BILL ANALYSIS Ó
AB 1073
Page 1
CONCURRENCE IN SENATE AMENDMENTS
AB
1073 (Ting)
As Amended September 4, 2015
Majority vote
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|ASSEMBLY: |76-0 |(May 14, 2015) |SENATE: |40-0 |(September 9, |
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Original Committee Reference: B. & P.
SUMMARY: Requires dispensers, upon request of a patient or
patient's representative, to provide translated directions,
provided by the Board of Pharmacy (BOP), for use on prescription
containers. Specifies that a dispenser is responsible for the
accuracy of the English-language directions provided to the
patient.
The Senate amendments:
1)Specify that, 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. If
translated directions for use appear on a prescription
container or label, the English-language version of the
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directions for use shall also appear on the container or
label, whenever possible, and may appear on other areas of the
label outside the patient-centered area. When it is not
possible for the English-language directions for use to appear
on the container or label, it shall be provided on a
supplemental document.
2)Permit a dispenser to use translations made available by the
board pursuant to subdivision (b) of Section 1707.5 of Title
16 of the California Code of Regulations.
3)Specify that a dispenser may provide his or her own translated
directions for use to comply with the requirements of this
section, and shall not be required to provide translated
directions for use beyond the languages that the board has
made available or beyond the directions that the BOP has made
available in translated form.
4)Indicate that 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.
5)Specify that a dispenser shall be responsible for the accuracy
of the English-language
directions for use provided to the patient. This section
shall not affect a dispenser's existing responsibility to
correctly label a prescription pursuant to Section 4076.
6)Clarify that for purposes of this section, a dispenser does
not include a veterinarian.
7)Specifies that a dispenser shall use professional judgment to
provide a patient with directions for use that enhance the
patient's understanding of those directions, consistent with
the prescriber's instructions.
FISCAL EFFECT: According to the Senate Appropriations
Committee, pursuant to Senate Rule 28.8, negligible state costs.
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COMMENTS:
Purpose. This bill is sponsored by the BOP. According to the
author, "Access to healthcare is undermined if patients and
medical professionals cannot communicate effectively. AB 1073
would help limited-English proficient (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. "
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 Web site 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 United States Census, of the
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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 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.
Analysis Prepared by:
Le Ondra Clark Harvey, Ph.D. / B. & P. / (916)
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319-3301 FN:
0002355