BILL ANALYSIS
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|SENATE RULES COMMITTEE | SB 1106|
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THIRD READING
Bill No: SB 1106
Author: Yee (D)
Amended: 4/5/10
Vote: 21
SENATE BUSINESS, PROF. & ECON. DEV. COMMITTEE : 5-2,
3/22/10
AYES: Negrete McLeod, Calderon, Florez, Oropeza, Yee
NOES: Wyland, Aanestad
NO VOTE RECORDED: Correa, Walters
SENATE APPROPRIATIONS COMMITTEE : Senate Rule 28.8
SUBJECT : Prescribers: dispensing of samples
SOURCE : Author
DIGEST : This bill prohibits a prescriber from dispensing
a drug sample or a starter kit unless the appropriate
manufacturers warning pamphlet is physically attached to
the package containing the drug sample or starter kit, or
the patient is provided a copy of the Food and Drug
Administration (FDA)-approved package insert for the drug
sample or starter kit.
ANALYSIS :
Existing law:
1. Provides for the licensure and regulation of pharmacies,
CONTINUED
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pharmacists and wholesalers of dangerous drugs or
devices by the Board of Pharmacy in the Department of
Consumer Affairs.
2. 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.
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.
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
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pharmacy of the patient's choice.
3. 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.
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.
This bill prohibits a prescriber from dispensing a drug
sample or a starter kit unless the appropriate
manufacturer's warning pamphlet is physically attached to
the package containing the drug sample or starter kit or
the manufacturer's warnings are affixed to the package
containing the drug sample or starter kit, or the patient
is provided a copy of the FDA-approved package insert for
the drug sample or starter kit.
Background
Existing law allows a physician and surgeon, optometrist,
naturopathic doctor, dentist, veterinarian, and podiatrist
to dispense drugs or dangerous devices to patients in their
offices or place of practice if specified conditions are
met. These conditions include the requirement that the
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drugs or devices are dispensed to the prescriber's own
patient, is necessary in the treatment of the condition for
which the prescriber is attending the patient, and to
fulfill all of the labeling requirements imposed upon
pharmacists when dispensing drugs. These labeling
requirements 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 date of issue, and the strength and quantity
of the drugs dispensed.
Existing law also states that the provisions establishing
conditions for a prescriber to dispense drugs or dangerous
devices does not prohibit the furnishing of a limited
quantity of samples to the patient, if the samples are
dispensed 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. However, this provision
does not apply to community clinics or free clinics,
clinics operated by the United States government, or a
clinic operated by a federally recognized Indian tribe or
tribal organization or clinics offering narcotic treatment
programs.
The FDA determines the requirement for drug product labels
or patient package insert for drugs. A patient package
insert is written information received when you purchase
prescription drugs that tells what the drug is, how it
should be used and how it works. It also contains
information regarding any possible safety concerns or
precautions necessary when taking the drug. This
information may be enclosed in the medication box, or may
be given as a printout from the pharmacist. Drug product
labels are available on the FDA's Web site.
Drug samples and prescribing practices . Free drug samples
is a common practice among physicians, but recently such
practice has been criticized for its drawbacks 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. An article
entitled "Effects of Using Free Sample Medications on the
Prescribing Practices of Family Physicians", published in
the Journal of the American Board of Family Medicine
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concluded that 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.
FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes
Local: Yes
SUPPORT : (Verified 4/14/10)
California Alliance for Retired Americans
California Public Interest Research Group
Consumer Attorneys of California
OPPOSITION : (Verified >)
>
ARGUMENTS IN SUPPORT : According to the author's office,
although sample prescription drugs have an important role
to play in our health care delivery system, patients need
to be armed with the same information that they are
provided from the pharmacy. There are no requirements in
current law that pertinent information be given to patients
who receive sample drugs.
ARGUMENTS IN OPPOSITION : >
JJA:mw 4/14/10 Senate Floor Analyses
SUPPORT/OPPOSITION: SEE ABOVE
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SUPPORT/OPPOSITION: NONE RECEIVED
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