Jakarta, CNN Indonesia —
National Agency of Drug and Food Control (BPOM) warned that the pharmaceutical industry that produces Ivermectin does not promote the drug as a therapeutic drug for patients exposed to the corona virus (Covid-19).
The appeal was issued because until now Ivermectin is still conducting clinical trials and has not yet obtained an emergency use permit (EUA). BPOM also emphasized that so far Ivermectin has only been included in the category of drugs with a special use expansion scheme alias expanded access program (EAP).
“Considering that Ivermectin is a strong drug and the EAP approval is not a distribution permit approval, it is emphasized to the pharmaceutical industry that produces the drug and any party not to promote the drug, either to health workers or to the public,” BPOM wrote, quoted from the official Pom website. go.id, Wednesday (21/7).
BPOM explained, Ivermectin is currently at the stage of clinical trials conducted 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 patients.
According to BPOM, if a wider use of Ivermectin is needed by health care facilities, the Ministry of Health can apply for Ivermectin use, but still with the EAP scheme.
“With the consideration that EAP drugs are drugs that are still used in the research framework and have the potential to be misused, BPOM needs to carry out supervision to oversee the distribution of EAP drugs only by approved Health Service Facilities,” they continued.
BPOM also emphasizes that the owner of the approval and the provider of EAP drugs are required to monitor pharmacovigilance and report unwanted events (KTD) and side effects from drug administration, as well as record and report every month related to the procurement, distribution, and use of EAP drugs to BPOM.
Separately, Epidemiologist from Airlangga University, Windhu Purnomo, urged officials who had ‘endorsed’ the medicinal product Ivermectin as a therapeutic drug for patients exposed to the corona virus to apologize to the public.
Windhu also asked that this incident not happen again. He considered, it is only natural that officials who do not have competence in medicine should not participate in promoting this drug. For this reason, he suggested that all parties wait for the results of the Ivermectin clinical trial and monitoring from BPOM.
This was stated by Windhu following the apology delivered by the President Director of PT Harsen Laboratories Haryoseno as the producer of the Ivermectin drug under the Ivermax12 brand which had become a polemic because of the presence of the drug related to COVID-19.
(khr/ain)
– .
