FDA Acts to Reduce Harm from Opioid Drugs
News Across the Profession
Written by TAC Staff   
Wednesday, 11 May 2011 19:46 Read : 1120 times

T
he White House unveiled a multi-agency plan aimed at reducing the “epidemic” of prescription drug abuse in the U.S.—including an FDA-backed education program that zeros-in on reducing the misuse and misprescribing of opioids.

Gil Kerlikowske, director of the White House Office of National Drug Control Policy, says the plan—a collaborative effort involving agencies of the departments of Justice, Health and Human Services, Veterans Affairs, Defense, and others—provides a national framework for reducing prescription drug abuse and the diversion of prescription drugs for recreational use.fdadrugs

Key elements of the plan—called Epidemic: Responding to America’s Prescription Drug Abuse Crisis—include:

  • expansion of state-based prescription drug monitoring programs
  • recommending convenient and environmentally responsible ways to remove unused medications from homes
  • supporting education for patients and health care providers
  • reducing the number of “pill mills” and doctor-shopping through law enforcement

In concert with the White House plan, the Food and Drug Administration (FDA) is announcing a new risk reduction program—called a Risk Evaluation and Mitigation Strategy—for all extended-release and long-acting opioid medications.

Opioids are synthetic versions of opium that are used to treat moderate and severe pain.

FDAbluemayFDA experts say extended-release and long-acting opioids—including OxyContin, Avinza, Dolophine, Duragesic, and eight other brand names—are extensively misprescribed, misused, and abused, leading to overdoses, addiction, and even deaths across the United States. FDA says a 2007 survey revealed that more than half of opioid abusers got the drug from a friend or relative.

Opioids—such as morphine and oxycodone—are used to treat moderate and severe pain. Over the past few decades, drug makers have developed extended-release opioid formulas to treat people in pain over a long period.

FDA estimates that more than 33 million Americans age 12 and older misused extended-release and long-acting opioids during 2007—up from 29 million just five years earlier. And in 2006, nearly 50,000 emergency room visits were related to opioids.

FDA has had the power to request companies to develop REMS since 2007. The plans may also include medication guides and patient package inserts.


 
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