Regulator issues guidelines for compassionate-use access for ivermectin

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  • Doctors would have to use the Section 21 portal to apply for the use of ivermectin
  • Special authorisation will also need to be given to importers of ivermectin
  • Additionally, special authorisation will be required for healthcare facilities to hold bulk stock of ivermectin

The South African Health Products Authority (Sahpra) has released guidelines on its "controlled, compassionate use programme" for the use of ivermectin in Covid-19.

The regulator had announced on Wednesday that it would allow for the product be used in special circumstances, if applied for (and approved by Sahpra), by a relevant healthcare practitioner.

Section 21 application

Sahpra states that the compassionate access programme will have a tiered system that ensures controlled access, monitored use and stringent reporting.

The organisation says that only quality-assured ivermectin products intended for human use will be made accessible, and will only be available through prescription

A doctor who wishes to use ivermectin for treating a patient would have to apply via the Section 21, the document states. 

“Section 21 allows registered medical practitioners to apply for approval of access to unregistered ivermectin for the management of Covid-19 in individual, named patients,” the document reads.

Authorisation 

Ivermectin for human use will need to be imported, and authorisation will only be issued to registered applicants and holders of a license to manufacture, import or to act as a wholesaler of or distribute a medicine, or scheduled substance.

Imported ivermectin must come from manufacturers who have the product registered at the country of origin’s national authorising body.

Authorisation of healthcare facilities to hold bulk stock must be a licensed healthcare facility such as a hospital, pharmacy or a medical practitioner who holds a dispensing licence.

This can be done through the Section 21 online submission portal facility to hold emergency stock of an ivermectin product obtained from an authorised importer.

“The intention of this authorisation is to limit the possible delays between obtaining Section 21 approval for an individual, named patient and accessing the ivermectin product requested.

"Applicants for authorisation are also required to notify Sahpra of the submission of applications for individual named patients by sending a short message service (SMS) to 072 134 4546 and 063 771 8906,” the document reads.

For medical practitioners, they may apply through the Section 21 online submission portal, for permission to prescribe ivermectin to an individual, named patient. The patient outcomes, both benefits and side effects are to be reported on Sahpra’s COVI-Vig programme.

In instances of the urgent use of the drug, doctors may access is available to bulk stock held by an authorised health facility, treatment may be initiated at the same time as an application for the individual is being sent to the regulator, Sahpra said.

Sahpra has committed to respond to all applications for individual, named patient access within 24 hours.

The key takeaways from the guidelines:

  • Only a registered medical practitioner may apply for permission to prescribe ivermectin to a patient
  • If approved, the practitioner must comply with all reporting requirements related to the Section 21 approval
  • As ivermectin for human use is not available in the country - as it is not authorised for use in humans in South Africa - it will need to be imported - authorisation to import ivermectin will only be be issued to registered applicants who hold a relevant license
  • Relevant, licensed healthcare facilities may apply to hold emergency stock of ivermectin, which must be obtained by an authorised importer
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