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New Abuse-Deterrent Formulations Reduce Opiate Prescriptions And Overdoses
Robert Glatter, MD Contributor/ 4/20/2015 @ 11:56AM
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Deaths from overdoses of opiate prescription drugs have reached epidemic proportions. According to current statistics from the CDC, 44 people in the US die every day as a result of overdoses of prescription painkillers. More striking is the fact that over 16,000 people died from opiate analgesic overdoses in 2013, up from 4,000 deaths just 10 years earlier.

Additional data from the CDC also reveals that overdoses from opiate prescriptions quadrupled as sales correspondingly increased during the period from 1999-2010. A link was also established between the supply of opioids and prescription overdose mortality at the state level.

Information from the CDC indicates that nearly 2 million Americans abused opiate prescription drugs in 2013 alone, with nearly 7,000 persons seen and evaluated in U.S. emergency departments for misuse and abuse of these dangerous drugs.




One solution to reduce tampering with such medications has been to change the basic formulation. By making them resistant to crushing, breaking or dissolution, drug manufacturers’ aim is to prevent them from being snorted or injected for a quick high—reinforcing the extended-release deterrent mechanism.


As an example, following the introduction of abuse-deterrent extended-release oxycodone and withdrawal of propoxyphene (Darvon) from the U.S. market in 2010, dispensing of prescription opioid pain medication and prescription opioid overdoses both dropped significantly.

The study detailing this important finding was published online April 20th in JAMA Internal Medicine.

An important advantage of the new abuse-deterrent OxyContin formulation is its ability to resist crushing and dissolving–approaches that have been utilized to bypass the extended-release mechanism to get a quicker and more intense high.

After propoxyphene (Darvon) was approved for the treatment of pain in 1957, reports of abuse soon followed. And, by 1977, propoxyphene was the second leading agent in prescription drug-induced deaths.

In response to mounting evidence of its adverse cardiac effects, propoxyphene was voluntarily withdrawn from the U.S. market. Many experts believed that reducing the availability and supply of prescription opioids would result in those persons already addicted to substitute with alternative prescription opioids or heroin, based on data from the JAMA study.

The lead study author, Dr. Marc R. Larochelle, of Harvard Medical School and Boston University School of Medicine, set out to study the association between these two supply-based interventions on opioid dispensing and overdose.

Researchers from the study reviewed insurance data claims from a prominent national U.S. health insurer, evaluating data from 31.3 million insured members from 2003 through 2012.

Results of the study demonstrated that total opioid prescriptions dropped by 19% from the expected rate two years after the market changes were introduced. In addition, the estimated overdose rate dropped by nearly 20% at the same time.


One caveat, the authors noted, was that heroin overdoses increased by 23%.

“Our results have significant implications for policymakers and health care professions grappling with the epidemic of opioid abuse and overdose,” said Larochelle. “Changes imposed through regulatory mandates or voluntary company actions may be a viable approach to stemming prescription abuse.”

On the other side of addiction, the value of opioids for those who truly benefit from such medications is an ongoing concern highlighted by the researchers.

“Identifying interventions that reduce opioid supply without affecting access to individuals who benefit from opioid therapy remains a challenge,” explained Larochelle.

“Finally, although restricted opioid supplies might decrease new-onset addiction in the future, it will not cure existing addiction. Regardless of the mediating mechanism, a transition from prescription opioid to heroin abuse has been well documented and further efforts are needed to improve identification and treatment of these individuals,” Larochelle concluded.

In an invited commentary published in JAMA Internal Medicine, Abuse-Deterrent Opioid Formulations: “Part of a Public Health Strategy to Reverse the Opioid Epidemic”, Hillary V. Kunins, M.D., M.P.H., M.S., of the New York City Department of Health and Mental Hygiene, explained, “Recasting the often-maligned ‘doctor-shopper’ instead as a patient with a substance use disorder reminds us that using public health strategies to promote judicious opioid prescribing, including via pharmaceutical market change to reduce overdose risk, needs to be accompanied by similar policy approaches to provide accessible and effective services for people who use drugs.”

“Policy and public health interventions that both prevent opioid use disorders and overdose and provide access to treatment and other services to address consequences of opioid use disorder once it occurs are the two prongs of a comprehensive public health approach to address the opioid epidemic,” added Kunins.

One expert offered his thoughts about stark realities of the ongoing U.S. opiate epidemic.

“Opioid abuse often follows a progression from oral administration to snorting or injection and can have serious consequences,” explained Dr. Scott Krakower, assistant unit chief of psychiatry at Zucker Hillside Hospital in Glen Oaks, N.Y.

Abuse deterrent formulations were designed to reduce the potential for crushing, breaking, or dissolving of tablet. They may help to prevent overdose, unintended therapeutic errors, and accidental ingestion (especially for minors),” added Krakower.

“Concerns have been raised,” explained Krakower, “that these abuse-deterrent formulations may lead to switching to alternative opioid agents that are more likely to be abused.”

Chief among the abused substances which we typically see an increase in is heroin when such abuse-deterrent formulations and market changes occur. Spikes in crime related to heroin, along with increased deaths due to adverse effects of heroin itself can occur in the immediate period after introduction of such market formulation changes.


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