Opioid Focus: Federal Crisis Response, Education Versus Regulations and Legislation

Highlight from the North American Spine Society 32nd Annual Meeting

“The fallout from our current approach to managing the opioid overdose problem is that the patient population is poorly understood, providers are poorly educated, there is way too much focus on decreasing the amount of pills and forgetting about the patient,” said Eric J. Muehlbauer, MJ, CAE, at the session, The Opioid Predicament: Implications for Spine Physicians and Surgeons, presented at the North American Spine Society (NASS) 32nd Annual Meeting.
Girl taking a lot of drugsCurrent guidelines on opioid use “tell us what not to do but little on what to do,” Mr. Muehlbauer said.Regulatory crackdowns increase fear, which leads to poor decision-making and poor outcomes, said Mr. Muehlbauer, who is Executive Director of NASS. Lack of knowledge on managing opioid use disorders comes from inadequate training in medical school, with a national survey of residency training directors showing that only 56.3% of all programs had substance use disorders training in the required curriculum.1

Furthermore, current guidelines on opioid use “tell us what not to do but little on what to do,” Mr. Muehlbauer said.

How Are Federal Agencies Responding to the Opioid Crisis?
Federal agencies have developed a variety of strategies for combating the opioid crisis, Dr. Muehlbauer explained. For example, the U.S. Department of Health and Human Services (HHS) launched a 5-point strategy that includes:2

  • Improving access to prevention, treatment, and recovery services, including medication-assisted treatments
  • Targeting availability and distribution of overdose-reversing drugs
  • Strengthening our understanding of the epidemic through better public health data and reporting
  • Providing support for cutting-edge research on pain and addiction
  • Advancing better practices for pain management

The U.S. Food and Drug Administration (FDA) is focused on reducing the rate of new addiction as well as reducing overall exposure to opioids.3 The FDA also is trying to get manufacturers to develop new products that are less prone to abuse or non-addictive, as well as better medical therapy to help those who are addicted, Mr. Muehlbauer explained.

The Centers for Disease Control and Prevention (CDC) is working with state health departments to describe best practices and improve prescription drug monitoring programs, Mr. Muehlbauer said.4 In addition, the CDC is tracking non-fatal opioid overdoses in order to have a better understanding of the scope of the problem, and launched the Rx Awareness communication campaign to educate the public on the risks of prescription opioids.4

Francis Collins, PhD, Director of the National Institutes of Health (NIH), has pointed to increasing relapse rates as a big issue, and stated that more options besides opioid antagonist drugs are needed to treat opioid use disorders, according to Mr. Muehlbauer. In addition, Dr. Collins expressed concern about the expense of naloxone injection kits and supported the NIH’s development of a nasal spray for more straightforward application of naloxone, Mr. Muehlbauer explained.

The Substance Abuse and Mental Health Services Administration (SAMHSA) is awarding Opioid State Targeted Response (STR) grants through the 21st Century Cures Act to allow states to focus on areas of the greatest need, including increasing access to treatment, reducing unmet treatment needs, and reducing opioid-related deaths, Mr. Muehlbauer explained.4

Patient Education and Treatment Agreements
The potential value of patient education is supported by ad hoc reviews, Mr. Muehlbauer explained. In addition, the U.S. Department of Veterans Affairs and the Department of Defense recommend both patient and family education in their 2017 guidelines on management of opioid therapy for chronic pain as do other pain treatment guidelines.5 Patient education also is necessary for truly informed consent, Mr. Muehlbauer said.6

“Informed consent encompasses the capacity to understand the risks, benefits, and alternatives of a treatment, and is particularly important when clinicians are prescribing potentially addictive medications,” Mr. Muehlbauer told the audience.

The agreements are helpful because they force prescribers to “communicate on a much more granular level with the patient,” Mr. Muehlbauer said. For example, “you have to explain to that patient that it’s illegal to give away, trade, share, or sell their prescription opioids.” Download Sample Patient Agreement Forms.

Mr. Muehlbauer encouraged the audience to visit the SCOPE of Pain Program, which is a series of medical education and continuing education activities. The program follows the FDA mandated Risk Evaluation and Mitigation Strategy (REMS), which requires manufacturers of extended release/long-acting opioid analgesics to make available comprehensive prescriber education on safe use of the medications.

Mr. Muehlbauer also highlighted the Prescription Drug Abuse Policy System (PDAPS), a source of rigorous legal data from researchers and detailed policy information for the public. The site, which is funded by the National Institute on Drug Abuse, features an interactive page where users can access regulatory information specific to their state.

“PDAPS has a section on good Samaritan laws, medical marijuana, and opioid-related controls for acute, emergency room, or chronic pain,” Mr. Muehlbauer said. “They have sections on prescription drug monitoring programs, drugged driving laws, medication-assisted treatment with methadone laws, and recreational marijuana laws.”

Mr. Muehlbauer concluded that “when you’re involved in opioid management, you have to be very careful. When you initiate a trial of opioid therapy, have an exit strategy.”

View the other presentations in this symposium:

Disclosure
Mr. Muehlbauer is Executive Director of the North American Spine Society.

Updated on: 12/07/17
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