Don’t experiment with COVID ‘cures,’ public urged

MANILA, Philippines — The Inter-Agency Task Force (IATF) on Emerging Infectious Diseases yesterday warned the public against using medicines that have not been approved by health authorities to cure the coronavirus disease 2019 (COVID-19).

Cabinet Secretary and IATF spokesman Karlo Nograles said there is no assurance that the medicines with unproven claims are effective against the disease, which has so far afflicted more than 4,000 people in the Philippines.

“If they are not approved by the Food and Drug Administration (FDA) and the Department of Health (DOH), do not experiment with these drugs. We do not know if they are effective,” Nograles said in a press briefing.

Last week, the FDA said there are no registered drugs or vaccines that are licensed specifically for use in COVID-19 treatment or prevention.

Clinical trials are being conducted, however, to test the safety and effectiveness of some drugs against COVID-19.

The FDA has also reminded companies that sell unlicensed products like PRODEX B and the Fabunan Antiviral Injections to register their products with its drug regulation and research center.

At the same briefing, Nograles said the DOH has been directed to come up with updated protocols on the use of rapid test kits.

“Subject to the requirements and recommendation of the Health Technology Assessment Council or HTAC, pursuant to Republic Act 11223 or the Universal Healthcare Act, the DOH is hereby directed to issue updated guidelines or protocol on the use of rapid test kits in the Philippines,” he said.

The IATF may also study the DOH’s advisory discouraging the public against spraying or misting disinfectants to kill viruses.

Last Saturday, the DOH said there is no evidence to support that spraying of surfaces or large-scale misting of indoor or outdoor areas with disinfecting agents, kills the coronavirus that causes COVID-19. Spraying may even cause the virus to spread further, the agency warned.

“The Department of Health came up with this recommendation... The IATF may discuss its pros and cons. In the meantime... we will honor the recommendation of the DOH,” Nograles said.

FDA waives registration

To address the high demand for personal protective equipment (PPE), ventilators and respirators, the FDA has temporarily waived the mandatory product registration for manufacturers.

“For manufacturers, who will only operate within the public health emergency period, no product registration/notification shall be required,”  FDA announced in a circular.

The circular has been issued as there has been a continuous rise in the number of hospitalized patients, which resulted in the increase on the demand for PPE, ventilators and respirators to manage severe cases of COVID-19.

The FDA stressed, however, that the development, design, functionality, performance testing, validation, risk management, sterilization and other considerations in the production of such shall be guided by the Philippine National Standard and applicable international standards.

The agency further noted that testing of the finished product shall be done to ensure the quality and safety in its use.

Manufacturers looking to pursue production of the medical devices must immediately secure a license to operate after the state of public health emergency in the country is lifted, according to the FDA.

The DOH is set to come out with guidelines on the proper utilization of PPEs, especially in medical facilities.

“We expect that through this system, we can have a more strategic use of our PPEs while we ensure the safety of our healthcare workers amid the limited supply we have,” Health Secretary Francisco Duque III said at a briefing last week.

Duque added that the guidelines include which PPE must be utilized and where it can be used or reused. – With Mayen Jaymalin