BILL ANALYSIS Ó
AB 486
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Date of Hearing: April 21, 2015
ASSEMBLY COMMITTEE ON HEALTH
Rob Bonta, Chair
AB 486
(Bonilla) - As Introduced February 23, 2015
SUBJECT: Centralized hospital packaging pharmacies: medication
labels.
SUMMARY: Clarifies existing law regarding medication labeling
requirements for centralized hospital packaging pharmacies by
requiring any label for each unit dose medication produced by a
centralized hospital packaging pharmacy to include certain
information on a human-readable label. Contains an urgency
clause to ensure that the provisions of this bill go into
immediate effect upon enactment. Specifically, 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 medications administration software
permits health care practitioners to ensure, before medication
is administered to a patient, that it is the right
medications, for the right patient, in the right dose, and via
the right route of administration.
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3)Requires any label for each unit dose medication produced by a
centralized hospital packaging pharmacy 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;
c) The quantity of each active ingredient;
d) Special storage or handling requirements;
e) The lot number or control number assigned by the
centralized hospital packaging pharmacy; and,
f) The name of the centralized hospital packaging pharmacy.
4)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,
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c) The National Drug Code Directory number.
5)Clarifies that centralized hospital packaging pharmacies are
preparing sterile compounded unit dose drugs.
EXISTING LAW:
1)Provides for the practice of pharmacy and the licensing and
regulation of pharmacies and pharmacists by the Board of
Pharmacy (Board) within the Department of Consumer Affairs.
2)Allows that a hospital pharmacy license to include a
centralized hospital pharmacy physically located outside of
the hospital or at a separate facility that is located within
a 75-mile radius and is under common ownership.
3)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
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to inpatients.
4)Specifies that a centralized hospital pharmacy may perform the
functions in 3) above only if the following information is
barcoded to be readable at the patient's bedside and the
following information is retrievable: the date the medication
was prepared, the components used in the drug product, the lot
number or control number; the expiration date; the National
Drug Code Directory number; and, the name of the centralized
hospital packaging pharmacy.
5)Requires the label for each unit dose medication produced by a
centralized hospital packaging pharmacy to contain the
expiration date, the established name of the drug, the
quantity of the active ingredient, and any special storage or
handling requirements.
6)Requires all specialized compounding and packaging functions
to be performed only in the licensed centralized hospital
packaging pharmacy, and for the pharmacy to comply with all
applicable federal and state statutes and regulations.
7)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.
FISCAL EFFECT: This bill has not been analyzed by a fiscal
committee.
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COMMENTS:
1)PURPOSE OF THIS BILL. According to the author, this bill is a
clean-up measure to AB 377 (Solorio), Chapter 687, Statutes of
2012, which requires specific data to be contained within
barcodes on medicine labels for use within centralized
hospital packaging pharmacies. The author states that the
goal of AB 377 was to make it easier for hospitals to set up,
and invest in, high-tech central pharmacies in order to reduce
medication errors. Unfortunately, hospital technology
development and procurement has not moved as quickly as
anticipated. The author notes that, additionally, the Board
has opined that wording in current law requires that only
barcodes now be used on medication and this has resulted in
the Board spending staff time and money issuing waivers to
hospitals to allow them to operate while technology catches
up. The author concludes that this bill clarifies that data
are allowed to be contained both within the barcode and in
human readable form, and includes much needed definitions that
will allow the Board to continue to provide oversight and
regulation in this area.
2)BACKGROUND. In 2012 the Governor signed AB 377 into law,
which allowed hospitals to create centralized hospital
packaging pharmacies (CHPPs) that can serve multiple
institutions under common ownership. AB 377 also requires
that medications produced in a CHPP be barcoded and that the
barcode retrieve specific information, such as the expiration
date and lot number, which can be read when the barcode is
scanned at the patient's bedside. However, as noted by the
author, the Board's new legal interpretation has suggested
that certain specific information required on the barcode,
also be immediately viewable on a screen. This is problematic
because current technology does not allow for this, making it
difficult for hospitals to establish CHPPs.
The Board has subsequently created a waiver for which
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hospitals can apply that allows the required information to be
physically listed on the label rather than being accessible in
electronic, barcode format. These waivers are only for a five
year term.
3)SUPPORT. The California Society of Health-System Pharmacists
(CSHP), the sponsor of this bill, states it will address the
gap between current healthcare technologies and the new law
afforded by AB 377, improving patient safety and ensuring the
optimal use of medication. CSHP notes that AB 377 was a
positive policy change in that it allowed hospitals to
establish these special pharmacies offsite of the main
hospital campus, allowing for the purchasing and placement of
large robotic packing and filling tools, which often are not
useable in hospitals simply due to space restrictions, and
that these tools dramatically decrease medication errors and
save lives.
The California Hospital Association (CHA) states in support
that this bill ensures that centralized hospital packaging
pharmacies can continue to operate and serve their member
hospitals efficiently. CHA notes that a new legal
interpretation has suggested that the specific retrievable
information from the barcode be immediately viewable on a
screen upon scanning the barcode is problematic because
current technology does not allow for this function. By
requiring the information to be displayed on a human-readable
label, CHA concludes that this bill provides a long-term
solution while maintaining the original intent of the law.
4)PREVIOUS LEGISLATION.
a) AB 2757 (Bocanegra) of 2014, was substantially similar
to this bill. AB 2757 passed the Senate Business,
Professions and Economic Development Committee, but was not
heard in any other policy or fiscal committee.
b) AB 377 authorizes a centralized hospital packaging
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pharmacy to prepare medications, 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.
c) AB 2077 (Solorio) of 2010, in its final version, was
virtually identical to AB 377. AB 2077 was vetoed by
Governor Arnold Schwarzenegger. 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."
d) AB 1370 (Solorio) of 2009 was similar to AB 377 but
would have created a separate licensing category for
centralized hospital pharmacies. AB 1370 was held in the
Assembly Committee on Business, Professions and Consumer
Protection.
e) SCR 49 (Speier), Chapter 123, Statutes of 2005, creates
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.
f) SB 1875 (Speier), Chapter 816, Statutes of 2000,
requires hospitals to adopt a formal plan to eliminate or
substantially reduce medication-related errors.
5)DOUBLE REFERRAL. This bill is double referred; upon passage
in this Committee, this bill will be referred to the Assembly
Business & Professions Committee.
REGISTERED SUPPORT / OPPOSITION:
Support
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California Society of Health-System Pharmacists (sponsor)
California Association of Physician Groups
California Hospital Association
California Pharmacists Association
Providence Health & Services, Southern California Region
Opposition
None on file.
Analysis Prepared by:Lara Flynn / HEALTH / (916) 319-2097