Abuse and Misuse of Opioid Medications

Fort Lauderdale—Opioid medications have been proven effective in treating chronic pain; however, they are also associated with misuse, abuse, and diversion. In 2010, there were 38,329 drug overdose deaths, including 16,651 due to prescription opioids. In 1999, there were 4030 deaths associated with prescription opioids.

“We have to address this,” said Charles E. Argoff, MD, director of the Comprehensive Pain Management Center and the Albany Medical Center in Albany, New York.

At the AAPM meeting, Dr. Argoff spoke during a satellite symposium titled Appropriate Use of Opioid Medications and the Role of Abuse-Deterrent Formulations. He was joined by Perry G. Fine, MD, professor of anesthesiology at the University of Utah School of Medicine in Salt Lake City. Pfizer Inc. supported the symposium.

Dr. Argoff said managing pain requires a comprehensive, interdisciplinary approach, including pharmacotherapy, interventions, psychological support, lifestyle changes, complementary and alternative medicine, and physical medicine and rehabilitation.

If patients with chronic pain do not have adequate relief from nonopioid treatments, they may switch to opioid medications, according to Dr. Argoff. Prescription opioids are also considered for painful diabetic neuropathy and postherpetic neuralgia, but they are not typically used as first-line therapies.

Dr. Argoff defined misuse as using medications other than as directed or indicated whether it is willful or unintentional or whether it is harmful. Abuse is using illegal drugs or medications for nonmedical purposes such as altering one’s state of consciousness, according to Dr. Argoff. He also described diversion as intentionally removing a medication from legitimate distribution and dispensing channels or sharing or purchasing drugs between family and friends.

From 2004 to 2009, emergency department visits for nonmedical use of prescription opioid medications increased 174%, and from 2000 to 2009, admissions for prescription opioid abuse treatment increased >500%.

In addition, approximately 70% of nonmedical users of prescription drugs received them from family or friends, according to Dr. Argoff. He added that people who abuse prescription opioids tamper with the drugs through crushing, dissolving, and extracting the opioid compound from the tablet.

Extended-release drugs are particularly prone to tampering for misuse and abuse. Of the people who abused oxycodone extended release (ER) from June 1, 2009, to August 8, 2010, 54.5% abused the drug orally, 52.7% snorted the drug, 6.4% smoked the drug, and 35.7% injected the drug. (The numbers total >100 because numerous people abused the drug in >1 way.)

Of the people who abused oxymorphone ER during that same time period, 38.2% abused the drug orally, 61.8% snorted the drug, 0.2% smoked the drug, and 8.6% injected the drug. In addition, of the people who abused morphine ER, 46.7% abused the drug orally, 25.3% snorted the drug, 0.9% smoked the drug, and 45.7% injected the drug.

Patients who were admitted to substance abuse treatment centers for using oxycodone controlled release typically had progressed from orally ingesting the drug to snorting or injecting at a mean of 19.2 months. Of those admitted to the treatment centers, 62% were snorting the drug, 26% were injecting the drug, and 14% were using the drug orally.

Abuse Deterrent Formulations

Dr. Fine emphasized that opioids should only be prescribed when appropriate and should be combined with risk mitigation strategies. To mitigate risks of abuse or misuse, healthcare professionals should assess the patients and the benefits and risks of extended-release and long-acting formulations, according to Dr. Fine. They should also know how to initiate, modify, and discontinue treatment and manage ongoing therapies. In addition, they should counsel patients and caregivers about the safe use of opioids and understand state and federal regulations.

Numerous pharmaceutical companies are developing abuse-deterrent formulations of opioids, according to Dr. Fine. Earlier this year, the FDA proposed studies to evaluate abuse-deterrent formulations, including pharmacokinetic and clinical abuse potential studies before approving the drugs. The clinical abuse studies should be randomized, double-blind, and placebo-controlled, include people who have abused the drugs, and measure drug liking, euphoria, and the probability of taking the drug again, the agency said. The FDA also proposed that companies conduct studies after their drugs are approved to determine if the drugs lead to a significant decrease in population and use-based estimates of abuse.

Dr. Fine cited a surveillance study involving patients abusing prescription opioids that found that 23.7% of patients abused oxycodone ER between June 1, 2009, and August 8, 2010. After the abuse-deterrent formulation of the drug was introduced on August 9, 2010, only 12.1% of patients abused oxycodone ER through March 31, 2012, a significant 49% reduction in abuse of the opioid (P<.0001).

In addition, self-administered surveys of 2566 opioid-dependent patients between July 1, 2009, and March 31, 2012, found that abuse of branded oxycodone ER decreased 64% after the abuse-deterrent formulation became available.

However, Dr. Fine said that 24% of patients were able to defeat the tampering-resistant properties and 66% switched to another opioid, with heroin being the most common alternative. 

Although opioid abuse has received much attention in the past few years, Dr. Fine cited an open-label, non-randomized, non-comparative study in which approximately 95% of primary care physicians underestimated the risk for opioid abuse. Among a group of patients who were at high risk of abusing opioids, doctors indicated 20% of patients were at low risk and 74% were at medium risk.

Stop Tampering of Prescription Pills Act

In January, the Wall Street Journal published a letter signed by Dr. Fine and Lynn Webster, MD, AAPM president, urging Congress to pass the Stop Tampering of Prescription Pills Act, which, Dr. Webster wrote, “would prevent generics from being approved that are copies of older, more abuse-prone formulations.”

In his letter, Dr. Fine wrote that the FDA should not make nontamper-resistant drugs available if the tamper-resistant formulations are on the market.

“Congress must pass the Stop Tampering of Prescription Pills Act, and the FDA and pharmaceutical companies, in addition to the health insurance industry, must work together to ensure that all patients with pain have access to the safest available treatments,” Dr. Fine wrote. “Our mission includes advancing patient safety through physician and patient education, which we believe will help to reverse a devastating trend. We urge the FDA and others to help us to achieve this mission by immediately acting so only the safest versions of medications are commercially available.”