EXPLAINER | Ivermectin is legal — now what?

If you have a script from a doctor, you should be able to get ivermectin that same day, or the next day at the latest, from a compounding pharmacy or a pharmacy holding stock.

This follows this week’s “unbanning” of the drug, traditionally used to kill parasites in humans and animals, allowing for its use in the prevention and treatment of Covid-19.

A compounding pharmacy is one where ingredients are combined or mixed on site to create a drug tailored to the needs of an individual patient, as opposed to a pharmacy which only sells retail and packaged medication.

Westville-based medical doctor Naseeba Kathrada who, along with about 50 other doctors under the banner “I Can Make a Difference”, was one of four groupings which successfully challenged the anti-ivermectin stance of the South African Health Products Regulatory Authority (Sahpra).

Earlier this year, Sahpra buckled slightly and agreed that individual applications for its use could be made on a patient-by-patient basis through its section 21 process (for the use of unregistered drugs) on “compassionate grounds”.

But doctors complained that this process took too long, more than an hour to fill in the paperwork and then sometimes weeks for a response.

Pharmacists said they could not legally access the drug.

Then, with four similar applications set down to be heard at the same time in the Pretoria high court, an ivermectin-based cream, Soolantra, was registered by Sahpra.

Kathrada said this was a game changer. “What this meant was that the active pharmaceutical ingredient (API) was now registered for human use, primarily for eczema. The process can take up to eight years ... and can cost R1m to R2m.

“With the pandemic we didn’t have the time, or the money, to go through that process. And that is why we went to court.”

She said now that the cream is registered, the API was registered and compounding pharmacists could now use the same API in another formulation — be it a syrup, capsule, cream or tablet — which can be prescribed for Covid-19.

Kathrada said since the granting of the court order, she had spent time finding out which compounding pharmacists had stock and “we have lots”.

Some pharmacists had kept stock for use in cases where there had been approval through the section 21 process — including for stubborn parasitic conditions before the pandemic.

It was as simple as sending through a script and, depending on where the patient lived, waiting for a delivery.

“From 25kg of powder, I believe it is possible to make four to five million tablets, depending on the dosage. Because it is weight-based, the milligrams per patient will differ.

“It’s important to get the message out, not only to the public but to doctors, so they know where the stock is and how to access it.”

Depending on the dosage, Kathrada said a pack of 10 tablets could cost anything between R70 and R90.

It was also possible for non-compounding pharmacies to carry stock and for doctors to carry “anticipatory stock” in the event of a huge rise in infections, she added.

Clinical trials on the use of ivermectin to combat the effects of the virus remain inconclusive about its efficacy.

According to the order, signed off by Pretoria high court judge Cassim Sardiwalla, Sahpra has to report back to the court every three months, detailing any developments in the use and availability of the drug.

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