Trying New Strategies to Curb Drug Abuse

The FDA issued draft guidance Jan. 9 to aid manufacturers trying to devise abuse-deterrent opioids. A county attorney in Arizona and the U.S. Navy recently tried other methods to deter abuse of synthetic drugs.

• By Jerry Laws
• Feb 01, 2013

Abuse of prescription drugs remains a major U.S. problem, even though some of the most recent SAMHSA data indicated the number of Americans ages 12 and older who used a prescription drug non-medically in the past month fell by 12 percent, from 7.0 million in 2010 to 6.1 million in 2011.

Gil Kerlikowske, director of National Drug Control Policy, credited law enforcement agencies' crackdown on pill mills, nationwide DEA take-back programs, and prescription drug monitoring programs adopted by 49 states. "New information indicates that we may be turning a corner when it comes to our nation's prescription drug abuse epidemic," he said Oct. 18, 2012. "While these new trends are promising, we remain focused on addressing this challenge in a comprehensive way."

ONDCP and the National Institute on Drug Abuse released new training modules last year for prescribers of opioid painkillers, include videos of model doctor/patient conversations on using the medications safely.

New draft guidance from the U.S. Food and Drug Administration is intended for manufacturers of opioid medications. Issued Jan. 9, it describes past efforts to deter common forms of abuse and then discusses methods for devising abuse-deterrent formulations, including physical or chemical barriers, agonist/antagonist combinations, aversion, alternative methods of drug delivery, and "prodrug" -– a formulation that lacks opioid activity until it is transformed in the gastrointestinal tract, making it unattractive for intravenous injection or intranasal routes of abuse.

"The FDA is extremely concerned about the inappropriate use of prescription opioids, which is a major public health challenge for our nation," FDA Commissioner Dr. Margaret A. Hamburg said. "This draft guidance is an important part of a larger effort by FDA aimed at preventing prescription drug abuse and misuse."

FDA's announcement indicated the science of abuse deterrence is relatively new, and both the formulation technologies and the methods for evaluating them are evolving rapidly. "While prescription opioids are an important component of pain management, abuse and misuse of these products have resulted in too many injuries and deaths across the United States," said Dr. Douglas Throckmorton, deputy director for regulatory programs in FDA’s Center for Drug Evaluation and Research. "An important step towards the goal of creating safer opioids is the development of products that are specifically formulated to deter abuse."

Four Pillars of Prescription Drug Abuse Prevention
The 2011 prescription drug abuse prevention plan used by Kerlikowske's office included four pillars:

• Education of parents, youths, and patients about the dangers of abusing prescription drugs, while requiring prescribers to receive education on appropriate and safe use and proper storage and disposal of prescription drugs.
• Monitoring programs in every state to reduce "doctor shopping" and diversion, making sure the programs can share data across states and that they are used by health care providers.
• Proper disposal of prescription drugs that is convenient and environmentally responsible, in order to decrease the supply of unused prescription drugs in homes.
• Enforcement, giving law enforcement the tools necessary to eliminate improper prescribing practices and to shut down pill mills.

Even with SAMHSA reporting a drop in recent use, the problem is still severe. Joseph T. Rannazzisi, deputy assistant administrator of the DEA, said in a July 2012 statement to the U.S. Senate Caucus on International Narcotics Control that the increase from 2001 to 2010 in opiate pain medication analyses conducted by forensic laboratories participating in the National Forensic Laboratory Information System (NFLIS) was "staggerering": 322 percent for oxycodone, 240 percent for hydrocodone, and 253 percent for morphine.

A county attorney in Arizona and the U.S. Navy recently tried other methods to deter abuse of synthetic drugs, including "bath salts." Sheila Sullivan Polk, Yavapai County Attorney in Prescott, Ariz., issued a notice Dec. 12, 2012, telling Internet website selling "Spice" and "bath salts" that she had obtained a permanent injunction barring the sale by all known retailers in the county. She asked online sites to voluntarily post notices stating these products will not be sold to residents and businesses in the county. She said operators of sites that do not cease such sales could face legal action. More than 100 affidavits from community members, hospitals, mental health care professionals, law enforcement officers, schools, probation officers, and the DEA Phoenix Field Division supported her request for the injunction.

"I am pleased with the successful outcome of a novel strategy to address these insidious drugs," Polk said. "I want to especially thank the agents and chemists at the DEA, whose assistance was vital to our effort."

The U.S. Navy posted a video in December 2012 that depicts the long-term damage users of "bath salts" may suffer. The video's subtitle is "It's not a fad … It's a nightmare." By Jan. 28, 2013, the YouTube video had been viewed 593,104 times.