scott burris
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Document Sample


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
Recipient is a
Provider is Pharmacist
“patient” at
licensed to fills valid
risk of opioid
prescribe prescription
overdose
Don’t
tell my
Mom
Prescribing Naloxone: No Legal
Problems
Recipient is a
Provider is Provider
“patient” at
licensed to dispenses the
risk of opioid
prescribe medication
overdose
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 is Recipient
Provider is
not at risk of administers
licensed to
opioid naloxone to
prescribe
overdose OD victim
Never
touch
the Hey, J.D.
stuff. 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:
A. 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
Licensin Drug Rx
g Program
Pain &
Boards s
Palliative
Police Care
Prisons Pharmacists
Prosecutors SEPs
Users
EMTs Peers
ER staff
The Risk Environment or the
Community Health Network
Licensin Drug Rx
g Program
Pain &
Boards s
Palliative
Police Care
Prisons Pharmacists
Prosecutors SEPs
Users
EMTs Peers/family
ER staff
The Risk Environment or the
Community Health Network
Licensin
g Peers may not call 9-1-1
Boards • Fear that police may come
Police
with EMTs and arrest
bystanders for
•Drug possession
•Paraphernalia possession
•Drug distribution
Prosecutors • Or may confiscate drugs
Users
and syringes
Peers/family
Licensin
g
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
Licensin Drug Rx
g Program
Pain &
Boards s
Palliative
Police Care
Prisons Pharmacists
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
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