Opioid Crisis: How Did We Get Here & Where Are We Going? Amirala Pasha, DO, MS Assistant Professor of Medicine Division of General Internal Medicine

Transcription

1 Opioid Crisis: How Did We Get Here & Where Are We Going? Amirala Pasha, DO, MS Assistant Professor of Medicine Division of General Internal Medicine

2 Disclosures: None

3 Disclaimer This presentation may contain copyrighted materials which may include text, images, graphics, audio and video clips, and other content (collectively, the Content ). The Content is available to you under the fair use doctrine. The Content is made available only for your personal, noncommercial educational and scholarly use. You may not use the Content for any other purpose, or distribute or make the Content available to others, unless you obtain any required permission from the copyright holder. You may not alter or remove any copyright or other proprietary notices included in the Content. In no way shall inclusion or reference to any Content, product, service or source be construed as an endorsement or validation of the Content, product, service or source. This presentation contains general medical information. The medical information is for instructional purposes only. It is not medical advice and should not be treated as such.

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5 Aims Brief summary of current state of affairs. Review contributing factors to current state opioid crisis in the U.S. Overview of federal and state efforts to combat opioid crisis. Critical review of evidence behind these efforts.

6 Opioid Epidemic

7 Opioid Epidemic

8 Opioid Epidemic

9 Opioid Epidemic

10 Opioid Epidemic

11 Opioid Epidemic

12 Opioid Epidemic

13 Opioid Epidemic

14 Opioid Epidemic

15 Opioid Epidemic

16 How Did We Get Here?

17 Brief History of Opioids In 1803 morphine, was extracted from opium by Friedrich Serturner of Germany. Dr. Eduard Livenstein, a German physician, produced the first accurate and comprehensive description of addiction to morphine, including the withdrawal syndrome and relapse, and argued that craving for morphine was a physiological response. Study published in Diacetylmorphine (brand name heroin) was synthesized and briefly promoted as more effective and less addictive than morphine. In the early 20th century, when heroin was legally marketed in pill form. By early 1900s, per-capita consumption of opiates sky-rocketed, with little to no oversight. Eugene O'Neill's Long Day's Journey Into Night drama of iatrogenic opioid addiction leading to first national narcotic law, the Harrison Narcotics Tax Act of 1914.

18 The Opioid Pendulum Theory Opiophilia Opiophobia

19 The Rebirth Multiple scientific publication reported on safety and efficacy of opioid therapy in chronic non-malignant pain (CNMP) in 1980s. The Tragedy of Needless Pain Published in Scientific American in 1990 by Dr. Ronald Melzack of McGill University Too often patients suffering from severe pain such as that of cancer receive insufficient amounts of the drug morphine. Why? Because physicians and other health-care workers fear it will turn the patients into addicts addiction occurs primarily when morphine is taken to elevate mood and not when it is administered to control pain.

20 Malpractice Liability Estate of Henry James v. Hillhaven Corporation, No. 89 CVS 64 (N.C. Super Ct., Jan. 15, 1991). $15 million verdict for failure to provide appropriate pain management. The nursing staff withheld pain medications previously prescribed for a terminal patient with metastatic prostate cancer due to concerns that he was "addicted to morphine." Bergman v. Wing Chin, MD and Eden Medical Center, No. H (Cal App. Dept Super Ct., Feb. 16, 1999). $1.5 million against a physician for failure to provide adequate pain control to a terminally ill patient. Bergman in Tomlinson v. Bayberry Care Center, No. C (Contra Costa County Super Ct., 2002). Cancer patient brought an action under the California elder abuse statute against a hospital, nursing home, and three physicians, claiming inadequate pain control during the final weeks of the patient's life. The case was settled prior to trial.

21 Medicine s Response JAMA 1995

22 Pain as a Vital Sign

23 The Joint Commission 2001 [T]here is no evidence that addiction is a significant issue when persons are given opioids for pain control. Claimed that concerns regarding addiction side effect "inaccurate and exaggerated.

24 OxyContin est stopoxy.com

25 OxyContin est

26 OxyContin I Got My Life Back

27 OxyContin I Got My Life Back Part II Created in year follow up. All patients were doing well. Returning to these patients after 2 years, shows that when pain treatment is successful, it stays successful. We doctors were wrong in thinking opioids can t be used long-term, they can be and they should be. We used to think they d stop working or the patients would become addicts or they d be sedated into inactivity. These six cases show how wrong those views were. Most importantly, they refute the myth that long-term opioid-use would inevitably lead to addiction, tolerance and passivity.

28 The Joint Commission

29 OxyContin The $30B Industry

30 Chronic Pain

31 Opioid Prescriptions Dispensed by US Retail Pharmacies

32 Admission to Opioid Abuse Programs

33 Opioid Deaths

34 How Did We Get Here?

35 How Did We Get Here?

36 Summary It is important to recognize that we arrived at this place on a path paved with good intentions. Nearly two decades ago, we were encouraged to be more aggressive about treating pain, often without enough training and support to do so safely. This coincided with heavy marketing of opioids to doctors. Many of us were even taught incorrectly that opioids are not addictive when prescribed for legitimate pain.

37 Where Are We Going?

38 The Opioid Pendulum Theory Opiophilia Opiophobia

39 Legislative & Regulatory Review Federal Level CDC Opioid Prescribing Guidelines FDA Opioid Action Plan

40 CDC Prescribing Guidelines

41 CDC Prescribing Guidelines Among the 12 recommendations in the Guideline, there are 3 principles that are especially important to improving patient care and safety: Nonopioid 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.

42 CDC Prescribing Guidelines JAMA 2016

43 CDC Prescribing Guidelines JAMA 2016

44 CDC Prescribing Guidelines JAMA 2016

45 CDC Prescribing Guidelines FAQs The Guideline is based on the evidence that is currently available. We don t know whether or not opioids provide effective pain relief over the long term. At the same time, we know now that opioid use disorder and overdose are real risks of prescription opioid use particularly with high doses and longterm use. Clinical guidelines are always based on best available evidence, including low quality evidence. When evidence is low quality, it does not necessarily mean there is not enough evidence to make a recommendation. It means that not enough randomized control trials were conducted to describe the evidence as high quality. We need more rigorous studies on effective treatments for pain. CDC agrees that we need more research on effective pain treatments and is dedicated to working with partners to improve the evidence base, and will refine our recommendations as better evidence becomes available.

46 FDA Opioids Action Plan Expand use of advisory committees. Develop warnings and safety information for immediate-release (IR) opioid labeling. Strengthen postmarket requirements. Update Risk Evaluation and Mitigation Strategy (REMS) Program. Expand access to abuse-deterrent formulations (ADFs) to discourage abuse. Support better treatment. Reassess the risk-benefit approval framework for opioid use.

47 FDA Opioids Action Plan Expand use of advisory committees. Develop warnings and safety information for immediate-release (IR) opioid labeling. Strengthen postmarket requirements. Update Risk Evaluation and Mitigation Strategy (REMS) Program. Expand access to abuse-deterrent formulations (ADFs) to discourage abuse. Support better treatment. Reassess the risk-benefit approval framework for opioid use.

48 Abuse-Deterrent Formulations (ADFs) Physical/chemical barrier that can prevent chewing, crushing, cutting, grating, or grinding of the dosage form. Dosage forms with chemical barriers should resist extraction of the opioid through use of common solvents. Agonist/antagonist combinations: An opioid antagonist is added to the formulation to interfere with the release of the opioid if the medication is taken in any other way than it was intended. Aversion: Substances are added to the dosage form to produce an unpleasant effect if the dosage form is manipulated prior to ingestion or if a higher dosage than directed is used. Delivery system: Alternative delivery systems such as a depot injectable or an implant that is more difficult to manipulate. Prodrug: Medication contains a prodrug that lacks opioid activity until it has been transformed in the gastrointestinal tract. Combination: 2 or more of the above methods can be combined to deter abuse. Novel approaches

49 ADFs NEJM 2017 NEJM 2017

50 ADFs NEJM 2017 Abuse-deterrent formulations don t prevent patients from taking higher doses than prescribed, which is the most common way opioids are misused. Yet one survey showed that nearly half of primary care physicians think abusedeterrent formulations are less addictive than standard formulations. Opioids with abuse-deterrent properties are not abuse-proof. Comments on YouTube videos instructing viewers on how to tamper with various products imply that abuse-deterrent formulations have spawned a cottage industry of sophisticated ways of defeating them. An HIV outbreak in southern Indiana in 2015 was linked to a reformulated version of Opana ER (oxymorphone) that apparently deterred nasal inhalation but could be injected.

51 ADFs JAMA Psychiatry 2015

52 ADFs JAMA Psychiatry 2015

53 ADFs

54 ADFs NBER The National Bureau of Economic Research (NBER): Founded in 1920, the NBER is a private, non-profit, non-partisan organization dedicated to conducting economic research and to disseminating research findings among academics, public policy makers, and business professionals. Twenty-six Nobel Prize winners in Economics and thirteen past chairs of the President's Council of Economic Advisers have held NBER affiliations. Supply-Side Drug Policy in the Presence of Substitutes: Evidence from the Introduction of Abuse-Deterrent Opioids (January 2017). Our results imply that a substantial share of the dramatic increase in heroin deaths since 2010 can be attributed to the reformulation of OxyContin. Estimate the reformulation to account for as much as 80% of the three-fold increase in heroin mortality since 2010.

55 ADFs NBER

56 Legislative & Regulatory Review State Level Prescription Drug Monitoring Programs (PDMPs) Opioid Prescribing Limits Morphine Milligram Equivalent Limits Closed Formulary (California) Dispensing Limitations Treatment Guidelines CME Requirements

57 Legislative & Regulatory Review Maine Jessica Bates, PharmD

58 Legislative & Regulatory Review State Level Prescription Drug Monitoring Programs (PDMPs) Opioid Prescribing Limits Morphine Milligram Equivalent Limits Closed Formulary (California) Dispensing limitations Treatment Guidelines CME Requirements

59 PDMP History First ever PDMP was established in New York in 1918 but was later dismantled and re-established again in California is credited with having the longest continuous PDMP in operation which was instituted in 1939.

60 PDMP Today

61 PDMP Mandatory Query

62 PDMP Data Health Affairs 2017

63 PDMP Data JAMA Internal Medicine 2015

64 PDMP Data Annals of Emergency Medicine 2013

65 PDMP The Future Unsolicited Reporting National PDMP

66 PDMP Board Reporting

67 PDMP Law Enforcement Access

68 National PDMP Intrastate Data Sharing Federal PDMP Fraudulent Prescription Prevention Act of 2011 RIP

69 Intrastate PDMP

70 Federal PDMP? Hamilton v. Kentucky Distilleries Co., 251 U.S. 146 (1919). [T]he United States lacks the police power, and that this was reserved to the States by the Tenth Amendment.

71 Federal PDMP? U.S. v. Lopez, 514 U.S. at 549 (1995). Invalidating a federal statute prohibiting gun possession in school zones. The Court held that upholding such statute would transform the commerce clause into "a general police power of the sort retained by the States."

72 Federal PDMP?

73 PDMP Summary Some evidence to support the approach especially regarding doctor shopping. Future enhancements: Unsolicited reporting National PDMP Easier access EHR integration Enchased interface

74 Opioid Prescribing Limits

75 Opioid Prescribing Limits

76 Opioid Prescribing Limits Evidence

77 Opioid Prescribing Limits Evidence The Journal of Hand Surgery 2012

78 Opioid Prescribing Limits Evidence

79 Benefits/Consequences Co-Pay and New York Law. Too early too tell!

80 Pain as a Vital Sign

81 Pain as a Vital Sign JGIM 2006

82 The Joint Commission

83 OxyContin The $30B Industry

84 The Opioid Pendulum Theory Opiophilia Opiophobia

85 The Opioid Pendulum Reality

86 Balanced Approach

87 Goal

88 Questions?