BILL ANALYSIS Ó
AB 1136
Page 1
Date of Hearing: April 23, 2013
ASSEMBLY COMMITTEE ON BUSINESS, PROFESSIONS AND CONSUMER
PROTECTION
Richard S. Gordon, Chair
AB 1136 (Levine) - As Amended: April 15, 2013
SUBJECT : Pharmacists: drug disclosures.
SUMMARY : Requires a pharmacist after July 1, 2014 to include a
written warning label on a prescription drug if the pharmacist
determines that the drug may impair a person's ability to
operate a vehicle or vessel. Specifically, this bill :
1)Requires, after July 1, 2014, a pharmacist to include a
written label on a drug container indicating that the drug may
impair a person's ability to operate a vehicle or vessel if
the pharmacist determines that the drug may have that effect.
2)Permits this warning to be printed on an auxiliary label that
is added to the prescription container.
3)Makes other technical and clarifying changes.
4)States that no reimbursement is required by this act pursuant
to Section 6 of Article XIIIB of the California Constitution
because the only costs that may be incurred by a local agency
or school district will be incurred because this act 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.
EXISTING LAW :
1)Provides for the practice of pharmacy and the licensing and
regulation of pharmacies and pharmacists by the Board of
Pharmacy (BOP) within the Department of Consumer Affairs.
(Business and Professions Code (BPC) Section 4000 et seq.)
2)Requires a pharmacist to inform a patient orally or in writing
of the harmful effects of a drug dispensed by prescription if
the drug poses substantial risk to the person consuming the
drug when taken in combination with alcohol or if the drug may
AB 1136
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impair a person's ability to drive a motor vehicle, if the
drug is determined by BOP to be a drug or drug type for which
this warning shall be given. (BPC 4074 (a))
3)Permits BOP to develop regulations requiring additional
information or labeling. (BPC 4074 (b))
4)Requires a health facility to establish and implement a
written policy to ensure that each patient receives
information, as specified, regarding each medication given at
the time of discharge. This information shall include the use
and storage of each medication, the precautions and relevant
warnings, and the importance of compliance with directions.
This information shall be given by a pharmacist or registered
nurse, unless already provided by a patient's prescriber, and
the written policy shall be developed in collaboration with a
physician, a pharmacist, and a registered nurse. The written
policy shall be approved by the medical staff. Nothing in
existing law shall be construed to require that only a
pharmacist provide this consultation. (BPC 4074 (d)).
5)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
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
AB 1136
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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. (BPC 4076)
FISCAL EFFECT : Unknown
COMMENTS :
1)Purpose of this bill . This bill requires a pharmacist to
include a written warning label on a prescription drug if the
pharmacist determines the drug may impair a person's ability
to operate a vehicle or vessel. This practice is already
permitted under current law, and is done voluntarily in many
pharmacies. This bill is author sponsored.
2)Author's statement . According to the author, "In California
there is no requirement to include a warning label or sticker
on prescription medication which BOP identifies as capable of
impairing a person's ability to drive. Current law only
requires that a pharmacist inform a patient orally or in
writing? AB 1136 combats the growing epidemic of drugged
driving by mandating best practices among California
pharmacies to ensure that warning labels are included on
dangerous drugs."
3)Current prescription drug labeling requirements . Current
regulations developed by BOP require each prescription
dispensed by a pharmacist to be in a container that meets
state and federal specifications. Labels must already
include:
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;
AB 1136
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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 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.
Current law also 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 when taken in
combination with alcohol or if the drug may impair a person's
ability to drive a motor vehicle. According to the California
Pharmacists Association, the use of warning labels that
caution patients about driving while using dangerous
medications is already standard practice in most pharmacies.
This bill may also be read to permit a pharmacist to identify
drugs in addition to those drugs identified by BOP for this
additional warning.
4)Related legislation . SB 204 (Corbett) would require a
pharmacist to use translations of the directions for drug use
in non-English languages published on the Board's Internet Web
site, as applicable, when labeling a prescription container
and authorizes a pharmacist to translate the directions for
drug use into additional non-English languages if certified
translation services are utilized to complete the additional
translations. SB 204 is pending in Senate Business,
Professions and Economic Development Committee.
AB 1136
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SB 205 (Corbett) would require the information on a
prescription label to be printed in at least a 12-point sans
serif typeface. SB 205 is pending in Senate Business,
Professions and Economic Development Committee.
SB 289 (Correa) would make 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 Senate Public Safety Committee.
5)Previous legislation . SB 472 (Corbett), Chapter 470, Statutes
of 2007, requires BOP 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.
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 the Assembly Business and Professions
Committee.
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, or other
specified drug prescriber to ask the patient or patient's
representative whether to indicate the intended purpose of the
prescription on the label. AB 657 died in the Senate
Business, Professions and Economic Development Committee.
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 the Assembly Health
Committee.
AB 2125 (Levine) of 2004 would have required a physician and
surgeon to indicate a patient's diagnosis on each
prescription, as specified, and required the prescription
label to include the condition for which the drug was
AB 1136
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described, unless the patient directs the pharmacist not to
include this information on the label. AB 2125 died in the
Assembly Health Committee.
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.
6)Double referred . This bill is double-referred, having been
previously heard by the Assembly Health Committee on April 2,
2013 and approved on an 11-1 vote.
REGISTERED SUPPORT / OPPOSITION :
Support
California Narcotic Officers' Association
California Senior Legislature
California State Sheriffs' Association
Opposition
None on file.
Analysis Prepared by : Sarah Huchel / B.,P. & C.P. / (916)
319-3301