BILL ANALYSIS Ó
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|Hearing Date:June 17, 2013 |Bill No:AB |
| |1136 |
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SENATE COMMITTEE ON BUSINESS, PROFESSIONS
AND ECONOMIC DEVELOPMENT
Senator Ted W. Lieu, Chair
Bill No: AB 1136Author:Levine
As Amended:April 15, 2013 Fiscal:Yes
SUBJECT: Pharmacists: drug disclosures.
SUMMARY: Requires a pharmacist to include a written label on a
prescription drug container indicating that the drug may impair a
person's ability to operate a vehicle or vessel.
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)
3) Requires a pharmacist to inform a patient orally or in writing of
the harmful effects of a drug if the drug poses substantial risk to
the person consuming the drug, when taken in combination with
alcohol, or if the drug may impair a person's ability to drive a
motor vehicle, whichever is applicable, and provided the drug is
determined by the Board to be a drug or drug type for which this
warning shall be given. States that the Board may require
additional information or labeling through regulations. (BPC §
4074)
4) Clarifies that the requirement for a pharmacist to inform a patient
as stated above does not apply to drugs furnished to patients in
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conjunction with treatment or emergency services provided in health
facilities. Requires a health facility to establish and implement
a written policy to ensure that each patient receives information
regarding each medication given at the time of discharge and each
medication given. Requires the information provided to include the
use and storage of each medication, the precautions and relevant
warnings, and the importance of compliance with directions.
Requires the information to be given by a pharmacist or registered
nurse, unless already provided by a patient's prescriber, and
states that the written policy shall be developed in collaboration
with a physician, a pharmacist, and a registered nurse. (Id.)
5) 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.
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.
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1) 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))
2) 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))
3) 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.
g) Technology requirements necessary to implement the standards.
This bill:
1) In addition to the requirements under current law for a pharmacist
to inform a patient orally or in writing of the harmful effects of
a drug, requires a pharmacist on and after July 1, 2014, when
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.
2) Provides that the label required may be printed on an auxiliary
label that is affixed to the prescription container.
FISCAL EFFECT: This bill has been keyed "fiscal" by Legislative
Counsel. According to the Assembly Committee on Appropriations
analysis dated May 8, 2013, this bill will result in "negligible state
costs."
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COMMENTS:
1. Purpose. The Author is the Sponsor of this bill. According to the
Author, "drugged driving is a growing problem. In California, both
statute and regulation pertaining to prescription drug warnings are
out of sync with federally adopted recommendations for patient and
consumer protection." The Author notes that current law does not
require a label for drugs that can impair a person's ability to
drive but rather the only requirement for these medications is that
a patient be informed orally or in writing. According to the
Author, "AB 1136 is a modest measure to increase patient and
consumer awareness regarding the potentially dangerous side-effects
of certain prescription drugs. The legislation respects a
pharmacist's discretion to determine which drugs can impact a
patient's ability to drive, and it does not supplant existing
consultation requirements. The legislation only adds an additional
and effective means of communicating a potentially life-saving
message to patients."
The Author further states that current label requirements deal with
generic patient information and not warning for specific or
potentially dangerous drugs in the same way this bill will. The
Author cites data from the National Highway Transportation Safety
Administration (NHTSA) that notes a marked increase in the number
of drivers testing positive for drugs. According to the Author, in
2005, NHTSA found drugs in 28 percent of fatally injured drivers
tested and in 2009, the number of fatally injured drivers testing
positive for drugs increased to 33 percent nationally. This bill
will codify a National Transportation Safety Board (NTSB)
recommendation to reduce drugged driving, specifically calling for
the establishment of a "clear, consistent, easily recognizable
warning label for all prescription and over-the-counter medications
that may interfere with an individual's ability to operate a
vehicle". The NTSB recommendation further recommended that the
warning label be prominently displayed on all packaging of such
medications.
According to the Author, compounding the growing problem of drugged
driving is the concentration of prescription medication taken by
seniors. The Centers for Disease Control (CDC) notes that people
ages 65 and older make up 13 percent of the population but account
for 34 percent of all prescription medications.
The Author also notes that "a prescription container warning should
not replace existing written and oral consultation requirements;
rather it serves as an additional opportunity to communicate the
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potential dangers of a drug to patient. The Journal of Traffic
Injury Prevention recently published a study which found that when
a medication includes a driving warning label, more than half of
patients recall seeing the warning, and of the population that sees
the label 78 percent report following the advice of the label."
2. California's Standardized Prescription Drug Label.
a) Legislative History. 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
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.
b) Implementation of the 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 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
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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 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
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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. Similar and Related Legislation This Session. SB 204 (Corbett)
requires a pharmacist to use translations of the directions for use
in non-English languages published on the Board's website when
labeling a prescription container. ( Status: The bill is currently
pending in the Assembly.)
SB 205 (Corbett) requires the information on the prescription label
to be printed in at least a 12-point sans serif typeface. ( Status:
The bill is currently pending in the Assembly.)
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
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accordance with a valid prescription issued to the person by a
licensed health care practitioner.
( Status: The bill is currently pending in the Senate Committee on
Public Safety).
AB 396 (Fox) 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. ( Status: The bill is currently
pending in the Assembly.)
2. Prior Related Legislation. 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. ( Status: 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) of 2007 would have required medication
prescribers to ask a patient if they wanted the intended use on the
prescription label. ( Status: The measure failed passage in the
Assembly Committee on Business and Professions.)
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
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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. ( Status: The bill was held in this Committee at the
request of the Author.)
AB 288 (Mountjoy) of 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. ( Status: The measure
was held in the Assembly Committee on Business and Professions at
the request of the Author.)
AB 2125 (Levine) of 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.
( Status: 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.
3. Arguments in Support. Supporters believe that this bill is common
sense and simply mandates best practices. According to the
California State Sheriffs Association , this bill combats the
growing epidemic of drugged driving.
The California Senior Legislature believes that disclosure of
harmful effects of drugs on the actual container will further help
protect the vulnerable group of elders and dependent adults.
4. California Pharmacists Association (CPhA) Has A Neutral Position.
CPhA writes that the organization is neutral to this bill and that
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based on research conducted by CPhA, the requirements contained in
AB 1136 constitute standard practice in most pharmacies.
SUPPORT AND OPPOSITION:
Support:
California Narcotics Officers' Association
California Senior Legislature
California State Sheriff's Association
Neutral:
California Pharmacists Association
Opposition:
None on file as of June 11, 2013.
Consultant:Sarah Mason