BILL ANALYSIS
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|Hearing Date:April 20, 2009 |Bill No:SB |
| |470 |
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SENATE COMMITTEE ON BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT
Senator Gloria Negrete McLeod, Chair
Bill No: SB 470Author:Corbett
As Introduced: February 26, 2009 Fiscal: Yes
SUBJECT: Prescriptions.
SUMMARY: Permits, if requested by patients, the purpose of the
prescribed medication to be listed on prescription drug labels.
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.
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i) The expiration date of the effectiveness of the drug.
j) The condition for which the drug was prescribed if requested
by the patient and the condition is indicated on the
prescription.
This bill revises the current prescription drug labeling requirement
to permit the label to include information on the purpose of the
prescribed medication instead of the condition for which it is
prescribed if requested by the patient.
FISCAL EFFECT: Unknown. This bill is keyed "fiscal" by Legislative
Counsel.
COMMENTS:
Purpose. According to the Sponsor, the California Board of Pharmacy ,
this measure is follow-up legislation to SB 472 (Corbett, Statutes of
2007), which charged the Board with standardizing prescription drug
labels to make them more patient-centered.
1.Background. As part of the SB 472 mandate, the Board of Pharmacy
was required to seek information from specified groups and to
consider that information in the development of patient-centered
drug label requirements. Over the last two years, the Board held
public meetings, attended community events and conducted consumer
surveys designed to elicit information from consumers. The Board
reports that a majority of surveyed consumers have so far expressed
a desire to have the purpose of the medication included on the
label.
In 2006, the Medication Errors Panel's report entitled Prescription
for Improving Patient Safety: Addressing Medication Errors examined
the causes of medication errors in outpatient settings and made a
number of recommendations to reduce errors associated with
prescription and over-the-counter medication use. The Panel,
created by SCR 49 (Speier, 2005), consisted of four legislators (two
from each house) and 13 individuals representing academia, consumer
advocacy groups, health professions (medicine, nursing, public
health and pharmacy) health plans, community pharmacies and the
pharmaceutical industry. One of the Panel's recommendations to
improve communication between prescribers, pharmacists and patients
was to include the drugs' purpose on the prescription label.
According to the Journal of the American Medical Association, 46
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percent of adults cannot understand the information listed on their
prescription drug labels. Furthermore, 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 and
senior citizens are especially vulnerable. Families USA reports
that 90 percent of Medicare patients take medications for chronic
conditions with nearly half of them taking five or more medications
a day. Given the large numbers of prescriptions that may be
prescribed, it is not easily discernable what the purpose for each
of these medications is. This increases the chances that a patient
may take the wrong medication increasing the likelihood of serious
injury or death.
2.Previous Legislation. AB 1276 (Karnette, 2007) would have required
medication prescribers to ask a patient if they wanted the intended
use on the prescription label. The measure failed passage in the
Assembly Committee on Business and Professions.
AB 657 (Karnette, 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. The bill was held in this committee at the request of the
Author.
AB 288 (Mountjoy, 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. The measure was held in the
Assembly Committee on Business and Professions at the request of the
Author.
SCR 49 (Speier, 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 a
report on its finding by June 1, 2006.
AB 2125 (Levine, 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
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included on the label unless otherwise directed by the patient. The
bill was held in the Assembly Committee on Business and Professions
at the request of the Author.
3.Arguments in Support. The Board of Pharmacy and the California
Society of Health-System Pharmacists state this measure will make
prescription labels more meaningful to consumers, improve medication
adherence and reduce medication errors. The Medical Board of
California (MBC) writes in support of this measure as they state it
will enhance consumer protections by requiring the physician to
include the intended purpose of the drug on the prescription label
and will help patients, caregivers and any other people who assist
patients in administering medication to prevent illness or death due
to medication errors. Additionally, the UCSF School of Pharmacy also
supports this bill as it "is straightforward and irrefutably
beneficial to patient safety."
4.Support if Amended. The California Medical Association (CMA) has
taken a support if amended position on the measure and offers the
following suggested amendments:
Amendment #1: page 2, line 15 to read as follows: A legible, clear
notice of the condition or purpose for which the drug is being
prescribed.
CMA contends this language will give greater flexibility to
prescribers to meet the needs of their patients. They state
"because patients can be required to take many drugs, allowing the
patient and physician to develop and place the most useful
information on the container label will reduce the number of
medication errors."
Amendment # 2: page 4, lines 24-26 to read as follows:
The condition or purpose for which the drug was prescribed if the
condition or purpose is indicated on the prescription. If the
patient requests the condition or purpose on the container label but
it is not included on the prescription, the pharmacist may include
this information only after consulting with the prescriber. The
consultation may be oral or electronic.
CMA asserts that as currently written, this section does not
specify who would determine what the condition or purpose for
the prescription is. They state "a particular drug may be
prescribed for different reasons or purposes and confusion
leading to a medication error may result if anyone other than
the prescriber is allowed to determine what is placed on the
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container label."
5.Oppose unless amended. The California Retailers Association
(CRA) and the National Association of Chain Drug Stores (NACDS)
request that SB 470 be amended to require the prescriber to
indicate on the prescription which, the condition or purpose,
shall be on the label if requested by the patient and require
the condition or purpose, as determined by the prescriber, to be
posted on the prescription label at the time of initial
prescription's dispensation. CRA and NACDS are concerned that
the allowing the patient to change the label and changing the
label after the initial prescription has been filled may lead to
medication error. They state that label change may confuse
patients and lead them to take the same medication twice.
Amendment # 3: page 4, lines 24-26 to read as follows:
The condition or purpose for which the drug was prescribed if the
condition or purpose is indicated on the initial prescription
provided by the prescriber . If the patient requests the condition
or purpose on the container label but it is not included on the
prescription, the pharmacist may include this information only after
consulting with the prescriber if it is requested at the time of
dispensing of the initial prescription . The consultation may be
oral or electronic .
SUPPORT AND OPPOSITION:
Support:
California Board of Pharmacy (Sponsor)
California Society of Health-System Pharmacists
Medical Board of California
UCSF School of Pharmacy
Support if Amended :
California Medical Association
Opposed unless Amended :
California Retailers Association
National Association of Chain Drug Stores
Opposition:
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None on file as of April 15, 2009.
Consultant:Sieglinde Johnson