In its simplest form, the pharmacy legislation requires that a pharmacy be conducted under the continuous personal supervision of a pharmacist and in accordance with good pharmacy practice as determined in rules made by Council. The pharmacist under whose continuous personal supervision the pharmacy is operated, is also responsible and accountable to Council for any act performed by or on behalf of the owner. However, through the valuable, continuous monitoring inspections, as well as the disciplinary process, Council is alarmed at the number of pharmacies that are being operated without Responsible Pharmacists, without pharmacists even being present at pharmacies and who are continuously not complying with the Rules relating to good pharmacy practice (GPP).
Council’s findings
- Despite the fact that Section 22 of the Pharmacy Act, 53 of 1974, read together with the Regulations relating to pharmacy practice, requires that each pharmacy have a Responsible Pharmacist, there are an alarming number of pharmacies that do not have a Responsible Pharmacist. When a Responsible Pharmacist ‘resigns’ at a particular pharmacy, the owner has 30 days in which to replace such Responsible Pharmacist. Failure to comply with this requirement has resulted in owners of pharmacies being charged for such an offence at the Committee of Formal Inquiry (CFI), with suspension from the register being the sentence of choice for these charges.
Being registered as the Responsible Pharmacist of a pharmacy means that such pharmacy needs to be conducted under your continuous personal supervision. This means that you, the Responsible Pharmacist, need to be present in the pharmacy. The GPP does allow for occasions when the Responsible Pharmacist may not be present, but this should be the exception and not the norm. So why are pharmacists who are employed at one pharmacy, agreeing to be appointed as Responsible Pharmacist at another pharmacy where they do not work, or where they are not present most of the time, if at all? This practice of being appointed as Responsible Pharmacist at a pharmacy where such Responsible Pharmacist does not practice/work has, in a recent CFI, resulted in a pharmacist being suspended from practice, i.e. the person can not practice as a pharmacist for a year. Such fraudulent Responsible Pharmacist/Owner relations will not be tolerated by the Council.
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Section 22A of the Medicines and Related Substances Act, 101 of 1965, provides that a pharmacist, pharmacy support personnel, and interns under the supervision of a pharmacist may dispense medicine. The scope of practice of the various cadres of pharmacy support personnel, as well as the pharmacist intern, requires that such supervision is direct supervision. Yet, alarmingly, inspections reveal a shocking number of pharmacies that are continuously being operated without any pharmacist present. Does this mean that pharmacists are handing over the responsibility of pharmaceutical services and care to pharmacy support personnel and, in some cases, even unregistered persons? Pharmacies that are operating without pharmacists stand to lose the recording of the pharmacy with the Council, and Council will recommend to the Director-General of the Department of Health to withdraw the pharmacy license. It should also be noted that pharmacy support staff (with the exception of a post-basic in a primary healthcare clinic) who practise without a pharmacist being present, and unregistered persons practising the scope of practice of a pharmacist, are committing a criminal offence and if found to be practicing will have criminal charges laid against them, either by the South African Pharmacy Council or South African Health Products Regulatory Authority.
- When did you last have a monitoring or a premises approval inspection? A Grade C inspection may result in disciplinary action being taken against you, the Responsible Pharmacist, as well as the removal of the pharmacy license. Section 22 of the Pharmacy Act states that pharmacies have to be conducted in terms of the Rules relating to good pharmacy practice (GPP). That means that pharmacies need to comply with the GPP Rules. While a pharmacy may get a Grade C outcome from an inspection, there is a responsibility on the owner and the Responsible Pharmacist to correct the GPP shortcomings identified by an inspection. Yet there are pharmacies that have the same long list of short comings at every inspection, without what appears to be any attempt to correct the shortcomings. Pharmacies that receive a Grade C inspection at least twice in a row, pharmacies that do not have registered Responsible Pharmacists and pharmacies that are being operating without a pharmacist present, will be handed over to the Professional Conduct unit for disciplinary action. In addition, such pharmacies stand the risk of having their licenses withdrawn by the Director General: Health.
Hippocrates said, “Whenever the art of medicine is loved, there is also a love of humanity!” Let’s show the love of humanity by being pharmacists who uphold the standards of pharmacy and provide pharmaceutical services and patient care that benefits our communities, instead of putting lives at risk with actions that do not meet the required standards.
