Amended in Assembly August 4, 2014

Amended in Assembly June 26, 2014

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

Senate Bill No. 1039

Introduced by Senator Hernandez

February 18, 2014

An act to amend begin delete Sections 4052.6 and end delete begin insert Section end insert 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, manipulative, repetitive, or other nondiscretionary tasks only while assisting and while under the direct supervision and control of a pharmacist, as specified. This bill would also authorize begin delete , in a licensed health care facility, as defined, end delete a pharmacy technician’s duties begin insert in a licensed general acute care hospital end insert to include, among other things, sealing emergency containers for use in the begin delete health care facility end delete begin insert hospital end insert .

(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 an intern pharmacist, under the direct supervision and control of a pharmacist, to stock, replenish, and inspect the drugs maintained in the 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 begin delete licensed health care facility, as defined, end delete begin insert licensed general acute care hospital at least once per month end insert pursuant to policies and procedures of the begin delete health care facility end delete begin insert hospital end insert . This bill would also authorize a begin delete licensed health care facility to dispense or furnish dangerous drugs and dangerous devices to inpatients and patients upon discharge end delete begin insert hospital pharmacy serving a licensed general acute care hospital to furnish a dangerous drug or dangerous device end insert pursuant to preprinted or electronic standing orders, order sets, and protocols begin insert of the end insert begin insert hospital end insert , as specified. This bill would require licensed begin delete health care facilities end delete begin insert general acute care hospitals end insert 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.

begin delete

(3) Existing law authorizes a pharmacist recognized by the board as an advanced practice pharmacist to perform specified functions, including performing patient assessments and ordering and interpreting drug therapy-related tests, and requires a pharmacist who orders and interprets those tests to ensure that the ordering of those tests is done in coordination with the patient’s primary care provider or diagnosing prescriber.

end delete begin delete

This bill would also authorize a pharmacist recognized by the board as an advanced practice pharmacist to order patient assessments and would require a pharmacist that orders and performs patient assessments to ensure that the ordering of those assessments is done in coordination with the patient’s primary care provider or diagnosing prescriber.

end delete begin delete

(4)

end delete

begin insert (3) end insert  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.

begin delete

(5)

end delete

begin insert (4) end insert  Existing law provides for the licensure and inspection of health facilities, including general acute care hospitals, by the State Department of Public Health begin insert and makes a violation of those provisions a crime end insert . 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 begin delete provide that end delete begin insert require end insert a licensed general acute care hospital or an acute psychiatric hospital, as defined, begin insert to adopt policies and procedures regarding the responsibility for ensuring proper methods of repackaging and labeling of bulk cleaning agents, solvents, chemicals, and nondrug hazardous substances used throughout the hospital and would specify that the hospital end insert is not required to consult a pharmacist regarding begin insert the end insert repackaging and labeling of begin delete bulk cleaning agents, solvents, chemicals, and nondrug hazardous end delete begin insert those end insert substances except for areas where sterile compounding is performed. begin insert Because a violation of these requirements would be a crime, the bill would impose a state-mandated local program. end insert

begin delete

(6)

end delete

begin insert (5) end 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.

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:

begin delete

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 performs patient assessments
pursuant to paragraph (1) of subdivision (a) and interprets tests
pursuant to paragraph (2) of subdivision (a) shall ensure that the
ordering of those assessments or 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.

end delete

begin delete SEC. 2. end delete
begin insert SECTION 1. end insert   

Section 4115 of the Business and Professions
Code is amended to read:

4115.  

(a) A pharmacy technician may perform packaging,
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 begin delete following. end delete begin insert following: end insert

(1) Packaging emergency supplies for use in the health care
facility and the hospital’s emergency medical system begin insert or end insert 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.

begin delete SEC. 3. end delete
begin insert SEC. 2. end insert   

Section 4119.6 is added to the Business and Professions
Code, to read:

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 emergency pharmaceutical supplies
container and the emergency medical system supplies of a begin delete licensed
general acute care hospital, as defined in end delete begin insert health care facility
licensed under end insert subdivision (a) of Section 1250 of the Health and
Safety Code.

begin delete SEC. 4. end delete
begin insert SEC. 3. end insert   

Section 4119.7 is added to the Business and Professions
Code, to read:

4119.7.  

(a)  begin delete 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 end delete begin insert Notwithstanding any other
law, a hospital pharmacy serving a health care facility licensed
under subdivision (a) of Section 1250 of the Health and Safety
Code may furnish a dangerous drug or dangerous device end insert pursuant
to preprinted or electronic standing orders, order sets, and protocols
established under the policies and procedures of the health care
facility, begin insert as approved according to the policies of the health care
facility’s governing body, end insert if the order is dated, timed, and
authenticated in the medical record of the patient to whom the
dangerous drug or dangerous device will be provided.

(b) A health care facility begin delete licensed under subdivision (a) of
Section 1250 of the Health and Safety Code end delete 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) An intern pharmacist under the direct supervision and
control, as defined in Section 4023.5, of a pharmacist, begin delete shall end delete begin insert may end insert
inspect the drugs maintained in the health care facility at least once
per month. The health care facility shall establish specific written
policies and procedures for inspections pursuant to this begin delete paragraph end delete
begin insert subdivision end insert .

begin insert

(d) For purposes of this section, “health care facility” means
a health facility licensed under subdivision (a) of Section 1250 of
the Health and Safety Code.

end insert

begin delete SEC. 5. end delete
begin insert SEC. 4. end insert   

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,
begin insert shall adopt policies and procedures regarding the responsibility
for ensuring proper methods of repackaging and labeling of bulk
cleaning agents, solvents, chemicals, and nondrug hazardous
substances used throughout the hospital. The hospital end insert is not
required to consult a pharmacist regarding begin insert the end insert repackaging and
labeling of begin delete bulk cleaning agents, solvents, chemicals, and nondrug
hazardous substances used throughout the hospital end delete begin insert these
substances, end insert except for areas where sterile compounding is
performed.

begin delete SEC. 6. end delete
begin insert SEC. 5. end insert   

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.

begin delete SEC. 7. end delete
begin insert SEC. 6. end insert   

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.

begin delete SEC. 8. end delete
begin insert SEC. 7. end 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.