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Ivermectin: The legal pitfalls facing a prescribing practitioner

A medical practitioner who prescribes Ivermectin to a patient takes on a considerable legal liability, including the possibility of legal censure, unless the letter of the law has been followed, writes Dr Graham Howarth, Head of Medical Services – Africa, for Medical Protection.

Dr Howarth writes:

Two years ago if you had watched an average TV news report from the last couple of months you would think you were watching an excerpt from a dystopian horror film.  Likewise a year ago, in South Africa, virtually only farmers and vets were aware of the existence of Ivermectin as a form of medication, despite its developer winning a Nobel prize in medicine.  The global pandemic has readjusted our insights into many things.

Ivermectin has long been classified as a Schedule 3 drug in South Africa albeit it was not registered as a drug for human consumption locally.  It could be legally prescribed and dispensed for and administered to animals but not under the Medical and Related Substances Act (MRSA).  Indeed the way animal Ivermectin is registered for animals makes  prescribing, dispensing or administration of animal Ivermectin unlawful for human consumption – a point well worth remembering.

The regulation of medications for human consumption in South Africa is under the aegis of the South African Health Products Regulatory Authority (SAHPRA)  which is a statutory body as set out by the MRSA.  SAHPRA are tasked with the extremely important functions of ensuring the safety, efficiency and quality of – amongst other things – prescription medication.  They are responsible for the registration of prescription medication in South Africa and with few exceptions as noted below it is unlawful to prescribe or dispense unregistered medication.  For important safety and efficiency reasons medication is heavily regulated with respect to research and registration, manufacture, importing, wholesaling, dispensing and prescribing.

By January of this year it was clear that many patients were taking Ivermectin.  The drug is cheap and according to its advocates, using social media, reported to be safe and efficient against Covid-19.  While its advocates are confident of its safety and efficiency the authorities do not share their optimism and indeed Merck who produces the drug have distanced themselves from its use in Covid-19, citing efficacy and safety concerns.

Following the interest in Ivermectin for the possible use in treating humans for Covid-19, interesting developments have occurred.  These have been largely driven by its low price, the low number of individuals currently vaccinated and Ivermectin’s advocates.  Initially those taking Ivermectin were either taking Ivermectin produced for animals or alternatively illegally imported Ivermectin.  The MRSA makes provision for unregistered drugs to be imported on a named-patient basis but that is slow and laborious.  In response to considerable outside pressure, SAHPRA initiated a compassionate access program in late-January to facilitate access via the named-patient basis. In early-February the High Court determined that when necessary doctors could prescribe Ivermectin once they had made the relevant application under the compassionate access program, prior to authorisation being given.  The process remained cumbersome and by mid-March there were apparently fewer than 200 applicants.

Apparently coincidentally, SAHPRA did indeed register a topical product containing Ivermectin in mid-March. This was a potential game changer because, now that Ivermectin was a registered drug in South Africa, compounding pharmacists could legally compound Ivermectin into medication for off-label indications.  Hurdles remained in the sense that the Ivermectin they use has to be imported legally using the relevant permits, and such rules and regulations are quite rightly necessary to control the process.

Now if a doctor feels that it is clinically relevant, Ivermectin may be prescribed and subsequently dispensed for the management of Covid-19.  The doctor will, however, have to be willing to justify the decision if necessary which may be difficult given efficiency, safety and quality concerns.  If a decision is made to prescribe Ivermectin to a patient, the patient needs to be informed of the potential advantages and disadvantages and the doctor would be well advised to take and retain written informed consent.  On the issue of consent, compounded medication is often not as well controlled as manufactured medication with respect to aseptic preparation and dosage and the practitioner would be well advised to include that in the documented consent process.

Likewise there is the issue of off-label prescribing, a term used as if it were a homogenous concept.  This is not a question of a minor tampering with the dosage or manner of administration, rather this is using a drug which is registered for dermatological use for an indication, where the authorities are unconvinced of its efficiency or safety, and where a major manufacturer has withdrawn their support based on similar concerns.  This is a major departure from the registration and the patient must be made aware. Again the sharing of such information should be documented and retained.

It does not end there.  If a doctor prescribes Ivermectin to a patient, a compounding pharmacist may compound a product in response to the doctor’s prescription and only for that patient.  Enough can only be prescribed and dispensed for a maximum of thirty days and the dispensed medication needs to be consumed in that thirty day period.  The product cannot be displayed nor advertised.  The regulations make a clear distinction between a compounding and a manufacturing pharmacist.  If you give a script to a patient and advise them to go to a specific pharmacy which you know, or should have known, is not working within the regulations then you too may be found to complicit in unlawful activity.

In summary, a healthcare professional who prescribes Ivermectin to a patient takes on a considerable legal liability given the official concerns about its safety and efficiency as well as the tensions created by indications which are far off-label. These risks are further compounded by the method in which the medication is produced.  Nobody should be holding stores of prepared Ivermectin for human consumption and nobody should be advertising or displaying prepared Ivermectin.  Not only is a prescribing practitioner taking on considerable legal liability, including the possibility of legal censure, indemnifiers or insurers are unlikely to assist unless the letter of the law has been followed.

To be clear, as a medical defence organisation (MDO), it is not Medical Protection’s place to be either pro or anti-Ivermectin. Our role on this issue is to help healthcare professionals understand the risks of prescribing Ivermectin, potential consequences of these risks, and – if they still believe it is in their patient’s best interests to prescribe – the steps that must be taken to do so lawfully.

As detailed above, the risks of prescribing Ivermectin are multiple and if a healthcare professional wishes to be involved in the use of Ivermectin, they are well advised to restrict themselves to advising patients, including advice that, at best, it may not work and, at worst, it may be dangerous particularly given the unlawful procurement.

Members can read MPS’s full advice on the prescribing of Ivermectin on our website. If in doubt, healthcare professionals should always contact their MDO.

In closing, perhaps a final word of warning.  Those who suggest that concerns raised are purveyors of false facts or news are perhaps best avoided.  The efficiency and safety has not been established to the satisfaction of the authorities and the patient, who is ultimately taking the risk, must be informed of the risks being taken and have their consent documented.  The consent needs to extend beyond the risks and benefits of Ivermectin itself but extend to include off-label prescribing and the compounding of the medication. Naturally the consent process should be documented and retained.

 

Author’s note:

At the time of writing, many healthcare professionals in South Africa are working in very challenging circumstances amidst civil unrest. Sadly this unrest is playing out against a third wave of Covid-19, of which healthcare professionals are bearing the brunt.

Medical Protection has written to members, not only to let them know our thoughts and best wishes are with them, but also to highlight the practical ways in which we can support them during this time. Support can include providing access to limited grades if their private practice work is being impacted either by Covid-19 or the current unrest, or access to our free and confidential counselling service.

Members can contact MPS for more information about support available.

 

Medical Protection will be hosting a webinar on Thursday 22 July 2021 from 1900 on: The use of off-label medication. Ivermectin, the medicolegal position.

 

Free to attend with 1 ethical CEU register here:

 

 

 

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