1. Law as Barrier to and Facilitator of Opioid Overdose Prevention Corey Davis, JD, MSPH Cross-System Collaboration to Respond to the Prescription Drug Epidemic November 12, 2012

2. Required Disclosure I have no disclosures to report.

3. Objectives  Provide an overview of legal and regulatory barriers to naloxone access  Describe interventions to reduce opioid overdose death via  Increased access to naloxone (“naloxone access laws”)  Increased access to emergency responders (“Good Samaritan laws”)  Other promising legal and regulatory strategies

4. Overview  Fatal opioid overdose is at epidemic levels  Opioid overdose death is largely preventable  Long period in which reversal is possible  Reversal easily accomplished w/ naloxone  Law and regulation are a barrier to naloxone access  Amending law and regulation to improve naloxone access is an effective and cost-effective intervention

5. Law as barrier to naloxone access  Barrier 1: Civil/Regulatory  Prescription status  Not a controlled substance  No abuse potential  Extremely good risk profile  Patients can only receive prophylactically from professional w/ prescription privileges  Prescribers are in short supply  Physician visits can be prohibitively expensive, particularly for uninsured/underinsured

6. Law as barrier to naloxone access  Barrier 1: Civil/Regulatory  In Ohio, patients in acute overdose can receive only from AEMT or EMT-Ps  EMR or EMT-Bs may be first responders, particularly in rural areas  Lack of availability may increase stigma and reduce knowledge

7. Law as barrier to naloxone access  Barrier 1: Civil/Regulatory  Prescriber concerns re: civil and professional liability  Evidence suggests risk is extremely low, but perceived risk is real barrier  Samaritan concerns re: civil liability  In general, existing Good Samaritan laws provide protection, but perceived risk may affect action

8. Law as barrier to naloxone access  Barrier 2: Criminal  Bystanders w/ naloxone may fear criminal sanctions for its use  Unauthorized practice of medicine  Possession of prescription drug (naloxone) w/o prescription  Bystanders w/o naloxone may fear calling 911  Fear arrest for drug possession, outstanding warrants or other reasons  Lots of evidence that this fear is both real and justified  Existing evidence mainly from heroin, but no reason to believe any different for prescription opioids

9. Removal of law as barrier  All of these legal/regulatory barriers are unintended consequences of attempts to address other problems  Unfortunately, they have an extraordinarily severe side effect: thousands of preventable deaths per year  Luckily, they can be easily modified to remove that side effect while maintaining original intent of laws/regulations

10. Critical Opportunity: Increase access  Remove the possibility of civil and professional penalties for prescribers and administrators acting in good faith  Remove the possibility of criminal penalties for prescribers and administrators acting in good faith  Explicitly endorse 3 rd party prescription  As of Oct. 15, 2012, 8 states (NM, NY, IL, WA, CA, RI, CT and MA) have explicitly amended law to increase access

11. Example Language  Naloxone or other opioid antagonist may lawfully be prescribed and dispensed to a person at risk of experiencing an opiate-related overdose or a family member, friend or other person in a position to assist a person at risk of experiencing an opiate-related overdose. For purposes of this chapter and chapter 112 [governing professional licensing and registration], any such prescription shall be regarded as being issued for a legitimate medical purpose in the usual course of professional practice. 2012 Mass. Acts 192 (2012)

12. Example Language  (a) A person may administer an opioid antagonist to another person if: 1) He or she, in good faith, believes the other person is experiencing a drug overdose; and (2) He or she acts with reasonable care in administering the drug to the other person. (b) A person who administers an opioid antagonist to another person pursuant to this section shall not be subject to civil liability or criminal prosecution as a result of the administration of the drug. 2012 R.I. Pub. Laws 251 (2012)

13. States w/ naloxone access laws

14. Critical Opportunity: Good Sam  Existing Good Samaritan laws provide protection from civil liability  But overdose bystanders are mainly worried about criminal penalties  Enter the overdose Good Samaritan law  Modeled after alcohol Good Sam policies now enacted on many college campuses  As of Oct. 15, 2012, ten states (NM, WA,  NY, CT, IL, CO, RI, FL, MA and CA) have passed overdose Good Sam laws

15. Example Language  (1) A person acting in good faith who seeks medical assistance for an individual experiencing a drug-related overdose may not be charged, prosecuted, or penalized pursuant to this chapter for possession of a controlled substance if the evidence for possession of a controlled substance was obtained as a result of the person’s seeking medical assistance. (2) A person who experiences a drug-related overdose and is in need of medical assistance may not be charged, prosecuted, or penalized pursuant to this chapter for possession of a controlled substance if the evidence for possession of a controlled substance was obtained as a result of the overdose and the need for medical assistance. (3) Protection in this section from prosecution for possession offenses under this chapter may not be grounds for suppression of evidence in other criminal prosecutions. 2012 Fla. Laws 36 (2012)

16. States w/ drug overdose Good Sam laws

17. Discussion  Changes are popular and have seen rapid uptake  Almost no organized opposition, good deal of law enforcement support

18. Discussion  “[Good Samaritan] laws are cost effective because they save investigative resources in the long run…The fact is that when most people witness an overdose, they’ll try all kinds of bizarre, dangerous ways to revive a person, sometimes based off things they saw on TV. We want them to call 911 and Good Samaritan laws remove the fear of calling for help in most cases…Addiction can happen to anyone – your brother, daughter, sister, son…if we can save one life, it’s worth it.”  - Det. Gary Martin, Palm Beach County Sheriff's Office  "Let's say two teens are sniffing spray paint and one has adverse reaction and goes into shock. Do you want that other child to ignore them for fear of arrest because of sniffing misdemeanor? Allowing them to call 911 [through Good Samaritan laws] is not condoning their behavior, it's just letting them get help."  – Assistant Chief Jim Pugel, Seattle Police Dep’t.

19. Discussion  Related promising regulatory changes  Permitting EMT-Bs to carry and administer naloxone  Talk about low-hanging fruit!  Standing orders for lay dispensing  Currently in place in CA, MA  Co-prescription as standard of care  State medical/pharmacy board  Changing law is not magic bullet  Change requires engagement with and action from public health and elected officials, the medical and treatment communities, law enforcement, clergy, community groups, etc.

20. Conclusion  Common sense and emerging evidence suggest that laws that make it easier for lay people to access naloxone, administer naloxone, and summon emergency assistance in the event of overdose can save lives and resources  Since such laws have possibility to save thousands of lives annually and no readily apparent downside, they should be enacted widely and with haste  As with all policy interventions, results should be independently and rigorously evaluated

21. Questions? Corey Davis, JD, MSPH Staff Attorney Network for Public Health Law cdavis@networkforphl.org