BILL ANALYSIS �
SB 1039
Page 1
Date of Hearing: June 24, 2014
ASSEMBLY COMMITTEE ON HEALTH
Richard Pan, Chair
SB 1039 (Ed Hernandez) - As Amended: June 18, 2014
SENATE VOTE : 32-0
SUBJECT : Pharmacy.
SUMMARY : Expands the tasks a pharmacy technician (PT) is
authorized to perform under the direct supervision or control of
a pharmacist; 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; and, makes technical changes in existing law to
reference new provisions related to advance practice pharmacists
(APP). Specifically, this bill :
1)Clarifies that when a PT is performing packaging,
manipulative, repetitive, or other nondiscretionary tasks
while under the direct supervision of a pharmacist, that the
pharmacist is responsible for the duties the PT performed
under his or her supervision.
2)Authorizes a pharmacy to furnish a dangerous drug or device to
the EMSS of a general acute care hospital for storage in
secured emergency pharmaceutical supplies container maintained
in accordance with the hospital's policies and procedures.
Allows a PT or intern pharmacist under the direct supervision
of a pharmacist to stock, replenish, and inspect the
hospital's emergency pharmaceutical supplies container.
3)Requires the hospital and the pharmacy dispensing the
dangerous drug or device to maintain records of each request
by, and the dangerous drugs and devices furnished to the
hospital's EMSS for at least three years. Requires controlled
substances to be furnished to the hospital's EMSS in
accordance with the California Uniform Controlled Substances
Act.
4)Authorizes a pharmacy to furnish a dangerous drug or device to
a general acute care hospital if pursuant to preprinted or
electronic standing orders and protocols pursuant to the
policies of the hospital's governing body if the order is
dated, timed and authenticated in the medical record of the
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patient and authorized by the hospital's policies and
procedures to write orders.
5)Requires the hospital to store and maintain drugs in
accordance with national standards regarding the storage area
and refrigerator or freezer temperature.
6)Requires a pharmacist, PT, or intern pharmacist under the
direct supervision of a pharmacist to inspect the drugs
maintained in the hospital at least once a month. Requires
the person conducting the inspection pursuant to 7) above to
report any irregularities to the director or chief executive
officer of the hospital.
7)Clarifies that a general acute care hospital or 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.
8)Conforms existing law to recognize the authority of:
a) An APP to write or issue a prescription;
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 reasonably necessary.
EXISTING LAW :
1)Permits a pharmacy technician to perform packaging,
manipulative, repetitive or other non-discretionary tasks,
only while assisting, and under the direct supervision and
control of a pharmacist. Prohibits a PT from performing any
act requiring the exercise of professional judgment by a
pharmacist.
2)Requires that a pharmacy with only one pharmacist have no more
than one PT performing packaging, manipulative, repetitive or
other non-discretionary tasks. Establishes a ratio of two PTs
for each additional pharmacist, except in specified settings.
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3)Defines "intern pharmacist" as a person licensed by the Board
of Pharmacy (BOP) for a period of one to six years if he or
she is enrolled in a school of pharmacy recognized by the BOP,
two years if he or she is a graduate of a school of pharmacy
recognized by the nonpotentially who has applied to become
licensed as a pharmacist, two years if he or she is a foreign
graduate, or one year if he or she has failed the pharmacist
license exam four times and has remained enrolled in a school
of pharmacy.
4)Authorizes an APP recognized by the BOP to:
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.
5)Establishes the California Uniform Controlled Substances Act
(Controlled Substances Act) which regulates controlled
substances. Permits only specified persons to write or issue
a prescription for a controlled substance, including, but not
limited to a: physician; dentist; podiatrist; veterinarian;
naturopathic doctor; pharmacist in certain settings or acting
within the scope of a health workforce pilot project
authorized by the Office of Statewide Health Planning and
Development (OSHPD); and, a registered nurse acting within the
scope of a health workforce pilot project authorized by OSHPD.
FISCAL EFFECT : According the Senate Appropriations Committee,
one-time costs of $80,000 to develop and adopt regulations by
BOP (Pharmacy Board Contingent Fund), and ongoing enforcement
costs of $126,000 in 2015-16 and $83,000 per year thereafter to
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perform inspections and oversee enforcement actions by the BOP
(Pharmacy Board Contingent Fund).
COMMENTS :
1)PURPOSE OF THIS BILL . According to the author, in response to
the primary care shortage in California coupled with millions
of newly insured individuals entering the health care market
as a result of implementation of the federal Patient
Protection and Affordable Care Act (ACA), SB 493 (Ed
Hernandez), Chapter 469, Statutes of 2013, was enacted. SB
493 gives health care facilities greater flexibility to focus
their pharmacist workforce on providing patient-centered
services as part of a multi-disciplinary team. This is
especially important given that previously uninsured patients
entering the health care system under the ACA will likely
suffer disproportionately from multiple comorbidities and have
low health literacy rates. However, this flexibility is in
conflict with existing regulatory requirements on pharmacists
that have been in place for decades and that have long been
outdated. Removing the burden of simple non-discretionary
activities unrelated to professional judgment of pharmacists,
such as checking expiration dates for drug stock or
repackaging or labeling cleaning agents, will help redirect
pharmacy resources where they are needed most - the patient.
This bill makes more efficient use of pharmacy personnel in
the facility setting expanding the types of non-discretionary
tasks that pharmacy technicians are permitted to perform,
freeing up pharmacists to focus on patient care.
2)BACKGROUND . A pharmacy technician 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 exclude all functions
restricted to a registered pharmacist. The BOP's regulations
related to PTs define "non-discretionary tasks" as removing
the drug or drugs from stock; counting, pouring, or mixing
pharmaceuticals; placing the product into a container;
affixing the label or labels to a container; and, packaging
and repackaging. To work as a PT in California, current
registration is required. The BOP may issue a license to high
school graduates or a person with a general educational
development (GED) certificate equivalent, and has obtained an
associate's degree in pharmacy technology, has completed a
course of training specified by the BOP, has graduated from a
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school of pharmacy recognized by the BOP, or is certified by
the Pharmacy Technician Certification Board. PT applications
are required to include a description of the applicant's
qualifications, along with supporting documentation for those
qualifications and applicants are required to undergo a
criminal background and fingerprint check. PTs must wear
identification clearly identifying themselves as a PT in a
pharmacy and may only perform duties under the direct
supervision of a pharmacist, ensuring that a pharmacist is
fully aware of all activities involved in the preparation and
dispensing of medications, including the maintenance of
appropriate records.
3)SUPPORT . The California Society of Health-System Pharmacists
are the sponsors of the bill and state it will address several
outdated regulations pertaining to hospital pharmacy practice
that have not been updated since the 1960's, and updating the
tasks that can and should be performed by trained pharmacy
technicians frees up hospital-based pharmacists to spend more
time directly working with physicians and nurses to assure the
safest and most effective care of the patient.
The California Hospital Association (CHA) writes that this
bill will permit PTs to do simple nondiscretionary activities
unrelated to professional judgment of pharmacists, such as
checking expiration dates for drug stock or repackaging or
labeling cleaning agents. CHA argues that these
nondiscretionary activities by pharmacists still exist today
because of outdated Title 22 regulations which do not
appropriately address current workforce needs.
The California Pharmacy Technician Association supports this
bill because it will utilize licensed PTs to complete certain
duties currently performed by licensed pharmacists but which
are much more suited to PTs.
4)PREVIOUS LEGISLATION . SB 493 (Ed Hernandez), 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
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pharmacist's responsibilities.
5)DOUBLE REFERRAL . This bill passed out of the Assembly
Business, Professions and Consumer Protection (BP&CP)
Committee on June 17, 2014, with a vote of 14-0.
6)TECHNICAL AMENDMENT . Technical amendments requested by the
BP&CP Committee and adopted on June 18, 2014 clarify a
reference to an APP's ability to order and perform patient
assessments and tests related to routine drug therapy-related
patient assessments. In order to further clarify the
reference, the bill should be amended as follows:
B&P 4052.6
(e) A pharmacist who orders and performs patient assessments
pursuant to paragraph (1) and 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.
REGISTERED SUPPORT / OPPOSITION :
Support
California Society of Health-System Pharmacists (sponsor)
California Pharmacy Technician Association
California Chronic Care Coalition
California Association of Physician Groups
Providence Health & Services Southern California
California Hospital Association
Numerous Individuals
Opposition
None received.
Analysis Prepared by : Lara Flynn / HEALTH / (916) 319-2097