BILL ANALYSIS �
SB 205
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Date of Hearing: August 13, 2013
ASSEMBLY COMMITTEE ON BUSINESS, PROFESSIONS AND CONSUMER
PROTECTION
Susan A. Bonilla, Chair
SB 205 (Corbett) - As Amended: July 1, 2013
SENATE VOTE : 23-9
SUBJECT : Prescription drugs: labeling.
SUMMARY : Requires specified information on a prescription
container regarding its name, manufacturer, recipient, use,
strength, and purpose to be printed in at least 12-point
typeface. Specifically, this bill :
1)Requires that the manufacturer's trade or generic name of a
drug, the manufacturer's name, directions for use, name of the
patient, strength of a drug, and the purpose for which a drug
was dispensed be printed in at least 12-point typeface.
2)States that no reimbursement is required by this bill pursuant
to Section 6 of Article XIIIB of the California Constitution
because the only costs that may be incurred by a local agency
or a school district will be incurred because this bill
creates a new crime or infraction, eliminates a crime or
infraction, or changes the penalty for a crime or infraction
within the meaning of Section 17556 of the Government Code, or
changes the definition of a crime within the meaning of
Section 6 of Article XIIIB of the California Constitution.
3)Makes other technical and clarifying changes.
EXISTING LAW
1)Establishes the Board of Pharmacy (BOP) for the licensing and
regulation of pharmacies and pharmacists under the Department
of Consumer Affairs. (Business and Professions Code (BPC)
Section 4001)
2)Prohibits a person from furnishing any dangerous drug or
device, except upon the prescription of a physician, dentist,
podiatrist, optometrist, veterinarian, or naturopathic doctor
as specified. (BPC 4059)
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3)Requires a pharmacist not to dispense any prescription except
in a container that meets the requirements of state and
federal law, as specified, and is correctly labeled with the
following:
a) Unless otherwise specified by the prescriber, the
manufacturer's trade name of the drug or the generic name
and the name of 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, prescription
number, or other means of identifying the prescription;
g) The strength of the drug or drugs dispensed;
h) The quantity of the drugs dispensed;
i) The expiration date of the effectiveness of the drug;
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, except for the
following:
i) Prescriptions dispensed by a veterinarian;
ii) A new drug for the first 20 days that the drug is on
the market and for the 90 days during which the national
reference file has no description on file; and,
iii) Dispensed medications for which no physical
description exists in any commercially available
database. (BPC 4076)
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4)Requires that labels on drug containers dispensed to patients
in California conform to the following format:
a) Each of the following items must be clustered into one
area of the label that compromises 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
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 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. (California Code of Regulations (CCR)
16 Section 1707.5)
b) Specifies that the BOP shall re-evaluate the
requirements, as specified, by December 2013 to ensure
optimal conformance with BPC 4076.5. (CCR 16 1707.5)
FISCAL EFFECT : Unknown
COMMENTS :
1)Purpose of this bill . This bill would require certain
information about a prescription drug to be printed in
12-point typeface on a prescription container label with the
aim of decreasing medication errors. This bill is
author-sponsored.
2)Author's statement . According to the author, "eyesight often
diminishes with age, and for seniors, it can be difficult to
read the small print on prescription labels. 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
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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. Making prescription medication 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."
3)Legislative history . Pursuant to SCR 49 (Speier) (Chapter
123, Statutes of 2005) the Medication Errors Panel (panel)
published a report in March 2007 titled Prescription for
Improving Patient Safety: Addressing Medication Errors. The
panel developed recommendations to improve prescription labels
to reduce errors associated with prescription and
over-the-counter medication use. As a result of SCR 49 and
the recommendations made by the panel, SB 472 (Corbett)
(Chapter 470, Statutes of 2007) was enacted to require the BOP
to promulgate regulations that required a standardized,
patient-centered, prescription drug label on all prescription
medication dispensed to patients in California.
4)Board of Pharmacy regulations . To inform the rulemaking
process, the BOP elicited feedback from consumers, between May
2008 and November 2009, regarding the development of
patient-centered prescription drug labels by creating an
open-ended prescription label survey which was distributed at
public outreach events. Survey results indicated that
consumers wanted prescription labels to have larger and darker
print to increase readability. The BOP also considered
testimony and information from the public, pharmaceutical
industry, pharmacy professionals, subject matter experts and
other stakeholders regarding the improvements to prescription
labeling issues.
After numerous meetings, BOP adopted regulations in 2010 to
create a standardized, patient-centered prescription drug
label. Among other requirements, the regulations require that
the name of the patient, name and strength of the drug,
directions for use, and the condition or purpose for which the
drug was prescribed to be printed in at least a 10-point sans
serif typeface, or if requested by the consumer, at least
12-point typeface. There are a limited number of pharmacies
that currently use a default 12-point typeface. This measure
will require that certain information automatically be printed
in 12-point typeface, as opposed to providing the consumer
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with the choice to have the information printed in either 10
or 12 point typeface.
5)Board of Pharmacy reports . As required by regulations, the
BOP is scheduled to reevaluate and release a report in
December of 2013 to update the Legislature and other
interested parties regarding the efficacy of the BOP's current
regulations related to prescription container labeling
requirements including the specific typeface size. The BOP's
Public Education and Communications Committee is currently in
the process of reviewing information and feedback from
numerous stakeholders pertaining to the patient-centered
labels for prescription drug use including the standard
typeface.
6)Arguments in support . The California Alliance for Retired
Americans writes in support, "We believe this bill will help
avoid medication disasters by printing prescription labels in
12-point typeface. The Centers for Disease Control and
Prevention recommend that adults read and follow directions to
reduce the risk of harm from medication. Seniors are having
difficulty reading the small print on their prescription
labels, and for those who are taking multiple medications,
their inability to read the label puts them in serious
danger."
7)Arguments in opposition . The California Pharmacists
Association writes in opposition, "While [the California
Pharmacists Association] appreciates the intent of [this
bill], we believe the changes are premature and would not
provide any additional benefit to consumers. The [BOP]
regulations already require specific portions of the label to
appear in at least 10-point font and to be printed in 12-point
font if the patient requests it. These regulations were
developed after an exhaustive, collaborative, rulemaking
process."
8)Question for the Committee . As noted above, the BOP is
already scheduled to release a report regarding the impact of
the regulations pertaining to patient-centered prescription
drug labels in December of 2013, and so the Committee may wish
to consider whether or not this bill might be premature. The
Committee may also wish to consider delaying the effective
date of this bill by two years so that the BOP report can be
completed and the results thoroughly discussed before the
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requirements of this bill would come into effect, allowing
legislators the time to amend the statute if the report
results suggest an outcome that differs from the 12-point
typeface approach contained in this bill.
9)Related legislation . SB 204 (Corbett) of 2013 would require
pharmacists to use the translated standard directions for use
from BOP's website when providing patients with translated
directions in Spanish, Chinese, Vietnamese, Korean, and
Russian on their prescription medication labels. It would
also require 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 pending
in the Assembly Health Committee.
AB 396 (Fox) of 2013 would require 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. The
bill was held in the Assembly without referral to a committee.
AB 1136 (Levine) of 2013 would require 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.
The bill is currently pending on the Senate Floor.
10)Previous legislation . SB 1390 (Corbett) of 2010 would have
repealed the requirement that the BOP 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 establish
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 BOP to
promulgate regulations that require a standardized,
patient-centered, prescription drug label on all prescription
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medication dispensed to patients in California. The Board
was required to report to the Legislature by January 1, 2010,
on its progress in implementing these regulations.
SCR 49 (Speier) of 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) of 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 the Senate Business, Professions and Economic Development
Committee.
REGISTERED SUPPORT / OPPOSITION :
Support
California Alliance for Retired Americans
California Commission on Aging
California Pan-Ethnic Health Network
Health Access California
Paramedics Plus
Vison y Compromiso
Opposition
California Pharmacists Association
Department of Consumer Affairs
National Association of Chain Drug Stores
Analysis Prepared by : Elissa Silva / B.,P. & C.P. / (916)
319-3301
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