It has been bubbling beneath the surface of widespread public awareness for years—though it certainly was well known to laboratorians and other professionals involved in the healthcare delivery system all along—but this past winter it emerged as a major national news story. It was widely discussed by presidential candidates in both parties, particularly when they were campaigning in the New Hampshire primaries, and it made headlines nationwide. “It,” of course, is the crisis in opioid addiction that plagues not only hard-hit New England but all
regions of the United States.
March was something of a watershed month for the issue. Legislation designed to reduce opioid overdose was introduced in the U.S. Senate. Two federal agencies—the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA)—issued new directives on the crisis. And, in a major speech, President Obama drew attention to the crisis and suggested new approaches.
On March 11, Senator Ed Markey (D-MA) introduced S. 707: Opioid Overdose Reduction Act of 2015. Its full title is “A bill to provide certain protections from civil liability with respect to the emergency administration of opioid overdose drugs.“According to the nonpartisan Congressional Research Service, “this bill exempts individuals from liability for harm caused by the emergency administration of an opioid overdose drug under certain circumstances.” The bill has five cosponsors: Sens. Kelly Ayotte (R-NH), Timothy Kaine (D-VA), Patrick Toomey (R-PA), Elizabeth Warren (D-MA), and Richard Blumenthal (D-CT). It was assigned to the Senate Judiciary Committee, which will consider it before possibly sending it on to the Senate as a whole.
CDC guideline
On March 15, the CDC released the “CDC Guideline for Prescribing Opioids for Chronic Pain, United States, 2016.” The document was designed to help primary care providers ensure the safest and most effective treatment for their patients. The guideline provides recommendations on the use of opioids in treating chronic pain (that is, pain lasting longer than three months or past the time of normal tissue healing).
Among the 12 recommendations in the guideline, the CDC highlights three key principles to improving patient care:
- Non-opioid therapy is preferred for chronic pain outside of active cancer, palliative, and end-of-life care.
- When opioids are used, the lowest possible effective dosage should be prescribed to reduce risks of opioid use disorder and overdose.
- Providers should always exercise caution when prescribing opioids and monitor all patients closely.
“Doctors want to help patients in pain and are worried about opioid misuse and addiction,” said Debra Houry, MD, MPH, director of CDC’s National Center for Injury Prevention and Control. “This guideline will help equip them with the knowledge and guidance needed to talk with their patients about how to manage pain in the safest, most effective manner.”
FDA warnings
On March 22, the FDA announced enhanced warnings for immediate-release (IR) opioid pain medications and that it is requiring class-wide safety labeling changes for IR opioid pain medications. Among the changes are a new boxed warning about the serious risks of misuse, abuse, addiction, overdose, and death.
The FDA is also requiring several additional safety labeling changes across all prescription opioid products to include additional information on the risk of these medications. This is part of the agency’s overall effort to help inform prescribers about the importance of balancing the serious risks of opioids with their role in managing pain.
As part of the boxed warning on IR opioid analgesics, the FDA now requires a precaution that chronic maternal use of opioids during pregnancy can result in neonatal opioid withdrawal syndrome (NOWS), which may be life-threatening if not recognized and treated using protocols developed by neonatology experts. NOWS may occur in a newborn exposed to opioid drugs for a prolonged period while in utero.
Presidential initiatives
On March 29, at the National Rx Drug Abuse & Heroin Summit in Atlanta, Georgia, President Obama announced that the Department of Health and Human Services (HHS) is issuing a proposed rule to increase the current patient limit for qualified physicians who prescribe buprenorphine to treat opioid use disorders from 100 to 200 patients, with the goal of expanding access to this evidence-based treatment while preventing diversion. HHS is also finalizing a rule to strengthen access to mental health and substance use services for people enrolled in Medicaid and Children’s Health Insurance Program (CHIP) plans by requiring that these benefits be offered at parity, meaning that they be comparable to medical and surgical benefits.
In addition, the Substance Abuse and Mental Health Services Administration (SAMHSA) is releasing a new $11 million funding opportunity to states to purchase and distribute the opioid overdose reversal drug naloxone and train first responders and others on its use, along with other overdose prevention strategies. Also, SAMHSA is releasing a new $11 million funding opportunity for up to 11 states to expand their medication-assisted treatment services, and distributing 10,000 pocket guides for clinicians that include a checklist for prescribing medication for opioid use disorder treatment.
The opioid addiction crisis has Washington’s attention. Will the momentum to combat the crisis continue to build?
