IMPROVING OPIOID PRESCRIPTION SAFETY AFTER SURGERY. Karsten Bartels, M.D.

Transcription

1 IMPROVING OPIOID PRESCRIPTION SAFETY AFTER SURGERY Karsten Bartels, M.D.

2 Conflicts of Interest None

3 Funding NIH / NIDA #K23DA Improving Opioid Prescrip?on Safety AEer Surgery

4 Primum Non Nocere Peter Pronovost, MD The Fairmont Copley Plaza, Boston MA

5 Defini0on of Pain An unpleasant sensory and emo0onal experience associated with actual or poten0al 0ssue damage, or described in terms of such damage. From Part III: Pain Terms, A Current List with Defini0ons and Notes on Usage" (pp ) Classifica0on of Chronic Pain, Second Edi0on, IASP Task Force on Taxonomy, edited by H. Merskey and N. Bogduk, IASP Press, SeaXle, 1994

6 Chronic pain is pain that persists or recurs for longer than three months IASP Taxonomy working Group (2011) Classification of Chronic Pain (Second Edition)

7 Epidemiology / Women In developed countries, chronic pain is present in: % of women aged % of women aged % of women aged % of women aged >66 Tsang A et al. J Pain Oct;9(10): doi: /j.jpain Common chronic pain conditions in developed and developing countries: gender and age differences and comorbidity with depression-anxiety disorders.

8 Epidemiology / Men In developed countries, chronic pain is present in: % of men aged % of men aged % of men aged % of men aged >66 Tsang A et al. J Pain Oct;9(10): doi: /j.jpain Common chronic pain conditions in developed and developing countries: gender and age differences and comorbidity with depression-anxiety disorders.

9 Chronic Pain Syndromes (ICD- 11) Chronic Pain Chronic Primary Pain Chronic Cancer Pain Chronic Postsurgical and PosXrauma0c Pain Chronic Neuropathic Pain Chronic Headache and Chronic Orofacial Pain Chronic Visceral Pain Chronic Muskuloskeletal Pain IASP Taxonomy working Group (2011) Classification of Chronic Pain (Second Edition)

10 Pharmacologic Therapy Nonsteroidal an0- inflammatory drugs (NSAIDs) An0depressants Tricyclic an0depressants Selec0ve Serotonin and Norepinephrine Reuptake Inhibitors An0convulsants Opioids Others

11 Efficacy The Number Needed to Treat (NNT) for pharmacologic therapy to significantly reduce neuropathic pain (e.g. 20 % reduc@on on a pain VAS) is between 2-5

12 Opioids Routes of administra0on include IV, IM, oral, rectal, intranasal and sublingual Receptors, namely mu (μ), delta (δ), and kappa (κ) Agonists (e.g. morphine, hydromorphone) Antagonists (e.g. naloxone, naltrexone) Par0al agonists (e.g. buprenorphine)

13 Opioids side effects Mood effects (e.g. euphoria) Seda0on Nausea / vomi0ng Cons0pa0on Respiratory depression Miosis An0tussive effect

14 CNS- mediated effects Tolerance Dependence Addic0on

15 1990s McCaffery M, Pasero CL. Pain ratings: the fifth vital sign. Am J Nurs. 1997;97(2):15-16

16 AHRQ 1992 Clinical Prac0ce Guideline for Surgical Pain Half of all do not get adequate relief Giving pa0ents pain medicine only "as needed" can result in prolonged delays because pa0ents may delay asking for help. Aggressive preven0on of pain is bexer than treatment because, once established, pain is more difficult to suppress. Pa0ents have a right to treatment that includes preven0on of or adequate relief from pain.

17 AHRQ 1992 Clinical Prac0ce Guideline for Surgical Pain Physicians need to develop pain control plans before surgery and inform the pa0ent what to expect in terms of pain during and aper surgery. Fears of postsurgical addic0on to opioids are generally groundless. Daniel B. Carr, M.D., Massachusetts General Hospital's Division of Pain Management, and Ada Jacox, Ph.D., R.N., Johns Hopkins University School of Nursing. Guideline Release Date: March 5, 1992.

18 Medicare Part D: OxyCon0n - Cost #18

19 Medicare Part D: Vicodin - Prescrip0ons #4

20 Hydrocodone On August 22, 2014, the Drug Enforcement Administra0on (DEA) published the final rule in the Federal Register to rescheduling hydrocodone combina0on products to Schedule II of the Controlled Substances Act Need to be converted into ac0ve metabolites (hydromorphone) via CYP2D6

21 Hydrocodone & Codeine Metabolism 5% to 10% of white people possess allelic variants of the CYP2D6 gene that are associated with reduced clearance 1% to 7% of white people carry CYP2D6 allelic variants associated with rapid metabolism African popula0ons are highly variable in their (0%- 34%) in regards to reduced clearance Bathum L, et al. Ultrarapid metabolism of sparteine: frequency of alleles with duplicated CYP2D6 genes in a Danish population as determined by restriction fragment length polymorphism and long polymerase chain reaction. Pharmacogenetics 1998;8(2): Løvlie R, et al. Ultrarapid metabolizers of debrisoquine: characterization and PCR-based detection of alleles with duplication of the CYP2D6 gene. FEBS Lett. 1996;392(1):30-34

22 Cost America s Addiction to Opioids: Heroin and Prescription Drug Abuse. May 14, 2014 presented by Nora D. Volkow, M.D.; Senate Caucus on International Narcotics Control

23 The Annual direct costs from opioid pain relievers to insurance companies are more than double the total NIH budget or about 70x the annual NIDA budget

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26 Opioid Analgesics: Sources for Nonmedical Users, United Stated, hxp:// rounds/archives/2011/pdfs/phgrrx17feb2011.pdf

27 Introduction Age-adjusted rates per 100,000 population for opioid pain releaver (OPR) deaths, crude rates per 10,000 population for OPR abuse treatment admissions, and crude rates per 10,000 population for kilograms of OPR sold. Centers for Disease C, Preven0on: Vital signs: overdoses of prescrip0on opioid pain relievers- - - United States, MMWR Morb Mortal Wkly Rep 2011; 60:

28 Prescrip?on Opioid Abuse an American Epidemic Accidents (uninten0onal injuries) were the 5th leading cause of death in the US in Among persons 1-44 years of age accidents represented #1 cause of death. Within this group, pharmaceu0cals were the #1 cause of death Dart RC, Surratt HL, Cicero TJ, Parrino MW, Severtson SG, Bucher-Bartelson B, Green JL. Trends in Opioid Analgesic Abuse and Mortality in the United States. N Engl J Med. 2015;372(3): v

29 Prescrip?on Opioid Abuse an American Epidemic Of the 22,134 medica0on induced deaths in 2010, 75.2% included opioid analgesics. Average health care costs for pa0ents abusing opioids are 8 0mes higher - $55.7 billion/year Dart RC, Surratt HL, Cicero TJ, Parrino MW, Severtson SG, Bucher-Bartelson B, Green JL. Trends in Opioid Analgesic Abuse and Mortality in the United States. N Engl J Med. 2015;372(3): v White AG, Birnbaum HG, Mareva MN, Daher M, Vallow S, Schein J, Katz N. Direct costs of opioid abuse in an insured population in the United States. J Manag Care Pharm. 2005;11(6): Birnbaum HG, White AG, Schiller M, Waldman T, Cleveland JM, Roland CL. Societal costs of prescription opioid abuse, dependence, and misuse in the United States. Pain Med. 2011;12(4):

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33 A 1980 lexer on the risk of Opioid Addic0on TO THE EDITOR Recently, we examined our current files to determine the incidence of narcotic addiction in 39,946 hospitalized medical patients1 who were monitored consecutively. Although there were 11,882 patients who received at least one narcotic preparation, there were only four cases of reasonably well documented addiction in patients who had no history of addiction. The addiction was considered major in only one instance. The drugs implicated were meperidine in two patients,2 Percodan in one, and hydromorphone in one. We conclude that despite widespread use of narcotic drugs in hospitals, the development of addiction is rare in medical patients with no history of addiction. Jane Porter Hershel Jick, M.D. Boston Collaborative Drug Surveillance Program Boston University Medical Center N Engl J Med 1980; 302:123

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36 Perceived impact of Incen0ves 0ed to formal pa0ent sa0sfac0on scores Preliminary data will be presented here not for public distribution

37 Who is at risk for long- term (>90 days) opioid prescrip?on aeer surgery? 39,140 opioid naïve geriatric pa0ents in Canada: younger age lower household income comorbidi0es type of surgical procedure Clarke H, Soneji N, Ko DT, Yun L, Wijeysundera DN. Rates and risk factors for prolonged opioid use after major surgery: population based cohort study. BMJ. 2014;348:g1251

38 Risk Factors for long- term opioid prescribing aeer surgery ambulatory surgery pa0ents 66 y/o Newly prescribed 7.1% within 7 days of being discharged from the hospital Opioids were prescribed to 7.7% at 1 year Pa0ents receiving an opioid prescrip0on within 7 days of surgery were 44% more likely to become long- term opioid users within 1 year Alam A, Gomes T, Zheng H, Mamdani MM, Juurlink DN, Bell CM. Long-term analgesic use after lowrisk surgery: a retrospective cohort study. Arch Intern Med. 2012;172(5):

39 Risk Factors for long- term opioid prescribing aper surgery Combina0on of two databases: Epic/Clarity & CO APCD All adult pa0ents who underwent inpa0ent surgery at the U. Colorado Hospital within a two- year 0me frame will be screened for inclusion using the EPIC database. Extrac0on of APCD opioid prescrip0on data for 1-30, 61-90, and days post- opera0on

40 Long- Term Opioid Use Aper Inpa0ent Surgery A Retrospec0ve Cohort Study Preliminary data will be presented here not for public distribution

41 Preliminary data will be presented here not for public distribution Active opioid ingredients in the post discharge opioid prescriptions in a cohort of 652 patients after Cesarean section.

42 Preliminary data will be presented here not for public distribution Cumulative opioid dose in oral morphine equivalents (OME) prescribed to 652 patients upon hospital discharge after Cesarean section.

43 Bartels K et al.; Opioid Use and Storage Patterns by Patients after Hospital Discharge following Surgery. PLoSOne 2016

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45 Thank you!