Transcript Click Here for the Power Point - Pharmacists Society of the State of

Role of Naloxone for
Pharmacists
John J. Faragon, Pharmacist, HIV Medicine
Regional Pharmacy Director,
NY/NJ AIDS Education and Training Center
Objectives
• Describe the correlation between prescription drug
abuse and the rate of opioid related overdose
deaths.
• Discuss the pharmacology of naloxone and its use
in the management of opioid overdose.
• List and describe the currently available naloxone
formulations and those under development.
• Describe the role of the pharmacist in opioid
overdose prevention and in the ESAP
program.
Overdose risk of those with prescriptions
MMWR / January 13, 2012 / Vol. 61 / No. 1
Poisoning Deaths with Opioids
NYSDOH Office of Quality and Patient Safety
Bureau of Vital Statistics 2014
Rates of prescription painkiller sales, deaths and
substance abuse treatment admissions (1999-2010)
National Vital Statistics System, 1999-2008; Automation of Reports and Consolidated
Orders System (ARCOS) of the Drug Enforcement Administration (DEA), 1999-2010;
Treatment Episode Data Set, 1999-2009
Number of opioid-analgesic poisoning deaths, by
involvement of benzodiazepines: United States, 1999–2011
Deaths from Opioid Overdoses
are Preventable
• Naloxone is the current antidote to reverse
opioids and is safe and effective
• First responders now use naloxone to
immediately reverse the effects of opiate
overdose
What puts people at risk for
overdose?
• Mixing Drugs
• Variation in strength and content of ‘street’ drugs (purity)
• Tolerance changes
• Using alone
• Health issues, such as liver function, weight loss
• Transient living – new dealers/new product
• Thinking you “know everything”
• Switching from sniffing/eating to injection
What are the Signs/Symptoms
of an OD?
• Blue skin tinge- usually lips and fingertips show
first
• Body very limp
• Face very pale
• Passing out
• Choking sounds or a gurgling/snoring noise
• Breathing is very slow, irregular, or has stopped
Strategies for Reducing
Overdose Deaths
• Prescription Monitoring Programs
– Reduce diversion of prescription medications, not demonstrated to
reduce overdose
– Obvious concern about increase in heroin use
• Methadone and Suboxone treatment
• Abstinence-based drug treatment
• Risk of overdose increases when relapse occurs
• Community Based Education
– Risk factors and identification of symptoms
– Effective response, rescue breathing, 911
– Naloxone administration training
• Naloxone Prescription Programs
Why Are People Dying
• Fear of stigma associated with drug use
• Failure to recognize symptoms of
overdose
• Fear of police involvement
• Bystanders not knowing what to do
delays or provides ineffective response
Opportunity for Family Intervention
• Majority of ODs occur in the presence of others
• ODs can be reversed by rescue breathing and/or Narcan (Naloxone)
administration
• Many younger drug users are still living at home or are still allowed
to visit the home.
• Treatment options can be discussed at the hospital with family
present in the case of an overdose.
• Realistic and useful education for families.
ISTOP
ISTOP - Benefits
• Allows for better understanding of a patient’s
controlled substance utilization based on
recent controlled substance prescription
history
• Provides a quick, confidential online report to
the practitioner and the pharmacist
• Available 24/7 • Information is based on
controlled substance prescription data
received from nearly 5,000 pharmacies
• Quick response at no cost to practitioner or
pharmacists
911 Good Samaritan Law
• Some individuals may fear that police will respond to a 911
call and that there will be criminal charges for themselves or
for the person who overdosed. Those fears should NEVER
keep anyone from calling 911 immediately. It may be a matter
of life or death.
• In September 2011, the 911 Good Samaritan Law went into
effect to address fears about a police response to an
overdose. This law provides significant legal protection
against criminal charge and prosecution for possession of
controlled substances, as well as possession of marijuana
and drug paraphernalia. This protection applies to both the
person seeking assistance in good faith as well as to the
person who has overdosed. Class A-1 drug felonies as well as
sale or intent to sell controlled substances are not covered by
the law.
NALOXONE PHARMACOLOGY
AND ADMINISTRATION
What is an Opioid Overdose?
Opioid fits exactly in
receptor
Opioid receptor
on brain
The brain has
many, many
receptors for
opioids. Too much
opioid fitting in too
many receptors
slow and stop the
breathing.
Naloxone
• Naloxone is an opioid receptor antagonist
at mu, kappa, and delta receptors
• Works at the opioid receptor to displace
opioid agonists
• Shows little to no agonist activity
• Shows little to no pharmacological effect in
patients who have not received opioids
Naloxone
• Reverses clinical and toxic effects of
opioid overdose
• Reverses respiratory depression,
hypotension, sedation
• Restores breathing
• Reverses analgesia
• Patients can experience withdrawal after
naloxone administration
Rapid Withdrawal Symptoms
• Use of naloxone can cause
– Agitation
– Tachycardia
– Pulmonary Edema
– Nausea
– Vomiting
– Seizures
Narcan reversing an OD
Opioid
Narcan
Opioid
receptor
Narcan has a stronger
affinity to the opioid
receptors than the opioid,
so it knocks the opioid off
the receptors for a short
time and lets the person
breathe again.
Overdose Prevention Using
Nasal Naloxone
• Simple device, medication and nasal spray
• Naloxone is a pure opiate antagonist
• No physiological effect other than blocking opiates
• No adverse reactions, except for potential withdrawal
• No potential for abuse or potential for OD
Standard Naloxone Kit
Components
Atomizer
BOX
Syringe
Glass vial
Instructions
Intranasal Naloxone Instructions
Intramuscular naloxone
•
•
•
•
•
•
A face mask for rescue breathing
Two safety syringes
2 pre-filled vials of Naloxone
2 alcohol swabs
2 latex gloves
1 brochure reviewing OD and rescue
steps.
• Contact information for program
Evzio auto injector
Evzio Instructions
Nasal Naloxone – Fast Track from
FDA
• Developed by AntiOp, but Reckitt Benkiser to
attain rights upon approval
• Commercial Intranasal naloxone formulation
• U.S. National Institutes of Health's National
Institute on Drug Abuse provided
– $3 million grant over 3 years to help develop the
spray.
– FDA previously agreed to waive its $2 million new
drug application fee
What Intranasal Naloxone Might
Look Like
SAMHSA Tool Kit
Released August 28, 2013
5 guidance documents
• Community Members
• First Responders
• Prescribers
• Patients
• Family Members
• Overdose Survivors
Essential Knowledge
• What does naloxone do?
• Overdose recognition
• Action
– Call EMS
– Administer naloxone
• Hands on practice with device if possible
• Recovery position
If an OD happens…
NALOXONE PROGRAMS
OD Education and Naloxone
Distribution Programs in U.S.
Number (#)
States w/ OENDs
Programs
People enrolled
Reported OD reversals
2007*
2010†
9
16
42
155
20,950
53,339
2,642
10,194
PMMWR, Centers for Disease Control, February 17, 2012, Volume 61, No.
6ngeles, Massachusetts, Mendocino County, CA, New Haven, New Mexico,
New York City, Oakland, Pittsburgh, Rhode Island, San Francisco, Wilkes
County, NC and more
* Knox, 2008 † Wheeler, E. NOPE Working Group - Harm Reduction Coalition. 2010
Massachusetts
• Massachusetts compared interrupted time series
of towns by enrollment in Opioid Education and
Naloxone Distribution programs
• 2912 kits distributed
• 327 rescues, 87% by drug users; 98% effective
EMS revived the other 3
Walley et al BMJ 2013
Community results
• Fatal opioid OD rates compared no
implementation
• Program enrollment 1-100 per 100k population
(ARR: 0.73)
• Program enrollment >100 per 100,000 (ARR:0.54)
• Of the 325 with 2 points of data on drug use:
– No increase in reported use of opioids, alcohol,
cocaine or number of substances used
Walley et al BMJ 2013, Doe-Simkins et al BMC Public Health 2014
Project Lazarus - North
Carolina
• In response to some of the highest drug overdose death
rates in the country, Project Lazarus developed a
community-based overdose prevention program with
routine physician prescription of naloxone when opioids
were prescribed for pain.
• Overdose death rate dropped from 46.6 per 100,000 in
2009 to 29.0 per 100,000 in 2010.
• Unpublished data indicates rate of death has continued to
drop to 7 deaths per 100,000 is 2011. (2010-2011 rates
based on provisional data from OCME via Wilkes Co.
Health Department.)
Pain Med. 2011 Jun;12 Suppl 2:S77-85
CURRENT NYS LEGISLATION
Case
• RJ comes into your pharmacy. His son is
actively using heroin and while most days
he is not home, there are times when he
comes back to stay and he is concerned
• He requests that you provide him a nasal
naloxone kit that he heard about at a
support group
What can you do??
A) Tell him that its not FDA approved so you
cant get it, even with a prescription
B) Refer him to the local harm reduction
coalition office for a free kit
C) Offer to call his physician for a
prescription and fill it once you order it
D) B and C
E) None of the above are legal
NYS Opioid Overdose Prevention
Programs
• A life-saving law took effect on April 1,
2006, making it legal in New York State for
non-medical persons to be provided with
naloxone and to administer it to another
individual to prevent an opioid/heroin
overdose from becoming fatal
NYS Opioid Prevention Programs
• Programs must register with the New York State
Department of Health to operate an Opioid Overdose
Prevention Program
• Eligible providers include
–
–
–
–
–
–
licensed health care facilities
Individual health care practitioners
drug treatment programs
not-for-profit community-based
Government agencies (state and local)
Pharmacies
• These programs train individuals how to respond to
suspected overdoses including the administration of
naloxone. Approximately 200 programs currently
throughout the State. Over 1,000 reversals have been
reported from these programs.
2014 Revisions to Law & Regs
•
Regulated programs through their prescribers may issue patient specific
and non-patient specific prescriptions for naloxone.
•
Someone other than the prescriber or a pharmacist can be designated in
the non-patient specific prescription to furnish the naloxone.
•
A non-patient specific prescription can be issued to an organization, with
trained individuals in that organization having shared access to, and use of,
that naloxone).
•
Shared access is beneficial to public safety and firefighting personnel, as
well as staff in agencies serving individuals at risk for overdose. These
responders no longer need to have unique, personal overdose kits
dispensed to them under a patient-specific prescription.
•
They can instead share the naloxone dispensed to the organization for
which they work under a non-patient-specific prescription. The
advisability of shared versus individual overdose kits is determined by the
prescription of the practitioner who authorized the drug to be dispensed.
2014 Revisions to Law & Regs
• Pharmacists are able to dispense naloxone
pursuant to patient-specific and non-patient
specific prescriptions.
• No dispensing should take place absent the
recipient having had a training which includes how
to recognize an overdose and how to respond to it
appropriately.
• Those appropriate responses should always include
summoning EMS (calling 911), if it has not already
taken place, and administering naloxone
Opioid Overdose Prevention
Program - Requirements
•
To operate Opioid Overdose Prevention Program, eligible providers must:
– Register with the NYSDOH
– Have a Program Director who has overall responsibility for the Program;
– Have a Clinical Director (i.e., physician, physician assistant or nurse
practitioner) who provides clinical oversight of the Program;
– Recruit and train overdose responders;
– Dispense opioid antagonists (i.e., naloxone) to trained responders
– Establish and maintain a record keeping system and
– Report administrations of opioid antagonists to NYSDOH
– Report on quarterly basis number of kits distributed and responders
trained
Pharmacy Role
Non-Patient Specific Prescriptions
Model I
• A pharmacy may register as an opioid
overdose prevention program.
– would need to identify a prescriber to act as
its opioid overdose program clinical director.
– clinical director could then issue a non‐patient
specific prescription covering potential
witnesses to an overdose as well as persons
who may be at risk of experiencing an opioid
overdose
Pharmacy role
Non-Patient Specific Prescriptions
Model II
• Pharmacists may work with non-pharmacy
currently registered opioid overdose
programs and dispense naloxone pursuant
to a non‐patient specific prescription
issued by the clinical directors of the
registered programs
Essential Knowledge
Patients may need to be trained- there are videos
available
• What does naloxone do?
• Overdose recognition
• Action
– Call EMS
– Administer naloxone
• Hands on practice with device if possible
• Recovery position
Pharmacy role
Patient-Specific Dispensing
• Pharmacists may dispense naloxone
pursuant to a patient‐specific prescription in
the same manner as any other prescription
medication
• Pharmacists may be pro-active in
recommending co-prescribing to physicians
• The New York State Department of Health is
working with community pharmacies to
ensure that naloxone in its various
formulations is more routinely stocked
Formulation
• When being dispensed as a pharmacy
benefit, community pharmacies can bill
Medicaid FFS for up to 2 x 0.4mg/ml
naloxone single-use pre-filled syringes or
single-use vials only with a valid prescription
from a Medicaid enrolled prescriber.
• Up to 5 refills are allowed per prescription.
Separate prescriptions are required for the
drug vs. needles or syringe w/needle.
Prescribetoprevent.org
Summary
• Role of naloxone crucial for prevention of
opioid overdose related deaths
• Programs from other states support both
role of community and pharmacy
involvement
• Future formulations promising
• Legislation supports non specific patient
prescription and pharmacy involvement