BILL ANALYSIS Ó
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|SENATE RULES COMMITTEE | SB 1039|
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UNFINISHED BUSINESS
Bill No: SB 1039
Author: Hernandez (D)
Amended: 8/4/14
Vote: 21
SENATE BUSINESS, PROF. & ECON. DEVELOP. COMM. : 9-0, 4/21/14
AYES: Lieu, Wyland, Berryhill, Block, Corbett, Galgiani,
Hernandez, Hill, Padilla
SENATE HEALTH COMMITTEE : 7-0, 4/30/14
AYES: Hernandez, Morrell, De León, DeSaulnier, Evans, Monning,
Wolk
NO VOTE RECORDED: Beall, Nielsen
SENATE APPROPRIATIONS COMMITTEE : 7-0, 5/19/14
AYES: De León, Walters, Gaines, Hill, Lara, Padilla, Steinberg
SENATE FLOOR : 32-0, 5/23/14 (Consent)
AYES: Anderson, Beall, Block, Cannella, Corbett, Correa, De
León, DeSaulnier, Gaines, Galgiani, Hancock, Hernandez, Hill,
Huff, Jackson, Knight, Lara, Leno, Lieu, Liu, Mitchell,
Monning, Morrell, Nielsen, Padilla, Pavley, Roth, Steinberg,
Torres, Vidak, Walters, Wolk
NO VOTE RECORDED: Berryhill, Calderon, Evans, Fuller, Hueso,
Wright, Wyland, Yee
ASSEMBLY FLOOR : 78-0, 8/14/14 (Consent) - See last page for
vote
SUBJECT : Pharmacy
CONTINUED
SB 1039
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SOURCE : California Association of Physician Groups
California Society of Health-System Pharmacists
DIGEST : This bill makes changes to the authorized tasks of a
pharmacy technician (PT) under the direct supervision or control
of a pharmacist; and authorizes intern pharmacists to perform
specified tasks.
Assembly Amendments delete the provision authorizing a
pharmacist to order patient assessments.
ANALYSIS :
Existing law, the Business and Professions Code:
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.
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 PT 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.
3. Requires the Board to adopt regulations to specify tasks
that a PT may perform under the supervision of a pharmacist.
Requires any pharmacy that employs a PT to 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.
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 as specified.
5. Prohibits anyone other than a pharmacist, an intern
pharmacist, an authorized officer of the law, or a person
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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. 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.
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.
7. Defines "intern pharmacist" as a person licensed by the
Board for a period of one to six years if he/she is enrolled
in a school of pharmacy recognized by the Board, two years if
he/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/she is a foreign graduate, or one year if
he/she has failed the pharmacist license exam four times and
has remained enrolled in a school of pharmacy.
8. Permits pharmacists in a number of specified settings to (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; and (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
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of initiated drug regimens to be transmitted within 24
hours). Specifies that a patient's treating prescriber may
prohibit pharmacists from making any changes or adjustments
to patients' drug regimens.
9. Authorizes an advanced practice pharmacist (APP) recognized
by the Board to (a) perform patient assessments; (b) order
and interpret drug-therapy related tests, as specified; (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 existing law
for pharmacists to perform certain procedures in a licensed
health care facility.
10.Requires an APP who adjusts or discontinues drug therapy to
promptly transmit written notification to the patient's
diagnosing prescriber or enter the appropriate information
into a patient record system shared with the prescriber.
Requires an APP who initiates drug therapy to 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.
11.Requires an APP to register with the Drug Enforcement
Administration prior to initiating or adjusting a controlled
substance.
Existing law, the Health and Safety Code:
1.Establishes the California Uniform Controlled Substances Act
(Controlled Substances Act) which regulates controlled
substances.
2.Specifies that no person other than the following shall write
or issue a prescription for a controlled substance:
A physician, dentist, podiatrist, veterinarian, or
naturopathic doctor; or
A pharmacist in specified settings or acting within the
scope of a health workforce pilot project authorized by the
Office of Statewide Health Planning and Development;
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A registered nurse acting within the scope of a health
workforce pilot project authorized by the Office of
Statewide Health Planning and Development;
A certified nurse-midwife, as specified.
A nurse practitioner, as specified;
A physician assistant, as specified;
An optometrist according to certain requirements; or
An out-of-state prescriber in emergency situations, if
his/her licensing classification is same as a license in
California that would permit prescribing of drugs or
devices.
1.Authorizes the above to prescribe for, furnish to, or
administer controlled substances to his/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/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.
2.Provides for the licensure and inspection of health
facilities, including general acute care hospitals by the
Department of Public Health. Existing regulations require a
hospital to have a pharmacy on the premises or a pharmacy
license, as specified, and to consult the pharmacist on proper
methods of, among other things, repackaging and labeling bulk
cleaning agents. Defines a licensed general acute care
hospital as a health facility having a duly constituted
governing body, as specified, and an organized medical staff
providing 24-hour inpatient care, including medical, nursing,
surgical, anesthesia, laboratory, radiology, pharmacy, and
dietary services.
This bill:
1.Provides that a pharmacist is responsible for the duties
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performed under his/her supervision by a PT. Specifies that,
in a licensed health care facility, as defined, a PT's duties
may include:
A. Packaging emergency supplies for use in the health care
facility and hospital's emergency medical system or as
authorized;
B. Sealing emergency containers for use in the health care
facility; and
C. Performing monthly checks of drug supplies stored
throughout the health care facility. Irregularities must
be reported within 24 hours to the pharmacist in charge and
the director or chief executive officer of the health care
facility, as specified.
2.Provides that an intern pharmacist under the direct
supervision of a pharmacist may stock, replenish, and inspect
the emergency pharmaceutical supplies container and the
emergency medical system supplies of a licensed health care
facility, as defined.
3.Permits a hospital pharmacy serving a licensed health care
facility to furnish dangerous drugs/devices to inpatients or
patients upon discharge pursuant to preprinted or electronic
standing orders, order sets, and protocols established under
the policies and procedures of the health care facility, as
approved according to the policies of the health care
facility's governing body, if the order is dated, timed, and
authenticated in the medical record of the patient to whom the
dangerous drug/device will be provided.
4.Requires a health care facility, as defined, to store and
maintain drugs in accordance with national standards regarding
the storage are and refrigerator or freezer temperature, and
otherwise pursuant to manufacturer's guidelines. Requires the
health care facility's policies and procedures to specify
these storage parameters.
5.Permits an intern pharmacist under the direct supervision of a
pharmacist to inspect the drugs maintained in the health care
facility at least once per month. Requires the health care
facility to establish specific written policies and procedures
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for these inspections.
6.Requires a licensed general acute care hospital, as defined,
or an acute psychiatric hospital, as defined, to adopt
policies and procedures regarding the responsibility for
ensuring proper methods of repackaging and labeling of bulk
cleaning agents, solvents, chemicals, and nondrug hazardous
substances used throughout the hospital. Specifies that the
hospital is not required to consult a pharmacist regarding the
repackaging and labeling of these substances, except for areas
where sterile compounding is performed.
Background
PTs . 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 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 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.
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
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up if the pharmacist has completed training and follows
specified procedures; furnishing self-administered hormonal
contraceptives, based on a state protocol developed jointly by
the Board of Pharmacy and Medical Board of California (MBC),
pursuant to guidelines of the Centers for Disease Control;
furnishing nicotine replacement products in accordance with a
state treatment protocol developed jointly by the Board and MBC;
and furnishing travel medications recommended by the Centers for
Disease Control for individuals traveling outside of the United
States.
Comments
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, SB 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 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.
FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes
Local: Yes
According to the Assembly Appropriations Committee, potential
oversight and enforcement cost to the Board, not likely to
exceed $100,000 per year (Pharmacy Board Contingent Fund).
SUPPORT : (Verified 8/15/14)
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California Association of Physician Groups (co-source)
California Society of Health-System Pharmacists (co-source)
California Chrome Care Coalition
California Hospital Association
California Narcotic Officers Association
California Pharmacy Technician Association
Providence Health & Services, Southern California
ARGUMENTS IN 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 high costs, which is contrary to ensuring
continued achievement of meeting the goals of the Affordable
Care Act to improve quality and limit costs.
ASSEMBLY FLOOR : 78-0, 8/14/14
AYES: Achadjian, Alejo, Allen, Ammiano, Bigelow, Bloom,
Bocanegra, Bonilla, Bonta, Bradford, Brown, Buchanan, Ian
Calderon, Campos, Chau, Chávez, Chesbro, Conway, Cooley,
Dababneh, Dahle, Daly, Dickinson, Donnelly, Eggman, Fong, Fox,
Frazier, Beth Gaines, Garcia, Gatto, Gomez, Gonzalez, Gordon,
Gorell, Gray, Grove, Hagman, Hall, Harkey, Holden, Jones,
Jones-Sawyer, Levine, Linder, Logue, Lowenthal, Maienschein,
Mansoor, Medina, Melendez, Mullin, Muratsuchi, Nazarian,
Nestande, Olsen, Pan, Patterson, Perea, John A. Pérez, V.
Manuel Pérez, Quirk, Quirk-Silva, Rendon, Ridley-Thomas,
Rodriguez, Salas, Skinner, Stone, Ting, Wagner, Waldron,
Weber, Wieckowski, Wilk, Williams, Yamada, Atkins
NO VOTE RECORDED: Roger Hernández, Vacancy
MW:nl 8/15/14 Senate Floor Analyses
SUPPORT/OPPOSITION: SEE ABOVE
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