BILL ANALYSIS �
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|Hearing Date:April 21, 2014 |Bill No:SB |
| |1039 |
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SENATE COMMITTEE ON BUSINESS, PROFESSIONS
AND ECONOMIC DEVELOPMENT
Senator Ted W. Lieu, Chair
Bill No: SB 1039Author:Hernandez
As Amended: April 10, 2014 Fiscal: Yes
SUBJECT: Pharmacies: furnishing drugs.
SUMMARY: Makes changes to the authorized tasks of a pharmacy
technician (PT) under the direct supervision or control of a
pharmacist by authorizing a PT to assist with emergency supply
packaging for hospitals and stock, replenish and inspect a hospital's
emergency pharmaceutical supplies container.
Existing law, the Business and Professions Code (BPC):
1)Establishes the Pharmacy Law which provides for the licensure and
regulation of pharmacies, pharmacists and wholesalers of dangerous
drugs or devices by the Board of Pharmacy (Board) within the
Department of Consumer Affairs (DCA).
2) 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)
3) Requires the Board to adopt regulations to specify tasks that a PT
may perform under the supervision of a pharmacist. Provides that
any pharmacy that employs a PT shall do so in conformity with the
regulations adopted by the board. Provides that no person shall
act as a PT without first being licensed by the Board as a PT.
(Id.)
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4) Provides that a pharmacy with only one pharmacist shall 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 in all practice settings except for: (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.
Provides that the pharmacist on duty shall be directly responsible
for the conduct of a PT supervised by that pharmacist. (Id.)
5) 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)
6) Prohibits anyone other than a pharmacist, an intern pharmacist, a
pharmacy technician, 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 dangerous devices are stored, possessed, prepared,
manufactured, derived, compounded, dispensed, or repackaged. (BPC
� 4117)
7) Defines "intern pharmacist" as a person licensed by the Board 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
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school of pharmacy. (BPC � 4033)
8) Permits pharmacists to perform the following procedures under
physician protocols in licensed health care facilities: (BPC
�4052.1)
a) Order and perform routine drug therapy-related patient
assessment procedures.
b) Order drug therapy-related laboratory tests.
c) Administer drugs and biologicals by injection pursuant to a
prescriber's order.
d) Initiate or adjust a patient's drug regimen pursuant to
authorization or order by the patient's prescriber.
9)Permits pharmacists in a number of specified settings to do the
following: (BPC � 4052.2)
a) Order and perform routine drug therapy-related patient
assessment procedures.
b) Order drug therapy-related laboratory tests.
c) Administer drugs and biologicals by injection pursuant to a
prescriber's order.
d) Initiate or adjust a patient's drug regimen pursuant to
authorization or order by the patient's treating prescriber.
Prohibits the substitution or selection of a different drug
unless authorized by protocol and requires prescriber
notification of initiated drug regimens to be transmitted within
24 hours.
e) Specifies that a patient's treating prescriber may prohibit
pharmacists from making any changes or adjustments to patients'
drug regimens.
f) Requires the governing policies, procedures and protocols to
be developed by specified health professionals and established
minimum requirements for those policies, procedures and
protocols.
g) Requires pharmacists performing procedures authorized by this
section to have successfully completed clinical residency
training or demonstrated clinical experience in direct patient
care delivery.
10)Authorizes an advanced practice pharmacist (APP) recognized by the
Board to do all of the following: (BPC � 4052.6)
a) Perform patient assessments.
b) Order and interpret drug-therapy related tests, ensuring
that the ordering of those tests is done in coordination with
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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.
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) Provides that an APP who adjusts or discontinues drug therapy shall
promptly transmit written notification to the patient's diagnosing
prescriber or enter the appropriate information into a patient
record system shared with the prescriber. Provides that an APP who
initiates drug therapy shall promptly transmit written notification
or enter the appropriate information into a patient record system
shared with the patient's primary care provider or diagnosing
provider. (Id.)
2) Requires an APP to register with the DEA prior to initiating or
adjusting a controlled substance. (Id.)
Existing law, the Health and Safety Code (HSC):
1)Establishes the California Uniform Controlled Substances Act
(Controlled Substances Act) which regulates controlled substances.
(HSC �� 11000-11651)
2)Specifies that no person other than the following shall write or
issue a prescription for a controlled substance: (HSC � 11150)
a) a physician,
b) dentist,
c) podiatrist,
d) veterinarian,
e) naturopathic doctor,
f) pharmacist in a number of settings as outlined above or acting
within the scope of a health workforce pilot project authorized
by the Office of Statewide Health Planning and Development
(OSHPD),
g) a registered nurse acting within the scope of a health
workforce pilot project authorized by OSHPD,
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h) 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 and occurs
under physician and surgeon supervision and is in accordance with
standardized procedures or protocols as specified,
i) a nurse practitioner, if it is consistent with a nurse
practitioner's educational preparation or for which clinical
competency has been established and maintained and occurs under
physician and surgeon supervision and is in accordance with
standardized procedures or protocols as specified,
j) a physician assistant acting within the scope of a health
workforce pilot project authorized by OSHPD or while under the
supervision of a physician and surgeon, under specified
conditions and protocols adopted by the supervising physician and
surgeon,
aa) a naturopathic doctor in accordance with standardized
procedures or protocols developed by the naturopathic doctors and
his or her supervising physician and surgeon,
bb) an optometrist according to certain requirements,
cc) 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.
3) Authorizes the above 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,
provided that it is prescribed or furnished or administered 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. (HSC � 11210)
This bill:
1) Adds emergency supply packaging and sealing in or for hospitals and
hospital unit inspections to the types of physical, manipulative,
repetitive, or other nondiscretionary tasks a PT may assist with,
while under the direct supervision and control of a pharmacist.
2) Authorizes 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 the hospital's policies and procedures and
provides that a PT or intern pharmacist under the direct
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supervision of a pharmacist may stock, replenish, and inspect the
hospital's emergency pharmaceutical supplies container.
3) Requires both 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 and provides that controlled
substances must be furnished to the hospital's emergency medical
services according to requirements set forth in the California
Uniform Controlled Substances Act (Division 10 (commencing with
Section 11000) of the Health and Safety Code).
4) Authorizes 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 the hospital 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.
5) Requires a pharmacist, PT, or an intern pharmacist under the direct
supervision 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. Requires any irregularities to be reported to the
director or chief executive officer of the hospital. Requires the
hospital to adopt policies and procedures regarding the
responsibility for assuring proper methods for 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.
6) Adds an APP to the list of those authorized to prescribe controlled
substances as outlined above.
FISCAL EFFECT: Unknown. This bill is keyed "fiscal" by Legislative
Counsel.
COMMENTS:
1. Purpose. This bill is sponsored by the California Society of
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Health System Pharmacists (CSHSP). According to the Author, "this
bill makes more efficient use of pharmacy personnel in the facility
setting expanding the types of nondiscretionary tasks that PTs are
permitted to perform, freeing up pharmacists to focus on patient
care."
According to the Author, his Senate Bill 493 (Hernandez, Chapter
469, Statutes of 2013) gives health care facilities greater
flexibility to focus their pharmacist workforce on providing
patient-centered services as part of a multi-disciplinary team.
The Author states that "this is especially important given that
previously uninsured patients entering the health care system under
the Affordable Care Act (ACA) will likely suffer disproportionately
from multiple comorbidities and have low health literacy rates.
The Author further states that this flexibility is in conflict with
existing regulatory requirements on pharmacists that have been in
place for decades and that have long been outdated. The Author
believes that removing the burden of simple nondiscretionary
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.
2. Background.
a) Pharmacy Technicians. The law creating the registration for
PTs was enacted in 1991 (AB 1244, Polanco, Chapter 841), in part
to free up pharmacists to perform additional duties that they had
been trained for and in some cases were being required to perform
(e.g., patient counseling). The rationale for AB 1244 was that
having a PT perform non-discretionary duties that do not require
a pharmacist's professional training or judgment would enable the
pharmacist to provide more services to a larger number of
patients. The Board's regulations (Title 16, Division 17,
Article 11, Section 1793.2) define "nondiscretionary 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.
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
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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.
b) The Patient Protection and Affordable Care Act. On March 23,
2010, President Obama signed the Patient Protection and
Affordable Care Act (ACA) into federal statute. The ACA, which
states will begin implementing in 2014, represents one of the
most significant expansions and overhauls of the United States
health care system since the passage of Medicare and Medicaid in
1965. The ACA is aimed at increasing the rate of health
insurance coverage for Americans and reducing the overall costs
of health care. It provides a number of mechanisms including
mandates, subsidies and tax credits to employers and individuals
in order to increase the rate of people with coverage. As a
result of implementation of the ACA, anywhere from 4-7 million
additional Californians will be eligible for health insurance
beginning in 2014. It is anticipated that the newly insured will
increase demand for health care on an already strained system.
c) Primary Care Workforce Shortage. A number of recent studies
and reports have highlighted a shortage in California of primary
care physicians. According to a report commissioned by the
California Health Care Foundation, Fewer and More Specialized: A
New Assessment of Physician Supply in California, the number of
primary care physicians actively practicing in California is at
the very bottom range of, or below, the state's need. The report
found that the distribution of these physicians is also poor and
that rural counties in particular suffer from low physician
practice rates and a shortage of primary care physicians.
According to the report, in 2008, there were 69,460 actively
practicing physicians in California (a figure which includes
Doctors of Medicine and Doctors of Osteopathic Medicine), but
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, which provides an ongoing assessment
of physician workforce trends, training issues and financing
policies, and recommends appropriate federal and private sector
efforts on these issues, 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. Less than one
third of Californians live in a community where they have access
to the health care services they need.
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d) SB 493. With the passage of SB 493 (Hernandez, Chapter 469,
Statutes of 2013), pharmacists are now authorized to perform
additional functions, according to specified requirements,
including: administering physician prescribed injectable
medications; furnishing immunizations for people ages three and
up if the pharmacist has completed training and follows specified
procedures; furnish self-administered hormonal contraceptives,
based on a state protocol developed jointly by the Board of
Pharmacy (Board) and Medical Board of California (MBC),pursuant
to guidelines of the Centers for Disease Control (CDC); furnish
nicotine replacement products in accordance with a state
treatment protocol developed jointly by the Board and MBC and;
furnish travel medications recommended by the CDC for individuals
traveling outside of the United States. SB 493 also established
"advanced practice pharmacist" recognition, allowing such
pharmacists to write or issue a prescription in certain settings;
perform patient assessments; order and interpret drug
therapy-related tests; refer patients to other providers;
initiate, adjust and discontinue drug therapy in specific
circumstances, providing notification to the diagnosing
prescriber; and participate in the evaluation and management of
diseases and health conditions in collaboration with other
providers.
1. Prior Related Legislation. SB 493 (Hernandez, Chapter 469,
Statutes of 2013) updated Pharmacy Law to authorize pharmacists to
perform certain functions according to specified requirements and
established advanced practice pharmacist (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.
AB 1244 (Polanco, Chapter 841, Statutes of 1991) provided for
registration of PTs by the Board.
2. Arguments in Support. Supporters like the California Hospital
Association (CHA) , California Society of Health System Pharmacists
(CSHSP) , California Pharmacy Technician Association (CPTA) ,
Providence Health & Services, Southern California and multiple
individuals believe this bill will maximize the efficiency of
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hospital resources by allowing licensed, trained pharmacy
technicians perform more routine and administrative functions which
do not require a pharmacist's professional judgment, so that the
pharmacists are able to focus their time and expertise delivering
direct patient care. Supporters also cite the severely outdated
Title 22 regulations governing hospital pharmacy practice that do
not recognize the evolution of the pharmacy practice. CSHSP states
that the work of each pharmacy technician is checked and documented
by a pharmacist before any medication prepared by a technician is
available for patient care and notes that the pharmacy technician
workforce is fully licensed and regulated. Supporters also note
that the modest changes in this bill to the authorized functions of
pharmacy technicians allow pharmacists to focus their energies on
patients, resulting in a better, smarter and more efficient system.
3. Arguments in Opposition. The California Medical Association (CMA)
has an "oppose unless amended" position on this measure. CMA
believes that this bill will expand the scope of practice of
pharmacists to include prescribing prescription medications. CMA
notes that while SB 493 expanded the role of a pharmacist and
established APP designation, it did not provide pharmacists the
ability to prescribe. CMA believes that amendments in this bill to
the Controlled Substances Act would allow pharmacists to write
prescriptions.
NOTE : Double-referral to Health Committee (second).
SUPPORT AND OPPOSITION:
Support:
California Society of Health System Pharmacies (Sponsor)
California Hospital Association
California Narcotic Officers Association
California Pharmacy Technician Association
Providence Health & Services, Southern California
A number of individuals
Opposition:
California Medical Association
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Consultant:Sarah Mason