Ivermectin rules for SA: Which COVID-19 patients will get the treatment?

The South African Health Products Regulatory Authority (SAHPRA) has given the green light to treat selected COVID-19 patients with Ivermectin. It’s been a bumpy week for the medical authority, after AfriForum took legal action against them to force through approval. On Wednesday, both parties came to a compromise – after Professor Karim expressed his doubts.

How will ivermectin be used in South Africa?

Issuing an update earlier this afternoon, SAHPRA confirmed that they will allow the use of ivermectin on our shores ‘through a controlled compassionate access programme’. All medical professionals wanting to use the drug to treat coronavirus patient must file a Section 21 application, and keep extensive records of patient progress.

“In response to the demand for access to ivermectin for human use, SAHPRA will enable a controlled compassionate access programme, using Section 21, until further data becomes available.”

“A person desiring to sell an unregistered medicine subject to registration in terms of section 14 of the Act, for purposes other than a clinical trial, shall apply to the Authority, on an application form obtainable from the office of the Chief Executive Officer, for authorisation in terms of Section 21 of the Act to sell such a medicine.”

SAHPRA statement

  • The process isn’t quick and easy, put it that way.
The guidance applies to medical practicioners and regulators only – Photo: SAHPRA

When is the right time to use this treatment?

This ‘compassionate’ approach is the best SAHPRA can do for the time being. Despite some studies suggesting that ivermectin can slash the mortality rates of COVID-19 by 80%, it remains extremely untested. Yes, it has shown some ‘promising signs’ – but the available data do not justify a wide-scale rollout at this particular moment.

So, under these guidelines, who will be prescribed ivermectin – and what will the process be?

  • Section 21 allows medical practitioners to apply for approval of access to unregistered ivermectin in COVID-19 cases.
  • Patients who receive ivermectin on this basis will have to be named and identified first.
  • These will be controlled as prescription-only Schedule 3 medicines. All sources must meet quality assurance standards.
  • Only quality-assured ivermectin products, intended for human use, will be made accessible.
  • Importation of ivermectin products for human use will only be allowed in accordance with Section 21.

COVID-19: Who is likely to receive Ivermectin?

Ivermectin will be prescribed to patients – IF they are not responding to other medicines or available treatments. The experimental nature of the drug means it will be reserved as a ‘Hail Mary’ attempt to help save lives, should a patient reach a severely critical stage of their illness. The administration of the drug will also help SA doctors assess its efficacy

“SAHPRA occasionally grants Section 21 permits for the use of unregistered ivermectin as a prescription medicine for the treatment of patients with pathogenic parasitic diseases not responding to other medicines. This access programme will utilise the opportunity to collect much-needed data on the performance of ivermectin in South African patients.”

“We have had discussions with clinical researchers who are proposing clinical trials of ivermectin targeting different prevention and treatment scenarios. SAHPRA continues to encourage the submission of clinical trial applications designed to establish the safety and efficacy of ivermectin.”

SAHPRA statement

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Presh JM Reporter

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