BILL ANALYSIS
AB 1916
Page 1
Date of Hearing: April 13, 2010
ASSEMBLY COMMITTEE ON HEALTH
William W. Monning, Chair
AB 1916 (Davis) - As Amended: April 8, 2010
SUBJECT : Pharmacies: prescriptions: reports.
SUMMARY : Requires a pharmacy to promptly report to the Board of
Pharmacy (Board) any occurrence known by the pharmacy of a
prescription drug being provided to a person other than the
patient named on the prescription or that patient's
representative and requires that report to include any adverse
reaction that may have occurred to the specified person.
EXISTING LAW :
1)Establishes the Board to regulate pharmacy.
2)Requires pharmacies to establish quality assurance programs
that shall document medication errors by the pharmacy or its
personnel so the pharmacy can take corrective action to
prevent a recurrence.
3)Specifies that records generated for and maintained as a
component of a pharmacy's ongoing quality assurance program
shall be considered peer review documents and not subject to
discovery in any arbitration, civil, or other proceeding,
except as specified.
4)Under federal law, establishes MedWatch, the voluntary safety
and adverse event reporting system, administered by the
Federal Food and Drug Administration (FDA).
FISCAL EFFECT : This bill has not been analyzed by a fiscal
committee.
COMMENTS :
1)PURPOSE OF THE BILL . The author believes that this bill will
assist in decreasing the number of medical errors that occur
in California pharmacies. According to the author, pharmacies
are not required to notify the state when a medication error
occurs. The responsibility currently falls on the patient who
may file a formal complaint to the Board. It is the author's
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belief that the burden to report a medical error should be
placed on the pharmacy rather than the patient. Additionally,
a recent report by a Sacramento television news station (KCRA)
showed that only 400 medication errors were reported in
California last year despite over 350 million prescriptions
being filled. KCRA investigators stated that many more
medication errors occurred that were never reported.
2)BACKGROUND . According to the Board, its mission is to protect
the health, safety, and welfare of Californians, which it does
by reviewing, evaluating, and resolving complaints submitted
by consumers regarding pharmacists. The Board states that
suspected misconduct by a pharmacist or an error in the
filling of a prescription may be violations of the law, and
should be reported, whether or not the patient was harmed.
The Board considers prescription errors to be incorrect
information entered on the label of the prescription
container, a prescription that is dispensed with the wrong
drug or wrong dosage, among others. According to the Board,
pharmacies are not required to notify the state every time a
medication error occurs.
3)MEDICATION ERRORS . According to a report in 2006 by the
Institute of Medicine of the National Academies, medication
errors (preventable adverse events) 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 costs 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 adverse drug events, perhaps on the order of
100 times more often. Medication errors also occur in
physicians' offices, pharmacies, and care delivered in the
home. Unfortunately, there are very little data describing
the extent of the problem outside of hospitals.
4)FDA MEDWATCH PROGRAM . MedWatch is a voluntary reporting
system established in MedWatch for health professionals and
consumers to report serious adverse events, product problems,
or medication errors they suspect are associated with the
drugs or medical devices they prescribe, dispense, or use.
MedWatch followed another FDA voluntary-reporting program
started in 1961. MedWatch reporting can be done on line, by
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phone, or by submitting the MedWatch 3500 form via mail or
fax.
The FDA also has a mandatory adverse drug event (ADE) reporting
process for drug manufacturers who are required to report to
the FDA any suspected ADE reports within 15 days of receipt of
such a report. In addition, user-facilities such as hospitals
and nursing homes are legally required to report suspected
medical device related deaths to both FDA and the
manufacturer, if known, and serious injuries to the
manufacturer or to FDA, if the manufacturer is unknown.
5)PREVIOUS LEGISLATION :
a) 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 of the programs.
b) SB 380 (Alquist) of 2005 would have required health care
providers to report suspicious serious adverse drug events
to the FDA. SB 380 died on the Assembly Floor.
6)DOUBLE REFERRAL : This bill has been double-referred. Should
this bill pass out of committee, it will be referred to the
Assembly Committee on Business, Professions and Consumer
Protection.
7)POLICY CONCERNS . The FDA operates a voluntary reporting
system for health professionals and consumers to report ADEs.
This bill requires pharmacists to report ADEs to the Board.
Also, it is unclear how a pharmacist would know about an ADE.
A personal physician is more likely to know about a patient
who has had an ADE, since physicians are the likely point of
contact for a person suffering from an ADE. Additionally, the
bill does not provide guidance to the Board on what to do with
the information once it is provided. The author should
clarify how the Board should collect and utilize the
information related to both medication errors and ADEs,
pursuant to this bill.
Additionally, the bill requires a pharmacy to report "any
occurrence known by the pharmacy" of a prescription being
furnished to the wrong person. This language is vague and
implies that pharmacies must report all medication errors and
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ADEs, even those caused by private individuals, medical
professionals, such as physicians and nurses, hospitals, and
long term care facilities. The author should clarify the
types of medication errors and ADEs pharmacies must report to
the Board.
REGISTERED SUPPORT / OPPOSITION :
Support
None on file.
Opposition
None on file.
Analysis Prepared by : Martin Radosevich / HEALTH / (916)
319-2097