BILL ANALYSIS
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|Hearing Date:April 13, 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.
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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.
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
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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 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
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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 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."
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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 container label."
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
Opposition:
None on file as of April 6, 2009.
Consultant:Sieglinde Johnson