BILL ANALYSIS Ó
AB 1073
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Date of Hearing: April 21, 2015
ASSEMBLY COMMITTEE ON BUSINESS AND PROFESSIONS
Susan Bonilla, Chair
AB 1073
(Ting) - As Amended April 6, 2015
SUBJECT: Pharmacy: prescription drug labels.
SUMMARY: Requires the Board of Pharmacy (BOP) to post
translated standardized directions for use in at least five
languages other than English on its website. The bill requires
pharmacists to provide these directions to patients with limited
English proficiency, and limits the liability against pharmacies
if the inaccurate standardized translations are provided to a
patient.
EXISTING LAW:
1)Provides for the licensure and regulation of pharmacists by
the BOP within the Department of Consumer Affairs (DCA).
(Business and Professions Code (BPC) § 4101 et seq.)
2)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: (BPC § 4076)
a) Unless otherwise ordered by the prescriber, the
manufacturer's trade name of the drug or the generic name
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and the name of the manufacturer;
b) The directions for the use of the drug;
c) The name of the patient or patients;
d) The name of the prescriber;
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 and the
condition 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.
3)Requires the BOP to promulgate regulations that require, on or
before January 1, 2011, a standardized, patient-centered,
prescription drug label on all prescription medicine dispensed
to patients in California. (BPC § 4076.5)
THIS BILL:
1) Requires a dispenser to use a standardized direction for use
on the label of the prescription container from a list in
existing regulations.
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2)Requires the BOP to make available translations of the
standardized directions for use, in a minimum of five (5)
languages other than English,
3)Requires the BOP to post the standardized directions for use
on its website.
4)Requires a dispenser, upon request of a patient, to provide
the appropriate translated standardized direction for use, and
append it to the label on a patient's prescription container
or provide it on a supplemental document.
5)Authorizes a dispenser to provide his or her own translated
directions as an alternative.
6)Exempts a dispenser who complies with the requirement to
select the translated standardized direction for use from
civil liability if there is an error in appending the
direction for use to the medication container or on a
supplemental document.
7)FISCAL EFFECT: Unknown. This bill is keyed fiscal by the
Legislative Counsel.
COMMENTS:
1)Purpose. This bill is sponsored by the Board of Pharmacy .
According to the author, "Access to healthcare is undermined
if patients and medical professionals cannot communicate
effectively. AB 1073 would help limited-English proficient
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(LEP) patients across California access healthcare in their
primary language by helping them understand prescription drug
information in their primary language, a need that can
literally be a matter of life and death. This bill would
require pharmacists to provide LEP patients with translated
directions for use on prescription drug labels, by ensuring
that all LEP patients understand how to take their medication
safely and without error."
2)Background. Business and Professions Code section 4076.5,
requires the BOP to develop standardized, patient-centered
prescription labels. In 2010, the BOP adopted regulations to
require directions for use and improved font types and sizes
on the labels of prescription drug containers.
In order to address the needs of patients with LEP, the BOP
regulations also require pharmacies to provide oral
translation services in at least 12 languages via on-site or
telephone - based interpretive services. The BOP is also
required to publish on its website standardized and translated
directions for use in at least five languages other than
English including, 1) Chinese, 2) Korean, 3) Russian, 4)
Spanish and 5) Vietnamese. However, these translations have
not been widely adopted by pharmacies due to concerns about
liability in the event that there are errors in the translated
materials that pharmacy staff may be unable to detect.
Patients with Limited English Proficiency (LEP). A report
from the Institute of Medicine estimates that at least 1.5
million Americans are sickened, injured or killed each year
because of medication errors. This is particularly troubling
when one examines the growing and diverse population of
California. According to data from the 2010 U.S. Census, of
the more than 6.5 million residents of California, one out of
every five speak English "less than very well." Additionally,
over 44% of Californians speak a language other than English
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at home and almost half of Medi-Cal enrollees have LEP.
It can be difficult for even the most educated patient to
understand complicated medication regimens. According to an
article in the Journal of the American Medical Association,
46% of adults cannot understand the information listed on
their prescription drug labels. When factoring in a patient
who has LEP, this problem is exacerbated as there are
communication barriers that may result in a lack of
understanding and a lack of adherence to a prescribed
medication regimen. For example, a study in the Journal of
the American Medical Association revealed that patients who
have LEP, who do not receive adequate interpreter services
when needed, are unlikely to understand their diagnosis and
treatment provided by their physician. Additionally, a study
in the Journal of General Internal Medicine found that
patients who have LEP, 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.
Other States. In 2007, a study in the Journal of the American
Medical Association found that of 200 pharmacists in New York
City, 88% reported serving patients with LEP. The pharmacists
reported that 78% of the patients spoke Spanish and 16% spoke
Chinese.
In 2012, New York enacted the first state law that requires
all chain and mail order pharmacies to provide comprehensive
translation and interpretation services for patients who have
LEP, including written translations of all prescription drug
labels and directions for use.
3)Prior Related Legislation. SB 204 (Corbett) of 2013,
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originally required translations of the direction for use in
non-English languages published on the BOP's website to be
used on labeling prescription containers, but was later
amended to require the BOP to survey pharmacists' compliance
with using standardized directions. NOTE: This bill was
vetoed by Governor Brown because he indicated that the BOP did
not have the resources to conduct the surveys.
ARGUMENTS IN SUPPORT:
The Board of Pharmacy (sponsor) writes in support, "The board
believes that AB 1073 contains important provisions to aid
patients in understanding how to take their prescription
medications accurately. Moreover, AB 1073 represents another
important milestone in the development of patient-centered
labels in California. Enactment of this bill will encourage
pharmacists to cut and paste the translations available from the
board's Web site, when applicable, who currently state they are
reluctant to use them because they cannot read the language
themselves - the waiver of liability for an inadvertent mistake
resolves this issue."
The California Healthy Nail Salon Collaborative writes in their
letter of support, "The Collaborative comprises over 40 public
health and environmental advocates, nail salon workers and
owners, and allies in government agencies. The Collaborative
focuses on language access for members of the nail salon
community, 59-80 % are Vietnamese. Many of those individuals
are Limited English Proficient?We think that AB 1073 is a good
idea and it's about time, especially given the diversity of
language in California."
The California Pan-Ethnic Health Network states in their letter
of support, "A patient's first and best source of information
about their medication is the prescription label?LEP patients
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are more than twice as likely as English speaking patients to
have difficulty understanding their medications. This lack of
understanding results in an increased risk of adverse drug
reactions and non-compliance with drug regimens."
AMENDMENT:
In order to clarify that it is the professional judgment of a
dispenser to decide when a standardized direction or use on the
label of a prescription is applicable, the following amendment
should be made:
On page 2, in line 4, after "when applicable" please add: and in
the professional judgment of a dispenser
ARGUMENTS IN OPPOSITION:
None on file.
REGISTERED SUPPORT:
Board of Pharmacy (sponsor)
California Healthy Nail Salon Collaborative
California Pan-Ethnic Health Network
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REGISTERED OPPOSITION:
None on file.
Analysis Prepared by:Le Ondra Clark Harvey, Ph.D. / B. & P. /
(916) 319-3301