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, 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 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 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 assessmentsbegin insert 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 prescriberend insert.
This bill would also authorize a pharmacist recognized by the board as an advanced practice pharmacist to order patient assessmentsbegin insert 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 prescriberend insert.
(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 4052.6 of the Business and Professions
2Code is amended to read:
(a) A pharmacist recognized by the board as an
4advanced practice pharmacist may do all of the following:
P4 1(1) Order and perform patient assessments.
2(2) Order and interpret drug therapy-related tests.
3(3) Refer patients to other health care providers.
4(4) Participate in the evaluation and management of diseases
5and health conditions in collaboration with other health care
6
providers.
7(5) Initiate, adjust, or discontinue drug therapy in the manner
8specified in paragraph (4) of subdivision (a) of Section 4052.2.
9(b) A pharmacist who adjusts or discontinues drug therapy shall
10promptly transmit written notification to the patient’s diagnosing
11prescriber or enter the appropriate information in a patient record
12system shared with the prescriber, as permitted by that prescriber.
13A pharmacist who initiates drug therapy shall promptly transmit
14written notification to, or enter the appropriate information into,
15a patient record system shared with the patient’s primary care
16provider or diagnosing provider, as permitted by that provider.
17(c) This section shall not interfere with a physician’s
order to
18dispense a prescription drug as written, or other order of similar
19meaning.
20(d) Prior to initiating or adjusting a controlled substance therapy
21pursuant to this section, a pharmacist shall personally register with
22the federal Drug Enforcement Administration.
23(e) A pharmacist who ordersbegin insert and performs patient assessments
24pursuant to paragraph (1) of subdivision (a)end insert and interprets tests
25pursuant to paragraph (2) of subdivision (a) shall ensure that the
26ordering of thosebegin insert assessments orend insert tests is done in coordination with
27the patient’s primary care provider or diagnosing prescriber, as
28
appropriate, including promptly transmitting written notification
29to the patient’s diagnosing prescriber or entering the appropriate
30information in a patient record system shared with the prescriber,
31when available and as permitted by that prescriber.
Section 4115 of the Business and Professions Code is
33amended to read:
(a) A pharmacy technician may perform packaging,
35manipulative, repetitive, or other nondiscretionary tasks, only while
36assisting, and while under the direct supervision and control of a
37pharmacist. The pharmacist shall be responsible for the duties
38performed under his or her supervision by a technician.
P5 1(b) This section does not authorize the performance of any tasks
2specified in subdivision (a) by a pharmacy technician without a
3pharmacist on duty.
4(c) This section does not authorize a pharmacy technician to
5perform any act requiring the exercise of professional judgment
6by a pharmacist.
7(d) The board shall adopt regulations to specify tasks pursuant
8to subdivision (a) that a pharmacy technician may perform under
9the supervision of a pharmacist. Any pharmacy that employs a
10pharmacy technician shall do so in conformity with the regulations
11adopted by the board.
12(e) No person shall act as a pharmacy technician without first
13being licensed by the board as a pharmacy technician.
14(f) (1) A pharmacy with only one pharmacist shall have no
15more than one pharmacy technician performing the tasks specified
16in subdivision (a). The ratio of pharmacy technicians performing
17 the tasks specified in subdivision (a) to any additional pharmacist
18shall not exceed 2:1, except that this ratio shall not apply
to
19personnel performing clerical functions pursuant to Section 4116
20or 4117. This ratio is applicable to all practice settings, except for
21an inpatient of a licensed health facility, a patient of a licensed
22home health agency, as specified in paragraph (2), an inmate of a
23correctional facility of the Department of Corrections and
24Rehabilitation, and for a person receiving treatment in a facility
25operated by the State Department of State Hospitals, the State
26Department of Developmental Services, or the Department of
27Veterans Affairs.
28(2) The board may adopt regulations establishing the ratio of
29pharmacy technicians performing the tasks specified in subdivision
30(a) to pharmacists applicable to the filling of prescriptions of an
31inpatient of a licensed health facility and for a patient of a licensed
32home health agency. Any ratio
established by the board pursuant
33to this subdivision shall allow, at a minimum, at least one pharmacy
34technician for a single pharmacist in a pharmacy and two pharmacy
35technicians for each additional pharmacist, except that this ratio
36shall not apply to personnel performing clerical functions pursuant
37to Section 4116 or 4117.
38(3) A pharmacist scheduled to supervise a second pharmacy
39technician may refuse to supervise a second pharmacy technician
40if the pharmacist determines, in the exercise of his or her
P6 1professional judgment, that permitting the second pharmacy
2technician to be on duty would interfere with the effective
3performance of the pharmacist’s responsibilities under this chapter.
4A pharmacist assigned to supervise a second pharmacy technician
5shall notify the pharmacist in charge in writing of his or her
6determination,
specifying the circumstances of concern with respect
7to the pharmacy or the pharmacy technician that have led to the
8determination, within a reasonable period, but not to exceed 24
9hours, after the posting of the relevant schedule. No entity
10employing a pharmacist may discharge, discipline, or otherwise
11discriminate against any pharmacist in the terms and conditions
12of employment for exercising or attempting to exercise in good
13
faith the right established pursuant to this paragraph.
14(g) Notwithstanding subdivisions (a) and (b), the board shall
15by regulation establish conditions to permit the temporary absence
16of a pharmacist for breaks and lunch periods pursuant to Section
17512 of the Labor Code and the orders of the Industrial Welfare
18Commission without closing the pharmacy. During these temporary
19absences, a pharmacy technician may, at the discretion of the
20pharmacist, remain in the pharmacy but may only perform
21nondiscretionary tasks. The pharmacist shall be responsible for a
22pharmacy technician and shall review any task performed by a
23pharmacy technician during the pharmacist’s temporary absence.
24Nothing in this subdivision shall be construed to authorize a
25pharmacist to supervise pharmacy technicians in greater ratios
26than those described in
subdivision (f).
27(h) The pharmacist on duty shall be directly responsible for the
28conduct of a pharmacy technician supervised by that pharmacist.
29(i) In a health care facility licensed under subdivision (a) of
30Section 1250 of the Health and Safety Code, a pharmacy
31technician’s duties may include any of the following.
32(1) Packaging emergency supplies for use in the health care
33facility and the hospital’s emergency medical system as authorized
34under Section 4119.
35(2) Sealing emergency containers for use in the health care
36facility.
37(3) Performing monthly checks of the drug supplies stored
38
throughout the health care facility. Irregularities shall be reported
39within 24 hours to the pharmacist in charge and the director or
P7 1chief executive officer of the health care facility in accordance
2with the health care facility’s policies and procedures.
Section 4119.6 is added to the Business and Professions
4Code, to read:
An intern pharmacist under the direct supervision and
6control, as defined in Section 4023.5, of a pharmacist may stock,
7replenish, and inspect the emergency pharmaceutical supplies
8container and the emergency medical system supplies of a licensed
9general acute care hospital, as defined in subdivision (a) of Section
101250 of the Health and Safety Code.
Section 4119.7 is added to the Business and Professions
12Code, to read:
(a) A health care facility licensed under subdivision
14(a) of Section 1250 of the Health and Safety Code, may administer,
15dispense, or furnish dangerous drugs and dangerous devices to
16inpatients or patients upon discharge pursuant to preprinted or
17electronic standing orders, order sets, and protocols established
18under the policies and procedures of the health care facility, if the
19order is dated, timed, and authenticated in the medical record of
20the patient to whom the dangerous drug or dangerous device will
21be provided.
22(b) A health care facility licensed under subdivision (a) of
23Section 1250 of the Health and Safety Code shall store and
24maintain
drugs in accordance with national standards regarding
25the storage area and refrigerator or freezer temperature, and
26otherwise pursuant to the manufacturer’s guidelines. The health
27care facility’s policies and procedures shall specify these storage
28parameters.
29(c) An intern pharmacist under the direct supervision and
30control, as defined in Section 4023.5, of a pharmacist, shall inspect
31the drugs maintained in the health care facility at least once per
32month. The
health care facility shall establish specific written
33policies and procedures for inspections pursuant to this paragraph.
Section 1250.06 is added to the Health and Safety
35Code, immediately following Section 1250.05, to read:
A licensed general acute care hospital, as defined
37pursuant to subdivision (a) of Section 1250, or an acute psychiatric
38hospital, as defined pursuant to subdivision (b) of Section 1250,
39is not required to consult a pharmacist regarding repackaging and
40labeling of bulk cleaning agents, solvents, chemicals, and nondrug
P8 1hazardous substances used throughout the hospital except for areas
2where sterile compounding is performed.
Section 11150 of the Health and Safety Code is
4amended to read:
No person other than a physician, dentist, podiatrist,
6or veterinarian, or naturopathic doctor acting pursuant to Section
73640.7 of the Business and Professions Code, or pharmacist acting
8within the scope of a project authorized under Article 1
9(commencing with Section 128125) of Chapter 3 of Part 3 of
10Division 107 or within the scope of Section 4052.1, 4052.2, or
114052.6 of the Business and Professions Code, a registered nurse
12acting within the scope of a project authorized under Article 1
13(commencing with Section 128125) of Chapter 3 of Part 3 of
14Division 107, a certified nurse-midwife acting within the scope of
15Section 2746.51 of the Business and Professions Code, a nurse
16practitioner acting within the scope of Section 2836.1 of the
17Business and Professions
Code, a physician assistant acting within
18the scope of a project authorized under Article 1 (commencing
19with Section 128125) of Chapter 3 of Part 3 of Division 107 or
20Section 3502.1 of the Business and Professions Code, a
21naturopathic doctor acting within the scope of Section 3640.5 of
22the Business and Professions Code, or an optometrist acting within
23the scope of Section 3041 of the Business and Professions Code,
24or an out-of-state prescriber acting pursuant to Section 4005 of the
25Business and Professions Code shall write or issue a prescription.
Section 11210 of the Health and Safety Code is
27amended to read:
A physician, surgeon, dentist, veterinarian, naturopathic
29doctor acting pursuant to Section 3640.7 of the Business and
30Professions Code, or podiatrist, or pharmacist acting within the
31scope of a project authorized under Article 1 (commencing with
32Section 128125) of Chapter 3 of Part 3 of Division 107 or within
33the scope of Section 4052.1, 4052.2, or 4052.6 of the Business and
34Professions Code, or registered nurse acting within the scope of a
35project authorized under Article 1 (commencing with Section
36128125) of Chapter 3 of Part 3 of Division 107, or physician
37assistant acting within the scope of a project authorized under
38Article 1 (commencing with Section 128125) of Chapter 3 of Part
393 of Division 107, or naturopathic doctor
acting within the scope
40of Section 3640.5 of the Business and Professions Code, or an
P9 1optometrist acting within the scope of Section 3041 of the Business
2and Professions Code may prescribe for, furnish to, or administer
3controlled substances to his or her patient when the patient is
4suffering from a disease, ailment, injury, or infirmities attendant
5upon old age, other than addiction to a controlled substance.
6The physician, surgeon, dentist, veterinarian, naturopathic doctor
7acting pursuant to Section 3640.7 of the Business and Professions
8Code, or podiatrist, or pharmacist acting within the scope of a
9project authorized under Article 1 (commencing with Section
10128125) of Chapter 3 of Part 3 of Division 107 or within the scope
11of Section 4052.1, 4052.2, or 4052.6 of the Business and
12Professions Code, or registered nurse acting within the scope of a
13project
authorized under Article 1 (commencing with Section
14128125) of Chapter 3 of Part 3 of Division 107, or physician
15assistant acting within the scope of a project authorized under
16Article 1 (commencing with Section 128125) of Chapter 3 of Part
173 of Division 107, or naturopathic doctor acting within the scope
18of Section 3640.5 of the Business and Professions Code, or an
19optometrist acting within the scope of Section 3041 of the Business
20and Professions Code shall prescribe, furnish, or administer
21controlled substances only when in good faith he or she believes
22the disease, ailment, injury, or infirmity requires the treatment.
23The physician, surgeon, dentist, veterinarian, or naturopathic
24doctor acting pursuant to Section 3640.7 of the Business and
25Professions Code, or podiatrist, or pharmacist acting within the
26scope of a project authorized under Article 1 (commencing
with
27Section 128125) of Chapter 3 of Part 3 of Division 107 or within
28the scope of Section 4052.1, 4052.2, or 4052.6 of the Business and
29Professions Code, or registered nurse acting within the scope of a
30project authorized under Article 1 (commencing with Section
31128125) of Chapter 3 of Part 3 of Division 107, or physician
32assistant acting within the scope of a project authorized under
33Article 1 (commencing with Section 128125) of Chapter 3 of Part
343 of Division 107, or a naturopathic doctor acting within the scope
35of Section 3640.5 of the Business and Professions Code, or an
36optometrist acting within the scope of Section 3041 of the Business
37and Professions Code shall prescribe, furnish, or administer
38controlled substances only in the quantity and for the length of
39time as are reasonably necessary.
No reimbursement is required by this act pursuant to
2Section 6 of Article XIII B of the California Constitution because
3the only costs that may be incurred by a local agency or school
4district will be incurred because this act creates a new crime or
5infraction, eliminates a crime or infraction, or changes the penalty
6for a crime or infraction, within the meaning of Section 17556 of
7the Government Code, or changes the definition of a crime within
8the meaning of Section 6 of Article XIII B of the California
9Constitution.
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