Durban - South African doctors, pharmacists and medical scientists are livid that the SA Health Products Regulatory Authority’s (SAHPRA) new requirements to apply for permission to prescribe Ivermectin to treat Covid-19 patients are more onerous and as costly as the previous rules.
They argue that dying patients who desperately need the drug would be kept waiting for days.
Doctors yesterday described SAHPRA’s media briefing held on Wednesday, where it announced that it would roll out a Compassionate Controlled Access Program for the prescribing of the drug, as nothing but a public relations exercise.
They claim that the six-page document outlining the process introduced more administrative work and did not open access. They also raised concern that the black market for Ivermectin would flourish while the stringent access process remained in place.
Doctors have to apply on a patient-by-patient basis under Section 21 of the Medicines and Related Substances Control Act for permission to use Ivermectin to treat them as the 40-year old drug is currently not registered for human use. However, a meta analysis of 18 studies of the drug by Dr Andrew Hill of the University of Liverpool, showed it appeared effective in the treatment of Covid-19, reducing the viral load and mortality by 75%.
Dr Naseeba Kathrada, who previously wrote to the president asking for permission to use the drug widely on behalf of doctors, vented her anger on social media in a video yesterday in which she said SAHPRA had thrown doctors “a big fat bone”.
“I just got the document as to how to access Ivermectin under the CCPA and I have just one word to say, wow. I am absolutely disappointed this is nothing more than a Section 21 with added admin. So now do we not only have to fill in this eight-page document and pay the R300 which we still had to pay last week, now we also have to send them an SMS to say we sent this and we have to give them feedback,” she said.
She said SAHPRA trusted doctors to prescribe schedule eight drugs like morphine and pethidine but did not trust doctors to dispense “this safe 40-year old drug”.
She said she had filed two applications for the drug last week, one for a patient who was dying in ICU, but SAHPRA had not yet approved them.
“This is nothing but a delaying tactic. Only God knows why you are doing this because now I am at a loss for words … anger and disappointment. I would like an explanation,” she said.
Dr Zainab Goondiwala said he was disappointed about the process and asked for the R300 application fee to be waived.
“Not only is this no different from the section 21 requirements but calls for additional administrative work. We reiterate that a bulk approval would be beneficial for all sides with ultimate benefit to the patient,” Goondiwala said.
“Our concern is that this approval will further fuel the black market and subsequently any adverse events of fake or non human preparations will negatively reflect on the legitimate process. The scientific evidence bears out the safety of the drug and an emergency registration during the pandemic is the humane course of action,” he said.
Dr Fahmida Shaik said the CCAP was “tedious and impractical especially under pandemic circumstances”.
“If the resurgence is anything remotely similar to that of the devastating second wave, healthcare workers would need a blanket ruling to have full access to use Ivermectin as deemed necessary. The drug is not to be considered for use in only severe Covid and emergency situations, but more importantly in early disease to reduce disease progression and limit the spread. Given the infection rates during the peaks, applying for clinical access for each patient would be impossible and ethically unjust,” she said.
Shaik asked how SAHPRA would justify not allowing healthcare workers the capacity to prescribe Ivermectin freely, if it continued to demonstrate its effectiveness in further studies.
The Ivermectin Interest Group, which comprises, medical scientists, doctors and pharmacists, spokesperson, Professor Colleen Aldous said the positivity over SAHPRA’s “apparently generous” announcement that it would allow controlled compassionate access to Ivermectin had dissipated after the guidelines for the programme were published yesterday.
“On January 6, SAHPRA had softened its initial stance on the use of Ivermectin, stating that it would entertain Section 21 applications and research proposals. Last week several Section 21 applications were submitted, and none were countenanced,” she said.
SAHPRA had not responded to a request for comment last night by the time of going to publication.