FDA Plans New Ineffective Painkiller Abuse Prevention Program


 FDA Plans New Ineffective Painkiller Abuse Prevention Program

The FDA has unveiled its plan to reduce the abuse and misuse of powerful painkillers that can be fatal in overdose. The agency has asked drugmakers that manufacture opioid painkillers to fund educational programs for doctors and offer safety information to patients explaining the appropriate use of drugs and risk of overdose.

Opioid painkillers, which include morphine, methadone and oxycodone, are among the most abused drugs. Overdose of theses caused 15,600 deaths in 2011. Though FDA has released several warnings on the inappropriate use, they have been ineffective. Even this program is not mandatory for all the doctors. The agency mandates that only about 20 companies provide money for training of at least 60 percent of 320,000 American doctors by 2016. The plan will be available by March 1, 2013.

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When some healthcare experts argued that the training should be made mandatory for all the prescribers, the FDA officials said making the program mandatory would require a new law from Congress. Michael C. Barnes, executive director of the Center for Lawful Access and Abuse Deterrence, says that, since it is not mandatory, the program may not be taken by doctors who need it the most.

Companies that provide continued medical education will be designing the course and training the doctors, for free or at a nominal cost. Drugmakers can’t participate in course design, curriculum or training; they just have to grant the money. A third party will audit the classes to confirm that the training is in compliance with FDA guidelines.

“Responsible physicians will welcome the education benefits provided by this program,” said Dr. Lynn Webster of the American Academy of Pain Medicine. FDA has been working to develop this plan since 2009.

The FDA found that sometimes doctors prescribe painkillers for migraine headaches and minor injuries, which is unapproved and may cause abuse.

Authorities expect that the course will help doctors and pharmacists provide appropriate dosage to legitimate patients, and restrain from dealers or addicts. Here lies the real problem. What if the customer continues to demand the drug? The pharmacists then have to give it to customer, because if they don’t, they can get sued. Pharmacists we have spoke to told us this is the law at least in New York. One  pharmacy owner told us that he is required to fill prescriptions, which he confirms a doctor wrote out, even if he knows the person is a drug dealer.

What do you think? Will training only a partial list of doctors and health professionals curb the problem?