BILL ANALYSIS Ó
AB 1073
Page 1
ASSEMBLY THIRD READING
AB
1073 (Ting)
As Amended April 28, 2015
Majority vote
------------------------------------------------------------------
|Committee |Votes |Ayes |Noes |
| | | | |
| | | | |
|----------------+------+---------------------+--------------------|
|Business & |14-0 |Bonilla, Jones, | |
|Professions | |Baker, Bloom, | |
| | |Campos, Chang, Dodd, | |
| | |Eggman, Gatto, | |
| | |Holden, Mullin, | |
| | |Ting, Wilk, Wood | |
| | | | |
|----------------+------+---------------------+--------------------|
|Appropriations |16-0 |Gomez, Bigelow, | |
| | |Bloom, Bonta, | |
| | |Calderon, Chang, | |
| | |Daly, Eggman, | |
| | |Eduardo Garcia, | |
| | |Holden, Jones, | |
| | |Quirk, Rendon, | |
| | |Wagner, Weber, Wood | |
| | | | |
| | | | |
------------------------------------------------------------------
AB 1073
Page 2
SUMMARY: Requires the Board of Pharmacy (BOP) to post translated
standardized directions for use in at least five languages other
than English on its Web site. This 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.
Specifically, this bill:
1)Requires a dispenser, in his or her professional judgment, to
use a standardized direction for use on the label of the
prescription container from a list in existing regulations.
2)Requires the BOP to make available translations of the
standardized directions for use, in a minimum of five languages
other than English,
3)Requires the BOP to post the standardized directions for use on
its Web site.
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.
AB 1073
Page 3
FISCAL EFFECT: According to the Assembly Committee on
Appropriations, the bill will result in minor and absorbable costs
to the BOP.
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.
AB 1073
Page 4
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 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.
AB 1073
Page 5
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.
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 are more
than twice as likely as English speaking patients to have
AB 1073
Page 6
difficulty understanding their medications. This lack of
understanding results in an increased risk of adverse drug
reactions and non-compliance with drug regimens."
Arguments in Opposition:
None on file.
Analysis Prepared by:
Le Ondra Clark Harvey, Ph.D. / B. & P. / (916)
319-3301 FN: 0000311