In allowing Section 21 applications as part of a controlled compassionate access programme, the South African Health Products Regulatory Authority (SAHPRA) has essentially shifted the responsibility for deciding whether Ivermectin is safe and effective enough to be used on to doctors. This places an enormous pressure on doctors, since those who do decide to prescribe the drug will be responsible for any potential side-effects, writes Adele Baleta for Spotlight.
The guidelines released last week were thin on details, but prescribing doctors will have to provide evidence of the drug’s registration and use in other countries and motivate for it as a treatment for their patients. They will need to provide package inserts and information on risks. They will also need to get patient consent.
The guidelines do not stipulate the dosages of Ivermectin to be prescribed, as there is not enough data to support one dose over another. It also does not contain any warnings of what dosages might be considered toxic. This means that doctors will decide the dosage and for how long the treatment is required with no guidance from SAHPRA.
Spotlight notes that while SAHPRA wants doctors to report on side-effects, it also did not provide any guidance on what doctors should be on the lookout for.
How high is high enough to kill the virus and when does it become toxic to humans? This has not been answered conclusively and doctors who prescribe the drug will to some extent be working in the dark. Presumably, it will come down to a doctor’s clinical experience, particularly with the treatment of infectious diseases.
Spotlight reports that ethical doctors who do decide to prescribe Ivermectin will probably stick to low doses taken only a few times and will have to monitor patients carefully for any potential side-effects. Such doctors will need to have independently studied the available evidence of the use of ivermectin in COVID-19 and be satisfied that the evidence supports their decision to prescribe it. They will, after all, be going against the advice of most leading regulators and health bodies that advise that ivermectin should not be used to treat COVID-19, except in clinical trials.
Spotlight says while it is obvious that doctors should take professional responsibility for such decisions, whether doctors can be held liable if anyone suffers Ivermectin-related complications is not clear. Although unlikely, given the public interest in ivermectin, in the worst-case scenario a doctor could be called before the Health Professions Council of SA.
The report says on the positive side, the compassionate access programme could help flag safety concerns with Ivermectin, if doctors report side-effects as they are required to, and if SAHPRA has the capacity to pull together and analyse all the safety reports – which might end up being very many. Our understanding is that SAHPRA has received no applications for full registration yet, but reading between the lines it is clear, based on the available evidence, it would not register the drug to treat COVID-19 should it receive such an application.
Spotlight points out that the World Health Organisation, the US Food and Drug Administration, the European Medicines Agency, the Australian Therapeutic Goods Administration and the UK’s Medicines and Healthcare Products Regulatory Agency, after having reviewed the data, have all decided not to authorise Ivermectin for COVID-19 – either for prevention or treatment – until more data is available.
Why then, if most leading health authorities advise against it, has SAHPRA said it would allow preapproval access outside of a clinical trial, Spotlight asks?
It seems that by instituting a Section 21 process, SAHPRA will at least ensure that only products from reputable manufacturers are permitted – something that could well reduce the potential harm from products that are not quality assured. But social and political pressure could also have played a role in the decision.
Either way, the jury is still out.
Full Spotlight report (Open access)
See also MedicalBrief archives:SAHPRA: Guidelines on accessing Ivermectin Compassionate Use Programme
SA experts scoff at the ‘flimsy’ evidence for Ivermectin to treat COVID-19
Fact File: Making sense of the Ivermectin controversy
Lower mortality for hospitalised COVID-19 patients taking Ivermectin – ICON study
Exotics hog the headlines but it’s an old workhorse that has done the COVID-19 job