Cape Town - Medical practitioners will have to jump through administrative hoops in order to dispense ivermectin, as an 11-page application form is required for each patient and is considered on a case-by-case basis.
The anti-parasite drug continues to be an unregistered product according to the South African Health Products Regulatory Authority (Sahpra), however doctors can apply to access the drug for human use if they submit a Section 21 application.
Earlier this week Sahpra revealed during an online press conference that it will allow a controlled, compassionate, access programme for use of ivermectin to treat Covid-19.
The access programme emphasises that doctors or healthcare facilities must submit a Section 21 application for each patient requiring the drug.
A Section 21 authorisation involves processing and evaluating applications from healthcare practitioners for access to unregistered medication within South Africa.
Human rights lawyer and director of RKP Attorneys, Rehana Khan Parker, says there should be widespread use of ivermectin without all the loopholes of having to apply for Section 21.
“It is an administrative nightmare. This is a time consuming and expensive exercise. Health practitioners take the Hippocratic Oath, which is ‘do no harm’. Why must there be another level of monitoring if the doctor is prescribing ivermectin for their patients. I fail to understand the necessity to file the application,” she said.
Despite the case-by-case application process, Sahpra has committed to respond to applications within 24 hours but reserves the right to query the application.
Civil society advocacy group SAHARI, said the application process is an added obstacle and places a further burden on an unequal health care system.
“There is nothing compassionate about the knowingly ridiculous expectation that medical practitioners must fill out 11-page forms, wait 24 hours and still expect to be declined access to ivermectin,” said spokesperson, Shabnam Palesa Mohamed.
Similarly, Parker says: “The problem that I have with this section 21 application is that this is only accessible for people who have money and who are able to go to a medical practitioner and pay for the service. What happens to the vulnerable and marginalised?”
Doctors do not have time to fill out lengthy application forms, Parker continued, because it will take long to fill out the applications and get approval.
Here’s what a doctor will need to submit for a Section 21 application:
* Pay R330 to submit the application
* Submit an 11-page application form for each patient
* A product brochure containing what the unregistered drug is made of
* A witnessed informed consent document
* A the details of registration of the medicine with any other regulatory authority
* Evidence of compliance of the manufacturer of the drug
* Reasons why a South African registered medicine cannot be used
After doctors have submitted their applications, Sahpra may request additional information and deny the application at their discretion.
If an application is approved, Sahpra requires doctors to submit a progress report every six months after the patient has taken ivermectin, as well as a progress report 30 days after the completion of the drug.
The regulatory authority said in a press release it will update its position as needed once more data becomes available.
“Sahpra has a team of expert reviewers on standby to review any new data on the use of ivermectin for the prevention and treatment of Covid-19 infections which are expected to become available in the forthcoming weeks and months,” read the statement.
SAHPRA's framework on Ivermectin pic.twitter.com/WsDcTEJsRv
— SAHPRA (@SAHPRA1) January 28, 2021