BILL ANALYSIS �
SB 204
Page 1
Date of Hearing: June 17, 2014
ASSEMBLY COMMITTEE ON HEALTH
Richard Pan, Chair
SB 204 (Corbett) - As Amended: June 10, 2014
SENATE VOTE : Not relevant.
SUBJECT : Prescription drugs: labeling.
SUMMARY : Requires Board of Pharmacy (BOP) to survey pharmacists
and electronic health record (EHR) vendors to determine
utilization of standardized prescription directions for use
adopted pursuant to Board regulations. Specifically, this bill :
1)Requires the BOP 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 the 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.
4)Requires the BOP to report the finding of the surveys at the
July 2016 BOP meeting, and publish the findings on its
Internet Website.
5)Sunsets the provisions of this bill on January 1, 2020.
EXISTING LAW :
1)Provides for the practice of pharmacy and the licensing and
regulation of pharmacies and pharmacists by the BOP within the
Department of Consumer Affairs.
2)Specifies certain requirements regarding the dispensing and
furnishing of dangerous drugs and devices and prohibits a
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person from furnishing any dangerous drug or device except as
prescribed by a physician, dentist, podiatrist, optometrist,
or veterinarian.
3)Requires that each prescription dispensed by a pharmacist to
be in a container meeting state and federal specification, and
requires the label to include certain information, including:
a) Unless otherwise ordered by the prescriber, the
manufacturer's trade name of the drug or the generic name
and the name of the manufacturer, as specified;
b) The directions for the use of the drug;
c) The name of the patient or patients;
d) The name of the prescriber, as specified;
e) The date of issue;
f) The name and address of the pharmacy and prescription
number or other means of identifying the prescription;
g) The strength of the drug or drugs dispensed;
h) The quantity of the drug or drugs dispensed;
i) The expiration date of the effectiveness of the drug
dispensed;
j) The condition or purpose for which the drug was
prescribed if the condition or purpose is indicated on the
prescription; and,
aa) The physical description of the dispensed medication,
including its color, shape, and any identification code
that appears on the tablets or capsules.
EXISTING REGULATIONS :
1)Requires labels on drug containers dispensed to patients in
California to conform to the following format:
a) Each of the following must be clustered into one area of
the label that comprises at least 50% of the label and be
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printed in at least 10-point sans serif typeface, or, if
requested by the consumer, at least a 12-point typeface,
and listed in the following order:
i) Name of the patient;
ii) Name of the drug and strength of the drug;
iii) Directions for the use of the drug; and,
iv) The condition or purpose for which the drug was
prescribed if the condition or purpose is indicated on
the prescription.
b) Requires for added emphasis, the label to highlight in
bold typeface or color, or use blank space to set off the
items listed in 1) a) above; and,
c) Requires the remaining elements that are required to be
printed on a label, as well as any other items of
information appearing on the label or the container, to be
printed so as not to interfere with the legibility or
emphasis of the primary elements specified in 1) a) above.
2)Requires the BOP, by October 1, 2011, and updated as
necessary, to publish on its Website translation of specified
directions for use into at least five languages other than
English, to facilitate their use by California pharmacies.
Specifies phrases that are required to be used for directions
for use , including:
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; or,
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.
3)Requires the BOP to collect and publish on its Website
examples of labels conforming to these requirements, to aid
pharmacies in label design and compliance.
4)Requires a pharmacy to have policies and procedures in place
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to help patients with limited or no English proficiency
understand the information on the label as specified in 1) a)
above in the patient's language. Requires the pharmacy's
policies and procedures to be specified in writing and to
include, at a minimum, the selected means to identify the
patient's language and to provide interpretive services in the
patient's language. Requires the pharmacy, at a minimum, to
provide interpretive services in the patient's language, if
interpretive services in such language are available, during
all hours that the pharmacy is open, either in person by
pharmacy staff or by use of a third-party interpretive service
available by telephone at or adjacent to the pharmacy counter.
FISCAL EFFECT : This bill, as amended, has not yet been analyzed
by a fiscal committee.
COMMENTS :
1)PURPOSE OF THIS BILL . According to the author, although the
BOP adopted regulations to develop a patient-centered
prescription label and standardized directions for use in
2010, the 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. The
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 further states that the 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 the BOP with the
necessary data to determine how to better ensure the use of
this important aspect of the patient-centered regulations.
2)BACKGROUND .
a) Medication Errors. SCR 49 (Speier), Resolution Chapter
123, Statutes of 2005, establishes the Medication Errors
Panel (Panel) which published a report in March 2007
entitled, "Prescription for Improving Patient Safety:
Addressing Medication Errors." The report listed six
general goals to reduce medication errors. Under each goal
were recommendations (12 in all) and methods to accomplish
each recommendation. The Panel report states that "the
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information that consumers need to know about their
medication is often complex and may include unfamiliar
language or concepts. Expecting a consumer to retain all
the pertinent knowledge from a brief verbal encounter may
not be reasonable in many instances." Although the Panel
did not come to consensus on the most important subset of
consumers that are at "high risk" for medication errors, it
did acknowledge that there are a variety of factors which
may increase an individual's risk for experiencing a
medication error. These include: i) low health literacy;
ii) limited English proficiency; iii) cultural incongruence
with healthcare providers; iv) physical, cognitive, and/or
other impairments that make understanding and/or complying
with medication instructions difficult; v) age at either
end of the age spectrum (the variability of a medication's
response, metabolism, and dose increases in children and
seniors); vi) multiple medications; vii) multiple
prescribers; viii) non-prescription medication use
(including herbals, dietary supplements, alcohol, and
tobacco); and, ix) medication procurement from more than
one pharmacy including mail-order. The Panel did state that
these factors must be taken into consideration in the
development of any consumer education efforts.
One bill that was pursued in response to the Panel report was
SB 472 (Corbett), Chapter 470, Statutes of 2007. SB 472
establishes the California Patient Medication Safety Act,
which requires the BOP to promulgate regulations on or
before January 1, 2011, that require a standardized,
patient-centered prescription drug label on all
prescription medicine dispensed to patients. Additionally,
the BOP was required to report to the Legislature by
January 1, 2010, on its progress in implementing these
regulations.
b) Report to the Legislature on the Implementation of SB
472. Pursuant to SB 472, the BOP submitted its report
entitled, "Prescription Drugs: Labeling Requirements" to
the Legislature in January 2010. The report indicated the
steps the BOP took prior to adopting the final regulations
to implement SB 472. Specifically, the BOP established a
"SB 472 Medication Label Subcommittee" in January 2008 to
conduct public forums and to work with organizations and
individuals to develop recommendations to implement the
provisions of the law to establish a patient-centered
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prescription drug label. In May 2008, the BOP developed an
open-ended prescription label survey for distribution at
public outreach events. A total of 606 consumers completed
the surveys. Specifically, when asked what to change on
the prescription label, 30.1% responded that print should
be larger or darker; 24.5% indicated nothing needs to be
changed on the label; and, 12% responded that the purpose
of the drug must be included. The BOP considered testimony
and information provided from the public, the
pharmaceutical industry, pharmacy professionals, and
literacy subject matter experts on medical literacy
research, improved directions for use, improved font types
and sizes, the placement of information that is
patient-centered, the needs of patients with limited
English proficiency, the needs of senior citizens, and
technology requirements necessary to implement the
standards developed. BOP members were also provided with
research articles on designing patient-centered labels. In
2009, the BOP discussed the requirements of the regulation
at regularly scheduled meetings and the final regulations
were adopted in 2010.
c) BOP Regulations on Translations and Interpretive
Services. Regulations adopted by the BOP in 2010 entitled
"Patient-Centered Labels for Prescription Drug Containers"
require a standardized, patient-centered prescription drug
label on all prescriptions dispensed to patients. Among
other requirements, the regulations require pharmacies to
have policies and procedures in place to help patients with
limited or no English proficiency to understand specified
information on the label in the patient's language. The
pharmacy's policies and procedures must be specified in
writing and are required to include at minimum, the
selected means to identify the patient's language and to
provide interpretive services in the patient's language.
The pharmacy must provide interpretive services in the
patient's language, if interpretive services in such
language are available, during all hours that the pharmacy
is open, either in person by pharmacy staff or by use of
third-party interpretive service available by telephone at
or adjacent to the pharmacy counter.
3)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,
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explicit, and specific instructions can help alleviate
patients' misunderstanding. Pursuant to previous legislation,
the BOP Pharmacy adopted standardized instruction, but there
is no data about whether pharmacies are actually using the
instructions.
4)DOUBLE REFERRAL . This bill is double referred, upon passage
of this Committee, it will be referred to the Assembly
Business, Professions & Consumer Protection Committee.
5)PREVIOUS LEGISLATION .
a) SB 205 (Corbett) of 2013 would have required the
information on the prescription label to be printed in at
least a 12-point sans serif typeface. SB 205 was vetoed by
the Governor, stating:
"The BOP of Pharmacy is required to provide an
update of its 2010 labeling guidelines to the
Legislature next month. I prefer to wait for their
findings before mandating such a change."
b) 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.
c) SB 472 requires the BOP to promulgate regulations that
require, on or before January 1, 2011, a standardized,
patient-centered prescription drug label on all
prescription medication dispensed to patients in
California.
d) SCR 49 establishes a panel to study the causes of
medication errors and recommend changes in the health care
system that would reduce errors associated with the
delivery of prescription and over-the-counter medication to
consumers.
e) SB 292 (Speier), Chapter 544, Statutes of 2003, requires
prescription labels to include a physical description of
the drug, including the color, shape, and any
identification code that appears on the tablet or capsule.
f) AB 2099 (Epple), Chapter 397, Statutes of 1993, requires
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that the condition for which the drug is being prescribed
must be included on the label if the patient requests that
information on the label.
REGISTERED SUPPORT / OPPOSITION :
Support
California Pan Ethnic Health Network (sponsor)
California Alliance for Retired Americans
Latino Coalition for a Healthy California
Western Center on Law and Poverty
Opposition
None on file for this version of the bill.
Analysis Prepared by : Dharia McGrew / HEALTH / (916) 319-2097