THE Department of Health yesterday said the controversial anti-parasitic drug ivermectin can now be used as an “off label” drug against the coronavirus disease (COVID-19).
Off-label use means a pharmaceutical drug is used for a disease or medical condition that it is not approved to treat.
Using ivermectin as an off-label drug means doctors will be liable for any adverse effects of the drug on their patients, Health Undersecretary Maria Rosario Vergeire said in a briefing.
The announcement came amid debates on whether the government should allow the sale and distribution of ivermectin as a COVID-19 treatment. The drug is being pushed by some politicians and medical groups to prevent or treat COVID-19.
Last Friday, the Food and Drug Administration issued a certificate of product registration (CPR) to Lloyd Laboratories for the manufacture and sale of ivermectin as an anti-nematode drug.
This is on top of compassionate special permits (CSPs) the FDA has given to five private hospitals. The CSPs allow the hospitals to prescribe ivermectin to their patients.
Vergeire said the CPR granted by the FDA to Lloyd Laboratories will pave the way for its availability in pharmacies either as anti-parasitic drug or for COVID-19.
“When we say there is a CPR for ivermectin, it means it can be used as indicated or for parasitic infections,” said Vergeire.
“Also, if a drug has a CPR already, it can also be used as an ‘off label’ drug. That is part of our regulatory protocol. A doctor has to prescribe this as an ‘off label’ drug before a patient can use it based on the indication stated by the doctor,” she added.
The Department of Health, FDA, and different medical societies have continuously advised against the use of ivermectin to treat COVID-19, saying there is not enough scientific evidence yet to prove its safety and efficacy.
Several lawmakers have been pressing the FDA and the DOH to allow the distribution of ivermectin as COVID-19 treatment.
Vergeire said doctors will be “accountable for their patients if ever they will allow the use or prescribe it to their patients.”
“They should be able to do this kind of monitoring for their patients so they can be sure it is safe for them,” she also said.
Manufacturers are also expected to monitor those using their drug products.
“Those that applied for ivermectin have a similar obligation to the government to do post-marketing surveillance,” she said.
REMDESIVIR
Vergeire said neither the government nor the DOH is procuring the antiviral drug remdesivir that is being used for COVID-19 patients.
“We don’t have a procurement for remdesivir precisely because it has no CPR. We will not do that because we follow regulatory protocols,” she said.
“We give these hospitals the funds to respond to COVID-19 cases so that they can use it to procure whatever investigational drugs are in the market,” she added,
She said all hospitals using remdesivir have acquired CSPs from the FDA.
“Our hospitals and doctors apply for CSP so they can use investigational drugs without CPRs,” she said.
On Sunday, two lawmakers advocating the use of ivermectin criticized the DOH for allegedly buying P1 billion worth of remdesivir.
This, according to Anakalusugan Rep. Michael Defensor and House deputy speaker Lito Atienza, is despite the World Health Organization’s rejecting remdesivir as a COVID-19 treatment.
The WHO is also advising against the use of ivermectin to treat COVID-19.
