THE Medicines Control Authority of Zimbabwe (MCAZ) have clarified their position regarding the use of Ivermectin human formulation in the treatment and management of COVID-19 saying they had not approved its blanket use and they were still running trials to determine its safety and efficacy.
By Patricia Mashiri
In an interview with HealthTimes Shingai Gwatidzo, Programs and Public Relations Officer, said the authority was yet to reach a conclusion on whether ivermectin human formulations are safe, effective and can be used in C0VID-19 management.
The Authority took note of the growing interest in use of ivermectin for prevention/ treatment of COVID-19. Although there are some vitro studies, case studies and clinical studies suggesting that ivermectin might have some beneficial effect in the management of COVID-19, there is still no conclusive scientific evidence as to support its use in the management of COVID-19,” said
He added the Authority sought approval from Secretary of Health and Child Care to have ivermectin to be used with special conditions and control, hence the development of the framework which will guide practitioners and other healthcare personnel who wish to use ivermectin human oral formulations for treatment/ prevention of COVID-19.
“The framework is an opportunity to conduct some form of operational research without necessary going through rigorous process of clinical trials, whilst generating the much-needed scientific data on safety and efficacy of ivermectin in the management of COVID-19.”
He added that the Authority has set certain conditions for those who want to use ivermectin which include submission of monthly reports detailing patient specific therapeutic outcomes in terms of efficacy and safety. The data gathered will be then be reviewed to determine whether ivermectin has some therapeutic value in the management of COVID-19. Practitioners are also required to submit adverse drug reaction reports for all patients who experience any side effects.
Meanwhile, The MCAZ released a statement which clearly states that the ivermectin be used in accordance with the developed framework whose objectives are to authorize procurement of quality assured human formulation of ivermectin for COVID-19 cases and ensure that qualified and suitably experienced healthcare providers have access to human formulations of ivermectin for management of COVID-19 cases.
“Only allowed authorized pharmaceuticals wholesale dealers will be allowed to import and supply ivermectin to authorized institutions. HealthCare facilities with qualified medical practitioners, nurses and pharmacists, patients wards and a licensed hospital pharmacy that seek authorization and commit to comply with the requirements of the MCAZ framework.