BILL ANALYSIS Ó
SENATE COMMITTEE ON
BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT
Senator Jerry Hill, Chair
2015 - 2016 Regular
Bill No: AB 1073 Hearing Date: July 6,
2015
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|Author: |Ting |
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|Version: |June 9, 2015 |
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|Urgency: |No |Fiscal: |Yes |
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|Consultant|Sarah Mason |
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Subject: Pharmacy: prescription drug labels.
SUMMARY: Requires a dispenser to use a standardized direction for use
on the label of a prescription container for limited English
proficient patients in five languages, according to translations
provided by the Board of Pharmacy on its website. Authorizes a
dispenser to provide his or her own translated directions in any
language other than English as an alternative to the
translations made available by the Board. Specifies that a
dispenser who provides the Board's translated directions for use
shall not be liable for civil damages for any error that results
from the inability of the dispenser to understand a translated
direction for use in a language other than English.
Existing law:
1)Under the Pharmacy Law, provides for the licensure and
regulation of pharmacies, pharmacists and wholesalers of
dangerous drugs or devices by the Board within the Department
of Consumer Affairs (DCA). (Business and Professions Code
(BPC) § 4000 et seq.)
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
upon the prescription of a physician, dentist, podiatrist,
optometrist, veterinarian or naturopathic doctor. (BPC §
4059)
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3)Requires that each prescription dispensed by a pharmacist must
be in a container complying with state and federal law and
correctly labeled as specified, 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 for which the drug was prescribed if
requested by the patient and the condition is indicated on
the prescription.
aa) The physical description of the dispensed
medication, including its color, shape, and any
identification code that appears on the tablets or
capsules. (BPC § 4076)
4)Requires the Board to promulgate regulations on or before
January 1, 2011, for a standardized, patient-centered,
prescription drug label on all prescription medication
dispensed in the state. (BPC § 4076.5 (a))
5)Requires the Board to hold public meetings statewide in order
to seek information on a standardized label from groups
representing consumers, seniors, pharmacists, the practice of
AB 1073 (Ting) Page 3
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pharmacy, other health care professionals, and other
interested parties. (BPC § 4076.5 (b))
6)Requires the Board, when considering the requirements for
prescription labels, to consider: (BPC § 4076.5 (c))
a) Medical literacy research.
b) Improved directions for use.
c) Improved font types and sizes.
d) Placement of information that is patient-centered.
e) The needs of patients with limited English proficiency.
f) The needs of senior citizens.
g) Technology requirements necessary to implement the
standards.
7)Establishes the Dymally-Alatorre Bilingual Services Act (Act)
which requires each state agency to conduct a survey, related
to its bilingual services, of each of its statewide offices
which render services to the public every two years to
determine specified information, and to report results and any
additional information requested to the California Department
of Human Resources (CalHR). Requires the survey to contain a
detailed description of complaints regarding language access
received by the agency. The Act also requires each agency
that serves a substantial number of non-English-speaking
people who comprise 5% or more of the people served to develop
an implementation plan, as specified, in every odd-numbered
year, and to submit the implementation plan to the department
for its review. Additionally, the Act requires CalHR, if it
determines that a state agency has not made reasonable
progress toward complying with the Act, to issue orders that
it deems appropriate to effectuate the purposes of the Act.
(Government Code Section 7290 et seq.)
8)Stipulates that, by July 1, 2015, a state agency subject to
the Act must translate and make accessible on the homepage of
its Internet Web site, forms and processes for submitting
complaints of alleged violations of the Act. Also, requires
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that the forms and processes be translated into all languages
spoken by a substantial number of non-English speaking people
served by the state agency. In addition, requires that
translated copies of the forms must be printed and made
available in the statewide office and any local office of the
state agency. (GC § 7299.3)
This bill:
1) Requires a dispenser to use a standardized direction for use
on the label of a prescription container from the list
provided in the Board's regulations establishing the patient
centered label.
2) Requires the Board to make available translations, in a
minimum of five languages other than English of the
standardized directions for use. Specifies that the
translations must be approved by qualified translators, as
determined by the Board and that the Board must post these
standardized directions for use on its Internet Web site.
Provides the dispenser a period of 180 days from the date of
adoption of the Board of any change to the translated
standardized directions for use to implement that change.
3) Provides that, upon request of a patient for a translated
direction for use, a dispenser shall select the appropriate
translated standardized direction for use from those made
available by the Board pursuant to the provisions in 2)
above, if available, and append the direction for use to the
label on the patient's prescription container or provide it
on a supplemental document.
4) Provides that if a translated direction for use appears on a
container, the English version of the direction for use shall
also appear on the label. Requires the translated direction
for use to appear in the patient-centered area of the label
in accordance with Board regulations. Authorizes the English
version to appear in an area of the label outside the
patient-centered area.
5) Authorizes a dispenser to provide his or her own translated
directions in any language other than English as an
alternative to the translations made available by the Board
and procedures outlined above. Requires the translated
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direction for use to appear in the patient-centered area of
the label in accordance with Board regulations. Requires the
English version of the direction to appear on the
prescription container if a translated direction for use
appears on a container. Authorizes the English version to
appear in an area of the label outside the patient-centered
area.
6) Provides that a dispenser who provides the Board's translated
directions for use shall not be liable for civil damages for
any error that results from the inability of the dispenser to
understand a translated direction for use in a language other
than English. States that this section does not affect
existing liability under this division for translated
directions not approved by the Board.
FISCAL EFFECT: This bill is keyed "fiscal" by Legislative
Counsel. According to the Assembly Committee on Appropriations
analysis dated May 6, 2015, this bill will result in minor and
absorbable costs to the Board.
COMMENTS:
1. Purpose. The Board of Pharmacy is the Sponsor of this
measure. According to the Author, as healthcare for
California's diverse population becomes increasingly
accessible through Covered California, it is more
critical than ever to ensure that all patients receive
culturally-competent care. The Author cites the 2010
U.S. Census which found that more than 6.5 million
residents of California, one out of every five, speak
English "less than very well." Over 44% of Californians
speak a language other than English at home.
Furthermore, almost half of Medi-Cal enrollees are
limited English proficient (LEP), with 3 million more
enrollees expected to need language assistance over the
next five years as the program expands. According to
the Author, research has found that difficulty in
understanding instructions results in lack of adherence
to a prescribed medication regimen, as well as dangerous
and sometimes fatal medical reactions that could have
been easily avoided. The Author states that this
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problem rings true for all patients, as prescription
medication information is complex and cannot be easily
imparted during brief consultations with a pharmacist.
The risk of falling victim to the problem is
particularly high for LEP patients who face
communication barriers with health care providers and
pharmacists.
According to the Author, research published in the
Journal of General Internal Medicine found that LEP
individuals who received translated standardized
directions for use were more likely to take a single
prescription medication appropriately, dose more
medications correctly in a multi-drug regimen, and
simplify medication use by consolidating when pills
should be taken.
According to the Author, there is no existing law that
requires dispensers to provide patients with translated
directions for use. According to the Author, in attempt
to address the needs of Limited English Proficient (LEP)
patients, Board regulations require pharmacies to
provide oral translation services in at least 12
languages via on-site or telephone-based interpretive
services, and require the Board to publish on its
website standardized and translated directions for use
in at least five languages other than English. The
Author notes that although translations have been posted
in Chinese, Korean, Russian, Spanish, and Vietnamese,
they have not been widely adopted by pharmacies.
According to the Author, the broad utilization of these
translated materials by pharmacies has been impeded by
concerns over liability in the event that there are
inadvertent errors in materials which pharmacy staff
cannot detect. The Author states that this bill would
require pharmacists to provide LEP patients with a
translated standardized direction for use, and remove
barriers for utilization of these translations, bringing
the state one big step closer to making patient-centered
prescription labels available.
2. Government Agency Efforts to Serve California's LEP
Population. The Dymally-Alatorre Bilingual Services Act
ensures that all residents, including those who are LEP,
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have equal access to public services. The Act requires
every state and local agency to have a sufficient number
of qualified bilingual staff and translated written
materials so that the LEP population they serve are able
to effectively access and communicate with government.
The Act became law in 1973 with the Legislative intent
of ensuring people are not precluded from accessing
public services because of language barriers. It
requires agencies to provide the same information that
is available in English in other languages if the agency
services a "substantial number" of non-English speakers.
To determine which languages must be included under the
defined threshold, agencies are required to conduct
surveys every other year to assess their contact with
non-English speakers. Then, they must create or update
implementation plans to ensure compliance and submit
them to CalHR.
3. Medication Errors and Legislative Response. According
to the Journal of the American Medical Association, 46
percent of adults cannot understand the information
listed on their prescription drug labels. Furthermore,
the Institute of Medicine of the National Academies
indicates that medication errors are among the most
common medical errors, harming at least 1.5 million
people annually. Families USA reports that 90 percent
of Medicare patients take medications for chronic
conditions with nearly half of them taking five or more
medications a day. Given the large numbers of
prescriptions that may be prescribed, it is not easily
discernable what the purpose for each of these
medications is. This increases the chances that a
patient may take the wrong medication increasing the
likelihood of serious injury or death.
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 regarding
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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 was pursued in response to the Panel report.
SB 472 , The California Patient Medication Safety Act,
(Corbett, Chapter 470, Statutes 2007) sought to deal
with the lack of uniformity in prescription drug labels
throughout the state and the resulting confusion and
medication errors that may arise. Much of the
conversation during the SB 472 debate focused on the
fact that individual pharmacies design and format their
own labels, resulting in a lack of standards across all
pharmacies which adversely affects medication users who
are elderly, suffer from poor vision, have difficulty
reading and understanding instructions on labels or have
limited English proficiency.
The bill required 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
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Legislature by January 1, 2010, on its progress in
implementing these regulations.
4. Implementation of a Standardized Prescription Drug Label
by the Board of Pharmacy. California is the first state
to require redesigned prescription container labels to
emphasize information most important to consumers
offering an element of safety and consistency since
prescription labels are the key source of patients'
reference for information when taking medications in
their homes. Part of this current requirement also
ensures that oral interpreter services are available to
limited English speaking patients in pharmacies, to
insure such patients have access to information about
how to take their medications.
The Board was charged with promulgating regulations that
require a standardized, patient-centered prescription
drug container label for all prescription drugs
dispensed to patients in California. The Board reported
on its efforts in a January 2010 report to the
Legislature. The Board established a "SB 472 Medication
Label Subcommittee" in January of 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.
When asked what to change on the prescription label, the
top responses were:
1. Print should be larger or darker = 30.1%
2. Nothing needs to be changed on the label
=24.6%
3. Include purpose of drug = 12%
The Board concluded that most consumers participating in
the survey requested larger and bolder type font on
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prescription labels to increase readability. Many
participants suggested that if a generic drug is
provided, the prescription label should state the name
of the generic drug name and the brand-name it is
generic for. They also noted that color printing and
highlighting on labels brings attention to important
information. Some participants suggested that the labels
themselves be color-coded to help differentiate between
multiple medications and family members. Many consumers
responded that they want to know "what the drug is for"
and suggested that "the purpose of drug" be printed
directly on prescription labels.
The Board approved a regulation per the requirements set
forth in SB 472 after engaging in a lengthy process.
The Board conducted outreach, hearings and information
gathering sessions throughout 2008, to collect data from
the public on prescription labels and standards for
those labels. 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.
Throughout early 2010, the Board held regulation
hearings to adopt the proposed regulation, a new section
at Title 16 California Code of Regulations Section
1707.5 - "Requirements For Patient-Centered Prescription
Container Labels." The regulation outlines that the
following items must be clustered into one area of the
label that comprises at least 50 percent of the label,
using at least 10-point font using sans serif typeface,
listing these items in the following order:
Name of the patient.
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Name of the drug and strength of the drug. ("Name
of the drug" means either the manufacturer's trade
name, or the generic name and the name of the
manufacturer.)
Directions for use.
Purpose or condition, if entered onto the
prescription by the prescriber, or otherwise known to
the pharmacy, and its inclusion on the label is
requested by the patient.
Since the adoption of the regulation, the Board has continued
to evaluate the implementation of the requirements provided
under SB 472. When the Board initially promulgated the
regulation, a requirement was included for the Board to
reevaluate the regulation by December 2013. In April 2013,
the Board's Public Education subcommittee began its review of
the regulation. As a result of discussions at these
subcommittee meetings (which are presented to the full Board
for further discussion at Board meetings), in April 2014 the
Board initiated a new rulemaking request to change the font
size to a minimum of 12-point, rather than the current
10-point. Additionally, the new rulemaking request requires
that only four items be clustered into one area of the label
that comprises at least 50 percent of the label. The Board
continues to discuss the directions for use component of the
standardized label at its Public Education subcommittee
meetings.
1. Translation Efforts by the Board. The regulation outlining
requirements for a patient-centered label also requires
pharmacies to have policies and procedures in place to help
patients with limited or no English proficiency and
understand the information on the label in the patient's
language. The pharmacy's policies and procedures must be
specified in writing, and must include, at minimum, the
selected means to identify the patient's language, and to
provide interpretive services in the patient's language.
Pharmacies must provide, at minimum, 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
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adjacent to the pharmacy counter.
Following the implementation of the patient-centered
prescription label requirements, the Board also promulgated a
regulation to amend its Notice to Consumers poster which has
also been printed in six additional languages: Chinese,
Korean, Russian, Spanish, Tagalog, and Vietnamese, and which
is available upon request from the Board or available for
download from the Board's website. Pharmacies are also
authorized to request Board approval of another format or
display methodology. The Board also developed a "Point to
Your Language" poster, which is required to be posted in
pharmacies at or adjacent to the pharmacy counter so that
consumers can point to a language to receive interpreter
services. The "Point to Your Language" text is printed in
12 languages: Arabic, Cambodian, Farsi, Korean, Russian,
Tagalog, Armenian, Cantonese, Hmong, Mandarin, Spanish and
Vietnamese.
According to the Board, The California Endowment, in an
effort to support quality labels for those who do not read
English, funded a project with national patient literacy
researchers to develop and vet translations of the Board's
standardized directions for use as outlined in the
patient-centered label regulation. According to information
provided to the Board by one of the project leaders, the
effort is a very intensive process and, while he would like
to include more languages, based on the timeline provided in
the regulation, translation of the standard directions for
use in five languages is reasonable. The Board determined
then that it will not require a pharmacy or pharmacist to
provide patients with written translated prescription drug
labels but specified that the adopted regulation does not
prohibit a pharmacy from providing translated prescription
drug labels to patients. The Board determined at the time it
provided a final statement of reasons for its proposed
regulation that providing fully vetted translations into five
languages other than English of the standard directions for
use, as well as the oral language interpretive services
available, serve the needs of LEP patients.
The Board's website provides the following disclosure related
to the translated directions for use stemming from the
California Endowment project: "While every effort was made
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to ensure accuracy and reliability of these translations, the
Board cannot ensure that a particular translation is
appropriate for a particular patient. The Board recommends
that each pharmacy and pharmacist confirm the validity and
the medical appropriateness of any given translation for a
particular patient before using it for the patient's drug
label.
2. Prior Related Legislation. AB 2253 (Ting, Chapter 469,
Statutes of 2014) updated the Dymally-Alatorre Bilingual
Services Act to require, by July 1, 2015, a state agency
subject to the Act to translate and make accessible on the
homepage of its Internet Web site, forms and processes for
submitting complaints of alleged violations of the Act.
Required that the forms and processes be translated into all
languages spoken by a substantial number of non-English
speaking people served by the state agency. Required that
translated copies of the forms must be printed and made
available in the statewide office and any local office of the
state agency. Required CalHR to issue orders that it deems
appropriate to effectuate the purposes of the Act if a state
agency has not made reasonable progress toward reaching
compliance.
SB 204 (Corbett) of 2013-14 originally would have required
pharmacists to use the translated standard directions for use
from the Board's website when providing patients with
translated directions in Spanish, Chinese, Vietnamese,
Korean, and Russian on their prescription medication labels
and would have required pharmacists to use certified
translation services if they choose to provide translations
in languages other than the five provided on the Board's
website. The bill was amended to require the Board to
conduct a survey of pharmacists and vendors of electronic
health records to gather information about the utilization
of, and the obstacles to, the use the Board's standardized
directions for use on prescription drug labels. ( Status:
The measure was vetoed by Governor Brown who indicated in his
veto message that "the Board currently does not have the
resources to conduct these surveys.")
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. ( Status: The bill was vetoed
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by Governor Brown who indicated in his veto message that "the
Board 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.")
AB 396 (Fox) of 2013 would have required 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.
Also, would have required that every prescription container
be correctly labeled to include that information, if
indicated on the prescription, unless the patient or
prescriber requests that this information be omitted.
( Status: The bill was never heard in a policy committee.)
AB 1136 (Levine, Chapter 304, Statutes of 2013) required 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 1390 (Corbett) of 2010 would have repealed the requirement
that the Board 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
established statutory requirements for standardized, patient
centered prescription drug labels. ( Status: The bill failed
passage 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 the
Pharmacy Board to promulgate regulations that require a
standardized, patient-centered, prescription drug label on
all prescription medication dispensed to patients in
California. Additionally, the Board was required to report
to the Legislature by January 1, 2010, on its progress in
implementing these regulations.
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AB 1276 (Karnette, 2007) would have required medication
prescribers to ask a patient if they wanted the intended use
on the prescription label. ( Status: The measure failed
passage in the Assembly Committee on Business and
Professions.)
SCR 49 (Speier, Resolution Chapter 123, Statutes 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, 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. ( Status: The bill
was held in this Committee at the request of the Author.)
AB 288 (Mountjoy, 2005) would have amended the prescription
labeling requirement to include the condition for which the
drug is prescribed unless the patient, physician or legal
guardian requested that the information be omitted. ( Status:
The measure was held in the Assembly Committee on Business
and Professions at the request of the Author.)
AB 2125 (Levine, 2004) would have required a physician and
surgeon to indicate the patient's diagnosis on each
prescription written, unless directed otherwise by the
patient and amended the prescription labeling requirement to
require that the condition be included on the label unless
otherwise directed by the patient. ( Status: The bill was
held in the Assembly Committee on Business and Professions at
the request of the Author.)
SB 292 (Speier, Chapter 544, Statutes of 2003) required
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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.
AB 2099 (Epple, Chapter 397, Statutes of 1993) required 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.
3. Arguments in Support. Writing in support of the bill, a
coalition of groups including the California Pan-Ethnic
Health Network , Asian Americans Advancing Justice-Los
Angeles , California Immigrant Policy Center , Latino
Coalition for a Health California , and Southeast Asia
Resource Action Center , states that studies show that a large
percentage of patients misunderstand dosage instructions on
their labels. The coalition cites The Institute of Medicine
estimate that at least 1.5 million Americans are sickened,
injured, or killed each year because of medication errors,
which are only exacerbated for California's LEP patients.
The coalition states that this lack of understanding results
in an increased risk of adverse drug reactions and
non-compliance with drug regimens. These groups support this
bills effort to reduce medical errors, increase patient
compliance, and meet the needs of LEP patients.
Justice in Aging , Asian Health Services , Touro University of
California , Greenlining Institute , The City Project , and the
California Healthy Nail Salon Collaborative all write in
support of the bill, stating that AB 1073 will improve
patient access to prescription drug information in their
primary languages. According to these organizations,
California is the most linguistically diverse state in the
nation. The 2010 U.S. Census found over 6.5 million
Californians speak English less than "very well," and 44% of
Californians speak a language other than English at home.
The organizations state that this bill will ensure all
Californians, regardless of the language they speak,
understand how to safely and correctly take their medication
by requiring a dispenser to use a standardized direction for
use on the label of the prescription container.
According to the American Federation of State, County and
Municipal Employees , AB 1073 would help LEP patients across
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California by helping them understand prescription drug
information in their primary language. The organization
states that it can be difficult for proficient English
patients to understand complicated medication regimens and
cites an article in the Journal of the American Medical
Association showing that 46% of adults do not understand the
information listed on their prescription drug labels and when
factoring in a patient who has LEP, this problem is
exacerbated.
The California State Board of Pharmacy states that AB 1073
contains important provisions to aid patients in
understanding how to take their prescription medications
accurately. According to the Board, enactment of this bill
will encourage pharmacists to use the translations available
from the Board's Web site, when the pharmacist deems it
appropriate. The Board states that pharmacists have advised
the Board that they are reluctant to use the online
translations because they cannot read the language themselves
and the waiver of liability for an inadvertent transcription
mistake contained in this bill resolves this issue.
Health Access California and Rite Aid Pharmacy state that
prescription medications are an important element of health
care, and AB 1073 recognizes the reality that many
Californians need prescription drug labels in languages other
than English in order for patient to adhere to medication
regimens.
4. Arguments in Opposition. The National Association of Chain
Drug Stores (NACDS) , the California Retailers Association ,
and the California Pharmacists' Association take an oppose
unless amended position and state that the bill would impose
new translation requirements on pharmacies without providing
proper liability protections. According to the
organizations, community pharmacies are required, by law, to
develop prescription labels that provide information in a
manner that is most useful and helpful to patients in
addition to providing oral interpreter services to patients.
A patient can request these interpreter services and the
pharmacy will bring in an interpreter by phone to help in
translating all information necessary for patients to
properly comply with their medications. The groups note that
in 2012, the Board finalized the patient centered labeling
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requirements but did not require translated labels due to
strong concerns raised by pharmacists about their compromised
ability to guarantee accurate information to a patient if a
label was in a language they could not read. According to
the organizations, AB 1073, while mandating translated
labels, does authorize pharmacies to develop and implement
their own translation services including translations on the
label or on an insert, however it does not provide any
liability protection for those pharmacists who work in
pharmacies that choose to provide translation services
through a different means than the Board's five translations
provided on their website. The groups state that in many
cases, pharmacies can develop a more sophisticated and
comprehensive translation program for their patients without
utilizing the more limited Board translations and that these
programs should be covered for liability purposes.
5. Proposed Author's Amendments. In response to concerns raised
by stakeholders as outlined above, the Author proposes
restructuring the bill according to the following:
Strike the current provisions of the bill and replace with:
(a) Upon the request of a patient or patient's
representative, a dispenser shall provide translated
directions for use, which shall be printed on the
prescription container, label, or on a supplemental document.
(b) A dispenser may use translations made available by the
board pursuant to subdivision (b) of Section 1707.5 of Title
16 of the California Code of Regulations to comply with the
requirements of this section.
(c) A dispenser shall not be required to provide translated
directions for use beyond the languages that the board has
AB 1073 (Ting) Page 19
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made available or beyond the directions that the board has
made available in translated form.
(d) Nothing in this section shall be construed to prohibit a
dispenser from providing translated directions for use in
languages beyond those that the board has made available or
beyond the directions that the board has made available in
translated form.
(e) A dispenser shall be responsible for the accuracy of the
English-language directions for use provided to the patient.
(f) For purposes of this section, a dispenser does not
include a veterinarian.
NOTE : Double-referral to Senate Judiciary Committee
SUPPORT AND OPPOSITION:
Support:
American Federation of State, County and Municipal Employees
Asian Americans Advancing Justice-Los Angeles
California Healthy Nail Salon Collaborative
California Immigrant Policy Center
California Pan-Ethnic Health Network
California State Board of Pharmacy (Sponsor)
Greenlining Institute
Health Access California
Justice in Aging, Asian Health Services
Latino Coalition for a Health California
Rite Aid Pharmacy
Southeast Asia Resource Action Center
Touro University of California
The City Project
Opposition:
California Pharmacists' Association
California Retailers Association
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National Association of Chain Drug Stores
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