BILL ANALYSIS
SB 1106
Page 1
Date of Hearing: June 29, 2010
ASSEMBLY COMMITTEE ON BUSINESS, PROFESSIONS AND CONSUMER
PROTECTION
Mary Hayashi, Chair
SB 1106 (Yee) - As Amended: April 5, 2010
SENATE VOTE : 25-6
SUBJECT : Prescribers: dispensing of samples.
SUMMARY : Requires a prescriber who dispenses a drug sample or
starter kit, as specified, to either provide the patient with a
copy of the federal Food and Drug Association (FDA)-approved
package insert for the drug sample or starter kit or ensure that
the manufacturer's warnings are affixed to the drug sample or
starter kit packaging.
EXISTING LAW :
1)Requires a prescriber, when dispensing dangerous drugs or
devices, to fulfill all of the labeling requirements
imposed upon pharmacists, as specified, and the
recordkeeping requirements, and the packaging
requirements of good pharmaceutical practice, including
the use of childproof containers;
2)Prescribes labeling requirements for prescription drugs
dispensed by a pharmacist to include the manufacturer's
trade name or generic name of the drug and the name of
the manufacturer; directions for the use of the drug; the
name of the patient; the name of the prescriber; the date
of issue; the strength of the drug; and the expiration
date of the effectiveness of the drug.
3)Permits the furnishing of a limited quantity of samples by a
prescriber if the prescriber dispenses the samples to the
patient in the package provided by the manufacturer, no
charge is made to the patient, and an appropriate record
is entered into the patient's chart.
4)Provides for the licensure and regulation of pharmacies,
pharmacists and wholesalers of dangerous drugs or devices
by the California State Board of Pharmacy (Board) under
the Department of Consumer Affairs (DCA).
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5)Specifies certain conditions for a prescriber to dispense
drugs or dangerous devices to patients in his or her
office or place of practice, including all of the
following:
a) The dangerous drugs or devices are dispensed to the
prescriber's own patient and not furnished by a nurse
or physician attendant;
b) The dangerous drugs or devices are necessary in the
treatment of the condition for which the prescriber is
attending the patient;
c) The prescriber does not keep a pharmacy, open shop,
or drugstore, advertised or otherwise, for the
retailing of dangerous drugs, devices, or poisons;
d) The prescriber does not use a dispensing device
unless he or she personally owns the device and the
contents of the device, and personally dispenses the
dangerous drugs or devices to the patient packaged,
labeled, and recorded, as specified;
e) The prescriber, prior to dispensing, offers to give
a written prescription to the patient that the patient
may elect to have filled by the prescriber or by any
pharmacy; and,
f) The prescriber provides the patient with written
disclosure that the patient has a choice between
obtaining the prescription from the dispensing
prescriber or obtaining the prescription at a pharmacy
of the patient's choice.
6)Defines a prescriber to mean a person who holds a physician
and surgeon's certificate, a license to practice
optometry, a license to practice naturopathic medicine, a
license to practice dentistry, a license to practice
veterinary medicine, or a certificate to practice
podiatry.
FISCAL EFFECT : Unknown
COMMENTS :
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Purpose of this bill . According to the author's office,
"Dispensing free samples is a common practice among physicians,
but recently such practice has been criticized because of the
lack of printed instructions on the free samples, and has been
regarded as a promotional tool by manufacturers to promote the
newest, least-tested drugs.
"The author believes that free samples are a great service,
especially for indigent patients. Free samples allow physicians
to immediately begin the course of therapy and allow physicians
to evaluate patient tolerance and adjust dosage before a full
prescription would be written for the patient.
"[This bill] strikes a balance between ensuring patients
receiving sample drugs have the appropriate information without
unnecessarily creating barriers to care."
Background . According to current law, an individual holding a
physician and surgeon's certificate, a license to practice
optometry, naturopathic medicine, dentistry, veterinary
medicine, or a certificate to practice podiatry may dispense
free drug samples. The samples may be dispensed if they are in
the package provided by the manufacturer, no charge is made to
the patient, and an appropriate record is entered into the
patient's chart.
Manufacturers regard samples as a promotional tool. Pfizer
alone dispensed 101 million samples worth $2.7 billion in 2007,
according to the company. Merck dispensed 39 million samples
worth about $356 million; Eli Lilly, 33 million worth $67
million; Wyeth, 52 million worth $64 million; Baxter
International, 33,000 worth $7 million and Abbott Laboratories
16 million worth $32 million. An article titled Effects of
Using Free Sample Medications on the Prescribing Practices of
Family Physicians, published in the Journal of the American
Board of Family Medicine concluded that family physicians who
distribute free sample medications are more likely to prescribe
those medications than physicians who do not.
A drug's patient package insert describes what the drug is, how
it should be used and how it works. It also contains
information regarding any possible safety concerns or
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precautions necessary when taking the drug. This information
may be enclosed in the medication box or given as a printout
from the pharmacist. FDA does require patient labeling for some
prescription drugs, including oral contraceptives, intrauterine
devices, and some asthma drugs. Not all samples include this
information, however.
Under the "learned intermediary" doctrine, a manufacturer of
prescription drugs has no duty to warn the consumer about
potential dangers of a drug, so long as the manufacturer has
provided adequate warning of the potential dangers to the
physician who prescribed the drug. The doctrine is based on the
belief that it is for the prescribing physician to use his own
independent medical judgment, taking into account the data
supplied to him from the drug manufacturer, other medical
literature, and any other source available to him, and weighing
that knowledge against the personal medical history of his
patient, whether to prescribe a given drug.
In 2006, the National Academies' Institute of Medicine reported
that medication errors injure 1.5 million people annually. The
report addressed labeling of prescription drugs and found that
there has been a growing unease among health care providers and
others about the way free samples are distributed, the lack of
documentation of medication use, as well as the bypassing of
drug interaction checks and counseling that are integral parts
of the standard prescription process when received through a
pharmacy.
Several states require labels on sample medications. North
Carolina offers no exemption from the packaging, labeling, and
record keeping requirements for sample prescription drugs, which
mandates a label affixed to the container with pertinent
information. North Carolina's Pharmacy Board's rule on patient
counseling and prospective drug use review also applies to
sample prescription drugs.
Massachusetts requires practitioners to label all sample
medications dispensed to patients. Labels must contain the
practitioner's name and address, the date of dispensing, the
name of the patient and, if not included on the manufacturers'
packaging of the sample medication, the name, dosage form and
strength of the medication, directions for use and any necessary
cautionary statements, and the date on which the medication will
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expire. Although the law requires specific information, the
method of labeling the medications is permitted to vary. For
example, sample medications may be placed in a larger container
such as an envelope with the required information written or
typed on the front.
This bill requires a prescriber who dispenses a drug sample to
either provide the patient with a copy of the FDA-approved
package insert or ensure that the manufacturer's warnings are
affixed to the package containing the drug sample or starter
kit. Discussions in the previous policy committee considered
amending the bill to require manufacturers to provide enough
patient package inserts for each sample, thereby facilitating
compliance with this bill.
Arguments in support . The Consumer Attorneys of California
write, "Currently, the oversight of sample prescription drugs is
often incomplete or non-existent. As a result, patients receive
drugs with inadequate information regarding potential side
effects, dosage amounts and drug interactions. Recent studies
have revealed that only 48% of the time do instructions
accompany the dispensing of sample drugs and that they are most
often verbal in nature. It is important that California
consumers receive key written information regarding dosages and
potential side effects and interactions of sample drugs."
Arguments in opposition . California Medical Association (CMA)
writes, "This bill will make it significantly more difficult for
physicians to give free samples or starter kits to patients who
often cannot afford to purchase necessary drugs. Especially
during this time of very high unemployment, with many
Californians being under- or uninsured, and with patients
struggling to make ends meet, the CMA does not believe this type
of legislation is in the public interest. Free samples are
often the only way a patient can comply with physician orders
and the legislature should encourage this activity."
Previous legislation . AB 2690 (Krekorian) of 2008 would have
declared that manufacturers of prescription pharmaceutical
products shall not be relieved of a duty to warn customers of
risks and side effects solely because the product was prescribed
to a patient by a physician. AB 2690 was held on the Assembly
Inactive File.
REGISTERED SUPPORT / OPPOSITION :
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Support
California Alliance for Retired Americans
Consumer Attorneys of California
CALPIRG
Opposition
California Medical Association
Analysis Prepared by : Sarah Weaver / B.,P. & C.P. / (916)
319-3301