BILL ANALYSIS �
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UNFINISHED BUSINESS
Bill No: SB 204
Author: Corbett (D)
Amended: 6/10/14
Vote: 21
PRIOR VOTES NOT RELEVANT
SENATE BUSINESS, PROF. & ECON. DEV. COMM. : 5-0, 8/26/14
(Pursuant to Senate Rule 29.10)
AYES: Lieu, Block, Corbett, Galgiani, Hill
NO VOTE RECORDED: Wyland, Berryhill, Hernandez, Torres
ASSEMBLY FLOOR : 55-23, 8/21/14 - See last page for vote
SUBJECT : Prescription drugs: labeling
SOURCE : California Pan-Ethnic Health Network
DIGEST : This bill requires the Board of Pharmacy (BOP) to
conduct a survey of pharmacists and vendors of electronic health
records (EHRs) to gather information about the utilization of,
and the obstacles to, the use of BOP's standardized directions
for use (standardized directions) on prescription drug labels.
Assembly Amendments delete the prior version of the bill
relating to prescription drug labeling translations, and insert
the current language relating to surveying the use of BOP's
standardized prescription directions.
ANALYSIS :
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Existing law:
1. Establishes BOP to license and regulate of pharmacies and
pharmacists under the Department of Consumer Affairs.
2. Specifies the information that must be printed on a
prescription drug container and how it must be presented.
3. Provides standardized directions as part of a
patient-centered label and requires BOP to publish on its Web
site translations of those standardized directions for use
into at least five languages other than English to facilitate
their use by California pharmacies.
4. Requires BOP, beginning in October 2011, to collect and
publish on its Web site examples of labels conforming to
these requirements, to aid pharmacies in label design and
compliance.
This bill:
1. Requires BOP to survey pharmacists to collect data on
whether and how often pharmacists utilize standardized
directions for use, challenges or barriers for use, and other
directions used by pharmacists.
2. Requires BOP to conduct a survey of vendors that provide
EHRs to pharmacies and prescribers to determine the type of
directions for use included in the software. Requires the
survey to include, but not be limited to, whether
standardized directions for use are used in the software,
challenges or barriers for use, and other directions used by
the vendor.
3. Specifies the surveys to be conducted with other surveys
performed during routine course of business. Requires BOP to
report the finding of the surveys at the July 2016 BOP
meeting, and publish the findings on its Internet Web site.
4. Sunsets the provisions of this bill on January 1, 2020.
Background
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The Medication Errors Panel (Panel) was created by SCR 49
(Speier, Resolution Chapter 123, Statutes of 2005) to study the
causes of medication errors and recommend changes to the
healthcare system. The Panel published its report in March
2007, Prescription for Improving Patient Safety: Addressing
Medication Errors. The Panel developed recommendations to
improve prescription labels to reduce errors associated with
prescription and over-the-counter medication use.
As a result of these recommendations, SB 472 (Corbett, Chapter
470, Statutes of 2007) was enacted to require BOP to promulgate
regulations that required a standardized, patient-centered,
prescription drug label on all prescription medication dispensed
to patients in California. In an effort to create a
consumer-friendly drug label, BOP elicited feedback from
consumers between May 2008 and November 2009, with an open-ended
prescription label survey which was distributed at public
outreach events. After numerous meetings, BOP adopted
regulations in 2010 to create a standardized, patient-centered
prescription drug label, which included the standardized
directions for use.
Comments
According to the author's office, although BOP adopted
regulations to develop a patient-centered prescription label and
standardized directions for use in 2010, BOP does not know how
many doctors are using these standardized directions, nor do
they have any method for determining whether or not pharmacies
are utilizing them. BOP also does not know and has no method
for determining if the vendors of EHRs are using the
standardized directions for use in the products that they market
to prescribers and pharmacies. The author's office further
states that BOP should determine if the standardized directions
for use are being utilized and what the barriers are to using
the standardized directions in prescriptions and EHRs for
prescribers and pharmacists. These surveys will provide BOP
with the necessary data to determine how to better ensure the
use of this important aspect of the patient-centered
regulations.
FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes
Local: No
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According to the Assembly Appropriations Committee, $50,000 in
estimated costs to BOP (Contingent Fund of the BOP) to contract
for mandated surveys.
SUPPORT : (Verified 8/21/14)
California Pan-Ethnic Health Network (source)
AllCare Alliance
California Alliance for Retired Americans
Latino Coalition for a Healthy California
Western Center on Law and Poverty
OPPOSITION : (Verified 8/21/14)
Board of Pharmacy
ARGUMENTS IN SUPPORT : The California Pan Ethnic Health
Network, sponsor of this bill, states that a large percentage of
patients misunderstand dosage instructions on their labels.
Simple, explicit, and specific instructions can help alleviate
patients' misunderstanding. Pursuant to previous legislation,
BOP adopted standardized instruction, but there is no data about
whether pharmacies are actually using the instructions.
ARGUMENTS IN OPPOSITION : The Board of Pharmacy writes, "As
currently written, SB 204 would require the board to perform two
surveys: one on pharmacies' use of the standardized directions
for use as specified in board regulations, and another of
electronic health record vendors to determine the types of
standardized directions included in software. The board opposed
SB 204 because it is unable to absorb the cost of conducting
these surveys, estimated to be approximately $50,000."
ASSEMBLY FLOOR : 55-23, 8/21/14
AYES: Alejo, Ammiano, Bloom, Bocanegra, Bonilla, Bonta,
Bradford, Brown, Buchanan, Ian Calderon, Campos, Chau,
Chesbro, Cooley, Dababneh, Daly, Dickinson, Eggman, Fong, Fox,
Frazier, Garcia, Gatto, Gomez, Gonzalez, Gordon, Gray, Hall,
Roger Hern�ndez, Holden, Jones-Sawyer, Levine, Lowenthal,
Medina, Mullin, Muratsuchi, Nazarian, Pan, Perea, John A.
P�rez, V. Manuel P�rez, Quirk, Quirk-Silva, Rendon,
Ridley-Thomas, Rodriguez, Salas, Skinner, Stone, Ting, Weber,
Wieckowski, Williams, Yamada, Atkins
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NOES: Achadjian, Allen, Ch�vez, Conway, Dahle, Donnelly, Beth
Gaines, Gorell,
Grove, Hagman, Harkey, Jones, Linder, Logue, Maienschein,
Mansoor, Melendez, Nestande, Olsen, Patterson, Wagner,
Waldron, Wilk
NO VOTE RECORDED: Bigelow
MW:k 8/26/14 Senate Floor Analyses
SUPPORT/OPPOSITION: SEE ABOVE
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