THREE private hospitals and three private hospitals have been given the green light to prescribe the Ivermectin, an antiparisite to treat COVID-19 by the Medicines Control Authority (MCAZ), the Herald has reported
With growing evidence that this antiworm drug has zero effect on COVID-19, MCAZ will be tightly monitoring its use.
Ivermectin is a broad spectrum anti-parasitic drug that is used to treat several tropical diseases such as onchocerciasis (river blindness), strongyloidiasis and other diseases caused by soil transmitted helminthiasis.
It is also used to treat scabies and the drug is also being evaluated for its potential to reduce the rate of malaria transmission by killing mosquitoes that feed on treated humans and livestock.
While the drug was tried out in Peru before vaccines became available and is wildly popular among Americans who refuse to be vaccinated, the general medical evidence growing around the world is that the laboratory tests that showed it could have some effect on Covid-19 are not being seen in clinical surroundings.
But the MCAZ is willing for the six to, in effect, run clinical trials in Zimbabwe on volunteer patients under strict conditions.
MCAZ projects and public relations officer Mr Shingai Gwatidzo said approval had been granted to Avenues Clinic, Mater Dei Hospital, Datlabs Clinic, Kenlink Pharmacies, Village Pharmacy and Racecourse Pharmacy.
“While there are some studies that suggest potential effectiveness in the prevention and management of Covid-19, the existing data from those studies has a number of limitations, which makes it inadequate to prove effectiveness.“The framework has therefore been put in place to obtain scientific data that is relevant to the Zimbabwean context. 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 for the safety and efficacy of Ivermectin within the Zimbabwean population,” said Mr Gwatidzo.
He said the authority had set strict reporting conditions for those wishing to use Ivermectin which included submission of monthly reports detailing patient specific therapeutic outcomes in terms of efficacy and safety.
The data gathered will then be reviewed to determine whether Ivermectin has any therapeutic value in the management of Covid-19.
Mr Gwatidzo said although the drug had been found to inhibit the replication of SARS-CoV-2 in laboratory studies, the doses used in the laboratory to produce those results were higher than those approved for use in humans.
“Therefore, data from well organised, randomised, controlled clinical trials are needed to provide conclusive evidence for the decision on the efficacy of Ivermectin for preventing and treating Covid-19,” he added.
In March, the World Health Organisation recommended the use of Ivermectin only within clinical trials as evidence on the use of the drug to treat Covid-19 patients was inconclusive. The recommendation, which applied to patients with Covid-19 of any disease severity, is part of the WHO’s guidelines on Covid-19 treatments.
According to MCAZ, there is currently inadequate scientific evidence from the pre-clinical studies on the therapeutic effect of Ivermectin for the management of Covid-19, inadequate evidence of its clinical efficacy for the management of patients with asymptomatic, mild, moderate or severe Covid-19 as well as inadequate safety data regarding the use of Ivermectin for Covid-19 in the majority of published studies. Hence the need for institutions to adhere to conditions set in the framework.
“Failure by prescribers, distributors and dispensers to submit the relevant information in accordance with the guidance in the framework would result in the withdrawal of privileges pertaining to the prescribing, distribution and dispensing of Ivermectin by those parties and restrict use of Ivermectin to the much rigorous clinical trial settings,” Mr Gwatidzo said.
There have been reports of health centres and pharmacies that have been prescribing the drug without approval from the regulatory authority.
Mr Gwatidzo reiterated that the sale and distribution of Ivermectin without the approval of MCAZ was prohibited. He also urged Zimbabweans to avoid self-prescribing and sourcing medication from unapproved sources.