The Philippine Pharmacists Association (PPhA) called on the Department of Health (DOH) and the Food and Drug Administration (FDA) to act "swiftly and decisively" on the group which distributed ivermectin during an event in Quezon City on Thursday, April 29.
"In light of the recent mass distribution of Ivermectin, the Philippine Philippine Pharmacists Association, Inc strongly opposes the irrational dispensing of an unregistered product and illegal compounding thereof," PPhA said in a statement on Friday, April 30.
"We call on the FDA, the DOH, and other concerned agencies to act on this matter swiftly and decisively, " PPhA added.
PPhA issued the statement after ivermectin was distributed on Thursday, April 29, to residents of Barangay Old Balara, Quezon City. The event was led by House Deputy Speaker Rodante Marcoleta and Anakalusugan Party-list Representative Mike Defensor.
"Medicines are developed, manufactured, prescribed, compounded, and dispensed based on sound, scientific, and evidence-based professional judgement," PPhA said.
Citing RA 10918 or the Pharmacy law, PPhA said that "compounding in large quantities is illegal, because the act already constitutes manufacturing of a pharmaceutical product. Hence, before the conduct of the manufacturing activity, a license to operate must be obtained from the Food and Drug Administration."
In the Philippines, the only ivermectin currently allowed – and freely sold online – is for the treatment of animal intestinal parasites and ectoparasites such as fleas and mites. For humans, ivermectin is available in the country "in topical formulations under prescription use only," the FDA said.
The FDA allows the use of ivermectin only on two instances – if the medical facility dispensing the drug secured a compassionate special permit (CSP), or if a doctor has prescribed it and the drug is compounded by a pharmacist according to the prescription.
So far, the FDA has granted CSPs to five hospitals to use ivermectin for COVID-19 treatment. A CSP allows for the limited use of investigational drugs or unregistered drugs only in medical facilities that secured permits.
The DOH earlier in April said that people who were dispensing ivermectin to treat COVID-19 are violating Republic Act (RA) No. 9711 or the FDA Act of 2009, as this type of ivermectin was not yet registered in the country.
Amid the debates, President Rodrigo Duterte ordered the Department of Science and Technology (DOST) and DOH to study the use of ivermectin as a possible treatment against COVID-19. He gave the order a week after the DOST itself said there was no need for local studies as there were ongoing trials abroad.
The PPhA statement also reiterated the importance of a valid prescription before compounding and distributing a drug. The group said, a valid prescription must contain the following:
Hours after the ivermectin distribution in Quezon City on Thursday, photos of supposedly medical prescriptions of the drug surfaced on social media. The prescriptions, however, were only written on a white sheet of paper without the name of the physician who prescribed the drug, the license number, and professional tax receipt numbers. The laws mandate that doctors include these details in prescriptions they dispense.
"We remind all stakeholders that dispensing of medicines, whether is it compounded, FDA-registered or under compassionate use permit must be done under direct and immediate supervision of a pharmacist," PPhA said.
In an interview with ANC's Matters of Fact on Thursday morning, FDA Director General Eric Domingo said that as long as the two lawmakers were compliant with rules on legal ways to dispense ivermectin, "there's no problem."
On Thursday night, the Quezon City government also urged the DOH and the FDA to issue a "firm stand" on the use of ivermectin.
Meanwhile in a statement on Friday, the DOH said that it would ask the Professional Regulation Commission to investigate reports of alleged invalid prescriptions.
"Given the necessary content of valid prescriptions, the DOH and FDA urged the public to be vigilant and sufficiently assess any prescriptions provided to them, as these prescriptions will protect them and ensure accountability from the issuing professional," the health department said. – Rappler.com