Bill Text: CA SB1039 | 2013-2014 | Regular Session | Amended
NOTE: There are more recent revisions of this legislation. Read Latest Draft
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
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
BILL NUMBER: SB 1039 AMENDED
BILL TEXT
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 pharmacies.
pharmacy.
LEGISLATIVE COUNSEL'S DIGEST
SB 1039, as amended, Hernandez. Pharmacies: furnishing
drugs. 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 of a pharmacist, as specified.
(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 inspect the drugs
maintained in the hospital at least once per month, and to report
any irregularities, as specified.
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. A violation of these
provisions is a misdemeanor punishable by a fine or imprisonment, or
by both a fine and imprisonment. 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 require instead provide
that a licensed general acute care hospital or an acute
psychiatric hospital , as defined, to adopt policies
and procedures for ensuring proper methods of is not
required to consult a pharmacist regarding
repackaging and labeling of bulk cleaning agents,
solvents, chemicals, and nondrug hazardous substances
according to state and federal law substances .
By expanding the scope of an existing crime, this bill would
create a state-mandated local program.
(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.
(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. 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 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.
(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 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 and control, as defined in Section
4023.5, 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.
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, shall adopt
policies and procedures regarding the responsibility for ensuring
proper methods for 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 according
to state and federal law and standards. hospital.
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.
