BILL ANALYSIS Ó
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| Hearing Date:April 29, 2013 |Bill No:SB |
| |493 |
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SENATE COMMITTEE ON BUSINESS, PROFESSIONS
AND ECONOMIC DEVELOPMENT
Senator Curren D. Price, Jr., Chair
Bill No: SB 493Author:Hernandez
As Amended:April 24, 2013Fiscal: Yes
SUBJECT: Pharmacy practice.
SUMMARY: Updates Pharmacy Law to authorize pharmacists to perform
certain functions according to specified requirements, including:
administer physician prescribed injectable medications; furnish
immunizations for people ages three and up if the pharmacist has
completed training and follows specified procedures; furnish
self-administered hormonal contraceptives, based on a statewide
protocol, similar to the existing authority for pharmacists to furnish
emergency contraceptive drug therapy; furnish smoking cessation drugs
and devices if the pharmacist has completed training and follows
specified procedures; furnish travel medications approved by the U.S.
State Department; and, order and interpret tests to monitor drug
safety. Establishes "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 physician protocol
or as part of an integrated system and; participate in the evaluation
and management of health conditions in collaboration with other
providers.
Existing law, the Business and Professions Code (BPC):
1) Establishes the Pharmacy Law which provides for the licensure and
regulation of pharmacies, pharmacists and wholesalers of dangerous
drugs or devices by the Board of Pharmacy (Board) within the
Department of Consumer Affairs (DCA) and establishes a scope of
practice for pharmacy as a profession.
2) Defines "furnish" as supply by any means, by sale or otherwise.
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(BPC § 4026)
3) Defines "dispense" as the furnishing of drugs or devices upon a
prescription from a physician, dentist, optometrist, podiatrist,
veterinarian, or naturopathic doctor or upon an order to furnish
drugs or transmit a prescription from a certified nurse-midwife,
nurse practitioner, physician assistant, naturopathic doctor, or
pharmacist acting within the scope of his or her practice.
Dispense also means and refers to the furnishing of drugs or
devices directly to a patient by a physician, dentist, optometrist,
podiatrist, or veterinarian, or by a certified nurse-midwife, nurse
practitioner, naturopathic doctor, or physician assistant acting
within the scope of his or her practice. (BPC § 4024)
4) Declares the practice of pharmacy as a profession which is dynamic,
patient-oriented health service that 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. Provides that pharmacy practice
is continually evolving to include more sophisticated and
comprehensive patient care activities. (BPC § 4050)
5) Permits a pharmacist to initiate a prescription according to
certain requirements. Permits a pharmacist to provide clinical
advice, information or patient consultation if as follows:
(BPC § 4051 (b))
a) The advice, information or consultation is provided to a
health care professional or patient.
b) The pharmacist has access to prescription, patient profile
or other relevant medical information for purposes of patient
and clinical consultation and advice.
c) Access to the information is secure from unauthorized use.
6)Permits a pharmacist to: (BPC § 4052)
a) Furnish a reasonable quantity of compounded drug product
to a prescriber for use in his or her office.
b) Transmit a valid prescription to another pharmacist.
c) Administer, orally or topically, drugs and biologicals
pursuant to a prescriber's order.
d) Perform certain procedures or functions in a licensed
health care facility.
e) Perform certain procedures or functions as part of the
care provided by a health care facility, licensed home health
agency, licensed clinic in which there is a physician
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oversight, provider who contracts with a licensed health care
service plan with regard to the care or services provided to
the enrollees of that plan or a physician.
f) Manufacture, measure, fit to the patient or sell and
repair dangerous devices or furnish instructions to a patient
or 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 professionals.
h) Furnish emergency contraception drug therapy.
i) Administer immunizations pursuant to a protocol with a
prescriber.
7) Provides that a pharmacist authorized to issue an order to
initiate or adjust a controlled substance therapy shall register
with the federal Drug Enforcement Administration (DEA). (BPC §
4052 (b))
8) Permits pharmacists to perform the following procedures under
physician protocols in licensed health care facilities: (BPC
§4052.1)
a) Order and perform routine drug therapy-related patient
assessment procedures.
b) Order drug therapy-related laboratory tests.
c) Administer drugs and biologicals by injection pursuant to
a prescriber's order.
d) Initiate or adjust a patient's drug regimen pursuant to
authorization or order by the patient's prescriber.
9)Permits pharmacists in a number of specified settings to do the
following: (BPC § 4052.2)
a) Order and perform routine drug therapy-related patient
assessment procedures.
b) Order drug therapy-related laboratory tests.
c) Administer drugs and biologicals by injection pursuant to
a prescriber's order.
d) Initiate or adjust a patient's drug regimen pursuant to
authorization or order by the patient's 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.
e) Specifies that a patient's treating prescriber may
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prohibit pharmacists from making any changes or adjustments to
patients' drug regimens.
f) Requires the governing policies, procedures and protocols
to be developed by specified health professionals and
established minimum requirements for those policies, procedures
and protocols.
g) Requires pharmacists performing procedures authorized by
this section to have successfully completed clinical residency
training or demonstrated clinical experience in direct patient
care delivery.
10)Permits a pharmacist to furnish emergency contraception drug
therapy (ECDT) in accordance with either standardized procedures or
protocols developed by the pharmacist and an authorized provider or
standardized procedures developed and approved by the Board and
Medical Board of California (MBC) in consultation with the American
College of Obstetricians and Gynecologists (ACOG), California
Pharmacists Association (CPhA) and other entities. Provides that
the Board and MBC have authority to ensure compliance and charges
both boards with enforcing this provision for its licensees.
Requires a pharmacist to complete a training program on emergency
contraception that consists of at least one hour of approved
continuing education on ECDT prior to furnishing emergency
contraception drug therapy. Provides that a pharmacist,
pharmacist's employer or pharmacist's agent may charge a patient an
administrative fee of up to $10 above the retail cost of the drug
but may not charge a patient a separate consultation fee for ECDT
services. Prohibits a pharmacist from requiring a patient to
provide individually identifiable medical information unless
otherwise specified before initiating ECDT. Requires a pharmacist
to provide ECDT recipients standardized factsheets developed in
consultation with the State Department of Public Health (DPH),
ACOG, CPhA and other health care organizations that include
indications for use of the drug, appropriate method for use, need
for medical followup and other appropriate information. Makes this
inoperative if ECDT are reclassified as over-the-counter products
by the FDA. (BPC § 4052.3)
11)Specifies certain requirements regarding the dispensing and
furnishing of dangerous drugs and devices, and prohibits a person
from furnishing any dangerous drug or device except upon the
prescription of a physician, dentist, podiatrist, optometrist,
veterinarian or naturopathic doctor. (BPC § 4059)
12)Authorizes pharmacists filling prescription orders for drug
products prescribed by their trade or brand names to substitute a
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drug product with a different form of medication with the same
active chemical ingredients of equivalent strength and duration of
therapy as the prescribed drug product when the change will improve
the ability of the patient to comply with the prescribed drug
therapy, subject to a patient notification and bottle labeling
requirement, 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 § 4052.5)
13)Authorizes pharmacists filling prescription orders for drug
products prescribed by their trade or brand names to substitute
generic drugs for orders if the generic contains the same active
chemical ingredients of equivalent strength and duration of
therapy, subject to a patient notification and bottle labeling
requirement, 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)
14)Specifies that dispensing of drugs in a non-profit community clinic
or primary care clinic, as defined, shall be performed only by a
physician, a pharmacist, or other person lawfully authorized to
dispense drugs, and only in compliance with all applicable laws and
regulations. (BPC § 4181)
15)Requires pharmacists to submit proof of completion of 30 hours of
approved continuing pharmacy education (CE) prior to license
renewal. (BPC § 4231)
This bill:
1) Makes various technical and clarifying changes.
2) Defines "advanced practice pharmacist" (APP) as a licensed
pharmacist who has been recognized as an advanced practice
pharmacist by the Board. Specifies that a Board-recognized APP is
entitled to practice advanced practice pharmacy as described in
Section 4052.6, within or outside of a licensed pharmacy as
authorized by this chapter.
3) Declares that pharmacists are health care providers who have the
authority to provide health care services.
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4) Deletes the requirement that pharmacists only administer drugs and
biological products orally or topically and instead permits
pharmacists to administer drugs and biological products by other
means including injection that have been ordered by a prescriber.
5) Permits an APP to perform specified procedures or functions.
6) Permits a pharmacist to provide consultation, training and
education about drug therapy, disease management and disease
prevention.
7) Permits a pharmacist to participate in multidisciplinary review of
patient progress, including appropriate access to medical records.
8) Permits a pharmacist to furnish self-administered hormonal
contraceptives, smoking cessation drugs and devices and
prescription medications not requiring a diagnosis that are
recommended by the CDC for individuals traveling outside of the
U.S., in addition to ECDT.
9) Permits a pharmacist to administer immunizations pursuant to a
protocol with a prescriber.
10)Permits a pharmacist to order and interpret tests for the purpose
of monitoring and managing the efficacy and toxicity of drug
therapies.
11)Permits a pharmacist to furnish self-administered hormonal
contraceptives in accordance with procedures and protocols
developed and approved by the Board and the MBC in consultation
with ACOG, CPhA and other appropriate entities. Specifies that
procedures or protocols shall require the patient to use a
self-screening tool based on the United States Medical Eligibility
Criteria for Contraceptive Use developed by the federal Centers for
Disease Control and Prevention (CDC) and that the pharmacist refer
the patient to their primary care provider or to nearby clinics.
Provides that the Board and the MBC have authority to ensure
compliance and charges both boards with enforcing this provision
for its licensees. Clarifies that this does not expand the
authority of a pharmacist to prescribe any prescription medication.
12)Expands the requirements in current law for providing ECDT
recipients standardized factsheets to include patients receiving
self-administered hormonal contraception and requires
contraindications of the drugs to be included on fact sheets.
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13)Provides that a pharmacist recognized by the Board as an APP is
permitted 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 or management of diseases
and health conditions in collaboration with other health care
providers.
e) Initiate, adjust or discontinue drug therapy pursuant to
the authority established in current law for pharmacists to
perform certain procedures in a licensed health care facility.
1) Provides that a pharmacist who adjusts or discontinues drug therapy
shall promptly transmit written notification to the patient's
diagnosing prescriber or enter the appropriate information into a
patient record system shared with the prescriber. Provides that a
pharmacist who initiates drug therapy shall promptly transmit
written notification to the patient's diagnosing prescriber or
enter the appropriate information into a patient record system
shared with the prescriber.
2) Requires a pharmacist to register with the DEA prior to initiating
or adjusting a controlled substance.
3) Permits a pharmacist to independently initiate and administer
vaccines listed on the routine immunization schedules recommended
by the federal Advisory Committee on Immunization Practices for
persons ages three and older.
4) Requires a pharmacist, in order to initiate and administer
vaccines, to do all of the following:
a) Complete an immunization training program endorsed by the
CDC or Accreditation Council for Pharmacy Education that
includes hands-on injection technique, clinical evaluation of
indications and contraindications of vaccines and recognizing
and treating emergency reactions to vaccines.
b) Be certified in basic life support.
c) Comply with all federal and state 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 CDC.
1) Permits a pharmacist who has met the requirements for initiating
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and administering vaccines to also initiate and administer
epinephrine or diphenhydramine by injection for the treatment of a
severe allergic reaction.
2) Permits a pharmacist to furnish prescription smoking cessation
drugs and devices, 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
provides the patient with a written record of the drugs or
devices if the patient does not have a primary care provider
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 Board.
d) The pharmacist completes one hour of continuing education
focused on smoking-cessation biennially.
21) Provides that in order to be recognized as an APP, a person must
meet all of the following
requirements:
a) Hold an active license with the Board and be in good
standing.
b) File an application with the Board for recognition as an
APP.
c) Pay the applicable fee to the Board.
22)Provides that in order to be recognized as an APP, a person must
satisfy two of the following criteria:
a) Possess certification in a relevant area of practice,
including but not limited to, ambulatory 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 other entity recognized by the Board.
b) Complete a one year postgraduate residency through an
accredited postgraduate institution where at least 50 percent
of the experience includes a provision of direct patient care
services with interdisciplinary teams.
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c) Have actively managed 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.
23)Provides that APP recognition is valid for two years.
24)Requires the Board to adopt regulations establishing the means of
documenting completion of the requirements for an APP.
25)Requires an APP to complete 10 hours of continuing education (CE)
each license renewal cycle for a subject matter in one or more
areas relevant to a pharmacist's clinical practice, in addition to
current CE requirements.
FISCAL EFFECT: Unknown. This bill has been keyed "fiscal" by
Legislative Counsel.
COMMENTS:
1.Purpose. This measure is sponsored by the Author. According to the
Author, pharmacists provide patient care that optimizes medication
therapy and promotes health, wellness, and disease prevention. The
Author states that pharmacists complete a four year post-graduate
doctoral training program that includes extensive training in human
anatomy and physiology, recognition and treatment of diseases and
conditions, pharmacology, optimal medication use, as well as
experience in direct patient care in multiple health care settings
through clinical rotations. The Author further acknowledges that
many pharmacists complete a residency program and obtain board
certification in a specialized area of practice. According to the
Author, this bill 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.
The Author believes that "Californians deserve access to high
quality primary care offered by a range of safe, efficient, and
regulated providers. Physician assistants, nurse practitioners,
pharmacists and optometrists have all significantly advanced their
educational, testing, and certification programs over the past
decade. They've enhanced clinical training, moved to graduate or
advanced degrees, and upgraded program accreditation processes."
2.Background.
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a) The Patient Protection and Affordable Care Act. On March 23,
2010, President Obama signed the Patient Protection and
Affordable Care Act (ACA) into federal statute. The ACA, which
states will begin implementing in 2014, represents one of the
most significant expansions and overhauls of the United States
health care system since the passage of Medicare and Medicaid in
1965. The ACA is aimed at increasing the rate of health
insurance coverage for Americans and reducing the overall costs
of health care. It provides a number of mechanisms including
mandates, subsidies and tax credits to employers and individuals
in order to increase the rate of people with coverage. As a
result of implementation of the ACA, anywhere from 4-7 million
additional Californians will be eligible for health insurance
beginning in 2014. It is anticipated that the newly insured will
increase demand for health care on an already strained system.
b) Primary Care Workforce Shortage. The Author provided a
number of studies and reports highlighting a shortage in
California of primary care physicians. According to a report
commissioned by the California Health Care Foundation, Fewer and
More Specialized: A New Assessment of Physician Supply in
California, the number of primary care physicians actively
practicing in California is at the very bottom range of, or
below, the state's need. The report found that the distribution
of these physicians is also poor and that rural counties in
particular suffer from low physician practice rates and a
shortage of primary care physicians. According to the report, in
2008, there were 69,460 actively practicing physicians in
California (a figure which includes Doctors of Medicine and
Doctors of Osteopathic Medicine), but only 35 percent of these
physicians reported practicing primary care. This equates to 63
active primary care physicians in patient care per 100,000
persons. According to the Council on Graduate Medical Education,
which provides an ongoing assessment of physician workforce
trends, training issues and financing policies, and recommends
appropriate federal and private sector efforts on these issues, a
range of 60 to 80 primary care physicians are needed per 100,000
in order to adequately meet the needs of the population. When
the same metric is applied regionally, only 16 of California's 58
counties fall within the needed supply range for primary care
physicians. Less than one third of Californians live in a
community where they have access to the health care services they
need.
c) Pharmacists. According to a recent report by the Center for
the Health Professions at the University of California, San
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Francisco, California's Health Care Workforce: Readiness for the
ACA Era., as of February 2011, there were 29,245 individuals with
a California address in possession of a current and valid license
to practice as a registered pharmacist in the state. The report
found that pharmacists are generally concentrated in the belt of
counties stretching from the Bay Area eastward across the state
and that several counties have very low license per 100,000
population rates, including Imperial, Kings, San Benito, Merced,
Mariposa, Yuba, and Tehama counties. Based on the report
findings, the range of 18 - 30 licenses per 100,000 population
ratio would mean there are between .9 - 1.5 pharmacists for every
5,000 people.
The number of pharmacists in California is only likely to grow.
For a number of years, California had only three schools of
pharmacy. Since the early 1990s, that number has increased to
eight schools today, with plans underway for eight additional
entities to open new schools of pharmacy in California in the
next few years. This change alone would double the current
number of schools, and presumably the number of California
graduates which would in turn result in growing numbers of
pharmacists eligible for licensure and ready to work.
Pharmacists are already well placed in every community throughout
the state to provide medication therapy management services;
including in rural and inner city communities where primary care
access is particularly impacted.
Pharmacists provide patient care with a goal of optimizing
medication therapy and promoting health, wellness, and disease
prevention. Pharmacists complete a four year post-graduate
doctoral training program that includes extensive training in
human anatomy and physiology, recognition and treatment of
diseases and conditions, pharmacology, optimal medication use, as
well as experience in direct patient care in multiple health care
settings through clinical rotations. Many pharmacists complete a
residency program and obtain board certification in a specialized
area of practice. Throughout the U.S., since 2003, all schools
of pharmacy now only offer a doctorate in pharmacy (Pharm D)
which includes course study on: Basic Life Support, Diagnosing &
Disease State Management of Diabetes, Infectious Diseases,
Hypertension, Heart Disease, Oncology; Immunization Training,
Medication Management, Pharmacy Law/Administration, Pharmacy
Practice, Therapeutic Drug Monitoring, Therapeutics. The Pharm
D, which has been the sole degree awarded in California since the
1970s, includes over 1000 hours in pharmacology as well as
clinical rotations, specifically one-two ambulatory rotations,
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one-three inpatient rotations, one or more retail rotations and
one or more elective rotations in either geriatrics, long-term
care or medication therapy management. Pharmacists may also
choose to complete certificate programs focused on the management
of specific disease or other certification to demonstrate
competency and expertise in a certain area. In addition to
meeting educational and experience requirements, an applicant for
licensure as a pharmacist must take and pass both the North
American Pharmacist Licensure Examination (NAPLEX) and the
California Practice Standards and Jurisprudence Examination for
Pharmacists (CPJE).
A December 2012 New York Times editorial, part of a continuing
examination by the paper of ways to cut medical costs while
improving quality, highlighted using pharmacists to provide
medical care as a sensible solution to the primary care shortage
crisis and as a means of ensuring health care delivery to
millions of new patients under ACA. Specifically, the editorial
noted a report by the chief pharmacist of the U.S. Public Health
Service who argued that pharmacists are underutilized given their
education, training and closeness to their communities except for
in the Department of Veterans Affairs (VA), Department of Defense
(DOD) and Indian Health Service (IHS) where they deliver health
care with minimal supervision. These federal pharmacists manage
the care of patients when medications are the primary treatment
and can start, stop or adjust medications, order and interpret
laboratory tests and coordinate follow-up care.
d) Scope of Practice and Access. Numerous entities have explored
amending scope of practice laws at the state level as a means of
meeting the overall goal of providing quality care and
controlling long-term health care costs. A report from the
Brookings Institution recommended creating incentives for states
to amend scope of practice laws to allow for greater use of
certain professions like nurse practitioners, pharmacists,
physician assistants and community health workers. A 2010 white
paper by the Citizen Advocacy Center in Washington D.C. addressed
the role of states like California in addressing scope of
practice, writing that scope of practice laws restrict health
care professionals from "performing the full range of skills for
which they have been trained" which in turns limits access to
care and inflates health care costs. The paper also cited data
from the National Practitioner Data Bank and Health Integrity and
Protection Data Bank where no trends or observations suggesting
increased liability for offices employing physician assistants or
advanced practice nurses and that the inclusion of these
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professionals has been a safe and beneficial undertaking.
1.Specific Practices Authorized by SB 493.
a) Permits pharmacists to administer physician prescribed
injectable medications.
Biological products are generally derived from living material,
human, animal, or microorganism and FDA regulations specify that
biological products include blood-derived products, vaccines, in
vivo diagnostic allergenic products, immunoglobulin products,
products containing cells or microorganisms, and most protein
products. These treatments are not widespread but rather used as
specialty drugs to treat serious conditions and diseases. In
some instances, patients undergoing treatments for serious
diseases receive biological injections, in addition to other
infusion therapies and could access those drugs directly from a
pharmacist under this bill.
b) Permits pharmacists to furnish immunizations for people ages
three and up if the pharmacist has completed specified training
and follow specified procedures.
Immunizations stand as a useful, cost-effective measure in
promoting public health and preventing the spread of disease.
According to the Institute of Medicine, more than 50,000 adults
and 300 children die annually in the United States from diseases
or complications arising from diseases that are considered
vaccine-preventable. Studies show that immunizations assist in
preventing an estimated 14 million cases of vaccine-preventable
diseases and 33,000 cases of death.
Vaccines against influenza have been especially useful in
preventing the spread of that virus and have recently been at the
center of a larger national and international vaccination
conversation. While CDC recommends vaccination against influenza
for over 70% of the population, actual rates of immunization are
much lower. CDC estimates that 36,000 people die each year from
influenza or its complications. The H1N1 outbreak of 2009
resulted in a CDC recommendation that everyone receive the
vaccine. Yet access to immunizations can be compounded by a
growing uninsured population in the state who may lack the
ability to be seen in a physician's office.
Pharmacies and pharmacists are able to play a unique role in
contributing to higher access to immunizations. CDC's ACIP
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recommendations for 2008 call for vaccinations to be provided in
alternative settings like pharmacies to help make progress toward
achieving national health objectives. According to an article in
the Journal of the American Pharmaceutical Association,
"Pharmacists and Immunizations," Gallup Polls have consistently
named the pharmacist among the most trusted professionals.
People in many communities, especially rural areas, look to their
community pharmacist for medical advice. This respect can be
pivotal in helping educate parents and other adults about the
importance of timely immunization. When parents and elderly
patients pick up prescriptions, pharmacists can take advantage of
their accessibility and reputation to ask them about their
immunization status and counsel them on the importance of
immunization. Pharmacies are located in many neighborhoods
throughout the state, have extended hours of operation and have
existing infrastructure to properly store vaccines.
c) Permits a pharmacist to furnish self-administered hormonal
contraceptives like the pill, the patch and the ring, based on a
statewide protocol, similar to the existing authority for
pharmacists to furnish ECDT.
Hormonal contraceptives are made up of female sex hormones:
estrogen or progestin (a synthetic form of progesterone).
Organizations like the World Health Organization (WHO), ACOG and
Planned Parenthood Federation of America have developed
evidence-based guidelines for hormonal contraceptive use based on
a self-reported medical history and measurement of blood
pressure. All of these guidelines acknowledge that hormonal
contraception can be safely provided and utilized without
requiring a pelvic examination.
The Institute of Medicine Committee (IOM) on Women's Health
Research recently reported a universal need for making
contraceptives more available, accessible, and acceptable (IOM,
2010b). They indicate the several barriers that women often face
that keep them from being able to successfully and correctly
utilize their birth control method. Among these are expensive
co-pays, insurance coverage limitations on prescriptions, and the
difficulty or delay when scheduling an office visit.
Under the Department of Health and Human Services, and with
guidance from the WHO, the CDC created the U.S. Medical
Eligibility Criteria for Contraceptive Use 2010 (USMEC) and
finalized the recommendations after consultation with a group of
health professionals who met in Atlanta, Georgia, in February of
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2009. The WHO's guidance includes recommendations for the use of
specific contraceptive methods by women and men who have certain
characteristics or medical conditions. The majority of the U.S.
guidance does not differ from the WHO guidance and covers more
than 60 characteristics or medical conditions. However, some WHO
recommendations were modified for use in the United States,
including recommendations about contraceptive use for women with
venous thromboembolism, valvular heart disease, ovarian cancer,
and uterine fibroids and for women who experience postpartum
depression or are breastfeeding. Recommendations were added to
the U.S. guidance for women with rheumatoid arthritis, history of
bariatric surgery, peripartum cardiomyopathy, endometrial
hyperplasia, inflammatory bowel disease, and solid organ
transplantation. The recommendations are intended to assist
health-care providers when they counsel women, men, and couples
about contraceptive method choice. Although the recommendations
are meant to serve as a source of clinical guidance, the CDC
cautioned that health-care providers should always consider the
individual clinical circumstances of each person seeking family
planning services.
d) Permits a pharmacist to furnish smoking cessation drugs and
devices if they have completed specified training and follow
specified procedures.
According to the CDC, tobacco use can lead to nicotine dependence
and serious health problems. CDC states that cessation, a process
of evaluation, education and support to aid patients who desire
to stop smoking can provide many health benefits like: lowering
the risk for lung and other types of cancer; reducing the risk
for coronary heart disease, stroke, and peripheral vascular
disease; reducing respiratory symptoms, such as coughing,
wheezing, and shortness of breath; reducing the risk of
developing chronic obstructive pulmonary disease (COPD), one of
the leading causes of death in the United States; decreasing
women's risk for infertility or having a low birth weight baby.
According to CDC, cessation treatment options currently include
brief clinical interventions (i.e., when a doctor takes 10
minutes or less to deliver advice and assistance about quitting),
counseling (e.g., individual, group, or telephone counseling),
behavioral cessation therapies (e.g., training in problem
solving) as well as over-the-counter medications like a nicotine
patch, gum, lozenge and prescription medications like a nicotine
inhaler, nasal spray and drugs like bupropion SR (Zyban) and
varenicline tartrate (Chantix).
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Safeway Inc. recently partnered with the UCSF School of Pharmacy
whereby Safeway's pharmacists will be trained in
smoking-cessation counseling techniques using a program developed
by UCSF pharmacy faculty. The project will allow smoking
cessation intervention to be applied systematically across a
network of pharmacies.
e) Permits a pharmacist to furnish travel medications approved by
the CDC.
Recommendations for the use of vaccines and other biologic
products (such as immune globulin products) in the U.S. are
developed by the CDC Advisory Committee on Immunization Practices
(ACIP) and other groups, such as the American Academy of
Pediatrics. These recommendations are based on scientific
evidence of benefits (immunity to the disease) and risks (vaccine
adverse reactions) and, where few or no data are available, on
expert opinion. The recommendations include information on
general immunization issues and the use of specific vaccines.
Recommendations for travelers are not always the same as routine
recommendations. CDC advises that individuals might benefit from
shots or medications before traveling outside of the U.S.
Recommended vaccines are those the CDC determines may protect
travelers from illnesses present in other parts of the world and
prevent the importation of infectious diseases across
international borders. Many pharmacies are already providing
services to travelers to determine which vaccines they should
receive and when they should receive them; the authority in this
bill will allow those patients to receive those vaccines at the
pharmacy.
f) Permits a pharmacist to order and interpret tests to monitor
drug safety. Permits APPs to perform physical assessments,
order and interpret medication-related tests, refer patients to
other providers, initiate, adjust and discontinue medications
under physician protocol or as part of an integrated system and
participate in the evaluation and management of health conditions
in collaboration with other providers.
A 2012 CDC program guide for public health, "Partnering with
Pharmacists in the Prevention and Control of Chronic Diseases"
outlines how the role of the pharmacist has expanded beyond just
dispensing medications and is evolving into active participation
in chronic disease management as a part of team-based care. At
the federal agency level, the IHS has been engaged in an advanced
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practice pharmacy model whereby pharmacists deliver direct
patient care services with physician collaboration since the
early 1970s. Similarly, the VA implemented a similar program in
1995 that updated prescribing authority for clinical pharmacy
specialists. These models have become a part of day-to-day care
within hospitals, clinics and educational facilities with
pharmacists performing many of the functions authorized in this
bill.
2.Related Legislation. SB 352 (Pavley) of 2013 would authorize a
nurse practitioner, physician assistant or certified nurse-midwife
to supervise medical assistants without a physician present and
according to standardized procedures and protocols created by the
physician. This bill is currently pending on the Senate Floor.
SB 491 (Hernandez) of 2013 Deletes the requirement that Nurse
Practitioners perform certain tasks pursuant to standardized
procedures and/or consultation with a physician or surgeon and
authorizes a Nurse Practitioner to perform those tasks
independently. Also requires, after July 1, 2016, that Nurse
Practitioners possess a certificate from a national certifying body
in order to practice. The bill is also up for consideration before
the Committee today.
SB 492 (Hernandez of 2013) Permits an optometrist to diagnose treat
and manage additional conditions with ocular manifestations,
directs the California Board of Optometry to establish educational
and examination requirements and permits optometrists to perform
vaccinations and surgical and non-surgical primary care procedures.
The bill is also up for consideration before the Committee today.
AB 2348 (Mitchell, Chapter 460, Statutes of 2012) authorized a
registered nurse to dispense specified drugs or devices upon an
order issued by a certified nurse-midwife, nurse practitioner, or
physician assistant within specified clinics. The bill also
authorized a registered nurse to dispense or administer hormonal
contraceptives in strict adherence to specified standardized
procedures.
SB 1524 (Hernandez, Chapter 796, Statutes of 2012) deleted the
requirement for at least
6 months duration of supervised experience by a physician before a
nurse-midwife could furnish or order drugs. The bill authorized a
physician and surgeon to determine the extent of the supervision in
connection with the furnishing or ordering of drugs and devices by
a nurse practitioner or certified nurse-midwife.
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AB 977 (Skinner) of 2010 would have authorized pharmacists to
administer influenza immunizations, pursuant to standardized
protocols developed and approved by the Medical Board of California
(MBC), to any person 18 years or older, until January 1, 2015. The
bill was never heard by a Senate policy committee.
SB 993 (Aanestad and Calderon) of 2007 would have revised the
Psychology Licensing Law to authorize a "prescribing psychologist,"
as defined, to prescribe and administer drugs, and requires the
Board of Psychology to establish and administer a certification
process to grant licensed psychologists the authority to write
prescriptions. The measure failed passage in this committee. SB
1427 (Calderon) of 2008 was substantially similar to SB 993 and
failed passage in the Senate Committee on Health.
AB 1436 (Hernandez, 2007) would have allowed a nurse practitioner
to perform comprehensive health care services according to his or
her educational preparation. The bill would have authorized a
nurse practitioner to admit and discharge patients from health
facilities, change a treatment regimen, or initiate an emergency
procedure, in collaboration with specified health practitioners.
The bill failed passage on the Senate Floor.
AB 2408 (Negrete McLeod, Chapter 777, Statutes of 2006) recasts
various provisions of the Pharmacy Law for purposes of clarifying
and updating the duties a pharmacist can perform, and makes other
technical changes. At one point the bill authorized a pharmacist
to adjust a prescription and provide cognitive services under
specified conditions; however, those provisions were removed from
the bill in the Senate.
AB 1711 (Strickland, Chapter 58, Statutes of 2005) authorized a
registered nurse or licensed pharmacist to administer influenza and
pneumoccocal immunizations without patient-specific orders to
patients age 50 years or older in a skilled nursing facility under
standing orders when they meet federal recommendations and are
approved by the medical director of the skilled nursing facility.
AB 2660 (Leno, Chapter 191, Statutes of 2004) reinstated
pharmacists authority to register with the DEA and therefore
initiate or adjust controlled substance drug therapy under
specified conditions.
AB 2560 (Montanez, Chapter 205, Statutes of 2004) authorized a
nurse practitioner to furnish drugs or devices under standardized
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procedures or protocols when the drugs and devices furnished or
ordered are consistent with the practitioner's educational
preparation or for which clinical competency has been established
and maintained.
SB 490 (Alpert, Chapter 651, Statutes of 2003) authorized a
licensed pharmacist to initiate ECDT in accordance with a
standardized procedure approved by the Board and MBC.
SB 111 (Alpert, Chapter 358, Statutes of 2001) amended the Medical
Practice Act to authorize a medical assistant to perform specified
services in community and free clinics under the supervision of a
physician assistant, nurse practitioner or nurse-midwife. The bill
authorized a physician and surgeon in these specified clinics to
provide written instructions for medical assistants, regarding the
performance of tasks or duties, while under the supervision of a
physician assistant, nurse practitioner or nurse midwife when the
supervising physician and surgeon was not on site.
SB 1169 (Alpert, Chapter 900, Statutes of 2001) authorized a
pharmacist to initiate ECDT in accordance with standardized
procedures or protocols developed by the pharmacist and an
authorized prescriber acting within their scope of practice.
AB 261 (Lempert, Chapter 375, Statutes of 1999) authorized
pharmacists to dispense emergency contraception pills for patients
who have a written authorization by the patient's physician.
3.Arguments in Support. Supporters write that the concept of
team-based care which is currently being utilized in hospital and
other health care settings should be expanded to community settings
in order to meet the demands of millions of Californians.
The American Society of Health-System Pharmacies notes that this
bill will allow pharmacists to use the full range of their
education and training to meet the demands of a growing patient
population in California.
According to the Bay Area Council , the business community
recognizes the importance of allowing highly-educated, well-trained
professionals like pharmacists to perform primary care services
that will improve efficiency, help control costs and create
additional capacity in our state's increasingly overburdened health
care system.
Blue Shield of California writes that this bill will help alleviate
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the access challenge and the continued contribution of pharmacists
will help control costs and reduce the strain in our overburdened
health care system.
Californians for Patient Care also supports this bill, stating that
they are especially pleased with the language designed to ensure
patients receive safe and high quality care when needed.
California Northstate University, College of Pharmacy writes in
support of this bill, stating that PharmD education consists of
close to 6,000 hours of post graduate clinical education and
training which extensively covers patient care, disease prevention
and management and clinical rotations in a variety of health care
settings.
According to the California Optometric Association , this
legislation is necessary to make the promise of ACA a reality.
The California Pharmacists Association (CPhA) and California
Society of Health-System Pharmacists (CSHP) state that California
must look at improving efficiencies in how care is delivered and
how the health care workforce is utilized. The organizations
believe that pharmacists are trained and qualified to provide more
services, pharmacists are one of the most accessible providers in
the health care system and pharmacists provide safe care that will
improve patient outcomes. CPhA and CSHP note that pharmacists will
be working in close collaboration with physicians whenever
modifying medication regimes and this bill will more fully
integrate the pharmacy profession into the health care team, "an
outcome that will strengthen interprofessional collaboration and
boost patient outcomes."
The California Retailers Association supports this bill, noting
that the bill proposes a number of novel concepts that will fill in
health care gaps and will not only better incorporate pharmacists
into the health care system but will do so appropriately, resulting
in significant cost savings for patients and the system as well as
improved patient outcomes.
According to the Indian Pharmacists Association of California ,
representing over 400 pharmacists, including 103 independent
pharmacy owners, pharmacists are widely recognized as being the
most overqualified and underutilized professionals. The group
writes that pharmacists' formal education appropriately prepares
them to successfully perform services related to the prevention and
control of disease and that the passing of this bill would be an
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important milestone in health care reform signaling much needed
empowerment of the pharmacy profession.
Pharmacy Choice and Access Now writes in support of this bill,
noting that to alleviate the congestion caused by increasing
numbers of patients and the current primary care physician
shortages, California should focus on utilizing highly trained
pharmacists.
According to the United Nurses Associations of California and Union
of Health Care Professionals , this bill will allow for better
utilization of our existing infrastructure of trainer medical
providers to bridge the provider gap through expanded practice.
Western University of Health Sciences (WU) notes the extensive
hours of training in a PharmD education and states that pharmacists
have been acting as direct care providers for decades in federal
and managed care systems. WU writes that this bill will enable
pharmacists to make more significant contributions to the care team
to improve care for patients.
6.Support if Amended. The California of Physician Groups (CAPG) has
adopted a support if amended position on this bill, writing that it
can help to increase access to care but the group has concerns.
Specifically, CAPG believes that APPs should be limited to current
health system delivery models rather than have authority for
independent, autonomous practice; that the training requirement in
this bill is too low for the type of functions expected of an APP
and unacceptable for independent practice; the CE requirements are
too low and; including travel vaccines is very dangerous.
The California Hospital Association (CHA) also writes that it
supports this bill if amended, noting that CHA is extremely
supportive of efforts to include pharmacists in the health care
clinical delivery teams of the future and is committed to working
with the Author to provide amendments to address "practice
safeguards and quality mechanisms to ensure of coordinated care
across the state".
Kaiser Permanente writes that it will be in full support of this
bill if the Author clarifies that an APP would be allowed to perform
"patient" assessments rather than "physical" assessments as the bill
currently provides.
7. Neutral. The American Federation of State, County and Municipal
Employees (AFSCME) has a neutral position on this bill due to
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differing positions taken by two of its impacted affiliates, the
United Nurses Associations of California/Union of Health Care
Professionals (AFSCME Local 1199) which supports the bill and the
Union of American Physicians and Dentists (AFSCME Local 206) which
opposes the bill.
8. Arguments in Opposition. Opponents of this bill support expanding
access to health care but believe that its provisions put patients
at risk.
According to BayBio and BIOCOM , the bill creates the ability of
pharmacists to perform therapeutic substitution of an agent
prescribed by a physician and that in contrast to generic
substitution where the product is chemically identical to that
ordered by a physician, this allows for substitution within a broad
general class, creating a conflict of interest for pharmacists who
could be motivated to switch to cheaper but also less appropriate
drugs strictly for financial considerations.
The American College of Emergency Physicians, California Chapter
(California ACEP) is concerned about the impact this bill will have
on patient safety and the potential conflicts of interest it
introduces. California ACEP believes that this bill undermines the
corporate ban on the practice of medicine because pharmacists are
not covered by the ban and it is foreseeable that a pharmacist
working for a retail chain could be paid to prescribe a drug by the
company profiting from the prescription.
The California Academy of Eye Physicians and Surgeons write that
pharmacists have no experience doing any of the things they are
requesting and the bill raises the specter of a "two-tiered system
where those who are less well-off make do with less trained
providers while those with greater resources (i.e. money) go
wherever they want."
According to the California Academy of Family Physicians (CAFP) ,
California Medical Association and Osteopathic Physicians and
Surgeons of California this bill puts patients at risk. The groups
cite the expanded authority to administer immunizations as unsafe
because safe administration requires extensive education,
experience and training. The groups also believe that the bill's
expanded authority to prescribe smoking cessation drugs could
result in increased likelihood of patient harm, particularly
because some of these drugs are associated with a substantial risk
of depression and should be used only under close medical
supervision. The groups write that allowing APPs to adjust or
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discontinue drug therapy allows the pharmacist to interfere with
the physician-patient relationship and make treatment decisions
based on their own judgment. They also state that APP
qualification requirements in the bill are unclear and inconsistent
with expanded practice authority and that the bill allows
pharmacists to practice medicine without being subject to the
Medical Practice Act.
The California Psychiatric Association echoes the statements above
about APP concerns, specifically stating problems with APPs having
ability to initiate, adjust or discontinue drug treatments and the
potential risks to the health and safety of patients who are taking
powerful, sometimes dangerous psychotropic medications which often
have serious side effects.
The California Right to Life Committee, Inc. is opposed to this
bill on the basis that the health of women using self-administered
hormonal contraceptive services could be at risk without an
attending physician and these drugs can act as abortifacients and
end the life of a pre-born child.
The California Society of Anesthesiologists believes that the
provisions in this bill would diminish physician involvement
essential for patient safety.
The California Society of Plastic Surgeons is concerned about the
expansion in the scope of services and the negative impact on
patient safety, as well as the lack of resources and expertise at
the Board which could lead to pharmacists being held to a lower
standard of care than physicians providing the same service.
Canvasback Missions, Inc. and Lighthouse for Christ Mission and Eye
Center write that pharmacists play an important role in healthcare
delivery but treating disease is not that role.
The Osteopathic Physicians and Surgeons of America states that
there is clear patient danger that exists by authorizing
pharmacists to independently furnish drugs and are also concerned
that the bill references oversight by MBC but makes no mention of
the Osteopathic Medical Board of California.
The Union of American Physicians and Dentists writes that this bill
is not a step in the right direction and that it rolls out an
uncertain and untested health care delivery system.
9. Recent Amendments.
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a) In response to concerns raised by organizations like
PhRMA, BIOCOM, BayBio and others, the Author recently amended
the bill to clarify that pharmacists cannot engage in
therapeutic substitutions. PhRMA has taken a neutral position
on this bill.
b) In response to concerns raised by Kaiser, the Author
recently amended the bill to clarify that an APP would be
allowed to perform "patient" assessments rather than
"physical" assessments.
c) In response to concerns raised by multiple organizations
about the qualification requirements for a pharmacist to be
recognized as an APP by the Board, the Author recently
strengthened the bill to specify the types of certification
and specific areas of practice an APP must be certified in,
and also added a requirement that an APP meet two of the
eligible criteria for APP recognition rather than just one.
SUPPORT AND OPPOSITION:
Support:
American Society of Health-System Pharmacists
Bay Area Council
Blue Shield of California
Californians for Patient Care
California Northstate University, College of Pharmacy
California Optometric Association
California Pharmacists Association
California Society of Health-System Pharmacists
California Retailers Association
Indian Pharmacists Association of California
Pharmacy Choice and Access Now
Union of Health Care Professionals
United Nurses Association of California
Western University of Health Sciences
Hundreds of individuals, including Pharm D students and numerous deans
of schools of pharmacy
Support if Amended:
California Association of Physician Groups
California Hospital Association
Kaiser Permanente
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Neutral:
AFSCME
Pharmaceutical Research and Manufacturers of America (PhRMA)
Opposition:
American College of Emergency Physicians, California Chapter
Bay Bio
Biocom
California Academy of Eye Physicians and Surgeons
California Academy of Family Physicians
California Healthcare Institute
California Medical Association
California Psychiatric Association
California Right to Life Committee, Inc.
California Society of Anesthesiologists
California Society of Plastic Surgeons
Canvasback Missions, Inc.
Lighthouse for Christ Mission and Eye Center
Osteopathic Physicians and Surgeons of California
Pharmaceutical Research and Manufacturers of America (PhRMA)
Union of American Physicians and Dentists
Hundreds of individuals
Consultant:Sarah Mason