BILL ANALYSIS �
SB 205
Page 1
Date of Hearing: June 25, 2013
ASSEMBLY COMMITTEE ON HEALTH
Richard Pan, Chair
SB 205 (Corbett) - As Amended: April 24, 2013
SENATE VOTE : 23-9
SUBJECT : Prescription drugs: labeling.
SUMMARY : Requires the following information that is currently
required to be included on the label of a prescription container
to be printed in 12-point sans serif typeface: 1) The
manufacturer's trade or generic name of the drug and the name of
the manufacturer, as specified; 2) Directions for the use of the
drug; 3) Name of the patient or patients; 4) Strength of the
drug or drugs dispensed; and, 5) The condition or purpose for
which the drug was prescribed if the condition or purpose is
indicated on the prescription. Makes other technical and
clarifying changes.
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.
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 as
prescribed by a physician, dentist, podiatrist, optometrist,
or veterinarian.
3)Requires that each prescription dispensed by a pharmacist must
be in a container meeting state and federal specifications and
correctly labeled, as specified, including:
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;
e) The date of issue;
f) The name and address of the pharmacy and prescription
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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 or purpose for which the drug was
prescribed if the condition or purpose is indicated on the
prescription; and,
aa) The physical description of the dispensed medication,
including its color, shape, and any identification code
that appears on the tablets or capsules.
EXISTING REGULATIONS :
1)Requires labels on drug containers dispensed to patients in
California to conform to the following format:
a) Each of the following must be clustered into one area of
the label that comprises at least 50% of the label and be
printed in at least 10-point sans serif typeface, or, if
requested by the consumer, at least a 12-point typeface,
and listed in the following order:
i) Name of the patient;
ii) Name of the drug and strength of the drug;
iii) Directions for the use of the drug; and,
iv) The condition or purpose for which the drug was
prescribed if the condition or purpose is indicated on
the prescription.
b) Requires for added emphasis, the label to highlight in
bold typeface or color, or use blank space to set off the
items listed in 1)a) above.
c) Requires the remaining elements that are required to be
printed on a label, as well as any other items of
information appearing on the label or the container, to be
printed so as not to interfere with the legibility or
emphasis of the primary elements specified in 1)a) above.
2)Requires the Board, by October 1, 2011, and updated as
necessary, to publish on its Website translation of specified
directions for use into at least five languages other than
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English, to facilitate their use by California pharmacies.
Specifies phrases that are required to be used for directions
for use , including:
a) Take 1 [insert appropriate dosage form] at bedtime;
b) Take 1 [insert appropriate dosage form] in the morning;
c) Take 1 [insert appropriate dosage form] in the morning,
and Take 1 [insert appropriate dosage form] at bedtime;
d) Take 1 [insert appropriate dosage form] in the morning,
1 [insert appropriate dosage form] at noon, and l [insert
appropriate dosage form] in the evening; or,
e) If you have pain, take [insert appropriate dosage form]
at a time. Wait at least __ hours before taking again. Do
not take more than [appropriate dosage form] in one day.
3)Requires the Board to collect and publish on its Website
examples of labels conforming to these requirements, to aid
pharmacies in label design and compliance.
4)Requires a pharmacy to have policies and procedures in place
to help patients with limited or no English proficiency
understand the information on the label as specified in 1) a)
above in the patient's language. Requires the pharmacy's
policies and procedures to be specified in writing and to
include, at a minimum, the selected means to identify the
patient's language and to provide interpretive services in the
patient's language. Requires the pharmacy, at a minimum, to
provide 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 : According to the Senate Appropriations
Committee, "One-time costs of about $75,000 to update
regulations and provide information to pharmacies by the Board
(Pharmacy Board Contingent Fund)."
COMMENTS :
1)PURPOSE 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%
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take 10 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. The
author points out that making prescription medical container
labels easier for patients to read is a simple way to help
avoid dosing or medication errors due to a patient's inability
to read the label.
2)BACKGROUND .
a) Medication Errors . 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
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these factors must be taken into consideration in the
development of any consumer education efforts.
One bill that was pursued in response to the Panel report was
SB 472 (Corbett), Chapter 470, Statutes of 2007. SB 472
established the California Patient Medication Safety Act,
which requires 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 bill is a follow-up to SB 472.
b) Report to the Legislature on the Implementation of SB
472 . Pursuant to SB 472, the Board submitted its report
entitled, "Prescription Drugs: Labeling Requirements" to
the Legislature in January 2010. The report indicated the
steps the Board took prior to adopting the final
regulations to implement SB 472. Specifically, the Board
established a "SB 472 Medication Label Subcommittee" in
January 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. Specifically, when asked
what to change on the prescription label, 30.1% responded
that print should be larger or darker; 24.5% indicated
nothing needs to be changed on the label; and, 12%
responded that the purpose of the drug must be included.
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, and the final
regulations were adopted in 2010.
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c) Board Regulations on Font Size . Regulations adopted by
the Board in 2010 which took effect on January 1, 2011,
entitled Patient-Centered Labels for Prescription Drug
Containers, require a standardized, patient-centered
prescription drug label on all prescriptions dispensed to
patients. Among other requirements, the regulations
require that the: i) name of the patient; ii) name of the
drug and strength of the drug, as specified, iii)
directions for the use of the drug; and, iv) the condition
or purpose for which the drug was prescribed if the
condition or purpose is indicated on the prescription be
clustered into one area of the label that comprises at
least 50% of the label. These items must also be printed
in at least a 10-point sans serif typeface, or if requested
by the consumer, at least a 12 point type face. For added
emphasis and to set off such items, they are required to be
highlighted in bold typeface or color or use blank space.
All other items that are additionally required to appear on
a label are required to be printed so as not to interfere
with the legibility or emphasis of these items and may
appear in any style, font, and size typeface.
d) Consumer Surveys Regarding Prescription Container
Labels . At the Board's April 2013 meeting, the Board's
Communication and Public Education Committee reported on
the results of surveys it conducted regarding prescription
container labels. An electronic version of the survey was
sent to several consumer groups including AARP, Consumers
Union, and the California Pan Ethnic Health Network
(CPEHN), who in turn distributed it to their ListServe
contacts. The survey was also translated in Chinese and
Spanish by the Board and distributed by CPEHN to the
appropriate audiences. The surveys were also distributed
and collected at local Senior Scam Stopper seminars
sponsored by the Contractors State License Board. A total
of 1204 completed surveys were received by the Board. A
sample of the survey is as follows: When asked if
prescription labels are easy to read, 58% of those surveyed
in English responded yes; 40% responded yes in Chinese; 35%
responded yes in Spanish; while 42% responded no in
English; 10% in Chinese; and, 62% in Spanish. When asked
what information on the label was most important, 49%
responded directions for use and clear dosing instructions;
when asked what changes would make the labels better, 26%
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responded larger font; and, when asked what information
could be improved 7% responded larger font.
Additionally, the Board conducted 767 patient-centered
labeling inspections of chain stores, community pharmacies,
and clinics to measure compliance with regulations. The
Board indicated that 70% of pharmacies are printing in
12-point font:
------------------------------------------------------------
|Patient-Centered Label: | Chain |Communit|Clinic |
| | Store | y | |
|---------------------------------+---------+--------+-------|
|Compliant | 355 | 339 | 1 |
|---------------------------------+---------+--------+-------|
|Noncompliant | 13 | 67 | 7 |
|---------------------------------+---------+--------+-------|
|Corrections Issued | 13 | 79 |7 |
------------------------------------------------------------
------------------------------------------------------------
|The label is usually printed in: | Chain |Communit|Clinic |
| | Store | y | |
|---------------------------------+---------+--------+-------|
|10 point font is the default | 40 | 73 | 0 |
|---------------------------------+---------+--------+-------|
|12 point font is the default | 280 | 161 | 1 |
|---------------------------------+---------+--------+-------|
|Both 10-point & 12-point font | 47 | 138 |0 |
|appear on the label | | | |
------------------------------------------------------------
e) Notice to Consumers . The Board also adopted regulations
to require every pharmacy to post in a conspicuous place a
notice informing consumers, among other information, of
their right to ask for and receive from any pharmacy,
prescription drug labels in 12-point font and the
availability of interpreter services upon request at no
cost. The pharmacy may post this notice in paper form or
on a video screen if the posted notice or video screen is
positioned so that a consumer can easily point to and touch
the statement identifying the language in which he or she
requests assistance. Otherwise, the notice shall be made
available on a flyer or handout clearly visible from and
kept within easy reach of each counter in the pharmacy
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where dangerous drugs are dispensed or furnished.
3)SUPPORT . The California Alliance for Retired Americans states
that 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. CPEHN states that research shows that 12
point font is a size that most consumers feel comfortable
with. Paramedics Plus states that this bill would save lives
and would provide patients with accurate and readable
prescription labels.
4)OPPOSITION . The California Pharmacists Association and the
National Association of Chain Drug Stores indicate that while
they appreciate the intent of this bill, they believe the
changes are premature and would not provide any additional
benefits to consumers. The existing Patient-Centered Labeling
Regulations are a product of months of discussion among the
Board, licensed pharmacists, patient advocacy groups, and
industry experts where every detail was scrutinized in
crafting each component of the regulation. To their
knowledge, there is no data indicating that the existing
regulations are insufficient and could unintentionally
interfere with the accurate communication of instructions to
patients. This opposition states that the Board will submit a
report to the Legislature this December on the labeling
requirements and before the Legislature overturns the
decisions of the Board, it is important to establish whether
there is a need for changes and the benefits to consumers.
5)DOUBLE REFERRAL . This bill is double referred, should it pass
out of this Committee, it will be referred to the Assembly
Business, Professions & Consumer Protection Committee.
6)RELATED LEGISLATION .
a) AB 396 (Fox) requires that every prescription 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. AB 396 also
requires that every prescription container be correctly
labeled to include that information, if so indicated on the
prescription, unless the patient or prescriber requests
that this information be omitted. AB 396 is pending in the
Assembly Rules Committee.
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b) AB 1136 (Levine) requires a pharmacist, on and after
January 1, 2014, if a pharmacist exercising his or her
professional judgment determines that a drug may impair a
person's ability to operate a vehicle or vessel, 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. Permits the label to be printed on an auxiliary
label that is affixed to the prescription container. AB
1136 is pending in the Senate Appropriations Committee.
c) SB 204 (Corbett) requires a pharmacist to use
translations of the directions for use in non-English
languages published on the Board's Internet Website, as
applicable, when labeling a prescription container;
authorizes a pharmacist to translate the directions for use
into additional non-English languages if certified
translation services are utilized to complete the
additional translations. SB 204 is pending in the Assembly
Health Committee.
d) SB 289 (Correa) makes it unlawful for a person to drive
a motor vehicle if his or her blood contains any detectable
amount of a drug classified in Schedules I, II, III, or IV
of the California Uniform Controlled Substance Act, unless
the drug was consumed in accordance with a valid
prescription issued to the person by a licensed health care
practitioner. SB 289 is pending in the Senate Public
Safety Committee.
7)PREVIOUS LEGISLATION .
a) SB 472 requires the Board to promulgate regulations that
require, on or before January 1, 2011, a standardized,
patient-centered, prescription drug label on all
prescription medication dispensed to patients in
California.
b) AB 1276 (Karnette) of 2007 would have required
prescribers of medications to ask the patient whether to
indicate the intended purpose of the prescription on the
prescription's label. AB 1276 died in Assembly Business
and Professions Committee.
c) SCR 49 established a panel to study the causes of
medication errors and recommend changes in the health care
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system that would reduce errors associated with the
delivery of prescription and over-the-counter medication to
consumers.
d) AB 657 (Karnette) of 2005 would have required
prescription labels to include the intended purpose of the
drug, if indicated on the prescription, and would have
required a physician, dentist, optometrist, podiatrist, and
other specified drug prescribers, to ask the patient, or
patient's representative whether to indicate the intended
purpose of the prescription on the label. AB 657 died in
Senate Business, Professions and Economic Development
Committee.
e) AB 288 (Mountjoy) of 2005 would have required the
prescription container to be labeled with the condition for
which the drug was prescribed, unless the patient,
physician, or a parent or legal guardian of a minor patient
requests that the information be omitted. AB 288 died in
Assembly Health Committee.
f) AB 2125 (Levine) of 2004 would have required a physician
and surgeon to indicate a patient's diagnosis on each
prescription, as specified, and would have required the
prescription label to include the condition for which the
drug was described, unless the patient directs the
pharmacist not to include this information on the label.
AB 2125 died in Assembly Health Committee.
g) SB 292 (Speier), Chapter 544, Statutes of 2003, requires
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.
h) AB 2099 (Epple), Chapter 397, Statutes of 1993, requires
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.
8)TECHNICAL AMENDMENT . The author has agreed to amend this bill
to delete the words "sans serif" and allow the use of any
12-point typeface.
REGISTERED SUPPORT / OPPOSITION :
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Support
California Alliance for Retired Americans
California Commission on Aging
California Pan-Ethnic Health Network
Paramedics Plus
Pharmacists Planning Services, Inc.
Vision y Compromiso
Opposition
California Grocers Association
California Pharmacists Association
National Association of Chain Drug Stores
Analysis Prepared by : Rosielyn Pulmano / HEALTH / (916)
319-2097