BILL ANALYSIS �
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|Hearing Date:April 22, 2013 |Bill No:SB |
| |205 |
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SENATE COMMITTEE ON BUSINESS, PROFESSIONS
AND ECONOMIC DEVELOPMENT
Senator Curren D. Price, Jr., Chair
Bill No: SB 205Author:Corbett
As Introduced: February 8, 2013 Fiscal:Yes
SUBJECT: Prescription drugs: labeling.
SUMMARY: Requires prescription labels to be printed in 12-point sans
serif typeface.
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.
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.
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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.
d) Placement of information that is patient-centered.
e) The needs of patients with limited English proficiency.
f) The needs of senior citizens.
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g) Technology requirements necessary to implement the standards.
This bill: Prohibits a pharmacist from dispensing any prescription
except in a container that meets the requirements of state and federal
law and is correctly labeled in at least a 12-point sans serif
typeface with information required under current law.
FISCAL EFFECT: Unknown. This bill is keyed "fiscal" by Legislative
Counsel.
COMMENTS:
1. Purpose. The Author is the sponsor of this bill. According to the
Author, "seniors are having difficulty reading the small print on
their prescription labels and, for those who take multiple
medications, their inability to read the label puts them in serious
danger." The Author states that among adults 65 years of age or
older, 40% take five to nine medications and 18% take ten or more
medications and that taking these incorrectly or mixed with other
medications can cause adverse drug events that can lead to injury
and death. The Author also notes that The New England Journal of
Medicine estimates that between 2007 and 2009, there were more than
260,000 emergency room visits for adverse drug events in U.S.
adults 65 years of age or older. Of those, almost 100,000 required
emergency hospitalizations, and nearly two-thirds of those
hospitalizations were due to unintentional overdoses.
2. Background.
a) Medication Errors and Legislative Response. According to
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 and senior citizens are especially
vulnerable. 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.
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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
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
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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) Font Size. According to information provided by the
Author, seniors are having
difficulty reading the small print on their prescription
labels and, for those who take multiple medications, their
inability to read the label puts them in serious danger.
Among adults 65 years of age or older, 40% take five to nine
medications and 18% take ten or more medications.
Medications that are taken incorrectly or mixed with other
medications can cause adverse drug events that can lead to
injury and death.
The New England Journal of Medicine estimates that between
2007 and 2009, there were more than 260,000 emergency room
visits for adverse drug events in U.S. adults 65 years of age
or older. Of those, almost 100,000 required emergency
hospitalizations, and nearly two-thirds of those
hospitalizations were due to unintentional overdoses.
According to a study on The Variability and Quality of
Medication Container Labels published in the Archives of
Internal Medicine, September 10, 2007, the prescription
container label may play an important role in the appropriate
administration of prescription medication. The study
identified characteristics of container labels that improve
readability and understanding, including larger font,
boldfacing and use of white space to emphasize important
details.
The United States Pharmacopeial Convention (USP), a
scientific nonprofit organization that sets standards for the
identity, strength, quality, and purity of medicines,
recommends the use of large font size to improve prescription
label readability. USP states that type smaller than size
10-point Times New Roman should not be used on prescription
labels, and suggests 12-point Times New Roman or 11-point
Arial.
1. Implementation of a Standardized Prescription Drug Label by the
Board of Pharmacy. California is the first state to require
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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 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 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:
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.
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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 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
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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 204 (Corbett) of 2013 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. The bill is also up for 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.
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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
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 can not 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
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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 Opposition. 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 cites a Board report provided at a
follow-up Public Education and Communication Committee meeting
which detailed consumer complaints about the fact that non-key
items on the label, like number of remaining refills, were too
crowded on the label making them difficult to read. CPhA also
notes that labels are naturally limited in terms of space to
provide information and there is already required information that
must occupy 50 percent of the label.
The California Grocers Association (CGA) is opposed to this
measure. CGA states that the typeface settings required by this
bill are unworkable in a real world setting. Current law requires
no fewer than 11 discrete pieces of information to be placed on a
prescription drug label. In some situations, where a patient's use
instructions are non-standard, more detailed information must be
included on the label. According to CGA, requiring size 12 Sans
Serif typeface will force pharmacists to dispense some medications
in very large containers to accommodate a label large enough to
include all the required information.
SUPPORT AND OPPOSITION:
Support:
None on file as of April 16, 2013.
Opposition:
California Pharmacists Association (CPhA)
California Grocers Association
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Consultant: Kristin Webb and Sarah Mason