Peter J. Pitts: Abuse Deterrent Opioids: Don't Fix the Blame, Fix the Problem

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By: Peter J. Pitts

Mark Twain quipped, “For every complex problem there is usually a simple answer – and it is usually wrong.” Welcome to the debate over opioid pain medications. What those seeking to solve the problem with one-shot solutions have ignored is that pain in America is a medical problem of enormous proportion.

One-hundred million Americans are now living with chronic pain. That’s a third of the U.S. population. Ten million of those have pain so severe that it disables them. Pain costs the U.S. economy roughly $600 billion dollars a year in lost productivity and healthcare costs. And lawsuits, recalls, and police action won’t change those dire statistics.

The vast majority of people who use opioids do so legally and safely. A subset of approximately 4% uses these medications illegally. In fact, from 2010 to 2011, the number of Americans misusing and abusing opioid medications declined from 4.6% to 4.2%.

One reason is the development of abuse deterrent opioid medications. According to the Journal of Pain, in a real-world study, abuse by snorting, smoking, and injecting prescription opioids declined by 66% after the reformulation of the drug with abuse deterrent properties. The New England Journal of Medicine has reported that, “the selection of OxyContin as a primary drug of abuse decreased from 35.6% of respondents before the release of the abuse deterrent formulation to just 12.8% twenty-one months later.”

“Abuse deterrent formulations” are opioids with physical and chemical properties that prevent chewing, crushing, grating, grinding or extracting, or contain another substance that reduces or defeats the euphoria that those susceptible to substance abuse disorders experience. The new law requires insurance companies to provide the same coverage for the new abuse deterrent formulations as non-abuse deterrents, and they are not permitted to shift any additional cost of these medications to patients. It makes doctors better able to prescribe these medications without pushback from insurance companies.

Abuse deterrent formulations are not the only solution, but they are a good step forward toward balancing the legitimate needs of pain patients with the need to reduce medication abuse. Other efforts must also include more robust education of both medical professionals and consumers to keep the medication out of the hands of potential abusers in the first place. Government statistics show that 78.5% of those who abuse prescription pain medication did not obtain the drugs from a doctor themselves.

“While the science of abuse deterrence is still evolving, the development of opioids that are harder to abuse is helpful in addressing the public health crisis of prescription drug abuse in the U.S.,” said Janet Woodcock, M.D., Director of the FDA’s Center for Drug Evaluation and Research. “Preventing prescription opioid abuse is a top public health priority for the FDA, and encouraging the development of opioids with abuse-deterrent properties is just one component of a broader approach to reducing abuse and misuse, and will better enable the agency to balance addressing this problem with ensuring that patients have access to appropriate treatments for pain.

Abuse deterrence is a worthy goal and will evolve when all the players work together in a more regular and synchronistic fashion. As the Japanese proverb goes, “Don’t fix the blame, fix the problem.”

Peter J. Pitts, a former FDA Associate Commissioner, is President of the Center for Medicine in the Public Interest.

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