ILOILO City – No hospitals in Western Visayas have been granted with a “compassionate special permit” (CSP) to use Ivermectin, a broad spectrum anti-parasitic agent, to prevent or treat coronavirus disease 2019 (COVID-19).
A health facility can only prescribe Ivermectin against COVID-19 if it has an CSP from the Food and Drug Administration (FDA), according to Dr. Bea Camille Fillaro-Natalaray, chief of the Department of Health (DOH) Region 6’s Non-Communicable Disease Sector.
Natalaray emphasized that the DOH and FDA do not recommend the use of Ivermectin for the prevention and treatment of COVID-19 because there is “insufficient evidence yet” to support its safety and efficacy for the coronavirus.
However, investigational drugs for the treatment of COVID-19 may be used if all regulatory processes are strictly followed. Specifically, off-label use can be allowed under a CSP or when it is compounded by a duly licensed pharmacy and properly dispensed by a pharmacist to a patient with a valid prescription.
“Off-label” use is an unapproved use of an approved drug, or that the drug is used for a disease or medical condition that it is not approved to treat.
“For example, ang Ivermectin para sia sa mga parasitic nga infection pero ginreseta na sia for COVID. Ang packaging nya anti-parasitic pero gin-prescribe sia para sa COVID-19. Dapat compounded ang prescription, kon pila ka milligrams… paano i-prepare. Dapat may ara gid prescription tapos dapat i-prepare gid sia sang pharmacist kon pila na-indicate sang doctor sa iya prescription. Ang prescription dapat kumpleto gid na sia, may date, may name sang physician, kumpleto ang details sang pasyente and of course ang instruction sang pharmacist kon paano i-prepare,” Natalaray further explained.
Earlier, the FDA has allowed the use of Ivermectin for humans as an anti-nematode.
“Before abi ang Ivermectin registered sia diri sa aton sa Philippines as veterinary drugs para sa mga hayop. Eventually may ara pharmaceutical company nga nag-apply for certificate of production registration sa FDA as anti-parasitic drug for humans, indi sia naka-indicate for COVID-19,” Natalaray said.
FDA has yet to grant an emergency use authorization for Ivermectin, although six hospitals were allowed to use it for COVID patients under CSP.
House Deputy Sspeaker Bernadette Herrera-Dy of Bagong Henerasyon party-list – one of the lawmakers who staunchly advocated for the use of Ivermectin as COVID-19 treatment – hailed FDA’s registration of the drug.
“I would like to personally thank FDA director general Eric Domingo for being open to our suggestions and for taking the necessary steps to ensure that this in-demand drug has clear regulation and quality-control standards,” Dy said./PN