BILL ANALYSIS �
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|Hearing Date:April 22, 2013 |Bill No:SB |
| |204 |
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SENATE COMMITTEE ON BUSINESS, PROFESSIONS
AND ECONOMIC DEVELOPMENT
Senator Curren D. Price, Jr., Chair
Bill No: SB 204Author:Corbett
As Introduced: February 8, 2013 Fiscal:Yes
SUBJECT: Prescription drugs: labeling.
SUMMARY: Requires pharmacists to use the translated standard
directions for use from the Board of Pharmacy's website when providing
patients with translated directions in Spanish, Chinese, Vietnamese,
Korean, and Russian on their prescription medication labels. Requires
pharmacists to use certified translation services if they choose to
provide translations in languages other than the five provided on the
Board's website.
Existing law:
1) Provides for the practice of pharmacy and the licensing and
regulation of pharmacies and pharmacists by the Board of Pharmacy
(Board) within the Department of Consumer Affairs (DCA).
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)
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, including: (BPC � 4076)
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.
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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.
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. (BPC �
4076.5 (a))
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. (BPC �
4076.5 (b))
4) 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.
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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.
This bill:
1) Provides that a pharmacist, when labeling a prescription container,
shall use translations of the directions for use in non-English
languages published on the Board's website.
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.
FISCAL EFFECT: Unknown. This bill is keyed "fiscal" by Legislative
Counsel.
COMMENTS:
1. Purpose. This bill is sponsored by the California Pan-Ethnic
Health Network (CPEHN) . According to the Author, 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, 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.
2. Background.
a) Medication Errors and Legislative Response. According to
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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, 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 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
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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 Legislature by January 1, 2010, on
its progress in implementing these regulations.
This measure is a follow-up to the Author's SB 472 which
created the patient-centered label standard.
b) Affordable Care Act (ACA). The passage of the federal
Patient Protection and Affordable Care Act has the potential
to require greater numbers of health professionals throughout
the nation and state, particularly pharmacists who are well
placed in communities to provide medication therapy
management services. The Author also provided background
information highlighting the impact of implementation of the
federal ACA. As a result of the ACA, anywhere from
4-7 million more Californians will be eligible for health
insurance starting in 2014.
1. 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
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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 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 '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
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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.
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..
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.
1. Related Legislation. SB 205 (Corbett) of 2013 requires the
information on the prescription label to be printed in at least a
12-point sans serif typeface. The bill is also up for
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consideration by the Committee at this hearing.
AB 396 (Fox) of 2013 requires 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. Requires 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. The bill is currently
pending in the Assembly.
AB 1136 (Levine) of 2013 requires 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. This bill is
currently pending before the Assembly Committee on Business,
Professions and Consumer Protection.
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. 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.
AB 1276 (Karnette, 2007) would have required medication prescribers
to ask a patient if they wanted the intended use on the
prescription label. The measure failed passage in the Assembly
Committee on Business and Professions.
SCR 49 (Speier, 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
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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. 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. 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.
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
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.
2. Arguments in Support. The 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 percent of individuals speak a
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language other than English at home and an estimated 6-7 million
are limited English proficient.
The Asian Law Alliance , California Health Advocates , California
Immigrant Policy Center and Street Level Health Project all write
in support, stating that millions of Californians will have
increased access to health care coverage and prescription
medications with the implementation of the 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 instructions that
they understand which will help reduce medical errors and improve
quality of care.
3. 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) writes in opposition to
this measure, citing the measure 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 Pharmacy
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
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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) is opposed to this
measure, citing the 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.
4. Staff Comments.
a) "Certified translation services." This bill requires
pharmacists to use "certified translation services;" however, it
is not clear what those are, who certifies translation services
and how this will be enforced. The Author may wish to clarify
what constitutes "certified" and how translation services can
attain certification.
SUPPORT AND OPPOSITION:
Support:
California Pan Ethnic Health Network (CPEHN), Sponsor
Asian American Center for Advancing Justice
Asian Law Alliance
California Health Advocates
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California Immigrant Policy Center
Street Level Health Project
Western Center on Law and Poverty
Opposition:
California Grocers Association
California Pharmacists Association
California Retailers Association
Rite Aid
Consultants: Sarah Mason and Kristin Webb