5/16/2016. Roadmap. Legal Competencies. Prescription Drug Overdose at Epidemic Levels

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1 Legal & Policy Approaches to Reducing Prescription Drug Overdose Disclaimer Funding for this activity was made possible (in part) by the Centers for Disease Control and Prevention. The views expressed in activity materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services, nor does the mention of trade names, commercial practices, or organizations imply endorsement by the U.S. Government. Written materials for this activity were supported by the Cooperative Agreement Number 1U38OT from the Centers For Disease Control and Prevention, Office for State, Tribal, Local and Territorial Support. Healthier communities for all through better laws and policies. 1

2 Roadmap 1. Overview of overdose epidemic 2. Legal interventions 3. Prescription Monitoring Programs 4. Best Practices Legal Competencies Identify legal tools, processes, and enforcement procedures to advance community public health goals that are consistent with relevant state, tribal, local, and/or territorial laws. Centers for Disease Control and Prevention, 2014 Prescription Drug Overdose at Epidemic Levels 2

3 Corey Davis, JD, MSPH Deputy Director Network for Public Health Law's Southeastern Region Provides legal technical assistance to public health officials, practitioners, and the public Studies effects of law and legal practice on public health outcomes Expert in legal efforts to reduce drug harm, including overdose Learning objectives 1. Describe the prescription drug overdose epidemic in the United States 2. Understand the continuum of responses to opioid overdose 3. Explainlegal, regulatory, and policy responses to the epidemic 4. Examinebest practices for prescription monitoring programs and naloxone access 5. CAPE Objective: Promote health improvement, wellness, and disease prevention in cooperation with patients, communities, at-risk populations, and other members of an interprofessional team of health care providers Overview of the opioid pain reliever overdose epidemic Deborah Dowell, MD, MPH May 20, 2014 The findings and conclusions in this report are those of the author and do not necessarily represent the official position of the Centers for Disease Control and Prevention/the Agency for Toxic Substances and Disease Registry. The presenter has no conflicts of interest to report. 3

4 Motor vehicle traffic and drug overdose death rates, United States, Deaths per 100,000 population motor vehicle traffic deaths drug overdose deaths Year NCHS Data Brief, December, Updated with 2009 and 2010 mortality data. Drug overdose deaths by major drug type United States, ,000 16,000 14,000 opioid pain relievers Number of deaths 12,000 10,000 8,000 6,000 4,000 2,000 cocaine benzodiazepines heroin Year CDC, National Center for Health Statistics, National Vital Statistics System, CDC Wonder. Updated with 2010 mortality data. Opioid pain reliever-related overdose deaths increasing at a faster rate than deaths from any major cause % change in number of deaths, United States, Rx opioid overdose Alzheimer's Hypertension Parkinson's Disease Nephritis Suicide Liver Disease Chronic Lower Respiratory disease Septicemia HIV Malignant Neoplasms Pneumonitis Diabetes Mellitus 0% Homicide -3% Perinatal Period -14% Heart disease -16% Motor vehicle traffic -22% Cerebro-vascular -23% Influenza & Pneumonia -23% Aortic Aneurysm -34% 47% 40% 36% 31% 20% 13% 11% 7% 4% 2% 68% 276% -50% 0% 50% 100% 150% 200% 250% 300% WISQARS, 2000 and 2010; CDC/NCHS, National Vital Statistics System 4

5 Middle-aged adults are at greatest risk for drug overdose in the US Deaths per 100,000 population Death rates by age CDC/NCHS, National Vital Statistics System Drug overdose death rate 2008 and opioid pain reliever sales rate 2010 Kg of opioid pain relievers used per 10,000 Age-adjusted rate per 100,000 National Vital Statistics System, DEA s Automation of Reports and Consolidated Orders System Prescriptions filled and opioid pain reliever overdose deaths New York City, Rates of hydrocodone and/or oxycodone filled by NYC neighborhood Rates of unintentional opioid pain reliever overdose deaths by NYC neighborhood *Paone D, Bradley O Brien D, Shah S, Heller D. Opioid analgesics in New York City: misuse, morbidity and mortality update. Epi Data Brief. April Available at 5

6 Opioid overdose deaths, sales, and treatment admissions, United States, Opioid Sales KG/10,000 Opioid Deaths/100,000 Opioid Treatment Admissions/10, Rate Year CDC. MMWR Updated with 2009 mortality and 2010 treatment admission data. Half of US opioids market is treatment for chronic, non-cancer pain JAMA 2011;305:

7 Patients receiving high doses of opioid pain relievers account for disproportionate share of overdoses 100% 90% 80% multiple doctors, high doses one doctor, high dose multiple doctors, high doses 70% 60% Percent 50% 40% one doctor, lower dose one doctor, high dose 30% 20% 10% one doctor, lower dose 0% patients receiving opioid pain relievers patients overdosing with opioid pain relievers CDC Grand Rounds: Prescription Drug Overdoses a U.S. Epidemic. MMWR Weekly. January 13, 2012 / 61(01); Opioid pain reliever overdose deaths: key points Increasing at a faster rate than deaths from any major cause in the United States Increasing dramatically along with increased prescribing of opioid pain relievers Patients receiving opioids at high doses and from multiple prescribers at highest risk Question Overdose deaths have increased by approximately what percentage in the past 3 decades? A. 200% B. 400% C. 600% D. 800% 7

8 Question Overdose deaths have increased by approximately what percentage in the past 3 decades? A. 200% B. 400% C. 600% D. 800% Roadmap 1. Overview of overdose epidemic 2. Legal interventions 3. Promising Practices Overdose Prevention Continuum Reducing improper prescribing Use of PMPs with best practices More non-opioid therapy Pharmacy lock-in where appropriate Prescriber and dispenser education Modification of insurance incentives (e.g. methadone as first-line pain treatment) Enforcement efforts Addressing addiction Patient education Increased $ and insurance coverage for evidence-based treatment Acknowledgement of addiction as medical condition Jail diversion programs Improving access to overdose care Increased naloxone access for: community members first responders Good Samaritan 911 legislation Law enforcement education 8

9 Policy & the Continuum of Risk Risk Prescribing Rules, PMPs Risk Evidence-Based Addiction Treatment, Patient Review & Restriction Programs Risk 9

10 Naloxone & Good Samaritan Laws Risk Prescription Monitoring Programs (PMPs) How can PMPs help address overdose? Reduce over-prescribing Improve surveillance Coordinate care 10

11 PMP Walkthrough PMP Patient PCP Pharmacist States with PMP Enabling Legislation Total Number of States (and DC) Question The main way PMPs are useful is in identifying doctor shoppers and others who are fraudulently obtaining prescriptions, and referring them to law enforcement. A: True B: False 11

12 Question The main way PMPs are useful is in identifying doctor shoppers and others who are fraudulently obtaining prescriptions, and referring them to law enforcement. A: True B: False A note on the maps All of the white background maps in this presentation were created by and are used with permission of the National Alliance for Model State Drug Laws. For updated versions of these maps, please visit 12

13 Data Privacy Identified data tightly controlled Medical professionals Law enforcement Regulatory agencies Data privacy protections Strong penalties for improper use & access Roadmap 1. Overview of overdose epidemic 2. Legal interventions 3. Promising Practices 13

14 PMP Best Practices: The Big 5 Best Practice #1 Monitor all federally controlled drugs as well as other drugs of abuse 14

15 Best Practice #2 Proactively provide data to authorized users 15

16 Best Practice #3 Ensure that data is timely & easily accessible 16

17 Best Practice #4 Ensure that all authorized users are trained on PMP goals and usage 17

18 Best Practice #5 Use de-identified data to reveal trends & evaluate PMP 10 PMP Promising Practices Mandatory registration & (at least in some cases) use Dedicated funding mechanisms Linkage to addiction treatment professionals 18

19 Slide Updated Derek Carr, 3/20/2015

20 11 Question As of 2015, all states have prescription monitoring programs. A: True B: False Question As of 2015, all states have prescription monitoring programs. A: True B: False 19

21 Slide Updated Derek Carr, 3/20/2015

22 PMP Evidence Base Some evidence that PMPs can: Inform sound clinical prescribing decisions Reduce doctor shopping Assist medical examiner practice Reduce insurer claims related to inappropriate prescribing Provide non-patient-specific surveillance Naloxone Access Laws Naloxone & Good Samaritan Laws Risk 20

23 What is Naloxone? Prescription medication Not a controlled substance No abuse potential Extremely good risk profile What is Naloxone? Reverses effects of opioid overdose Reverses respiratory depression, hypotension, sedation Restores breathing Reverses analgesia May precipitate withdrawal Can be given intramuscularly or via nasal spray Barriers to Naloxone Access Prescribers in short supply Physician visits can be prohibitively expensive Bystanders often fail to summon first responders First responders do not always have naloxone 21

24 Question Naloxone can be used to get high, so it s important that it be carefully monitored. A: True B: False Question Naloxone can be used to get high, so it s important that it be carefully monitored. A: True B: False Naloxone Access/Good Samaritan Best Practices: The Big 4 22

25 Best Practice #1 Limit liability for naloxone prescribers & administrators acting in good faith Question The liability risk to medical professionals for prescribing or dispensing naloxone, or to laypeople for administering it, is higher than the risk associated with other medications. True False Question The liability risk to medical professionals for prescribing or dispensing naloxone, or to laypeople for administering it, is higher than the risk associated with other medications. True False 23

26 Best Practice #2 Permit 3 rd party prescription & prescription via standing order; encourage co-prescription and collaborative practice Best Practice #3 Provide criminal immunity to Good Samaritans who report overdose in good faith Question It is always illegal for a doctor to prescribe a medication outside of the doctor/patient relationship. A: True B: False 24

27 Question It is always illegal for a doctor to prescribe a medication outside of the doctor/patient relationship. A: True B: False Best Practice #4 Modify scope of practice so that trained first responders can administer naloxone Support for Increased Naloxone Access American Medical Association American Pharmaceutical Association American Public Health Association American Society of Addiction Medicine Attorney General of the United States National Association of Drug Diversion Investigators Office of National Drug Control Policy U.S. Conference of Mayors 25

28 Parting Thoughts Coordination Evaluation Evidencebased Practices Resources CDC National Center for Injury Prevention and Control CDC Public Health Law Program The National Alliance for Model State Drug Laws The Network for Public Health Law PDMP Center of Excellence, Brandeis University The PDMP Training and Technical Assistance Center, Brandeis University How to reach us Corey Davis, JD, MSPH Deputy Director The Network for Public Health Law (919) x105 26

29 CDC DISCLAIMER These course materials are for instructional use only and are not intended as a substitute for professional legal or other advice. While every effort has been made to verify the accuracy of these materials, legal authorities and requirements may vary from jurisdiction to jurisdiction. Always seek the advice of an attorney or other qualified professional with any questions you may have regarding a legal matter. The contents of this presentation have not been formally disseminated by the Centers for Disease Control and Prevention and should not be construed to represent any agency determination or policy. Thank You For Attending Our Training! To ensure successful completion of this module, you are required to take the post-assessment. At the end of this training, you will be directed to the CDC TRAIN website. Once you re back in TRAIN, click the post-assessment link that will appear in your dashboard, in the My Actions section. If you have questions, please us at info@changelabsolutions.org or call us at Image Attribution Slide 1: Creative Commons Flickr/Tulane Public Relations Slide 4 & 5: Creative Commons Flickr/Magic Madzik Slide 6: StockMonkeys.com Slide 8: Creative Commons Flickr/wwarby Slide 29: Creative Commons Flickr/Charles Williams Slides 30, 31, 32, 60, & 70: Microsoft clip art Slides 34, 36, 39-41, 43, 45, 46, 48, 50, 52: The National Alliance for Model State Drug Laws, March 2014 Slide 33: Creative Commons Flickr/Karen_O D Slide 37 & 59: Creative Commons Flickr/.reid Slide 38: Creative Commons Flickr/Michael Chen, Fillmore Photography Slide 42: Creative Commons Flickr/Mercy Health Slide 44: Creative Commons Flickr/woodleywonderworks Slide 47: Creative Commons Flickr/Mercy Health Slide 49: Microsoft clip art Slides 53 & 68: Creative Commons Flickr/Jason Rogers Slide 54: CBS News Slides 56 & 64: Creative Commons Flickr/PunchingJudy 27

30 Image Attribution (continued) Slide 57: From How to Use EVZIO, Kaleo, inc Slide 58: Creative Commons Flickr/LisaW123 Slide 61: Creative Commons Wikimedia Commons/Intropin upload.wikimedia.org/wikipedia/commons/0/0e/naloxone_%281%29.jpg Slide 62: Creative Commons Flickr/Dominik Syka Slide 63: Creative Commons Flickr/pasa47 Slide 65: Creative Commons Wikimedia Commons/Georges Biard upload.wikimedia.org/wikipedia/commons/f/f5/philip_seymour_hoffman_2011.jpg Slide 72: Photo by Tim Wagner for Partnership for the Public s Health Slide 73: Creative Commons Flickr/austinevan Slide 74: Creative Commons Flickr/splityarn Slide 75: Creative Commons Flickr/giulia.forsythe 28