BILL ANALYSIS �
SENATE COMMITTEE ON HEALTH
Senator Ed Hernandez, O.D., Chair
BILL NO: SB 1039
AUTHOR: Hernandez
AMENDED: April 10, 2014
HEARING DATE: April 30, 2014
CONSULTANT: Moreno
SUBJECT : Pharmacies: furnishing drugs.
SUMMARY : Makes a number of changes to the tasks that a pharmacy
technician is authorized to perform, under the direct
supervision or control of a pharmacist, including permitting
them to assist with emergency supply packaging for hospitals,
and stock, replenish and inspect a hospital's emergency
pharmaceutical supplies container. Adds an advance practice
pharmacist to the list of those authorized to prescribe
controlled substances under existing law.
Existing law:
1.Permits a pharmacy technician (PT) 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 to 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.
3.Defines "intern pharmacist" as a person licensed by the Board
of Pharmacy for a period of one to six years if he or she is
enrolled in a school of pharmacy recognized by the Board, two
years if he or she is a graduate of a school of pharmacy
recognized by the Board 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 advanced practice pharmacist (APP) recognized by
the Board to:
Continued---
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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.
1.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 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); a
registered nurse acting within the scope of a health workforce
pilot project authorized by OSHPD; a certified nurse-midwife,
if furnished or ordered incidentally to the provision of
family planning services, routine health care or perinatal
care, or care rendered consistent with the certified
nurse-midwife's practice, as specified; a nurse practitioner,
as specified; a physician assistant, as specified; an
optometrist, as specified; and, an out-of-state prescriber in
emergency situations, if his or her licensing classification
is same as a license in California that would permit
prescribing of drugs or devices.
This bill:
1.Clarifies that PTs, in performing packaging, may perform
emergency supply packaging and sealing in or for hospitals,
hospital unit inspections, and other physical tasks, only
while assisting and under the direct supervision and control
of a pharmacist.
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2.Permits a pharmacy to furnish a dangerous drug or dangerous
device to the emergency medical services system of a licensed
general acute care hospital for storage in a secured emergency
pharmaceutical supplies container maintained within the
hospital in accordance with its policies and procedures.
Permits 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.
3.Requires the hospital and the dispensing pharmacy to 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.
4.Requires controlled substances to be furnished to the
hospital's emergency medical services system under this
section in accordance with the Controlled Substances Act.
5.Permits a pharmacy to furnish a dangerous drug or dangerous
device to a hospital 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 drug or 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.
6.Requires the hospital to 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.
7.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 inspections. Requires the person conducting
the inspection to 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.
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8.Requires the hospital to adopt policies and procedures
regarding the responsibility for ensuring proper methods for
repackaging and labeling of bulk cleaning agents, solvents,
chemicals, and non-drug hazardous substances used throughout
the hospital according to state and federal law and standards.
9.Adds an APP to the list of those authorized to prescribe
controlled substances under the Controlled Substances Act.
FISCAL EFFECT : This bill has not been analyzed by a fiscal
committee.
COMMENTS :
1.Author's statement. 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 Affordable Care Act
(ACA), SB 493 (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.The ACA. On March 23, 2010, President Obama signed the ACA
into law (Public Law 111-148), as amended by the Health Care
and Education Reconciliation Act of 2010 (Public Law 111-152).
The ACA greatly expands health insurance coverage in
California. Beginning in 2014, millions of low- and
middle-income Californians began gaining access to coverage
under the expansion of Medi-Cal, and through premium and
cost-sharing subsidies offered through the California Health
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Benefit Exchange (known as Covered California). As a result of
the coverage expansions under the ACA, between 89 and 91
percent of non-elderly Californians are predicted to have
health coverage, and the number of uninsured is projected to
decrease by between 1.8 and 2.7 million by 2019. The newly
insured will increase demand for health care on an already
strained system. Furthermore, the ACA aims to change how care
is delivered. It will provide incentives for expanded and
improved primary care, which may affect demand for some health
care professionals more than others, and create team-based
models of service delivery. Research indicates that health
care reform will place higher skill demands on all members of
the health care workforce as systems try to improve quality
while limiting costs. The scale of change with health care
reform is unlike anything that the state has previously faced.
Many newly insured Californians will have a pent-up demand
for services and will create even more pressure on the already
strained health care system, particularly in medically
underserved areas.
3.Primary Care Physician Workforce Shortage. According to a
report commissioned by the California Health Care Foundation,
the number of primary care physicians actively practicing in
California is at or below the very bottom range of the state's
need based on Council on Graduate Medical Education estimates.
The distribution of these physicians is also poor. In 2008,
there were 69,460 actively practicing physicians in California
(this includes Doctors of Medicine and Doctors of Osteopathic
Medicine), and only 35 percent of these physicians reported
practicing primary care. This equates to 63 active primary
care physicians in patient care per 100,000 persons.
According to the Council on Graduate Medical Education, a
range of 60 to 80 primary care physicians are needed per
100,000 in order to adequately meet the needs of the
population. When the same metric is applied regionally, only
16 of California's 58 counties fall within the needed supply
range for primary care physicians. In other words, less than
one-third of Californians live in a community where they have
access to the health care services they need.
4.Pharmacy Technicians. According to the Board of Pharmacy, 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
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excludes all functions restricted to a registered pharmacist.
The Board'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 Board
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 Board, has graduated from a school of pharmacy recognized
by the Board, 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.
5.Double referral. This bill was heard in the Senate Business,
Professions, and Economic Development Committee on April 21,
2014, and passed by a vote of 9-0.
6.Prior legislation. SB 493 expands the scope of practice of a
pharmacist to recognize an APP; permits pharmacists to furnish
certain hormonal contraceptives, nicotine replacement
products, and prescription medications for travel, as
specified; and authorizes pharmacists to independently
initiate and administer certain vaccines and treatments for
severe allergic reactions.
7.Support. The California Society of Health-System Pharmacists
states that this bill addresses several outdated regulations
that have not been updated since the 1960s, and will free 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 and Providence Health & Services, Southern
California writes that unnecessary use of health care
personnel, such as those non-discretionary activities
pharmacists are required to do now, drive inefficiencies and
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high costs, which is contrary to ensuring continued
achievement of meeting the goals of the ACA to improve quality
and limit costs. The California Pharmacy Technician
Association states that when utilized appropriately in
accordance with existing law, PTs increase the efficiency of
the healthcare system by allowing pharmacists to focus their
time and expertise on delivering direct patient care services.
8.Author's amendments. The author request that the Committee
approve amendments to move language currently contained in
Business and Profession Code 4119.7 (d) to an appropriate
Health and Safety Code section and add language that states
that any regulations promulgated by the Board of Pharmacy that
are inconsistent with this bill are void and not enforceable.
SUPPORT AND OPPOSITION :
Support: California Chronic Care Coalition
California Hospital Association
California Pharmacy Technician Association
California Society of Health-System Pharmacists
Providence Health and Services, Southern California
48 individuals
Oppose: None received.
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