BILL ANALYSIS Ó
AB 1535
Page 1
CONCURRENCE IN SENATE AMENDMENTS
AB 1535 (Bloom)
As Amended June 24, 2014
Majority vote
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|ASSEMBLY: |73-0 |(May 8, 2014) |SENATE: |35-0 |(August 7, |
| | | | | |2014) |
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Original Committee Reference: B., P. & C.P.
SUMMARY : Permits a pharmacist to furnish naloxone hydrochloride
(NH) pursuant to standardized procedures or protocols developed
and approved by the California Board of Pharmacy (BOP) and the
Medical Board of California (MBC).
The Senate amendments authorize BOP to adopt emergency
regulations to establish the standardized procedures or
protocols.
FISCAL EFFECT : According to the Senate Appropriations
Committee:
1)One-time costs less than $75,000 to develop protocols and
adopt regulations by the MBC (Contingent Fund of the MBC).
2)One-time costs less than $75,000 to develop protocols and
adopt regulations by the BOP (Pharmacy Board Contingent Fund).
3)Minor anticipated enforcement costs to the BOP (Pharmacy Board
Contingent Fund).
COMMENTS :
1)Purpose of this bill. This bill will allow a pharmacist to
furnish NH to a person at risk of an opioid-related overdose,
a family member, friend, or other person in a position to
assist a person experiencing or reasonably suspected of
experiencing an overdose, pursuant to standardized procedures
or protocols developed and approved by BOP and MBC. This bill
will enable the wider distribution of a safe,
easy-to-administer and life-saving drug in accordance with
recommendations from the United States Department of Health
and Human Services. This bill is sponsored by the Drug Policy
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Alliance.
2)Naloxone hydrochloride. NH is an antidote to opioids. It is
traditionally used in the hospital setting to reverse the
effects of opiates given during surgery, and may be given to
newborns to decrease the effects of opiates received by the
pregnant mother prior to delivery. It is currently available
by prescription only, but is not a scheduled drug.
NH reverses an overdose by blocking the central nervous system
effects of several types of opiate medications such as
morphine, oxycodone, methadone, or illegal substances such as
heroin. According to its Food and Drug Administration (FDA)
approved label, NH only causes pharmacologic effects if there
are opioids in someone's body. This means that if NH is
administered to someone who is not overdosing, nothing will
happen. NH is not addictive and has not shown to produce
either physical or psychological dependence.
According to the Opioid Overdose Toolkit from the Substance
Abuse and Mental Health Services Administration, a division of
the United States Department of Health and Human Services:
The safety profile of NH is remarkably high,
especially when used in low doses and titrated to
effect. When given to individuals who are not
opioid-intoxicated or opioid-dependent, NH produces no
clinical effects, even at high doses. Moreover, while
rapid opioid withdrawal in tolerant patients may be
unpleasant, it is not life-threatening.
NH can be safely be used to manage opioid overdose in
pregnant women.
NH is administered by injection into a large muscle, such as
the thighs, buttocks, or shoulder, or through a nasal spray,
and can reverse the effects of an opioid overdose. The
purpose is to restart the patient's breathing, but may not
necessarily cause complete revival. NH is effective for 30 to
90 minutes, during which time emergency services should be
sought for the patient. When injected into an overdose victim
whose heart is still beating, "it's virtually 100% effective,"
said Wilson Compton, deputy director at the National Institute
on Drug Abuse.
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According to the National Institute of Health, NH has a shelf
life of approximately two years and should be stored at room
temperature and away from direct light. A typical injectable
or nasal spray NH kit costs $15 to $25 per dose.
3)Current California pharmacist furnishing laws. California
pharmacists are currently authorized to furnish the following
medications without a prescription after appropriate training
and pursuant to specified conditions:
a) Emergency contraception drug therapy and
self-administered hormonal contraceptives;
b) Nicotine replacement products;
c) Prescription medications not requiring a diagnosis that
are recommended by the Centers for Disease Control and
Prevention (CDC) for individuals traveling outside of the
United States;
d) Administer immunizations; and,
e) Initiate and administer epinephrine.
4)Calls for greater access. There are several community-based
efforts underway (discussed further below) to encourage
physicians to prescribe NH concurrently with opioids for
patients who meet criteria for higher overdose risk. However,
data on concurrent prescription rates are limited and not
suggestive of frequent application. Medi-Cal data of 2013
provided by this bill's sponsors indicate that while 62% of
Medi-Cal prescribers prescribe opioids, less than two-tenths
of 1% prescribe NH.
The findings of a 2012 Morbidity and Mortality Weekly Report
(MMWR), a publication of the CDC, suggests that wider
distribution of NH and training in its administration might
prevent numerous deaths from opioid overdoses and save
thousands of dollars in public funds. However, nearly half of
the responding NH programs reported problems obtaining NH due
to cost and supply chain availability. The MMWR report framed
this as a significant public health issue: "To address the
substantial increases in opioid-related drug overdose deaths,
public health agencies could consider comprehensive measures
that include teaching laypersons how to respond to overdoses
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and administer naloxone to those in need."
5)Role of pharmacists in furnishing NH. According to a March
2014 research letter published in the Journal of the American
Medical Association, the highest-risk and highest-use group of
opioid users is more likely to obtain opioids from a
physician's prescription than from a drug dealer. And these
prescriptions are filled at pharmacies.
The Center for Pharmacy Services (CPS), a community pharmacy
in Pittsburgh, Pennsylvania, collaborated with the Overdose
Prevention Project to develop a model that enlists pharmacists
in overdose prevention. The model uses pharmacists to educate
patients and physicians about opioid safety and the
effectiveness of prophylactic prescription of NH to prevent
fatal overdose.
Beginning in February 2011, patients presenting at CPS with a
prescription for an opioid analgesic were offered counseling
on opioid safety, including potential side effects, how to
take opioid pain relievers safely, possible signs of opioid
over-medication and/or overdose, and safe disposal of unused
prescription medicines. Patients are also provided with
opioid safety educational materials. The patient and/or
caregiver also receives instruction on how to identify and
effectively respond to an overdose and how to administer
naloxone.
In the CPS program, a patient who receives the opioid safety
education can request a prescription for NH. The pharmacist
facilitates this by fax, sending a simple form to the
prescribing physician requesting they sign an order to
prescribe NH along with the opioids prescribed.
This bill seeks to follow the CPS model by allowing
pharmacists to furnish NH pursuant to a protocol, thereby
streamlining the process by which an individual receives the
drug.
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Analysis Prepared by : Sarah Huchel / B., P.& C.P. / (916)
319-3301
FN: 0004293