THE PRESCRIPTION OPIOID EPIDEMIC: IN SEARCH OF MISSION CONTROL. G. Caleb Alexander, MD, MS November 11, 2014

Size: px

Start display at page:

Download "THE PRESCRIPTION OPIOID EPIDEMIC: IN SEARCH OF MISSION CONTROL. G. Caleb Alexander, MD, MS November 11, 2014"

Debra Weaver
5 years ago
Views:

1 THE PRESCRIPTION OPIOID EPIDEMIC: IN SEARCH OF MISSION CONTROL G. Caleb Alexander, MD, MS November 11, 2014

Disclosures and Funding Disclosures Consultant: IMS Health Chair, Food and Drug Administration, Peripheral and Central Nervous System (PCNS) Advisory Committee

2 Disclosures and Funding Disclosures Consultant: IMS Health Chair, Food and Drug Administration, Peripheral and Central Nervous System (PCNS) Advisory Committee Funding Agency for Healthcare Research and Quality National Heart, Lung and Blood Institute PhRMA Center for Disease Control and Prevention Robert Wood Johnson Foundation

3 What is the top selling drug in the U.S.? A. Aripiprazole (Abilify ) B. Sildafenil (Viagra ) C. Hydrocodone/APAP (Vicodin ) D. Atorvastatin (Lipitor ) E. Esomeprazole (Nexium ) F. Etanercept (Enbrel ) 3

4 4

5 5

6 6

8 Motor vehicle traffic, poisoning, and drug poisoning death rates of all intents, United States, " Motor"Vehicle"Traffic" Poisoning" Drug"Poisoning" Rate per 100,000 20" 15" 10" 5" 0" Source: National Center for Health Statistics Data Brief, Dec

9 Overdose deaths of all intents by major drug type, United States, ,000 Number of deaths 16,000 14,000 12,000 10,000 8,000 6,000 4,000 Opioid analgesic Cocaine Heroin 2,000 0 '99 '00 '01 '02 '03 '04 '05 ' Year Source: National Center for Health Statistics Data Brief, Dec

11 Baldwin G. Centers for Disease Control and Prevention.

12 Houston, we have a problem 12

13 Complex Problem Stakeholders Diversion Externalities Addiction Undertreatment Of Pain 13

14 National trends in treatment of patients with musculoskeletal pain, % Propor=on of pa=ents receiving therapy 50% 40% 30% 20% 10% 0% Opioids NSAIDs Acetaminophen Any analgesic treatment 14 Daubresse, et al. Medical Care

15 Similarities Between Illicit & Prescription Drugs Dr. Nora D. Volkow, Director, (NIDA) Na=onal Ins=tute of Health.

16 16 hqp://

17 17 youthresearchhub.com Alexander et al. JAMA

18 Rates of Prescription Opioid Sales, Death and Substance Abuse Treatment Admissions,

19 19 Joranson D. University of Wisconsin Pain and Policy Studies Group.

20 The Blind Man and the Elephant? Stakeholders Health insurers Prescribers Pharmacies Wholesalers Consumer groups Manufacturers Public health agencies Regulatory authorities Key issues Coverage determinations; costs of care; quality Prescriber autonomy; tension between regulatory oversight and ability for professional self-discipline Pharmacist autonomy; pressure to identify and intervene upon rogue prescribers or dispensaries Important role in supply chain; subject to fines and other legal action for support of pill-mills Access to therapies; historical under treatment of pain Marketing and promotion of therapies; effort to identify safer therapies less prone to abuse or diversion Availability of treatment services; costs for the safety net Monitoring and intervening at multiple steps of supply chain to reduce abuse 20

21 11/19/ 14 World Health Summit 21

22 Interventions Regulatory (FDA) Interventions Naloxone and Good Samaritan Laws Prescription Drug Take-Back Programs Prescription Drug Monitoring Programs 22

Regulatory Interventions Up-scheduling hydrocodone Labeling revisions Prescriber and patient education Risk Evaluation and Mitigation Strategies (REMS) Abuse

23 Regulatory Interventions Up-scheduling hydrocodone Labeling revisions Prescriber and patient education Risk Evaluation and Mitigation Strategies (REMS) Abuse deterrent formulations Treatments for opioid overdose and dependency Improved packaging and storage strategies to prevent abuse 23 Qato DM, Alexander GC. JAMA

24 24

25 11/19/ 14 25

26 Regulatory: Patient Education Medication Guides for long-acting opioids should be given to every patient who receives a prescription. FDA partners with outside organizations to help educate patients about the best uses of opioids. including DrugFree.org (formerly the Partnership for Drug Free America) and is a member of the National Council on Patient Information and Education. FDA maintains a website to educate patients on the appropriate disposal of opioids once they re no longer needed. Segal J

Abuse Deterrent Formulations Abuse-deterrent formulations target the known or expected routes of abuse, such as crushing in order to snort or dissolving in order to inject, for the

27 Abuse Deterrent Formulations Abuse-deterrent formulations target the known or expected routes of abuse, such as crushing in order to snort or dissolving in order to inject, for the specific opioid drug substance in that formulation. FDA considers the development of abuse-deterrent formulations to be a public health priority and is encouraging their development. Segal J

28 Types of Abuse Deterrence Type of Abuse Deterrence Physical Barrier Chemical Barrier Agonist/Antagonist Combina3on Aversion Alternate Route of Delivery/ Administra3on Prodrug Defini3on Prevents physical tampering such as chewing, cuyng, crushing, grinding, or gra=ng Resists extrac=on with common solvents such as water or alcohol Antagonist is released upon manipula=on, which reduces or defeats euphoric feeling Produces unpleasant and irrita=ng effects if drug is tampered or dosage is altered Method of drug administra=on, such as intramuscular injec=on or subcutaneous implant, disfavors abuse Biologically inac=ve un=l metabolized into an ac=ve form, usually in the gastrointes=nal tract Example(s) OxyCon=n OP, Opana ER, ReXista, DEXERx (COL- 003), TQ- 1015, Exalgo, Ultram ER Acurox, OxyCon=n OP, ReXista, DEXERx, Egalet Morphine, Ultram ER Talwin NX, Suboxone, Embeda, Oxytrex, OxyNal OXECTA, Acurox Probuphine NRP- 290 Lourenço, et al Expert Opin Drug Deliv. 2013;10:

29 Abuse-Deterrent Formulations Increased heroin use --- not really the goal N Engl J Med 2012; 367: July 12, /19/ 14 29

Naloxone/Good Samaritan Laws Intranasal naloxone Effective and low risk of lay administration Increasing support among professional organizations American Medical Association, June 2012 American

30 Naloxone/Good Samaritan Laws Intranasal naloxone Effective and low risk of lay administration Increasing support among professional organizations American Medical Association, June 2012 American Public Health Association, October 2012 United Nations Office on Drugs and Crime/WHO, June 2013 Good Samaritan Laws Washington State (RCW ) Current state of the matter No evidence concerning the impact of immunity provisions Law currently a barrier rather than facilitator of these programs 30 Mello MM, et al. AJPH

31 31 Fain KM, Alexander GC. AJPH

state Main goal of PDMPs is to reduce prescription drug diversion and abuse

32 Prescription Drug Monitoring Programs Collect, analyze, and report information on prescribing and utilization of prescription drugs within a state Main goal of PDMPs is to reduce prescription drug diversion and abuse Some PDMPs also fulfill educational and law enforcement roles Grant Baldwin. CDC

33 Prescription Drug Monitoring Programs Evidence that PDMPs are associated with: Decrease in prescriptions (Sigler 1984; Simeone 2007) Decrease in rates of drug abuse (Reisman 2009) Decrease in doctor shopping (Pradel 2007) No reduction in mortality rates (Paulozzi 2011) Many, many limitations of prior analyses PDMP Feature Year operational Governing agency Schedules monitored Proactivity Operating costs Non-participation penalties Definition and/or basis for policy interest There may be a substantial lag between enactment and operationability Ranges from consumer protection to health departments to enforcement May include state schedules (e.g., tramadol) in addition to federal ones Ability to routinely search for unusual dispensing, prescribing or utilization Wide variation in investments made in these programs Criminal penalties or sanctions against pharmacies failing to submit data 33

34 Drug Overdose Death Rates by State, 2008

35 35

37 Informing Evidence with Action Scaling up evidence-based interventions; rapidly implementing and evaluating promising policies and programs; searching for new solutions Intervening Comprehensively All along the supply chain; clinic, community and addiction treatment settings; primary, secondary and tertiary prevention strategies; creating synergies across different interventions Promoting appropriate and safe opioid use Reducing overuse; focus attention on safe use, storage and disposal of these products; optimizing use in accordance with best practices 37

38 Working Groups 1. Engineering strategies that address drugs and their packaging - Implementing greater access and dosing controls through packaging; Expanding warnings on prescription bottles regarding potential risks 2. Prescribing - Enhanced prescription counseling in clinical settings; Validating highrisk controlled substance score; Enhancing clinical policies re: opioid use in military; Expanding PBM products to support primary and secondary prevention 3. Prescription drug monitoring programs - Improving the use and effectiveness of PDMPs, such as by requiring mandatory use or linking with payers 4. Naloxone distribution - Mandating co-prescription of naloxone with high-dose opioids; Improving naloxone availability and administration 5. Community-based prevention initiatives Media training; Expanding primary prevention in community; Take-back programs to reduce over-supply; Law enforcement strategies for reducing opioid use 6. Other - Improving warm hand-offs and continuity following clinical treatment; Expanded access to treatment for opioid dependency 38

40 CDC MMWR. May 14, 1999/Vol. 48/No. 18.

41 42

A LOOK AT ABUSE-DETERRENT OPIOIDS

A LOOK AT ABUSE-DETERRENT OPIOIDS JULY 2017 Drugs Under Review ICER s report reviewed evidence on ten abuse-deterrent formulations (ADF) of opioids. Nine of the drugs were extended release (ER) opioids, and one was immediate release (IR).