Agency issues reminder amid lawmakers' plan to distribute anti-parasitic drug
MANILA — The administration of ivermectin to COVID-19 patients can only be done by hospitals granted compassionate special permit (CSP) by the Food and Drug Administration (FDA), the Department of Health reiterated Wednesday.
Health Undersecretary Maria Rosario Vergeire issued the statement after being asked about reports that Reps. Rodante Marcoleta and Mike Defensor are planning to distribute the anti-parasitic drug through a community pantry-like event.
“We’ve heard of this,” Vergeire said of the report, during a virtual briefing.
“Bukod po dito sa mga ospital na nakakuha ng CSP ay wala pa hong iba na pwedeng mag-distribute o pwedeng magpamigay ng gamot na ito dahil nga po hindi pa ito rehistrado,” she said.
(Besides these hospitals that have CSP, there are no other groups that can distribute this drug because this is not registered.)
Five hospitals have so far been granted CSP for use of ivermectin as potential treatment for COVID-19.
The FDA said in an advisory last month that registered ivermectin products in the country for human use were in topical formulations under prescription use only. This is used for the treatment of external parasites, such as head lice, and skin conditions, such as rosacea.
The registered oral and intravenous preparations of ivermectin are veterinary products, which are approved for use in animals for the prevention of heartworm disease and treatment of internal and external parasites in certain animal species, the FDA had said.
Vergiere said the Living CPG group of experts that include members of medical societies and health institutions, such as the DOH and the FDA, had re-evaluated studies on ivermectin.
“Nagpalabas po tayo na yung re-evaluation of these newer evidences of ivermectin. Still, sinasabi nila insufficient pa rin ang evidence para i-recommend natin ang ivermectin in the treatment of mild to moderate COVID-19 patients,” Vergeire said.
(We released a re-evalutaion of these newer pieces of evidence on ivermectin. Still, they are saying that the evidence is insufficient to recommend ivermectin for the treatment of mild to moderate COVID-19 patients.)
She said the experts also recommended against the use of the drug for those with severe COVID-19.
“Also, we suggest against the use of ivermectin combined with doxycycline for the treatment of patients with COVID-19. These are all conditional recommendations because of the very low quality of evidence existing right now internationally,” she said.
The health official said this is why they are looking forward to the planned clinical trial for ivermectin in the country to see if the drug, approved only for veterinary use in the Philippines, can really be used to treat COVID-19.
According to a joint statement of Defensor and Marcoleta on Tuesday, their respective party lists, along with the Lifecore Bio-Integrative Inc., Concerned Doctors and Citizens-PH, and the Malayang Quezon City will launch on Thursday, April 29, their "Ivermectin Initiative" project.
The event, to be held at the Matandang Balara Barangay Hall, "endeavors to provide access to the poor to avail of the ivermectin drug in our fight against COVID-19."
They said doctors will be prescribing the drug to the "poor senior citizens" of the said barangay, which has "one of the highest incidence of COVID-19" and where "the poorest of the poor who cannot afford the financial burden of hospitalization" belong.
In a Zoom interview with reporters on Wednesday, Defensor said their initiative is legal, and has been coordinated with the Quezon City government.
"I know I would not be violating any law, unless they tell me otherwise. As far as I'm concerned, based on the two committee hearings, based on their public statement, a licensed compounding laboratory is allowed to produce with doctor's prescription ngayon (now)," he said.
He vowed to fight in court any attempt to stop their distribution program.
Vergeire did not say if Defensor and Marcoleta will face any penalties if they push through with distributing ivermectin.
Earlier this month, the DOH said that dispensing ivermectin is a violation of the FDA law.
The FDA previously said besides having a CSP, pharmacies that have a compounding license can use ivermectin. But these are for special prescriptions for individuals and are not to be distributed to a large group of people.
- with a report from RG Cruz, ABS-CBN News