FDA Proposes Training Programs to Prevent Prescription Drug Abuse

on 07/22/2012

The Food and Drug Administration is putting much of the onus on preventing and reducing the number of prescription drug use and abuse-related fatalities every year on the pharmaceutical companies that manufacture these drugs.  Concerned at the increasing number of prescription drug fatalities, especially opioid painkiller-related fatalities in the country, the agency has proposed rules that would require pharmaceutical companies to invest in training programs for both doctors as well as patients.

The statistics are alarming to any product liability lawyer.  In 2009, 15,600 people were killed due to the misuse of prescription pain killing drugs.  As many as 425,000 people had to be rushed to hospital emergency rooms that same year from side effects caused by the misuse of prescription painkillers.  Painkiller-related fatalities account for a large percentage of the millions of prescription drug-related adverse events that occur every year.

For too long, pharmaceutical companies have been able to avoid their responsibility in this safety crisis.  The Food and Drug Administration's new plans require that pharmaceutical companies invest in training targeted at prescribers of drugs.  All pharmaceutical companies must invest in at least 2 to 3 hours of training targeted at the prescribers. 

Furthermore, the Food and Drug Administration plan would require that companies provide such training to 60% of the 320,000 prescribers nationwide within 3 years of the launch of the program.  Additionally, pharmaceutical companies will also be required to provide safety brochures to patients.  These brochures will explain the risks of the opioid painkillers, as well as instructions that would advise patients to seek emergency care in the event of an overdose.  Several opioid painkillers like OxyContin, and Duragesic are included in the agency's plan.


Tags: Product Liability

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