HYDROCODONE RESCHEDULING AND MEDICAL MARIJUANA Lynn R. Webster, M.D. Vice President of Scientific Affairs PRA Health Sciences Salt Lake City, UT [email protected] (801) 892-5140 www.LynnWebsterMD.com Twitter: @LynnRWebsterMD 12-Month Financial Disclosures • AstraZeneca • Mallinckrodt • Cara Therapeutics • Marathon Pharmaceuticals • Charleston Laboratories • Merck • Collegium Pharmaceuticals • Orexo • Depomed • Pfizer • Egalet • Inspirion Pharmaceuticals • Insys Therapeutics • Kaléo Pharmaceuticals Updated 10/1/15 • Proove Biosciences • Signature Therapeutics • TEVA • Trevena • Zogenix The Impact of Hydrocodone Rescheduling in People With Pain: The First 100 Days Jan F. Chambers1, Rae Marie Gleason1, Kenneth L. Kirsh2, Bob Twillman3, Lynn Webster4, Jon Berner5, Steven D. Passik2 1National Fibromyalgia & Chronic Pain Association (NFMCPA); 2Millennium Research Institute; 3American Academy of Pain Management; 4PRA Health Sciences; 5Woodinville Psychiatric Background • On October 6, 2014, the DEA rescheduled hydrocodone products from Schedule III to Schedule II in an effort to curb abuse • The NFMCPA partnered with health care professionals (HCPs), PRA Health Sciences, the AAPM, and MRI to create a survey to track the rescheduling consequences on patients’ lives during the first 100 days Abbreviations: AAPM, American Academy of Pain Management; DEA, Drug Enforcement Administration; MRI, Millennium Research Institute. Materials and Methods • Survey • Cross-sectional, anonymous, blinded • IRB approved through Aspire IRB, Santee, California • Administered online via SurveyMonkey® • Explored patients’ experiences after hydrocodone rescheduling Abbreviation: IRB, institutional review board. Materials and Methods (cont’d) • Participants • Recruited via newsletters, e-mails, Web pages, and social media by the NFMCPA, the U.S. Pain Foundation, and other patient organizations • Eligibility requirements • >18 years of age • Had been prescribed hydrocodone • Survey dates • Launched: February 5, 2015 • Closed: April 3, 2015 Respondent Demographics Primary Pain Site 6420 Total Participants 53% 90% Caucasian 59% Married 19% 61% Private Insurance 90% Women 82% At Least Some College Global body Leg Lower back Pelvis Neck Other Respondent Demographics (cont’d) Age Employment Status 35 50 % of Respondents % of Respondents 30 25 20 15 10 40 30 20 10 0 5 0 18-24 25-34 35-44 45-54 55-64 65-74 Age, y Abbreviations: FT, full-time; PT, part-time. 75+ Duration of Hydrocodone Use 18% >1 year 1 year or less 82% • 38% of patients who had been on hydrocodone for at least 1 year had required at least 1 dose escalation Hydrocodone Use After Rescheduling 13% borrowed hydrocodone because they were unable to refill their prescriptions 18% borrowed hydrocodone to supplement their prescribed supply Prescribing Changes After Rescheduling Change in Hydrocodone Prescribinga None Dose lowered Dose lowered with intent to discontinue Immediate discontinuation with no substitute Alternative drug prescribed a Most commonly reported changes are shown. Reponses, No. (%) 2296 (39.0) 501 (8.5) 343 (5.8) 525 (8.9) 873 (14.8) Changes After Hydrocodone Rescheduling 62% used marijuana 47% consumed alcohol Hydrocodone Discontinued (n=1628) 8% used illicit drugs 66% borrowed medications Impact of Rescheduling Impact on Patients Reponses, No (%) Increased frequency of HCP visits 3699 (64.2) Increased expenditures on prescriptions 3301 (57.4) Increased sense of stigma about being a pain patient 2984 (51.8) Worsened relationship with HCP 1007 (17.5) Unable to get prescription filled 883 (15.4) Experienced withdrawal (difficulty getting pharmacy to fill prescription) 598 (10.4) Experienced withdrawal (difficulty physically getting to pharmacy) 416 (7.2) Note: Percentages are based on total number of responses for each survey question. Not all participants responded to all questions. Reasons for Refusal to Fill Prescriptions Not enough medication in stock No hydrocodone in stock National shortage of medication Pharmacy no longer stocking hydrocodone No reason given Pharmacist believed dose was inappropriate Pharmacist believed medication was inappropriate Other 0 5 10 15 20 25 30 % of Respondents 35 40 45 Pharmacy Issues 3% of pharmacists refused to submit hydrocodone claims to an insurance company 9% of pharmacists asked respondents to pay cash for prescriptions Alternative Opioids Prescribed Other (30.2%) Oxycodone (16.7%) None (30.4%) Tramadol (22.7%) Patient Perspectives on Fairness Patient Perspective on Regulatory Changes Reponses, No. (%)a Deny chronic pain patients their right to adequate treatment 4288 (88.0) Will not hinder addicts in their quest to acquire illegal prescription drugs 3673 (75.3) Will not hinder criminals in acquiring and distributing illegal prescription drugs 3618 (74.2) Harmful to people with chronic pain 3568 (73.2) Result in prescription of less effective medications for patients with chronic pain (so doctors can avoid legal hassles) 3427 (70.3) Have increased my cost of care 2280 (46.8) a Participants could select >1 response. Missed Work Increased pain (76%) Missed Work Because of Hydrocodone Rescheduling (n=801) Increased number of HCP visits (71%) More time spent getting prescriptions filled (29%) Additional Consequences of Rescheduling 19% 27% Qualitative Data The hydrocodone rescheduling “makes legitimate chronic pain sufferers feel as though they are criminals,” and “All we want is to live life pain-free and be our normal selves again without being treated like pill addicts.” Survey Limitations • Sampling bias – Recruitment via patient advocacy Web sites – May impact generalizability of findings • Men not well represented Conclusions • Negative consequences of hydrocodone rescheduling • Increased pain • Withdrawal symptoms • Inconvenience • Increased cost • Stigma • Alienation from physicians and pharmacists MEDICAL MARIJUANA Prevalence of Marijuana Use Lifetime Marijuana/Hashish Use 100% 80% 60% 52% 46% 40% 20% 16% 0% Ages 12 to 17 Ages 18 to 25 National Institute on Drug Abuse. http://www.drugabuse.gov/drugs-abuse/marijuana. Accessed September 18, 2015. Ages 26 or Older Marijuana Substance Abuse Number of Adolescents Admitted to Publically Funded Substance Abuse Treatment Facilities on a Typical Day 300 266 250 200 150 100 58 50 12 0 Marijuana Alcohol 10 3 Heroin or Stimulants Cocaine Other Opiates 8 Other Drugs Substance Abuse and Mental Health Services Administration. The CBHSQ Report: A Day in the Life of American Adolescents: Substance Use Facts Update. Rockville, MD: Center for Behavioral Health Statistics and Quality; 2013. Legal Status of Marijuana • Illegal at the federal level (classified as Schedule I by the DEA) Bryn B; American Association for the Advancement of Science. http://www.aaas.org/news/cannabis-new-frontier-therapeutics. Published February 15, 2015. Accessed September 18, 2015. Cannabinoids in Marijuana • >100 cannabinoids in marijuana • Major cannabinoids: cannabidiol (CBD) and tetrahydrocannabinol (THC) CBD-type cannabinoids (noneuphoriant) Elsohly MA, Slade D. Life Sci. 2005;78(5):539-548. Δ8-trans-THC-type cannabinoids (euphoriant) Trend Toward Increased THC and Decreased CBD in Illicit Marijuana Burgdorf JR, Kilmer B, Pacula RL. Drug Alcohol Depend. 2011;117(1):59-61. Targets of Cannabinoids Abbreviations: CB1, cannabinoid receptor type 1; CB2, cannabinoid receptor type 2. Peak Pharmaceuticals. http://peakpharma.com/science/overview/. Accessed September 18, 2015. Signaling via Central CB1 Receptor Hill MN, Patel S. Biol Mood Anxiety Disord. 2013;3(1):19. EVIDENCE IN THE LITERATURE OF THE EFFICACY AND SAFETY OF MEDICAL MARIJUANA CBD Decreased Vomiting Induced by Lithium Chloride Mean Number of Vomiting Episodes Vehicle (n=14) *p<0.05 vs other groups in study (not all shown). Rock EM, et al. Br J Pharmacol. 2012;165(8):2620-2634. CBD (n=16) CBD Attenuated Mucosal Damage in a Human Colonic Explant Model Luminal Epithelial Damage (%) Control Incubation IL-17A Control Abbreviations: AEA, anandamide; IL, interleukin. ****p<0.0001 vs incubation control; †††p<0.001 vs IL-17A; ††††p<0.0001 vs IL-17A. Harvey BS, Sia TC, Wattchow DA, Smid SD. Cytokine. 2014;65(2):236-244. IL-17A + AEA IL-17A + hydrocortisone IL-17A + CBD Summary of Randomized Controlled Studies on Cannabinoids and Pain Jensen B, Chen J, Furnish T, Wallace M. Curr Pain Headache Rep. 2015;19(10):524. Summary of Randomized Controlled Studies on Cannabinoids and Pain (cont’d) Jensen B, Chen J, Furnish T, Wallace M. Curr Pain Headache Rep. 2015;19(10):524. Cannabinoids in Pain, Meta-analysis Note: Nabiximols contain THC and CBD. Whiting PF, et al. JAMA. 2015;313(24):2456-2473. Cannabinoid Safety, Meta-analysis *Incidence rate = events/person-years. The number of person-years was 445 for cannabinoid exposure and 239 for control. Wang T, Collet JP, Shapiro S, Ware MA. CMAJ. 2008;178(13):1669-1678. Cannabinoid Safety, Meta-analysis (cont’d) *Incidence rate = events/person-years. The number of person-years was 445 for cannabinoid exposure and 239 for control; †For both cannabinoid exposure and control, all events in this category were classified as “altered mood”; ‡Due to myocardial ischemia. Wang T, et al. CMAJ. 2008;178(13):1669-1678. Cannabinoid Safety, Meta-analysis (cont’d) *Classified according to Medical Dictionary for Regulatory Activities. Wang T, et al. CMAJ. 2008;178(13):1669-1678. THE IMPACT OF MEDICAL MARIJUANA ON OPIOID ABUSE Reductions in Death From Opioid Overdose After Medical Marijuana Was Legalized Bachhuber MA, Saloner B, Cunningham CO, Barry CL. JAMA Intern Med. 2014;174(10):1668-1673. Impact of Medical Marijuana Dispensaries Treatment Admission for Opioid Pain Reliever Addiction Opioid Overdose Deaths Powell D, Pacula RL, Jacobson M. Do Medical Marijuana Laws Reduce Addictions and Deaths Related to Pain Killers? Cambridge, MA: National Bureau of Economic Research; 2015. THE FUTURE OF MEDICAL MARIJUANA Evolving Public Opinion Pew Research Center. http://www.people-press.org/2013/04/04/majority-now-supports-legalizing-marijuana/. Published April 4, 2013. Accessed September 21, 2015. Options for Improved Regulation • Hold medical marijuana to the same standards as other drugs • Standardize • Ensure quality control • More consistently control THC and CBD content Summary/Next Steps for Medical Marijuana • Cannabinoids are a promising therapeutic option for pain and other therapeutic areas • Additional rigorous research is needed • Legalization facilitates investigations of efficacy and safety The Painful Truth • Available now for purchase from online and local retailers • Find out more at thepainfultruthbook.com • Watch for “The Painful Truth” Documentary to be released late Fall 2015! Thank You! [email protected] Twitter: @LynnRWebsterMD www.LynnWebsterMD.com
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