Target Audience

All healthcare professionals.

Educational Need

The “ER/LA Opioid REMS” program has been developed by the Collaborative for REMS Education (CO*RE). The American Osteopathic Association (AOA) is a CO*RE partner. CO*RE recently received approval from the REMS Program Committee (RPC) for its national initiative to support educational activities addressing the public health crisis surrounding the use, abuse, diversion and overdose associated with Extended-Release/Long-Acting (ER/LA) opioids. 

A Risk Evaluation and Mitigation Strategy (REMS) is a risk management program required by the U.S. Food and Drug Administration (FDA) to ensure that the benefits of a drug outweigh its risks. The FDA has determined that a single, shared REMS is required for all brand and generic ER/LA opioid pain medicines.  This is the first time the FDA has mandated a REMS to include accredited professional education. The FDA has also required the pharmaceutical companies that produce these agents to provide financial support for independent professional education. The “ER/LA Opioid REMS” program uses a standardized education module based on the approved FDA Blueprint. The program is presented by DOs who have participated in the CO*RE master faculty training.

In the mid‐1990s, the use of prescription opioids traditionally reserved for treating cancer and acute pain expanded to include treatment of other chronic pain conditions. In part, this change resulted from ethical concerns related to the under-treatment of chronic pain. State medical boards and legislatures changed regulations, ending a prohibition on opioid use for chronic non-cancer pain, while new policies from state and national medical boards encouraged the use of opioids for long‐term pain control. Following this change, a dramatic rise in opioid-related poisoning deaths was seen, with a parallel increase in overall consumption of opioid analgesic, nonmedical use of drugs, and an increased potential for abuse. As of  2012, prescription opioid drug abuse, misuse, and addiction are considered an epidemic and a significant public health concern. The problems of pain and misuse of pain treatments are well documented. Opioids now exceed cocaine and heroin in causing unintentional overdose deaths, having increased from causing 8,048 deaths in the US in 1999 to 47,600 in 2017. The misuse of opioids has become the most common form of poisoning treated in US emergency departments (EDs). With regard to diversion of opioids in particular, the National Drug Intelligence Center (NDIC) estimated the costs to public and private insurers to be $72.5 billion per year. 

At the same time, numerous clinical reports suggest that chronic pain remains undertreated. Approximately 50 million Americans experience chronic pain. However, 80% of patients worldwide receive inadequate treatment and pain management, and half of American who suffers from chronic pain receives inadequate treatment and pain management. In terms of financial impact, the U.S. spends approximately $560-$635 billion annually on healthcare utilization due to chronic pain.  

In response to a 2006 Institute of Medicine (IOM) report on drug safety, the Food and Drug Administration Amendments Act (FDAAA) was signed into law in 2007; this gave the FDA authority to require risk evaluation and mitigation strategies (REMS) to have an increased focus on drug safety and post-marketing surveillance.   In July 2012, the FDA approved a REMS for extended-release and long-acting (ER/LA) opioids, mandating that manufacturers of these drugs implement a multi-faceted program to “reduce risks and improve safe use of ER/LA opioids while continuing to provide access to these medications for patients in pain.” A central component of these efforts is an education program for prescribers, outlined in the document FDA’s Opioid Analgesic REMS Education Blueprint for Health Care Provider’s Involved in the Treatment and Monitoring of Patients with Pain. 

In 2011, the CO*RE Partners designed and conducted an in-depth, multi-method needs assessment to evaluate current literature, barriers to change, barriers to best practice, perceived educational needs, health care professionals’ attitudes, and gaps in knowledge, skills, and competence. Findings revealed that respondents perceive significant need for education, including initial assessment of the patient, development of a treatment plan, assessment of risk for abuse, and ongoing reassessment of the patient.   

For continuous improvement of the CO*RE curriculum, the 2014 needs assessment was designed to build on that needs assessment and identify where and how clinician needs have evolved over the past 3 years. Results of a quantitative assessment of perceived competency gaps are illustrated in the figure below. Primary care and specialist providers rated their current and desired levels of competency; the average difference between these represents the gap or perceived need. All of the measured competencies recorded gaps above 0.5, which is considered meaningful; many gaps fall between 1.0 and 2.0, the ideal range for health care professional education.

The survey additionally revealed that learners perceive many barriers to best practices, particularly concern about accidental overdose, patients’ concerns that they may become dependent or addicted, and limited access to pain specialists for consultation or referral.  The fear of abuse and need to recognize potential diversion were identified as major concerns for opioid prescribers.

Furthermore, the findings suggested that those who participated in opioid REMS education have lower perceived needs and greater competency related to managing patients with chronic pain and use of ER/LA opioids. Individuals who partake REMS education utilize more tools and resources  when assessing patients and managing patient’s pain. These learner’s have also used methods to reduce the abuse and diversion of opioids. However, significant competency gaps and barriers to best practice still remain prevalent. 

Learning Objectives

• Accurately assess patient with pain for consideration of an opioid trial.
• Establish realistic goals for pain management and restoration of function.
• Initiate opioid treatment (IR and ER/LA) safely and judiciously, maximizing efficacy while minimizing risks.
• Monitor and re-evaluate treatment continuously; discontinue safely when appropriate.
• Counsel patient and caregivers about use, misuse, abuse, diversion, and overdose.
• Educate patients about safe storage and disposal of opioids. 

References

1. Oxford Academic. (2019). Changes in Mortality Involving Extended-Release and Long-Acting Opioids After Implementation of a Risk Evaluation and Mitigation Strategy. 
2. White House. Epidemic: Responding to America's Prescription Drug Abuse Crisis. 
3. U.S. Food and Drug Administration. FDA Education Blueprint for Health Care Providers Involved in the Management or Support of Patients with Pain. (2017)
4. National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Health Sciences Policy; Committee on Pain Management and Regulatory Strategies to Address Prescription Opioid Abuse; Phillips JK, Ford MA, Bonnie RJ, editor. (2017) Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use.
5. National Institute of Drug Abuse.(2019) Overdose Death Rates. 
6. U.S. Department of Health and Human Services Behavioral Health Coordinating Committee Prescription Drug Abuse Subcommittee.(2013) Addressing Prescription Drug Abuse in the United States. 
7. National Institute on Drug Abuse.(2018) Emerging Trends and Alerts. 
8. Association of Healthcare Internal Auditors. (2018) Drug Diversion Prevention & Detection Using a Comprehensive Risk & Internal Audit Approach. 
9. American Journal of Public Health. Brennnan, F. et al. Access to Pain Management as Human Rights. (2019):p.1-5
10. Bulls, Hailey ., Goodin, Burel R., and Scott – Herbet, Matthew. A Biopsychosocial Perspective on the Assessment and Treatment of Chronic Pain in Older Adults. (2018): pp 131-152  
11. The Journal of the International Association for the Study of Pain. Schug, Stephan A. et al. The IASP Classification of Chronic Pain for ICD -11. (2019)
12. Lindsey E. Dayer, Jacob T. Painter, Kelsey McCain, Jarrod King, Julia Cullen & Howell R. Foster (2019) A recent history of opioid use in the US: Three decades of change, Substance Use & Misuse, 54:2, 331-339, DOI: 10.1080/10826084.2018.1517175
13. Centers for Disease Control and Prevention. Morbidity and Mortality Report: Prevalence of Chronic Pain and High – Impact Chronic Pain Among Adults – United States, 2016. (2018) 67(36);1001-1006
14. U.S. National Library of Medicine National Institute of Health. Towards Effective Pain Management: Breaking the Barriers. (2017) DOI:10.5001/omj.2017.69 
15. Glajcjen, Myra MSW. Chronic Pain: Treatment Barriers and Strategies for Clinical Practice. (2019) 
16. Pizzi LT, Carter CT, Howell JB, et al. Work loss, healthcare utilization, and costs among US employees with chronic pain. Dis Manag Health Outcomes. 2005;13(3):201-208.
17. U.S. National Library of Medicine National Institute of Health. Res Pain, J. Just how much does it cost? A cost study of chronic pain following cardiac surgery. (2018) doi: 10.2147/JPR.S175090 
18. Institute of Medicine. The future of drug safety: promoting and protecting the health of the public. September 22, 2006; Accessed July 7, 2011.
19. 110th United States Congress. Food and Drug Administration Amendment Act of 2007.  Accessed July 7, 2011.