Doctors who issued token prescriptions for ivermectin should be made accountable for any adverse effect, Health Secretary Francisco Duque III warned Friday, a day after lawmakers publicly distributed the drug.
The warning was raised as the Food and Drug Administration began investigating reports that prescriptions for ivermectin were written on a sheet of paper and not on a prescription pad during the distribution of the anti-parasitic drug in Quezon City on Thursday.
“Our regulatory enforcement unit is looking into the situation,” FDA chief Eric Domingo told GMA News Online in a text message on Friday.
Duque said that while doctors could prescribe it for human use against the COVID-19 infection, they have to follow the protocol for which the compassionate permit was issued.
Taking the drug with prescriptions lacking details as prescribed by law is another story.
“The law is clear. All prescriptions must contain the name of the prescriber, office address, professional registration number…” Duque said during an ANC's Headstart interview.
“Moving forward, the way to deal with this immediately is that the patients who received it can call up FDA (Food and Drug Administration) anytime for adverse reaction if any, and further advise. The doctor who prescribed it will be held accountable in accordance with our statutes. The important thing is the doctor must be made accountable,” Duque said in a mix of English and Filipino.
Duque said the FDA had issued compassionate special permits to hospitals that have applied for it.
“There are conditions. There is an enumeration of what has to be done—patients name, everything, doses, side effects, positive effects. Number 2, FDA also authorized the compounding of the ivermectin by authorized pharmacies and that there has to be a doctor's prescription. If all these conditions have been met I don’t think there’s anything illegal about the actions,” said Duque.
Meanwhile, Anakalusugan party-list Rep. Mike Defensor, who led the ivermectin distribution, said Duque's issue was "petty."
“I cannot fully comprehend while in the middle of this war where 16,000 people are already dead and hundreds of thousands are sick, your highest ranking general is looking at prescriptions instead of pro- actively supporting a winning strategy that may win to save the lives of our people and emancipate us from this economic debacle," the lawmaker said.
"The issue is petty. You have four known doctors giving prescriptions to patients who collect ivermectin from a nearby table. The patients submitted their records beforehand and are recorded," he added.
Defensor, who is not a doctor, said he was confident ivermectin will eventually be proven effective against COVID-19.
Defensor and Sagip Party-list Rep. Rodante Marcoleta distributed capsules of ivermectin to residents in Quezon City despite warnings from various health authorities and medical groups.
The FDA has so far granted five hospitals access to ivermectin as an investigational drug to treat COVID-19.
Meanwhile, a group of pharmacists on Friday expressed concern over the distribution of free capsules of ivermectin in Quezon City.
Philippine Pharmacists Association president Gilda Saljay, in an interview on Teleradyo, cited potential side effects and possible violation of the country's pharmacy law.
Saljay said photos circulating on social media showed that the prescription for ivermectin did not contain a physician's name and a license number, which is a violation of the Philippine Pharmacy Act.
"The patients would have no one to hold responsible if something bad happens to them. In the healthcare practice, we always believe in accountability, especially with ivermectin, which is still under CSP or compassionate special permit,” she said.
Saljay said pharmacists could only compound drugs for specific patients with a valid prescription.
In related developments, the Quezon City government is asking the Department of Health and the Food and Drug Administration to make a “clear stand on the safety and general use of ivermectin.”
Dr. Esperanza Arias, the city health officer, said a firm stand by the national regulatory agencies would help set the record straight regarding the legality and efficacy of the drug, including its distribution to the general public.
"We were not given a go signal by the FDA to use ivermectin as prophylaxis or cure against COVID-19 since it's still pending further studies. Hence, we cannot use it nor endorse it," she said.
"But on the other hand, we cannot also stop the distribution since the use of it against COVID has not been declared illegal as well," she added.
Meanwhile, three mayors in Metro Manila said they would wait first for approval by medical experts before using the controversial antiparasitic drug or any other treatment against COVID-19 to ensure the safety of the people.
Taguig City Mayor Lino Edgardo Cayetano said they would only follow the recommendations of medical experts and health officials on the use of any medicine against the deadly coronavirus disease.
Mayor Vico Sotto of Pasig City urged the people to take expert advice on the use of Ivermectin.
Pasay City Mayor Imelda Rubiano also said the city government was open to the idea using Ivermectin and other alternative treatments against COVID-19 as long as they were certified as safe and approved by FDA.