There are rumors that BPOM has allowed Ivermectin to be a ‘drug’ COVID-19 some time ago appeared due to a misunderstanding. To date, BPOM has not issued the UAE for Ivermectin as a ‘medicine’ for COVID-19.
As COVID-19 cases spike, the need for medicines increases. As a result, a number of information emerged regarding the use of drugs for COVID-19 patients, even though there are no specific drugs or products that have been proven to be effective in treating COVID-19. For example, ivermectin.
The Food and Drug Supervisory Agency (BPOM) emphasized that a special drug use expansion scheme is needed which is still in the research stage or called the Expanded Access Program (EAP).
This scheme regulates the expansion of use drug which is still in the clinical trial stage so that it can be used outside of clinical trials, if needed in an emergency.
“The use of drugs used through the EAP scheme must be carried out at Health Service Facilities (Hospitals or Health Centers) appointed by the Ministry of Health, and use the same dosages and rules of use as those used in clinical trials,” said BPOM in its official release, Wednesday (26/12). 21/7/2021).
“One of the drugs that is suspected to have potential in handling COVID-19 and still requires proof through clinical trials is Ivermectin. Currently, Ivermectin is in the clinical trial stage carried out by the Health Policy Assessment Agency (Health Research and Development Agency) of the Ministry of Health to obtain data on efficacy and safety in curing COVID-19,” explained BPOM.
If the Health Service Facility needs to use ivermectin, the Ministry of Health can apply under the EAP scheme.
BPOM emphasized that Ivermectin is a strong drug and EAP approval is not a marketing authorization approval. Thus, the pharmaceutical industry that produces the drug is asked not to promote ivermectin, either to health workers or the public.
“With the consideration that EAP drugs are drugs that are still used in the research framework and have the potential to be misused, the POM needs to carry out supervision to oversee the distribution of EAP drugs only by approved Health Service Facilities,” concluded BPOM.
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