BILL ANALYSIS Ó
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|SENATE RULES COMMITTEE | SB 204|
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THIRD READING
Bill No: SB 204
Author: Corbett (D)
Amended: 4/24/13
Vote: 21
SENATE BUSINESS, PROF. & ECON. DEV. COMMITTEE : 7-2, 4/22/13
AYES: Price, Block, Corbett, Hernandez, Hill, Padilla, Yee
NOES: Emmerson, Wyland
NO VOTE RECORDED: Galgiani
SENATE APPROPRIATIONS COMMITTEE : 4-1, 5/13/13
AYES: De León, Lara, Padilla, Steinberg
NOES: Hill
NO VOTE RECORDED: Walters, Gaines
SUBJECT : Prescription drugs: labeling
SOURCE : California Pan-Ethnic Health Network
DIGEST : This bill, beginning January 1, 2016, requires
pharmacists to use the translated standard directions for use
from the Board of Pharmacys (Board) Web site when providing
patients with translated directions in Spanish, Chinese,
Vietnamese, Korean, and Russian on their prescription medication
labels; and requires pharmacists to use certified translation
services if they choose to provide translations in languages
other than the five provided on the Board's Web site.
ANALYSIS :
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Existing law:
1. Requires that each prescription dispensed by a pharmacist
must be in a container complying with state and federal law
and correctly labeled as specified.
2. 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.
3. 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
pharmacy, other health care professionals, and other
interested parties.
4. Requires the Board, when considering the requirements for
prescription labels, to consider medical literacy research,
improved directions for use, improved font types and sizes,
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.
This bill:
1. Provides that, beginning January 1, 2016, a pharmacist, when
labeling a prescription container, shall use translations of
the directions for use in non-English languages published on
the Board's Web site.
2. Authorizes a pharmacist to translate the directions for use
in additional non-English languages if certified translation
services are utilized to complete the additional
translations.
Background
Medication errors and legislative response . According to the
Journal of the American Medical Association, 46% of adults
cannot understand the information listed on their prescription
drug labels. Furthermore, the Institute of Medicine of the
National Academies, medication errors are among the most common
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medical errors, harming at least 1.5 million people annually.
Families USA reports that 90% 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 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." The Panel acknowledged that there are a
variety of factors which may increase an individual's risk for
experiencing a medication error. These include (1) low health
literacy; (2) limited English proficiency; (3) cultural
incongruence with healthcare providers; (4) physical, cognitive
and/or other impairments that make understanding and/or
complying with medication instructions difficult; (5) age at
either end of the age spectrum (the variability of a
medication's response, metabolism and dose increases in children
and seniors); (6) multiple medications; (7) multiple
prescribers; (8) non-prescription medication use (including
herbals, dietary supplements, alcohol, and tobacco); and (9)
medication procurement from more than one pharmacy including
mail-order. The Panel stated 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
(Corbett, Chapter 470, Statutes of 2007), the California Patient
Medication Safety Act, 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
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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 Legislature by January 1, 2010, on its progress in
implementing these regulations.
Implementation of a standardized prescription drug label by the
Board . 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:
Print should be larger or darker = 30.1%
Nothing needs to be changed on the label = 24.6%
Include purpose of drug = 12%
The Board concluded that most consumers participating in the
survey requested larger and bolder type font on prescription
labels to increase readability. Many participants suggested
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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 "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% of the
label, using at least a 10-point font sans serif typeface,
listing these items in the following order: (1) name of the
patient; (2) 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); (3) directions
for use; and (4) 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.
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The regulation also requires pharmacies to have policies and
procedures in place to help patients with limited or no English
proficiency, 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
adjacent to the pharmacy counter.
FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes
Local: Yes
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).
SUPPORT : (Verified 5/6/13)
California Pan-Ethnic Health Network (source)
Asian American Center for Advancing Justice
Asian Americans for Civil Rights and Equality
Asian Law Alliance
Asian Pacific American Legal Center
Asian Pacific Community in Action
Asian Pacific Islander Caucus for Public Health
California Alliance for Retired Americans
California Communities United Institute
California Health Advocates
California Immigrant Policy Center
California State Retirees, Chapter 1
Health Through Action Arizona
Latino Coalition for a Healthy California
Paramedics Plus
Southeast Asia Resource Action Center California
Street Level Health Project
Visión y Compromiso
Western Center on Law and Poverty
Worksite Wellness LA
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OPPOSITION : (Verified 5/6/13)
California Grocers Association
California Pharmacists Association
California Retailers Association
National Association of Chain Drug Stores
Rite Aid
ARGUMENTS IN SUPPORT : According to the author's office,
existing regulations provide for interpretation services at a
pharmacy, but neither existing law, nor existing regulations,
provide for translated directions on prescription medication
container labels. The author states that "It is troubling that
studies show about 1/3 of California pharmacies are not
providing translated directions in the patient's preferred
language, upon request. Patients cannot follow directions if
they cannot read them. This large population of Californians is
in danger of misusing their prescription medications and
suffering an adverse drug event because the directions are
provided in a language they cannot read." According to the
author's office, adverse drug events cause over 700,000
emergency room visits around the country every year, and every
year almost 120,000 patients are hospitalized after an emergency
room visit for adverse drug events.
The bill's sponsor, California Pan-Ethnic Health Network
(CPEHN), writes that "for prescription drug labels to meet the
needs of California's limited English proficient patients,
pharmacies should utilize the translated instructions provided
by the Board of Pharmacy. This will provide limited English
patients with prescription instructions that they will
understand which helps increase patient compliance and reduce
medical errors." CPEHN states that in California, 40% of
individuals speak a language other than English at home and an
estimated six to seven million are limited English proficient.
The Asian Law Alliance, California Health Advocates, California
Immigrant Policy Center, and Street Level Health Project state
that millions of Californians will have increased access to
health care coverage and prescription medications with the
implementation of the federal Patient Protection and Affordable
Care Act, among them patients with limited English proficiency
who will benefit from a translated label. They believe that
this bill will finally provide these patients prescription drug
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instructions that they understand which will help reduce medical
errors and improve quality of care.
ARGUMENTS IN OPPOSITION : The California Grocers Association
(CGA) is concerned that the requirements in this bill are
unworkable and could lead to additional confusion for patients
and providers. CGA points out that some pharmacies already
provide oral or written translation services based on community
needs, and that requiring pharmacies to use rigid pre-set use
translations will disrupt those pharmacies' practices despite
the fact that there is no evidence the system is failing to meet
consumer safety needs.
The California Retailers Association (CRA) cites that this bill
may be premature. "The current regulation for the label just
became effective less than two years ago, after the Board and
stakeholders went through a lengthy rule-making process. CRA
believes that before we adopt changes to the current label
standard, it is important to determine whether there is a need
for these changes and whether these changes would provide
consumers with added benefit." CRA also expresses concern that
patient safety may be jeopardized by improper translations, and
cites the difficulty of providing accurate written translations,
as demonstrated by the Board's struggle to adopt standard
translations for the five languages currently translated. Many
languages have different dialects and some languages have
multiple ways of stating the same thing. This bill may do a
disservice to limited English proficient individuals throughout
the state if they are provided with translation that is wrong,
faulty, or does not match with their specific understanding or
ability to read the dialect used on the label. CRA states that
allowing a patient to communicate with a live translator over
the phone will enable a dialogue, and should provide the patient
with more accurate instructions, the opportunity to ask
questions in their primary language, and greater assistance than
a translated label would provide. CRA also points out that many
pharmacies have invested in labeling software that does not have
the flexibility to accommodate incorporating different languages
into the label. Many pharmacies would have to bear significant
costs to purchase software enhancements that would be necessary
for them to comply with the translation requirements of this
bill.
The California Pharmacists Association (CPhA) cites the
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reasonable balance that was struck during the Board's
exhaustive, collaborative rulemaking process to implement a
standardized label and lack of data indicating that the existing
regulations are insufficient to protect patients. CPhA believes
that pharmacists would lose their ability to verify the accuracy
of directions printed in a language other than English and notes
the risk of patient harm, as discussed during the rulemaking
process that can result from misinterpretation of directions
printed in a non-English language.
Rite Aid states that there is no need for the requirements
imposed by this bill and that there is no evidence that the
current practice of pharmacies providing live translation
services involving a three-way consultation between the patient,
pharmacist and translator over the phone is not working
effectively.
MW:k 5/14/13 Senate Floor Analyses
SUPPORT/OPPOSITION: SEE ABOVE
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