Senate Bill No. 1039

Introduced by Senator Hernandez

February 18, 2014

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

LEGISLATIVE COUNSEL’S DIGEST

SB 1039, as introduced, Hernandez. Pharmacies: furnishing drugs.

(1) Existing law, the Pharmacy Law, the violation of which is a crime, provides for the licensing 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 of a pharmacist, as specified.

Because a violation of these provisions would be a crime, the bill would impose a state-mandated local program.

(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, or a pharmacy technician or an intern pharmacist under the direct supervision of a pharmacist, to inspect the drugs maintained in the hospital at least once per month, and to report any irregularities, as specified.

Because a violation of these provisions would be a crime, the bill would create a state-mandated local program.

(3) Existing law authorizes a pharmacist to write or issue a prescription under specified circumstances, including in a health care facility in accordance with policies, procedures, or protocols developed by health professionals, with the concurrence of the facility administrator, or as part of the care provided by among others, a health care facility, a licensed home health agency, or a physician, in accordance with the policies, procedures, or protocols of that facility, home health agency, or physician.

This bill would authorize a pharmacist recognized by the board as an advanced practice pharmacist to write or issue a prescription when the pharmacist is performing functions within the scope of practice of an advanced practice pharmacist.

(4) 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 4115 of the Business and Professions
Code is amended to read:

4115.  

(a) A pharmacy technician may perform packaging,
begin insert including emergency supply packaging and sealing in or for
hospitals, hospital unit inspections, and other physical, end insert
manipulative, repetitive, or other nondiscretionary tasks, only while
assisting, and while under the direct supervision and control of a
pharmacist.

(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.

SEC. 2.  

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 intern pharmacist under the direct supervision of a pharmacist
may stock, replenish, and inspect the hospital’s emergency
pharmaceutical supplies container.

(b) Both the hospital and the dispensing pharmacy 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 in accordance with the
California Uniform Controlled Substances Act (Division 10
(commencing with Section 11000) of the Health and Safety Code).

SEC. 3.  

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 subdivision (a) of Section 1250
of the Health and Safety Code, 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, 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.

(b) The hospital 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.

(c) (1) A pharmacist, pharmacy technician, or an intern
pharmacist under the direct supervision of a pharmacist, shall
inspect the drugs maintained in the hospital at least once per month.
The hospital 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.

(d) The hospital shall adopt policies and procedures regarding
the responsibility for assuring proper methods for repackaging and
labeling of bulk cleaning agents, solvents, chemicals, and nondrug
hazardous substances used throughout the hospital according to
state and federal law and standards.

SEC. 4.  

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 begin delete either end delete Section 4052.1 begin delete or end delete begin insert , end insert
4052.2 begin insert , or 4052.6 end insert 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. 5.  

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.