MCAZ Has Approved Use Of Ivermectin For COVID-19

The Medicines Control Authority of Zimbabwe (MCAZ) has approved the use of Ivermectin oral formulations for the prevention and/or treatment of COVID-19. Pindula News present the statement by MCAZ on the matter.

RE: REGULATORY ADVICE REGARDING USE OF IVERMECTIN HUMAN ORAL FORMULATIONS FOR PREVENTION AND/OR TREATMENT OF COVID-19

The Medicines Control Authority of Zimbabwe ( MCAZ) is aware of media reports suggesting that the Authority had issued a blanket approval for the widespread use of ivermectin human formulations for the prevention and treatment of COVID-19. Several clinical studies are still being undertaken to evaluate ivermectin’s safety and efficacy in treating the COVID-19 infection in vivo, but there has been no conclusive evidence yet to support its use. In an effort to add more options to the list of medicines with potential evidence-based therapeutic value in the prevention and/or treatment of COVID-19. the Authority sought approval from the Secretary for Health and Child Care to establish a framework that would provide guidance on the use of ivermectin in COVID-19. in the form of operational research. The Authority, therefore, advises that isvonct.-tin human formulations must only be used in accordance with the developed framework for use of ivermectin in COVID-19. whose objectives are to:

1. Authorise procurement of quality-assured human formulations of ivermectin for use in COV ID-19 cases.

2. Ensure that qualified and suitably experienced healthcare providers have access to human formulations of ivermectin for management of COV ID-19 cases.

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3. Gather information on whether patients are obtaining clinical benefits from use of human formulations of ivermectin in management of COVID-19 cases.

4. Monitor and report any side effects and any unexpected adverse events associated with use of human ivermectin for management of COVID-19 cases.

Only authorised pharmaceutical wholesale dealers will be allowed to import and supply ivermectin to authorised institutions i.e.:

1. Healthcare Facilities: COVID-19 care facilities with qualified medical practitioners. nurses. pharmacists. patients wards and a licensed hospital pharmacy that seek authorisation and comma to comply with the requirements of the MCAZ framework.

2. Dispensing Medical Practitioners serving ambulatory outpatients with mild to moderate COVID-19 cases who have applied in writing and have committed to abide by this framework.

3. Dispensing Community Pharmacies (DCP) that have applied in writing and made undertakings to abide by the conditions of using human ivermectin formulations.

Points to Note:

1. Sale and distribution of ivermectin without the approval of MCAZ is therefore prohibited.

2. Members of the public are strongly urged to desist from self-prescribing and sourcing unapproved medication from unapproved sources.

3. The MCAZ will continue to evaluate any emerging peer-reviewed publications or data on the use of ivermectin for the treatment of COVID- 19. Data obtained from use of ivermectin in Zimbabwe will be critical in monitoring the safety and efficacy of ivermectin within the Zimbabwean population.

4. Failure by prescribers. distributors and dispensers to submit the relevant information in accordance with the guidance in the framework could result in the withdrawal of privileges pertaining to the prescribing. distribution and dispensing of ivermectin by those parties.

MEDICINES CONTROL AUTHORITY OF ZIMBABWE

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