BILL ANALYSIS �
SB 204
Page 1
Date of Hearing: June 25, 2013
ASSEMBLY COMMITTEE ON HEALTH
Richard Pan, Chair
SB 204 (Corbett) - As Amended: May 23, 2013
SENATE VOTE : 21-14
SUBJECT : Prescription drugs: labeling.
SUMMARY : Requires, beginning on January 1, 2016, translations
of the directions for use in non-English languages published on
the Board of Pharmacy's (Board) Internet Website to be used, as
applicable, when labeling a prescription container.
Specifically, this bill :
1)Requires, beginning on January 1, 2016, translations of the
directions for use in non-English languages published on the
Board's Internet Website to be used, as applicable, when
labeling a prescription container pursuant to existing
requirements.
2)Allows the directions for use established by regulation to be
translated into additional non-English languages if certified
translation services are utilized to complete the additional
translations.
3)Authorizes a pharmacy, as an alternative to 1) above, to
provide its own translations of the directions for use
established by regulation by the Board in the non-English
language published on the Board's Website when labeling a
prescription container.
4)Provides that if a pharmacist reasonably believes that a
translation of the directions for use contains an error due to
software or equipment malfunction, he or she may provide the
English language directions for use established by regulation
by the Board, as specified.
5)States that a pharmacist that reasonably uses the translations
of the directions for use in non-English languages published
on the Board's Website has not breached his or her legal duty
if the published translations contain an error and the
pharmacist did not know, or did not have reason to know, of
the error.
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EXISTING LAW :
1)Provides for the practice of pharmacy and the licensing and
regulation of pharmacies and pharmacists by the Board within
the Department of Consumer Affairs.
2)Specifies certain requirements regarding the dispensing and
furnishing of dangerous drugs and devices and prohibits a
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 must
be in a container meeting state and federal specification, and
the label must 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
printed in at least 10-point sans serif typeface, or, if
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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.
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 Board, by October 1, 2011, and updated as
necessary, to publish on its Website translation of specified
directions for use into at least five languages (Chinese,
Korean, Russian, Spanish and Vietnamese) other than English,
to facilitate their use by California pharmacies. Specifies
and translates 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 Board 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
to help patients with limited or no English proficiency
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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 : According to the Senate Appropriations
Committee, there are potential one-time costs of about $75,000
to adopt regulations by the Board (Pharmacy Board Contingent
Fund).
COMMENTS :
1)PURPOSE OF THIS BILL . The California Pan-Ethnic Health
Network (CPEHN) is the sponsor of this bill. According to the
author, an estimated seven million Californians are limited
English proficient (LEP). A 2010 study shows that about
two-thirds of California pharmacies are providing some form of
translated directions upon request. However, the availability
of these translations is inconsistent and limited. Patients
cannot follow directions if they cannot read them. This large
population of Californians has an increased risk of
accidentally misusing their prescription medications because
the directions are provided in a language they cannot read.
2)BACKGROUND .
a) Medication Errors . SCR 49 (Speier), Resolution Chapter
123, Statutes of 2005, established 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
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
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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
established the California Patient Medication Safety Act,
which requires the Board 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 Board was required to report to the Legislature by
January 1, 2010, on its progress in implementing these
regulations. This bill is a follow-up to SB 472.
b) Report to the Legislature on the Implementation of SB
472 . Pursuant to SB 472, the Board submitted its report
entitled, "Prescription Drugs: Labeling Requirements" to
the Legislature in January 2010. The report indicated the
steps the Board took prior to adopting the final
regulations to implement SB 472. Specifically, the Board
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 prescription drug label. In May 2008, the
Board developed an open-ended prescription label survey for
distribution at public outreach events. A total of 606
consumers completed the surveys. Specifically, when asked
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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 Board 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. Board members were also provided with
research articles on designing patient-centered labels. In
2009, the Board discussed the requirements of the
regulation at regularly scheduled meetings and the final
regulations were adopted in 2010.
c) Board Regulations on Translations and Interpretive
Services . Regulations adopted by the Board 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.
The regulations also require the Board to publish on its
Website translations of the directions for use, as
specified, into at least five languages (Chinese, Korean,
Russian, Spanish, and Vietnamese) other than English, to
facilitate the use of such translations by California
pharmacies. The Board is required to re-evaluate the
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requirements of the regulations and submit its findings to
the Legislature by December 2013 .
d) Interpretive Services Compliance . At the Board's April
2013 meeting, the Board's Communication and Public
Education Committee reported the results of
Patient-Centered Labeling inspections. For purposes of
compliance with regulations relating to interpretive
services, the Board conducted 767 patient-centered labeling
inspections of chain stores, community pharmacies, and
clinics to measure compliance with regulations. The table
below illustrates pharmacy compliance with interpretive
services:
------------------------------------------------------------
|Interpretive Services: | Chain |Community|Clinic|
| | Store | | |
|----------------------------------+--------+---------+------|
|Compliant (all 12 languages in | 349 | 253 | 0 |
|2)e) above) | | | |
|----------------------------------+--------+---------+------|
|Noncompliant | 23 | 150 | 1 |
|----------------------------------+--------+---------+------|
|Corrections Issued | 23 | 146 |1 |
------------------------------------------------------------
------------------------------------------------------------
|If Compliant, interpretive | Chain |Communit|Clinic |
|services provided by: | Store | y | |
|----------------------------------+--------+--------+-------|
|Staff only | 17 | 2 | 0 |
|----------------------------------+--------+--------+-------|
|Telephone (e.g. language line) | 68 | 51 | 0 |
|----------------------------------+--------+--------+-------|
|Combination of staff and | 260 | 199 | 43 |
|telephone | | | |
|----------------------------------+--------+--------+-------|
|Other | 0 | 1 |0 |
| | | | |
------------------------------------------------------------
e) Notice to Consumers . The Board also adopted regulations
to require every pharmacy to post, in a conspicuous place,
a notice informing consumers, among other information, of
their right to ask for, and receive from any pharmacy,
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prescription drug labels in 12-point font and the
availability of interpreter services upon request at no
cost. The required notice includes the following: "Point
to your language. Interpreter services will be provided to
you upon request at no cost." This text is required to be
repeated in at least the following 12 languages: Arabic,
Armenian, Cambodian, Cantonese, Farsi, Hmong, Korean,
Mandarin, Russian, Spanish, Tagalog, and Vietnamese. The
pharmacy may post this notice in paper form or on a video
screen if the posted notice or video screen is positioned
so that a consumer can easily point to and touch the
statement identifying the language in which he or she
requests assistance. Otherwise, the notice is required to
be made available on a flyer or handout clearly visible
from and kept within easy reach of each counter in the
pharmacy where dangerous drugs are dispensed or furnished.
f) United States Pharmacopeia Convention (USP)
Recommendations . USP is a non-profit organization and it
is the official pharmacopeia of the United States,
published dually with the National Formulary as the USP-NF.
USP establishes written (documentary) and physical
(reference) standards for medicines, food ingredients, and
dietary supplement products and ingredients. These
standards are used by regulatory agencies and manufacturers
to help to ensure that these products are of the
appropriate identity, as well as strength, quality, purity,
and consistency. Prescription and over-the-counter
medicines available in the United States must, by federal
law, meet USP-NF public standards, where such standards
exist. Many other countries use the USP-NF instead of
issuing their own pharmacopeia or to supplement their
government pharmacopeia.
In addressing LEP, USP indicated that whenever possible, the
directions for use on a prescription container label should
be provided in the patient's preferred language. Otherwise
there is a risk of misinterpretation of instructions by
patients with LEP, which could lead to medication errors
and adverse health outcomes. Additionally, whenever
possible, directions for use should also appear in English,
to facilitate counseling; the drug name is required to be
in English so that emergency personnel and other
intermediaries can have quick access to the information.
Translation of prescription medication labels should be
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produced using a high quality translation process such as
translation by a trained translator who is a native speaker
of the target language; review of the translation by a
second trained translator; and, reconciliation of the
differences. If a high-quality translation process cannot
be provided, labels should be printed in English and
trained interpreter services used whenever possible to
ensure patient comprehension. The use of
computer-generated translations should be limited to
programs with demonstrated quality because dosage
instructions can be inconsistent and potentially hazardous.
Standardized translated instructions and technology
advances are needed to ensure the accuracy and safety of
prescription container labeling for LEP patients.
g) Developing Translations . CPEHN submitted an article to
the Committee entitled, "Developing Multilingual
Prescription Instructions for Patients with Limited English
Proficiency," which describes how the translations of the
directions for use that were published on the Board's
Website were developed and adopted into Chinese, Korean,
Russian, Spanish, and Vietnamese. According to the
article, to be patient-centered, the instructions took into
account:
i) Literacy. Instructions were written in Arial (a
sans-serif font), used numbers instead of the written
equivalent and were written in sentence format, with only
the first letter capitalized. Simpler terms were used
instead of less familiar or difficult terms.
Medication-taking was associated with four distinct time
periods (morning, noon, evening, bedtime);
ii) Language. The instructions were translated into the
five languages via a committee approach, involving three
translators to allow for multiple viewpoints and diverse
skill; and,
iii) Culture. Beyond language, cultural distinctions
that could affect the way in which medication
instructions were understood. For example, translators
suggested avoiding any mention of meals in directions.
The study also specified certain challenges that were
encountered, including: (1) finding equivalent terms; (2)
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ensuring similar reading levels; (3) accounting for
regional differences; and, (4) managing changes in label
and formatting. The article concluded that this study
constitutes a first step towards developing
patient-centered, multilingual medication instructions for
use within current pharmacy labeling practices. Findings
from the process of improving, translating, and adapting
medication instructions can be used to better inform the
development of other patient materials, within the pharmacy
or in other health care settings.
h) Computer-Generated Medicine Labels . In 2010, the
Journal of the American Academy of Pediatrics published a
study entitled, "Accuracy of Computer-Generated,
Spanish-Language Medicine Labels." The objective of the
study was to evaluate the accuracy of translated
Spanish-language medicine labels among pharmacies in a
borough in New York with a large Spanish-speaking
population. As part of the study, a cross-sectional,
telephone survey of all pharmacies in the Bronx, New York
was performed. Selected pharmacies were visited to learn
about the computer software being used to generate Spanish
medicine labels. Outcomes included the proportion of
pharmacies providing Spanish medicine labels, frequency of
computerized translation, and description of Spanish
medicine labels produced. The study identified 14
different computer programs used to generate Spanish
labels. Overall, 32 Spanish labels (43%) included
incomplete translations (a mixture of English and Spanish)
and six additional labels contained misspellings or grammar
errors, which resulted in an overall error rate of 50%.
The study indicated that phrases that were not translated
included "dropperfuls, apply topically, for seven days, for
30 days, apply to affected areas, with juice, take with
food, and once a day"
3)SUPPORT . CPEHN states in support of this bill that: a) LEP
patients often have more trouble understanding prescription
instructions than patients who read English and that while
having access to an interpreter or bilingual pharmacist or
physician helps LEP patients understand how to take their
medication, patients still need to be able to understand
written prescription instructions once they are at home; b)
quality multilingual prescription drug instructions are
available; and, c) as California moves forward with the
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implementation of the Patient Protection and Affordable Care
Act, more LEP individuals will have access to health care
coverage and prescription medications, and for pharmacies to
meet the needs of Californians, translated instructions
provided by the Board must be utilized.
The California Alliance for Retired Americans, Latino Coalition
for a Healthy California, California Health Advocates, Asian
Law Alliance, California Immigrant Policy Center, Southeast
Asia Resource Action Center, and California State Retirees all
support this bill and state that many medication disasters can
be avoided by simply printing translated directions onto
prescription medication labels and this bill would assist LEP
patients to read and understand their prescriptions.
4)OPPOSITION . Rite Aid indicates in opposition that the
requirements of this bill are unnecessary and there is no
evidence that the current regulations adopted by the Board are
not working effectively. The California Retailers
Association, California Pharmacists Association, National
Association of Chain Drug Stores, and California Grocers
Association state the following:
a) Liability. A pharmacist can only certify the accuracy
of instructions in languages in which a pharmacist can
read, write, and understand, and they cannot be expected to
know whether the non-English instructions are correct. If
the label is incorrect, not only does that make a
pharmacist liable for the accuracy and clarity of
instructions that he or she does not understand, it also
places the patients at risk and could lead to more patient
medication errors.
b) Unnecessary. The Board already requires pharmacies to
provide live, over-the phone interpreter services in more
than 150 languages and dialects to patients upon request
and at no cost to the consumer. The live interpreter
services involve a three-way consultation between the
patient, the pharmacist, and the translator.
c) Lack of Studies. There are no peer-reviewed studies
that ties English labels to medication errors.
5)DOUBLE REFERRAL . This bill is double referred, should it pass
out of this Committee, it will be referred to the Assembly
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Business, Professions & Consumer Protection Committee.
6)RELATED LEGISLATION .
a) AB 396 (Fox) requires that every prescription 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. AB 396 also
requires that every prescription container be correctly
labeled to include that information, if so indicated on the
prescription, unless the patient or prescriber requests
that this information be omitted. AB 396 is currently in
the Assembly Rules Committee awaiting referral.
b) AB 1136 (Levine) 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.
AB 1136 is pending in the Senate Appropriations Committee.
c) SB 205 (Corbett) requires the information on the
prescription label to be printed in at least a 12-point
sans serif typeface. SB 205 is pending in the Assembly
Health Committee.
d) SB 289 (Correa) makes it unlawful for a person to drive
a motor vehicle if his or her blood contains any detectable
amount of a drug classified in Schedules I, II, III, or IV
of the California Uniform Controlled Substance Act, unless
the drug was consumed in accordance with a valid
prescription issued to the person by a licensed health care
practitioner. SB 289 is pending in Senate Public Safety
Committee.
7)PREVIOUS LEGISLATION .
a) SB 472 (Corbett), Chapter 470, Statutes of 2007,
requires the Board 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.
b) AB 1276 (Karnette) of 2007 would have required
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prescribers of medications to ask the patient whether to
indicate the intended purpose of the prescription on the
prescription's label. AB 1276 died in Assembly Business
and Professions Committee.
c) SCR 49 established 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.
d) AB 657 (Karnette) of 2005 would have required
prescription labels to include the intended purpose of the
drug, if indicated on the prescription, and would have
required a physician, dentist, optometrist, podiatrist, and
other specified drug prescriber, to ask the patient, or
patient's representative whether to indicate the intended
purpose of the prescription on the label. AB 657 died in
Senate Business, Professions and Economic Development
Committee.
e) AB 288 (Mountjoy) of 2005 would have required the
prescription container to be labeled with the condition for
which the drug was prescribed, unless the patient,
physician, or a parent or legal guardian of a minor patient
requests that the information be omitted. AB 288 died in
Assembly Health Committee.
f) AB 2125 (Levine) of 2004 would have required a physician
and surgeon to indicate a patient's diagnosis on each
prescription, as specified, and would have required the
prescription label to include the condition for which the
drug was described, unless the patient directs the
pharmacist not to include this information on the label.
AB 2125 died in Assembly Health Committee.
g) 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.
h) AB 2099 (Epple), Chapter 397, Statutes of 1993, requires
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.
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8)POLICY COMMENTS .
a) Certification . This bill authorizes the translations of
the directions of use into additional non-English languages
if certified translation services are utilized. It is not
clear what those are, who certifies translation services,
and how this will be enforced. The Committee may wish to
amend this bill and specify certification requirements, or
in the alternative, allow the Board to certify these
translation services.
b) Pharmacy Translations . This bill authorizes a pharmacy,
as an alternative to the translations published on the
Board's Website, to use its own translations. However, the
bill does not include standards for the development of
these translations and this could have the unintended
effect of creating inconsistent and erroneous translation.
It is important for purposes of patient safety to have
accurate translations and to have an entity that is
accountable for the accuracy of translations, aside from
the pharmacists. The Committee may wish to amend this bill
to require pharmacies to use certified translation services
when the Board's translations are not utilized.
c) Directions for use in English . To minimize errors and
facilitate counseling with physicians, other health care
providers, and caregivers who are not able to read and
understand the translations, the Committee may wish to
amend this bill to require that the directions for use also
be printed in English.
REGISTERED SUPPORT / OPPOSITION :
Support
California Pan Ethnic Health Network (sponsor)
Asian Americans for Civil Rights and Equality
Asian Law Alliance
Asian Pacific American Legal Center
Asian Pacific Community in Action
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Asian Pacific Islander Caucus for Public Health
California Alliance for Retired Americans
California Commission on Aging
California Communities United Institute
California Health Advocates
California Immigrant Policy Center
California State Retirees, Chapter 1
Consumers Union
Health Through Action Arizona
Korean Community Center of the East Bay
Latino Coalition for a Healthy California
National Association of Social Workers, California Chapter
Paramedics Plus
Pharmacists Planning Services, Inc.
Southeast Asia Resource Action Center
Street Level Health Project
Vision y Compromiso
Western Center on Law and Poverty
Worksite Wellness LA
Opposition
California Grocers Association
California Korean American Pharmacists Association
California Pharmacists Association
California Retailers Association
National Association of Chain Drug Stores
Rite Aid
Analysis Prepared by : Rosielyn Pulmano / HEALTH / (916)
319-2097