Amended in Senate May 28, 2013

Amended in Senate April 24, 2013

Amended in Senate April 1, 2013

Senate BillNo. 493


Introduced by Senator Hernandez

February 21, 2013


An act to amend 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, the Business and Professions Code, relating to pharmacy.

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. 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.

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 patient assessments, and certain other functions, as specified.begin insert The bill would authorize the boardend insertbegin insert, by regulationend insertbegin insert,end insertbegin insert to set the fee for the issuance and renewal of advanced practice pharmacist recognition at the reasonable cost of regulating advanced practice pharmacists pursuant to these provisions, not to exceed $300.end insert Because a violation of these provisions would be a crime, the bill would impose a state-mandated local program.

The bill would make other conforming and technical changes.

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.

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

Vote: majority. Appropriation: no. Fiscal committee: yes. State-mandated local program: yes.

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

P2    1

SECTION 1.  

Section 733 of the Business and Professions Code
2 is amended to read:

3

733.  

(a) A licentiate shall not obstruct a patient in obtaining
4a prescription drug or device that has been legally prescribed or
5ordered for that patient. A violation of this section constitutes
6unprofessional conduct by the licentiate and shall subject the
7licentiate to disciplinary or administrative action by his or her
8licensing agency.

9(b) Notwithstanding any other law, a licentiate shall dispense
10drugs and devices, as described in subdivision (a) of Section 4024,
11pursuant to a lawful order or prescription unless one of the
12following circumstances exists:

13(1) Based solely on the licentiate’s professional training and
14judgment, dispensing pursuant to the order or the prescription is
15contrary to law, or the licentiate determines that the prescribed
P3    1drug or device would cause a harmful drug interaction or would
2otherwise adversely affect the patient’s medical condition.

3(2) The prescription drug or device is not in stock. If an order,
4other than an order described in Section 4019, or prescription
5cannot be dispensed because the drug or device is not in stock, the
6licentiate shall take one of the following actions:

7(A) Immediately notify the patient and arrange for the drug or
8device to be delivered to the site or directly to the patient in a
9timely manner.

10(B) Promptly transfer the prescription to another pharmacy
11known to stock the prescription drug or device that is near enough
12to the site from which the prescription or order is transferred, to
13ensure the patient has timely access to the drug or device.

14(C) Return the prescription to the patient and refer the patient.
15The licentiate shall make a reasonable effort to refer the patient to
16a pharmacy that stocks the prescription drug or device that is near
17enough to the referring site to ensure that the patient has timely
18access to the drug or device.

19(3) The licentiate refuses on ethical, moral, or religious grounds
20to dispense a drug or device pursuant to an order or prescription.
21A licentiate may decline to dispense a prescription drug or device
22 on this basis only if the licentiate has previously notified his or
23her employer, in writing, of the drug or class of drugs to which he
24or she objects, and the licentiate’s employer can, without creating
25undue hardship, provide a reasonable accommodation of the
26licentiate’s objection. The licentiate’s employer shall establish
27protocols that ensure that the patient has timely access to the
28prescribed drug or device despite the licentiate’s refusal to dispense
29the prescription or order. For purposes of this section, “reasonable
30accommodation” and “undue hardship” shall have the same
31meaning as applied to those terms pursuant to subdivision (l) of
32Section 12940 of the Government Code.

33(c) For the purposes of this section, “prescription drug or device”
34has the same meaning as the definition in Section 4022.

35(d) This section applies to emergency contraception drug therapy
36and self-administered hormonal contraceptives described in Section
374052.3.

38(e) This section imposes no duty on a licentiate to dispense a
39drug or device pursuant to a prescription or order without payment
40for the drug or device, including payment directly by the patient
P4    1or through a third-party payer accepted by the licentiate or payment
2of any required copayment by the patient.

3(f) The notice to consumers required by Section 4122 shall
4include a statement that describes patients’ rights relative to the
5requirements of this section.

6

SEC. 2.  

Section 4016.5 is added to the Business and Professions
7Code
, to read:

8

4016.5.  

“Advanced practice pharmacist” means a licensed
9pharmacist who has been recognized as an advanced practice
10pharmacist by the board, pursuant to Section 4210. A
11board-recognized advanced practice pharmacist is entitled to
12practice advanced practice pharmacy, as described in Section
134052.6, within or outside of a licensed pharmacy as authorized by
14this chapter.

15

SEC. 3.  

Section 4050 of the Business and Professions Code is
16amended to read:

17

4050.  

(a) In recognition of and consistent with the decisions
18of the appellate courts of this state, the Legislature hereby declares
19the practice of pharmacy to be a profession.

20(b) Pharmacy practice is a dynamic, patient-oriented health
21service that applies a scientific body of knowledge to improve and
22promote patient health by means of appropriate drug use,
23drug-related therapy, and communication for clinical and
24consultative purposes. Pharmacy practice is continually evolving
25to include more sophisticated and comprehensive patient care
26activities.

27(c) The Legislature further declares that pharmacists are health
28care providers who have the authority to provide health care
29services.

30

SEC. 4.  

Section 4051 of the Business and Professions Code is
31amended to read:

32

4051.  

(a) Except as otherwise provided in this chapter, it is
33unlawful for any person to manufacture, compound, furnish, sell,
34or dispense a dangerous drug or dangerous device, or to dispense
35or compound a prescription pursuant to Section 4040 of a prescriber
36unless he or she is a pharmacist under this chapter.

37(b) Notwithstanding any other law, a pharmacist may authorize
38the initiation of a prescription, pursuant to Section 4052.1, 4052.2,
394052.3, or 4052.6, and otherwise provide clinical advice, services,
P5    1information, or patient consultation, as set forth in this chapter, if
2all of the following conditions are met:

3(1) The clinical advice, services, information, or patient
4consultation is provided to a health care professional or to a patient.

5(2) The pharmacist has access to prescription, patient profile,
6or other relevant medical information for purposes of patient and
7clinical consultation and advice.

8(3) Access to the information described in paragraph (2) is
9secure from unauthorized access and use.

10

SEC. 5.  

Section 4052 of the Business and Professions Code is
11amended to read:

12

4052.  

(a) Notwithstanding any other law, a pharmacist may:

13(1) Furnish a reasonable quantity of compounded drug product
14to a prescriber for office use by the prescriber.

15(2) Transmit a valid prescription to another pharmacist.

16(3) Administer drugs and biological products that have been
17ordered by a prescriber.

18(4) Perform procedures or functions in a licensed health care
19facility as authorized by Section 4052.1.

20(5) Perform procedures or functions as part of the care provided
21by a health care facility, a licensed home health agency, a licensed
22clinic in which there is a physician oversight, a provider who
23contracts with a licensed health care service plan with regard to
24the care or services provided to the enrollees of that health care
25service plan, or a physician, as authorized by Section 4052.2.

26(6) Perform procedures or functions as authorized by Section
274052.6.

28(7) Manufacture, measure, fit to the patient, or sell and repair
29dangerous devices, or furnish instructions to the patient or the
30patient’s representative concerning the use of those devices.

31(8) Provide consultation, training, and education to patients
32 about drug therapy, disease management, and disease prevention.

33(9) Provide professional information, including clinical or
34pharmacological information, advice, or consultation to other
35health care professionals, and participate in multidisciplinary
36review of patient progress, including appropriate access to medical
37records.

38(10) Furnish the following medications:

39(A) Emergency contraception drug therapy and self-administered
40hormonal contraceptives, as authorized by Section 4052.3.

P6    1(B) Prescription smoking cessation drugs and devices, as
2authorized by Section 4052.9.

3(C) Prescription medications not requiring a diagnosis that are
4recommended by the federal Centers for Disease Control and
5Prevention for individuals traveling outside of the United States.

6(11) Administer immunizations pursuant to a protocol with a
7prescriber.

8(12) Order and interpret tests for the purpose of monitoring and
9managing the efficacy and toxicity of drug therapies.

10(b) A pharmacist who is authorized to issue an order to initiate
11or adjust a controlled substance therapy pursuant to this section
12shall personally register with the federal Drug Enforcement
13Administration.

14(c) This section does not affect the applicable requirements of
15law relating to either of the following:

16(1) Maintaining the confidentiality of medical records.

17(2) The licensing of a health care facility.

18

SEC. 6.  

Section 4052.3 of the Business and Professions Code
19 is amended to read:

20

4052.3.  

(a) (1) Notwithstanding any other law, a pharmacist
21may furnish self-administered hormonal contraceptives in
22accordance with standardized procedures or protocols developed
23and approved by both the board and the Medical Board of
24California in consultation with the American Congress of
25Obstetricians and Gynecologists, the California Pharmacists
26Association, and other appropriate entities. The standardized
27procedure or protocol shall require that the patient use a
28self-screening tool, based on the United States Medical Eligibility
29Criteria (USMEC) for Contraceptive Use developed by the federal
30Centers for Disease Control and Prevention, and that the pharmacist
31refer the patient to the patient’s primary care provider or, if the
32patient does not have a primary care provider, to nearby clinics.

33(2) The board and the Medical Board of California are both
34authorized to ensure compliance with this subdivision, and each
35board is specifically charged with the enforcement of this
36subdivision with respect to its respective licensees. This subdivision
37does not expand the authority of a pharmacist to prescribe any
38prescription medication.

P7    1(b) (1) Notwithstanding any other law, a pharmacist may furnish
2emergency contraception drug therapy in accordance with either
3of the following:

4(A) Standardized procedures or protocols developed by the
5pharmacist and an authorized prescriber who is acting within his
6or her scope of practice.

7(B) Standardized procedures or protocols developed and
8 approved by both the board and the Medical Board of California
9in consultation with the American Congress of Obstetricians and
10Gynecologists, the California Pharmacists Association, and other
11appropriate entities. The board and the Medical Board of California
12are both authorized to ensure compliance with this clause, and
13each board is specifically charged with the enforcement of this
14provision with respect to its respective licensees. This subdivision
15does not expand the authority of a pharmacist to prescribe any
16prescription medication.

17(2) Prior to performing a procedure authorized under this
18subdivision, a pharmacist shall complete a training program on
19emergency contraception that consists of at least one hour of
20approved continuing education on emergency contraception drug
21therapy.

22(3) A pharmacist, pharmacist’s employer, or pharmacist’s agent
23shall not directly charge a patient a separate consultation fee for
24emergency contraception drug therapy services initiated pursuant
25to this subdivision, but may charge an administrative fee not to
26exceed ten dollars ($10) above the retail cost of the drug. Upon an
27oral, telephonic, electronic, or written request from a patient or
28customer, a pharmacist or pharmacist’s employee shall disclose
29the total retail price that a consumer would pay for emergency
30contraception drug therapy. As used in this paragraph, total retail
31price includes providing the consumer with specific information
32regarding the price of the emergency contraception drugs and the
33price of the administrative fee charged. This limitation is not
34intended to interfere with other contractually agreed-upon terms
35between a pharmacist, a pharmacist’s employer, or a pharmacist’s
36agent, and a health care service plan or insurer. Patients who are
37insured or covered and receive a pharmacy benefit that covers the
38cost of emergency contraception shall not be required to pay an
39administrative fee. These patients shall be required to pay
40copayments pursuant to the terms and conditions of their coverage.
P8    1This paragraph shall become inoperative for dedicated emergency
2contraception drugs if these drugs are reclassified as
3over-the-counter products by the federal Food and Drug
4Administration.

5(4) A pharmacist shall not require a patient to provide
6individually identifiable medical information that is not specified
7in Section 1707.1 of Title 16 of the California Code of Regulations
8before initiating emergency contraception drug therapy pursuant
9to this subdivision.

10(c) For each emergency contraception drug therapy or
11self-administered hormonal contraception initiated pursuant to this
12section, the pharmacist shall provide the recipient of the drug with
13a standardized factsheet that includes, but is not limited to, the
14indications and contraindications for use of the drug, the
15appropriate method for using the drug, the need for medical
16followup, and other appropriate information. The board shall
17develop this form in consultation with the State Department of
18Public Health, the American Congress of Obstetricians and
19Gynecologists, the California Pharmacists Association, and other
20health care organizations. This section does not preclude the use
21of existing publications developed by nationally recognized
22medical organizations.

23

SEC. 7.  

Section 4052.6 is added to the Business and Professions
24Code
, to read:

25

4052.6.  

(a) A pharmacist recognized by the board as an
26advanced practice pharmacist may do all of the following:

27(1) Perform patient assessments.

28(2) Order and interpret drug therapy-related tests.

29(3) Refer patients to other health care providers.

30(4) Participate in the evaluation and management of diseases
31and health conditions in collaboration with other health care
32providers.

33(5) Initiate, adjust, or discontinue drug therapy in the manner
34specified in paragraph (4) of subdivision (a) of Section 4052.2.

35(b) A pharmacist who adjusts or discontinues drug therapy shall
36promptly transmit written notification to the patient’s diagnosing
37prescriber or enter the appropriate information in a patient record
38system shared with the prescriber. A pharmacist who initiates drug
39therapy shall promptly transmit written notification to, or enter the
40appropriate information into, a patient record system shared with
P9    1the patient’s primary care provider or diagnosing provider, as
2appropriate.

3(c) This section shall not interfere with a physician’s order to
4dispense a prescription drug as written, or other order of similar
5meaning.

6(d) Prior to initiating or adjusting a controlled substance therapy
7pursuant to this section, a pharmacist shall personally register with
8the federal Drug Enforcement Administration.

9

SEC. 8.  

Section 4052.8 is added to the Business and Professions
10Code
, to read:

11

4052.8.  

(a) In addition to the authority provided in paragraph
12(9) of subdivision (a) of Section 4052, a pharmacist may
13independently initiate and administer vaccines listed on the routine
14immunization schedules recommended by the federal Advisory
15Committee on Immunization Practices (ACIP), in compliance with
16individual ACIP vaccine recommendations, and published by the
17federal Centers for Disease Control and Prevention (CDC) for
18persons three years of age and older.

19(b) In order to initiate and administer an immunization described
20in subdivision (a), a pharmacist shall do all of the following:

21(1) Complete an immunization training program endorsed by
22the CDC or the Accreditation Council for Pharmacy Education
23that, at a minimum, includes hands-on injection technique, clinical
24evaluation of indications and contraindications of vaccines, and
25the recognition and treatment of emergency reactions to vaccines,
26and shall maintain that training.

27(2) Be certified in basic life support.

28(3) Comply with all state and federal recordkeeping and
29reporting requirements, including providing documentation to the
30patient’s primary care provider and entering information in the
31appropriate immunization registry designated by the immunization
32branch of the State Department of Public Health.

33(c) A pharmacist administering immunizations pursuant to this
34section, or paragraph (9) of subdivision (a) of Section 4052, may
35also initiate and administer epinephrine or diphenhydramine by
36injection for the treatment of a severe allergic reaction.

37

SEC. 9.  

Section 4052.9 is added to the Business and Professions
38Code
, to read:

P10   1

4052.9.  

A pharmacist may furnish prescription smoking
2cessation drugs and devices, and provide smoking cessation
3services if all of the following conditions are met:

4(a) The pharmacist maintains records of all prescription drugs
5and devices furnished for a period of at least three years for
6purposes of notifying other health care providers and monitoring
7the patient.

8(b) The pharmacist notifies the patient’s primary care provider
9of any drugs or devices furnished to the patient. If the patient does
10not have a primary care provider, the pharmacist provides the
11patient with a written record of the drugs or devices furnished and
12 advises the patient to consult a physician of the patient’s choice.

13(c) The pharmacist is certified in smoking cessation therapy by
14an organization recognized by the board.

15(d) The pharmacist completes one hour of continuing education
16focused on smoking cessation therapy biennially.

begin insert

17(e) The pharmacist shall consult with the patient’s primary care
18provider before furnishing a smoking cessation drug to the patient
19that may produce serious neuropsychiatric events.

end insert
20

SEC. 10.  

Section 4060 of the Business and Professions Code
21 is amended to read:

22

4060.  

A person shall not possess any controlled substance,
23except that furnished to a person upon the prescription of a
24physician, dentist, podiatrist, optometrist, veterinarian, or
25naturopathic doctor pursuant to Section 3640.7, or furnished
26pursuant to a drug order issued by a certified nurse-midwife
27pursuant to Section 2746.51, a nurse practitioner pursuant to
28Section 2836.1, a physician assistant pursuant to Section 3502.1,
29a naturopathic doctor pursuant to Section 3640.5, or a pharmacist
30pursuant to Section 4052.1, 4052.2, or 4052.6. This section does
31not apply to the possession of any controlled substance by a
32manufacturer, wholesaler, pharmacy, pharmacist, physician,
33podiatrist, dentist, optometrist, veterinarian, naturopathic doctor,
34certified nurse-midwife, nurse practitioner, or physician assistant,
35if in stock in containers correctly labeled with the name and address
36of the supplier or producer.

37This section does not authorize a certified nurse-midwife, a nurse
38practitioner, a physician assistant, or a naturopathic doctor, to order
39his or her own stock of dangerous drugs and devices.

P11   1

SEC. 11.  

Section 4210 is added to the Business and Professions
2Code
, to read:

3

4210.  

(a) A person who seeks recognition as an advanced
4practice pharmacist shall meet all of the following requirements:

5(1) Hold an active license to practice pharmacy issued pursuant
6to this chapter that is in good standing.

7(2) Satisfy any two of the following criteria:

8(A) Earn certification in a relevant area of practice, including,
9but not limited to, ambulatory care, critical care, nuclear pharmacy,
10nutrition support pharmacy, oncology pharmacy, pediatric
11pharmacy, pharmacotherapy, or psychiatric pharmacy, from an
12organization recognized by the Accreditation Council for Pharmacy
13Education or another entity recognized by the board.

14(B) Complete a one-year postgraduate residency through an
15accredited postgraduate institution where at least 50 percent of the
16experience includes the provision of direct patient care services
17with interdisciplinary teams.

18(C) Have actively managed patients for at least one year under
19a collaborative practice agreement or protocol with a physician,
20advanced practice pharmacist, pharmacist practicing collaborative
21drug therapy management, or health system.

22(3) File an application with the board for recognition as an
23advanced practice pharmacist.

24(4) Pay the applicable fee to the board.

25(b) An advanced practice pharmacist recognition issued pursuant
26to this section shall be valid for two years, coterminous with the
27certificate holder’s license to practice pharmacy.

28(c) The board shall adopt regulations establishing the means of
29documenting completion of the requirements in this section.

begin insert

30(d) The board shall, by regulation, set the fee for the issuance
31and renewal of advanced practice pharmacist recognition at the
32reasonable cost of regulating advanced practice pharmacists
33pursuant to this chapter. The fee shall not exceed three hundred
34dollars ($300).

end insert
35

SEC. 12.  

Section 4233 is added to the Business and Professions
36Code
, to read:

37

4233.  

A pharmacist who is recognized as an advanced practice
38pharmacist shall complete 10 hours of continuing education each
39renewal cycle in addition to the requirements of Section 4231. The
P12   1subject matter shall be in one or more areas of practice relevant to
2the pharmacist’s clinical practice.

3

SEC. 13.  

No reimbursement is required by this act pursuant to
4Section 6 of Article XIII B of the California Constitution because
5the only costs that may be incurred by a local agency or school
6district will be incurred because this act creates a new crime or
7infraction, eliminates a crime or infraction, or changes the penalty
8for a crime or infraction, within the meaning of Section 17556 of
9the Government Code, or changes the definition of a crime within
10the meaning of Section 6 of Article XIII B of the California
11Constitution.



O

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