BILL ANALYSIS Ó
-----------------------------------------------------------------
|SENATE RULES COMMITTEE | AB 1136|
|Office of Senate Floor Analyses | |
|1020 N Street, Suite 524 | |
|(916) 651-1520 Fax: (916) | |
|327-4478 | |
-----------------------------------------------------------------
THIRD READING
Bill No: AB 1136
Author: Levine (D)
Amended: 4/15/13 in Assembly
Vote: 21
SENATE BUSINESS, PROF. & ECON. DEV. COMM. : 10-0, 6/17/13
AYES: Lieu, Emmerson, Block, Corbett, Galgiani, Hernandez,
Hill, Padilla, Wyland, Yee
SENATE APPROPRIATIONS COMMITTEE : 6-0, 7/1/13
AYES: De León, Walters, Gaines, Hill, Lara, Steinberg
NO VOTE RECORDED: Padilla
ASSEMBLY FLOOR : 70-1, 5/16/13 - See last page for vote
SUBJECT : Pharmacists: drug disclosures
SOURCE : Author
DIGEST : This bill requires a pharmacist, on or after July 1,
2014, 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, if in the pharmacist's
professional judgment, he/she determines that the drug may
impair a person's ability to operate a vehicle or vessel.
ANALYSIS :
Existing law:
CONTINUED
AB 1136
Page
2
1.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 of Pharmacy
(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.
2.Clarifies that the requirement for a pharmacist to inform a
patient as stated above does not apply to drugs furnished to
patients in 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; and 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.
3.Requires that each prescription dispensed by a pharmacist must
be in a container complying with state and federal law and
correctly labeled as specified.
4.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.
5.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.
6.Requires the Board, when considering the requirements for
prescription labels, to consider (a) medical literacy
research; (b) improved directions for use; (c) improved font
types and sizes; (d) placement of information that is
CONTINUED
AB 1136
Page
3
patient-centered; (e) the needs of patients with limited
English proficiency; (f) the needs of senior citizens; and (g)
technology requirements necessary to implement the standards.
This bill:
1.Additionally, requires, a pharmacist, on or after July 1,
2014, 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, if in the pharmacist's
professional judgment, he/she determines 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.
Background
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 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. When asked
what to change on the prescription label, the top responses
were: print should be larger or darker (30.1%); nothing needs
CONTINUED
AB 1136
Page
4
to be changed on the label (24.6%); and 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 (Corbett, Chapter 470, Statutes of 2007), the
California Patient Medication Safety Act, 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% of the label, using at least 10-point
font using sans serif typeface, listing these items in the
following order: (1) name of the patient; (2) name of the drug
CONTINUED
AB 1136
Page
5
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); (3) directions for use; and (4) 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.
FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes
Local: Yes
According to the Senate Appropriations Committee, potential
one-time costs up to $75,000 to update existing regulations on
prescription drug labeling (Pharmacy Board Contingent Fund).
This bill does not explicitly require the adoption of
regulations. However, because there are existing regulations
that govern prescription drug labels, the Board is likely to
incorporate the requirements of this bill into the existing
regulations.
SUPPORT : (Verified 7/1/13)
California Narcotics Officers' Association
California Senior Legislature
California State Sheriffs' Association
ARGUMENTS IN SUPPORT : 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 existing law does
CONTINUED
AB 1136
Page
6
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% of fatally injured
drivers tested and in 2009, the number of fatally injured
drivers testing positive for drugs increased to 33% 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 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 notes that
people ages 65 and older make up 13% of the population but
account for 34% 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 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% report following the
CONTINUED
AB 1136
Page
7
advice of the label."
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.
ASSEMBLY FLOOR : 70-1, 5/16/13
AYES: Achadjian, Alejo, Ammiano, Atkins, Bigelow, Bloom,
Blumenfield, Bocanegra, Bonilla, Bonta, Bradford, Brown,
Buchanan, Ian Calderon, Campos, Chau, Chávez, Chesbro, Conway,
Cooley, Dahle, Daly, Dickinson, Eggman, Fong, Fox, Frazier,
Garcia, Gatto, Gomez, Gordon, Gorell, Gray, Hagman, Hall,
Harkey, Roger Hernández, Jones, Jones-Sawyer, Levine, Linder,
Logue, Lowenthal, Maienschein, Mansoor, Medina, Mitchell,
Mullin, Muratsuchi, Nazarian, Nestande, Olsen, Patterson,
Perea, V. Manuel Pérez, Quirk, Quirk-Silva, Rendon, Salas,
Skinner, Ting, Torres, Wagner, Waldron, Weber, Wieckowski,
Wilk, Williams, Yamada, John A. Pérez
NOES: Donnelly
NO VOTE RECORDED: Allen, Beth Gaines, Grove, Holden, Melendez,
Morrell, Pan, Stone, Vacancy
MW:ej 7/2/13 Senate Floor Analyses
SUPPORT/OPPOSITION: SEE ABOVE
**** END ****
CONTINUED