Transcript Naloxone

IMPLEMENTING
NALOXONE RESCUE
KITS FOR OPIOID
OVERDOSE:
THE RHODE
ISLAND PHARMACY
EXPERIENCE
Jef
Bratberg,
PharmD,
BCPS
Clinical
Professor of
Pharmacy
Practice
University
of Rhode
Island
College of
Pharmacy
OBJECTIVES
1 . Apply the implementation steps of a naloxone collaborative
practice agreement for naloxone in community pharmacy chains
in Rhode Island to the participants’ area.
2. Compare and contrast regulations and statutes relating to
pharmacy -based prescribing, dispensing, and furnishing of
naloxone.
3. Develop a plan to partner with harm reductionists, health
departments, boards of pharmacy and medicine, and health
professional training programs and others to expand access to
naloxone via community pharmacies.
EXISTING PHARMACY PARTNERSHIPS
 Harm Reduction
 New syringes
 Syringe containers
 Drug testing
 Referrals/collaborations
 Treatment
 Recovery
 Medication-Assisted
Therapy
 Buprenorphine
 Methadone (int’l only)
 Dispense prescription
opioids
 Counseling on safety
 Interactions
 Prescription Monitoring
Program (PMP)
 Lockboxes
 Disposal
 In-pharmacy
 Community 
From: "Rich, Josiah MD" <[email protected]>
To: "'[email protected]'"
<[email protected]>,
"McKenzie, Michelle" <[email protected]>
Subject: FW: Naloxone: ready, set...
Date: Thu, 13 Jul 2006 10:43:45 -0400
Hi Jef,
Are pharmacists legally allowed to dispense
naloxone?
From: Jeffrey Bratberg [email protected]
Thanks
Subject: Fwd: FW: Naloxone: ready, set...
Jody
Date: July 13, 2006 at 12:16 PM
To: Cathy Cordy [email protected]
-----Original Message----From: J. Brooke Huffman
[mailto:[email protected]]
Cathy - We should talk about this at our regualtory
Sent: Friday, Julymeeting
07, 2006- I7:12
PMcatching up on email when I return
will be
To: [email protected]
to RI tonight. IF you possibly have a quick answer,
Subject: Naloxone:
ready,
set...
please
send
to me at your convenience!
Hi Jody-
THanks
jef
A CPA was drafted collaboratively by researchers
and members of the RI Board of Pharmacy
 RI Pharmacy Board approved the CPA in Sept 2011

 Requires at least one prescriber to be involved as the
“CPA prescriber”
 Requires an individual CPA agreement between the
prescriber and every participating pharmacist
 Permits CPA-certified pharmacists to
▪ Initiate a naloxone prescription to honor a community-based
overdose prevention and naloxone training
▪ Initiate a naloxone prescription after identifying and training a
patient who presents with risk factors for opioid overdose
CPAN IMPLEMENTATION STEPS
SEPT 2012
 University of Rhode Island College of Pharmacy
Student Tara Thomas ’13 develops 1-hour online
Continuing Professional Education (CPE) Program
with URI CPE Office
“Opioids: Addiction, Overdose Prevention (Naloxone)
and Patient Education.”
 Four Walgreens locations are selected as CPA pilot
sites located near clusters of opioid overdose deaths
 RI Pharmacy Foundation funds ten pharmacists to
participate
CPAN IMPLEMENTATION STEPS
JUNE 2013
Michael Botticelli holds
overdose prevention
roundtable in
Woonsocket, RI
CPA extended to fifth
Walgreen’s store in
Woonsocket and then to
all 26 RI locations after
Board of Pharmacy
approval.
CPAN IMPLEMENTATION STEPS
SUMMER-FALL 2014
CVSHealth
Online training for CPAN finalized
CPA waiver approved by Board of Pharmacy
Wholesaler atomizer stocking / ordering
Naloxone and atomizers stocked and
dispensed with overdose education
COLLABORATIVE PRACTICE AGREEMENT
 Pharmacist qualifications:
 Possess an active RI pharmacist license in good standing
 CPR certified
 Complete a appropriate training program containing:
 Identifying those who are at risk for opioid overdose
 Identifying the signs and symptoms of opioid overdose
 Use of naloxone in overdose situations
 Dispensing of naloxone pursuant to this protocol
 Naloxone administration techniques
 Patient and caregiver counseling regarding the use of
naloxone and overdose response steps
CPA CONTINUING PROFESSIONAL
EDUCATION REQUIREMENTS
 1 hour of ACPE-accredited continuing professional
education (CPE) annually
 CPE may include any of the following:
 Opioid overdose prevention
 Reducing the risk of prescription opioid abuse
 The safe use of opioids for the management of chronic pain
 The use of screening tools to detect opioid abuse or
dependency, specialist referrals and management of
difficult patients
 Preventing diversion of prescribed opioid medications
 Treating patients with pain and addiction
 Naloxone administration technique
 Review of collaborative practice agreement
Request
Screen
Consent
Prescribe
Naloxone formulations discussed with
person and she chooses intranasal
Pharmacist logs Rx date dispensed,
manufacturer, and lot #
Document
Pharmacist initiates naloxone
prescription with collaborating
prescriber as prescriber
In 5-10 minutes*, pharmacist trains
person in OD prevention,
identification, response, naloxone
admin & gives her naloxone handout
Educate
Person completes and signs an
informed consent authorizing release
of her PHI to Collaborating Prescriber
Person’s private insurance is
successfully billed for 2 prefilled
naloxone syringes & she pays generic
drug copay plus ~$10 for 2 atomizers
Bill
Person is identified as being in
contact with someone at risk and/or
at risk herself for opioid overdose
Dispense
Person requests naloxone for child at
risk of overdose from Overdose
Trained Pharmacist
Select
HOW IT WORKS: CPAN
Rx & consent faxed to Collaborating
12
Prescriber within 7 days
*Behar, E., et al., Brief overdose education is sufficient for naloxone distribution to opioid users. Drug Alcohol Depend. (2015), http://dx.doi.org/10.1016/j.drugalcdep.2014.12.009
OFFER NALOXONE TO EVERYONE
•
•
•
•
•
•
Opt-in Options
Friends and family of
those at risk
Syringe buyer request
Prescriptions
Referral from
treatment
Referral from
correctional
institution
Referral from
behavioral health
Opt-out Options
• Any opioid
prescription
• Has prescription for
IR & ER opioid
• Any opioid/benzo rx
combination
• Any methadone (pain)
• Any buprenorphine
• Syringe purchase w/o
concurrent injectable
medication
Pharmacists & Naloxone
Based on data collected by NASPA (updated June 2015)
WA
MT
OR
ME
ND
ID
MN
VT
WI
SD
MI*
WY
NV*
CA
AZ
CO
PA
IA
NE*
UT
NY
IL
KS
OK
NM
MO
OH
WV VA
KY
MS
AL
DC
NC
TN
AR
AK
TX
IN
NH
MA
RI*
CT
NJ
DE
MD
SC
GA
LA
HI
FL
Statewide naloxone protocol or prescriptive authority for pharmacists
Broad** collaborative practice provisions
*
Broad collaborative practice provisions but need a separate agreement for each pharmacist
Pharmacists are authorized to dispense without a prescription
Statewide protocol or prescriptive authority bill proposed in 2015 session
**Broad = Allow initiation of therapy, community pharmacists authorized to participate, no drug restrictions (may need to
specify within the agreement), laws/regulations silent regarding the relationship between the prescriber and the patient
PHARMACY BASED NALOXONE TRAINING
Trainer
University
Association
Prescribetoprevent.org
Government
Health Department
Corporate provider
Pharmacy Owner
Pharmacist
Corporate community
Independent community
Transition of Care
Hospital outpatient
Emergency department
Inpatient pre-discharge
University students
QUESTIONS/UNKNOWNS
Necessity, Sustainability
Format, Content, Frequency, Length
Interdisciplinary
Updates, mandates, retention
Carer &
3rd party
Victim
SUBSTANCE ABUSE: THE PHARMACY EDUCATOR’S ROLE
IN PREVENTION AND RECOVERY
CURRICULAR GUIDELINES FOR PHARMACY (AACP 2010)
“Prepare student
pharmacist to
problem-solve issues
concerning alcohol
and other drug
abuse and addictive
diseases affecting
patients, families,
colleagues,
themselves, and
society.”
Four Content Areas
 Psychosocial aspects
 Pharmacology/Toxicol
ogy
 People with substance
use disorders (SUD)
 Identification
 Intervention
 Treatment
 Legal/ethical issues
RHODE ISLAND STATEWIDE NALOXONE
DISTRIBUTION
JAN 2014-MAY 2015
100% IN
Community
Distribution
(PONI) (n=950)
39%
100% IM
40% IM
60% IN
Dept of
Corrections (n=20)
1%
100% IN
56% IN
44% IM
Hospital
Emergency Depts
(n=223)
9%
Treatment
Facilities
(n=682)
28%
Pharmacies
(n=572)
23%
Green TC. “Overdose
Prevention and Response
Training: Lessons from
Rhode Island.”
Exploring Naloxone Uptake
and Use – A Public
Meeting. Food and Drug
Administration. July 2015.
http://www.fda.gov/downl
oads/Drugs/NewsEvents/U
CM454773.pdf
NALOXONE DISTRIBUTION PROGRAMS +
OD DEATHS / 100K – JUNE 2014PRESENT
MMWR. June 19, 2015; 64(23): 631-635.
RI NALOXONE
PHARMACY
ACCESS
Pop: 1 million
~200 retail
pharmacy locations
>2/3 rds of all
community
pharmacies stock
naloxone
>400 pharmacists
trained
NALOXONE ROLLOUT
Engage Champions
Prescribers
Pharmacists
Administrators
Policymakers
Parents/friends
Health departments
Harm reductionists
Public Health
advocates
Academia
Create Demand
Co-prescribing
Naloxone/atomizer
stocking
Legal changes
Public awareness
-IDU
-Rx
Evaluate Naloxone
Rx #
Furnished #
Refill #
Health IT
Overdose
epidemiology
Marketing
Released 11-4-15
Last day to comment
TODAY at
Strategicplanri.org
Plan Goal: Reduce
overdose deaths
By 1/3rd in 3 years.
OVERDOSE DEATHS AND PBN DISTRIBUTION
RI STRATEGIC PLAN: OVERDOSE RESCUE
11-4-2015
Prescribers, treatment programs, and
pharmacists offer naloxone and overdose
education as standard of care
 All C-2 opioids prescribed/dispensed
 All Rx and OTC syringe
 All benzo+C2 co-prescriptions within 30 days
Strategy would have reached
 86% of overdose victims prescribed opioid
 58% of ALL overdose deaths 2014-15
 Of 148 deaths in 2015, NONE had naloxone
AHRQ PHARMACY-BASED NALOXONE
(PBN) GRANT 8/1/15-7/31/18
MA and RI
Multidisciplinary team
(MD, PhD, PharmD)
 Lifespan Pharmacies
(RI, 2 locations)
 Independent
pharmacies (MA, Eaton Aims
 Implement PBN
Apothecary, 13
locations) RI-pending)
 Factors for PBN success
 Boston Medical Center
 PBN impact
pharmacies (MA, 3
 Sustainability and
locations)
dissemination
 CVSHealth (MA and RI,
418 locations)
Bratberg, J.
APhA-APPM Report:
Pharmacist
s have
essential
role in
opioid
overdose
prevention.
J Am Pharm Assoc
(2003). 2015;55: 1417.