BILL ANALYSIS �
SB 204
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Date of Hearing: June 24, 2014
ASSEMBLY COMMITTEE ON BUSINESS, PROFESSIONS AND CONSUMER
PROTECTION
Susan A. Bonilla, Chair
SB 204 (Corbett) - As Amended: June 10, 2014
SENATE VOTE : Vote not relevant.
SUBJECT : Prescription drugs: labeling.
SUMMARY : 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.
Specifically, this bill :
1)Requires the BOP to conduct a survey of a representative
sample of licensed pharmacists to determine the utilization of
the standardized directions in current law.
2) Requires the survey to address, but not be limited to, the
following:
a) Whether the pharmacist utilizes the standardized
directions;
b) How often the pharmacist utilizes the standardized
directions;
c) Challenges or barriers to utilizing the standardized
directions; and,
d) Other directions utilized by the pharmacist.
3)Requires the BOP to conduct a survey of vendors that provide
EHRs to pharmacies and prescribers to determine the type of
directions included in the vendor's EHR programming.
4)Requires the survey to address, but not be limited to, the
following:
a) Whether California's standardized directions are
included in the vendor's EHR programming;
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b) Challenges or barriers to utilizing the standardized
directions in the vendor's EHR programming; and,
c) Other directions utilized by the vendor in its EHR
programming.
5)Authorizes the surveys to be conducted with other routine
surveys conducted by the BOP during its regular course of
business.
6)Requires the BOP to report the findings of the surveys at its
July 2016 meeting and publish the findings on its Internet Web
site, as specified.
7)Repeals the above provisions on January 1, 2020.
EXISTING LAW :
1)Establishes BOP to license and regulate of pharmacies and
pharmacists under the Department of Consumer Affairs.
(Business and Professions Code (BPC) Section 4001)
2)Specifies the information that must be printed on a drug
container and how it must be presented. (Title 16 Code of
California Regulations (CCR) Section 1707.5)
3)Provides standardized directions as part of a patient-centered
label and requires the BOP to publish on its Website
translations of those standardized directions for use into at
least five languages other than English to facilitate their
use by California pharmacies. The following are examples of
the standardized directions:
a) Take 1 [insert appropriate dosage form] at bedtime;
b) Take 1 [insert appropriate dosage form] in the morning;
c) Take 1 [insert appropriate dosage form] in the morning,
and Take 1 [insert appropriate dosage form] at bedtime;
d) Take 1 [insert appropriate dosage form] in the morning,
1 [insert appropriate dosage form] at noon, and l [insert
appropriate dosage form] in the evening; and,
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e) If you have pain, take [insert appropriate dosage form]
at a time. Wait at least __ hours before taking again. Do
not take more than [appropriate dosage form] in one day.
(16 CCR 1707.5)
4)Specifies that beginning in October 2011, the BOP shall
collect and publish on its Web site examples of labels
conforming to these requirements, to aid pharmacies in label
design and compliance. (16 CCR 1707.5)
FISCAL EFFECT : Unknown
COMMENTS :
1)Purpose of this bill . This bill requires the BOP to conduct
surveys of pharmacists and vendors of EHRs to identify if and
how pharmacists and vendors of EHRs are utilizing standardized
directions on prescription labels. The results of the survey
are intended to help the BOP identify if any changes are
necessary to make the standardized directions more effective
for consumers, pharmacists and EHR vendors. This bill is
sponsored by the California Pan-Ethnic Health Network.
2)Author's statement . According to the author, "According to
the U.S. Pharmacopeial Convention, the main cause for
medication errors and patient misunderstanding is a lack of
universal standards. In 2010, the [BOP] adopted regulations
to develop a patient-centered prescription label and
standardized directions for use. Despite this very important
step towards reducing dosage errors, the [BOP] does not know
how many pharmacies are using these standardized directions,
nor do they have any method for determining whether or not
pharmacies are utilizing them. They also do not know and have
no method for determining if the vendors of [EHR] are using
the standardized directions for use in the products that they
market to prescribers and pharmacies.
"[This bill] directs the [BOP] to gather this important
information to determine if the standardized directions are
being used and what the barriers are to using the them in
prescriptions and [EHR] for prescribers and pharmacists. These
surveys will provide the [BOP] with the necessary data to
determine how we can better ensure the use of this important
aspect of the patient-centered regulations."
SB 204
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3)Legislative history of prescription drug labels . The
Medication Errors Panel (Panel) was created by SCR 49 (Speier)
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 the 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, the 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.
This bill requires the BOP to conduct a survey of both
pharmacists and vendors of EHRs to elicit feedback regarding
the use, challenges and barriers to use, of the standardized
directions. While this bill does not specifically require the
survey of licensed pharmacists to report back on the
standardized directions in different languages, the data
received would most likely capture information about the use
of standardized directions in the five languages available on
the BOP's Web site.
A 2006 Institute of Medicine report recommended that a way to
reduce medication errors is to ensure that drug information is
communicated clearly and effectively to providers and
patients. This bill may help the BOP better determine if the
current standardized directions are sufficient to prevent
medication errors.
4)Arguments in support . According to the California Pan-Ethnic
Health Network, "a patient's first and best source of
information about their medications is the prescription
container label. However, the Institute of Medicine estimates
that at least 1.5 million Americans are sickened, injured, or
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killed each year because of medication errors? Pursuant to
previous legislation, the BOP adopted standardized
instructions for use with the help of research experts;
however, there is no data about whether pharmacies are
actually using the instructions."
Arguments in opposition . There is no opposition on file.
5)Senate vote not relevant . This bill was voted off the Senate
Floor (21-14), on May 28, 2013, as a substantially different
subject.
6)Previous legislation . SB 205 (Corbett), of 2013, would
require specified information on a prescription container
regarding its name, manufacturer, recipient, use, strength,
and purpose to be printed in at least 12-point typeface. This
bill was vetoed by the Governor.
AB 396 (Fox) of 2013, would require every prescription to
include a legible, clear notice of the condition or purpose
for which the drug is prescribed, unless the patient or
prescriber requests that this information be omitted. The
bill was held in the Assembly without referral to a committee.
AB 1136 (Levine) Chapter 304, Statutes of 2013, requires a
pharmacist to include a written label on the drug container
indicating that the drug may impair a person's ability to
operate a vehicle or vessel.
SB 306 (Torres) of 2013, would authorize an automated drug
delivery to be located in a specified group practice and would
authorize specified entities, including a group practice that
uses an automated drug delivery system, to purchase drugs at
wholesale for administration or dispensing, under the
direction of a physician and surgeon or other prescriber, as
specified. This bill was amended to an unrelated topic.
SB 1390 (Corbett) of 2010, would have repealed the
requirement that the BOP promulgate regulations requiring a
standardized, patient-centered, prescription drug label on
all prescription medications dispensed to patients in
California on or before January 1, 2011, and instead
establish statutory requirements for standardized, patient
centered prescription drug labels. The bill failed passage
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in the Assembly Committee on Business, Professions and
Consumer Protection.
SB 470 (Corbett) (Chapter 590, Statutes of 2009) permitted,
if requested by patients, the purpose of the prescribed
medication to be listed on prescription drug labels.
SB 472 (Corbett) (Chapter 470, Statutes of 2007), the
California Patient Medication Safety Act, required BOP to
promulgate regulations that require a standardized,
patient-centered, prescription drug label on all prescription
medication dispensed to patients in California. The Board
was required to report to the Legislature by January 1, 2010,
on its progress in implementing these regulations.
SCR 49 (Speier) 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.
This resolution required the panel to convene by October 1,
2005, and to submit to the Assembly Committee on Health and
the Senate Committee on Health a report on its finding by
June 1, 2006.
AB 657 (Karnette) of 2005, would have required prescription
drug labels to include the intended purpose of the drug, if
indicated on the prescription, and required prescribers to
ask the patient, or the patient's authorized representative,
if the patient is either incapacitated or a minor who cannot
provide informed consent, whether to indicate the intended
purpose of the prescription on the label. The bill was held
in the Senate Business, Professions and Economic Development
Committee.
7)Double referral . This bill was double-referred from the
Assembly Health Committee where it passed (13-5) on June 17,
2014.
REGISTERED SUPPORT / OPPOSITION :
Support
California Pan-Ethnic Health Network (sponsor)
California Alliance for Retired Americans
SB 204
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Opposition
None on file
Analysis Prepared by : Elissa Silva / B.,P. & C.P. / (916)
319-3301