imageWith one brief anecdote about a toddler dying after exposure to a discarded fentanyl patch while visiting his grandmother in a nursing home, FDA Commissioner Margaret Hamburg, MD, crystallized the current prescription drug epidemic into its most human and tragic element.

“Nobody noticed that he had stuck the patch on himself; he suffered an overdose and passed away two days later,” related Dr. Hamburg during a joint press telebriefing in April with representatives from the Centers for Disease Control and Prevention (CDC), Drug Enforcement Administration (DEA) and Office of National Drug Control Policy (ONDCP). The telebriefing highlighted new data on the nation’s prescription drug crisis. “As a physician, stories like this have both a professional and personal impact on me. Fentanyl patches have instructions to be flushed, not thrown away; this tragedy indicates that a safety and disposal gap still exists in our homes and hospitals.”

Dr. Hamburg was joined by Michele Leonhart, DEA administrator; Gil Kerlikowske, ONDCP director; and Ileana Arias, PhD, CDC principal deputy director, to discuss, among other things, a new data analysis showing where Americans who abuse prescription drugs are getting them.

The press briefing was timed to occur immediately prior to the DEA’s 2012 prescription drug Take-Back Day, an initiative that all participants agreed has been a success. Ms. Leonhart said that when the first Take-Back Day was held four years ago, 121 tons of expired and/or unused prescription drugs were turned in to thousands of sites nationwide; through 2011, nearly 500 tons of prescription drugs available for potential misuse have been taken out of circulation.

And yet all agreed that the work is far from finished. CDC data from 2008 show that prescription painkillers were involved in 14,800 overdose deaths, more than that attributed to the use of cocaine and heroin combined. Describing the current crisis as “unprecedented,” Dr. Arias related how drug overdose deaths have quadrupled from 10 years ago, and now occur more frequently than automobile-related fatalities. More than 75% of the prescription drug–related overdoses involve opioids, she said. What’s more, Dr. Arias said that for every 2009 death involving the use of an opioid, there were nine drug rehabilitation admissions, and the annual economic impact now approaches $72 billion.

Data Provide New Opportunities

Existing 2009-2010 data from the National Survey on Drug Use and Health (which garnered more than 70,000 responses) were reanalyzed, and showed that more than 70% of the 2.4 million Americans who abuse prescription drugs for the first time each year get them from family and friends; roughly one-third are teenagers. About 55% of casual abusers of prescription drugs (less than once a week over the past year) reported getting them for free from family and friends, whereas 11% purchased them from the same individuals. About 5% took them from these sources without permission. Among chronic users (those misusing or abusing pain relievers once a week or more over the past year), roughly 41% obtained prescription drugs from family or friends, with or without permission, whereas 25% reported purchasing them from dealers or the Internet; roughly the same percentage obtained them from doctors.

Mr. Kerlikowske said that the new data show a very important distinction between new and casual abusers and chronic abusers, with the former group more likely to get them from family or friends and the latter group more apt to purchase them, obtain them from physicians or doctor shop. This information, he said, may be the key to curbing abuse in the future.

“First [it shows that] prevention is key,” he said. “Since we know most of these pills are coming from home medicine cabinets, we all have a role to play in properly disposing of the unused, expired or unneeded medications that are available in too many of our homes. Second, it shows us how we can target our approach to this problem and where to focus our resources.”

The telebriefing participants used the event as an opportunity to highlight the successes of the Obama Administration’s year-old plan to combat the national prescription drug abuse problem. The administration’s program includes a strong focus on prescription drug monitoring programs; the development of convenient and environmentally responsible disposal methods; more effective substance abuse treatment; better education for patients and health care providers; law enforcement efforts geared toward shutting down disreputable pain clinics or “pill mills” and reducing diversion and doctor shopping; more effective pharmacy practices; and improved clinical practice through clinical guideline development. The goal, said Dr. Arias, is to “use science to inform policy, finding the best practices for prevention and the best models for laws.”

“A year later, I can report that substantial progress has been made in our efforts,” said Mr. Kerlikowske, citing that online prescription drug databases have been instituted in 48 states. He added that the DEA also has successfully “taken down operators of pill mills through targeted enforcement efforts. And finally, we are beginning to see some preliminary data indicating that young people’s perception of risk regarding prescription drugs is increasing—an important trend that we hope is a harbinger for declines in abuse.”

He stressed the continued importance of getting the message out to the public. “Last year, Congress did not fund our media campaign; this year we will try and push forward funding.” Yet according to Mr. Kerlikowske, the efforts to increase awareness of the prescription drug abuse epidemic have put it squarely in the public consciousness, to the point where he has heard accounts of realtors instructing homeowners to lock up the medications in their homes prior to open houses.

Enforcement Efforts Across the ‘Whole Supply Chain’

According to Ms. Leonhart, the current prescription drug epidemic is being driven largely by availability and demand, both of which need to be addressed.

“There are people going to jail for setting up these pill mills, and they are nothing more than major drug traffickers,” she said. “If you are breaking the Controlled Substances Act—whether you are a practitioner or drug dealer on the corner—we have ways of catching you.” She stressed that most of the nation’s 1.2 million medical practitioners “do their very best, but a few do not, and it is the DEA’s responsibility to find them.”

According to Ms. Leonhart, the DEA is “monitoring the whole supply chain, from manufacturers to pharmacists,” and is wholly supportive of state efforts on drug monitoring.

“This is all new to a lot of prosecutors,” she said of pill mill and doctor-shopping cases, adding, however, that “the penalties are [in place]; now, it is really about education.”

Not Just Florida

For several years, said Ms. Leonhart, Florida was the “national epicenter of pill mills and doctor shopping,” but through DEA efforts like Operation Pill Nation 1 and Operation Pill Nation 2, nearly 100 Florida doctors were caught, and dozens of pill shops were closed. She cited examples of major dealers being apprehended, such as twin brothers in South Florida who were convicted of distributing nearly 20 million oxycodone pills.

Yet although Florida has served as a focal point for the problems of pill mills and doctor shopping, Mr. Kerlikowske stressed that these are issues faced across the country, citing Texas and California as other examples of prescription drug abuse hotbeds. Dr. Hamburg added that the pharmaceutical industry continues to play an important role in diffusing both these issues by developing products “that are less subject to abuse … that serve medical needs but don’t serve the pleasure-oriented goals of [some] end users.”

Pharmacy holdups and thefts—like the quadruple homicide in Long Island last year—are another byproduct of the epidemic, and another focus of the agencies, who are organizing their efforts with pharmacies and law enforcement.

“Clearly, when you are in the disease of addiction you are going to do almost anything,” said Mr. Kerlikowske. Yet, money plays a major role as well, he said, citing a recent robbery and shooting in a Harlem pharmacy where the perpetrators asked specifically for oxycodone and Percocet.

“With street values of $50, $60, $70 and $80 a pill, there is a financial incentive even if you are not involved in the addiction issue, and it is quite concerning and quite frightening to pharmacy staff,” he said.

Dr. Hamburg stressed that with the strong focus on preventing the misuse and abuse of prescription drugs, the need for opioid medications for those who suffer from chronic pain must not be lost.

“The FDA will continue to work closely with other agencies to help prevent misuse and abuse, while improving the safe utilization of opioids,” she said. “Opioids must continue to be available to those in pain, and combating abuse while still allowing for use is a problem that touches all of us.”



image Film geek alert: The accompanying art for this story was inspired by the original Italian movie poster for the 1966 Clint Eastwood film, “The Good, the Bad, and the Ugly.”