BILL ANALYSIS Ó
SB 493
Page 1
Date of Hearing: August 6, 2013
ASSEMBLY COMMITTEE ON BUSINESS, PROFESSIONS AND CONSUMER
PROTECTION
Susan A. Bonilla, Chair
SB 493 (Hernandez) - As Amended: August 5, 2013
SENATE VOTE : 34-4
SUBJECT : Pharmacy practice.
SUMMARY : Expands the pharmacist scope of practice 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.
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. If
the patient does not have a primary care provider, the
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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.
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.
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
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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
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, 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;
c) File an application and pay the applicable fee with BOP
for recognition as an APP.
14)States that an APP recognition shall be valid for two years,
coterminous with the certificate holder's license to practice
pharmacy.
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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
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 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.
20)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.
21)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.
22)Requires an APP to personally register with the federal Drug
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Enforcement Administration (DEA) prior to initiating or
adjusting a controlled substance therapy.
23)Permits a pharmacist to independently initiate and administer
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.
24)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.
25)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;
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b) The pharmacist notifies the patient's primary care
provider of any drugs or devices furnished to the patient.
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.
26)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.
27)Authorizes an APP to practice advanced practice pharmacy
inside or outside of a licensed pharmacy, as specified.
28)Makes a legislative declaration that pharmacists are health
care providers who have the authority to provide health care
services.
29)Makes other technical and clarifying amendments.
30)States that no reimbursement is required by this act pursuant
to Section 6 of Article XIIIB of the California Constitution
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, or
changes the penalty for a crime or infraction, within the
meaning of Section 17556 of the Government Code, or changes
the definition of a crime within the meaning of Section 6 of
Article XIIIB of the California Constitution.
EXISTING LAW :
1)Establishes the Pharmacy Law which provides for the licensure
and regulation of pharmacies, pharmacists and wholesalers of
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dangerous drugs or devices by BOP and establishes a scope of
practice for pharmacy as a profession. (Business and
Professions Code (BPC) Sections 4000 et seq.)
2)Declares the practice of pharmacy as a profession which is
dynamic, patient-oriented health service that applies a
scientific body of knowledge to improve and promote patient
health by means of appropriate drug use, drug-related therapy,
and communication for clinical and consultative purposes, and
further provides that pharmacy practice is continually
evolving to include more sophisticated and comprehensive
patient care activities. (BPC 4050)
3)Permits a pharmacist to initiate a prescription and provide
clinical advice, information or patient consultation, as
specified. (BPC 4051)
4)Permits a pharmacist to furnish emergency contraception drug
therapy and administer immunizations pursuant to a protocol
with a prescriber. (BPC 4052)
5)Requires a pharmacist who is authorized to issue an order to
initiate or adjust a controlled substance therapy to register
with the DEA. (BPC 4052 (b))
6)Permits pharmacists to perform the following procedures under
physician protocols in licensed health care facilities:
a) Order and perform routine drug therapy-related patient
assessment procedures including temperature, pulse, and
respiration;
b) Order drug therapy-related laboratory tests;
c) Administer drugs and biologicals by injection pursuant
to a prescriber's order; and,
d) Initiate or adjust a patient's drug regimen pursuant to
authorization or order by the patient's prescriber and in
accordance with the policies, procedures, or protocols of
the licensed health care facility. (BPC 4052.1)
7)Permits pharmacists in specified settings who act as part of a
multidisciplinary group to initiate or adjust a patient's drug
regimen pursuant to authorization or order by the patient's
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treating prescriber. Prohibits the substitution or selection
of a different drug unless authorized by protocol and requires
prescriber notification of initiated drug regimens to be
transmitted within 24 hours. (BPC 4052.2)
8)Requires pharmacists performing specified procedures to have
successfully completed clinical residency training or
demonstrated clinical experience in direct patient care
delivery. (BPC 4052.2)
9)Permits a pharmacist to furnish emergency contraception drug
therapy in accordance with either standardized procedures or
protocols developed by the pharmacist and an authorized
provider or standardized procedures developed and approved by
MBC in consultation with the American College of Obstetricians
and Gynecologists, California Pharmacists Association and
other entities. (BPC 4052.3)
10)Authorizes pharmacists filling prescription orders for drug
products prescribed by their trade or brand names to
substitute a generic drug product, as specified, unless the
prescriber specifies that a pharmacist may not substitute
another drug product by either indicating on the form
submitted for the filling of the prescription drug orders "Do
not substitute" or words of similar meaning or selecting a
box on the form marked "Do not substitute." (BPC 4073)
FISCAL EFFECT : Unknown
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 the
recognition of and expanded scope for advanced practice
pharmacists and establishes for. This bill is
author-sponsored.
2)Author's statement . According to the author, "[SB 493] will
establish 'advanced practice pharmacist' recognition, allowing
such pharmacists to perform physical assessments; order and
interpret medication-related tests; refer patients to other
providers; initiate, adjust, and discontinue medications under
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physician protocol or as part of an integrated system such as
an [accountable care organization]; and participate in the
evaluation and management of health conditions in
collaboration with other providers. This will align California
law more consistently with federal programs such as the
Department of Defense, the Veterans Administration, and Indian
Health Service, where pharmacists have been practicing in this
collaborative way for over 40 years."
8)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
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. 31 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.
9)The Affordable Care Act (ACA) . The federal Affordable Care
Act (ACA) was passed in March 2010 to provide quality,
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
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Patient and Health System Outcomes through Advanced Pharmacy
Practice, A Report to the U.S. Surgeon General," in which it
was demonstrated that "though 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 by:
a) Performing patient assessments and developing
therapeutic plans;
b) Utilizing authorities to initiate, adjust, or
discontinue medications;
c) Ordering, interpreting, and monitoring appropriate
laboratory tests;
d) Providing care coordination and other healthcare
services for wellness and prevention; and,
e) Developing partnerships with patients for ongoing and
follow-up care.
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.
1)Arguments in support . The California Pharmacists Association
writes, "Health experts agree that team-based delivery models
such as Patient Centered Medical Homes, and payment models
like Accountable Care Organizations, represent our best
opportunities at achieving the ACA triple aim of improving
quality and patient satisfaction, improving health outcomes,
and reducing per capita cost.
"SB 493 seeks to hold true to these principles by including
pharmacists as members of the care team with authorities
consistent with their education and expertise. Pharmacists are
the foremost experts in medications and more than 80% of
health conditions are treated with prescription medications.
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Many chronic diseases like hypertension, diabetes, and high
cholesterol require ongoing management to ensure the maximum
efficacy of the medications. The model that SB 493 promotes is
consistent with models that have been shown to be effective
and with the CDC's recommendation for incorporating
pharmacists into team-based strategies for preventing and
managing chronic disease.
"To be clear, pharmacists are not looking to replace other
healthcare providers or fragment the delivery of care. Rather,
they are looking to expand their current statutory authorities
into new systems of care, which will allow them, as
community-based providers, to assist physicians and other
healthcare practitioners in expanding access and improving
care. SB 493 ensures pharmacists are able to participate in
team-based care consistent with their level of training."
2)Arguments in opposition . The Union of American Physicians and
Dentists write, "UAPD/AFSCME applauds the author of SB 493 in
attempting to expand health care access to residents of
California. SB 493 is not, however, a step in the right
direction. The legislation does not expand health care access
for residents of the State. Instead, SB 493 rolls out an
uncertain and untested health care delivery system? with
patients subject to adverse side effects resulting from
prescribing pharmacists. Moreover, physicians are trained to
respond in the event of such adverse side effects to
medications. Pharmacists lack the medical training to respond
to these patient crises. Medical collaboration with
pharmacists remains critical to safe patient outcomes!"
3)Related legislation . SB 491 (Hernandez) of 2013 permits a
nurse practitioner (NP) to practice independently after a
period of physician supervision if the NP has national
certification and liability insurance. SB 491 is pending in
the Assembly Business, Professions and Consumer Protection
Committee.
SB 492 (Hernandez) of 2013 would expand the scope of practice
for optometrists. SB 492 is pending in the Assembly Business,
Professions and Consumer Protection Committee.
4)Previous legislation . AB 1711 (Strickland) Chapter 58,
Statutes of 2005, authorized a registered nurse or licensed
pharmacist to administer influenza and pneumococcal
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immunizations without patient-specific orders, as specified.
AB 2660 (Leno) Chapter 191, Statutes of 2004, authorized
pharmacists to register with the DEA and initiate or adjust
controlled substance drug therapy under specified conditions.
SB 490 (Alpert) Chapter 651, Statutes of 2003, authorized a
licensed pharmacist to initiate emergency contraceptives in
accordance with a standardized procedure approved by BOP and
MBC.
REGISTERED SUPPORT / OPPOSITION :
Support
American Society of Health-System Pharmacists
Bay Area Council
Blue Shield of California
California Association for Nurse Practitioners
California Association of Physician Groups
California Association of Public Hospitals and Health Systems
California Chronic Care Coalition
California Family Health Council
California Hospital Association
California Immunization Coalition
California Korean American Pharmacists Association
California Northstate University, College of Pharmacy
California Optometric Association
California Primary Care Association
California Pharmacists Association
California Retailers Association
California Society of Health-System Pharmacists
California State Board of Pharmacy
Californians for Patient Care
Cedars-Sinai Medical Center
Indian Pharmacists Association of California
Kaiser Permanente
Loma Linda University School of Pharmacy
Medical Board of California
National Asian American Coalition
National Association of Chain Drug Stores
Pharmacy Choice and Access Now
Private Essential Access Community Hospitals
Safeway
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Sharp HealthCare
The United Nurses Association of California/Union of Health Care
Professionals
The University of California
Touro University California, College of Pharmacy
United Nurses Associations of California/Union of Health Care
Professionals
University of California, San Diego, Skaggs School of Pharmacy
and Pharmaceutical Sciences
University of California, San Francisco
University of Southern California School of Pharmacy
Western University of Health Sciences
211 individuals
Opposition
Blind Childrens Center
California Academy of Eye Physicians and Surgeons
California Academy of Family Physicians
California Chapter of the American College of Emergency
Physicians
California Psychiatric Association
California Right to Life Committee, Inc.
California Society of Anesthesiologists
California Society of Plastic Surgeons
Canvasback Missions, Inc.
Diabetes Coalition of California
Here For Them, Inc.
Latino Physicians of California
Let's Face it Together
Lighthouse for Christ Mission
Minority Health Institute, Inc.
The Dream Machine Foundation
Time for Change Foundation
Union of American Physicians and Dentists (UAPD/AFSCME)
Ventura County American Chinese Medical Dental Association
207 individuals
Analysis Prepared by : Sarah Huchel / B.,P. & C.P. / (916)
319-3301
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