Despite issuing waivers, doctors giving out ivermectin must still report adverse reactions - expert

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Metro Manila (CNN Philippines, May 3) — Issuing waivers for ivermectin use does not remove the responsibility of doctors from monitoring and reporting potential adverse reactions on those who took the drug, a medical expert said Monday.

Dr. Rontgene Solante, head of the adult infectious diseases unit at San Lazaro hospital, said the authority given to physicians to prescribe the anti-parasitic drug also comes with the responsibility of checking the health conditions of those who took it.

"Kasama sa CSP (compassionate special permit) ang monitoring of possible health reaction. Kaya nga ang pag-issue ng CSP is doctor-driven. Kung sino ang [magbibigay] ng gamot na ito, siya ang bibigyan ng permit ng authority para magbigay sa pasyente na iyon," Solante told CNN Philippines' The Source.

[Translation: The granting of a compassionate special permit also requires monitoring of possible health reactions. That's why the issuance of CSP is doctor-driven. Only those who can give the medicine are those who were granted the authority to prescribe to the patient.]

"He (doctor) should also be liable kung ano yung mga adverse reaction kasi magrereport din siya ng mga adverse reactions based doon sa binibigay na gamot under CSP," Solante added.

[Translation: The doctor should aso be liable on whatever adverse reactions will be experienced and he must be the one to report them based on the drug allowed by the CSP.]

Solante shared the sentiments of other medical groups that there is still no established evidence that ivermectin can be used to treat or prevent COVID-19.

Only five hospitals have been granted compassionate special permits to use ivermectin on COVID-19 patients. The drug can also be distributed with a valid prescription, but only when it is compounded by licensed pharmacies.

READ: Two more hospitals granted limited use of ivermectin vs COVID-19 

But last week, ivermectin advocates Mike Defensor of Anakalusugan Party-list, Sagip Party-list Rep. Rodante Marcoleta, and some physicians from the Concerned Doctors and Citizens of the Philippines led the distribution of ivermectin to residents of Barangay Old Balara, Quezon City. Doctors onsite used a bond paper to simply hand out the drug which is not yet registered for human use in the country, as clinical trials are still slated for May.

READ: Ivermectin advocate solon says prescription on blank paper during distribution a 'non-issue' 

Prior to receiving ivermectin, residents were also required to sign a waiver which holds distributors free from any legal liability.

"The waiver only gives you the permission that the patient knows that there are possible adverse events. There is also the possible benefit but despite this event or adverse reaction, they will take the medication because this has been explained," said Solante, reacting to the ivermectin giveaway event.

"Pero iba ang waiver, iba 'yung kapag nagdevelop ka ng adverse reaction. Saan ba pupunta ang mga pasyente pag nagdevelop niyang adverse reaction? Sa ospital pa rin. Sinong mananagot niyan?" He added.

[Translation: The waiver is different, it's different from when you actually develop an adverse reaction. Where would the patient go if he gets an adverse reaction? Still in the hospital. Who will be held responsible for that?]

The World Health Organization and even ivermectin maker Merck have repeatedly emphasized there is not enough proof ivermectin can be used to treat or prevent COVID-19. They also warned high doses could cause brain damage in humans, or even death.

In a statement on Sunday, the Philippine Medical Association stressed that the prescription of ivermectin as a prophylactic medicine against the virus is "strongly not advised."

The Philippine College of Physicians added that ivermectin does not improve clinical outcomes or reduce deaths among adults with mild COVID-19 infection, based on current scientific studies.

"Let us also refrain from thinking that we are saving our countrymen from the complications of COVID-19 by giving them medicines that are not proven remedies. We may be exposing them to unwanted and possibly harmful side effects," the PCP said.