One essential instrument for evaluating pharmacies’ adherence to legal standards is the South African Pharmacy Council’s (SAPC) Inspection Checklist. This checklist guarantees that pharmacies adhere to the requirements for patient safety, legal compliance, and good pharmacy practice.
1. Legal and Regulatory Compliance
- Valid SAPC registration for the pharmacy and responsible pharmacist.
- Display of pharmacy license and certificates in a visible area.
- Compliance with the Medicines and Related Substances Act and the Pharmacy Act.
2. Facility Standards
- Proper storage conditions for medicines, including temperature and humidity control.
- Security measures such as restricted access to controlled substances.
- A clean, organized, and hygienic environment with appropriate waste disposal systems.
3. Pharmacist and Staff Requirements
- Verification of registered pharmacists and pharmacy support personnel.
- Adequate training records and continuous professional development (CPD) compliance.
- Proper delegation of duties following scope of practice regulations.
4. Medicine Management
- Correct procurement and stock control procedures.
- Proper dispensing practices, including prescription validation and patient counseling.
- Secure handling and record-keeping for Schedule 5 & 6 medicines.
5. Record-Keeping and Documentation
- Maintenance of accurate patient records and prescription details.
- Up-to-date drug registers and pharmacy logs.
- Compliance with electronic or manual record-keeping requirements.
6. Patient Care and Counseling
- Availability of a private consultation area for patient counseling.
- Provision of adequate information on medication use, side effects, and interactions.
- Implementation of pharmacovigilance practices for reporting adverse drug reactions.
7. Equipment and Technology
- Functional dispensing software for tracking prescriptions and stock.
- Availability of essential pharmaceutical equipment (e.g., refrigerators, balances, measuring devices).
- Secure internet access for online regulatory updates and SAPC notifications.
8. Emergency Preparedness
- Accessibility of first aid kits and emergency medicines.
- Established procedures for dealing with power failures or disasters.
- Proper fire safety measures, including extinguishers and evacuation plans.
The SAPC inspection checklist is essential for ensuring compliance with national pharmacy standards and protecting public health. Regular self-assessments and adherence to these requirements help pharmacies maintain operational integrity and avoid regulatory penalties.