A registered topical cream which contains 1% ivermectin now allows doctors to prescribe ivermectin in tablet form on a per script basis.
On Monday, lobby group AfriForum and Dr George Coetzee obtained a settlement in court regarding the compounding of and access to ivermectin with the South African Health Products Regulatory Authority (Sahpra).
Drug compounding is the process of combining, mixing or altering ingredients to create a medication tailored to the needs of an individual patient.
Earlier this month, Sahpra registered a cream formulation called Soolantra, which contains 1% ivermectin and is used to treat a type of skin rash in adult patients.
The health regulator said the registration of the cream is not in response to any of the current pending court cases regarding access to ivermectin for the prevention or treatment of Covid-19.
SAHPRA has not approved Ivermectin for COVID 19 Treatment https://t.co/FfOoFevDjb via @YouTube
— SAHPRA (@SAHPRA1) March 29, 2021
Due to the fact that Soolantra contains ivermectin as an active ingredient and is now registered, ivermectin can be compounded for other purposes and used off-label.
Head of research at AfriForum, Barend Uys, said doctors will no longer need to file a Section 21 application if they require compounded ivermectin from a compounding pharmacy.
“The practical implication of this settlement is that doctors can prescribe ivermectin to patients if, in their judgement, it is required, and patients can then take this prescription to any pharmacy where compounded ivermectin is available and buy ivermectin,” he said.
The settlement was not made an order of court and the case proceeds on Thursday.
General practitioner and founder of the Covid Home Management Team, Dr Naseeba Kathrada, says registration of Soolantra is a victory in their fight to have ivermectin registered as a Covid-19 treatment.
Compounding pharmacies will be able to compound and produce ivermectin in tablet form which Sahpra said is allowed in accordance with the provisions of section 14(4) of the Medicines Act such as for specific patients, on the basis of a prescription by a medical practitioner.
“For non-dispensing doctors, this is a huge achievement because Soolantra, which is a 1% ivermectin cream, was registered and is an active pharmaceutical ingredient (API). It means a compounding pharmacy can compound ivermectin into a tablet or capsule form on a per script basis. Doctors don’t have to fill in a Section 21 application per patient, all they have to do is fill in a script and give it to a compounding pharmacy and make it available immediately to the patient for treatment,” said Kathrada.
Sahpra has held fast to the position that ivermectin is not registered as a medicine for the treatment of Covid-19 and that the Soolantra cream is not for the prevention or treatment of Covid-19.
In January, the health regulator announced that it would allow the controlled compassionate use of Ivermectin to treat Covid-19.
“Unregistered ivermectin-containing finished pharmaceutical products may only be accessed under Saphra’s Ivermectin Controlled Compassionate Use Programme Guideline through the authorised suppliers of such products,” the health regulator said in a statement.
Kathrada said doctors can send a script to a compounding pharmacy such as Galderma.
“It’s a huge victory for us and it’s amazing that we can do this and be prepared for the third wave. This will get people off the black market tablets, and people will be able to get the right tablets in the right dose.
“We can send a script to a compounding pharmacy and they will compound the drug for us. When I give the drug to my patient I have to explain to them that the ivermectin pill is off-label and I will need to get their consent,” Kathrada said.