Nurse Practitioners and DEA Prescribing: Where Do We Go From Here?

1. Nurse Practitioners and DEA Prescribing: Where Do We Go From Here? Alicia Craig-Rodriguez, DNP-c, MBA, BSN, RN Florida State University Cynthia Drew, MSN, ARNP Presented to the 2015 FLANP Annual Meeting August 8, 2015

2. Objectives • Demonstrate understanding of opioid medication management/prescribing • Describe brief history of opioid prescribing in Florida and the state's current monitoring requirements for opioid prescribing • Describecore competency requirements  to ensure safe and effective prescribing of opioids in clinical practice  • Discuss next steps and available continuing educational options that fulfill criteria for FDA OPIOID REMS for extended release and long acting opioids

3. Related Topics • Pharmacokinetics and pharmacodynamics of opioid medications. • Core competencies needed to ensure safe and effective prescribing of opioids • Results of Florida Needs Assessment Survey on Nurse Practitioner readiness for future opioid prescribing and its implications for advanced nursing practice

4. DEA Schedule Drug Enforcement Administration (2015). Retrieved from http://www.dea.gov/druginfo/ds.shtml

5. "Florida is on the verge of recovering from a massive statewide pill-mill crisis. Yet now, the Florida House is considering a bill that would unleash thousands of new practitioners into our communities with prescription pads poised to prescribe narcotics." - Alan Harmon, FMA President (2014)

6. Opioids • Also known as narcotics, any drug, natural or synthetic, that has actions similar to its prototype, morphine • Mechanism of action: attach to specific opioid receptors, and mimic the actions of endogenous peptides, primarily at mu receptors • Pharmacologic actions: reduced perception of pain, increased sense of well-being/euphoria, anxiety reduction • Common adverse effects include sedation, confusion, hypotension, constipation and respiratory depression, tolerance and physical dependence Lehne & Rosenthal (2014)

7. Opioids: Key Terms • Tolerance: a state in which a larger dose is required to produce the same response • Physical Dependence: a state in which an abstinence syndrome will occur if opioid use is abruptly stopped • Abuse: drug use that is inconsistent with medical/social norms Fishman, 2012; Lehne & Rosenthal, 2014; Webster & Dove, 2007.

8. Opioids: Key Terms • Misuse: use of any drug in a manner other than how it was prescribed • Addiction: characterized by continued use of a psychoactive substance despite physical, physiologic or social harm • Abuse Liability:a drug’s propensity to be abused, producing adverse public health consequences Fishman, 2012; Lehne & Rosenthal, 2014; Webster & Dove, 2007.

9. Prevalence of Misuse, Abuse, and Addiction Misuse 40% Abuse: 20% Total PainPopulation Addiction: 2% to 5% Webster LR, Webster RM. Pain Med. 2005;6(6):432-442.

10. Opioid Prescribing for Chronic Pain • Serious Gaps in Prescriber Knowledge, Attitudes and Beliefs (MDs and ARNPs) • Lack of standardized training • Lack of Consensus of Pain Treatment Guidelines for chronic, non-cancer pain

11. Opioid Prescribing in the US • Opioids are the most prescribed class of medications in the United States (>90% of world’s total); yet many practitioners (including MDs) feel inadequately prepared/trained to prescribe • Currently, 49 states and DC allow Nurse Practitioners to prescribe DEA controlled substances (in accordance with state laws) National Institute on Drug Abuse, 2014. Retrieved from http://www.drugabuse.gov/about-nida/legislative-activities/testimony-to-congress/2014/americas-addiction-to-opioids-heroin-prescription-drug-abuse#_ftn5

12. Opioid Prescribing in the US Total number of prescriptions dispensed in the U.S. by various specialties for IR and ER/ LA opioids, year 2009. American Society of Interventional Pain Physicians (2012).

13. History of Opioid Prescribing in Florida

14. Opioid Prescribing (2010) “OxyExpress” 1,000 pain clinics $1m oxycodone pills sold monthly 90+ of the top 100 MDs purchasing oxycodone in the U.S. practiced in Florida($650m pills shipped) Drug Enforcement Administration (2010-2012)

15. Opioid Prescribing (Now) • E-FORCSE PDMP initiated 2011 • Dispensers of controlled substances must report transactions within 7 days • Provides real-time access • Oxy Prescriptions fell by 24% • Deaths fell by 52%

16. Are Florida NPs Ready to Prescribe Opioids?

17. FDA and ER/LA Opioids • Approximately 3.8 million patients, annuallyreceive ER/LA opioids in the OP setting • ~ ½ of ER/LA opioids are prescribed by PCPs, usually for chronic pain conditions • Risk Mitigation & Evaluation Strategy (REMS) launched in 2012 to reduce serious outcomes while maintaining access to ER/LA pain medications • Core competency training made available to prescribers Food and Drug Administration, 2012

18. ER/LA Opioid Training • 2012: FDA issued Risk Evaluation and Mitigation Strategy (REMS) blueprint for extended release (ER) and long acting (LA) opioid medications • Collaborative on REMS Education (CO*RE) designed core curriculum based to meet FDA educational requirements • Other comparable training resources available (see appendix) • CO*RE Nursing Partners • American Association of Nurse Practitioners • Nurse Practitioner Healthcare Foundation • Medscape for Nurses

19. NPs and Future Opioid Prescribing: A Needs AssessmentAlicia Craig-Rodriguez, DNP-c, MBA, BSN, RNFlorida State University

20. Knowledge Domains • What is your current level of knowledge and to what extent would this limit your opioid prescribing in the following areas: • Federal and state regulatory guidelines • Opioid classes and the proper doses • Risk assessment (skills to detect abuse, misuse or diversion of opioids) • Monitoring: (treatment goals, contracts, and patient response) • Ability to deal confidently with challenges of opioid prescribing

21. Needs Assessment • December 2014-February 2015: Online survey sent tolicensed ARNPs in Florida database • Respondents asked whether current level of knowledge would limit prescribing • Addressed all 5 knowledge domains. • 1511 surveys completed/returned (16.8% response rate)

22. Participant Demographics

23. Education, Experience & Training

24. Key Findings: • Neither Level of NP experience nor Level of NP education had a significant (positive) effect on confidence in prescribing opioids in all knowledge domains (p= < .005) • When compared with all other work settings, more respondents who work in Pain Management indicated no limitations with prescribing • Those with current or prior DEA licensure had a significant (positive) effect on confidence(fewer limitations) in prescribing opioids in all knowledge domains (p= < .005) • Those with prior opioid training had a significant (positive) effect on confidence (fewer limitations) in prescribing opioids in all knowledge domains (p= < .005)

25. NPs and Opioid Prescribing: Where Do We Go From Here?

26. "Florida is on the verge of recovering from a massive statewide pill-mill crisis. Yet now, the Florida House is considering a bill that would unleash thousands of new practitioners into our communities with prescription pads poised to prescribe narcotics." - Alan Harmon, FMA President (2014)

27. Changing Prescriptive Authority We have a professional responsibility to: • Prepare APNs for a new scope of practice before, not after legislationpasses • Socialize APNs and APN students to value full autonomy • Educate policymakers about the benefits of fully autonomous APN practice Kaplan, L. & Brown, M.A. (2007). The transition of nurse practitioners to changes in prescriptive authority. Journal of Nursing Scholarship, 39(2), 184-190. Klein, T., & Kaplan, L. (2010). Prescribing competencies for advanced practice registered nurses. The Journal for Nurse Practitioners, 6(2), 115-122.

28. Implications for Practice Although the FDA Risk Evaluation and Mitigation Strategy has been implemented, there is no mandatory requirement to participatein any training program Recent studies estimate that ~50% of physicians are seeking training in FDA-compliant opioid prescribing Imagine the impact if100% of Florida’s ARNPs proactively completed FDA-compliant Opioid Training prior to the 2016 legislative session? Slevin, K. A., & Ashburn, M. A. (2010)

29. Appendix:FDA-Compliant Opioid Training Options/Resources for Nurse Practitioners

30. Opioid Training (AANP) • Pain Inventory Tools • Risk Assessment Tools • Treatment Guidelines • Sample Agreements and Consents for Chronic Opioid Therapy • Urine Drug Screening and Testing • Tools for Monitoring • State guidelines • Patient Counseling Document AANP CO*RE Training online curriculum meets FDA Blueprint Guidelines

31. Opioid Training (Medscape) REMS for ER/LA Opioid Analgesics: The Keys to Safe Use CME/CE Katherine E. Galluzzi, DO; Barbara St. Marie, PhD, ANP, GNP, ACHPN CME/CE Released: 03/26/2015 ; Valid for credit through 03/26/2016 CE: 2 hours Cost: Free This 3-part, online curriculum series meets FDA Blueprint Guidelines

32. Opioid Training (NPHF) ER/LA OPIOID REMS Achieving Safe Use While Improving Patient Care Presented by: CO*RE Collaboration Partners https://www.nphf-core.com/ CE: 3 Pharmacology hours Cost: Free NPHF is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation Online curriculum for nurse practitioners consisting of six modules presented through high definition, streaming video with interactive, embedded questions

33. Opioid Training Fishman (2014) • 3 Training Modules: • Risk Assessment, patient selection and treatment planning • Initiating, documenting monitoring and discontinuing therapy • Managing special risks populations/situations • CE included with book

34. Opioid Training: Webster and Dove (2007) • Resource Manual Only (No CE) • Epidemiology • Neurobiology of Addiction • Risk Factors • Assessing for Abuse • Documentation Tools • Monitoring Patients • Legal Issues • Abuse Deterrent Opioids

35. Web Resources

36. Questions? Alicia (Ali) Craig-Rodriguez, DNP-c, MBA, BSN, RN Florida State University FSU Email: aac13c@my.fsu.edu

37. References Craig-Rodriguez, A. (2014). Educational interventions to improve opioid prescribing in primary care: A synthesis of the literature. Unpublished manuscript, Department of Nursing, Florida State University, Tallahassee, Florida. Fishman, S.M. (2012). Responsible opioid prescribing. A clinician’s guide. Washington, DC: Waterford Life Sciences. Food and Drug Administration. Press Release: FDA Commissioner Margaret A. Hamburg Statement on Prescription Opioid Abuse. April 3, 2014. Retrieved from http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm391590.htm Florida Office of the Attorney General (2012). Florida’s Prescription Drug Diversion and Abuse Roadmap 2012-2015. Retrieved from http://myfloridalegal.com/webfiles.nsf/WF/KGRG-8T8L5K/$file/PrescriptionDrugDiversionAndAbuseRoadmap.pdf Institute of Medicine. Relieving Pain in America: A blueprint for transforming care, education and research. The National Academies Press: 2011. LaxmaiahManchikanti, M. D., Standiford Helm, I. I., MA, J. W. J., PhD, V. P., MSc, J. S. G., & DO, P. (2012). Opioid epidemic in the United States. Pain physician, 15, 2150-1149. Lehne, R. A., & Rosenthal, L. (2014). Pharmacology for nursing care. Elsevier Health Sciences. Kaplan, L. & Brown, M.A. (2007). The transition of nurse practitioners to changes in prescriptive authority. Journal of Nursing Scholarship, 39(2), 184-190. Klein, T., & Kaplan, L. (2010). Prescribing competencies for advanced practice registered nurses. The journal for nurse practitioners, 6(2), 115-122. Slevin, K. A., & Ashburn, M. A. (2010). Primary care physician opinion survey on FDA opioid risk evaluation and mitigation strategies. Journal of opioid management, 7(2), 109-115. Webster, L. R., & Dove, B. (2007). Avoiding opioid abuse while managing pain. Sunrise River Press.