Grading of pharmacies as approved by Council and implemented in 2013
The grading of a pharmacy is an indication of a pharmacy’s level of compliance with the rules of good pharmacy practice. Council regards all shortcomings in pharmacies in a serious light, and stiff penalties are imposed on pharmacy owners and responsible pharmacists whose pharmacies don’t make the grade.
e-Pharmaciae examines the grading system and explains how the grades are determined.
Council resolved in 2009 to introduce a pharmacy grading system instead of scheduling inspections for all pharmacies on a two-year cycle regardless of their level of compliance.
Inspection grading was implemented in 2013 as an audit tool to monitor and compare the level of compliance (across all categories of pharmacies) with good pharmacy practice (GPP) standards.
The inspection grading was developed on the following principles:
- questions within the inspection questionnaires are weighted per section (see Table 1)
- all questions in a specific section have the same weighting
- the final percentage compliance of a pharmacy is determined by the sum of the percentage compliance of all the individual sections divided by the number of sections.
Table 1: The different sections of an institutional pharmacy inspection questionnaire and their weightings
The weightings in Table 1 are explained in Table 2.
Table 2: Weighting explanation
In addition to the weighting allocated per section, non-negotiable criteria per section have also been developed, although all sections are recognised as equally important in terms of the GPP and ideally should have the same weighting. The non-negotiable criteria for the different sections consist of different values that vary from 30% for the General Section to 90% for the Control of Medicine Section (see Table 3).
Pharmacies that perform badly on a section that carries a high percentage on the non-negotiable criteria automatically obtain a lower Grade. This means that a pharmacy may obtain one or two shortcomings on the non-negotiable section, perform well on other sections, but end up with a Grade C.
Table 3: Non-negotiable criteria per section
There are no non-negotiable criteria for four sections: Inspection Details, Pharmacy Details, Recommendations in Respect of Training and Signatures. These sections are not evaluated for the purpose of grading.
When the grading system was introduced, it was envisaged that, over time, all sections would be weighted equally as GPP recognises all sections as equally important.
Council’s main objective in conducting inspections is to monitor the compliance of pharmacies with the rules relating to GPP, and to allow owners and responsible pharmacists to engage inspectors and improve future outcomes of their inspections.
Inspection questionnaires for all categories of pharmacies are available on the SAPC website. They are useful self-inspection tools for pharmacy owners and responsible pharmacists wanting to assess their compliance with GPP and proactively correct shortcomings prior to an actual inspection.
The frequency of a pharmacy inspection is dependent on the outcome of the previous grading, which is an indication of the level of compliance. Table 3 summarises pharmacy grading and inspection cycles.
Table 3: Inspection cycle per pharmacy grade
A pharmacy owner may choose to correct identified shortcomings during an inspection and apply for a re-inspection, and pay a prescribed fee, before the next inspection.
Although the names of all pharmacies due for inspections are published on Council’s website annually, section 30(A) of the Pharmacy Act, 53 of 1974 empowers Council to conduct an inspection at any reasonable time.
Owners or responsible pharmacists of a pharmacy classified as Grade A or B who have responded to identified shortcomings may train pharmacist interns and pharmacy support personnel upon applying for premises approval for training and paying the relevant fees.
What a Grade C means to the pharmacy owner and responsible pharmacist
Grade C pharmacies are to be inspected annually (see Table 3). Once a pharmacy is classified as Grade C, the system automatically notifies Council’s Legal Services and Professional Conduct to initiate a disciplinary action against the responsible pharmacist or owner.
At the beginning of each year, all Grade C pharmacies are allocated for inspection and invoiced a fee approved by Council to recover the cost of the annual inspection.
Disciplinary actions are taken to encourage all pharmacists to strive towards attaining a Grade A classification, which indicates that they offer a pharmaceutical service from a facility that complies with GPP.
Council take serious steps against responsible pharmacists of Grade A and B pharmacies who fail to respond to shortcomings identified during an inspection
Pharmacy owners and responsible pharmacists are required to respond to all shortcomings identified during an inspection regardless of the grading achieved. Once an inspection is conducted and shortcomings are identified, a shortcoming letter is sent to the responsible pharmacist. If they fail to respond to the shortcomings, a follow-up letter is sent.
Effective from 2017, all responsible pharmacists who fail to respond to the shortcomings identified in Grade A and B pharmacies will be referred to Council’s legal services and professional conduct for disciplinary action.
Responses must be submitted online on the secure site of the SAPC website. Guidelines for responding to shortcomings are available on the website under custom services link: http://www.pharmcouncil.co.za/B_CS_Guidelines.asp
An article on the graphs reflecting the total number of inspection conducted 2014 and 2016, with pharmacy grading in order to demonstrate trends in different categories will be presented in the next issue of e-Pharmaciae.