Pharma Industry Regulation
18.7K views | +78 today
Follow
 
Scooped by Pharma Guy
onto Pharma Industry Regulation
Scoop.it!

Less Than 40% of 80,000 Opioid-Prescribing Docs Are Trained in Safe Prescribing

Less Than 40% of 80,000 Opioid-Prescribing Docs Are Trained in Safe Prescribing | Pharma Industry Regulation | Scoop.it

A panel of FDA advisers meets next week to review risk-management plans put in place nearly four years ago to reduce misuse and abuse of long-acting painkillers, powerful opioid drugs at the center of a national wave of abuse and death.

 

Under the current risk-management programs, drugmakers fund voluntary training for physicians on how to safely prescribe their medications. However, many experts — including a previous panel of FDA advisers — said those measures don’t go far enough and that physician training should be mandatory.

 

According to FDA figures, only 37,500 physicians had completed the voluntary training programs by March 2015, less than half of the targeted number of 80,000. In fact, surveys conducted by drugmakers showed that 40 percent of prescribers were unaware of the programs more than a half-year after they launched.

 

The FDA says its own findings ‘‘show mixed results that make it difficult to draw conclusions regarding the success of the program,’’ according to briefing documents posted online.

 

The FDA will present its findings over a two-day meeting beginning next Tuesday, then ask its panel of outside safety experts what changes should be made to improve the plans. The panel’s advice is not binding.

 

In the last year, government authorities have launched a number of steps intended to reduce painkiller deaths, including new federal prescribing guidelines from the Centers for Disease Control and Prevention and state measures that restrict and track opioid prescribing.

 

Prescription opioid overdoses have been rising steadily for well over a decade, reaching nearly 19,000 in 2014 — the highest number on record. Total opioid overdoses exceeded 28,600 that year when combined with heroin, which many abusers switch to after becoming hooked on painkillers.

 

While public health advocates urged the agency to apply the measures to all painkillers, the FDA decided to limit its action to long-acting painkillers like OxyContin and Opana, because of their high levels of drug ingredients. The risk-management measures don’t apply to the most commonly-used opioids like Vicodin and Percocet.

 

The FDA has its own authority to require specialty training for certain drugs, but says such measures ‘‘impose significant burdens on the health care system and reduce patient access.’’

Pharma Guy's insight:

Does it really make a difference whether or not more dosc are trained when the patient him/herself is not educated about the dangers and when patients - including celebrities like Prince - can go from doc to doc to get all the Oxycontin they need?

more...
No comment yet.
Pharma Industry Regulation
Stories & Insights Regarding Marketing Regulations & Guidelines
Curated by Pharma Guy