BILL ANALYSIS Ó
AB 377
Page 1
( Without Reference to File )
CONCURRENCE IN SENATE AMENDMENTS
AB 377 (Solorio)
As Amended August 24, 2012
Majority vote
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|ASSEMBLY: |70-0 |(May 12, 2011) |SENATE: |32-0 |(August 29, |
| | | | | |2012) |
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|COMMITTEE VOTE: |11-2 |(August 30, 2012) |RECOMMENDATION: |concur |
|(HEALTH) | | | | |
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Original Committee Reference: HEALTH
SUMMARY : Authorizes 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. Imposes
issuance and annual renewal fees for a specialty license from the
State Board of Pharmacy (BOP).
The Senate amendments :
1)Authorize a centralized hospital packaging pharmacy to prepare
medications 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, by performing the following
specialized functions:
a) Preparing unit dose packaging for single administration to
inpatients from bulk containers, if each unit dose package is
barcoded to contain information required by this bill;
b) Preparing compounded unit dose drugs for parenteral therapy
for administration to inpatients, if each compounded unit dose
drug is barcoded to contain at least the information required
by this bill; and,
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c) Preparing compounded unit dose drugs for administration to
inpatients, if each unit dose package is barcoded to contain at
least the information required by this bill.
2)Define common ownership where the ownership information on file
with the BOP for the licensed pharmacy is consistent with the
ownership information on file with the BOP for other licensed
pharmacy or pharmacies for purposes of preparing medications, as
specified.
3)Require a centralized hospital packaging pharmacy to obtain a
specialty license from the BOP prior to engaging in functions
authorized by 1) above.
4)Require an applicant seeking a specialty license to apply to the
BOP on specified forms. Specifies other requirements for
licensure and licensure renewals, including fees for the issuance
and renewal of a license.
5)Require the BOP, prior to issuing a specialty license to inspect a
pharmacy and ensure that the pharmacy is in compliance with
specified requirements.
6)Specify that a license to perform the functions specified in 1)
above may only be issued to a pharmacy that is licensed by the BOP
as a hospital pharmacy.
7)Authorize a centralized hospital packaging pharmacy to prepare and
store a limited quantity of the unit dose drugs authorized by 1)
above in advance of receipt of a patient-specific prescription in
a quantity as is necessary to ensure continuity of care for an
identified population of inpatients of the general acute care
hospital based on a documented history of the prescriptions for
that patient population.
8)Require any dose medication produced by a centralized hospital
packaging pharmacy to be barcoded to be readable at the
inpatient's bedside. States that upon reading the barcode, the
following information shall be retrievable:
a) The date the medication was prepared;
b) The components used in the drug product;
c) The lot number or control number;
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d) The expiration date;
e) The National Drug Code Director number; and,
f) The name of the centralized hospital packaging pharmacy.
9)Require the label for each unit dose medication produced by a
centralized hospital packaging pharmacy to contain all of the
following:
a) The expiration date;
b) The established name of the drug;
c) The quantity of the active ingredient;
d) Special storage or handling requirements.
10)Require that all compounding and packaging functions specified in
1) above be performed only in the licensed centralized hospital
packaging pharmacy and the pharmacy must comply with all
applicable federal and state statutes and regulations, including,
but not limited to, regulations regarding compounding and, when
appropriate, sterile injectable compounding.
11)Require a centralized hospital packaging pharmacy and the
pharmacists working in the pharmacy to be responsible for the
integrity, potency, quality, and labeled strength of any unit dose
drug product prepared by the centralized hospital packaging
pharmacy.
AS PASSED BY THE ASSEMBLY , this bill provided that a hospital
pharmacy license can include a centralized hospital pharmacy
physically located outside of the hospital or at a separate facility
that is located within a 100-mile radius of the hospital and
regulated under the hospital's license. This bill also authorized
the centralized pharmacy to deliver non-patient specific unit dose
medications to hospitals and to prepare both pill/capsule, as well
as injectable and intravenous medications for hospital patients.
FISCAL EFFECT : According to the Senate Appropriations Committee,
this bill would have minor costs annually to BOP from the Pharmacy
Board Contingent Fund, offset by fees. This bill would also have
potentially major costs annually to DPH from the Licensing and
Certification Program Fund.
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COMMENTS : According to the author, the problem of medication errors
in hospitals has been recognized for a number of years, and there
are currently laws addressing data collection and plans to reduce
errors. However, some of the best approaches to reducing medication
errors are expensive. It is widely accepted that having unit dose
medications packaged and bar-coded for delivery to the bedside for
administration, thereby allowing efficient and accurate verification
before administration, is a sound goal. Hospitals that are planning
to implement programs to accomplish this goal face both
technological and legal impediments. In most circumstances, it is
simply cost prohibitive to invest in the technology on a
per-hospital basis. Even a large hospital may not be able to afford
it; clearly small and rural hospitals cannot. Thus, a clear unique
structure and economies of scale, has become federally licensed as a
pharmaceutical manufacturer, thereby implementing a program similar
to this bill's goal without need for a change in California law.
The BOP licenses and regulates pharmacies in this state. A hospital
licensed by DPH with a bed capacity of 100 or more beds must have a
pharmacy on the premises licensed by the BOP. Hospitals with fewer
than 100 beds shall have a pharmacy license issued by the BOP, as
specified. In hospital pharmacies, pharmaceutical services may only
be provided to registered hospital patients who are on the premises
of the same physical plant where the pharmacy is located and those
services must be directly related to the services or treatment plan
administered in the physical plant. Moreover, a hospital pharmacy
that compounds sterile drug products must additionally obtain a
separate compounding license from the BOP unless accredited, as
specified. This bill authorizes a centralized hospital packaging
pharmacy to prepare and compound unit dose drugs to inpatients for
one or more hospitals as long as the hospitals are under common
ownership and located within a 75-mile radius of each other as long
as a specialty license is obtained from the BOP.
This bill further requires that a centralized hospital packaging
pharmacy that obtains a specialty license pursuant to this measure
to barcode unit dose medication that it produces. Specified
retrievable information must be included in the bar code, and each
unit dose medication must include information about the drug.
Automated processes implemented by a hospital or health system have
the potential to provide additional patient protection through a
reduction in medication errors. Many medication errors in hospitals
have resulted from inadequate and inconsistent labeling and a lack
of proper mechanisms to track medication through the distribution
process to the patient. Recent reports show that technology, like
bar-coding, facilitates more efficient medication administration and
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decreases medication errors. According to a study published in the
New England Journal of Medicine, "Effect of Bar-Code Technology on
the Safety of Medication Administration," the use of the bar-code
substantially decreased the rate of errors as well as potential
adverse drug events. The report also concluded that the bar-code
electronic medication administration is an important intervention to
improve patient safety.
Analysis Prepared by : Rosielyn Pulmano / HEALTH / (916) 319-2097
FN: 0005856