BILL ANALYSIS
AB 1916
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Date of Hearing: April 20, 2010
ASSEMBLY COMMITTEE ON BUSINESS, PROFESSIONS AND CONSUMER
PROTECTION
Mary Hayashi, Chair
AB 1916 (Davis) - As Amended: April 8, 2010
SUBJECT : Pharmacies: prescriptions: reports.
SUMMARY : Requires a pharmacy to report to the Board of
Pharmacy (Board) any known occurrence of a prescription being
furnished to a person other than the patient named on the
prescription or that patient's representative. Requires the
report to include any adverse reaction that may have occurred as
a result of the person to whom the prescription was furnished
using the prescribed drug.
EXISTING LAW
1)Provides for the licensure and regulation of pharmacies by the
Board.
2)Authorizes a pharmacy to furnish dangerous drugs only to,
among others, a patient or another pharmacy pursuant to a
prescription or as otherwise authorized by law.
3)Requires every pharmacy to establish a quality assurance
program to assess errors in dispensing or furnishing
prescription drugs. A knowing violation of the Pharmacy Law
is a crime unless otherwise specified.
FISCAL EFFECT : Unknown
COMMENTS :
Purpose of this bill . According to the author's office,
"Pharmacists aren't required to notify the state when an error
occurs. The responsibility currently falls on the patient. It
is the author's belief that this burden to report when a
pharmacy has made a medical error should not be placed on the
patient. The burden to report pharmacy medical errors should be
on the pharmacy which made the error."
Background . The Board's mission is to protect the health,
safety, and welfare of Californians by reviewing, evaluating,
AB 1916
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and resolving consumer complaints regarding pharmacists. The
Board states that suspected pharmacist misconduct or a
prescription filling error may be violations of the law that
should be reported, whether or not the patient was harmed. The
Board considers prescription errors to be incorrect information
entered on the prescription label, or a prescription that is
dispensed with the wrong drug or dosage, among others.
According to a 2006 report by the Institute of Medicine of the
National Academies, medication errors (preventable adverse drug
events (ADEs)) are among the most common medical errors, harming
at least 1.5 million people every year. While researchers state
that there is insufficient data to accurately determine the cost
of medication errors, conservative estimates suggest that the
cost of treating drug-related injuries occurring in hospitals
alone amount to $3.5 billion a year. Medication errors occur
much more frequently than preventable ADEs, perhaps on the order
of 100 times more often. Medication errors also occur in
physicians' offices, pharmacies, and home care. Unfortunately,
there are very little data describing the extent of the problem
outside of hospitals.
MedWatch is a voluntary reporting system established for health
professionals and consumers to report serious ADEs, product
problems, or medication errors they suspect are associated with
the drugs or medical devices they prescribe, dispense, or use.
MedWatch followed another federal Food and Drug Agency (FDA)
voluntary-reporting program started in 1961. MedWatch reporting
can be done online, by phone, or by submitting a form via mail
or fax.
The FDA also has a mandatory ADE reporting process for drug
manufacturers who are required to report to the FDA any
suspected ADE reports within 15 days of receipt. In addition,
user facilities such as hospitals and nursing homes are legally
required to report suspected medical device-related deaths or
injuries to both FDA and the manufacturer.
Previous legislation . SB 1339 (Figueroa), Chapter 677, Statutes
of 2000, requires pharmacies to establish quality assurance
programs to reduce medication errors and requires the Board to
adopt a regulation specifying the requirements.
SB 380 (Alquist), of 2005 required health care providers to
report suspicious serious ADEs to the FDA. This bill was held
AB 1916
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on the Assembly Floor.
REGISTERED SUPPORT / OPPOSITION :
Support
None on file.
Opposition
California Retailers Association
California Society of Health-System Pharmacists
National Association of Chain Drug Stores
Analysis Prepared by : Sarah Weaver / B.,P. & C.P. / (916)
319-3301