BILL ANALYSIS �
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|Hearing Date:August 11, 2014 |Bill No:AB |
| |2757 |
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SENATE COMMITTEE ON BUSINESS, PROFESSIONS
AND ECONOMIC DEVELOPMENT
Senator Ted W. Lieu, Chair
Bill No: AB 2757Author:Bocanegra
As Amended:August 4, 2014 Fiscal: Yes
SUBJECT: Centralized hospital packaging pharmacies: medication
labels.
SUMMARY: Provides that certain information located in 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)
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)
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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.)
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.
1)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
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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.
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.
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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.
FISCAL EFFECT: This bill is keyed fiscal by Legislative Counsel.
COMMENTS:
1.Purpose. The Author is the Sponsor of this measure. According to
the Author, "this bill would permit hospitals to comply with
provisions specified in AB 377 (Solorio, Chapter 687, Statutes of
2012) by allowing the necessary information elements required for a
centralized hospital packaging pharmacy license to be displayed on a
human-readable label (containing the lot number or control number),
rather than the barcode. The Author states that "In order to verify
that the medication to be given is the correct medication, dosage,
and route of administration for that patient, the bill would require
that a medication's barcode be machine readable using software that
compares the information contained in the barcode to the electronic
medical record of the inpatient."
2.Background. The Board of Pharmacy was a strong proponent of AB 377,
as it 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.
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
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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 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 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.)
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.
SUPPORT AND OPPOSITION:
Support:
California Council for the Advancement of Pharmacy
California State Board of Pharmacy
California Hospital Association
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California Society of Health-System Pharmacists
Providence Health & Services, Southern California
Opposition: None received as of August 6, 2014.
Consultant: Mark Mendoza