Policy Elements of Community Overdose Prevention

Policy Elements of Community Overdose Prevention Scott Burris Temple University Beasley School of Law & The Center for Law and the Public’s Health/Johns Hopkins Bloomberg School of Public health A CDC/WHO/PAHO Collaborating Center

Overview • Prescribing and dispensing naloxone to opiod drug users at risk of overdose • Prescribing naloxone to lay “savers” who are not themselves at risk of opiod overdose • Legal problems • Statutory and practical solutions • Removing barriers to seeking help • Addressing the community “risk environment” • Statutory solutions

Law: The Simple Part • Naloxone is NOT a controlled substance • No DEA license is required to prescribe ≠

Law: The Simple Part • Naloxone is a prescription drug like any other • The general rules that apply to any prescription apply to naloxone – and no more =

Prescribing Naloxone: No Legal Problems    Provider is licensed to prescribe Recipient is a “patient” at risk of opioid overdose Pharmacist fills valid prescription Don’t tell my Mom

Prescribing Naloxone: No Legal Problems    Provider is licensed to prescribe Recipient is a “patient” at risk of opioid overdose Provider dispenses the medication Don’t tell my Mom

Teaching Others to Help the Patient is Fine • “Injection partners” • Family members, friends • As long as the patient/recipient is at risk of OD Technically, only a licensed professional can administer prescription medicines, but in real life it obviously happens all the time.

Trial Lawyers? No Worries! • We’ve been watching for years and have not come across even one lawsuit against a health care provider for prescribing naloxone in or outside of an OD prevention program • No reason to see this as a serious risk • Might be riskier NOT to prescribe it…

It Gets More Complicated when the Recipient is a Non-Using Good Samaritan  ? Practicing medicine without a license? Recipient administers naloxone to OD victim Provider is licensed to prescribe Recipient is not at risk of opioid overdose Never touch the stuff. Hey, J.D. stands for Doctor of law

Enlisting Savers • Just do it. • Work with the authorities • In an opinion issued to the Baltimore health commissioner, the state Attorney General suggested that the commissioner “appeal to the appropriate prosecuting and regulatory agencies to exercise their prosecutorial discretion to permit the Health Department to operate a pilot program without fear of prosecution.”

Insect Sting Analogy • Many states have laws allowing this: • Notwithstanding any other law, a person may administer epinephrine to another person who is suffering from a severe allergic reaction if the person acts in good faith and without compensation for the act of administering the epinephrine and a health professional who is qualified to administer epinephrine is not immediately available. --Arizona Rev .Stat. § 36-2226

Enlisting Savers • Pass a New Mexico or NY-style law: • Creates a program model • Authorizes training/certification of lay people to act as savers • Authorizes lay administration of naloxone • Provides immunity for those acting in good faith and with reasonable care • Potential disadvantages: • Enshrines one model of intervention in law • May prevent innovation, especially lower-threshold models

Enlisting Savers • The no-authorization but no punishment approach • Bills in IL and RI are simply immunizing from criminal or civil (licensure) action • Licensed health care providers who prescribe or dispense naloxone to savers • Savers who possess and/or administer the drug to save a life

The Risk Environment -- or the Community Health Network Drug Rx Programs Licensing Boards Pain & Palliative Care Police Pharmacists Prisons Prosecutors SEPs Users EMTs Peers ER staff

The Risk Environment or the Community Health Network Drug Rx Programs Licensing Boards Pain & Palliative Care Police Prisons Pharmacists Prosecutors SEPs Users EMTs Peers/family ER staff

The Risk Environment or the Community Health Network Licensing Boards • Peers may not call 9-1-1 • Fear that police may come with EMTs and arrest bystanders for • Drug possession • Paraphernalia possession • Drug distribution • Or may confiscate drugs and syringes Police Prosecutors Users Peers/family

Licensing Boards Police Prosecutors Users Peers/family Or prosecutors can refuse to pursue cases

“Good Samaritan” Legislation N.M. Stat. Ann. 1978, § 30-31-42 (West 2007): OVERDOSE PREVENTION--LIMITED IMMUNITY.-- A. A person who, in good faith, seeks medical assistance for someone experiencing a drug-related overdose shall not be charged or prosecuted for possession of a controlled substance pursuant to the provisions of Section 30-31-23 NMSA 1978 if the evidence for the charge of possession of a controlled substance was gained as a result of the seeking of medical assistance. B. A person who experiences a drug-related overdose and is in need of medical assistance shall not be charged or prosecuted for possession of a controlled substance pursuant to the provisions of Section 30-31-23 NMSA 1978 if the evidence for the charge of possession of a controlled substance was gained as a result of the overdose and the need for medical assistance. C. The act of seeking medical assistance for someone who is experiencing a drug-related overdose may be used as a mitigating factor in a criminal prosecution pursuant to the Controlled Substances Act.

The Risk Environment or the Community Health Network Drug Rx Programs Licensing Boards Pain & Palliative Care Police Pharmacists Prisons Prosecutors SEPs Users EMTs Peers/family ER staff

Pharmacy counseling for opioid recipients?

Prescription monitoring for OD prevention?

For the Future • Even without proper funding levels for this important topic (Hello, NIDA and FDA) the evidence suggests that naloxone • Is effective in an intra-nasal formulation • May be used safely and effectively without M.D. supervision  may be appropriate for over-the-counter sale • Both steps require FDA approval, and, potentially, some expensive clinical trials

Policy Elements of Community Overdose Prevention