In terms of Section 22A (5) and (6) of the Medicines and Related Substances Act, 101 of 1965, all Schedule 3 or higher medicines and health products should be dispensed only on the presentation of a valid prescription; this requirement should also be fulfilled when dispensing ivermectin-containing products (in this case, proof of Section 21 Authorisation should also be presented).
Patients wishing to access ivermectin-containing products, or other Schedule 3 or higher medicines without valid prescriptions and/or authorisations should be advised to first consult their medical practitioner or a health care facility such as a clinic or hospital for diagnosis and treatment. Primary Care Drug Therapy (PCDT) pharmacists, and other persons with relevant permits, should continue with the treatment of conditions and prescription of medicines in line with the parameters of their permits.
Ivermectin-containing products may only be dispensed in line with the South African Health Products Regulatory Authority’s (SAHPRA) Ivermectin Controlled Compassionate Use Programme. That is, the dispensing of these products is subject to the patient or their prescriber providing proof of a Section 21 authorisation issued in the name of the patient. Only unregistered ivermectin-containing products obtained through importers/manufacturers authorised by SAHPRA for import may be dispensed; these are available at this link: https://s21portal.sahpra.org.za/
For awareness, pharmacy professionals may access the SAHPRA Ivermectin Controlled Compassionate Use Programme Guidelines at this link: https://www.sahpra.org.za/unregistered-products-guidelines/
Other than PCDT pharmacists fulfilling their scope of practice within the confines of their permits, pharmacists and pharmacy support personnel who are found to have dispensed Schedule 3 or higher medicines without valid prescriptions may face disciplinary action in terms of Chapter V of the Pharmacy Act, 53 of 1974.
