MANILA, Philippines — The Philippine Pharmacists Association has raised the alarm on the distribution of ivermectin, citing potential side effects on unmonitored usage of the anti-parasitic drug and violation of the country’s pharmacy law.
Gilda Saljay, president of PPA, said in an interview with Teleradyo’s Sakto said that as pharmacists, their job entails ensuring the safety of patients. “I, with my fellow pharmacists in the country, are deeply concerned over the way of distribution of ivermectin as protection against COVID-19,” she said in Filipino.
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Deputy Speaker Rodante Marcoleta (Sagip party-list) and Rep. Michael Defensor (Anakalusugan party-list) pushed through with their distribution of ivermectin capsules to some 200 Quezon City residents, defying warnings from medical organizations on the thin evidence that backs the drug for the prevention and treatment of COVID-19.
Saljay pointed out that reports stated that those who wanted ivermectin were made to sign a waiver first. Doctors on-site also handed prescriptions written on crudely prepared sheets of paper without their names or license numbers.
The PPA president said this may be a violation of Republic Act 10918 or the Philippine Pharmacy Act.
“It is clear that they used violative prescriptions,” Saljay said, adding that the supposed prescription did not also bear any establishment or hospital.
She stressed that it is important for patients given medicine to be monitored by the doctor or a hospital. “The patients would have no one to hold responsible if something adverse happens to them,” she added.
“In the healthcare practice, we always believe in accountability, especially int his drug ivermectin that is under CSP or compassionate special permit,” Saljay added.
Ten medical societies, along with the DOH and the FDA have examined six clinical trials on ivermectin and found that it did not significantly reduce deaths or improve other clinical outcomes among COVID-19 patients. Clinical trials on its use, however, are ongoing worldwide, including one in the country under President Rodrigo Duterte’s orders.
To date, the Food and Drug Administration has given CSPs to five hospitals.
READ: DOH: Only hospitals with special permits can give ivermectin for COVID-19
The regulatory body also said ivermectin may be given if it was compounded by a registered pharmacist upon a doctor’s prescription.
Saljay explained that compounding is one of the competencies of pharmacists, but she stressed that this should be done with valid prescription from doctor for a specific patient.
“This cannot be done for many, or to compound many. Otherwise, this will no longer be compounding but what we call manufacturing,” she said.
“For a drug under CSP, manufacturing is not yet allowed because there is still no license or certificate of product registration,” she added.
DOJ: Legal bases for ivermectin use unclear
Justice Secretary Menardo Guevarra said that “on its face,” the distribution of ivermectin is a violation of the FDA law, which prohibits the promotion of unregistered medical products in the country.
While Guevarra noted that the FDA gave two exceptions, these legal bases are unclear and may still need further study.
“I wouldn’t really blame Reps. Defensor and Marcoleta if they would proceed but as I said, this is subject to a further determination if there is legal basis for the exemption. So I leave it to them,” the DOJ chief said Thursday.
The Quezon City Health Department, meanwhile, said the DOH and FDA should come up with a clear stand on the safety and use of ivermectin as it can neither endorse its use or stop its distribution.
"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," said Quezon City Health Department officer-in-charge Esperanza Arias.
"We cannot also stop the distribution since use of it against COVID has not been declared illegal as well," she said. — Kristine Joy Patag with report from Xave Gregorio