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New Plan Of Action For Prescription Drug Abuse

April 20, 2011

The US Food and Drug Administration (FDA) is requiring drugmakers to provide educational material to help train physicians on the correct use of drugs as part of the government’s new plan to fight prescription drug abuse in the United States.

Prescription drug overdose is the fastest-growing drug problem in the country. It is higher than the number of overdoses from the crack cocaine epidemic of the 80s and the black tar heroin epidemic of the 70s combined, the Obama administration says.

The FDA sent letters to drugmakers of opioids asking them to prepare the materials that physicians and pharmacists can use when counseling patients about the risks and benefits of opioid use.

While documents will be prepared by drugmakers, the FDA will approve them before they are implemented, FDA commissioner Margaret Hamburg said at a news conference on Tuesday.

Drugs that now require the new educational guidelines include Johnson & Johnson’s Duragesic, Pfizer Inc unit King Pharma’s Avinza and Embeda, Actavis’ Kadian and Endo Pharmaceuticals’ Opana ER. The list also includes generic opioid drugs made by Mylan, Teva Pharmaceutical Industries, Watson Pharmaceuticals, Novartis unit Sandoz, KV Pharmaceuticals and Impax Laboratories.

The FDA gave the drugmakers 4 months to propose a plan for their drugs.

The new guidelines, which include doctor training, patient counseling and other risk reduction methods as part of the risk evaluation and mitigation strategies (REMS), is expected to become effective in early 2012.

“The prescriber education component of the opioid REMS balances the need for continued access to these medications with stronger measures to reduce their risks,” Hamburg told Reuters.

The plans aim to ensure specific drugs are used only for the purposes for which they are approved for and not anything else, thus cutting down misuse.

“The toll our nation’s prescription drug abuse epidemic has taken in communities nationwide is devastating,” said Gil Kerlikowske, White House director of national drug control policy. “We share a responsibility to protect our communities from the damage done by prescription drug abuse.”

About 28,000 deaths were attributed to drug overdoses in 2007, according to the Office of National Drug Control Policy. Most were accidental and were related to prescription drugs.

“Today, we are making an unprecedented commitment to combat the growing problem of prescription drug abuse,” said Vice President Joe Biden as he announced the new plans Tuesday morning. “The government, as well as parents, patients, health care providers, and manufacturers all play a role in preventing abuse. This plan will save lives, and it will substantially lessen the burden this epidemic takes on our families, communities, and workforce.”

Prescriptions for opioids have increased dramatically over the past decade. In 2000, pharmacies filed 174 million opioid prescriptions. By 2009 that number was 257 million.

According to the Substance Abuse and Mental Health Services Administration, hospital ER visits linked to prescription drug abuse or misuse doubled over the past five years.

“Unintentional drug overdose is a growing epidemic in the U.S. and is now the leading cause of injury death in 17 states,” said Dr. Thomas Frieden, director of the Centers for Disease Control and Prevention (CDC).

“There are effective and emerging strategies out there to address this problem. Support for this action plan will help us implement those strategies which will go a long way to save lives and reduce the tremendous burden this problem has on our health care system and our society,” said Frieden.

The Drug Enforcement Agency will be heavily involved in enforcement with the new plan, recovering prescription drugs, and focusing on doctors who illegally prescribe them. They will also target “doctor shoppers” — people who visit multiple doctors to secure multiple prescriptions and pill mills.

“When abused, prescription drugs are just as dangerous and just as addictive as drugs like methamphetamine or heroin,” DEA Administrator Michele Leonhart told CNN. “The more we can do to stop the abuse of prescription drugs, the more effective we will be in reducing the death, destruction and despair that accompanies all drug abuse.”

Other federal agencies will also be involved in the effort, including Department of Health and Human Services, Justice Department, Defense Department, and Veterans Affairs.

However, the new efforts are not expected to put further burden on the already-expensive healthcare system, Kerlikowske told Reuters. “There is very little money involvement.”

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