FDA: curbing painkiller abuse doesn’t go far enough

BACKGROUND:
The need for adequate pain control is an element of good medical practice. In this context, some persons suffering from pain need access to potent opioid drug products; however, inappropriate prescribing, addiction and death due to prescription opioid abuse and misuse have been increasing over the last decade.

Federal health advisers said Friday a government proposal to curb misuse of powerful painkillers does not go far enough to fix a problem linked to hundreds of fatal overdoses annually.

Powerful pain medications such as OxyContin can prove deadly in the wrong hands. These formulations pack enough drug to last an entire day, but illicit users can defeat the release properties by chewing or snorting the pill or dissolving it in water to inject, resulting in an instant high.

The FDA’s Safe Use Initiative aims to reduce preventable harm from medication use primarily through education, but an emerging trend involves tamper-proofing dangerous drugs through drug reformulation.

According to the FDA, 25 to 33 percent of Americans suffer from chronic, non-cancer pain.the FDA will present a proposal for a class-wide opioid REMS for drug sponsors that will address the serious adverse outcomes of overdose, addiction, and death that result from inappropriate prescribing, misuse, and abuse of long-acting and extended release opioid drugs. Elements of the proposal include medication guides, prescriber and patient education, and a timetable for program assessment.

The FDA’s proposed REMS would require manufacturers of extended-release opioids to:

• Develop educational programs to guide physicians in patient selection, dosing, and patient monitoring. Prescribers would also be trained to counsel their patients on how to safely store and dispose of opioids.
• Provide FDA-approved patient education sheets for physicians to use in their interactions with patients.
• Create “medication guides” that will accompany each prescription highlighting the safe use of opioid drug products.

Related posts:

1. U.S. officials: Rise In Prescription Painkiller