BILL ANALYSIS Ó
AB 1136
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Date of Hearing: April 2, 2013
ASSEMBLY COMMITTEE ON HEALTH
Richard Pan, Chair
AB 1136 (Levine) - As Amended: March 20, 2013
SUBJECT : Pharmacists: drug disclosures.
SUMMARY : Requires 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. 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
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,
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aa) The physical description of the dispensed medication,
including its color, shape, and any identification code
that appears on the tablets or capsules.
4)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
impair a person's ability to drive a motor vehicle, whichever
is applicable, and provided the drug is determined by the
Board, as specified, to be a drug or drug type for which this
warning shall be given. Allows the Board by regulation, to
require additional information or labeling. Exempts from
these provisions drugs furnished to patients in conjunction
with treatment or emergency services provided in health
facilities, as specified.
FISCAL EFFECT : This bill has not yet been analyzed by a fiscal
committee.
COMMENTS :
1)PURPOSE OF THIS BILL . According to the author, inclusion of
an additional label on prescription drug containers will
further aid seniors who consume a disproportionate amount of
prescription medication. In addition, a recent study by the
National Institutes of Health found that "there is a
communication gap between seniors and their physicians around
prescription medications. Meeting these challenges will
require that more attention be devoted to medication
management during all clinical encounters." A label
requirement as required by this bill is one of several steps
that can be taken to increase communication and medication
management.
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
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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
these factors must be taken into consideration in the
development of any consumer education efforts.
One bill was pursued in response to the Panel report. SB 472
(Corbett), Chapter 470, Statutes of 2007, established the
California Patient Medication Safety Act which 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) Board of Pharmacy Report to the Legislature . Pursuant
to SB 472, the Board submitted its report entitled
"Prescription Drugs: Labeling Requirements" to the
Legislature on January 2010. The report indicated the
steps the Board took prior to adopting the final
regulations to implement SB 472. Specifically, the Board
conducted public hearings to collect information from the
public, developed a survey filled out by consumers at
various public outreach events and surveys, including a
radio-sponsored survey.
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The final regulations adopted by the Board required drug
containers to conform to a specified format, including a
12-point sans serif typeface, which lists the name of the
patient, name of the drug (manufacturer's trade name or
generic name and name of the manufacturer) and strength of
the drug, directions for use, and purpose or condition, if
entered onto the prescription by the prescriber, or
otherwise known to the pharmacy and its inclusion on the
label is desired by the patient. The regulations also
require the Board to publish on its Web site translation of
the directions for use into at least five languages other
than English to facilitate their use by California
pharmacies. Examples of labels must also be collected and
published on the Board's Web site to aid pharmacies in
label design and compliance. Additionally, the regulations
provide that for patients who have limited English
proficiency, upon request by the patient, the pharmacy must
provide an oral language translation of the prescription
container label's information. The Board is also required
to re-evaluate the requirements of the regulations by
December 2013.
3)SUPPORT . The California Senior Legislature states that
disclosure of harmful effects of drugs on the actual label
container will further help protect the vulnerable group of
elders and dependent adults.
4)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.
5)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 would
also require 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 currently in
the Assembly Rules Committee awaiting referral.
b) SB 204 (Corbett) requires a pharmacist to use
translations of the directions for use in non-English
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languages published on the Board's Internet Web site, 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 Senate
Business, Professions and Economic Development Committee.
c) SB 205 (Corbett) requires the information on the
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.
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 Senate Public Safety
Committee.
6)PREVIOUS LEGISLATION .
a) SB 472 (Corbett), Chapter 470, Statutes of 2007,
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
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
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drug, if indicated on the prescription, and required a
physician, dentist, optometrist, podiatrist, and 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 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 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, 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.
h) 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.
7)POLICY QUESTIONS .
a) Is this bill necessary ? Current law already requires a
pharmacist to inform a patient orally or in writing of the
harmful effects of a drug dispensed 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, and provided
the drug is determined by the Board to be a drug or drug
type for which this warning shall be given.
b) Is this bill too broad ? The way this bill is drafted,
it requires a pharmacist to include a written label on
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every drug container that the drug may impair a person's
ability to operate a vehicle or vessel. Should this bill
apply only to drugs that are of the type for which such
warning is necessary? It is also unclear why the risk of
driving a vehicle or vessel is particularly required to be
included in a label given that there are a variety of
warnings that a pharmacist may include (e.g. do not drink
alcohol, or drinking may increase the effect of the drug,
take on an empty stomach or take with plenty of water)
depending on the particular drug.
REGISTERED SUPPORT / OPPOSITION :
Support
California Senior Legislature
Opposition
None on file.
Analysis Prepared by : Rosielyn Pulmano / HEALTH / (916)
319-2097