No blanket approval for ivermectin use

Source: No blanket approval for ivermectin use – #Asakhe – CITE

THE Medicine Control Authority of Zimbabwe (MCAZ) has dismissed claims that it issued a blanket approval for the widespread use of ivermectin for the prevention and treatment of Covid-19 due to a surge in hospital admissions.

Only authorised pharmaceutical wholesale dealers are the ones allowed to import and supply ivermectin to authorised institutions such as Covid-19 healthcare facilities equipped with staff and patients in line with MCAZ’s framework.

Ivermectin is an antiparasitic drug for veterinary use but formulations have been done for human consumption, though are not yet licensed for use and according to MCAZ Acting Director-General, Richard Rukwata, several clinical studies are under study to evaluate ivermectin’s safety and efficacy in treating Covid -19 infections in vivo ( studies performed in living organisms such as humans).

“But there has been no conclusive evidence yet to support its use,” he said in a press statement.

“MCAZ is aware of media reports that suggested the regulatory authority had issued a blanket approval for the widespread use of ivermectin human formulations for the prevention and or treatment of Covid-19.”

When Zimbabwe witnessed a rise of Covid-19 cases last year leading to early this year, there was social media promotion of unethical use of a number of medicines such as ivermectin to protect against the fast-spreading virus.

Read: https://cite.org.zw/medical-experts-warn-of-ivermectin-overdose/

Therefore, in an effort to add more options to the list of medicines with potential evidence-based therapeutic value in the prevention and treatment of Covid -19, Rukwata said MCAZ had sought approval from the permanent secretary in the Ministry of Health and Child Care (Air Commodore, Jasper Chimedza) to establish a framework that would provide guidance on the use of ivermectin against the coronavirus in the form of operational research.

“The authority, therefore, advises that ivermectin human formulations must only be used in accordance with the developed framework for use if ivermectin in Covid-19,” said the acting director-general.

Rukwata noted that the objectives of the developed framework are to:

“Authorise procurement of quality-assured human formulations of ivermectin for use in Covid-19 cases. Ensure that qualified and suitably experienced providers have access to human formulations of ivermectin for the management of Covid-19 cases. Gather information on whether patients are obtaining clinical benefits from use of human formulations of ivermectin in the management of Covid-19 cases. Monitor and report any side effects and any unexpected adverse associated with use of human ivermectin for management of Covid-19 cases.”

The MCAZ official added that only authorised pharmaceutical wholesale dealers would be allowed to import and supply ivermectin to authorised institutions such as Covid-19 healthcare facilities with qualified medical practitioners, nurses pharmacists, patients wards and a licensed hospital pharmacy that seek authorisation and commit to comply with the requirements of the authority.

“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. Dispensing community pharmacies (DCP) that have applied in writing and made undertakings to abide by the conditions of using human ivermectin formulations,” he said.

Rukwata also warned that the sale and distribution of ivermectin without approval of MCAZ is prohibited.

“Members of the public are strongly urged to desist from self-prescribing and souring unapproved medication from unapproved sources. 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 the use of ivermectin in Zimbabwe will be critical in monitoring the safety and efficacy of ivermectin within the Zimbabwean population,” he said.

“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.”

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