On 28 January 2021 SAHPRA implemented an Ivermectin controlled compassionate use programme under Section 21 of the Medicines and Related Substances Act, relating to the prescribing of Ivermectin in the management of COVID-19.
Since then there has been an agreed Court order which allows for a second lawful way in which Ivermectin can be prescribed. In brief, SAHPRA recently registered a topical cream containing Ivermectin for the treatment of certain skin conditions. Under Section 14 of the South African Medicines Act, once a drug has been registered for some form of human use in South Africa it is possible for a doctor to write a prescription (on an individual named patient basis for their personal use only) to be taken to a compounding pharmacy, which will compound and dispense Ivermectin for COVID treatment. This medication can only be made in response to a personal script for the named patient, cannot be prescribed for longer than 30 consecutive days and has to be consumed within those 30 days.
This means that there are now two legal routes by which Ivermectin can be prescribed for the treatment of COVID-19, namely:
• Section 21 compassionate use programme
• Being individually compounded at a compounding pharmacy under Section 14.
A note of caution
Although there are now legal routes by which Ivermectin can be prescribed for the treatment of COVID-19, neither of these are risk free, and practitioners who are considering prescribing Ivermectin need to be aware of the potential pitfalls in doing so.
Clinical trials are still ongoing, but the most recent findings to be published1 report that there was no "statistically significant benefit" found from using Ivermectin, and although apparently low, there are risks of patients suffering adverse reactions to the drug, which may potentially be compounded if co-administered with other medications.
In light of the latest clinical trial results, the South African Health Department has updated its Ivermectin review, whereby they conclude that;
"The current evidence for the use of Ivermectin in COVID-19 does not suggest any clear benefits with respect to mortality, clinical improvement, or viral clearance."Illegally or incorrectly dispensing or administering Ivermectin could also potentially lead to charges being brought by the HPCSA for unprofessional conduct, or in the worst case scenario, the practitioner being tried criminally or pursued through the civil courts.
Will I be indemnified?
Subject to meeting our individual patient notification and Ivermectin prescribing requirements, members will have the right to request assistance for matters arising from the prescribing of Ivermectin through either Section 21 or Section 14, although we do reserve the right to take such action as we feel appropriate – including the cessation of further indemnity should the situation change, or where an individual member’s level of prescribing appears disproportionate to that of their peers.
We do have some conditions in relation to both Section 21 and Section 14 with regards to the obtaining of consent and the adherence to the non-advertising of Ivermectin as a commercial enterprise. These are provided at the end of this article.
If you are intending to prescribe Ivermectin to an individual patient – pursuant to a Section 21 application – you must contact Medical Protection within 7 days of receiving SAHPRA approval: advising us of the SAHPRA reference number and date of approval. This should be done via our online notification form which can be found
here.
Once we have received the notification, a confirmation email will be sent to you when the notification has been processed. This may take up to 3 working days. There is no need for you to wait for our confirmation before prescribing Ivermectin, as you will have already been granted Section 21 authorisation.
If you have already obtained Section 21 authorisations, we ask that you contact us to retrospectively notify us of the SAHPRA reference number[s] and date of approval[s].
Information on SAHPRA’s stance on Ivermectin prescribing is available here:
sahpra.org.za/news-and-updates/sahpra-clarifies-its-stance-on-ivermectin/
sahpra.org.za/press-releases/sahpra-statement-high-court-order-ivermectin/
You can find answers to common questions relating to the use of Ivermectin and your Medical Protection membership here
Medical Protection’s requirements around Ivermectin prescribingThe right to seek assistance is conditional upon:
• Being in receipt of authorisation under Section 21 of the Medicines and Related Substances Act 1965 from SAHPRA to prescribe for that named individual patient.
OR
The member having complied with all the requirements of Section14(4) of the Medicines and Related Substances Act 1965 including that the prescription is limited to the quantity required by the individual patient concerned, and that it is lawfully compounded by a compounding pharmacy for the treatment of COVID-19 only.
• Any prescription must be for the treatment of COVID-19 only, in strict compliance with the terms and conditions set out in the relevant Section 21 application and authorisation or if prescribing pursuant to Section 14, must comply with the requirements that apply as stated above and the members must be able to demonstrate such compliance.
• In either case, the decision to prescribe must follow a face-to-face consultation (which may take place remotely where clinically necessary) between the member and the patient where the member is acting within the scope of their normal specialty or area of practise. Where the patient’s health is such that the member is unable to discuss matters personally with the patient, the member must document in writing the basis on which they concluded that the prescription of Ivermectin was clinically appropriate for that patient.
• The member will not advertise or publicise the availability or prescription of Ivermectin or otherwise seek to promote its availability as a commercial enterprise.
• If prescribing pursuant to Section 14, the member should inform the patient that medication is being prescribed off-label and the possible disadvantages thereof. They will also need to inform the patient of the potential problems related to compounding, which include the correct and lawful sourcing of Ivermectin as well as any issues regarding the possibility of contamination and dosing.
• The member must in any event obtain and retain suitable documentary evidence that patient consent has been appropriately obtained in accordance with the requirements set out in Sections 6-8 of the National Health Act (Act 61 of 2003.Sections 6, 7 & 8 of the NHA.) Such consent must be based on discussions relating to the most recent clinical trial data available as to the efficacy – or otherwise – of Ivermectin (including reported contraindications, adverse reactions, and side effects), the limitations of such data and any consequent limitation regarding the member’s ability to fully advise as to such risks and benefits of its use for the treatment of COVID-19. If consent has to be obtained from an appropriate third party (e.g. next of kin) due to the clinical condition of the patient making personal consent impossible, the same level of information should be discussed, and the detail of the discussion and the consent obtained must be documented and retained and made available should it be required in the defence of a claim against the member.
• If utilising Section 21, the member must retain records of all applications submitted and of their outcomes and provide Medical Protection with such data as requested relating to the number and dates of Section 21 authorisations received.
• The right to seek assistance with claims arising from the prescription of Ivermectin for the treatment of COVID-19 is limited to claims by or on behalf of the patients to whom it is prescribed, and arising out of alleged negligent acts or omissions by the member in the course of their clinical practice. It does not extend to claims by third parties, or based on Product Liability or breach of contractual or statutory provisions. |
1Vallejos Julio et al. ‘Ivermectin to prevent hospitalizations in patients with COVID-19 (IVERCOR-COVID19) a randomized, double-blind, placebo-controlled trial’ BMC Infect Dis Jul 2;21(1):635 (2021). doi: 10.1186/s12879-021-06348-5.