Special permit required for Ivermectin use vs COVID-19

CEBU, Philippines — The use of anti-parasitic drug Ivermectin for COVID-19 treatment should only be authorized by doctors and hospitals with Compassionate Special Permit (CSP), an official of the Food and Drugs Administration (FDA) said.

FDA recently granted CSP to a hospital for the use of Ivermectin to treat coronavirus patients.

CSP allows doctors or hospitals to use unregistered medical products for limited off-label use. A specialized institution or specialty society will be the only ones to file a request for CSPs.

The move comes amid growing discussions over the use of Ivermectin as a potential treatment for or prophylactic against COVID-19. Scientific evidence for its efficacy remains thin, with medical authorities across the globe advising against the use of drug to treat COVID-19, a respiratory disease.

FDA director general Eric Domingo said a doctor or a hospital can request for CSP from FDA if there are drugs unavailable in the country, but are registered overseas.

“Ang isang doctor o isang hospital ay pwedeng mag-apply ng CSP kung mayroong gamot na hindi available dito sa Pilipinas pero rehistrado sa ibang bansa, available sa ibang bansa o di kaya yung gamot ay kasama sa mga clinical trials para sa pagtugon sa kasakitan na yun, in this case, COVID-19,” said Domingo in yesterday’s virtual presser with DOH.

Domingo said most of the medicines for COVID-19 are yet under clinical trials.

The Department of Health does not recommend the use of Ivermectin for COVID-19 treatment.

The World Health Organization, in its guidance, said it does not recommend Ivermectin “in patients with COVID-19 except in the context of a clinical trial.”

The United Nations health agency also said the effects of Ivermectin on mortality, mechanical ventilation, hospital admission, duration of hospitalization and viral clearance “remain uncertain because of very low certainty of evidence addressing each of these outcomes.”

Moreover, FDA clarified that CSP is not a product registration nor a marketing authority.

“Hindi siya registration at hindi rin marketing authorization. And in fact, walang garantiya ang FDA sa quality at efficacy ng gamot lalo na kung clinic trial plot pa, “said Domingo.

With no guarantee of efficacy from FDA, it’s the doctor’s responsibility to the patients. The patient should also be informed and should give consent to it.

“Kapag ang doctor ay nanghingi ng special permit, they take it upon themselves the complete responsibility over the use of the product. In in fact kasama yun sa kanilang application. Edi-discuss nila ito sa kanilang pasyente in case wala silang magagamit na gamot,” he said.

For CSP application, the doctor and/or hospital should also indicate the number of patients and tablets to be prescribed.

The applicant is not allowed to sell the drug commercially.

The FDA said the only registered oral and intravenous preparations of Ivermectin are veterinary products, and are only approved for use to prevent heartworm disease and treat internal and external parasites.

What is currently available in the country for human use is in topical formulation, which is used to treat head lice and skin conditions such as rosacea. — KQD (FREEMAN)