BILL ANALYSIS
SB 470
Page 1
Date of Hearing: June 23, 2009
ASSEMBLY COMMITTEE ON HEALTH
Dave Jones, Chair
SB 470 (Corbett) - As Amended: April 30, 2009
SENATE VOTE : 37-1
SUBJECT : Prescriptions.
SUMMARY : Permits, if requested by the patient, the purpose of
the prescribed medication to be listed on a prescription drug
label.
EXISTING LAW :
1)Provides for the licensure and regulation of pharmacies,
pharmacists, and wholesalers of dangerous drugs or devices by
the California State Board of Pharmacy (Board) in the
Department of Consumer Affairs.
2)Requires dispensed prescription drugs to be stored in
specified containers and correctly labeled with the following
information:
a) The trade name of the drug or the generic and the name
of the manufacturer;
b) The directions for the use of the drug;
c) The name of the patient;
d) The name of the prescriber;
e) The date of issue;
f) The name and address of the pharmacy and the
prescription number;
g) The strength of the drug;
h) The quantity of the drug or drugs dispensed;
i) The expiration date of the effectiveness of the drug;
SB 470
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j) The condition for which the drug was prescribed, if
requested by the patient and the condition is indicated on
the prescription; and,
aa) The physical description of the drug, including its
color, shape, and any identification code that appears on
the tablets or capsule, except as follows:
i) Prescriptions dispensed by a veterinarian;
ii) Prescriptions for a new drug, as specified; or,
iii) Dispensed medications for which no physical
description exists in any commercially available
database.
3)Requires the Board to promulgate regulations that require a
standardized, patient-centered, prescription drug label on all
prescription medication dispensed to patients in California by
January 1, 2010.
FISCAL EFFECT : According to the Senate Appropriations
Committee, pursuant to Senate Rule 28.8, negligible state costs.
COMMENTS :
1)PURPOSE OF THIS BILL . Under existing law, prescription drug
labels must include specified information. In addition, the
label may include the condition for which the drug was
prescribed to be listed if the patient requests. According to
the author, this bill allows the purpose as an alternative.
The author states that when there are a large number of
prescriptions, it is not easily discernible what the purpose
for each is, which increases the chance that a patient may
take the wrong medication. According to the Board, sponsor of
this bill, having the purpose on the label better communicates
to patients how to take the medication and will improve
adherence to the directions. The Board also points out that
there are many drugs with similar sounding names. The Board
contends that if the purpose is on the label, it is more
likely that an error caused by a mix-up will be discovered or
prevented. The Board also asserts that allowing purpose as an
alternative to condition gives more flexibility to the
prescriber and will allow for information that is most useful
to the patient. Finally, according to the author, this bill
is in response to public input from consumers.
2)BACKGROUND . In SB 472 (Corbett), Chapter 470, Statutes of
2007, the Board is charged with standardizing the prescription
SB 470
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drug label to make it patient-centered. SB 472 requires the
Board to seek information from specified groups and to
consider the information gathered in developing the
requirements. According to the Board, a standardized label
format will be developed by January 2011. The implementing
regulations are expected by January 2010. If this bill is
enacted, the Board reports that it will implement it as part
of that process.
As part of the SB 472 mandate, the Board held public meetings,
attended community events, and conducted consumer surveys
designed to elicit information from consumers. A majority of
those surveyed expressed a desire to have the purpose of the
medication included on the label.
The author also cites the Journal of the American Medical
Association statistic that 49% of adults cannot understand the
information listed on their prescription drug labels.
According to the Institute of Medicine of the National
Academies, medication errors are among the most common medical
errors, harming at least 1.5 million people annually.
SCR 49 (Speier), Resolution Chapter 123, Statutes of 2005,
sponsored by the California Pharmacists Association, calls for
creation of an expert panel to study the causes of medication
errors in the outpatient setting and to recommend changes to
the health care system that would reduce errors associated
with prescription and over-the-counter medication use. The
Medication Errors Panel was assembled in 2006 and consisted of
four legislators (two from each house) and 13 individuals
representing academia, consumer advocacy groups, health
professionals (medicine, nursing, public health, and pharmacy)
health plans, community pharmacies, and the pharmaceutical
industry. One of the panel's recommendations was to improve
the quality and accuracy of communications between
prescribers, pharmacists, and patients by requiring the
intended use of the medication to be included on the label at
the option of the patient.
3)STANDARDIZED LABEL . As directed by SB 472, the Board is in
the process of developing a uniform label that is
patient-centered. At the same time, there have been various
efforts to move to an electronic system for prescriptions.
For instance, CalPERS is conducting a pilot project. The
Board is planning to design the label with a place for
SB 470
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condition even though it is by patient request only. The
Board prefers the additional flexibility of expanding to
include the purpose. The development of the uniform label
also provides a unique opportunity to publicize this option
and to educate prescribers, pharmacists and patients.
4)PREVIOUS LEGISLATION .
a) SCR 49 (Speier), Resolution Chapter 123, Statutes of
2005 creates a panel to study the causes of medication
errors and recommend changes in the health care system to
reduce errors associated with the delivery of prescription
and over the counter medication to consumers. ACR 49
requires 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.
b) AB 1276 (Karnette) of 2007 would have required
medication prescribers to ask a patient if they wanted the
intended use on the prescription label. AB 1276 failed
passage in the Assembly Committee on Business and
Professions.
c) 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 can not provide informed consent, whether to
indicate the intended purpose of the prescription on the
label. AB 657 was held in the Assembly Health Committee at
the request of the author.
d) 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. AB 288 was held in the Assembly Committee on
Business and Professions at the request of the author.
e) 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
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to require that the condition be included on the label
unless otherwise directed by the patient. AB 2125 was held
in the Assembly Committee on Business and Professions at
the request of the author.
5)POLICY ISSUES . The law which allows a patient to request the
condition be put on the prescription label is not well known
or utilized, and may be viewed as an invasion of patient
privacy. Furthermore, the background studies point out that
labels with limited space are already very full of
information. The author may want to address why this bill
will not merely add to already confusing labels. The author
may also want to discuss how it relates to other initiatives
that the Board is undertaking to improve prescription labels,
reduce medication errors, and educate prescribers,
pharmacists, and patients.
REGISTERED SUPPORT / OPPOSITION :
Support
California State Board of Pharmacy (sponsor)
AARP
California Alliance for Retired Americans
California Medical Association
California Pan Ethnic Health Network
California Retailers Association
California Society of Health-System Pharmacists
Kaiser Permanente
National Association of Chain Drug Stores
Pharmacy Foundation of California
University of California San Francisco School of Pharmacy
Opposition
None on file.
Analysis Prepared by : Marjorie Swartz / HEALTH / (916)
319-2097