BILL ANALYSIS
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|Hearing Date:March 22, 2010 |Bill No:SB |
| |1106 |
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SENATE COMMITTEE ON BUSINESS, PROFESSIONS
AND ECONOMIC DEVELOPMENT
Senator Gloria Negrete McLeod, Chair
Bill No: SB 1106Author:Yee
As Introduced: February 17, 2010 Fiscal:Yes
SUBJECT: Prescribers: dispensing of samples.
SUMMARY: 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.
Existing law:
1)Provides for the licensure and regulation of pharmacies, pharmacists
and wholesalers of dangerous drugs or devices by the California
State Board of Pharmacy (Board) 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
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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 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 Food and Drug Administration (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
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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.
FISCAL EFFECT: Unknown. This bill is keyed "fiscal" by Legislative
Counsel.
COMMENTS:
1. Purpose. According to the Author , 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.
2. 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 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. This
bill would add a requirement that any drug sample or starter kit
provided by a prescriber to a patient to include the appropriate
manufacturer's warning pamphlet that is physically attached to the
drug sample or starter kit.
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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
website.
3. 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 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.
4. Other States. Massachusetts is an example of a state that has more
comprehensive requirements for providing information to patients
when it comes to dispensing sample medications. This State
requires practitioners to label all sample medications dispensed to
patients, including those provided as part of an indigent patient
drug program. 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 expire. Although the law
requires specific information, the method of labeling the
medications may vary. For example, sample medications may be
placed in a larger container such as an envelope with the required
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information written or typed on the front. Alternatively, the label
may be a piece of paper affixed to the sample packaging or to a
container holding the samples. The label may also be inserted
inside a container holding the drug samples. This container may be
a plastic or paper bag, an envelope or a box. However, a container
must hold only one type of drug sample. Thus, different drugs and
their accompanying labels may not be mixed in a single container.
Massachusetts allows pharmaceutical companies to assist prescribers
by providing pre-printed labels.
5. Comments. This bill would limit the prescriber to using the
manufacturer's warning pamphlet physically attached to the drug
sample or starter kit. There may be instances where the
manufacturer's warning pamphlet is unavailable or is not physically
affixed to the sample. The author may wish to offer flexibility on
the specific information provided and the method of labeling the
medications, and consider the Massachusetts model, as discussed in
#4) above.
6. Author's Suggested Amendment. The Author would like to amend this
bill to give the prescriber the option to use a copy of the FDA's
approved package insert for the drug sample or starter kit rather
than just the manufacturer's warning pamphlet.
7. Arguments in Support. In supporting this bill, the Consumer
Attorneys of California points out that the oversight of sample
prescription drugs is often incomplete or non-existent and patients
receive drugs with inadequate information regarding potential side
effects, dosage amounts and drug interactions. It states that
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 the dosages and
potential side effects and interactions with sample drugs.
SUPPORT AND OPPOSITION:
Support: Consumer Attorneys of California
Opposition: None on file as of March 16, 2010
Consultant:Rosielyn Pulmano
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