A group of pharmacists have joined the legal chorus seeking to get blanket approval for the use of ivermectin, presently only registered in SA for veterinary and agricultural use, for the prevention and treatment of Covid-19.
The application by the eight pharmacists, who operate under the Pharma Valu chain of pharmacies, will be heard along with three others instituted by AfriForum, the ACDP and a group of 55 doctors callings themselves the “I can make a difference doctors and medical practitioners group” at the end of March.
Attorney Kuben Moodley, who represents the doctors, said the applications had been allocated to Pretoria high court judge Cassim Sardiwalla to case manage and determine.
“The legal representatives made submissions to the judge regarding the urgency and public importance of the matters. They have been allocated three court days for hearing, beginning on March 29,” he said.
The doctors are seeking an order compelling the SA Health Products Regulatory Authority (Sahpra) to allow them to freely prescribe the drug, claiming the authority’s “compassionate use programme”, through which individual applications can be made, is too restrictive.
They agree it must be a schedule three drug and only available on prescription and under medical supervision, but say “there is little worse for an attending doctor to watch a patient unresponsive to every available treatment, knowing that ivermectin, used by hundreds of millions of people, is showing promise in certain circumstances but it is not available”.
The pharmacists want an order that they can lawfully stock and compound the drug for human use.
Pretoria pharmacist Johannes Jacobus Strydom, who deposed to the affidavit, said because ivermectin was registered for use in animals, it could be purchased over the counter at any farmer's co-operative and even over the internet.
“The present state of affairs is that farmer’s co-operatives have run out of stock because people are buying it and using it for the treatment and prevention of Covid-19.
“If it were made available in terms of the provisions of the medicines act, the vast benefit would be that it would be provided in terms of a script by a medical practitioner and dispensed in a form fit for human consumption,” he said.
But Sahpra is fiercely opposed. Chief executive officer Boitumelo Semete-Makokotlela, in court papers, said the compassionate use programme is “manifestly appropriate”.
As at mid-February, 127 applications had been lodged of which 95 had been processed and 54 approved.
She said the relief sought to bypass the programme “that responds to an evolving medical and scientific environment regarding the use of ivermectin” with no expert affidavits.
“It requires the court to assume the mantle of the authority of the regulator of medicines. We have statutory obligations. The programme is reasonable and the evidence does not yet support the use of ivermectin as treatment for Covid-19,” she said.
“The fundamental errors all the applicants make is that because ivermectin is safe for human use for its indicated purposes, it will be safe for treatment of Covid-19.
“This is a fallacy. Medicines are registered for particular treatments of particular diseases and each indication requires its own set of trials and evidence to support its use. There is no one-size-fits-all approach. That would be irresponsible and dangerous.”
Semete-Makokotlela said while it was true it was a breakthrough drug for parasitic infections in parts of Africa, it was misleading and dangerous to claim it was therefore safe and effective for the treatment of Covid-19.
“The evidence these claims are based on are derived from small, poorly designed and poorly powered trials. An effective dose has not been established in clinical trials.”
She said the use of the veterinary formulation in humans was dangerous and experimental.
“The issues at stake in these matters involve highly technical and intrinsically complex questions of science, medicines regulations and public safety.”