On Wednesday, Sahpra announced the facilitation of a ‘controlled compassionate’ access to Ivermectin. This is what is means and this is how it will affect medical professionals wanting to administer it to patients.
DURBAN – THE South African Health Products Regulatory Authority (Sahpra) on Thursday granted “controlled compassionate”’ access to Ivermectin. Over the last few weeks, medical practitioners and the members of the general public have called for Ivermectin to be administered to Covid-positive patients – this despite the medication being used by vets.
Sahpra chief executive Dr Boitumelo Semete-Makokotlela said they will facilitate a controlled, compassionate, access programme for Ivermectin.
“This does not mean that our position changes around the lack of availability of scientific data, but we had to as a regulator have very in-depth discussions around the context which we find ourselves in with the pandemic with limited options,” she said.
Sahpra said the compassionate access programme will follow a tiered mechanism that ensures controlled access, monitored use and stringent reporting.
The tiered approach will ensure that quality-assured products are available, that appropriate measures are taken to ensure timely access, and that approval is granted for individual, named patients, with the obligation to report on patient outcomes.
Authorisation 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, issued in terms of Section 22C(1)(b) of the act :
Authorisation will only be issued to registered applicant(s) and holder(s) of a licence to manufacture, import or to act as a wholesaler of or distribute a medicine or scheduled substance, issued in terms of Section 22C (1) (b) of the act to import, hold in bulk and distribute an authorised product to health-care facilities that have received Section 21 authorisation to hold emergency stock of the unregistered medication.
Applications for authorisation must identify the Ivermectin product(s) to be imported, the manufacturer of such products, the registration status in the country of origin and any other countries, whether the product(s) is/are registered by any national medicines regulatory authority with which Sahpra is aligned, or whether the product(s) is/are pre-qualified by the World Health Organization.
If importation is authorised, the authorised pharmaceutical company must provide Sahpra with a product validation report, a certificate of analysis, and the outcomes of post-importation testing (identification, assay and dissolution testing) for all imported Ivermectin product(s) when that product/products is/are received in South Africa. These documents are to be emailed to [email protected]
Authorisation of health-care facilities to hold bulk stock:
A licensed health-care facility (hospital or pharmacy) or a medical practitioner who holds a Section 22C(1)(a) dispensing licence may apply for authorisation via the Section 21 online submission portal facility to hold emergency stock of an Ivermectin product obtained from an authorised importer (as described above). 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 an SMS to 072 134 4546 and 063 771 8906.
Authorisation of individual named patients:
A registered medical practitioner may apply, via the Section 21 online submission portal, for permission to prescribe Ivermectin to an individual, named patient. In addition, the applicant must notify Sahpra of the submission of applications for individual named patients by sending an SMS to 072 134 4546 and 063 771 8906.
The medical practitioner authorised to prescribe unregistered Ivermectin to an individual, named patient must comply with the reporting requirements stated in the Section 21 approval. The patient outcomes (both benefits and harms) are to be reported on Sahpra’s Covi-Vig programme. The reporting portal can be accessed by clicking on ONLINE SERVICES and navigating to Covi-Vig reporting system on the Sahpra website homepage, www.sahpra.org.za
Where urgent access to Ivermectin is required, in the clinical judgement of the attending medical practitioner, and 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, named patient is submitted to Sahpra. Nonetheless, authorisation is not guaranteed, and Sahpra retains the right to refuse permission for access, as required by the act and regulations.
A full justification is required for each individual patient, as stipulated in the regulations and enabled on the Section 21 online submission portal. Each application must identify the specific Ivermectin product requested and the authorised supplier of that product.
Sahpra undertakes to respond to all applications for individual, named patient access within 24 hours of submission. Where additional information is requested, responses will be dealt with accordingly.
Semete-Makokotlela said they hoped that the controlled access will allow Sahpra to ensure that the product is used properly and limit the black market.