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FDA acts to fight opioid overdose “epidemic”

methadoneiiDrug manufactures that market opioid painkiller medications will be required to train U.S. doctors, nurses and other health care professionals in the ways of safe use of the drugs, which have caused an epidemic of overdose deaths according to the Center for Disease Control (CDC).

The FDA introduced new safety measures for extended-release and long-acting opioid medications, such as oxycodone, hydrocodone, and methadone.  It comes in the form of a mandated blueprint on best practices measures directed at upwards of 20 companies that manufacture opioid analgesics, including how best to educate physicians who prescribe the medications.

New safety measures come from the FDA after the CDC published myriad striking statistics regarding drastically rising opioid overdose deaths.

The Federal requirement handed down from the FDA comes in the wake of a failed U.S. Congressional bill that went to vote several weeks ago.

“Although many Americans don’t realize it, prescription drug abuse is our swiftest growing drug problem. Many of those abuses involve opioids,” said Dr. Margaret Hamburg, commissioner of the Food and Drug Administration. “In 2008, nearly 15,000 Americans died where opioids were involved. In 2009, that number went up to 16,000.”

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Congress hesitates to impose austere regulations on painkillers

800px-Pills_MC_inverseThe New York Times did a piece today on a bill that would have handed down stricter controls on drugs such as hydrocodone and oxycodone.  Efforts by Congress to pass the bipartisan bill were apparently impeded by a massive wave of lobbying from pharmacists and drugstore chains.  The bill ultimately fell flat yesterday.

Everyone knows about the rampant abuse of pain killers, but what struck me were some of the facts that Congress was looking at.  Apparently abuse has spiked over the past ten years.  A recent report by the federal Centers for Disease Control and Preventions said that lethal overdoses involving prescription painkillers are at “epidemic levels” and currently kill more Americans than heroin and cocaine combined.  “The death toll from overdose of prescription painkillers has more than tripled in the past decade.”  Wow!  Please everyone, be very careful with your medications!

I guess what the pharmacists and drugstores objected to was the high cost that it would take to comply with tightened security, e.g. storage would require more substantial safes, etc.  They also claimed that it would be harder for us, the patients, to get out meds, but there seems to be some contention on that point.

I personally understand the need to address the out-of-control abuse of these drugs, but I’m not sure these measures would be the best angle to attack it from.  I feel like it’s already a pain to get narcotic medications, and placing more hoops in front of people isn’t going to solve the problem.  Perhaps pain management doctors are  prescribing recklessly.  I know there aren’t really any viable alternatives, but passing the buck onto the drugstores is rather unfair.  It’s a very difficult and concerning issue to take on, and I can’t imagine many easy answers. 

I guess the moral of the story is to be careful with your meds.  Does anyone have any thoughtful comments on the issue?