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Duque says FDA must probe into ‘token prescriptions’ at ‘ivermectin pantry’

Duque says FDA must probe into 'token prescriptions' at 'ivermectin pantry'

MANILA, Philippines (Updated 5:23 p.m.) — The Food and Drug Administration should look into the prescriptions—that lacked doctors’ information—given to recipients of the anti-parasitic drug ivermectin in Quezon City, the Department of Health said Friday.

At the so-called “pantry” organized by two lawmakers despite warnings from medical authorities, doctors handed beneficiaries prescriptions for ivermectin. But the prescriptions, written on sheets of paper, did not contain their names, license numbers and professional tax receipt numbers.

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“If the reports that the prescription was written on a tissue or bond paper were true, then the FDA needs to investigate such reports. But the accountability is clear it’s the doctor who prescribed it who has to answer for his actions,” DOH Secretary Francisco Duque III said in an interview with ABS-CBN News Channel. 

“All prescriptions must contain the name of the prescriber, office address, professional registration number, professional tax receipt number… They should follow this. They cannot issue token prescriptions,” he added. 

In a separate briefing, Health Undersecretary Maria Rosario Vergeire said such details are required as mandated by the Consumer Act of the Philippines 1991, Generics Act of 1988, and the FDA Act of 2009. 

In a statement issued Thursday afternoon, the DOH said it will endorse the reports of invalid prescriptions to the Professional Regulation Commission “to investigate the veracity of the reports and impose sanctions as deemed necessary based on existing laws.” 

The DOH and the FDA urged those who received the prescriptions and the drugs to report any invalid prescriptions to the PRC, and any adverse reactions to the FDA at (02) 8809-5596 or pharmacovigilance@fda.gov.ph.

Legal?

While he said the FDA must investigate the prescriptions given to beneficiaries, Duque said there may be nothing illegal about the move of Deputy Speaker Rodante Marcoleta (Sagip party-list) and Rep. Michael Defensor (Anakalusugan party-list) to give away ivermectin if they followed the exemptions set by the FDA.

“As mentioned by FDA Director General Eric Domingo, as long as it was from compounding pharmacy, as long as there are doctors prescribing, then it is part of the process and it is legal. Let’s leave it at that,” Vergeire also said.

Previously, she said only hospitals with compassionate special permits can give ivermectin as an off-label COVID-19 treatment. But the health official maintained Friday there is scant evidence to support the use of ivermectin to prevent or treat COVID-19.

The differing views of the DOH and the FDA on whether the drug can be distributed to the public prompted the Quezon City Health Department to say the two agencies should come up with a clear stand on the use of ivermectin.

Vergeire also said there are two “pathways” on any drug-related decisions: regulatory and clinical. Regulatory pathway falls under the FDA, while the clinical pathway is taken by the DOH and medical experts.

‘Listen to medical experts’

In the briefing hosted by the DOH, two mayors from Metro Manila urged Filipinos to listen to medical experts on the use of ivermectin.

Pasig City Mayor Vico Sotto cautioned the public against “conspiracy theories.”

“Let’s relax and not get carried away by conspiracy theories. Just because there’s a little bit of positive news or a little bit of possibility or little scientific basis, that’s not enough to say, ‘Okay, that’s good enough.’ We are not doctors, we are not medical experts. Let’s listen to them,” Sotto said.

“We listen to medical experts. When the time comes that it is approved by the FDA and the DOH, by all means we will not just support it, we will advocate it, we will buy it,” Taguig City Mayor Lino Cayetano said.

President Rodrigo Duterte ordered the Department of Science and Technology to conduct clinical trials to test the efficacy of ivermectin against COVID-19. The study may begin by end-May or early June, and may last for six months. — with report from Xave Gregorio

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