More Information Needed for Ivermectin Use in COVID-19 Patients

The Ministry of Health & Wellness has spent considerable time reviewing the information on Ivermectin and has  concluded that there is not enough information to recommend, for or against, the drug for use in COVID-19 treatment.

There has been extensive review of Ivermectin use in Covid 19 by recognized bodies such as the National Institute of Health in the United States and the USA Food and Drug Administration (FDA) and have concluded that there is not enough evidence to recommend for or against. The World Health Organization/ Pan American Health Organization (WHO/ PAHO) has also indicated that more clinical studies are needed.

According to Chief Medical Officer, Dr. Jacquiline Bisasor McKenzie, β€œThe Ministry of Health and Wellness has a responsibility to ensure that recommendations given from a policy level regarding medicines and therapeutics, includes medicines with proven safety, effectiveness and efficacy. The use of unproven drugs can lead to a waste of resources, harmful effects and can also reduce availability of the drug for its recommended use.”

Although there is mounting pressure both locally and internationally from medical professionals as well as other private sector organizations for National Regulatory Authorities to provide approval for use in COVID-19 as a policy directive, the Ministry of Health & Wellness awaits the outcome of several large scale studies that are currently on-going to provide further guidance on safety and efficacy.

β€œThe Ivermectin drug when used as labelled, as an anti-parasitic, has been found to be safe. We recognize however that in patient-doctor relationships, some doctors and their patients are using the medication for treatment of COVID19 based on the available information.  This is ideally done in the framework of a clinical study. In these situations, there should be discussion and agreement between patient and doctor and appropriate documentation and follow up.”  Dr. Bisasor-McKenzie added.  

As for its availability of the drug in Jamaica, Ivermectin is currently recommended by the manufacturer for human and animal use as an anti-parasitic medication. There has been previously no demand for human use in Jamaica and no preparation for human use is presently registered in country. Animal preparations are not to be used in humans.

Additionally, there has been no application for registration of the drug by any distributor and Ministry will process registration of the drug for its labelled use as an anti-parasitic once it receives an application.

Where doctors choose to prescribe for their patients, they must note that there is insufficient evidence to establish safety in pregnancy; safety in children <15kg is not well established as there is no pediatric data to support use for COVID-19 in children; and an effective and safe dose for COVID-19 treatment has not been established through well designed studies.

Ivermectin is a Food and Drug Administration (FDA)-approved anti-parasitic drug that is used to treat several neglected tropical diseases, including onchocerciasis, helminthiases, and scabies.