BPOM Opens Opportunities For Stopping The Use Of Hydroxychloroquine And Chloroquine For COVID-19 Drugs

Illustrated. (Irfan Meidianto / VOI)

JAKARTA - The Food and Drug Administration (BPOM) emphasized that it could issue a ban on the use of hydroxychloroquine and chloroquine malaria drugs for positive patients infected with COVID-19. However, this is done if the results of clinical trials indicate a greater risk to the patient due to the use of the drug.

The world health organization (WHO) has also asked the Indonesian government to stop using the two drugs in the treatment of COVID-19. This is related to the safety of the malaria drug in treating patients.

Director of Drug Registration BPOM, Lucia Rizka Andalusia said, currently in Indonesia it is still using the drug for positive patients with COVID-19. However, the use of these drugs is only intended for patients with critical conditions and through close monitoring by doctors.

Furthermore, Lucia said, doctors closely monitored its use because the drug was a hard drug. So that its use is only for emergencies or through an emergency use authorization policy.

"Until now, the use of the drug is still allowed. Later when we have collected data and it is proven that it must be stopped, we will review the approval for the use of the drug," he said, in a virtual discussion, Tuesday, June 23.

Lucia said, with the existence of emergency use authorization rules, every government agency engaged in the health sector must conduct research on the risks of drug use through clinical trials and strict safety monitoring. Including, hydroxychloroquine and chloroquine. Although these two drugs have been used in several countries.

Recommendations for use, said Lucia, can be changed at any time to a ban if the clinical trial results are found to be of no efficacy or even tend to harm patients using this drug.

Meanwhile, Lucia said, WHO, which previously conducted clinical trials, had stopped testing hydroxychloroquine and chloroquine for positive patients with COVID-19. This is a consideration, but what determines is the results of domestic clinical trials.

"Of course, these are also factors that must be considered. Therefore, we must have our own clinical trials of the drugs used," he said.

As is known, the Indonesian government uses hydroxychloroquine and chloroquine drugs for handling COVID-19 patients because other countries use them first and have passed clinical trials. Countries that use them are China and the United States.

Indonesia will still use chloroquine and hydroxychloroquine for the treatment of COVID-19 patients. This decision was stated in the appeal letter submitted by the Indonesian Lung Doctors Association (PDPI) dated May 28, 2020. The letter was signed by PDPI Chairperson Agus Dwi Susanto and Chairperson of the Working Group for Infection Erlina Burhan.

Meanwhile, several European countries have begun responding to WHO requests to temporarily stop trials of hydroxychloroquine for the treatment of COVID-19. Germany also stopped testing this malaria drug on Thursday, May 28.