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Rx drug abuse: Congress, FDA study solutions to ‘growing problem’

Editor’s Note: This article is part of a series produced by the Southwest Times Record in Fort Smith. The entire series will be published online at www.carlisleindependent.com.

An estimated 20 percent of people in the United States have used prescription drugs for non-medical reasons in their lifetime and prescription drug abuse is a “serious and growing problem,” according to the National Institute of Health.

In a National Institute on Drug Abuse survey published in October 2011, it was reported an estimated 7 million people had abused a prescription medication in the previous month. More than 5 million people reported the drug they abused was a painkiller.

Deaths from drug overdose increased for the 11th consecutive year in 2010, the last year with complete data available, with almost 60 percent of the deaths involving pharmaceutical drugs, according to Center for Disease Control data released in February.

Nearly 60 percent — 22,134 — of the total 38,329 overdose deaths in 2010 involved pharmaceutical drugs, with painkillers such as oxycodone, hydrocodone and methadone involved in about 75 percent of the pharmaceutical overdose deaths, according to CDC.

Hydrocodone is the most prescribed opioid in the United States and “is associated with more drug abuse and diversion than any other licit or illicit opioid,” according to a Drug Enforcement Administration drug fact sheet.

In 2012, U.S. Sen. Joe Manchin, D-W.Va., offered an amendment to the Food and Drug Administration Safety Innovation Act that would reclassify hydrocodone from a Schedule III to a Schedule II controlled substance under the Controlled Substances Act. Oxycodone and methadone are Schedule II controlled substances.

The American Pharmacists Association, Food Marketing Institute, International Academy of Compounding Pharmacists, National Association of Chain Drug Stores and National Community Pharmacists Association sent a joint letter opposing the Manchin amendment to all senators and representatives.

The organizations argued that reclassifying hydrocodone would impact the quality of life for patients suffering from chronic pain because doctors can’t call in prescriptions for Schedule II drugs and electronic prescribing of Schedule II drugs is illegal in some states, according to a Drug Store News article from June 1, 2012.

Schedule III drug prescriptions can be transmitted to a pharmacy by phone or fax and can include up to five refills in a six-month period, according to DEA regulations.

Schedule II drug prescriptions require a written prescription, allowing for faxed prescriptions under a narrow set of circumstances and refills are prohibited. Multiple written prescriptions, equaling a 90-day supply, can be issued to patients under certain conditions.

Many state also have laws that further restrict how Schedule II drugs are dispensed.

The pharmacy organizations also argued that reclassifying hydrocodone would result in higher drug costs for consumers, because of regulations regarding the record keeping, inventory management and storage requirements of Schedule II drugs, according to the Drug Store article.

The amended act passed the Senate, but the House removed the amendment, approved the act and returned it to the Senate, where it was approved without the Manchin amendment.

Multiple members of Congress continue to push for a legislative solution.

On March 20, U.S. Sen. Mark Kirk, R-Ill., and Manchin introduced the “Safe Prescribing Act of 2013” in the Senate which would reclassify hydrocodone as Schedule II. An identical measure was introduced in the House.

“As responsible leaders, we cannot stand by and let prescription drug abuse become one of the fastest-growing epidemics in our country,” Kirk stated in a news release. “Hydrocodone addictions already account for more than 60 percent of all drug addictions, and that number continues to rise. This bill will give law enforcement greater tools to monitor the distribution of these drugs and curb their abuse. I am proud to join this bipartisan, bicameral group to help curtail the amount of drug-related deaths in this country.”

Under the proposed act in addition to reclassifying hydrocodone, traffickers would be subject to harsher fines and penalties, according to the news release.

Sen. Mark Pryor, D-Ark., voted for the FDA Safety Innovation Act with the Manchin amendment in 2012 and “would be supportive” if the Safe Prescribing Act comes up for a vote, said Lucy Speed, Pryor’s press secretary.

When Rep. Steve Womack, R-Rogers, was asked where he stands on the Safe Prescribing Act, his communications director Claire Burghoff said he knows all too well about how drugs can impact individuals, families and society.

“As such, he is supportive of policies that address this growing epidemic and is committed to working with his House and Senate colleagues to win the war against drugs,” Burghoff said.

Sen. John Boozman, R-Ark., provided the following statement through press secretary Sara Lasure.

“Prescription drug abuse is a growing problem that impacts Arkansas communities and families every day. We must take immediate steps to improve coordination, awareness, and enforcement in order to combat this trend. I recognize the challenges we face and I’m examining relevant legislation, including the Safe Prescribing Act, to address this pressing issue,” Boozman said.

The office of Rep. Tom Cotton, R-Dardanelle, didn’t respond last week when asked for comment.

While Congress considers the issue, the FDA continues its research.

In January, the Drug Safety and Risk Management Advisory Committee, an advisory panel to the FDA, recommended by a 19-10 vote that hydrocodone be reclassified as a Schedule II controlled substance.

The FDA is continuing scientific and medical research on the issue, which began anew in 2009 at the request of the DEA, said Morgan Liscinsky, an FDA press officer.

In 1999, the DEA received a citizen petition requesting reclassification of hydrocodone, and in 2004 the agency requested the FDA begin a scientific and medical evaluation on hydrocodone and provide a scheduling recommendation, according to a Drug Safety and Risk Management Advisory Committee briefing report.

In March 2008, the Assistant Secretary for Health for the U.S. Department of Health and Human Services recommended to the DEA that hydrocodone remain a Schedule III controlled substance based on FDA findings and the concurrence of the National Institute on Drug Abuse.

In 2009, after collecting and analyzing new date, the DEA asked the FDA’s Center for Drug Evaluation and Research to reconsider the findings reported to the Assistant Secretary for Health that resulted in that office’s 2008 recommendation, according to the briefing report.

Liscinsky said the research on the request is continuing and could offer no timetable for how it would proceed.

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