Bill Text: CA SB1039 | 2013-2014 | Regular Session | Amended

NOTE: There are more recent revisions of this legislation. Read Latest Draft

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Bill Title: Pharmacy.

Spectrum: Partisan Bill (Democrat 1-0)

Status: (Passed) 2014-09-15 - Chaptered by Secretary of State. Chapter 319, Statutes of 2014. [SB1039 Detail]

Download: California-2013-SB1039-Amended.html

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BILL NUMBER: SB 1039	AMENDED
	BILL TEXT

	AMENDED IN ASSEMBLY  JUNE 18, 2014
	AMENDED IN ASSEMBLY  JUNE 5, 2014
	AMENDED IN SENATE  MAY 5, 2014
	AMENDED IN SENATE  APRIL 10, 2014
	AMENDED IN SENATE  MARCH 28, 2014

INTRODUCED BY   Senator Hernandez

                        FEBRUARY 18, 2014

   An act to amend Sections 4052.6 and 4115 of, and to add Sections
4119.6 and 4119.7 to, the Business and Professions Code, and to amend
Sections 11150 and 11210 of, and to add Section 1250.06 to, the
Health and Safety Code, relating to pharmacy.


	LEGISLATIVE COUNSEL'S DIGEST


   SB 1039, as amended, Hernandez. Pharmacy.
   (1) Existing law, the Pharmacy Law, the violation of which is a
crime, provides for the licensure and regulation of pharmacies,
pharmacists, intern pharmacists, and pharmacy technicians by the
California State Board of Pharmacy. The Pharmacy Law authorizes an
intern pharmacist to perform all functions of a pharmacist, and
authorizes a pharmacy technician to perform packaging, manipulative,
repetitive, or other nondiscretionary tasks, in each case under
supervision of a pharmacist, as specified.
   This bill would authorize a pharmacy technician to perform
packaging  , including emergency supply packaging and sealing
in or for hospitals, hospital unit inspections, and other physical
 , manipulative, repetitive, or other nondiscretionary tasks
 under supervision   only while assisting and
while under the direct supervision and control  of a pharmacist,
as specified.  This bill would also authorize, in a licensed
health care facility, as defined, a pharmacy technician's duties to
include, among other things, sealing emergency containers for use in
the health care facility. 
   (2) Existing law authorizes a pharmacy to furnish a dangerous drug
or dangerous device to a licensed health care facility for storage
in a secured emergency pharmaceutical supplies container maintained
within the facility in accordance with facility regulations of the
State Department of Public Health and other existing law
requirements, as specified.
   This bill would authorize  a pharmacy to furnish a
dangerous drug or dangerous device to the emergency medical services
system of a licensed general acute care hospital, as defined, for
storage in a secured emergency pharmaceutical supplies container
maintained within the hospital in accordance with the hospital's
policies and procedures. The bill would require both the hospital and
the dispensing pharmacy to maintain records pertaining to the
dangerous drugs or dangerous devices furnished to the hospital's
emergency medical services system for at least 3 years. The bill
would also authorize a pharmacy to furnish a dangerous drug or
dangerous device to a licensed general acute care hospital pursuant
to preprinted or electronic standing orders, order sets, and
protocols established under the policies and procedures of a licensed
general acute care hospital under specified conditions. The bill
would require a pharmacist, a pharmacy technician, or  an
intern pharmacist, under the direct supervision and control of a
pharmacist, to  stock, replenish, and  inspect the drugs
maintained in the  hospital at least once per month, and to
report any irregularities, as specified.   emergency
pharmaceutical supplies container and the emergency medical system
supplies of a licensed general acute care   hospital, as
defined. 
    This bill would   authorize an intern pharmacist to
inspect the drugs maintained in a licensed health care facility, as
defined, pursuant to policies and procedures of the health care
facility. This bill would also authorize a licensed health care
facility to dispense or furnish dangerous drugs and dangerous devices
to inpatients and patients upon discharge pursuant to preprinted or
electronic standing orders, order sets, and protocols, as specified.
This bill would require licensed health care facilities to store and
maintain drugs in accordance with national standards regarding the
storage area and refrigerator or freezer temperature and in
accordance with the manufacturers' guidelines. 
   Because a violation of certain provisions of the bill would be a
crime, the bill would create a state-mandated local program.
   (3) Existing law authorizes a pharmacist recognized by the board
as an advanced practice pharmacist to perform specified functions,
including performing patient assessments.
   This bill would also authorize a pharmacist recognized by the
board as an advanced practice pharmacist to order patient
assessments.
   (4) Existing law authorizes a pharmacist to initiate or adjust the
drug regimen of a patient under specified circumstances. Existing
law authorizes specified practitioners, including a pharmacist acting
within the scope of an authorized pilot project, to prescribe,
furnish, or administer controlled substances to a patient suffering
from a disease, ailment, injury, or infirmity, but only when in good
faith he or she believes the disease, ailment, injury, or infirmity
requires the treatment, and only in the quantity and for the length
of time as reasonably necessary.
   This bill would modify that list of practitioners to include a
pharmacist initiating or adjusting the drug regimen of a patient as
authorized under existing law.
   (5) Existing law provides for the licensure and inspection of
health facilities, including general acute care hospitals, by the
State Department of Public Health. Existing regulations require a
hospital to have a pharmacy on the premises or a pharmacy license, as
specified. Existing regulations also require the hospital to consult
the pharmacist on the proper methods of, among other things,
repackaging and labeling bulk cleaning agents.
   This bill would instead provide that a licensed general acute care
hospital or an acute psychiatric hospital, as defined, is not
required to consult a pharmacist regarding repackaging and labeling
of bulk cleaning agents, solvents, chemicals, and nondrug hazardous
substances  except for areas where sterile compounding is
performed  .
   (6) 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:

  SECTION 1.  Section 4052.6 of the Business and Professions Code is
amended to read:
   4052.6.  (a) A pharmacist recognized by the board as an advanced
practice pharmacist may do all of the following:
   (1) Order and perform patient assessments.
   (2) Order and interpret drug therapy-related tests.
   (3) Refer patients to other health care providers.
   (4) Participate in the evaluation and management of diseases and
health conditions in collaboration with other health care providers.
   (5) Initiate, adjust, or discontinue drug therapy in the manner
specified in paragraph (4) of subdivision (a) of Section 4052.2.
   (b) 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, as permitted by that 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 permitted by that provider.
   (c) This section shall not interfere with a physician's order to
dispense a prescription drug as written, or other order of similar
meaning.
   (d) Prior to initiating or adjusting a controlled substance
therapy pursuant to this section, a pharmacist shall personally
register with the federal Drug Enforcement Administration.
   (e) A pharmacist who orders and interprets tests pursuant to
paragraph (2) of subdivision (a) shall ensure that the ordering of
those tests is done in coordination with the patient's primary care
provider or diagnosing prescriber, as appropriate, including promptly
transmitting written notification to the patient's diagnosing
prescriber or entering the appropriate information in a patient
record system shared with the prescriber, when available and as
permitted by that prescriber.
  SEC. 2.  Section 4115 of the Business and Professions Code is
amended to read:
   4115.  (a) A pharmacy technician may perform packaging, 
including emergency supply packaging and sealing in or for hospitals,
hospital unit inspections, and other physical, 
manipulative, repetitive, or other nondiscretionary tasks, only while
assisting, and while under the direct supervision and control of a
pharmacist.  The pharmacist shall be responsible for the duties
performed under his or her supervision by a technician. 
   (b) This section does not authorize the performance of any tasks
specified in subdivision (a) by a pharmacy technician without a
pharmacist on duty.
   (c) This section does not authorize a pharmacy technician to
perform any act requiring the exercise of professional judgment by a
pharmacist.
   (d) The board shall adopt regulations to specify tasks pursuant to
subdivision (a) that a pharmacy technician may perform under the
supervision of a pharmacist. Any pharmacy that employs a pharmacy
technician shall do so in conformity with the regulations adopted by
the board.
   (e) No person shall act as a pharmacy technician without first
being licensed by the board as a pharmacy technician.
   (f) (1) A pharmacy with only one pharmacist shall have no more
than one pharmacy technician performing the tasks specified in
subdivision (a). The ratio of pharmacy technicians performing the
tasks specified in subdivision (a) to any additional pharmacist shall
not exceed 2:1, except that this ratio shall not apply to personnel
performing clerical functions pursuant to Section 4116 or 4117. This
ratio is applicable to all practice settings, except for an inpatient
of a licensed health facility, a patient of a licensed home health
agency, as specified in paragraph (2), an inmate of a correctional
facility of the Department of Corrections and Rehabilitation, and for
a person receiving treatment in a facility operated by the State
Department of State Hospitals, the State Department of Developmental
Services, or the Department of Veterans Affairs.
   (2) The board may adopt regulations establishing the ratio of
pharmacy technicians performing the tasks specified in subdivision
(a) to pharmacists applicable to the filling of prescriptions of an
inpatient of a licensed health facility and for a patient of a
licensed home health agency. Any ratio established by the board
pursuant to this subdivision shall allow, at a minimum, at least one
pharmacy technician for a single pharmacist in a pharmacy and two
pharmacy technicians for each additional pharmacist, except that this
ratio shall not apply to personnel performing clerical functions
pursuant to Section 4116 or 4117.
   (3) A pharmacist scheduled to supervise a second pharmacy
technician may refuse to supervise a second pharmacy technician if
the pharmacist determines, in the exercise of his or her professional
judgment, that permitting the second pharmacy technician to be on
duty would interfere with the effective performance of the pharmacist'
s responsibilities under this chapter. A pharmacist assigned to
supervise a second pharmacy technician shall notify the pharmacist in
charge in writing of his or her determination, specifying the
circumstances of concern with respect to the pharmacy or the pharmacy
technician that have led to the determination, within a reasonable
period, but not to exceed 24 hours, after the posting of the relevant
schedule. No entity employing a pharmacist may discharge,
discipline, or otherwise discriminate against any pharmacist in the
terms and conditions of employment for exercising or attempting to
exercise in good faith the right established pursuant to this
paragraph.
   (g) Notwithstanding subdivisions (a) and (b), the board shall by
regulation establish conditions to permit the temporary absence of a
pharmacist for breaks and lunch periods pursuant to Section 512 of
the Labor Code and the orders of the Industrial Welfare Commission
without closing the pharmacy. During these temporary absences, a
pharmacy technician may, at the discretion of the pharmacist, remain
in the pharmacy but may only perform nondiscretionary tasks. The
pharmacist shall be responsible for a pharmacy technician and shall
review any task performed by a pharmacy technician during the
pharmacist's temporary absence. Nothing in this subdivision shall be
construed to authorize a pharmacist to supervise pharmacy technicians
in greater ratios than those described in subdivision (f).
   (h) The pharmacist on duty shall be directly responsible for the
conduct of a pharmacy technician supervised by that pharmacist. 
   (i) In a health care facility licensed under subdivision (a) of
Section 1250 of the Health and Safety Code, a pharmacy technician's
duties may include any of the following.  
   (1) Packaging emergency supplies for use in the health care
facility and the hospital's emergency medical system as authorized
under Section 4119.  
   (2) Sealing emergency containers for use in the health care
facility.  
   (3) Performing monthly checks of the drug supplies stored
throughout the health care facility. Irregularities shall be reported
within 24 hours to the pharmacist in charge and the director or
chief executive officer of the health care facility in accordance
with the health care facility's policies and procedures. 
  SEC. 3.  Section 4119.6 is added to the Business and Professions
Code, to read: 
   4119.6.  (a) Notwithstanding any other law, a pharmacy may furnish
a dangerous drug or dangerous device to the emergency medical
services system of a licensed general acute care hospital, as defined
in subdivision (a) of Section 1250 of the Health and Safety Code,
for storage in a secured emergency pharmaceutical supplies container
maintained within the hospital in accordance with the hospital's
policies and procedures. A pharmacy technician or 
    4119.6.    An  intern pharmacist under the
direct supervision and control, as defined in Section 4023.5, of a
pharmacist may stock, replenish, and inspect the  hospital's
 emergency pharmaceutical supplies container  and the
emergency medical system supplies of a licensed general acute care
  hospital, as defined in subdivision (a) of 
Section 1250 of the Health and Safety Code  . 
   (b) Both the hospital and the dispensing pharmacy acting under
this section shall maintain records of each request by, and dangerous
drugs or dangerous devices furnished to, the hospital's emergency
medical services system, for at least three years.  

   (c) Controlled substances shall be furnished to the hospital's
emergency medical services system under this section in accordance
with the California Uniform Controlled Substances Act (Division 10
(commencing with Section 11000) of the Health and Safety Code).

  SEC. 4.  Section 4119.7 is added to the Business and Professions
Code, to read:
   4119.7.  (a)  Notwithstanding any other law, a pharmacy
may furnish a dangerous drug or dangerous device to a licensed
general acute care hospital, as defined in   A health
care facility licensed under  subdivision (a) of Section 1250 of
the Health and Safety Code,  may administer, dispense, or
furnish dangerous drugs and dangerous devices to inpatients or
patients upon discharge  pursuant to preprinted or electronic
standing orders, order sets, and protocols established under the
policies and procedures of the  hospital, as approved
according to the policies of the hospital's governing body, 
 health care facility,  if the order is promptly
 dated, timed, and authenticated in the medical record of
the patient to whom the dangerous drug or dangerous device 
is dispensed by the ordering practitioner or another practitioner
responsible for the care of that patient and authorized by the
hospital's policies and procedures to write orders.  
will be provided. 
   (b)  The hospital   A health care facility
licensed under subdivision (a) of Section 1250 of the Health and
Safety Code  shall store and maintain drugs in accordance with
national standards regarding the storage area and refrigerator or
freezer temperature, and otherwise pursuant to the manufacturer's
guidelines.  The health care facility's policies and procedures
shall specify these storage parameters. 
   (c)  (1)     A
pharmacist, pharmacy technician, or an   An  intern
pharmacist under the direct supervision and control, as defined in
Section 4023.5, of a pharmacist, shall inspect the drugs maintained
in the  hospital   health care facility  at
least once per month. The  hospital   health
care facility  shall establish specific written policies and
procedures for inspections pursuant to this paragraph. 
   (2) The person conducting the inspection pursuant to paragraph (1)
shall report any irregularities to the director or chief executive
officer of the hospital, or other person holding an equivalent
position, and in accordance with the hospital's policy. 
  SEC. 5.  Section 1250.06 is added to the Health and Safety Code,
immediately following Section 1250.05, to read:
   1250.06.  A licensed general acute care hospital, as defined
pursuant to subdivision (a) of Section 1250, or an acute psychiatric
hospital, as defined pursuant to subdivision (b) of Section 1250, is
not required to consult a pharmacist regarding repackaging and
labeling of bulk cleaning agents, solvents, chemicals, and nondrug
hazardous substances used throughout the  hospital. 
 hospital except for areas where sterile compounding is
performed. 
  SEC. 6.  Section 11150 of the Health and Safety Code is amended to
read:
   11150.  No person other than a physician, dentist, podiatrist, or
veterinarian, or naturopathic doctor acting pursuant to Section
3640.7 of the Business and Professions Code, or pharmacist acting
within the scope of a project authorized under Article 1 (commencing
with Section 128125) of Chapter 3 of Part 3 of Division 107 or within
the scope of Section 4052.1, 4052.2, or 4052.6 of the Business and
Professions Code, a registered nurse acting within the scope of a
project authorized under Article 1 (commencing with Section 128125)
of Chapter 3 of Part 3 of Division 107, a certified nurse-midwife
acting within the scope of Section 2746.51 of the Business and
Professions Code, a nurse practitioner acting within the scope of
Section 2836.1 of the Business and Professions Code, a physician
assistant acting within the scope of a project authorized under
Article 1 (commencing with Section 128125) of Chapter 3 of Part 3 of
Division 107 or Section 3502.1 of the Business and Professions Code,
a naturopathic doctor acting within the scope of Section 3640.5 of
the Business and Professions Code, or an optometrist acting within
the scope of Section 3041 of the Business and Professions Code, or an
out-of-state prescriber acting pursuant to Section 4005 of the
Business and Professions Code shall write or issue a prescription.
  SEC. 7.  Section 11210 of the Health and Safety Code is amended to
read:
   11210.  A physician, surgeon, dentist, veterinarian, naturopathic
doctor acting pursuant to Section 3640.7 of the Business and
Professions Code, or podiatrist, or pharmacist acting within the
scope of a project authorized under Article 1 (commencing with
Section 128125) of Chapter 3 of Part 3 of Division 107 or within the
scope of Section 4052.1, 4052.2, or 4052.6 of the Business and
Professions Code, or registered nurse acting within the scope of a
project authorized under Article 1 (commencing with Section 128125)
of Chapter 3 of Part 3 of Division 107, or physician assistant acting
within the scope of a project authorized under Article 1 (commencing
with Section 128125) of Chapter 3 of Part 3 of Division 107, or
naturopathic doctor acting within the scope of Section 3640.5 of the
Business and Professions Code, or an optometrist acting within the
scope of Section 3041 of the Business and Professions Code may
prescribe for, furnish to, or administer controlled substances to his
or her patient when the patient is suffering from a disease,
ailment, injury, or infirmities attendant upon old age, other than
addiction to a controlled substance.
   The physician, surgeon, dentist, veterinarian, naturopathic doctor
acting pursuant to Section 3640.7 of the Business and Professions
Code, or podiatrist, or pharmacist acting within the scope of a
project authorized under Article 1 (commencing with Section 128125)
of Chapter 3 of Part 3 of Division 107 or within the scope of Section
4052.1, 4052.2, or 4052.6 of the Business and Professions Code, or
registered nurse acting within the scope of a project authorized
under Article 1 (commencing with Section 128125) of Chapter 3 of Part
3 of Division 107, or physician assistant acting within the scope of
a project authorized under Article 1 (commencing with Section
128125) of Chapter 3 of Part 3 of Division 107, or naturopathic
doctor acting within the scope of Section 3640.5 of the Business and
Professions Code, or an optometrist acting within the scope of
Section 3041 of the Business and Professions Code shall prescribe,
furnish, or administer controlled substances only when in good faith
he or she believes the disease, ailment, injury, or infirmity
requires the treatment.
   The physician, surgeon, dentist, veterinarian, or naturopathic
doctor acting pursuant to Section 3640.7 of the Business and
Professions Code, or podiatrist, or pharmacist acting within the
scope of a project authorized under Article 1 (commencing with
Section 128125) of Chapter 3 of Part 3 of Division 107 or within the
scope of Section 4052.1, 4052.2, or 4052.6 of the Business and
Professions Code, or registered nurse acting within the scope of a
project authorized under Article 1 (commencing with Section 128125)
of Chapter 3 of Part 3 of Division 107, or physician assistant acting
within the scope of a project authorized under Article 1 (commencing
with Section 128125) of Chapter 3 of Part 3 of Division 107, or a
naturopathic doctor acting within the scope of Section 3640.5 of the
Business and Professions Code, or an optometrist acting within the
scope of Section 3041 of the Business and Professions Code shall
prescribe, furnish, or administer controlled substances only in the
quantity and for the length of time as are reasonably necessary.
  SEC. 8.  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.