In terms of Regulation 71 of the Regulations relating to the registration of persons and the maintenance of registers, the South African Pharmacy Council (SAPC) may inspect pharmacy premises and provide the pharmacy owner with a written report of the findings of such inspection. Should the findings be adverse, disciplinary action may be taken. This usually happens when the pharmacy does not meet prescribed requirements or when, in the opinion of the SAPC, the premises are unsuitable for operating a pharmacy.
The SAPC started incorporating pharmacy grading in the inspection process five years ago. This incorporation allowed the SAPC to observe compliance trends over time – worryingly, there has been a fraction of pharmacy facilities that have consistently failed to fully comply with Good Pharmacy Practice (GPP) standards – with repeated achievement of a Grade C or Grade B inspection grading. To this end, the SAPC is currently compiling a policy to handle the removal of pharmacies that record repeated non-compliance from the register.
The implementation of this policy will occur in tandem with the last phases of the inspection and grading review process, which is currently underway. The first phase of this project included reviewing the inspection questionnaires – this resulted in questions being thematically grouped and rearranged into new sections. Council approved the revised questionnaires in October 2018. This was then followed by the development of a new online inspection app, which is available on the Microsoft App Store (SAPC Pharmacy Inspections). The new inspection app will be piloted with 100 pharmacies in Gauteng to perform field testing of the new questionnaire and the functionality of the app both offline and online.
The last phase of this project will be to review the grading methodology of pharmacies, which is currently underway. Council will, in the last quarter of this year, conduct workshops with all responsible pharmacists to introduce them to the new inspection processes and grading methodology.
Pharmacy inspection grading in a nutshell
The SAPC enforces compliance by conducting inspections and grading pharmacies. Introduced in 2013, inspection grading was implemented as an audit tool to monitor and compare the level of compliance (across all categories of pharmacies) with Good Pharmacy Practice (GPP) standards. Following an inspection, and depending on the extent of compliance with standards, pharmacies may attain any of the following grades:
- Grade A – the pharmacy complies with most of the GPP standards and can be accredited for purposes of training pharmacist’s assistants and interns. The inspection cycle of a Grade A pharmacy once every 3 years.
- Grade B – the pharmacy complies with some of the GPP standards, can be accredited for purposes of training pharmacist’s assistants and interns, and is subject to inspection every two years.
- Grade C – the pharmacy does not comply with most of the GPP standards, is to be inspected yearly, and is required to pay for the cost of conducting an inspection.