The opioid abuse epidemic in the United States has grown dramatically in recent years. The number of opioid prescriptions in the U.S. increased from 144 million in 2002 to more than 259 million in 20121 .  Each day, 44 people in the United States die from an overdose of prescription painkillers 2 .  The issue has resulted in one of the most serious public health concerns of our time.  Policy makers and activists are looking for ways to address and reverse this problem.  The best solutions are likely to come from the combined efforts of patients, prescribers, health plan payers, government officials, and the opioid manufacturers. The compliance teams of opioid manufacturers must make sure their company’s promotional efforts address the abuse concerns and risks of the drugs.

What are opioids?

Opioids are commonly prescribed medications for the treatment of chronic, non-cancerous pain, such as back pain or osteoarthritis. According to the Center for Disease Control (CDC), the most common drugs involved in prescription overdose death include:

  • Hydrocodone (e.g., Vicodin)
  • Oxycodone (e.g., OxyContin)
  • Oxymorphone (e.g., Opana)
  • Methadone (especially when prescribed for pain)

Recent trends likely to impact the opioid compliance landscape

On February 4, 2016 the FDA announced that it will conduct a sweeping review of agency policies aimed at reversing the “opioid abuse epidemic.”  As part of this review, the FDA will re-examine the risk-benefit paradigm and update REMS requirements for opioids, as well as developing a new framework for opioid review, approval, and monitoring.

The outcome of this heightened scrutiny is certain to present regulatory/compliance challenges, along with new expectations for opioid manufacturers.

On February 5, 2016 a California judge sentenced a physician to 30 years to life for the murder of 3 of her patients that died as a result of prescription drug overdoses.  This was a precedent-setting case that is sure to have an impact on opioid prescribing behavior by physicians. There will likely be additional compliance pressures on opioid manufacturers to modify their promotional activities and further reinforce risk-benefit information.

What can the compliance teams of opioid manufacturers do proactively to address abuse?

Pharmaceutical compliance colleagues are expected to mitigate risk and help keep their organization in safe harbor.  The opioid promotional efforts of pharma companies are likely to be further scrutinized.  As such, the compliance teams should:

  • Clarify the opioid risk-benefit profile with all customer-facing colleagues
  • Reiterate any opioid REMS requirements with sales and medical teams
  • Provide training to ensure selling messages are understood and properly communicated
  • Establish a field based monitoring process to observe and validate compliant opioid selling behaviors

Based on recent trends and issues, the compliance landscape for opioids will change.  Make sure your organization’s compliance department is prepared to respond to the changes.

Wendy L. Heckelman, Ph.D.

Dr. Wendy Heckelman, president and founder of WLH Consulting, Inc. has over 30 years of experience working with Fortune 100 industry clients. These include pharmaceutical, biotech, health care, animal health medicines, and consumer products, as well as international non-profit organizations and growing entrepreneurial companies.

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