BILL ANALYSIS Ó
-----------------------------------------------------------------
|SENATE RULES COMMITTEE | SB 493|
|Office of Senate Floor Analyses | |
|1020 N Street, Suite 524 | |
|(916) 651-1520 Fax: (916) | |
|327-4478 | |
-----------------------------------------------------------------
THIRD READING
Bill No: SB 493
Author: Hernandez (D)
Amended: 5/28/13
Vote: 21
SENATE BUSINESS, PROF. & ECON. DEV. COMM. : 9-0, 4/29/13
AYES: Price, Emmerson, Block, Corbett, Galgiani, Hernandez,
Hill, Padilla, Yee
NO VOTE RECORDED: Wyland
SENATE APPROPRIATIONS COMMITTEE : 7-0, 5/23/13
AYES: De León, Walters, Gaines, Hill, Lara, Padilla, Steinberg
SUBJECT : Pharmacy practice
SOURCE : Author
DIGEST : This bill updates Pharmacy Law to authorize
pharmacists to perform certain functions according to specified
requirements; establishes advanced practice pharmacist (APP)
recognition; and authorizes the Board of Pharmacy (Board) to set
the fee, not to exceed $300, for the issuance and renewal of APP
recognition.
ANALYSIS :
Existing law:
1. Establishes the Pharmacy Law which provides for the
licensure and regulation of pharmacies, pharmacists and
CONTINUED
SB 493
Page
2
wholesalers of dangerous drugs or devices and establishes a
scope of practice for pharmacy as a profession.
2. Defines "furnish" as supply by any means, by sale or
otherwise; and 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/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/her practice.
3. Makes legislative declarations regarding the practice of
pharmacy as a profession.
4. Permits a pharmacist to initiate a prescription according to
certain requirements and to provide clinical advice,
information or patient consultation if (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, and (c) access to the information is secure from
unauthorized use.
5. Permits a pharmacist to (a) furnish a reasonable quantity of
compounded drug product to a prescriber for use in his/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 or as part of the care provided by a health care
facility, licensed home health agency, licensed clinic in
which there is a physician 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; (e) 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
CONTINUED
SB 493
Page
3
those devices; (f) provide consultation to patients and
professional information, including clinical or
pharmacological information, advice or consultation to other
health professionals; (g) furnish emergency contraception
drug therapy; and (h) administer immunizations pursuant to a
protocol with a prescriber.
6. 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).
7. Permits pharmacists to perform procedures as specified in
accordance with protocols developed by health professionals.
Specifies that a patient's treating prescriber may prohibit
pharmacists from making any changes or adjustments to
patients' drug regimens. Requires pharmacists performing
procedures, as authorized, to have successfully completed
clinical residency training or demonstrated clinical
experience in direct patient care delivery.
8. 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 the 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 ECDT. 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
Department of Public Health, ACOG, CPhA and other health care
CONTINUED
SB 493
Page
4
organizations that include indications for use of the drug,
appropriate method for use, need for medical follow-up and
other appropriate information. Makes this inoperative if
ECDT are reclassified as over-the-counter products by the
federal Food and Drug Administration.
9. 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.
10.Authorizes pharmacists filling prescription orders for drug
products prescribed by their trade or brand names to
substitute a 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."
11.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."
12.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.
CONTINUED
SB 493
Page
5
13.Requires pharmacists to submit proof of completion of 30
hours of approved continuing pharmacy education prior to
license renewal.
This bill:
1. Makes various technical and clarifying changes.
2. Defines "advanced practice pharmacist" as a licensed
pharmacist who has been recognized as an APP by the Board.
Specifies that a Board-recognized APP is entitled to practice
advanced practice pharmacy as described in Business and
Professions Code 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.
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 federal Centers for Disease Control and
Prevention (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.
CONTINUED
SB 493
Page
6
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 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 existing 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.
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
CONTINUED
SB 493
Page
7
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 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 the pharmacist meets all of the following
conditions:
CONTINUED
SB 493
Page
8
A. 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. 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. Is certified in smoking-cessation therapy by an
organization recognized by the Board.
D. Completes one hour of continuing education focused on
smoking-cessation biennially.
E. Consults with the patient's primary care provider
before furnishing a smoking cessation drug to the patient
that may produce serious neuropsychiatric events.
1. 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.
1. 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.
CONTINUED
SB 493
Page
9
B. Complete a one-year postgraduate residency through an
accredited postgraduate institution where at least 50% of
the experience includes a provision of direct patient care
services with interdisciplinary teams.
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.
1. Provides that APP recognition is valid for two years.
2. Requires the Board to adopt regulations establishing the
means of documenting completion of the requirements for an
APP.
3. Requires the Board, by regulation, to set the fee, not to
exceed $300, for issuance and renewal of APP recognition at
the reasonable cost of regulating APP.
4. Requires an APP to complete 10 hours of continuing education
each license renewal cycle for a subject matter in one or
more areas relevant to a pharmacist's clinical practice, in
addition to current continuing education requirements.
NOTE: For detailed background, refer to the Senate Business,
Professions and Economic Development Committee analysis.
FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes
Local: Yes
According to the Senate Appropriations Committee:
One-time costs of about $200,000 to adopt new regulations
and upgrade the existing system for processing license
applications (Pharmacy Board Contingent Fund).
Ongoing costs of about $300,000 per year for licensing and
enforcement (Pharmacy Board Contingent Fund).
Indeterminate impact on state health care programs, such as
the California Public Employees' Retirement System and
Medi-Cal.
CONTINUED
SB 493
Page
10
SUPPORT : (Verified 5/28/13)
American Society of Health-System Pharmacists
Bay Area Council
Blue Shield of California
California Association for Nurse Practitioners
California Chronic Care Coalition
California Hospital Association
California Korean American Pharmacists Association
California Medical Board
California Northstate University, College of Pharmacy
California Optometric Association
California Pharmacists Association
California Retailers Association
California Society of Health-System Pharmacists
California State Board of Pharmacy
Californians for Patient Care
Cedars-Sinai Medical Center
Indian Pharmacists Association of California
Kaiser Permanente
National Asian American Coalition
Pharmacy Choice and Access Now
United Nurses Association of California/Union of Health Care
Professionals
Western University of Health Sciences
OPPOSITION : (Verified 5/28/13)
American College of Emergency Physicians, California Chapter
California Academy of Eye Physicians and Surgeons
California Academy of Family Physicians
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
Union of American Physicians and Dentists
ARGUMENTS IN SUPPORT : The author believes that "Californians
deserve access to high quality primary care offered by a range
CONTINUED
SB 493
Page
11
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." According to the
author's office, 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.
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 the access challenge and the continued contribution of
pharmacists will help control costs and reduce the strain in our
overburdened health care system.
The California Pharmacists Association and California Society of
Health-System Pharmacists 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 notes that this bill
proposes a number of novel concepts that will fill in health
CONTINUED
SB 493
Page
12
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.
The United Nurses Associations of California/Union of Health
Care Professionals state that this bill will allow for better
utilization of our existing infrastructure of trainer medical
providers to bridge the provider gap through expanded practice.
Kaiser Permanente writes, "This legislation provides another
pathway for specially qualified pharmacists to achieve the
authority to support inter-professional group practice."
ARGUMENTS IN OPPOSITION : Opponents of this bill support
expanding access to health care but believe that its provisions
put patients at risk.
The American College of Emergency Physicians, California Chapter
is concerned about the impact this bill will have on patient
safety and the potential conflicts of interest it introduces.
They believe 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 this 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."
The California Academy of Family Physicians, California Medical
Association, and Osteopathic Physicians and Surgeons of
California cite the expanded authority to administer
immunizations as unsafe because safe administration requires
extensive education, experience and training. The groups write
that allowing APPs to adjust or 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 this bill are unclear and inconsistent with expanded practice
CONTINUED
SB 493
Page
13
authority and that this bill allows pharmacists to practice
medicine without being subject to the Medical Practice Act.
MW:k 5/28/13 Senate Floor Analyses
SUPPORT/OPPOSITION: SEE ABOVE
**** END ****
CONTINUED