthcare services provided to patients.