BILL ANALYSIS
AB 521
Page 1
Date of Hearing: April 8, 2003
ASSEMBLY COMMITTEE ON HEALTH
Dario Frommer, Chair
AB 521 (Diaz) - As Introduced: February 18, 2003
SUBJECT : Prescription drug warnings.
SUMMARY : Requires a pharmacist to include a large-print
informational insert with each prescription drug informing the
patient when the drug poses a substantial risk of harm if the
drug is taken in combination with alcohol or other medications,
including nonprescription drugs.
EXISTING LAW 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 when taken in
combination with alcohol or if the drug may impair a person' s
ability to drive a motor vehicle.
FISCAL EFFECT : Unknown
COMMENTS :
1)PURPOSE OF THIS BILL . According to the author, this bill is
necessary because the inappropriate use of prescription drugs
is a problem that is particularly acute for the elderly. The
elderly use more prescription drugs than any other age group
and are more likely to be taking multiple prescription drugs,
which increases the probability of adverse drug reactions.
The insert required by this bill will provide valuable
information in a format that can be easily read.
2)BACKGROUND . According to the National Council on Patient
Information and Education (NCPIE), an often-overlooked public
health problem is the inappropriate use of medicines. NCPIE
states that in the year 2000, nearly three billion retail
prescriptions were dispensed. According to NCPIE, studies
show that up to half of all prescribed medicines are used
improperly, and as a result, preventable medicine-related
illnesses annually account for over $75 billion in doctors'
visits, unnecessary prescriptions, absences and loss of
productivity at work, increases in emergency room visits,
hospitalizations, and nursing home admissions, and even death.
AB 521
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Board of Pharmacy regulations require pharmacists to provide
oral consultation to their patients when requested by the
patient or whenever the pharmacist deems it warranted in the
exercise of his or her professional judgment. In addition,
regulations require consultation whenever a prescription drug
has not previously been dispensed to a patient, or whenever a
prescription drug not previously dispensed to a patient in the
same dosage form, strength or with the same written
directions, is dispensed by the pharmacy. Finally,
regulations require that prior to consultation, a pharmacist
must review a patient's drug therapy and medication record
before each prescription drug is delivered and the review must
include screening for severe potential drug therapy problems.
NCPIE emphasizes the important role of communication between
consumers and health care professionals whenever medicines are
prescribed and used. NCPIE endorses the use of large print
written information that answers questions that patients may
have, including what foods, drinks, other medicines, or
activities should be avoided while taking any given
medication. Generally, pharmacists do include written
instructions with each dispensed prescription drug that often
list contraindications and side effects.
3)SUPPORT . The Congress of California Seniors argues that the
large print notice required by this bill will be an additional
reminder and safeguard for patients, in addition to the
consultation requirement under existing law.
4)OPPOSITION . The California Pharmacists Association (CPhA)
argues that this bill will impose significant new costs on
pharmacies without a commensurate benefit to the public. CPhA
believes that this issue can be better addressed by greater
enforcement of the existing consultation requirements on
pharmacists and by greater awareness of this requirement on
the part of consumers.
5)BOARD OF PHARMACY . The Board of Pharmacy has not yet taken a
position on this bill, but the board's Legislation and
Regulation Committee has recommended a "support if amended"
position on this bill to the full board. The committee
recommended amendments that would specify that the information
mandated would be provided on the patient package insert
currently provided by most pharmacies, specify a minimum type
size rather than indicate "large print" and extend the
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effective date of the bill for one year to allow pharmacies
time to make the required system changes.
6)AMENDMENT REQUESTED . The Consumer Attorneys of California
requests this bill be amended by the addition of the phrase:
"Nothing in this section is intended to or does restrict
current remedies, rights, and protections under current law."
The author has stated that he is willing to accept this
amendment.
7)TECHNICAL AMENDMENT . On page 2, line 4, the word "dispersed"
should be "dispensed."
8)POLICY QUESTION . Could this bill's intent be accomplished in
a more cost-effective manner if the insert were required only
when requested by the patient?
REGISTERED SUPPORT / OPPOSITION :
Support
Congress of California Seniors (Sponsor)
FORUM, the Federation of Retired Union Members of Santa Clara
and San Benito Counties
One individual
Opposition
California Pharmacists Association
Rite Aid
Analysis Prepared by : John Gilman / HEALTH / (916) 319-2097