Amended in Senate April 1, 2013

Senate Bill No. 493

Introduced by Senator Hernandez

February 21, 2013

An act to amend begin delete Section end delete begin delete 4050 of end delete begin insert Sections 733, 4050, 4051, 4052, 4052.3, and 4060 of, and to add Sections 4016.5, 4052.6, 4052.8, 4052.9, 4210, and 4233 to, end insert the Business and Professions Code, relating to begin delete pharmacies end delete begin insert pharmacy end insert .

LEGISLATIVE COUNSEL’S DIGEST

SB 493, as amended, Hernandez. Pharmacy practice.

The Pharmacy Law provides for the licensing and regulation of pharmacists by the California State Board of Pharmacy in the Department of Consumer Affairs begin delete , and states that pharmacy practice 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 and drug-related therapy end delete . begin insert The law specifies the functions pharmacists are authorized to perform, including to administer, orally or topically, drugs and biologicals pursuant to a prescriber’s order, and to administer immunizations pursuant to a protocol with a prescriber. Pharmacists may also furnish emergency contraception drug therapy pursuant to standardized procedures if they have completed a training program. A violation of the Pharmacy Law is a crime. end insert

begin delete

This bill would make a technical, nonsubstantive change to that provision.

end delete begin insert

This bill, instead, would authorize a pharmacist to administer drugs and biological products that have been ordered by a prescriber. The bill would expand other functions pharmacists are authorized to perform, including, among other things, to furnish self-administered hormonal contraceptives, prescription smoking-cessation drugs, and prescription medications not requiring a diagnosis that are recommended for international travelers, as specified. Additionally, the bill would authorize pharmacists to order and interpret tests for the purpose of monitoring and managing the efficacy and toxicity of drug therapies, and to independently initiate and administer routine vaccinations, as specified. This bill also would establish board recognition for an advanced practice pharmacist, as defined, would specify the criteria for that recognition, and would specify additional functions that may be performed by an advanced practice pharmacist, including, among other things, performing physical assessments, and certain other functions, as specified. Because a violation of these provisions would be a crime, the bill would impose a state-mandated local program.

end insert begin insert

The bill would make other conforming and technical changes.

end insert begin insert

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

end insert begin insert

This bill would provide that no reimbursement is required by this act for a specified reason.

end insert

Vote: majority. Appropriation: no. Fiscal committee:  begin delete no end delete begin insert yes end insert . State-mandated local program:  begin delete no end delete begin insert yes end insert .

The people of the State of California do enact as follows:

begin insert

begin insert SECTION 1. end insert   

end insert

begin insert Section 733 of the end insert begin insert Business and Professions Code end insert
begin insert is amended to read: end insert

733.  

(a)  begin delete No end delete begin insert A end insert licentiate shall begin insert not end insert obstruct a patient in obtaining
a prescription drug or device that has been legally prescribed or
ordered for that patient. A violation of this section constitutes
unprofessional conduct by the licentiate and shall subject the
licentiate to disciplinary or administrative action by his or her
licensing agency.

(b) Notwithstanding any other begin delete provision of end delete law, a licentiate
shall dispense drugs and devices, as described in subdivision (a)
of Section 4024, pursuant to a lawful order or prescription unless
one of the following circumstances exists:

(1) Based solely on the licentiate’s professional training and
judgment, dispensing pursuant to the order or the prescription is
contrary to law, or the licentiate determines that the prescribed
drug or device would cause a harmful drug interaction or would
otherwise adversely affect the patient’s medical condition.

(2) The prescription drug or device is not in stock. If an order,
other than an order described in Section 4019, or prescription
cannot be dispensed because the drug or device is not in stock, the
licentiate shall take one of the following actions:

(A) Immediately notify the patient and arrange for the drug or
device to be delivered to the site or directly to the patient in a
timely manner.

(B) Promptly transfer the prescription to another pharmacy
known to stock the prescription drug or device that is near enough
to the site from which the prescription or order is transferred, to
ensure the patient has timely access to the drug or device.

(C) Return the prescription to the patient and refer the patient.
The licentiate shall make a reasonable effort to refer the patient to
a pharmacy that stocks the prescription drug or device that is near
enough to the referring site to ensure that the patient has timely
access to the drug or device.

(3) The licentiate refuses on ethical, moral, or religious grounds
to dispense a drug or device pursuant to an order or prescription.
A licentiate may decline to dispense a prescription drug or device
on this basis only if the licentiate has previously notified his or
her employer, in writing, of the drug or class of drugs to which he
or she objects, and the licentiate’s employer can, without creating
undue hardship, provide a reasonable accommodation of the
licentiate’s objection. The licentiate’s employer shall establish
protocols that ensure that the patient has timely access to the
prescribed drug or device despite the licentiate’s refusal to dispense
the prescription or order. For purposes of this section, “reasonable
accommodation” and “undue hardship” shall have the same
meaning as applied to those terms pursuant to subdivision (l) of
Section 12940 of the Government Code.

(c) For the purposes of this section, “prescription drug or device”
has the same meaning as the definition in Section 4022.

(d)  begin delete The provisions of this section shall apply to the end delete begin insert This section
applies to emergency contraception end insert drug therapy begin insert and
self-administered hormonal contraceptives end insert described in Section
4052.3.

(e) This section imposes no duty on a licentiate to dispense a
drug or device pursuant to a prescription or order without payment
for the drug or device, including payment directly by the patient
or through a third-party payer accepted by the licentiate or payment
of any required copayment by the patient.

(f) The notice to consumers required by Section 4122 shall
include a statement that describes patients’ rights relative to the
requirements of this section.

begin insert

begin insert SEC. 2. end insert   

end insert

begin insert Section 4016.5 is added to the end insert begin insert Business and Professions
Code end insert begin insert , to read: end insert

begin insert

begin insert 4016.5. end insert   

“Advanced practice pharmacist” means a licensed
pharmacist who has been recognized as an advanced practice
pharmacist by the board, pursuant to Section 4210. A
board-recognized advanced practice pharmacist 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.

end insert

begin delete SECTION 1. end delete
begin insert SEC. 3. end insert   

Section 4050 of the Business and Professions Code is
amended to read:

4050.  

(a) In recognition of and consistent with the decisions
of the appellate courts of this state, the Legislature hereby declares
the practice of pharmacy to be a profession.

(b) Pharmacy practice 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. Pharmacy practice is continually evolving
to include more sophisticated and comprehensive patient care
activities.

begin insert

(c) The Legislature further declares that pharmacists are health
care providers who have the authority to provide health care
services.

end insert

begin insert

begin insert SEC. 4. end insert   

end insert

begin insert Section 4051 of the end insert begin insert Business and Professions Code end insert begin insert is
amended to read: end insert

4051.  

(a) Except as otherwise provided in this chapter, it is
unlawful for any person to manufacture, compound, furnish, sell,
or dispense begin delete any end delete begin insert a end insert dangerous drug or dangerous device, or to
dispense or compound begin delete any end delete begin insert a end insert prescription pursuant to Section 4040
of a prescriber unless he or she is a pharmacist under this chapter.

(b) Notwithstanding any other law, a pharmacist may authorize
the initiation of a prescription, pursuant to Section 4052.1, 4052.2,
begin delete or end delete 4052.3, begin insert or 4052.6, end insert and otherwise provide clinical advice begin delete or end delete begin insert ,
services, end insert information begin insert , end insert or patient consultation begin insert , as set forth in this
chapter, end insert if all of the following conditions are met:

(1) The clinical advice begin delete or end delete begin insert , services, end insert information begin insert , end insert or patient
consultation is provided to a health care professional or to a patient.

(2) The pharmacist has access to prescription, patient profile,
or other relevant medical information for purposes of patient and
clinical consultation and advice.

(3) Access to the information described in paragraph (2) is
secure from unauthorized access and use.

begin insert

begin insert SEC. 5. end insert   

end insert

begin insert Section 4052 of the end insert begin insert Business and Professions Code end insert begin insert is
amended to read: end insert

4052.  

(a) Notwithstanding any other begin delete provision of end delete law, a
pharmacist may:

(1) Furnish a reasonable quantity of compounded drug product
to a prescriber for office use by the prescriber.

(2) Transmit a valid prescription to another pharmacist.

(3) Administer begin delete , orally or topically, drugs and biologicals
pursuant to a prescriber’s order end delete begin insert drugs and biological products that
have been ordered by a prescriber end insert .

(4) Perform procedures or functions in a licensed health care
facility as authorized by Section 4052.1.

(5) Perform procedures or functions as part of the care provided
by a health care facility, a licensed home health agency, a licensed
clinic in which there is a physician oversight, a provider who
contracts with a licensed health care service plan with regard to
the care or services provided to the enrollees of that health care
service plan, or a physician, as authorized by Section 4052.2.

begin insert

(6) Perform procedures or functions as authorized by Section
4052.6.

end insert begin delete

(6)

end delete

begin insert (7) end insert  Manufacture, measure, fit to the patient, or sell and repair
dangerous devices begin insert , end insert or furnish instructions to the patient or the
patient’s representative concerning the use of those devices.

begin delete

(7)

end delete

begin insert (8) end insert  Provide consultation begin insert , training, and education end insert to patients
begin delete and end delete begin insert about drug therapy, disease management, and disease
prevention. end insert

begin insert (9) end insert begin insert   end insert begin insert Provide end insert professional information, including clinical or
pharmacological information, advice, or consultation to other
health care professionals begin insert , and participate in multidisciplinary
review of patient progress, including appropriate access to medical
records end insert .

begin delete

(8) Furnish emergency

end delete begin insert

(10) Furnish the following medications:

end insert

begin insert (A) end insert begin insert   end insert begin insert Emergency end insert contraception drug therapy begin insert and self-administered
hormonal contraceptives, end insert as authorized by Section 4052.3.

begin insert

(B) Prescription smoking-cessation drugs and devices, as
authorized by Section 4052.9.

end insert begin insert

(C) Prescription medications not requiring a diagnosis that are
recommended by the federal Centers for Disease Control and
Prevention for individuals traveling outside of the United States.

end insert begin delete

(9)

end delete

begin insert (11) end insert  Administer immunizations pursuant to a protocol with a
prescriber.

begin insert

(12) Order and interpret tests for the purpose of monitoring
and managing the efficacy and toxicity of drug therapies.

end insert

(b) A pharmacist who is authorized to issue an order to initiate
or adjust a controlled substance therapy pursuant to this section
shall personally register with the federal Drug Enforcement
Administration.

begin delete

(c) Nothing in this section shall affect the requirements of
existing law relating to maintaining the confidentiality of medical
records.

end delete begin delete

(d) Nothing in this section shall affect the requirements of
existing law relating to the licensing of a health care facility.

end delete begin insert

(c) This section does not affect the applicable requirements of
law relating to either of the following:

end insert begin insert

(1) Maintaining the confidentiality of medical records.

end insert begin insert

(2) The licensing of a health care facility.

end insert

begin insert

begin insert SEC. 6. end insert   

end insert

begin insert Section 4052.3 of the end insert begin insert Business and Professions Code end insert
begin insert is amended to read: end insert

4052.3.  

(a)  begin insert (1) end insert begin insert   end insert begin insert Notwithstanding any other law, a pharmacist
may furnish self-administered hormonal contraceptives in
accordance with standardized procedures or protocols developed
and approved by both the board and the Medical Board of
California in consultation with the American Congress of
Obstetricians and Gynecologists, the California Pharmacists
Association, and other appropriate entities. The standardized
procedure or protocol shall require that the patient use a
self-screening tool, based on the United States Medical Eligibility
Criteria (USMEC) for Contraceptive Use developed by the federal
Centers for Disease Control and Prevention, and that the
pharmacist refer the patient to the patient’s primary care provider
or, if the patient does not have a primary care provider, to nearby
clinics. end insert

begin insert

(2) The board and the Medical Board of California are both
authorized to ensure compliance with this subdivision, and each
board is specifically charged with the enforcement of this
subdivision with respect to its respective licensees. This subdivision
does not expand the authority of a pharmacist to prescribe any
prescription medication.

end insert

begin insert (b) end insert   begin insert (1) end insert begin insert   end insert Notwithstanding any other begin delete provision of end delete law, a pharmacist
may furnish emergency contraception drug therapy in accordance
with either of the following:

begin delete

(1)

end delete

begin insert (A) end insert  Standardized procedures or protocols developed by the
pharmacist and an authorized prescriber who is acting within his
or her scope of practice.

begin delete

(2)

end delete

begin insert (B) end insert  Standardized procedures or protocols developed and
approved by both the board and the Medical Board of California
in consultation with the American begin delete College end delete begin insert Congress end insert of
Obstetricians and Gynecologists, the California begin delete Pharmacist end delete
begin insert Pharmacists end insert Association, and other appropriate entities. begin delete Both the end delete
begin insert The end insert board and the Medical Board of California begin delete shall have authority end delete
begin insert are both authorized end insert to ensure compliance with this clause, and
begin delete both boards are end delete begin insert each board is end insert specifically charged with the
enforcement of this provision with respect to begin delete their end delete begin insert its end insert respective
licensees. begin delete Nothing in this clause shall be construed to end delete begin insert This
subdivision does not end insert expand the authority of a pharmacist to
prescribe any prescription medication.

begin delete

(b)

end delete

begin insert (2) end insert  Prior to performing a procedure authorized under this
begin delete paragraph end delete begin insert subdivision end insert , a pharmacist shall complete a training
program on emergency contraception that consists of at least one
hour of approved continuing education on emergency contraception
drug therapy.

begin delete

(c)

end delete

begin insert (3) end insert  A pharmacist, pharmacist’s employer, or pharmacist’s agent
begin delete may end delete begin insert shall end insert not directly charge a patient a separate consultation fee
for emergency contraception drug therapy services initiated
pursuant to this begin delete paragraph end delete begin insert subdivision end insert , but may charge an
administrative fee not to exceed ten dollars ($10) above the retail
cost of the drug. Upon an oral, telephonic, electronic, or written
request from a patient or customer, a pharmacist or pharmacist’s
employee shall disclose the total retail price that a consumer would
pay for emergency contraception drug therapy. As used in this
begin delete subparagraph end delete begin insert paragraph end insert , total retail price includes providing the
consumer with specific information regarding the price of the
emergency contraception drugs and the price of the administrative
fee charged. This limitation is not intended to interfere with other
contractually agreed-upon terms between a pharmacist, a
pharmacist’s employer, or a pharmacist’s agent, and a health care
service plan or insurer. Patients who are insured or covered and
receive a pharmacy benefit that covers the cost of emergency
contraception shall not be required to pay an administrative fee.
These patients shall be required to pay copayments pursuant to the
terms and conditions of their coverage. begin delete The provisions of this
subparagraph shall cease to be operative end delete begin insert This paragraph shall
become inoperative end insert for dedicated emergency contraception drugs
begin delete when end delete begin insert if end insert these drugs are reclassified as over-the-counter products
by the federal Food and Drug Administration.

begin delete

(d)

end delete

begin insert (4) end insert  A pharmacist begin delete may end delete begin insert shall end insert not require a patient to provide
individually identifiable medical information that is not specified
in Section 1707.1 of Title 16 of the California Code of Regulations
before initiating emergency contraception drug therapy pursuant
to this begin delete section end delete begin insert subdivision end insert .

begin delete

(e)

end delete

begin insert (c) end insert  For each emergency contraception drug therapy begin insert or
self-administered hormonal contraception end insert initiated pursuant to
this section, the pharmacist shall provide the recipient of the
begin delete emergency contraception drugs end delete begin insert drug end insert with a standardized factsheet
that includes, but is not limited to, the indications begin insert and
contraindications end insert for use of the drug, the appropriate method for
using the drug, the need for medical followup, and other
appropriate information. The board shall develop this form in
consultation with the State Department of Public Health, the
American begin delete College end delete begin insert Congress end insert of Obstetricians and Gynecologists,
the California Pharmacists Association, and other health care
organizations. begin delete The provisions of this section do end delete begin insert This section does end insert
not preclude the use of existing publications developed by
nationally recognized medical organizations.

begin insert

begin insert SEC. 7. end insert   

end insert

begin insert Section 4052.6 is added to the end insert begin insert Business and Professions
Code end insert begin insert , to read: end insert

begin insert

begin insert 4052.6. end insert   

(a) A pharmacist recognized by the board as an
advanced practice pharmacist may do all of the following:

(1) Perform physical assessments.

(2) Order and interpret drug therapy-related tests.

(3) Refer patients to other health care providers.

(b) In addition to the authority provided in subdivision (a), a
pharmacist recognized as an advanced practice pharmacist who
is acting in collaboration with a patient’s health care providers,
operating under a protocol with a physician, health care facility,
or health plan or disability insurer, or participating in a medical
home, accountable care organization, or other system of care, may
do both of the following:

(1) Initiate, adjust, or discontinue drug therapy. As used in this
section, “adjust” means changing the dosage, duration, frequency,
or potency of a drug.

(2) Participate in the evaluation and management of diseases
and health conditions in collaboration with other health care
providers.

(c) A pharmacist who adjusts or discontinues drug therapy shall
promptly transmit written notification to the patient’s diagnosing
prescriber or enter the appropriate information in a patient record
system shared with the prescriber. A pharmacist who initiates drug
therapy shall promptly transmit written notification to, or enter
the appropriate information into, a patient record system shared
with the patient’s primary care provider or diagnosing provider,
as appropriate.

(d) This section shall not interfere with a physician’s order to
dispense a prescription drug as written, or other order of similar
meaning.

(e) Prior to initiating or adjusting a controlled substance
therapy pursuant to this section, a pharmacist shall personally
register with the federal Drug Enforcement Administration.

end insert

begin insert

begin insert SEC. 8. end insert   

end insert

begin insert Section 4052.8 is added to the end insert begin insert Business and Professions
Code end insert begin insert , to read: end insert

begin insert

begin insert 4052.8. end insert   

(a) In addition to the authority provided in paragraph
(9) of subdivision (a) of Section 4052, a pharmacist may
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
federal Centers for Disease Control and Prevention (CDC) for
persons three years of age and older.

(b) In order to initiate and administer an immunization
described in subdivision (a), a pharmacist shall do all of the
following:

(1) Complete an immunization training program endorsed by
the CDC or the Accreditation Council for Pharmacy Education
that, at a minimum, includes hands-on injection technique, clinical
evaluation of indications and contraindications of vaccines, and
the recognition and treatment of emergency reactions to vaccines,
and shall maintain that training.

(2) Be certified in basic life support.

(3) 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 State Department of Public Health.

(c) A pharmacist administering immunizations pursuant to this
section, or paragraph (9) of subdivision (a) of Section 4052, may
also initiate and administer epinephrine or diphenhydramine by
injection for the treatment of a severe allergic reaction.

end insert

begin insert

begin insert SEC. 9. end insert   

end insert

begin insert Section 4052.9 is added to the end insert begin insert Business and Professions
Code end insert begin insert , to read: end insert

begin insert

begin insert 4052.9. end insert   

A pharmacist may 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. If the patient does
not have a primary care provider, the pharmacist provides the
patient with a written record of the drugs or devices furnished and
advises the patient to consult a physician of the patient’s choice.

(c) The pharmacist is certified in smoking-cessation therapy by
an organization recognized by the board.

(d) The pharmacist completes one hour of continuing education
focused on smoking-cessation therapy biennially.

end insert

begin insert

begin insert SEC. 10. end insert   

end insert

begin insert Section 4060 of the end insert begin insert Business and Professions Code end insert
begin insert is amended to read: end insert

4060.  

begin delete No end delete begin insert A end insert person shall begin insert not end insert possess any controlled substance,
except that furnished to a person upon the prescription of a
physician, dentist, podiatrist, optometrist, veterinarian, or
naturopathic doctor pursuant to Section 3640.7, or furnished
pursuant to a drug order issued by a certified nurse-midwife
pursuant to Section 2746.51, a nurse practitioner pursuant to
Section 2836.1, a physician assistant pursuant to Section 3502.1,
a naturopathic doctor pursuant to Section 3640.5, or a pharmacist
pursuant to begin delete either end delete Section 4052.1 begin delete or end delete begin insert , end insert 4052.2 begin insert , or 4052.6 end insert . This
section begin delete shall end delete begin insert does end insert not apply to the possession of any controlled
substance by a manufacturer, wholesaler, pharmacy, pharmacist,
physician, podiatrist, dentist, optometrist, veterinarian, naturopathic
doctor, certified nurse-midwife, nurse practitioner, or physician
assistant, begin delete when end delete begin insert if end insert in stock in containers correctly labeled with the
name and address of the supplier or producer.

begin delete

Nothing in this section authorizes

end delete

begin insert This section does not authorize end insert a certified nurse-midwife, a nurse
practitioner, a physician assistant, or a naturopathic doctor, to order
his or her own stock of dangerous drugs and devices.

begin insert

begin insert SEC. 11. end insert   

end insert

begin insert Section 4210 is added to the end insert begin insert Business and Professions
Code end insert begin insert , to read: end insert

begin insert

begin insert 4210. end insert   

(a) A person who seeks recognition as an advanced
practice pharmacist shall meet all of the following requirements:

(1) Hold an active license to practice pharmacy issued pursuant
to this chapter that is in good standing.

(2) Satisfy any one of the following criteria:

(A) Earn certification in a relevant area of practice from an
organization approved by a board-recognized accrediting agency
or another entity recognized by the board.

(B) Complete a one-year postgraduate residency where at least
50 percent of the experience includes the 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,
advanced practice pharmacist, pharmacist practicing collaborative
drug therapy management, or health system.

(3) File an application with the board for recognition as an
advanced practice pharmacist.

(4) Pay the applicable fee to the board.

(b) An advanced practice pharmacist recognition issued
pursuant to this section shall be valid for two years, coterminous
with the certificate holder’s license to practice pharmacy.

end insert

begin insert

begin insert SEC. 12. end insert   

end insert

begin insert Section 4233 is added to the end insert begin insert Business and Professions
Code end insert begin insert , to read: end insert

begin insert

begin insert 4233. end insert   

A pharmacist who is recognized as an advanced practice
pharmacist shall complete 10 hours of continuing education each
renewal cycle in addition to the requirements of Section 4231. The
subject matter shall be in one or more areas of practice relevant
to the pharmacist’s clinical practice.

end insert

begin insert

begin insert SEC. 13. end insert   

end insert begin insert

No reimbursement is required by this act pursuant
to Section 6 of Article XIII B of the California Constitution because
the only costs that may be incurred by a local agency or school
district will be incurred because this act creates a new crime or
infraction, eliminates a crime or infraction, or changes the penalty
for a crime or infraction, within the meaning of Section 17556 of
the Government Code, or changes the definition of a crime within
the meaning of Section 6 of Article XIII B of the California
Constitution.

end insert