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Report: Long, Complex Effort Needed to Stem Opioid Abuse

Narcan nasal spray

Narcan, a nasal spray formulation of naloxone, approved by FDA (Adapt Pharma Ltd)

13 July 2017. A report released today says years of coordinated public health efforts are needed at all levels to contain and reverse the current opioid abuse epidemic. The report by the National Academies of Sciences, Engineering, and Medicine was conducted at the request of and sponsored by U.S. Food and Drug Administration.

FDA requested the study in March 2016 as part of its opioids action plan. The panel conducting the inquiry looked into the state of the science on pain research, care, and education and to identify actions the FDA and others can take to respond to the opioid epidemic. The group, led by Richard Bonnie, a law professor at University of Virginia, also focused on ways FDA could incorporate individual and societal considerations into its risk-benefit framework for opioid approval and monitoring.

The problem of opioid addiction is intertwined with relief and management of pain, for which opioid drugs are usually prescribed. Opioids work by reducing the intensity of pain signals to the brain, particularly regions of the brain controlling emotion, which reduces effects of the pain stimulus. Examples of leading opioid prescription pain medications are hydrocodone, oxycodon, morphine, and codeine. Heroin is also considered an opioid.

The scale of the opioid abuse problem is huge. As of 2015, some 2 million Americans age 12 and older are addicted prescription opioid drugs, while 600,000 are addicted to heroin. Drug overdose, mainly by opioids, is now the leading cause of death from unintentional injury in the U.S. Today, about 90 Americans die each day from opioid overdoses. The number of overdose deaths tripled between 1999 and 2011, but leveled off since then. Since 2011, however, the number of overdose deaths tripled from illicit opioids, such as heroin and fentanyl, a synthetic opioid.

Because of legitimate needs to relieve and manage pain, the panel said there are no easy or simple fixes to the problem, but instead will require a sustained and coordinated effort over a number of years. Recommended actions include steps to restrict supply of opioid pain drugs, reduce their demand by patients, reduce harm to patients from abuse of opioids, attack heroin and other illicit opioid markets, and change the regulatory oversight role of FDA.

Among the steps recommended by the panel are changing the culture surrounding pain medications, including mandated training for health professionals dealing with pain and raising more awareness of options for pain relief among the general public. In addition, drug prescribers and pharmacists need to recognize and provide counseling to people susceptible to opioid use disorder or overdose.

Another set of recommendations address supply and demand issues, which can get complicated because of the relationship between legitimate drug needs and illicit markets. Abrupt restrictions on legal opioids, for example, could force people with opioid use disorder into illicit markets, such as for heroin or fentanyl. As a result, laws reducing access to legal opioids, says the committee, need to be accompanied by wider access to effective treatments for opioid abuse, such as through hospitals and prisons, as well as substance abuse clinics.

The committee recommended as well that the overdose drug naloxone, which blocks or reverses the effects of opioids, be made more widely available, with laypersons, third parties, and first responders be permitting to administer the drug to prevent overdoses. In addition, civil and criminal penalties should be relaxed for prescribers of naloxone, as well as immunity granted to laypersons and first responders using the drug to stop an opioid overdose.

The panel called on FDA to broaden its oversight of opioid drugs to include public health impacts of drugs, beyond conventional reviews for safety and efficacy. Additional steps include expanding drug take-back programs to any pharmacies, making the programs continuous, not just during specific limited periods, and adjusting insurance reimbursement practices to encourage more use of non-opioid pain drugs. And the committee called for agencies in the Department of Health and Human Services to make better use of data from drug monitoring programs and sponsor research on the nature of pain, as well as support development of new non-addictive treatments for pain.

FDA Commissioner Scott Gottlieb, in an agency statement, largely endorsed the panel’s recommendations, pointing out specific steps FDA is already taking that parallel or support the recommendations. But Gottlieb also endorsed the serious nature of the problem and difficulty in solving it. “This complex public health emergency,” said Gottleib, “demands the attention and involvement of all parties, including the FDA and other government agencies, health care providers, the medical products industry, policy makers, patients, and their families.”

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