BILL ANALYSIS
SB 1106
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Date of Hearing: June 22, 2010
ASSEMBLY COMMITTEE ON HEALTH
William W. Monning, Chair
SB 1106 (Yee) - As Amended: April 5, 2010
SENATE VOTE : 25-6
SUBJECT : Prescribers: dispensing of samples.
SUMMARY : Requires a prescriber dispensing a drug sample or
starter kit, as defined, to either provide the patient with a
copy of the federal Food and Drug Administration (FDA) approved
package insert for the drug sample or starter kit, or ensure
that the manufacturer's warnings are attached to the package
containing the drug sample or starter kit.
EXISTING LAW :
1)Provides for the licensure and regulation of pharmacies,
pharmacists and wholesalers of dangerous drugs or devices by
the Board of Pharmacy in the Department of Consumer Affairs.
2)Defines a prescriber to mean a person who holds a physician's
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.
3)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 dangerous devices are dispensed
to the prescriber's own patient, and the drugs or dangerous
devices are not furnished by a nurse or physician
attendant;
b) The dangerous drugs or dangerous 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, dangerous devices, or poisons;
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d) The prescriber fulfills all of the labeling requirements
imposed upon pharmacists, as specified, and all of the
recordkeeping requirements, and all of the packaging
requirements of good pharmaceutical practice, including the
use of childproof containers;
e) 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
dangerous devices to the patient packaged, labeled, and
recorded, as specified;
f) 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,
g) 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.
4)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.
5)Prescribes the labeling requirements for prescription drugs
dispensed by a pharmacist to include the manufacturer's trade
name of the drug or the generic name 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 dispensed.
6)Establishes the FDA to, among other things, regulate
prescription and over-the-counter pharmaceutical drugs,
medical devices and biopharmaceuticals.
FISCAL EFFECT : According to the Senate Appropriations
Committee, pursuant to Senate Rule 28.8, negligible state costs.
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COMMENTS :
1)PURPOSE OF THE BILL . According to the author, the practice of
physicians dispensing free drug samples has been criticized
because of the lack of printed instructions. While the author
acknowledges that free medications provide a great service,
particularly to indigent patients, this bill would ensure that
patients receiving sample medications have the appropriate
information without creating barriers to care.
2)PRESCRIPTION DRUG SAMPLES . Recently the practice of providing
free samples to patients has come under scrutiny because of
the lack of printed instructions on the free samples, and has
been regarded as a tool by manufacturers to promote the
newest, least-tested drugs. According to a recent article in
the Journal of the American Board of Family Medicine entitled,
"Effects of Using Free Sample Medications on the Prescribing
Practices of Family Physicians," family physicians who
distribute free sample medications are more likely to
prescribe those medications than physicians who do not. The
article stated that physicians' attitudes toward the use of
free sample medications vary considerably; many believe that
free samples are a great service, especially for indigent
patients, free samples immediately begin the course of
therapy, and free samples would allow physicians to evaluate
patient tolerance and adjust dosage before a full prescription
would be written for the patient. The article also points out
that more substantial problems associated with free samples
relate to physicians' inclinations to prescribe the newer and
more expensive medications that may be no more effective than
well-known established drug therapies.
3)RISING COST OF PRESCRIPTION DRUGS . According to a recent
report by the Kaiser Family Foundation, spending on
prescription drugs in the U.S. in 2006 was five times higher
than the amount spent in 1990 (rising from $40.3 billion to
$216.7 billion in 2006). The report attributes three main
factors driving the cost, which are: increased use of
prescription drugs; increased prices of prescription drugs;
and, changes in the types of drugs used (more costly specialty
drugs). Additionally, the report mentions that increases in
prescription drug use and shifts to higher cost drugs are due
to advertising by pharmaceutical companies and increased
coverage for prescription drugs. Last of all, the report
cites that pharmaceutical manufacturers were among the most
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profitable industries in the nation from 1995-2002, with
profits (profits as a percent of revenues) of 15.8% in 2007,
compared to an average of 5.7% for all other Fortune 500
firms.
4)UNLABELED DRUG SAMPLES AND "LEARNED INTERMEDIARY" DOCTRINE .
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. However, a recent report
in Food and Drug Law Journal entitled, "Unlabeled Drug Samples
and the Learned Intermediary: The Case for Drug Company
Liability without Preemption," makes the case that people who
suffer injuries resulting from the absence of warnings on
samples of prescription drugs should be permitted to sue drug
manufacturers, regardless of the learned intermediary rule
because the rule only serves to shield drug companies from
liability while saving them the cost of providing warning
labels. The author points to research that shows that drug
companies' promotion, marketing, and packaging of sample
prescription drugs put patients at risk as a result of
insufficient disclosure as to the risks involved in the use of
those sample prescription drugs. Additionally, the
manufacturer is better equipped and has more resources to
effectively label prescription drug samples. In the absence
of a complete disclosure of known risks and side effects as
would be required for a full prescription, the risk of harm
from unlabeled prescription drugs should be shared between
physicians and drug companies in a way that more accurately
accounts for the degree to which each party has responsibility
for that risk.
5)SUPPORT . The California Alliance for Retired Americans
supports this bill as it addresses a huge concern for senior
citizens. According to supporters, patients often need more
than just verbal instructions from their doctor on taking a
sample medication. The supporters believe that patients must
receive key written information to be sure the drugs they are
taking are safe and will not jeopardize their health.
6)OPPOSITION . The California Medical Association (CMA) opposes
this bill as it would make it more difficult for physicians to
give free samples or starter kits to patients who often cannot
afford to purchase necessary drugs. Additionally, CMA is
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concerned about the increased risk of lawsuits for alleging
that the required information was not attached or given to the
patient at the time of receiving the free sample. CMA also
states that shifting the burden to the doctor to make a
photocopy of the insert for each patient who receives a sample
out of a multi-pack provided to the doctor's office is an
undue burden and creates a risk of error of coupling a
particular sample with a photocopy of the wrong information.
7)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 died on the
Assembly Inactive File.
8)DOUBLE REFERRAL . This bill has been double-referred. Should
this bill pass out of this committee, it will be referred to
the Assembly Committee on Business, Professions, and Consumer
Protection.
9)POLICY QUESTIONS . Should physicians be responsible for
providing information about a free sample prescription drug,
given the fact that drug manufacturers produce the drug and
have ability to attach the information to the samples? Does
imposing a new requirement on physicians have the unintended
consequence of shielding pharmaceutical companies from
liability? Also, should pharmaceutical manufacturers be
responsible for providing instructions in different languages?
REGISTERED SUPPORT / OPPOSITION :
Support
California Alliance for Retired Americans
California Public Interest Research Group
Consumer Attorneys of California
Opposition
California Medical Association
Analysis Prepared by : Martin Radosevich / HEALTH / (916)
319-2097
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