BILL ANALYSIS Ó
AB 486
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Date of Hearing: April 28, 2015
ASSEMBLY COMMITTEE ON BUSINESS AND PROFESSIONS
Susan Bonilla, Chair
AB 486
(Bonilla) - As Introduced February 23, 2015
NOTE: This bill is double-referred, having been previously
heard by the Assembly Committee on Health on April 21, 2015 and
approved on a 19-0 vote.
NOTE: This bill adds an urgency clause.
SUBJECT: Centralized hospital packaging pharmacies: medication
labels.
SUMMARY: Requires labels on medications produced by centralized
hospital packaging pharmacies (CHPP) to also include specific
information on the label in human readable form.
EXISTING LAW:
1)Provides for the practice of pharmacy and licensing and
regulation of pharmacies and pharmacists by the Board of
Pharmacy (Board) within the Department of Consumer Affairs
(DCA). (Business and Professions Code (BPC) § 4001 et seq.)
2)Provides that a CHPP may prepare medications, by performing
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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 or California Department of Youth Authority. (BPC
§ 4029)
5)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. (BPC § 4029)
6)Specifies that the pharmacy services provided shall be
directly related to the services or treatment plan
administered in the physical plant. (BPC § 4029)
7)Requires any unit dose medication produced by a CHPP to
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display a readable barcode at the inpatients bedside. The
readable barcode will display the following information: (BPC
§ 4128.4)
a) The date the medication was prepared;
b) The components used in the drug product;
c) The lot number or control number;
d) The expiration date;
e) The National Drug Code Directory number; and,
f) The name of the centralized hospital packaging pharmacy.
8)Requires the label for each unit dose medication produced by a
centralized hospital packaging pharmacy contain the following
information: (BPC § 4128.5)
a) The expiration date;
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b) The established name of the drug;
c) The quantity of the active ingredient; and,
d) Special storage or handling requirements.
9)Permits a centralized hospital pharmacy to perform the
following specialized functions:
a) Preparing unit dose packages for single administration
to inpatients from bulk containers;
b) Preparing compounded unit dose drugs for parenteral
therapy administration (e.g. by subcutaneous,
intramuscular, intrasternal or intravenous injection) to
inpatients; and,
c) Preparing compounded unit dose drugs for administration
to inpatients.
10)Requires all specialized compounding and packaging functions
to be performed only in the licensed CHPP, and for the
pharmacy to comply with all applicable federal and state
statutes and regulations. (BPC § 4128.6)
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11)Specifies that the pharmacy and the pharmacists working in
the pharmacy are responsible for the integrity, potency,
quality, and labeled strength of any unit dose drug product
prepared by the pharmacy. (BPC § 4128.7)
THIS BILL:
1)Clarifies that any unit dose medication produced by a
centralized hospital packaging pharmacy be barcoded to be
machine readable at the patient's bedside using barcode
medication administration software.
2)Specifies that barcode medication administration software
permits health care practitioners to ensure, before medication
is administered to an inpatient, that it is the right
medications, for the right patient, in the right dose, and via
the right route of administration.
3)Defines "barcode medication administration software" to mean a
computerized system designed to prevent medication errors in
health care settings.
4)Requires any label for each unit dose medication produced by a
CHPP to display a human-readable label that contains all of
the following:
a) The date that the medication was prepared;
b) The beyond-use date;
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c) The established name of the drug;
d) The quantity of each active ingredient;
e) Special storage or handling requirements;
f) The lot number or control number assigned by the
centralized hospital packaging pharmacy; and,
g) The name of the centralized hospital packaging pharmacy.
5)Requires, for quality control and investigative purposes, a
pharmacist be able to retrieve all of the following
information using the lot number or control number:
a) The components used in the drug product;
b) The expiration date of each of the drug's components;
and,
c) The National Drug Code Directory number.
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6)Clarifies that CHPPs are preparing sterile compounded unit
dose drugs.
FISCAL EFFECT: Unknown. This bill is keyed fiscal by the
Legislative Counsel.
COMMENTS:
1)Purpose. This bill is sponsored by the California Society of
Health System Pharmacists . According to the author, "In 2012,
AB 377 was signed into law. This bill required that
medications produced in [CHPPs] have a barcode which retrieves
specific information, such as medication expiration date and
lot number, which can be read when the barcode is scanned at
the patient's bedside. There is also a requirement that
patient information be scanned by barcode as well. In an
effort to assist hospitals that do not have the technology
infrastructure to provide certain patient information via
barcode, the Board of Pharmacy has created a waiver that
allows information to be listed in text form on the label.
These waivers are only for a five year term. AB 486 creates a
long-term solution while maintaining the intent of current
law."
2)Background. Business and Professions Code § 4128.4 allows
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.
The term "retrievable" within BPC § 4128.4 has caused
confusion and different interpretations between the Board of
Pharmacy and hospital chains. The intent of the word
"retrievable" was not that the elements be immediately
readable on the label, but instead that the data elements on
the barcode be able to be linked to a database where the
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elements would be retrievable.
Several hospitals approached the Board of Pharmacy and
highlighted limitations in their software that would prohibit
full compliance with the barcode requirements. According to
the hospitals, hospital information technology vendors will
have to reconfigure their systems to make all the elements
listed in BPC § 4128.4 immediately readable upon scan. These
medical groups requested that the Board of Pharmacy interpret
the meaning of the provisions more broadly to allow for ample
time following licensure to fully comply with the
requirements.
The Board of Pharmacy ultimately approved five-year waivers to
organizations who 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.
3)Prior Related Legislation. AB 2757 (Bocanegra) of 2014, was
substantially similar to this bill. NOTE: The bill passed the
Senate Committee on Business, Professions and Economic
Development but was not heard in any policy or fiscal
committee in the Assembly.
AB 377 (Solario), Chapter 687, Statutes of 2012, authorized a
centralized hospital packaging pharmacy to prepare
medications, by performing specified functions for
administration only to inpatients within its own general acute
care hospital, or one or more general acute care hospitals
under the same ownership and located within 75 miles of each
other.
AB 2077 (Solario) of 2010, in its final version, was virtually
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identical to AB 377 (Solario). NOTE: This bill was vetoed by
Governor Schwarzenegger due to concern that the bill would
result in, "a greater likelihood of product mix-up, loss of
product identity, contamination and cross-contamination, and
lack of adequate control systems."
AB 1370 (Solario) of 2009, was similar to AB 377, but created
a separate licensing category for centralized hospital
pharmacies. NOTE: The bill was held in the Assembly
Committee on Business and Professions and Consumer Protection.
SCR 49 (Speier), Chapter 123, Statutes of 2005, created a
panel to study the causes of medication errors and recommend
changes in the health care system that reduces errors
associated with the delivery of prescription and over the
counter medication to consumers.
SB 1875 (Speier), Chapter 816, Statutes of 2000, required
hospitals to adopt a formal plan to eliminate or substantially
reduce medication-related errors.
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ARGUMENTS IN SUPPORT:
The California Association of Health-System Pharmacists
(sponsor) support the bill and write in their letter, "AB 486
amends [BPC] section 4128 to be less proscriptive than the
original law - replacing the word "retrievable" with more
clarifying language about barcode medication administration
software capabilities and giving centralized hospital packaging
pharmacies the flexibility to work with existing technology and
adapt to new technology as it becomes available. AB 486 also
clarifies that this technology can be used for multiple purposed
and at multiple locations within the hospital, improving patient
safety."
The California Hospital Association echoes the expressed support
for the bill and they write in their letter, "AB 486 provides a
long-term solution while maintaining the original intent of the
law."
The California Pharmacists Association writes, "AB 486 creates
and effective system for bar-coding medications while clarifying
that this technology can be used for multiple purposes within a
hospital in order to reduce the rates of medication errors and
improve patient safety."
Providence Health & Services of Southern California writes in
their letter, "Providence appreciates this reasonable solution
to assure that centralized hospital packaging pharmacies can
continue to operate as intended and have essential elements for
patient safety readily available."
The California Association of Joint Powers Authorities supports
the bill and writes, "Many public acute care hospitals in
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California participate in public entity risk pools. CAJPA
believes that AB 486 provides clarity to existing law and
provides centralized hospital packaging pharmacies the
flexibility to work with existing technology and adapt to new
technology as it becomes available."
The California Council for the Advancement of Pharmacy supports
the bill, "?because its long-term care pharmacy members have
experienced similar challenges with the California State Board
of Pharmacy's regulations regarding patient-centered labeling,
where by exemptions from the regulation must be sought on an
individual basis...AB [486] would remedy the onerous task of
requesting waivers while still maintaining the security of a
hospital patient's information and providing more efficient,
safe and effective patient care."
ARGUMENTS IN OPPOSITION:
None on file.
REGISTERED SUPPORT:
California Society of Health-System Pharmacists (sponsor)
California Association of Joint Powers Authorities
California Association of Physician Groups
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California Council for the Advancement of Pharmacy
California Hospital Association
California Pharmacists Association
Providence Health & Services Southern California
REGISTERED OPPOSITION:
None on file.
Analysis Prepared by:Le Ondra Clark Harvey, Ph.D. / B. & P. /
(916) 319-3301
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