BILL ANALYSIS Ó
SB 493
Page 1
SENATE THIRD READING
SB 493 (Ed Hernandez)
As Amended September 6, 2013
Majority vote
SENATE VOTE : 34-4
BUSINESS & PROFESSIONS 14-0 HEALTH 18-0
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|Ayes:|Bonilla, Jones, |Ayes:|Pan, Ammiano, Atkins, |
| |Bocanegra, Campos, | |Bonilla, Bonta, Chesbro, |
| |Dickinson, Eggman, | |Gomez, |
| |Gordon, Hagman, Holden, | |Roger Hernández, |
| |Maienschein, Mullin, | |Lowenthal, Maienschein, |
| |Skinner, Ting, Wilk | |Mansoor, Mitchell, |
| | | |Nazarian, Nestande, V. |
| | | |Manuel Pérez, Wagner, |
| | | |Wieckowski, Wilk |
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APPROPRIATIONS 16-0
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|Ayes:|Gatto, Harkey, Bigelow, | | |
| |Bocanegra, Bradford, Ian | | |
| |Calderon, Campos, Eggman, | | |
| |Gomez, Hall, Holden, | | |
| |Linder, Pan, Quirk, | | |
| |Wagner, Weber | | |
|-----+--------------------------+-----+--------------------------|
| | | | |
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SUMMARY : Expands the scope of practice of a pharmacist to
recognize an "advanced practice pharmacist"; permits pharmacists
to furnish certain hormonal contraceptives, nicotine replacement
products, and prescription medications for travel, as specified;
and authorizes pharmacists to independently initiate and
administer certain vaccines and treatments for severe allergic
reactions. Specifically, this bill :
1)Permits a pharmacist to provide clinical services if the
clinical services are provided to a health care professional
or to a patient.
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2)Permits a pharmacist to provide consultation, training, and
education to patients about drug therapy, disease management,
and disease prevention.
3)Permits a pharmacist to participate in a multidisciplinary
review of patient progress, including appropriate access to
medical records.
4)Permits a pharmacist to furnish the following medications:
a) Self-administered hormonal contraceptives, as specified;
b) Nicotine replacement products, as specified; and,
c) Prescription medications not requiring a diagnosis that
are recommended by the federal Centers for Disease Control
and Prevention (CDC) for individuals traveling outside of
the United States.
5)Requires a pharmacist to notify the patient's primary care
provider of any drugs or devices furnished to the patient, or
enter the appropriate information in a patient record system
shared with the primary care provider, as permitted by that
primary care provider. If the patient does not have a primary
care provider, the pharmacist must provide the patient with a
written record of the drugs or devices furnished and advise
the patient to consult a physician of the patient's choice.
6)Permits a pharmacist to order and interpret tests for the
purpose of monitoring and managing the efficacy and toxicity
of drug therapies, and requires a pharmacist who orders and
interprets tests to ensure that the ordering of those tests is
done in coordination with the patient's primary care provider
or diagnosing prescriber, as appropriate, including promptly
transmitting written notification to the patient's diagnosing
prescriber or entering the appropriate information in a
patient record system shared with the prescriber, when
available and as permitted by that prescriber.
7)Requires a pharmacist to dispense self-administered hormonal
contraceptives legally prescribed or ordered for a patient
unless certain circumstances exist, including the absence of
stock, objection on personal religious grounds, or belief of
the pharmacist that a harmful drug interaction would result.
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8)Permits a pharmacist to furnish self-administered hormonal
contraceptives in accordance with standardized procedures or
protocols developed and approved by both the Board of Pharmacy
(BOP) and the Medical Board of California (MBC) in
consultation with the American Congress of Obstetricians and
Gynecologists, the California Pharmacists Association, and
other appropriate entities. The standardized procedure or
protocol shall require that the patient use a self-screening
tool that will identify patient risk factors for use of
self-administered hormonal contraceptives, and that the
pharmacist refer the patient, as specified, upon furnishing a
self-administered hormonal contraceptive, or if it is
determined that use of a self-administered hormonal
contraceptive is not recommended.
9)States that BOP and MBC are both authorized to ensure
compliance with the administration of hormonal contraceptives
by pharmacists, and each board is specifically charged with
the enforcement with respect to its respective licensees.
States that a pharmacist's ability to furnish
self-administered hormonal contraceptives does not expand the
authority of a pharmacist to prescribe any prescription
medication.
10)Requires a pharmacist to provide the recipient of
self-administered hormonal contraception with a standardized
fact sheet that includes, but is not limited to, the
indications and contraindications for use of the drug, the
appropriate method for using the drug, the need for medical
follow-up, and other appropriate information. Requires BOP to
develop this form in consultation with the State Department of
Public Health, the American Congress of Obstetricians and
Gynecologists, the California Pharmacists Association, and
other health care organizations. States that the use of
existing publications developed by nationally recognized
medical organizations is not precluded.
11)Clarifies that this bill does not expand the authority of a
pharmacist to prescribe any prescription medication.
12)Defines an "advanced practice pharmacist" (APP) as a licensed
pharmacist who has been recognized as an advanced practice
pharmacist by BOP, as specified.
13)Requires a pharmacist seeking recognition as an APP to meet
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the following requirements:
a) Hold an active license to practice pharmacy issued
pursuant to this chapter that is in good standing.
b) Satisfy any two of the following criteria:
i) Earn certification in a relevant area of practice,
including, but not limited to, ambulatory care, critical
care, geriatric pharmacy, nuclear pharmacy, nutrition
support pharmacy, oncology pharmacy, pediatric pharmacy,
pharmacotherapy, or psychiatric pharmacy, from an
organization recognized by the Accreditation Council for
Pharmacy Education or another entity recognized by BOP;
ii) Complete a one-year postgraduate residency through
an accredited postgraduate institution where at least 50%
of the experience includes the provision of direct
patient care services with interdisciplinary teams; or,
iii) Have provided clinical services to patients for at
least one year under a collaborative practice agreement
or protocol with a physician, APP, pharmacist practicing
collaborative drug therapy management, or health system;
and,
c) File an application and pay the applicable fee with BOP
for recognition as an APP.
14)States that APP recognition shall be valid for two years,
coterminous with the certificate holder's license to practice
pharmacy.
15)Requires BOP to adopt regulations establishing the means of
documenting completion of the requirements in this section.
16)Requires BOP to adopt regulations setting the fee for the
issuance and renewal of APP recognition at the reasonable cost
of regulating APPs, which shall not exceed $300.
17)Requires an APP to complete 10 hours of continuing education
each renewal cycle in a subject matter relevant to the
pharmacist's clinical practice.
18)Permits a pharmacist recognized by BOP as an APP to do all of
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the following:
a) Perform patient assessments;
b) Order and interpret drug therapy-related tests;
c) Refer patients to other health care providers;
d) Participate in the evaluation and management of diseases
and health conditions in collaboration with other health
care providers; and,
e) Initiate, adjust, or discontinue drug therapy, as
specified.
19)Requires an APP who orders and interprets tests to ensure
that the ordering of those tests is done in coordination with
the patient's primary care provider or diagnosing prescriber,
as appropriate, including promptly transmitting written
notification to the patient's diagnosing prescriber or
entering the appropriate information in a patient record
system shared with the prescriber, when available and as
permitted by that prescriber.
20)Requires an APP who initiates, adjusts, or discontinues drug
therapy to promptly transmit written notification to the
patient's diagnosing prescriber or enter the appropriate
information in a patient record system shared with the
prescriber, as permitted by that prescriber.
21)Requires an APP who initiates drug therapy to promptly
transmit written notification to, or enter the appropriate
information into, a patient record system shared with the
patient's primary care provider or diagnosing provider, as
permitted by that provider.
22)States that an APP's abilities shall not interfere with a
physician's order to dispense a prescription drug as written,
or other order of similar meaning.
23)Requires an APP to personally register with the federal Drug
Enforcement Administration (DEA) prior to initiating or
adjusting a controlled substance therapy.
24)Permits a pharmacist to independently initiate and administer
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vaccines listed on the routine immunization schedules
recommended by the federal Advisory Committee on Immunization
Practices (ACIP), in compliance with individual ACIP vaccine
recommendations, and published by the CDC for persons three
years of age and older if the pharmacist:
a) Completes an immunization training program endorsed by
the CDC or the Accreditation Council for Pharmacy Education
that, at a minimum, includes hands-on injection technique,
clinical evaluation of indications and contraindications of
vaccines, and the recognition and treatment of emergency
reactions to vaccines, and maintains that training;
b) Is certified in basic life support; and,
c) Complies with all state and federal recordkeeping and
reporting requirements, including providing documentation
to the patient's primary care provider and entering
information in the appropriate immunization registry
designated by the immunization branch of the State
Department of Public Health.
25)Permits a pharmacist to initiate and administer epinephrine
or diphenhydramine by injection for the treatment of a severe
allergic reaction either pursuant to protocols, or under the
requirements for administering vaccines to persons three years
of age and older.
26)Permits a pharmacist to furnish nicotine replacement products
approved by the federal Food and Drug Administration for use
by prescription only in accordance with standardized
procedures and protocols developed and approved by both BOP
and MBC in consultation with other appropriate entities and
provide smoking cessation services if all of the following
conditions are met:
a) The pharmacist maintains records of all prescription
drugs and devices furnished for a period of at least three
years for purposes of notifying other health care providers
and monitoring the patient;
b) The pharmacist notifies the patient's primary care
provider of any drugs or devices furnished to the patient,
or enters the appropriate information in a patient record
system shared with the primary care provider, as permitted
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by that primary care provider. If the patient does not
have a primary care provider, the pharmacist provides the
patient with a written record of the drugs or devices
furnished and advises the patient to consult a physician of
the patient's choice;
c) The pharmacist is certified in smoking cessation therapy
by an organization recognized by BOP; and,
d) The pharmacist completes one hour of continuing
education focused on smoking cessation therapy biennially.
27)Authorizes BOP and MBC to ensure that pharmacists are
compliant with the requirements for furnishing nicotine
replacement products, and states that each board is
specifically charged with the enforcement of this section with
respect to their respective licensees. States that nothing in
the ability for pharmacists to furnish nicotine replacement
products shall be construed to expand the authority of a
pharmacist to prescribe any other prescription medication.
28)Authorizes an APP to practice advanced practice pharmacy
inside or outside of a licensed pharmacy, as specified.
29)Makes a legislative declaration that pharmacists are health
care providers who have the authority to provide health care
services.
30)Makes other technical and clarifying amendments.
31)Adds language to avoid chaptering out issues with SB 205
(Corbett) of the current legislative session.
32)States that no reimbursement is required because the only
costs that may be incurred by a local agency or school
district will be incurred because this act creates a new crime
or infraction, eliminates a crime or infraction, changes the
penalty for a crime or infraction, or changes the definition
of a crime.
FISCAL EFFECT : According to Assembly Appropriations Committee,
all costs would accrue to the Pharmacy Board Contingent Fund.
1)One-time costs to BOP of $100,000 for regulations establishing
APP recognition process, rules, and fees. In addition,
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one-time costs of $20,000 to modify information technology
systems to accommodate a new licensure type.
2)Ongoing costs of approximately $300,000 annually for licensing
and regulation of APPs.
3)Potential fee revenues of approximately $300,000 annually.
4)Unknown potential increase in enforcement costs. Since the
activities permitted under this bill are newly allowed for
pharmacists outside the supervision of a physician, it is
unclear whether or how many increased complaints may occur.
The Department of Justice (DOJ) and/or the BOP may experience
increased enforcement costs; any DOJ costs would be reimbursed
by the Pharmacy Board Contingent Fund.
5)The net effect on health care costs from expanding the role of
pharmacists in delivery of care is unclear. Increased access
to care may result in increased costs due to greater
utilization, which could be counterbalanced by cost savings
related to improved medication adherence, reduced hospital
readmissions, and other benefits stemming from provision of
care pharmacists would provide.
COMMENTS :
1)Purpose of this bill . This bill further develops the
pharmacists' role as part of a primary care team by expanding
pharmacists' scope of practice to allow for more autonomy in
furnishing certain drugs and devices pursuant to standardized
procedures and protocols. It also provides for an expanded
scope for, the recognition of, advanced practice pharmacists.
This bill is author-sponsored.
2)The profession of pharmacy . California licensed pharmacists
are required to have at least a baccalaureate degree in
pharmacy from a specially accredited college of pharmacy
program, have completed 1,500 intern hours of pharmacy
practice experience, and have passed a national and state
exam. There are 38,440 licensed pharmacists in California.
Pharmacists consistently rank amongst the most trusted
healthcare personnel in nationwide Gallup polls and have a
broader knowledge of medicines, both prescription and
over-the-counter, than any other member of the health care
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team. According to a 2012 report by the CDC, engaging
pharmacists as members of the health care system can
significantly improve treatment of diabetes, better control
high blood pressure, improve management of cholesterol, and
reduce overall health care costs. Thirty-one states,
including California, have laws that allow physicians and
pharmacists to collaborate in providing advanced services such
as those authorized by this bill.
This bill will permit APPs to perform patient assessments,
order and interpret drug therapy-related tests, participate in
the evaluation and management of diseases and health
conditions in collaboration with other health care providers;
and initiate, adjust, or discontinue drug therapy in certain
circumstances.
3)The Affordable Care Act (ACA) . The federal Affordable Care
Act (ACA) was passed in March 2010 to provide affordable
healthcare for all Americans and improve the quality and
efficiency of that care. The January 2014 implementation date
of ACA will result in millions more Californians entering the
primary care market.
The CDC argues that pharmacists are well positioned to augment
primary care teams and help manage patient's medications and
chronic conditions. The U.S. Department of Health and Human
Services (HHS) authored a 2011 report, entitled "Improving
Patient and Health System Outcomes through Advanced Pharmacy
Practice, A Report to the U.S. Surgeon General," in which it
was demonstrated that "through evidence-based outcomes, many
expanded pharmacy practice models, implemented in
collaboration with physicians or as part of a health team,
improve patient and health system outcomes and optimize
primary care access and delivery." The report recommended
that pharmacists work in collaboration with physicians and
primary care clinicians.
This measure builds upon pharmacists' current scope of
practice to more fully enable them to participate in a
multidisciplinary patient management team, and provides for
the recognition of APPs, who would be able to provide many of
the advanced health management techniques recommended by the
HHS report.
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Analysis Prepared by : Sarah Huchel / B.,P. & C.P. / (916)
319-3301
FN: 0002550