Tag Archives: opioids

Recycle to Reduce Drug Overdoses

Recycling and prescription drug overdoses have something in common.

Recycling has become second nature in many parts of America. Bins and containers to collect excess paper, bottles and cans are ubiquitous. Yet, only a few a few decades ago, recycling seemed foreign, was not convenient, and took some effort and resolve on an individual’s part.

Keith N. Humphreys, Ph.D. (Sherry Boschert/Elsevier Global Medical News)

That same evolution has to happen in the way that we handle leftover medications, Keith N. Humphreys, Ph.D., told physicians at the American Academy of Pain Medicine annual meeting. There’s an epidemic of opioid overdose deaths in the United States, and the most common source of misused opioids is leftover medications obtained from friends and family.

He’s talking about a huge cultural shift – with consumers going from saving and sharing costly medications that can be hard to come by in the current health system to recognizing their potential for harm and routinely returning leftover drugs on “take-back days” organized by law enforcement or even depositing them in specialized “recycling” bins.

The number of opioid prescriptions dispensed by U.S. retail pharmacies increased from 76 million in 1991 to 210 million in 2010, according to a report by the National Institute on Drug Abuse. And since 1990, the rate of drug overdoses has tripled, increasing approximately from 4 per 100,000 people to 12 per 100,000 people, the Centers for Disease Control and Prevention report.

As someone who worked in hospices for a decade, Dr. Humphries knows the valuable role that opioids can play in relieving pain. So, how do we make opioids available but reduce the risk of addiction, abuse and accidental overdose?

There is no policy framework that will eliminate the tension between these two goals, but some policies will help avoid it, said Dr. Humphreys, acting director of the Center for Health Care Evaluation, Veterans Health Administration, Menlo Park, Calif., and a professor of psychiatry at Stanford University. He recently served as senior policy adviser at the White House Office of National Drug Control Policy, and  reports having no financial conflicts of interest on this issue.

Here, he said, are five emerging public policies, codes of practice, and cultural norms that “most people can agree on” while working toward harder-to-implement options like expanding addiction treatment programs:

1) Build prescription monitoring programs (PMPs). The idea is that physicians could check to see if a patient has received another opioid prescription recently before handing over a new prescription, to prevent drug-seeking patients from “doctor-shopping” to get more opioids. Thirty-six states have PMPs, though most are early versions that are slow, clunky and virtually worthless. Fourteen states and the District of Columbia have enacted legislation to create PMPs, and two states have no PMP plans.

PMPs “may be resisted and resented by many professionals, but they’re inevitable” and deserve support to quickly improve, Dr. Humphreys said. Plus, there’s a bonus for prescribers: In some states, checking with the PMP before prescribing an opioid gives physicians presumptive immunity from legal liability.

2) Lock doctor shoppers into one prescriber. Every week, a West Virginian dies of a drug overdose while holding prescriptions from five or more health care providers. Public and private insurers could tell patients who have opioid prescriptions from multiple providers that they must get all prescriptions from a single provider if they want their insurance to cover costs.

Recycling bins at the Palm Springs (Calif.) Convention Center, where the AAPM met. (Sherry Boschert/Elsevier Global Medical News)

3) Make prescription “recycling” a cultural norm. Legally, opioid narcotics can be returned to any Drug Enforcement Agency law enforcer, though some states also allow pharmacies to take back leftover drugs. When sheriffs in one small Arkansas town (population 20,000) organized a drug take-back day, residents brought in 25,000 pills, Dr. Humphreys said. A physician at the meeting from Santa Maria, Calif., said a drug take-back day organized by sheriffs there was so successful that they installed a permanent drop-off box outside the sheriff’s office. Dr. Humphreys urged physicians to promote drug take-back days in their communities.

4) Make abuse-resistant medication approvals easier. Currently, developing an abuse-resistant version of an addictive medication requires a new drug application, engendering a lengthy approval process and potentially hundreds of millions of dollars in costs. Government regulators should find a way to ease this massive disincentive for pharmaceutical companies to develop safer pain medicines, he said.

5) Change opioid-related medical practice. A potpourri of short- and long-term strategies could improve practice, he suggested. Patients should be told that sharing opioids is dangerous and illegal. Both patients and physicians need to learn that opioids are not the only response to pain. Emergency physicians should break their habit of automatically writing prescriptions for 30 days’ worth of a drug, and write for shorter time lengths when appropriate. Health care workers need to get better at recognizing addiction, and more attention should go toward ways of preventing “iatrogenic” addiction caused by the health care system itself.

Physicians need to lead the way in these efforts. “Who else?” he asked.

–Sherry Boschert (@sherryboschert on Twitter)

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Filed under Anesthesia and Analgesia, Drug And Device Safety, Emergency Medicine, Family Medicine, Geriatric Medicine, Health Policy, Hospice and Palliative Care, Hospital and Critical Care Medicine, IMNG, Internal Medicine, Primary care, Psychiatry, Uncategorized

Drug Makers Go High-Tech to Prevent Opioid Abuse

Daytona 500 practice run (U.S. Air Force photo by Larry McTighe via Wikimedia Commons)

In the heart of Appalachia, there have long been doughty renegades who prefer not to pay taxes on their whiskey (also known as moonshine or a potential substance of abuse). These ingenious individuals have continually come up with imaginative ways to distill and distribute their products, while evading law enforcement (also known as revenuers). In fact, one of America’s favorite pastime — NASCAR — was born of the need of moonshiners to outrun the revenuers.

These days though, the game is being played the other way around.  Drugmakers, with encouragement from the government, are coming up with some pretty cool ways to prevent the abuse and misuse of opioids and other prescription drugs, which have become another of American’s favorite pastimes. In 2009, 16 million Americans age 12 and older had taken a prescription pain reliever, tranquilizer, stimulant, or sedative for nonmedical purposes at least once in the year prior to being surveyed, according to the National Survey on Drug Use and Health.

Dr. Lynn Webster discussed some innovative technologies to prevent opioid misuse at the annual meeting of the American Academy of Pain Medicine. So what’s on the horizon?

Approved in 2010, Exalgo is an extended-release formulation of hydromorphone that is indicated for once-daily administration for the management of moderate-to-severe pain in opioid-tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time. The drug uses a new technology – osmotic-controlled release oral delivery system (OROS) — which uses osmosis to attract water in the body to the inside of the capsule to trigger release of hydromorphone. It takes about 6 hours for the drug to release effective levels of hydromorphone and 4-5 days of use to reach a steady state of the drug in the body, said Dr. Webster.

Oxycontin abuse (courtesy of 51fifty via Wikimedia Commons)

Acurox is an oral immediate-release oxycodone tablet with a proposed indication for the relief of moderate to severe pain. Acurox uses another new technology, this one designed to deter misuse and abuse by intentional swallowing of excess quantities of tablets, intravenous injection of dissolved tablets, and nasal snorting of crushed tablets.

Collegium Pharmaceutical is developing an extended-release opioid formulation using DETERx technology to thwart abuse. Crushing or chewing prior to ingestion is a commonly used method of abusing oxycodone. Company studies have demonstrated that the plasma profile for the new DETERx formulation pill, when chewed, was bioequivalent to the taking the pill whole and as intended. This suggests that attempting to breakdown the sustained-release microspheres by chewing would not result in a meaningful increase in plasma level.
“It’s an abuse-resistant formulation, in that [potential abusers]can’t extract more than is intended for drug delivery,” said Dr. Webster.

Perhaps the most interesting and impressive technology is being developed by PharmacoFore. According to the company, the delivery system’s developer, the novel Bio-Activated Molecular Delivery (Bio-MD) technology effectively deters prescription drug abuse at a molecular level. “This technology does not involve the reformulation of existing opioid drugs in physical matrices that are easily circumvented by simple extraction methods. Our opioid Bio-MD systems are “activated” to release clinically effective opioid drugs only when exposed to the correct physiologic conditions (i.e., ingested).”

The system uses a mechanism “that locks in the amount of release of an opioid from a moiety, which is attached to a molecule … it can be any opioid … it’s an inert compound until it’s activated to be released,” said Dr. Webster. Essentially, the opioid molecule is attached to this delivery compound, which is “kind of like a clock. The intrinsic trypsin in our GI tract will activate that clock, which will cause a process to begin … and it will allow that drug to be released.” The “clock” compound determines how much time it will take for the active compound to be released and can be attached to any opioid. “It’s very early on though,” cautioned Dr. Webster. This molecular delivery system is in phase I trials.

Moonshine still in Knox County, Tennessee photographed by TVA in 1936 (courtesy of Wikimedia Commons)

Still, if the drug companies are able to get these technologies approved, we could see a drop in prescription drug abuse. It remains to be seen if there will be a corresponding increase in moonshine.

Kerri Wachter

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Filed under Anesthesia and Analgesia, Family Medicine, IMNG, Internal Medicine, Oncology, Primary care

Long-term Opioids Help Some Chronic Noncancer Pain

Photo by Flickr user rhomboideus under Creative Commons.

Long-term use of opioids to manage chronic noncancer pain (such as chronic back pain after failed surgery) has been on the rise in the past decade, but so have deaths from opioid overdose and abuse of prescription painkillers. It would be nice to know if chronic opioids do help people who desperately need relief from chronic pain, and what the risk for addiction or abuse is with long-term opioid use.

A new study begins — but only begins — to answer those questions. The Cochrane Collaboration reviewed the medical literature (see my story here) and came away underwhelmed with the small number of studies on long-term opioid use for noncancer pain, and the “crummy” quality of those studies — a description used by one of the pain experts that I interviewed.

The review found that many patients dropped out of studies on long-term opioid use (6%-23%, depending on whether they took opioids orally, transdermally, or intrathecally and whether they dropped out due to lack of pain relief or side effects). Most of the studies excluded patients with a history of drug abuse or addiction.

In those who finished the studies — a very select group at this point — chronic opioids continued to provide significant pain relief up to 48 months after starting therapy, and only 0.03% showed signs of addiction or took the drugs inappropriately. So many caveats were attached to the findings that it’s still unclear what many of the long-term effects may be. What about how the patient functions? Quality of life? Effects on patients who stop opioid therapy? Or use in the kinds of patients that worry clinicians when considering prescribing opioids for chronic noncancer pain–those who have psychiatric comorbidities or substance abuse issues, young patients, or those with ill-defined pain syndromes?

I foresee a lot of research ahead on improving and maximizing long-term use of opioids for chronic pain. As Dr. Perry Fine, president-elect of the American Academy of Pain Medicine, said, the study is “very encouraging, but it’s far from the whole story.”

–Sherry Boschert (@sherryboschert on Twitter)

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Filed under Anesthesia and Analgesia, Drug And Device Safety, Family Medicine, Internal Medicine