BILL NUMBER: SB 490	AMENDED
	BILL TEXT

	AMENDED IN ASSEMBLY  SEPTEMBER 3, 2003
	AMENDED IN ASSEMBLY  JULY 16, 2003
	AMENDED IN SENATE  APRIL 24, 2003
	AMENDED IN SENATE  MARCH 27, 2003

INTRODUCED BY   Senator Alpert
   (Coauthor:  Senator Bowen)
   (Coauthor:  Assembly Member Cohn)

                        FEBRUARY 20, 2003

   An act to amend Section 4052 of the Business and Professions Code,
relating to pharmacy.


	LEGISLATIVE COUNSEL'S DIGEST


   SB 490, as amended, Alpert.  Pharmacy:  prescriptions.
   Existing law, the Pharmacy Law, creates the California State Board
of Pharmacy and makes it responsible for regulating the practice of
pharmacy.  A knowing violation of the Pharmacy Law is a crime.  Under
that law, a pharmacist may not, in general, furnish a dangerous drug
except upon the prescription of a physician, dentist, podiatrist,
optometrist, or veterinarian.  However, existing law authorizes a
pharmacist to initiate emergency contraception drug therapy in
accordance with standardized protocols developed by the pharmacist
and an authorized prescriber acting within his or her scope of
practice.
   This bill would also authorize a pharmacist to furnish emergency
contraception drug therapy in accordance with a standardized
procedure or protocol developed and approved by both the board and
the Medical Board of California, in consultation with specified
entities.  The bill would require a pharmacist to complete a
specified training program before performing emergency contraception
drug therapy.  Because a violation of this bill would be a crime, the
bill would impose a state-mandated local program.
  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.  
   This bill would also incorporate additional changes to Section
4052 of the Business and Professions Code proposed by SB 545 that
would become operative only if SB 545 and this bill are both enacted
and become effective on or before January 1, 2004, and this bill is
enacted last. 
   Vote:  majority.  Appropriation:  no.  Fiscal committee:  yes.
State-mandated local program:  yes.


THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:


  SECTION 1.  Section 4052 of the Business and Professions Code is
amended to read:
   4052.  (a) Notwithstanding any other provision of law, a
pharmacist may:
   (1) Furnish a reasonable quantity of compounded medication to a
prescriber for office use by the prescriber.
   (2) Transmit a valid prescription to another pharmacist.
   (3) Administer, orally or topically, drugs and biologicals
pursuant to a prescriber's order.
   (4) Perform the following procedures or functions in a licensed
health care facility in accordance with policies, procedures, or
protocols developed by health professionals, including physicians,
pharmacists, and registered nurses, with the concurrence of the
facility administrator:
   (A) Ordering or performing routine drug therapy related patient
assessment procedures including temperature, pulse, and respiration.

   (B) Ordering drug therapy related laboratory tests.
   (C) Administering drugs and biologicals by injection pursuant to a
prescriber's order (the administration of immunizations under the
supervision of a prescriber may also be performed outside of a
licensed health care facility).
   (D) Initiating or adjusting the drug regimen of a patient pursuant
to an order or authorization made by the patient's prescriber and in
accordance with the policies, procedures, or protocols of the
licensed health care facility.
   (5) (A) Perform the following 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, in accordance, as
applicable, with policies, procedures, or protocols of that facility,
the home health agency, the licensed clinic, the health care service
plan, or that physician, in accordance with subparagraph (C):
   (i) Ordering or performing routine drug therapy related patient
assessment procedures including temperature, pulse, and respiration.

   (ii) Ordering drug therapy related laboratory tests.
   (iii) Administering drugs and biologicals by injection pursuant to
a prescriber's order (the administration of immunizations under the
supervision of a prescriber may also be performed outside of a
licensed health care facility).
   (iv) Initiating or adjusting the drug regimen of a patient
pursuant to a specific written order or authorization made by the
patient's prescriber for the individual patient, and in accordance
with the policies, procedures, or protocols of the health care
facility, home health agency, licensed clinic, health care service
plan, or physician.  Adjusting the drug regimen does not include
substituting or selecting a different drug, except as authorized by
the protocol.  The pharmacist shall provide written notification to
the patient's prescriber, or enter the appropriate information in an
electronic patient record system shared by the prescriber, of any
drug regimen initiated pursuant to this clause within 24 hours.
   (B) A patient's prescriber may prohibit, by written instruction,
any adjustment or change in the patient's drug regimen by the
pharmacist.
   (C) The policies, procedures, or protocols referred to in this
paragraph shall be developed by health care professionals, including
physicians, pharmacists, and registered nurses, and, at a minimum,
meet all of the following requirements:
   (i) Require that the pharmacist function as part of a
multidisciplinary group that includes physicians and direct care
registered nurses.  The multidisciplinary group shall determine the
appropriate participation of the pharmacist and the direct care
registered nurse.
   (ii) Require that the medical records of the patient be available
to both the patient's prescriber and the pharmacist.
   (iii) Require that the procedures to be performed by the
pharmacist relate to a condition for which the patient has first been
seen by a physician.
   (iv) Except for procedures or functions provided by a health care
facility, a licensed clinic in which there is physician oversight, or
a provider who contracts with a licensed health care plan with
regard to the care or services provided to the enrollees of that
health care service plan, require the procedures to be performed in
accordance with a written, patient-specific protocol approved by the
treating or supervising physician.  Any change, adjustment, or
modification of an approved preexisting treatment or drug therapy
shall be provided in writing to the treating or supervising physician
within 24 hours.
   (6) Manufacture, measure, fit to the patient, or sell and repair
dangerous devices or furnish instructions to the patient or the
patient's representative concerning the use of those devices.
   (7) Provide consultation to patients and professional information,
including clinical or pharmacological information, advice, or
consultation to other health care professionals.
   (8)  (A)  Furnish emergency contraception drug therapy in
accordance with either of the following:  
   (A)  
   (i)  Standardized procedures or protocols developed by the
pharmacist and an authorized prescriber who is acting within his or
her scope of practice.  
   (B)  
   (ii)  Standardized procedures or protocols developed and
approved by both the board and the Medical Board of California in
consultation with the American College of Obstetricians and
Gynecologists, the California Pharmacist Association, and other
appropriate entities.  Both the board and the Medical Board of
California shall have authority to ensure compliance with this
 subparagraph   clause  , and both boards
are specifically charged with the enforcement of this provision with
respect to their respective licensees. Nothing in this 
subparagraph   clause  shall be construed to expand
the authority of a pharmacist to prescribe any prescription
medication.  
   (9)  
   (B)  Prior to performing a procedure authorized under
 paragraph (8)   this paragraph  , a
pharmacist shall complete a training program on emergency
contraception consisting of at least one hour of approved continuing
education on emergency contraception drug therapy.
   (b) (1) Prior to performing any procedure authorized by paragraph
(4) of subdivision (a), a pharmacist shall have received appropriate
training as prescribed in the policies and procedures of the licensed
health care facility.
   (2) Prior to performing any procedure authorized by paragraph (5)
of subdivision (a), a pharmacist shall have either (A) successfully
completed clinical residency training or (B) demonstrated clinical
experience in direct patient care delivery.
   (3) For each emergency contraception drug therapy initiated
pursuant to paragraph (8) of subdivision (a), the pharmacist shall
provide the recipient of the emergency contraception drugs with a
standardized factsheet that includes, but is not limited to, the
indications 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 Health Services, the American College of
Obstetricians and Gynecologists, the California Pharmacists
Association, and other health care organizations.  The provisions of
this section do not preclude the use of existing publications
developed by nationally recognized medical organizations.
   (c) Nothing in this section shall affect the requirements of
existing law relating to maintaining the confidentiality of medical
records.
   (d) Nothing in this section shall affect the requirements of
existing law relating to the licensing of a health care facility.

  SEC. 2.  
  SEC. 1.5.  Section 4052 of the Business and Professions Code is
amended to read: 
   4052.  (a) Notwithstanding any other provision of law, a
pharmacist may:
   (1) Furnish a reasonable quantity of compounded medication to a
prescriber for office use by the prescriber.
   (2) Transmit a valid prescription to another pharmacist.
   (3) Administer, orally or topically, drugs and biologicals
pursuant to a prescriber's order.
   (4) Perform the following procedures or functions in a licensed
health care facility in accordance with policies, procedures, or
protocols developed by health professionals, including physicians,
pharmacists, and registered nurses, with the concurrence of the
facility administrator:
   (A) Ordering or performing routine drug therapy-related patient
assessment procedures including temperature, pulse, and respiration.

   (B) Ordering drug therapy-related laboratory tests.
   (C) Administering drugs and biologicals by injection pursuant to a
prescriber's order (the administration of immunizations under the
supervision of a prescriber may also be performed outside of a
licensed health care facility).
   (D) Initiating or adjusting the drug regimen of a patient pursuant
to an order or authorization made by the patient's prescriber and in
accordance with the policies, procedures, or protocols of the
licensed health care facility.
   (5) (A) Perform the following 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, in accordance, as
applicable, with policies, procedures, or protocols of that facility,
the home health agency, the licensed clinic, the health care service
plan, or that physician, in accordance with subparagraph (C):
   (i) Ordering or performing routine drug therapy-related patient
assessment procedures including temperature, pulse, and respiration.

   (ii) Ordering drug therapy-related laboratory tests.
   (iii) Administering drugs and biologicals by injection pursuant to
a prescriber's order (the administration of immunizations under the
supervision of a prescriber may also be performed outside of a
licensed health care facility).
   (iv) Initiating or adjusting the drug regimen of a patient
pursuant to a specific written order or authorization made by the
patient's prescriber for the individual patient, and in accordance
with the policies, procedures, or protocols of the health care
facility, home health agency, licensed clinic, health care service
plan, or physician.  Adjusting the drug regimen does not include
substituting or selecting a different drug, except as authorized by
the protocol.  The pharmacist shall provide written notification to
the patient's prescriber, or enter the appropriate information in an
electronic patient record system shared by the prescriber, of any
drug regimen initiated pursuant to this clause within 24 hours.
   (B) A patient's prescriber may prohibit, by written instruction,
any adjustment or change in the patient's drug regimen by the
pharmacist.
   (C) The policies, procedures, or protocols referred to in this
paragraph shall be developed by health care professionals, including
physicians, pharmacists, and registered nurses, and, at a minimum,
meet all of the following requirements:
   (i) Require that the pharmacist function as part of a
multidisciplinary group that includes physicians and direct care
registered nurses.  The multidisciplinary group shall determine the
appropriate participation of the pharmacist and the direct care
registered nurse.
   (ii) Require that the medical records of the patient be available
to both the patient's prescriber and the pharmacist.
   (iii) Require that the procedures to be performed by the
pharmacist relate to a condition for which the patient has first been
seen by a physician.
   (iv) Except for procedures or functions provided by a health care
facility, a licensed clinic in which there is physician oversight, or
a provider who contracts with a licensed health care plan with
regard to the care or services provided to the enrollees of that
health care service plan, require the procedures to be performed in
accordance with a written, patient-specific protocol approved by the
treating or supervising physician.  Any change, adjustment, or
modification of an approved preexisting treatment or drug therapy
shall be provided in writing to the treating or supervising physician
within 24 hours.
   (6) Manufacture, measure, fit to the patient, or sell and repair
dangerous devices or furnish instructions to the patient or the
patient's representative concerning the use of those devices.
   (7) Provide consultation to patients and professional information,
including clinical or pharmacological information, advice, or
consultation to other health care professionals.
   (8)  Initiate   (A) Furnish  emergency
contraception drug therapy in accordance with  standardized
  either of the following:
   (i) Standardized  procedures or protocols developed by the
pharmacist and an authorized prescriber who is acting within his or
her scope of practice.  Prior  
   (ii) Standardized procedures or protocols developed and approved
by both the board and the Medical Board of California in consultation
with the American College of Obstetricians and Gynecologists, the
California Pharmacist Association, and other appropriate entities.
Both the board and the Medical Board of California shall have
authority to ensure compliance with this clause, and both boards are
specifically charged with the enforcement of this provision with
respect to their respective licensees.  Nothing in this clause shall
be construed to expand the authority of a pharmacist to prescribe any
prescription medication.
   (B) Prior  to performing  any   a 
procedure authorized under this paragraph, a pharmacist shall
 have completed   complete  a training
program on emergency contraception  , which includes, but is
not limited to, conduct of sensitive communications, quality
assurance, referral to additional services, and documentation
  that consists of at least one hour of approved
continuing education on emergency contraception drug therapy  .

   (C) A pharmacist, pharmacist's employer, or pharmacist's agent may
not directly charge a patient a separate consultation fee for
emergency contraception drug therapy services initiated pursuant to
this paragraph, 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 subparagraph, 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.
The provisions of this subparagraph shall cease to be operative for
dedicated emergency contraception drugs when these drugs are
reclassified as over-the-counter products by the federal Food and
Drug Administration.
   (D) A pharmacist may 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
paragraph. 
   (b) (1) Prior to performing any procedure authorized by paragraph
(4) of subdivision (a), a pharmacist shall have received appropriate
training as prescribed in the policies and procedures of the licensed
health care facility.
   (2) Prior to performing any procedure authorized by paragraph (5)
of subdivision (a), a pharmacist shall have either (A) successfully
completed clinical residency training or (B) demonstrated clinical
experience in direct patient care delivery.
   (3) For each emergency contraception drug therapy initiated
pursuant to paragraph (8) of subdivision (a), the pharmacist shall
provide the recipient of the emergency contraception drugs with a
standardized factsheet that includes, but is not limited to, the
indications 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 Health Services, the American College of
Obstetricians and Gynecologists, the California Pharmacists
Association, and other health care organizations.  The provisions of
this section do not preclude the use of existing publications
developed by nationally recognized medical organizations.
   (c) Nothing in this section shall affect the requirements of
existing law relating to maintaining the confidentiality of medical
records.
   (d) Nothing in this section shall affect the requirements of
existing law relating to the licensing of a health care facility.

  SEC. 2.  Section 1.5 of this bill incorporates amendments to
Section 4052 of the Business and Professions Code proposed by both
this bill and SB 545.  It shall only become operative if (1) both
bills are enacted and become effective on or before January 1, 2004,
(2) each bill amends Section 4052 of the Business and Profession
Code, and (3) this bill is enacted after SB 545, in which case
Section 1 of this bill shall not become operative.
  SEC. 3.   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.