BILL ANALYSIS
SB 1828
Page 1
Date of Hearing: June 27, 2000
ASSEMBLY COMMITTEE ON JUDICIARY
Sheila James Kuehl, Chair
SB 1828 (Speier) - As Amended: June 6, 2000
SUBJECT : DANGEROUS DRUGS: PRESCRIBING OVER THE INTERNET
KEY ISSUES :
1)SHOULD PRESCRIBING, DISPENSING OR FURNISHING DANGEROUS DRUGS
ON THE INTERNET BE PROHIBITED WITHOUT A GOOD FAITH PRIOR
EXAMINATION OF THE PATIENT?
2)SHOULD THIS BILL BE AMENDED TO CLARIFY THAT LEGITIMATE ONLINE
PHARMACIES ARE NOT TARGETED?
SUMMARY : Seeks to penalize "rogue" Internet sites and the
physicians who enable these dangerous operations by prescribing
medications for patients in violation of California law.
Specifically, this bill :
1)Prohibits, in the Medical Practice Act, any person or entity
from prescribing, dispensing or furnishing dangerous drugs or
devices on the Internet for delivery to any person in this
state without a good faith prior examination which establishes
a medical indication for the medication.
2)Prohibits, in the Pharmacy law, any person or entity from
dispensing or furnishing dangerous drugs or dangerous devices,
as defined, on the Internet for delivery to any person in this
state without a prescription issued pursuant to a good faith
prior examination.
3)Provides that a violation of either of the above prohibitions
is punishable by either a fine of up to $25,000 per occurrence
pursuant to a citation issued by the Medical Board of
California or the Board of Pharmacy, or a civil penalty of
$25,000 per occurrence.
4)Requires that if the person or entity in violation of these
provisions is not a resident of this state, the violation
shall be reported to the person's or entity's appropriate
professional licensing authority, if applicable.
SB 1828
Page 2
5)Allows the Attorney General to bring an action to enforce
these prohibitions and to collect the civil penalties
authorized by the bill.
6)Requires the Franchise Tax Board (FTB), beginning January 1,
2002, to subtract the amount of the civil penalties or fines
authorized under the bill from any tax refund or lottery
winnings due to the person who is a defendant in the action.
Requires the amount collected by FTB to be forwarded to the
Medical Board of California or the Board of Pharmacy for
deposit in the contingent funds of these boards.
7)Specifies that nothing in the bill prohibits the Medical Board
from commencing a disciplinary action against a physician and
surgeon for prescribing drugs without a good faith prior
examination.
8)Provides that nothing in the bill shall be construed to permit
the unlicensed practice of pharmacy or to limit the authority
of the Board of Pharmacy to enforce any other provision of the
Pharmacy Law.
EXISTING LAW :
1)Licenses and regulates physicians through the Medical Practice
Act under the Medical Board of California, and licenses and
regulates pharmacists through the Pharmacy Law under the Board
of Pharmacy. (Business and Professions Code sections 2000 et
seq. and 4000 et seq. All further statutory references are to
this Code.)
2)Defines "dangerous drugs" or "dangerous devices" as drugs or
devices that, by federal or state law, can be lawfully
dispensed only by prescription. (Section 4022.)
3)Prohibits persons from prescribing dangerous drugs or devices
without a valid license as a physician, podiatrist, dentist,
optometrist, or veterinarian, and provides that prescribing,
dispensing or furnishing dangerous drugs without a good faith
prior examination and without a medical indication constitutes
unprofessional conduct. (Section 2242.)
4)Prohibits the dispensing or furnishing of dangerous drugs
without a prescription, subject to limited exceptions.
(Section 4059.)
SB 1828
Page 3
5)Requires pharmacies to be licensed by the Board of Pharmacy
and requires all pharmacies located outside the state that
ship, mail or deliver dangerous drugs or devices into the
state to register with the Board of Pharmacy. (Sections 4110
and 4112.)
FISCAL EFFECT : The bill as currently in print is keyed fiscal.
COMMENTS : This bill was passed out of the Assembly Health
Committee on June 13, 2000, by a vote of 14-0. According to the
author, this bill is intended to penalize "rogue"Internet sites
and the physicians who enable these dangerous operations by
prescribing medications for patients in violation of California
law. In support of the bill, the author states:
As the Internet is increasingly becoming a source of
health care services, including prescription drugs, it is
necessary to maintain public protection in this arena.
According to a New England Journal of Medicine article on
10/28/99, the availability of prescription medicines over
the Internet may increase the inappropriate use of
medications and the risk of adverse events by limiting
physicians' ability to identify contraindications,
patients' ability to learn about the risks and benefits
of medications, and pharmacists' ability to identify drug
interactions and educate patients.
This bill is not intended to interfere with the
legitimate use of the Internet and technology. For
example, patient[s] can request direct delivery of
medications over the Internet after their doctors have
submitted prescriptions by telephone or on paper. Also,
patients can contact their physicians over the Internet,
request a medication, and have the physicians send the
prescription to the pharmacy. This could be a legitimate
use of the Internet as long as there exists [a] prior
physician-patient relationship.
The author notes that online pharmacies offering online
prescriptions often get physicians licensed in another state to
approve the consultation forms. According to the author, the
New York Times reported the following on June 27, 1999:
Dr. Leandro Pasos was 68 years old and struggling to make
SB 1828
Page 4
a living when, about a year ago, an unusual advertisement
in a Seattle newspaper caught his eye. Doctors with
active licenses, the ad said, could earn up to $10,000 a
month doing "fully automated on-line review." The ad was
placed by Performance Drugs, Inc., a fledging company
that had set up shop on the Internet to market Viagra.
The company had lined up pharmacies in Miami and Las
Vegas to ship the pills to patients. But it needed
doctors to write the prescriptions. ?
Thus did Dr. Pasos join the ranks of a growing breed of
physicians: cyberdocs. His patients were strangers to
him, his examinations took place in the facelessness of
cyberspace. That got Dr. Pasos into trouble with the
Washington Medical Quality Assurance Commission, which in
May cited him for unprofessional conduct for prescribing
drugs to people he had not physically examined, and fined
him $500.
Background on Online Pharmacies. On November 19, 1999, the
Assembly Health Committee held an interim hearing entitled
"Examining the Practice of Online Pharmacies: Legal Issues and
Safety Concerns Regarding Prescribing and Dispensing Drugs Over
the Internet."
Testimony at this hearing made it clear that online pharmacies
generally fall into two categories: (1) those online pharmacies
that only fill valid prescriptions issued from licensed
physicians and (2) those online pharmacies that are willing to
provide a "prescription" after an online "consultation," and
then dispense drugs based on this online "prescription." The
former type of online pharmacies are generally considered
legitimate, and typically conform to state law. The latter type
of pharmacies typically require the individual to fill out an
online medical questionnaire for an additional fee. The
websites will often state that a physician will review this
questionnaire before providing a prescription. However, many of
these online pharmacies are not legitimate enterprises
conforming to California legal requirements. For example,
California law requires all pharmacies located outside the state
that ship, mail or deliver dangerous drugs or devices into the
state to register with the Board of Pharmacy. It is not clear
that these online pharmacies have complied with this
requirement.
SB 1828
Page 5
Good Faith Prior Examination Required. California is one of
only a small number of states that has a specific requirement
that a prescription is illegal unless the physician conducts a
good faith prior examination of the patient and there is a
medical indication for the prescription. Online pharmacies that
provide patients with a prescription by simply requiring them to
complete a brief online consultation form raise the serious
concern of whether the required "good faith prior examination
and medical indication therefor" condition for a valid
prescription has been met.
Rather than define in statute what constitutes a good faith
prior examination, the law treats the concept as a standard of
care issue. That is, it is judged based on the specific facts
of a particular case and is inherently subjective. Thus, in
some circumstances, it is entirely reasonable for a physician to
conduct the good faith prior examination without being
physically present to exam the patient. Depending on the
records possessed by the physician, the symptomology presented,
and the history between the patient and the physician, a
web-based examination could meet the standard of care.
Therefore, it would be unduly restrictive to simply bar Internet
prescribing. Instead, the bill seeks to enforce California's
standard of care concept with physicians who claim to be beyond
the reach of California law, even though they are prescribing
dangerous drugs for delivery into California, and the bill's
proposed penalties are intended, in part, to crack down on those
pharmacies that are simply using an online questionnaire to
satisfy the requirement for a prescription.
Additionally, the author cites a Medical Board of California
report which stated "while the law does not specifically address
all of the elements needed in an examination, a reasonable
person can interpret it to mean the physician has a supportable
medical basis for prescribing the drug. Certainly there should
be more than a series of 'yes' or 'no' questions on a
questionnaire and a Visa card number. Clearly completing a
questionnaire with no tests, no scientific verification or
evaluation, and no prior relationship between the physician and
patient cannot meet the good faith examination requirement."
No Prescription? No Problem. A visit to an online pharmacy
called "KwikMed" illustrated the problem addressed by this bill
( www.kwikmed.com , visited June 15, 2000). Among other
prescription drugs, the online pharmacy sells Viagra (for
SB 1828
Page 6
impotence) and Xenical (for obesity). KwikMed's homepage states
"No Prescription? No Problem." Another page provides "Welcome!
You've found the easiest way to order the Hottest Prescription
drugs in the world, right over the Internet. Just complete our
Online Consultation form. When approved, our physician will
write a prescription for you and the product will be shipped
direct to your doorstep, immediately and discreetly."
The online consultation form for Viagra requires the
individual's name, address, phone number and credit card
information. The individual must check a box, among others,
stating "I understand the side-effects of this drug." The
medical history portion requests the individual's height,
weight, sex, age, other medications taken, other medical
problems, and sexual history. The online consultation form for
Xenical requests the same identifying information, credit card
information, medical history, several brief questions relating
to allergies, other drugs taken and whether there is a family
history of breast cancer and an answer to the question "Is there
any reason why you believe you may not be able to take Xenical?"
The website provides information on frequently asked questions
and side effects of the drugs which individuals may access by
clicking on a separate heading entitled "Questions." However,
no verifiable and reliable evidence of actual patient review, or
understanding, is required.
Needed Clarifying Amendment. This bill provides, under the
Pharmacy Law, that a person or entity shall not dispense or
furnish dangerous drugs or devices on the Internet for delivery
to any person in this state without a prescription issued
pursuant to a good faith prior examination. This language may
inadvertently result in additional responsibility placed on
online pharmacies which arguably must determine whether a
prescription was issued pursuant to a good faith prior
examination.
While the Pharmacy Law, which regulates pharmacies, prohibits
the dispensing or furnishing of dangerous drugs without a
prescription, it does not state that the prescription must have
been issued pursuant to a good faith examination. Instead, this
language is included under the Medical Practice Act, which
regulates physicians. The law states that prescribing,
dispensing or furnishing dangerous drugs without a good faith
prior examination and medical indication therefor constitutes
SB 1828
Page 7
unprofessional conduct on the part of the physician.
As noted above, the author has indicated that the intent of this
bill is to penalize "rogue" Internet sites and the physicians
who enable these operations by prescribing medications for
California patients in violation of California law. Because the
author therefore does not intend that this bill interfere with
the legitimate use of the Internet, the Committee may wish to
discuss with the author the need to amend the bill to clarify
that the bill does not preclude legitimate use of the Internet
for dispensing or furnishing medications unless the person or
entity knew, or reasonably should have known, that the
prescription was not issued in accordance with Section 2242 of
the Medical Practices Act , requiring a good faith prior
examination prior to issuing a prescription. If so, the
Committee may wish to instruct staff counsel to work with the
author's office to craft appropriate amendment language.
ARGUMENTS IN SUPPORT : The California Pharmacists Association
supports the bill, stating that its provisions will "protect the
public health and safety by allowing California to enforce
current law regarding the prescribing and dispensing of
prescription drug products to products sold through the
Internet. Such law has been absent and is needed in order to
protect those who may unintentionally fall victim to
unscrupulous marketers of popular prescription drugs such as
Viagra or Propecia."
The California State Board of Pharmacy also supports the bill,
stating that it "provides the Board of Pharmacy with a valuable
enforcement tool" and notes that "a cursory search of the
internet reveals thousands of sites that sell prescription drugs
without a license and sometimes without a prescription of any
variety. Existing fines for these violations are capped at
$2,500 per investigation and are a small deterrent given the
potential profits at stake. With the penalties in this bill,
these rogue websites are faced with a financial risk capable of
destroying their profits and more."
REGISTERED SUPPORT / OPPOSITION :
Support
American Association of Retired Persons, California State Office
Attorney General
SB 1828
Page 8
California Coalition of Nurse Practitioners
California Medical Association
California Pharmacists Association
California State Board of Pharmacy
Medical Board of California
Opposition
None on file
Analysis Prepared by : Saskia I. Kim / JUD. / (916) 319-2334