BILL ANALYSIS �
SB 1039
Page 1
Date of Hearing: June 17, 2014
ASSEMBLY COMMITTEE ON BUSINESS, PROFESSIONS AND CONSUMER
PROTECTION
Susan A. Bonilla, Chair
SB 1039 (Hernandez) - As Amended: June 5, 2014
SENATE VOTE : 32-0
SUBJECT : Pharmacy
SUMMARY : Authorizes an advanced practice pharmacist (APP) to
order patient assessments, expands the duties of a pharmacy
technician (PT) and intern pharmacist, and establishes
procedures for a pharmacy to furnish a dangerous drug or
dangerous device to the emergency medical services system (EMSS)
of a licensed general acute care hospital, as specified.
Specifically, this bill :
1)Authorizes an APP to order patient assessments.
2)Authorizes a PT to perform emergency supply packaging and
sealing in or for hospitals, perform hospital unit
inspections, and perform other physical tasks while assisting,
and under the direct supervision and control of, a pharmacist.
3)Authorizes a pharmacy to furnish a dangerous drug or dangerous
device to the EMSS of a licensed general acute care hospital
for storage in a secured emergency pharmaceutical supplies
container maintained within the hospital in accordance with
the hospital's policies and procedures. Authorizes a PT or
intern pharmacist under the direct supervision and control of
a pharmacist to stock, replenish, and inspect the hospital's
emergency pharmaceutical supplies container.
4)Requires both the hospital and the dispensing pharmacy to
maintain records for at least three years of each request by
the hospital's EMSS for dangerous drugs or dangerous devices
and the dangerous drugs or dangerous devices furnished.
5)Requires controlled substances to be furnished to the
hospital's EMSS in accordance with the California Uniform
Controlled Substances Act.
6)Authorizes a pharmacy to furnish a dangerous drug or dangerous
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device to a licensed general acute care hospital if:
a) The dangerous drug or dangerous device is furnished
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;
b) 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,
c) The order is authorized by the hospital's policies and
procedures.
7)Requires the hospital to store and maintain drugs in
accordance with national temperature standards regarding the
storage area and refrigerator or freezer, and otherwise
pursuant to the manufacturer's guidelines.
8)Requires a pharmacist, PT, 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.
Requires the hospital to establish specific written policies
and procedures for these inspections.
9)Requires the pharmacist, PT, or an intern pharmacist under the
direct supervision and control of a pharmacist, who inspects
the drugs maintained in the hospital to report any
irregularities to the director or chief executive officer of
the hospital, or other person holding an equivalent position,
in accordance with the hospital's policy.
10)States that a licensed general acute care hospital or an
acute psychiatric hospital 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.
11)Makes conforming changes in current law to recognize the
authority of:
a) An APP to write or issue a prescription;
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b) An APP or pharmacist to 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; and,
c) An APP or pharmacist to prescribe, furnish, or
administer controlled substances 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 are reasonably necessary.
12)Makes other clarifying and technical changes.
EXISTING LAW :
1)Establishes the Board of Pharmacy (BOP) within the Department
of Consumer Affairs to license and regulate the practice of
pharmacy. (Business and Professions Code (BPC) Sections 4000
et seq.)
2)Authorizes a pharmacist to order or perform routine drug
therapy-related patient assessment procedures including
temperature, pulse, and respiration in a licensed health care
facility in accordance with policies, procedures, or protocols
developed by health professionals, including physicians,
pharmacists, and registered nurses, with the concurrence of
the facility administrator. (BPC 4052.1)
3)Authorizes a PT to perform packaging, manipulative,
repetitive, or other nondiscretionary tasks, only while
assisting, and while under the direct supervision and control
of a pharmacist. Clarifies that a pharmacy technician can
only perform the above tasks with a pharmacist on duty.
Prohibits a PT from performing any act requiring the exercise
of professional judgment by a pharmacist. (BPC 4115)
4)Defines "direct supervision and control" to mean that a
pharmacist is on the premises at all times and is fully aware
of all activities performed by either a PT or intern
pharmacist. (BPC 4023.5)
5)Requires BOP to adopt regulations to specify tasks that a PT
may perform under the supervision of a pharmacist. Requires
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any pharmacy that employs a PT to do so in conformity with the
regulations. (BPC 4115)
6)Requires a pharmacy with only one pharmacist to have no more
than one PT performing packaging, manipulative, repetitive or
other nondiscretionary tasks. Establishes a ratio of no more
than two PTs to one pharmacist practicing in all settings
except:
a) An inpatient of a licensed health facility;
b) A patient of a licensed home health agency;
c) An inmate of a correctional facility of the Department
of Corrections and Rehabilitation; and,
d) 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. (BPC 4115)
7)Prohibits anyone other than a pharmacist, an intern
pharmacist, an authorized officer of the law, or a person
authorized to prescribe from being in an area, place, or
premises in a pharmacy where controlled substances or
dangerous drugs or dangerous devices are stored, possessed,
prepared, manufactured, derived, compounded, dispensed, or
repackaged. States that a pharmacist is responsible for any
individual who enters the pharmacy for the purposes of
receiving consultation from the pharmacist or performing
clerical, inventory control, housekeeping, delivery,
maintenance, or similar functions relating to the pharmacy if
the pharmacist remains present in the pharmacy during all
times as the authorized individual is present. (BPC 4116)
8)Prohibits anyone other than a pharmacist, an intern
pharmacist, a PT, an authorized officer of the law, a person
authorized to prescribe, a registered nurse, a licensed
vocational nurse, a person who enters the pharmacy for
purposes of receiving consultation from a pharmacist, or a
person authorized by the pharmacist in charge to perform
clerical, inventory control, housekeeping, delivery,
maintenance, or similar functions relating to the pharmacy
from being in that area, place, or premises described in the
hospital where controlled substances, dangerous drugs, or
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dangerous devices are stored, possessed, prepared,
manufactured, derived, compounded, dispensed, or repackaged.
(BPC 4117)
9)Authorizes an APP to do all of the following:
a) Perform patient assessments;
b) Order and interpret drug-therapy related tests, ensuring
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;
c) Refer patients to other health care providers;
d) Participate in the evaluation or management of diseases
and health conditions in collaboration with other health
care providers; and,
e) Initiate, adjust or discontinue drug therapy pursuant to
the authority established in current law for pharmacists to
perform certain procedures in a licensed health care
facility. (BPC 4052.6)
10)Establishes the California Uniform Controlled Substances Act,
which regulates controlled substances. (Health and Safety
Code Sections 11000-11651)
FISCAL EFFECT : Unknown
COMMENTS :
1)Purpose of this bill . This bill authorizes an APP to order
patient assessments, expands the duties of a pharmacy
technician (PT) and intern pharmacist, and establishes
procedures for a pharmacy to furnish a dangerous drug or
dangerous device to the emergency medical services system
(EMSS) of a licensed general acute care hospital, as
specified. This bill allows for more efficient use of
lower-level pharmacy professionals, freeing up a pharmacist to
perform more advanced tasks. This bill is sponsored by the
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California Society of Health System Pharmacists.
2)Author's statement . According to the author's office, "This
bill makes more efficient use of pharmacy personnel in the
facility setting expanding the types of nondiscretionary tasks
that pharmacy technicians are permitted to perform, freeing up
pharmacists to focus on patient care."
3)The Affordable Care Act (ACA) and APPs . The federal ACA was
passed in March 2010 to provide quality, affordable healthcare
for all Americans and improve the value and efficiency of that
care. The January 2014 implementation date of ACA resulted in
millions more Californians entering the primary care market.
The CDC argues that pharmacists are well positioned to augment
primary care teams and help manage patient's medications and
chronic conditions. The U.S. Department of Health and Human
Services (HHS) authored a 2011 report, entitled "Improving
Patient and Health System Outcomes through Advanced Pharmacy
Practice, A Report to the U.S. Surgeon General," in which it
was demonstrated that "though evidence-based outcomes, many
expanded pharmacy practice models, implemented in
collaboration with physicians or as part of a health team,
improve patient and health system outcomes and optimize
primary care access and delivery." The report recommended
that pharmacists work in collaboration with physicians and
primary care clinicians by:
a) Performing patient assessments and developing
therapeutic plans;
b) Utilizing authorities to initiate, adjust, or
discontinue medications;
c) Ordering, interpreting, and monitoring appropriate
laboratory tests;
d) Providing care coordination and other healthcare
services for wellness and prevention; and,
e) Developing partnerships with patients for ongoing and
follow-up care.
SB 493 (Hern�ndez), Chapter 469, Statutes of 2013 built upon
pharmacists' current scope of practice to more fully enable
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them to participate in a multidisciplinary patient management
team, and provided for the recognition of APPs, who are now
able to provide many of the advanced health management
techniques recommended by the HHS report.
1)Pharmacy technicians (PTs) and intern pharmacists . PTs were
established in 1991 (AB 1244 (Polanco), Chapter 841, Statutes
of 1991) to allow pharmacists to delegate simpler tasks so
that the pharmacist may provide professional services to a
larger number of patients. A PT is an individual who, under
the direct supervision and control of a pharmacist, performs
packaging, manipulative, repetitive, or other
non-discretionary tasks related to the processing of a
prescription in a licensed pharmacy, but may not perform
functions restricted to a registered pharmacist.
Intern pharmacists are individuals who are working on or have
completed their education to become a pharmacist and have
registered with the Board of Pharmacy. An intern pharmacist
may perform any activity restricted to a pharmacist while
under the supervision of a registered pharmacist. A
pharmacist may not supervise more than two intern pharmacists
at any one time.
This bill updates current law to supersede outdated code that
does not permit PTs to perform certain non-discretionary
tasks. This bill also clarifies that both preprinted and
electronic standing orders are permissible, and that
pharmacists do not have to be consulted on proper methods for
repackaging and labeling of bulk cleaning supplies.
2)Committee comments . The author's office has committed to
taking the following technical and non-substantive amendments
in Assembly Health Committee, should this bill pass:
a) Place all permissible PT duties in a single section for
purposes of clarity;
b) Clarify that this bill does not conflict with BPC
4126.5, regarding persons to whom a pharmacist may furnish
dangerous drugs; and,
c) Make other clarifying and technical amendments.
3)Arguments in support . The sponsors, California Society of
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Health-System Pharmacists, writes, "For decades, hospitals
have been living with outdated regulations that require
pharmacists to perform menial and administrative tasks that
have long since become better suited for PTs to perform.
California hospitals are still governed by some provisions of
[California Code of Regulations] Title 22 regarding hospital
'pharmaceutical services' that were first written in the
1960s. The pharmacy profession has dramatically evolved
between the 1960s and the present, but the regulations have
not kept pace.
"One important difference between the 1960s and today is that
the PT workforce is fully licensed and regulated. California
statutes authorizing the creation of a licensed pharmacy
technician workforce was introduced in the mid-1990s. Under
the supervision of pharmacists in a hospital setting, licensed
PTs today compound and prepare drugs for hospital use, manage
drug inventory and purchasing and assist in numerous other
functions. The work of each PT is checked and documented by a
pharmacist before any medication the PT helped prepare is
available for patient care.
"?SB 1039 simply helps bring Title 22 and other sections in
line with modern hospital pharmacy practice. The changes do
not expand the scope of practice of pharmacists. Instead, the
changes ensure administrative functions are performed by
trained and licensed PTs, thereby freeing up pharmacists to
work in coordination with physicians and other providers [of]
patient care. The end result will be better, smarter, and
more efficient care."
4)Previous legislation . SB 493 (Hern�ndez) Chapter 469,
Statutes of 2013, updated the Pharmacy Law to authorize
pharmacists to perform certain functions and established APP
recognition.
AB 536 (Bates) Chapter 352, Statutes of 2001, increased the
one-to-one ratio of PTs to pharmacists to two PTs for each
additional pharmacist in those pharmacies with more than one
pharmacist, and authorized a pharmacist to refuse to supervise
a second PT if the pharmacist determines that a second PT
would interfere with the effective performance of the
pharmacist's responsibilities.
5)Double referred . This bill is double-referred to the Assembly
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Health Committee, where this bill will be referred to if
passed by this Committee.
REGISTERED SUPPORT / OPPOSITION :
Support
California Society of Health-System Pharmacists (co-sponsor)
California Association of Physician Groups (CAPG) (co-sponsor)
California Chronic Care Coalition
California Hospital Association
California Pharmacy Technician Association
Providence Health & Services, Southern California
176 individuals
Opposition
None on file.
Analysis Prepared by : Sarah Huchel / B.,P. & C.P. / (916)
319-3301