We would expect members to practise lawfully and ethically – meaning Ivermectin should only be prescribed to patients where the member believes the drug is clinically indicated, and in accordance with the requirements of s14 or s21 of the Medicines and Related Substances Act. Prescriptions have to be such that the drug is lawfully compounded or alternatively under SAHPRA’s compassionate program. We would expect that the relevant consent is taken, documented, and retained, and appropriate follow up monitoring to be in place. Our full list of the requirements that we expect members to adhere to can be found here.

Yes, you would have the right to request assistance with matters arising in accordance with the terms of your membership, and subject to compliance with Medical Protection’s individual patient notification and Ivermectin prescribing requirements, so long as proof of the SAHPRA approval has been received – which would include any SAHPRA identification /reference number and the date of approval.

No – the principles remain the same.

No, without SAHPRA approval under Section 21 you would not be entitled to request assistance with any matters arising from Ivermectin prescribing.

Medical Protection cannot comment on clinical issues.

Provided the Section 21  approval is granted, you will have the right to request assistance with matters arising in accordance with the terms of your membership, and subject to compliance with Medical Protection’s individual patient notification and Ivermectin prescribing requirements, so long as proof of the SAHPRA approval has been received – which includes any SAHPRA identification /reference number and the date of approval.

Medical Protection cannot comment on clinical issues. 

The right to seek subsequent assistance would be dependent on a Section 21 application having been submitted and approved – even if you are prescribing without awaiting the regulator’s approval. So long as approval is subsequently given, and the SAHPRA reference number and date of approval is shared with us – and our individual patient notification and Ivermectin prescribing requirements are met – then you would have the right to request assistance with matters arising. 

While the active ingredients are the same, the formulations are different and some of the excipients (carrier ingredients) or preservatives in animal formulations are toxic to humans. Veterinary Ivermectin should not be given to humans under any circumstances both for health and legal reasons.

Yes, even if you are not anticipating prescribing to any further patients pursuant to Section 21, you would still need SAHPRA approval and we would still require you to notify us of the SAHPRA approval reference and date of approval, and have you comply with our Ivermectin prescribing requirements.

Our understanding is that the only way this would be possible is if the commercially manufactured Ivermectin for human consumption had been imported legally in response to a Section 21 application for a named patient. This commercially manufactured imported human use Ivermectin should only be dispensed to patients where a Section 21 compassionate use application has been made to SAPHRA, and approved by SAPHRA.

No, you would need to notify us about each request pertaining to the prescribing of Ivermectin pursuant to Section 21, and would be required to provide us with each individual SAHPRA approval reference and date of approval.

No. Our requirements state that ‘the member will not advertise or publicise the availability or prescription of Ivermectin or otherwise seek to promote its availability as a commercial enterprise’. Indeed, no doctor should be involved in the advertising or promotion of medicines, even if they have a dispensing licence. Additionally, Schedule 3 drugs may not be advertised to the general public or patients and even when advertised to health care professionals advertisements must be restricted to the limits of the drug’s registration.

Every dispensed scheduled product should be accompanied by a prescription to allow the patient lawful possession. Prescriptions should be preceded by a physical examination of the patient.

Also, unless you are licensed to compound, you should be writing a prescription that the patient can take to a compounding pharmacist so the product can be compounded in response to the prescription.

In truth you can be sued by anybody, at any time, for anything. The question is not whether or not you can be sued, but rather, can you be sued successfully?

To be sued successfully it would have to be proven that a particular patient would likely not have suffered the damage claimed for had you prescribed Ivermectin. Given SAPHRA is not moved on the benefits of Ivermectin for COVID-19 it is highly unlikely any such litigation would be successful. Even were information subsequently to come to light that Ivermectin is effective against COVID-19, you would be judged against information available at the time.

While we appreciate your dilemma, ethical prescribing dictates that to prescribe the medication you must be of the justifiable opinion that the drug is clinically necessary and to a patient’s benefit.

Were you to prescribe it only to retain the patient and said as much to them, and if the patient subsequently sued you following a related complication and had proof of the conversation, then it is likely their litigation would be successful.

It is also worth noting that under the Consumer Protection Act a product has to be reasonably suitable for its intended purpose.

There are three main risks. Firstly, as far as the authorities are concerned the drug is of unproven benefit so that means that Ivermectin is not registered for use against COVID-19. As Ivermectin is now registered for human use, albeit as a dermatological preparation, the active ingredient may now be administered to humans, but only after compounding thereof in line with the law. 

Secondly, you would be prescribing it for an indication it is not registered for, and as such, your prescription would be off-label.

Thirdly, with the possible exception of manufactured human Ivermectin having been legally imported for compassionate use, no manufactured Ivermectin is lawfully available for human consumption in South Africa. Under the circumstances orally available Ivermectin has to be made up; known as compounding.

So currently there are three risks – the unproven benefit of the medication, the fact that it is prescribed off-label and the medication available for oral consumption is compounded.

Yes. However, you’d need to address each risk independently via informed consent – which should be documented (written) and retained.

The patient needs to know that as far as the South African authorities are concerned the use of Ivermectin is of unproven benefit and that as with all drugs Ivermectin is not without its potential side effects or complications and these should be discussed.

You will also need to advise that the authorities have not accepted COVID-19 as an indication for Ivermectin, and as such, you will be prescribing it off-label as you believe it may be of benefit to them, however, they need to understand it is being prescribed off-label.

Finally, given the medication will be compounded, the regulatory checks and balances regarding the production of their prescription is less vigorous than that of a commercially manufactured drug.

The patient needs to know the potential advantages and disadvantages of the drug, and needs to understand that the drug is not registered for use in COVID-19 in South Africa and why. They also need to be aware that you will be prescribing it off-label. Finally, the patient needs to know that you can only prescribe the drug such that it will be compounded, and that “compounded drugs do not have the same regulatory oversight as manufactured drugs.

Ideally you could put together a brief consent form that the patient signs. Alternatively, and less ideally, you could document the conversation in the patient’s contemporaneous notes. It would be helpful if the notes were signed by the patient or their representative.

Yes, you are always responsible for the drugs that you prescribe but prescribing drugs off-label increases your responsibility.

When you prescribe according to the drug’s registration you do so in the knowledge that rigorous research has gone into the efficiency and safety of the drug under those conditions. That research is not usually available when you prescribe a drug off-label and the patient, who takes the risk, should be made aware of those risks.

You may say that you prescribe off-label on a daily basis and that may well be true. However, the off-label prescribing that you usually do is probably broadly accepted practice and quite possibly backed by research. In the case of Ivermectin for COVID-19 there can be little doubt that the indication is controversial, and the indication differs substantially from the drugs registered indication. As such, you have an obligation to monitor closely and ensure that there are appropriate investigations and follow up.

Our understanding of a prescription under Section 14 of the Medicines and Related Substances Act is that the medication must be compounded in response to a prescription. The prescription must be preceded by an examination of the patient, as is required by the HPCSA. The medication is produced for a specific patient in response to a prescription for that patient and the medication should not be pre-prepared. The prescription may not be for more than 30 days medication, is only for the patient for whom it is prescribed and must be consumed in that 30 days. One produced the medication may not be displayed nor advertised.

It is our understanding that there are not provisions in the Medicines and Related Substances Act for a doctor or pharmacist to stock a compounded product in anticipation of requirement; compounding occurs subsequent to consultation and prescription. Were that not the case then compounding pharmacists would differ little from manufacturing pharmacists.

No, without SAHPRA approval under Section 21 you would not be entitled to request assistance with any matters arising from Ivermectin prescribing.