BILL ANALYSIS Ó
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|SENATE RULES COMMITTEE | AB 486|
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THIRD READING
Bill No: AB 486
Author: Bonilla (D)
Introduced:2/23/15
Vote: 27 - Urgency
SENATE BUS, PROF. & ECON. DEV. COMMITTEE: 9-0, 6/8/15
AYES: Hill, Bates, Berryhill, Block, Galgiani, Hernandez,
Jackson, Mendoza, Wieckowski
SENATE APPROPRIATIONS COMMITTEE: Senate Rule 28.8
ASSEMBLY FLOOR: 78-0, 5/14/15 (Consent) - See last page for
vote
SUBJECT: Centralized hospital packaging pharmacies:
medication labels
SOURCE: California Society of Health-System Pharmacists
DIGEST: This bill provides that certain information located on
a medications barcode now be displayed on a human readable label
or be retrievable using a lot number or control number.
Requires a medication's barcode be machine readable using a
medication administration software (software) and that the
software cross reference the information contained in the
barcode to the electronic medical record of the patient in order
to verify the correct medication, dosage, and route of
administration for the patient. This is an urgency measure.
ANALYSIS:
Existing law:
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1)Provides for the practice of pharmacy and licensing and
regulation of pharmacies and pharmacists by the Board of
Pharmacy (Board) and within the Department of Consumer Affairs
(DCA).
2)Provides that a centralized hospital packaging pharmacy may
prepare medications, by performing specialized functions, for
administration only to inpatients within its own general acute
care hospital and one or more general acute care hospitals if
the hospitals are under common ownership and located within a
75-mile radius of each other. (Business and Professions Code
(BPC) § 4128)
3)Defines "hospital pharmacy" as a pharmacy licensed by the
Board, located within any licensed hospital, institution, or
establishment that maintains and operates organized facilities
for the diagnosis, care, and treatment of human illnesses to
which persons may be admitted for overnight stay. (BPC §
4029)
4)Provides that "hospital pharmacy" also includes a pharmacy
that may be located outside of the hospital, in another
physical plant that is regulated under a hospital's
consolidated license issued by the California Department of
Corrections and Rehabilitation or California Department of
Youth Authority. Specifies that the pharmacy in another
physical plant shall provide pharmaceutical services only to
registered hospital patients who are on the premises of the
same physical plant in which the hospital is located.
Specifies that the pharmacy services provided shall be
directly related to the services or treatment plan
administered in the physical plant. (Id.)
5)Requires any unit dose medication produced by a central
hospital packaging pharmacy to display a readable barcode at
the inpatients bedside that displays the date the medication
was prepared, the components used in the drug product, the lot
or control number, the expiration date, the National Drug Code
Directory number, the name of the centralized hospital
packaging pharmacy. (BPC § 4128.4)
6)Requires the label for each unit dose medication produced by a
centralized hospital packaging pharmacy to contain the
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expiration date, established name of the drug, quantity of the
active ingredient and special storage or handling requirements
(BPC § 4128.5)
This bill:
1)Defines "barcode medication administration software" as a
computerized system designed to prevent medication errors in
health care settings.
2)Permits a barcode medication administration software to cross
reference a health care practitioner to ensure that, before a
medication is administered to an inpatient, it is the right
medication, for the right patient, in the right dose, and via
the right route of administration.
3)Permits the software to verify that the medication satisfies
these criteria by reading the barcode on the medication and
comparing the information retrieved to the electronic medical
record of the patient.
4)Requires any unit dose medication produced by a central
hospital packaging pharmacy to display a human-readable label.
5)Specifies that the human readable label include:
a) The date that the medication was prepared.
b) The beyond-use date.
c) The established name of the drug.
d) The quantity of the active ingredient.
e) Special storage or handling requirements.
f) The lot number or control number assigned by the
centralized hospital packaging pharmacy.
g) The name of the centralized hospital packaging pharmacy.
6)Provides that for quality control and investigative purposes,
a pharmacist shall be able to retrieve all of the following
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information using the lot number or control number as
described above:
a) The components used in the drug product.
b) The expiration date of each of the drugs components.
c) The National Drug Code Directory number by the lot
number or control number.
7)Makes other technical and conforming changes.
8)Specifies that this is an urgency measure for the purpose of
eliminating, at the earliest possible time, requirements that
exceed the current technological capabilities of hospitals and
that create overly burdensome administrative costs for the
Board.
Background
This bill is intended to make clarifying changes to provisions
in the Pharmacy Law established by AB 377 (Solorio, Chapter 687,
Statutes of 2012). That measure authorized a centralized
hospital pharmacy to perform certain services for patients of a
hospital pharmacy and required that specific data be contained
within barcodes on centrally packaged medication labels.
According to bill proponents, hospital technology development
and procurement has not moved as quickly as anticipated and the
software used by some health systems does not meet the Board's
interpretation of the law.
The Board was a strong proponent of AB 377, as the centralized
hospital recognition makes it easier for hospitals to set up and
invest in high-tech central pharmacies, utilizing the latest in
technological innovations (such as robotics), effectively
lowering rates of medication errors and reducing unnecessary
costs. Language contained in Section 4128.4 of the Business and
Professions Code, specifically the word "retrievable," has
caused confusion and different interpretations between the Board
and hospital chains. The intent of the word "retrievable" by
the bill's Author, was not that the elements be immediately
readable on the label, but instead AB 377 was to link the data
elements on the barcode to a database where the elements would
be present and retrievable.
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Recently, hospitals such as Loma Linda University Medical
Center, Scripps Health San Diego, and Sharp Health Care have
come to the Board and highlighted limitations in their software
that would prohibit full compliance with the barcode
requirements specified in Section 4128.4. According to the
hospitals, hospital IT vendors will have to reconfigure their
systems to make all the elements listed in Section 4128.4
immediately readable upon scan. These medical groups requested
that the Board interpret the meaning of the provisions more
broadly to allow for ample time following licensure to fully
comply with the requirements.
The Board ultimately approved five-year waivers to organizations
which have fallen out of compliance, allowing the requisite
information elements to be physically listed on the label rather
than having them in electronic, barcode format. This bill would
clarify the requirements on labels to allow health systems to
use barcode technology, eliminating the need for Board waivers.
FISCAL EFFECT: Appropriation: No Fiscal
Com.:YesLocal: Yes
SUPPORT: (Verified 6/22/15)
California Society of Health System Pharmacists (source)
California Association of Joint Powers Authorities
California Council for the Advancement of Pharmacy
California Hospital Association
California Pharmacists Association
California State Board of Pharmacy
Providence Health & Services
OPPOSITION: (Verified 6/22/15)
None received
ARGUMENTS IN SUPPORT: Supporters state that this bill clarifies
existing law in a way that ensures centralized hospital
packaging pharmacies have the ability to work with existing
technology and add that it creates an effective system for
barcoding medication while clarifying that this technology can
be used for multiple purposes in order to reduce the rates of
medication errors and improve patient safety.
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ASSEMBLY FLOOR: 78-0, 5/14/15
AYES: Achadjian, Alejo, Travis Allen, Baker, Bigelow, Bloom,
Bonilla, Bonta, Brough, Brown, Burke, Calderon, Campos, Chang,
Chau, Chávez, Chiu, Chu, Cooley, Cooper, Dababneh, Dahle, Daly,
Dodd, Eggman, Frazier, Beth Gaines, Gallagher, Cristina Garcia,
Eduardo Garcia, Gatto, Gipson, Gomez, Gonzalez, Gordon, Gray,
Grove, Hadley, Harper, Roger Hernández, Holden, Irwin, Jones,
Jones-Sawyer, Kim, Lackey, Levine, Lopez, Low, Maienschein,
Mathis, Mayes, McCarty, Melendez, Mullin, Nazarian, Obernolte,
O'Donnell, Olsen, Patterson, Perea, Quirk, Rendon,
Ridley-Thomas, Rodriguez, Salas, Santiago, Steinorth, Mark
Stone, Thurmond, Ting, Wagner, Waldron, Weber, Wilk, Williams,
Wood, Atkins
NO VOTE RECORDED: Linder, Medina
Prepared by:Sarah Mason / B., P. & E.D. / (916) 651-4104
6/23/15 10:23:18
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