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Impact of New Opioid Prescribing Laws on Sickle Cell Disease

This presentation discusses the impact of new opioid prescribing laws and guidelines on patients with sickle cell disease, including an overview of federal and state responses, forces impacting decisions, and the CDC opioid prescribing guidelines.

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Impact of New Opioid Prescribing Laws on Sickle Cell Disease

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  1. New Opioid Prescribing Laws and Guidelines: Impact on Sickle Cell Disease Wally R. Smith MD Florence Neal Cooper Smith Professor of Sickle Cell Disease Virginia Commonwealth University Presented as part of The Cahllenges of Opioid Use and Prescribing: Building Bridges Between Patients and PRoviders; 10th Annual Sickle Cell Disease educational Seminar, Sacramento ,California Some slides courtesy Steve Prakken, MD Chief Medical Pain Service Duke Pain Medicine

  2. Outline • How we got here: the Opioid Epidemic, Opioid Prescribing Policy • Federal Response • State Response • What it means to SCD

  3. Forces impacting decisions • CDC • State Boards of Medicine • Food and Drug Administration • Drug Enforcement Agency • Quality improvement standards • Shrill opinions • Other physicians • Patients

  4. “Trump says opioids are a national emergency. Here’s what happens next.” • “The opioid crisis is an emergency, and I'm saying officially right now it is an emergency,” Trump told reporters at his golf club in Bedminster, N.J. • Washington Post, August 10, 2017

  5. Va. Opioid deaths- A Different Perspective

  6. Va. Fentanyl deaths (RX, Illicit, and Analogs)

  7. Past Month Nonmedical Use in Age 12 and Older

  8. Illicit Drug Use Age 50-64

  9. Substance Dependence or Abuse in the Past Year among Persons Aged 12 or Older

  10. Opioid Prescribing Guidelines • Early Guidelines • Pain societies (1990s-2000s) • NHLBI Consensus Panel • NIH Pathways to Prevention Workshop Recommendations • 2014 • Interagency Pain Research Coordinating Committee Recommendations • 2015 • CDC Opioid Prescribing Guidelines • 2016

  11. State Laws • Mandated Prescription Drug Monitoring Programs (PDMP) • All but 1 • Mandated checking of PDMP • 8 states and counting • Mandated opioid limits • 5 states • Total counts • Total days per script

  12. CDC Recommendations 3/16 • Intended for Primary Care Providers: Internists, Family Practitioners, and Mid-levels (NP, PA) in OUTPATIENT setting • Not for cancer pain, palliative care, end-of-life care • Age >18 years! • Voluntary Guidelines! • Define chronic pain as lasting “>3 months or past the time of normal tissue healing” • Not the first (or last): APS/AAPM, ASA, VA, Washington State have all published their own guidelines • “Offers clarity on recommendations” • GRADE method of clinical evidence

  13. How the guidelines came to be: • Guidelines drawn up from research 2008 to 2014 • “Core Expert Group” • Subject matter experts (“appropriate academic/clinical training, proven scientific excellence in opioid prescribing”, representatives of primary care professional societies/state agencies • CDC excluded anyone with conflict of interest or perceived conflict of interest • Offered their guidance on draft recommendations: no voting/consensus • CDC chose what to change or not; they had no preview of final draft

  14. CDC Guideline Negative Impacts • For the sickle cell community, the most egregious CDC guideline relates to morphine milligram equivalents (MME)/day of prescribed opioid.   • Lifetime of Rx, high tolerant, no evidence of high opioid-related mortality

  15. Federation of State Medical Boards • Development of a Treatment Plan and Goals • Informed Consent and Treatment Agreement • Initiating an Opioid “Trial” • Ongoing Monitoring and Treatment Adaptation • Periodic Drug Testing • Consultation and Referral • Discontinuing Opioid Therapy • Medical Records

  16. Federation of State Medical Boards • Long history, since 1912 • Initially suggesting more aggressive tx • 1998 protection from legislative action for even large opioid dosing. • 2004 suggesting states make under-treatment punishable • 2013 largest shift in course, suggesting the need for more thoughtful opioid prescribing.

  17. Federation of State Medical Boards • Development of a Treatment Plan and Goals • Informed Consent and Treatment Agreement • Initiating an Opioid “Trial” • Ongoing Monitoring and Treatment Adaption • Periodic Drug Testing • Consultation and Referral • Discontinuing Opioid Therapy • Medical Records

  18. NC Medical Board policy statement 2014 • Based upon Federation of State Medical Boards Revision 2013 • Overview of changes • discouragement of use as first line tx. and high risk dosing • encouragement of “therapeutic trial” approach • emphasis on demonstrated functional improvement • more attention to risk assessment, monitoring, and referral • routine use of prescription monitoring programs (CSRS) • expected interventions for identified abuse, including use of addiction treatment referrals

  19. NCMB 4/16 • NCMB, in late 2015, began receiving prescribing information based on DHHSdata (CSRS) • The Board will contact (investigate) prescribers who meet one or more of the following criteria: • The prescriber falls within the top one percent of those prescribing 100 milligrams of morphine equivalents (MME) per patient per day. • The prescriber falls within the top one percent of those prescribing 100 MMEs per patient per day in combination with any benzodiazepine and is within the top one percent of all controlled substance prescribers by volume. • The prescriber has had two or more patient deaths in the preceding twelve months due to opioid poisoning

  20. State Laws • Mandated Prescription Drug Monitoring Programs (PDMP) • All but 1 • Mandated checking of PDMP • 8 states and counting • Mandated opioid limits • 5 states • Total counts • Total days per script

  21. Example: Virginia Law • Physicians • Check PMP and document checking • Monitor and lower MME to 120 MME/day • No opioids co-prescribed with Benzodiazepines • Document Opioid urine screening regularly, randomly, • Patient “contract” signed by patient and MD • Prescribe Naloxone inhaled • Institutions • Prior authorizations for drug and Quantity encouraged for insurance, pharmacies, health plans, etc.

  22. Prescription Monitoring Program

  23. CDC Recommendations 3/16 • Intended for Primary Care Providers: Internists, Family Practitioners, and Mid-levels (NP, PA) in OUTPATIENT setting • Not for cancer pain, palliative care, end-of-life care • Age >18 years! • Voluntary Guidelines! • Define chronic pain as lasting “>3 months or past the time of normal tissue healing” • Not the first (or last): APS/AAPM, ASA, VA, Washington State have all published their own guidelines • “Offers clarity on recommendations” • GRADE method of clinical evidence

  24.  Most Egregious CDC Guideline—DoseLimitation • Whenopioids are started, cliniciansshouldprescribethelowesteffectivedosage. Cliniciansshouldusecautionwhenprescribingopioids at anydosage, shouldcarefullyreassessevidence of individualbenefits and riskswhenconsideringincreasingdosage to≥50 morphinemilligramequivalents (MME)/day, and shouldavoidincreasingdosage to ≥90 MME/dayor carefullyjustify a decision to titratedosage to ≥90 MME/day(recommendationcategory: A, evidence type: 3).

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