BILL ANALYSIS Ó
SB 493
Page 1
Date of Hearing: August 13, 2013
ASSEMBLY COMMITTEE ON HEALTH
Richard Pan, Chair
SB 493 (Ed Hernandez) - As Amended: August 5, 2013
SENATE VOTE : 34-4
SUBJECT : Pharmacy practice.
SUMMARY : Establishes a new category of pharmacists referred to
as advance practice pharmacists (APPs), authorizes the Board of
Pharmacy (BOP) to recognize APPs, and establishes functions for
APPs; authorizes a pharmacist to independently initiate and
administer vaccines, as specified; authorizes a pharmacist to
perform additional functions including the furnishing of
nicotine replacement products (NRPs), as specified; and, the
ordering and interpreting of tests, as specified. Specifically,
this bill :
1)Defines APP as a licensed pharmacist who has been recognized
as an advanced pharmacist by the BOP, as specified. Provides
that a BOP-recognized APP is entitled to practice advance
practice pharmacy, as specified, within or outside a licensed
pharmacy, as specified.
2)Authorizes APPs to initiate a prescription and provide
clinical advice, services, information or patient consultation
if certain conditions are met. Applies all of the following
existing conditions to APPs when initiating a prescription or
providing clinical advice or patient consultation:
a) The clinical advice, services, information, or patient
consultation are provided to a health care professional or
to a patient;
b) The pharmacist has access to prescription, patient
profile, or other relevant medical information for purposes
of patient and clinical consultation and advice; and,
c) Access to the information specified in 2)b) above is
secure from unauthorized access and use.
3)Authorizes pharmacists to additionally do the following:
a) Perform procedures or functions authorized for APPs;
b) Provide consultation, training, and education to
patients about drug therapy, disease management, and
disease prevention;
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c) Participate in multidisciplinary review of patient
progress, including appropriate access to medical records;
d) Furnish the following medications: i) NRPs, as
specified; and, ii) prescription medications not requiring
a diagnosis that are recommended by the Federal Centers for
Disease Control and Prevention (CDC) for individuals
traveling outside the United States. Requires the
pharmacist to notify the patient's primary care provider
(PCP) of any drugs or devices furnished to the patient. If
the patient does not have a PCP, requires the pharmacist to
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; and,
e) Order and interpret tests for the purpose of monitoring
and managing the efficacy and toxicity of drug therapies.
4)Authorizes pharmacists to furnish self-administered hormonal
contraceptives in accordance with standardized procedures or
protocols developed and approved by both the BOP and the
Medical Board of California (MBC) in consultation with the
American Congress of Obstetricians and Gynecologists, the
California Pharmacists Association, or other appropriate
entities. Requires the standardized procedures or protocols
to require that the patient use a self-screening tool, based
on the United States Medical Eligibility Criteria for
Contraceptive Use developed by the CDC, and the pharmacist to
refer the patient to the patient's PCP, or, if the patient
does not have a PCP, to nearby clinics. Requires pharmacists
to provide a recipient of self-administered hormonal
contraception a fact sheet about the drug, as specified.
5)Authorizes the BOP and the MBC to ensure compliance with 4)
above, and each board is charged with its enforcement with
respect to their respective licensees. Indicates that 4)
above does not expand the authority of a pharmacist to
prescribe any prescription medication.
6)Authorizes pharmacists recognized by the 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,
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e) Initiate, adjust, or discontinue drug therapy, pursuant
to the manner specified in existing law which includes: the
requirement of a specific written order or authorization
made by the individual patient's treating prescriber, in
accordance with policies, procedures, or protocols, as
specified, that adjusting a regimen does not include
substituting or selecting a different drug, except as
authorized by the protocol, and requiring the pharmacist to
provide written notification to the patient's treating
prescriber, or enter the appropriate information in an
electronic patient record systems shared by the prescriber,
of any drug regimen initiated within 24 hours.
7)Requires pharmacists who adjust or discontinue 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. Requires
pharmacists who initiate drug therapy to promptly transmit
written notification to, or enter the appropriate information
into, a patient record system shared with the patient's PCP or
diagnosing provider, as appropriate. Requires pharmacists,
prior to initiating or adjusting a controlled substance
therapy to personally register with the federal Drug
Enforcement Administration (DEA).
8)Provides that 6) and 7) above is not to interfere with a
physician's order to dispense a prescription drug as written,
or other order of similar meaning.
9)Authorizes pharmacists, in addition to the current authority
of pharmacists to administer immunizations pursuant to a
protocol with a prescriber, 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. Requires pharmacists to
do all of the following to initiate and administer such
immunizations:
a) Complete an immunization training program endorsed by
the CDC or the Accreditation Council for Pharmacy Education
(ACPE) 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 maintain
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that training;
b) Be certified in basic life support; and,
c) Comply 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 Department of
Public Health;
10)Authorizes pharmacists administering immunizations to also
initiate and administer epinephrine or diphenhydramine by
injection for the treatment of a severe allergic reaction.
11)Authorizes pharmacists to furnish NRPs approved by the Food
and Drug Administration for use by prescription only in
accordance with standardized procedures and protocols
developed and approved by both the BOP and the 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 PCP of any drugs
or devices furnished to the patient. If the patient does
not have a PCP, 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 the BOP; and,
d) The pharmacist completes one hour of continuing
education (CE) focused on smoking cessation biennially.
12)Authorizes the BOP and the MBC to ensure pharmacists'
compliance with 11) above, and each board is specifically
charged with enforcement, as specified, and prohibits
construing 11) above to expand the authority of a pharmacist
to prescribe any other prescription medication.
13)Requires a person seeking recognition as an APP to meet all
of the following requirements:
a) Hold an active license to practice pharmacy, as
specified;
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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 ACPE or another entity recognized by the BOP;
ii) Complete a 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 with the BOP for recognition as APP
and pay the applicable fee.
14)Indicates that APP recognition issued pursuant to 13) above
is valid for two years, coterminous with the certificate
holder's license to practice pharmacy.
15)Requires the BOP to adopt regulations establishing the means
of documenting completion of the requirements for an APP
recognition, as specified.
16)Requires the BOP, by regulation, to set the fee for the
issuance and renewal of APP recognition at the reasonable cost
of regulating the practice of an APP. Prohibits the fee from
exceeding $300.
17)Requires a pharmacist recognized as an APP to complete 10
hours of CE each renewal cycle in addition to the other CE
requirements. Requires the subject matter to be in one or
more areas of practice relevant to the pharmacist's clinical
practice.
18)Finds and declares that pharmacists are health care providers
who have the authority to provide health care services.
19)Makes other technical, clarifying, and conforming changes.
EXISTING LAW :
1)Establishes the BOP to regulate the practice of pharmacy,
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including the licensure of pharmacists.
2)Provides that the practice of pharmacy is a 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. Indicates that
pharmacy practice is continually evolving to include more
sophisticated and comprehensive patient care activities.
3)Makes it unlawful for any person to manufacture, compound,
furnish, sell, or dispense any dangerous drug or dangerous
device, or to dispense or compound any prescription of a
prescriber unless that person is a pharmacist.
4)Defines prescription to mean an oral, written, or electronic
transmission order that is both: a) given individually for the
person or persons for whom it was ordered, as specified; and,
b) issued by a physician, dentist, optometrist, podiatrist,
veterinarian, or naturopathic doctor, as specified, by a
certified nurse-midwife, nurse practitioner (NP), physician
assistant (PA), or naturopathic doctor or by a pharmacist, as
specified.
5)Authorizes a pharmacist to initiate a prescription in
specified settings, including a licensed health care facility,
home health agency, or a licensed clinic, as specified.
6)Authorizes a pharmacist to furnish emergency contraception
drug therapy in accordance with standardized procedure or
protocols developed by the pharmacist and an authorized
prescriber, as specified.
7)Authorizes a pharmacist to do the following:
a) Furnish a reasonable quantity of compounded drug product
to a prescriber for office use by the prescriber;
b) Transmit a valid prescription to another pharmacist;
c) Administer, orally or topically, drugs and biologicals;
d) Perform procedures or functions in a licensed health
care facility, as specified;
e) Perform procedures or functions as part of the care
provided by a health care facility, licensed home health
agency, a licensed clinic, a provider who contracts with a
licensed health care service plan, or a physician, as
specified;
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f) Manufacture, measure, fit to the patient, or sell and
repair dangerous devices or furnish instructions to the
patient or the patient's representative concerning the use
of those devices;
g) Provide consultation to patients and professional
information, including clinical or pharmacological
information, advice, or consultation to other health care
professionals; and,
h) Administer immunizations pursuant to a protocol with a
prescriber.
8)Requires a pharmacist who is authorized to issue an order to
initiate or adjust a controlled substance therapy to
personally register with the DEA.
9)Prohibits the BOP, unless exempted, from issuing or renewing a
license to conduct a pharmacy to: a) person/s authorized to
prescribe or write a prescription (physician, dentist,
optometrist, podiatrist, veterinarian, naturopathic doctors,
certified nurse midwife, NP, or PA); b) person/s with whom
those specified in 9)a) above share a community or other
financial interest in the permit sought; or, c) any
corporation that is controlled by, or in which 10% or more of
the stock is owned by a person prohibited from pharmacy
ownership pursuant to 9)a) or b) above.
10)Prohibits a person from conducting a pharmacy unless he or
she has obtained a licensed from the BOP. Requires a license
for each pharmacy owned or operated by a specific person.
FISCAL EFFECT : According to the Senate Appropriations
Committee:
1)One-time costs of about $200,000 to adopt new regulations and
upgrade the existing system for processing license
applications (Pharmacy Board Contingent Fund).
2)Ongoing costs of about $300,000 per year for licensing and
enforcement (Pharmacy Board Contingent Fund).
3)Indeterminate impact on state health care programs, such as
the California Public Employees' Retirement System and
Medi-Cal.
COMMENTS :
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1)PURPOSE OF THIS BILL . According to the author, as a result of
the implementation of the Patient Protection and Affordable
Care Act, about 4.7 million more Californians will be eligible
for health insurance starting in 2014. The newly insured will
increase demand for healthcare services and will create more
pressure on an already strained health care system,
particularly in medically underserved areas. This bill will
allow for better utilization of the existing infrastructure of
trained medical providers to bridge the provider gap through
expanded practice. Californians deserve access to high
quality primary care offered by a range of safe, efficient,
and regulated providers. PAs, NPs, pharmacists and
optometrists all have significantly advanced degrees and an
upgraded program accreditation process. Other states have
recognized these advances with practice acts that align with
professional competence and advanced education. But
California's practice acts have not kept pace. We can no
longer afford to get by on a fraction of our professional
capacity. California has a robust network of providers who
are well-trained, evenly distributed throughout the state, and
well positioned to pay particular attention to currently
underserved areas. Deploying these professionals in a
team-based delivery model where they work collaboratively with
physicians will allow California to meet the demands placed on
the healthcare systems.
2)BACKGROUND .
a) The Practice of Pharmacy . Current law authorizes
pharmacists to furnish compounded drug products, transmit a
valid prescription to another pharmacist, administer,
orally or topically, drugs and biologicals pursuant to a
prescriber's order, perform procedures or functions in a
licensed health care facility, licensed home health agency,
manufacture, measure, fit to the patient or sell and repair
dangerous devices or furnish instructions to the patient
regarding the use of such devices, furnish emergency
contraception drug therapy, and provide consultation and
professional information, including clinical or
pharmacological information to patients, advice, or
consultation to other health care professionals, and
administer immunizations pursuant to a protocol with a
prescriber.
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In a licensed health care facility, a home health agency, a
licensed clinic in which there is physician oversight, a
provider who contracts with a licensed health plan for the
provision of services to enrollees of the health care
service plan or a physician, and pursuant to policies,
procedures, or protocols developed by health professionals,
a pharmacist could perform additional functions, including:
i) ordering or performing routine drug therapy-related
patient assessment procedures including temperature, pulse,
and respiration; ii) ordering drug therapy-related
laboratory tests; iii) administering drugs and biologicals
by injection pursuant to a prescriber's order; iv)
initiating or adjusting the drug regimen of a patient
pursuant to an order or authorization made by the patient's
prescriber. It should be noted that many of the functions
that this bill authorizes for APPs are functions that are
already performed by pharmacists in the above settings.
b) Education and Training of Pharmacists . According to the
BOP, there are approximately 40,000 licensed pharmacists in
California, and eight pharmacy schools based in the state.
The Pharmacy Act requires that pharmacists, to obtain
licensure, must have graduated from a college of pharmacy
or department of pharmacy of a university recognized by the
BOP; have completed at least 150 semester units of
collegiate study in the United States, or the equivalent
thereof in a foreign country, and no less than 90 of those
units must be completed while in resident attendance at a
school or college of pharmacy; have earned at least a
baccalaureate degree in a course of study devoted to the
practice of pharmacy; have completed 1,500 hours of
pharmacy practice or experience; and, have passed the North
American Pharmacist Licensure Examination and the
California Practice Standards and Jurisprudence Examination
for Pharmacists. For purposes of the 1,500 hours of
pharmacy practice experience, the BOP requires the
following: i) a minimum of 900 hours must be obtained in a
pharmacy; ii) a maximum of 600 hours may be granted at the
discretion of the BOP for other experience substantially
related to the practice of pharmacy; iii) experience in
both community pharmacy and institutional pharmacy
settings; and, iv) pharmacy experience that satisfies the
requirements for both introductory and advanced pharmacy
practice experiences established by the ACPE. The BOP also
requires pharmacists to complete 30 hours of CE every two
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years for purposes of license renewal.
The ACPE is the national agency for the accreditation of
professional degree programs in pharmacy and providers of
pharmacy CE. All pharmacy schools in the country and
California are ACPE-accredited. ACPE initially established
standards for the baccalaureate degree in pharmacy, then
added the doctor of pharmacy standards as an alternative,
and in 2000 announced the conversion to the doctor of
pharmacy (PharmD) as the sole entry-level degree for the
profession of pharmacy.
c) Vaccines . This bill authorizes a pharmacist to
independently administer vaccines listed on the routine
immunization schedules recommended by ACIP. According to
the CDC, vaccines are responsible for the control of many
infectious diseases that were once common in this country
and around the world, including polio, measles, diphtheria,
pertussis (whooping cough), rubella (German measles),
mumps, tetanus, and Haemophilus influenzae type b (Hib).
Vaccine-preventable diseases have a costly impact,
resulting in doctor's visits, hospitalizations, and
premature deaths. Sick children can also cause parents to
lose time from work. Vaccines contain the same antigens or
parts of antigens that cause diseases, but the antigens in
vaccines are either killed or greatly weakened. Vaccine
antigens are not strong enough to cause disease but they
are strong enough to make the immune system produce
antibodies against them.
Federal law requires ACIP to provide advice and guidance to
the Secretary of the U.S. Department of Health and Human
Services (HHS), the Assistant Secretary for Health, and the
CDC on the most effective means to prevent
vaccine-preventable diseases. Another goal of ACIP is to
increase the safe usage of vaccines and related biological
products. ACIP consists of 15 experts in fields associated
with immunization who have been selected by the HHS
Secretary, and is the only entity in the federal government
which develops recommendations for the routine
administration of vaccines to children and adults, along
with schedules regarding the age for vaccine
administration, appropriate dosage, dosing intervals,
precautions, and contraindications applicable to the
vaccines
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d) Healthcare Workforce Shortage . On March 23, 2010,
President Obama signed the ACA (Public Law (PL) 111-148),
as amended by the Health Care and Education Reconciliation
Act of 2010 (PL 111-152). Among other provisions, the new
law requires most U.S. citizens and legal residents to have
health insurance; creates state-based American Health
Benefit Exchanges through which individuals can purchase
coverage, with premium and cost sharing credits, and
creates separate exchanges through which small businesses
can purchase coverage. A 2011 study by the Center for the
Health Professions of the University of California, San
Francisco entitled "California's Health Care Workforce:
Readiness for the ACA Era" indicates that with California's
implementation of the ACA, 4-6 million Californians will
obtain coverage. As such, there is a need not only for a
sufficient number of providers but also providers who can
meet the needs of a diverse and changing public.
Specifically, the study points out that primary care will
be the area most immediately affected because preventive
care and chronic disease management become increasingly
important.
In March 2012 and March 2013, the Senate Health Committee
conducted informational hearings relating to healthcare
workforce and the ACA. The hearings explored the supply,
and expected demand, for various healing arts practitioners
as part of ACA implementation. Additionally, several
options were discussed to address workforce needs.
3)SUPPORT . The University of California states that full and
consistent recognition of scope of practice and provider
status by health care payers for California pharmacists would
enable the pharmacy profession to make significant strides
forward. In this era of limited resources, the changes
proposed by this bill would help increase workforce capacity,
improve access to care, more fully integrate the pharmacy
profession into the health care team, and potentially offer
much-needed costs savings to California.
Pharmacy schools such as Touro University state that this bill
allows more pharmacists to practice to their level of
education. It states that graduates are trained to manage
chronic diseases such as hypertension, diabetes, and
hyperlipidemia.
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The California Chronic Care Coalition states that pharmacists
are highly-trained health care workers, who can provide some
preventative health care measures and medications in very safe
conditions to people who would otherwise go without health
care.
Blue Shield of California indicates that this bill will help
alleviate the healthcare access challenge, help control costs,
and reduce the strain in our overburdened healthcare system.
The California Retailers Association indicates that pharmacists
are one of the most underutilized healthcare professionals
within the healthcare system and historically their role in
providing direct patient care has been fairly limited.
However, pharmacists are well- equipped with the clinical and
professional experience to do much more and are uniquely and
conveniently situated within communities to help patients
optimize medication use, prevent medication-related problems,
and improve health outcomes through the delivery of direct and
frequent patient care services such as Medication Therapy
Management, health promotion and education among other
functions.
The California Board of Pharmacy states that the functions and
services that an APP may perform under this bill are not new
and pharmacists can currently perform these types of functions
and services in certain settings under certain conditions.
Pharmacists are highly educated, with extensive training in
patient care and disease prevention and management, and are
one of the most accessible health care providers to patients.
4)OPPOSITION . The California Chapter of the American College of
Emergency Physicians opposes a previous version of this bill
and states that "pharmacists have no education training to
perform physical examinations nor do they have any training to
diagnose medical conditions. As physicians educated and
trained in the complexities of human physiology and
epidemiology, we cannot imagine how someone without adequate
education or training could safely perform physical exams or
render diagnosis. Additionally, the bill introduces potential
conflicts of interest and undermines the corporate ban on the
practice of medicine because pharmacists are not covered by
the ban. It is foreseeable that a pharmacist working for a
retail chain could be paid to prescribe a drug by the company
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profiting from the prescription.
The California Psychiatric Association opposes the APP
provisions of this bill because of the potential risks to the
health and safety of patients of psychiatrists or other
physicians who are taking powerful, sometimes dangerous
psychotropic medications which often have serious side
effects.
5)OPPOSE UNLESS AMENDED . The California Academy of Family
Physicians has an oppose unless amended position on a prior
version of this bill and states that the single training
course required for pharmacists to administer vaccines puts
patients at risk; smoking cessation drugs and devices should
only be used under close medical supervision; fragmented
primary care received in a pharmacy may not be an appropriate
venue in which to monitor patients using these medications;
and, the authority of an APP to adjust drug therapy should be
contingent upon notice to the prescriber.
The Osteopathic Physicians and Surgeons of California (OPS) also
has an oppose unless amended position on a prior version of
this bill and indicates concerns regarding giving authority to
pharmacists to furnish self-administered hormonal
contraception, prescription smoking-cessation drugs, and
medications required for international travelers. OPS states
that unlike physicians, pharmacists do not conduct full
patient assessments in the course of their practice that would
identify potential contraindications from these medications.
6)NEUTRAL . The California Medical Association (CMA) has taken a
neutral position on this bill and indicates that this bill, as
amended, enables pharmacists, with the appropriate training
and education, to attain the APP designation and this would
help improve the communication and coordination between the
patient, the physician, and their pharmacists. CMA also
points out that the amendments have the potential to improve
access to vaccines for children and access to nicotine based
smoking cessation products for adults seeking to end their
addiction to tobacco products.
7)RELATED LEGISLATION .
a) SB 491(Ed Hernandez), among other provisions, authorizes
a NP to practice independently if the NP meets specified
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experience and certification requirements. SB 491 is
pending in the Assembly Business, Professions and Consumer
Protection Committee.
b) SB 492 (Ed Hernandez), among other provisions, expands
the scope of practice of optometrists, as specified, and
states the Legislature's intent that the Office of
Statewide Health Planning and Development, under the Health
Workforce Pilot Projects Program, designate a pilot project
intended to test, demonstrate, and evaluate expanded roles
for optometrists in the performance of management and
treatment of diabetes mellitus, hypertension, and
hypercholesterolemia. SB 492 is pending in the Assembly
Business, Professions and Consumer Protection Committee.
8)PREVIOUS LEGISLATION .
a) AB 2408 (Negrete McLeod), Chapter 777, Statutes of 2006,
among various provisions, authorizes a pharmacist to
perform certain procedures or functions in specified
facilities, including a health care facility, home health
agency, or licensed clinic.
b) AB 1711 (Strickland), Chapter 58, Statutes of 2005,
authorizes a registered nurse or licensed pharmacist to
administer in skilled nursing facilities influenza and
pneumococcal immunizations to patients over 50 years of
age, as specified.
c) SB 490 (Alpert), Chapter 651, Statutes of 2003,
authorizes a licensed pharmacist to initiate emergency
contraceptives in accordance with standardized procedure
approved by BOP and MBC.
9)DOUBLE-REFERRAL . This bill is double referred, it was heard
in the Assembly Business, Professions and Consumer Protection
Committee on August 6, 2013, and passed out on a
14-0 vote.
10)POLICY CONCERNS .
a) Patient Assessments . This bill authorizes an APP to
perform patient assessments. However, it is unclear
whether patient assessments include conducting full or
partial physical examinations. Under existing law, a
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pharmacist in a health care facility could order and
perform routine drug therapy-related patient assessment
procedures including temperature, pulse, and respiration.
The Chair recommends that the performance of patient
assessments should only be for purposes of drug therapy, as
in existing law for pharmacists in a health care facility.
b) Vaccines . This bill authorizes a pharmacist to
independently initiate and administer vaccines listed on
the routine immunization schedules recommended by ACIP for
persons three years of age and older and requires a
pharmacist to complete an immunization training program, as
specified. The Chair recommends that the training required
in this bill specifically include demonstrated proficiency
annually in the application of ACIP's recommended
immunization schedules.
c) Order and Interpret Tests . Provisions relating to the
ordering and interpreting of tests are contained in two
different sections of this bill. First, Section 4052 (a)
(12) authorizes a pharmacist to order and interpret tests
for the purpose of monitoring and managing the efficacy and
toxicity of drug therapies. According to the author, this
authority is limited to monitoring the efficacy and
toxicity of drug therapies, and does not allow the
pharmacist to take any action/s based on the results of the
test. On the other hand, Section 4052.6 authorizes an APP
to order and interpret drug therapy-related test which is
broader and aligns with an APP's additional authority to
adjust, initiate, or discontinue drug therapy pursuant to a
protocol, as specified. The Chair is concerned that these
provisions provide no parameters on how these functions
could be accomplished. For example, this bill provides no
practice guidelines for ordering and interpreting these
tests, the need to evaluate the test results in the context
of a patient's full medical history, which a pharmacist may
not have access to, the handling of abnormal test results
that require discussion or consultation with a physician,
and the need for additional patient assessments. As such,
the Chair recommends that a pharmacist orders and
interprets these tests under the direction of a physician
who is actively involved in the direct care of the patient,
such as the prescribing physician. This recommendation
would correspond to current practice by health system
pharmacists who are members of the patient care team.
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Additionally, there is nothing in this bill that requires a
pharmacist to provide a copy of the test results to the
patient or the physician who is actively involved in the
direct care of the patient, which is required under this
bill when drugs and devices are furnished to the patient,
and also when a pharmacist initiates, adjusts, or
discontinues drug therapy. To be consistent and facilitate
communication with the physician, the Chair recommends that
a pharmacist who orders and interprets tests must provide a
copy of the test results to the patient or the physician
who is actively involved in the direct care of the patient.
d) Corporate Influence . This bill expands the role of
pharmacists by, among other functions, authorizing them to
independently administer vaccines, order and interpret
tests, and initiate a prescription (APP). In those
instances that a corporation employs these pharmacists, the
Chair is concerned that that the financial goals of a
corporation may conflict with the professional goals of a
pharmacist. The Chair recommends including a provision in
this bill to make it unprofessional conduct for a person
(defined in the Pharmacy Act to include a firm,
association, partnership, corporation, limited liability
company, state governmental agency, or political
subdivision) who conducts a pharmacy to exert undue
influence on a pharmacist to commit any act or omission
with the primary purpose of increasing revenue, sales, or
other financial influence.
REGISTERED SUPPORT / OPPOSITION :
Support
Adventist Health
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 Hospital Association
California Immunization Coalition
California Korean American Pharmacists Association
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California Medical Board
California Northstate University, College of Pharmacy
California Optometric Association
California Pharmacists Association
California Primary Care Association
California Retailers Association
California Society of Health-System Pharmacists
California State Board of Pharmacy
Californians for Patient Care
Cedars-Sinai Medical Center
Dignity Health
Indian Pharmacists Association of California
Kaiser Permanente
Loma Linda University
National Asian American Coalition
National Association of Chain Drug Stores
Pharmacy Choice and Access Now
Private Essential Access Community Hospitals
Safeway
St. Elizabeth Community Hospital
Touro University-California, College of Pharmacy
United Nurses Association of California/Union of Health Care
Professionals
University of California
University of California, San Diego, Skaggs School of Pharmacy
and Pharmaceutical Sciences
University of California, San Francisco
Western University of Health Sciences
Numerous pharmacy students
Opposition
American College of Emergency Physicians, California Chapter
Blind Children's Center
California Academy of Eye Physicians and Surgeons
California Academy of Family Physicians
California Psychiatric Association
California Right to Life Committee, Inc.
California Society of Anesthesiologists
California Society of Plastic Surgeons
Canvasback Missions, Inc.
Dream Machine Foundation
Here for Them, Inc.
Let's Face It Together Foundation
Lighthouse for Christ Mission and Eye Center
SB 493
Page 18
Osteopathic Physicians and Surgeons of California
Sansum Diabetes Research Institute
Time for Change Foundation
Union of American Physicians and Dentists
Ventura County American Chinese Medical Dental Association
Analysis Prepared by : Rosielyn Pulmano / HEALTH / (916)
319-2097