As predicted in last week’s MedicalBrief, the SA Health Products Regulatory Authority (SAPRA) has had to moderate its hardline refusal to allow South African doctors to use Ivermectin for the treatment of COVID-19, when the believe it to be clinically appropriate.
SAHPRA announced at a press conference that it would allow "a controlled compassionate use of Ivermectin to treat COVID. It will unveil the access protocols for the drug in the coming days.
“We at Sahpra have considered all of this, and the approach that we will be taking going forward is that we will facilitate a controlled, compassionate, access programme for Ivermectin. This does not mean that our position changes around the lack of availability of scientific data, but we had to as a regulator have very in-depth discussions around the context which we find ourselves in with the pandemic with limited options,” said Sahpra chief executive Dr Boitumelo Semete-Makokotlela
“We hope the controlled access will enable us that the product is used properly and limit the black market. It’s important to note that Sahpra has listened and heard what people have been saying about Ivermectin.The programme will be open to all patients. We will review every application as it comes through.” said Semete-Makokotlela.
Professor Helen Rees, chair of SAHPRA said at the press the evidence for Ivermectin wasn't strong, which was the regulator was allowing the controlled and compassionate use of the drug. During this phase, SAHPRA would be collecting crucial data on Ivermectin's effectiveness.
“We will be collecting, particularly safety data and looking at that, but at least this will give time as we wait for better data to normalise the situation and to ensure that if doctors are using this lawfully that at least the quality of the product that they are choosing to administer is of good quality, which at the moment we have no guarantee and, as I say, that in itself is a safety issue.”
Rees said that while Ivermecin was prescribed for human use in some countries “just about every other agency, locally, and internationally saying the same thing; the evidence [for its use] isn't strong”. While she understood people’s desperation to protect themselves from the virus, she warned that people should be cautious about self-medicating with Ivermectin.
MedicalBrief wrote last week:
“Fanned by despair and social media, there has been a massive movement, both locally and internationally, for the immediate repurposing of anti-parasitic drug Ivermectin to treat COVID-19 writes MedicalBrief. In South Africa, despite stern warnings from the medicines’ regulator and the Medical Advisory Committee, there is growing illegal use of the drug. There are also, this week, the first signs that the SA authorities are softening their position.
“The clamour in the media on social engagement platforms like Twitter, Facebook, Instagram and YouTube around Ivermectin has been intense and growing. It echoes the hype that during the early days of the COVID-19 pandemic punted hydroxychloroquine, chloroquine and azithromycin, until hastily conducted trials proved not only were they not efficacious but potentially dangerous.
“It also takes place against a shifting of position in the United States of the National Institutes of Health. On 15 January the NIH upgraded their recommendation, making Ivermectin an option for use in COVID-19. This new designation upgraded the status of ivermectin from “against” to “neither for nor against”, which is the same recommendation given to monoclonal antibodies and convalescent plasma, both widely used across the US. This may clear its path towards emergency use approval.”
Fact File: Making sense of the Ivermectin controversy