BILL ANALYSIS Ó
SENATE COMMITTEE ON
BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT
Senator Jerry Hill, Chair
2015 - 2016 Regular
Bill No: AB 486 Hearing Date: June 8,
2015
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|Author: |Bonilla |
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|Version: |February 23, 2015 |
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|Urgency: |Yes |Fiscal: |Yes |
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|Consultant|Sarah Mason |
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Subject: Centralized hospital packaging pharmacies: medication
labels.
SUMMARY: Provides that certain information located on a medication's
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.
Existing law:
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)
AB 486 (Bonilla) Page 2
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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.
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.)
AB 486 (Bonilla) Page 3
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5) Requires any unit dose medication produced by a central
hospital packaging pharmacy to 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.
f) The name of the centralized hospital packaging
pharmacy.
6) 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.
b) The established name of the drug.
c) The quantity of the active ingredient.
d) Special storage of handling requirements.
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
AB 486 (Bonilla) Page 4
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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.
1)Provides that for quality control and investigative purposes,
a pharmacist shall be able to retrieve all of the following
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.
1)Makes other technical and conforming changes.
2)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
California State Board of Pharmacy.
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FISCAL
EFFECT: This measure has been keyed "fiscal" by Legislative
Counsel. According to the Assembly Appropriations Committee
analysis, dated May 6, 2015, this bill will result in a
negligible state fiscal effect.
COMMENTS:
1. Purpose. The California Society of Health-System Pharmacists
is the Sponsor of this measure. According to the Author,
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 the Author,
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 Author states that AB 486 makes necessary
changes by allowing data to be both contained within the
barcode and also be available in human readable form, while
also including much needed definitions that will allow the
Board to continue to provide oversight and regulation in this
area.
2. Background. The Board of Pharmacy 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 of Pharmacy 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.
3. Prior Related Legislation. AB 2757 (Bocanegra of 2014) was
identical to this bill. ( Status: The bill was never heard
in a policy Committee of the Senate prior to the close of the
2013-14 Legislative Session.)
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 identical to AB 377 (Solario). The bill was vetoed
by the Governor. In his veto message, the Governor expressed
concern that the bill could 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 bill but
created a separate licensing category for centralized
hospital pharmacies. ( Status: The bill was held in the
Assembly Committee on Business and Professions.)
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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.
4. Arguments in Support. The California Hospital Association
(CHA) writes in support of the bill, stating that it ensures
centralized hospital packaging pharmacies can continue to
operate and serve their member hospitals efficiently,
providing a long-term solution while maintain the original
intent of the law.
SUPPORT AND OPPOSITION:
Support:
California Association of Joint Powers Authorities (CAJPA)
California Hospital Association (CHA)
Opposition:
None on file as of June 2, 2015.
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