DDB expands access to unregistered medicines laced with dangerous drugs

Published January 8, 2020, 12:00 AM

by manilabulletin_admin

By Chito Chavez 

The Dangerous Drugs Board (DDB) said the agency’s approved resolution will now allow patients with legitimate medical needs to gain access on locally unregistered medicines laced with dangerous drugs.

Dangerous Drugs Board (Dangerous Drugs Board Facebook / MANILA BULLETIN)
Dangerous Drugs Board (Dangerous Drugs Board Facebook / MANILA BULLETIN)

After close coordination and intense consultation with the Department of Health (DOH), Food and Drug Administration (FDA) and other concerned agencies, the DDB approved Board Regulation No. 8, Series of 2019 that provides the issuance of license to acquire, possess and use drug products containing dangerous drugs that are not registered in the Philippines but are registered in other countries.

This development was a result of the initiative of the Senate Committee on Health and Demography headed by Senator Christopher Lawrence “Bong” T. Go which was geared towards providing the concerned patients with a safe, affordable and access to these kinds of medicine for public consumption and compassionate use.

As mandated in the resolution, the license may be applied with the Philippine Drug Enforcement Agency (PDEA) by the patient, his/her parent, spouse, guardian, or relative within the fourth degree of consanguinity or affinity.

Previously, under the Compassionate Special Permit for Restricted Use of Unregistered Drug and Device Product/Preparation by the FDA (DOH Administrative Order No. 4, Series of 1992), only specialized institution or specialty society can file a request for Compassionate Special Permit.

The resolution also explicitly states that the license will be issued for the use or acquisition of drug products for patients with medical conditions involving diseases covered by Republic Act 10747 or the “Rare Disease Act of the Philippines,” life threatening and debilitating diseases, cancer and terminal diseases, rare forms of neurological conditions, and other diseases with limited therapeutic options identified by the DOH.

For unregistered products without dangerous drugs, DOH AO No. 4, Series of 1992 still apply.

With mounting queries regarding this development, the DDB explained that license shall only be granted for the use of products in medicine form that have been registered in FDA counterparts in reference countries.

Other than registered medicines with existing dosage delivery system, no other products with dangerous drugs will be authorized.

Apart from improving access to dangerous drugs for medical purposes, DDB Chairman Catalino Cuy cited the urgency to ensure that only registered products that have been proven safe for use will be allowed under these regulations.

The DDB with the PDEA and the DOH shall formulate the procedural guidelines for license application within 60 days from the approval of the regulation.

The regulation was approved by the DDB last December 17, 2019.

Cuy also noted the DDB was also exploring the possibility of reclassifying medicines containing cannabidiol with no more than 0.1 percent tetrahydrocannabinol from Schedules 1 and 2 to Schedule 4 of the Philippine Schedule.

In the Philippines, substances with no currently accepted medical use in treatment and no accepted safety use under medical supervision are classified under Schedule 1.

Substances with currently accepted medical use in treatment but has high potential for abuse that may lead to severe psychological or physical dependence are classified under Schedule 2.

From these schedules, it is proposed that medicines with no more than 0.1 percent tetrahydrocannabinol be classified under Schedule 4 for substances with currently accepted medical use in treatment.

The 0.1 percent threshold was based on the approved tetrahydrocannabinol threshold of the United States Drug Enforcement Agency.