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How To Buy Drugs Online
Buying Drugs
Online:
It's Convenient
and Private, but Beware of 'Rogue Sites'
by John Henkel
The scene is becoming increasingly
common in the United States: Consumers are replacing a trip to the corner
drugstore with a click onto the Internet, where they find hundreds of Websites
selling prescription drugs and other health products.
Many of these are lawful enterprises
that genuinely offer convenience, privacy, and the safeguards of traditional
procedures for prescribing drugs.
For the most part, consumers can
use these services with the same confidence they have in their neighborhood
pharmacist. In fact, while some are familiar large drugstore chains, many
of these legitimate businesses are local "mom and pop" pharmacies, set
up to serve their customers electronically.
But consumers must be wary of others
who are using the Internet as an outlet for products or practices that
are already illegal in the offline world.
These so-called "rogue sites" either
sell unapproved products, or if they deal in approved ones, often sidestep
established procedures meant to protect consumers.
Example
For example, some sites require customers
only to fill out a questionnaire before ordering prescription drugs, bypassing
any face-to-face interaction with a health professional.
"This practice undermines safeguards
of a direct medical supervision and physical evaluation performed by a
licensed health professional," says Jeffrey Shuren, M.D., medical officer
in the Food and Drug Administration's Office of Policy, Planning and Legislation.
"The Internet makes it easy to bypass this safety net."
Skirting the system this way sets
the stage for problems that include dangerous drug interactions and harm
from contaminated, counterfeit or outdated drugs.
"Websites that prescribe based on
a questionnaire raise additional health concerns," says Shuren. "Patients
risk obtaining an inappropriate medication and may sacrifice the opportunity
for a correct diagnosis or the identification of a contraindication to
the drug."
To date, FDA has received only a
few reports of adverse events related to Internet drug sales, but some
of these cases point out the potential danger of buying prescription drugs
on the basis of just a questionnaire.
Death From
"Unqualified" Prescription
For example, a 52-year-old Illinois
man with episodes of chest pain and a family history of heart disease died
of a heart attack in March 1999 after buying the impotence drug Viagra
(sildenafil citrate) from an online source that required only answers to
a questionnaire to qualify for the prescription.
Though there is no proof linking
the man's death to the drug, FDA officials say that a traditional doctor-patient
relationship, along with a physical examination, may have uncovered any
health problems such as heart disease and could have ensured that proper
treatments were prescribed.
FDA is investigating numerous pharmaceutical
Websites suspected of breaking the law and plans to take legal action if
appropriate. The agency has made Internet surveillance an enforcement priority,
targeting unapproved new drugs, health fraud, and prescription drugs sold
without a valid prescription.
A Brave
New World
More and more consumers are using
the Internet for health reasons. According to the market research firm
Cyber Dialogue Inc., health concerns are the sixth most common reason people
go online.
Internet drugstores, however, won't
make "brick and mortar" pharmacies obsolete anytime soon. Over 3 billion
prescriptions were dispensed in 1999, and though no reliable figures gauging
total online sales are yet available, industry sources say that number
is likely still fairly small.
For some people, buying prescription
drugs online offers advantages not available from a local drugstore, including:
-
greater availability of drugs for shut-in
people or those who live far from the pharmacy
-
the ease of comparative shopping among
many sites to find the best prices and products
-
greater convenience and variety of products
-
easier access to written product information
and references to other sources than in traditional storefront pharmacies
-
the ability for consumers to order products
and consult with a pharmacist in the privacy of their homes
Internet drug shopping also purports
to save consumers money. In some cases this is true.
A survey in the fall of 1999 by Consumer
Reports showed that buyers could save as much as 29 percent by obtaining
certain drugs online.
But another study, conducted in 1999
by the University of Pennsylvania and published in the Annals of Internal
Medicine, tracked Internet sales of Viagra and Propecia and found that
the two drugs were an average of 10 percent more expensive online than
at local Philadelphia-area pharmacies.
In another part of that study, researchers
Bernard Bloom, Ph.D., and Ronald Iannocone found that 37 of the 46 sites
they examined either required a prescription from a personal physician
or offered to prescribe a medication based solely on a questionnaire.
But nine sites, all based outside
the United States, did not require a prescription. The researchers also
found that even when Websites offered a questionnaire with the promise
that a physician would review the form, nothing was generally known about
the doctor's qualifications, and it was easy for users to provide false
information to obtain a prescription.
Consumers seeking health products
online can find dozens of sites that FDA officials say are legally questionable.
A number of them specialize in providing drugs such as Viagra, the baldness
therapy Propecia (finasteride), or the weight-loss treatment Xenical (orlistat).
Others, based in foreign countries,
promise to deliver prescription drugs at a much cheaper price than their
domestic cost, but the drugs may be different from those approved in the
United States or may be past their expiration dates.
Still other sites make fraudulent
health claims or blatantly advertise that a customer can buy drugs with
no prescription. Online drug sites can now be located in nearly any state
or country having phone lines.
Some feel new laws will be needed
to improve this situation. "Currently, there is nothing to require a drug-dispensing
Website to disclose anything to the public," says Rep. Ron Klink (D-Pa.),
who is sponsoring Internet pharmacy legislation.
"Buyers have no way of knowing whether
a site is licensed or if the site uses licensed doctors or pharmacists
or even in what state they are located."
Klink's bill would require internet-based
pharmacies to list the name, address and phone number of the principal
place of business, the name of each pharmacist and health professional
who provides medical consultation, and the states where the pharmacy, pharmacists,
and other health professionals are licensed.
Certain pharmacy industry representatives
oppose legislation or additional powers for regulatory agencies on the
premise that current laws are sufficient to address the problem. "There
are [controls] already in place for regulating pharmaceutical sales," says
Mary Ann Wagner, vice president of pharmacy regulatory affairs for the
National Association of Chain Drug Stores. "That hasn't changed."
Overseeing
Online Sales
Whether new legislation will improve
oversight of online pharmacies remains to be seen.
For the moment, regulators have entered
what FDA's Shuren calls "a whole new ball game" that cuts across the limited
jurisdictions of several federal and state agencies.
State medical boards regulate medical
practice, while state pharmacy boards oversee pharmacy practice. FDA and
the Federal Trade Commission ensure that drug sellers make legal claims
for their products. Numerous other agencies such as the U.S. Customs Service
and the U.S. Postal Service enforce laws regarding the shipment of drug
products.
FDA regulates the safety, effectiveness
and manufacturing of pharmaceutical drugs, as well as a part of the prescribing
process.
"It is a violation of the Food, Drug,
and Cosmetic Act to sell a prescription drug without a valid prescription,"
says Shuren. "Therefore, FDA can take action against sites that bypass
this requirement."
He adds that the advantage of FDA
being involved is that states have difficulty enforcing their laws across
state boundaries. If one state successfully shuts down an illegal Website
within its borders, the site theoretically still has 49 other potential
locales in which to sell.
However, if the federal government
shuts down an illegal Website, that operation is out of business.
In July 1999, FDA announced that
it was joining forces with state regulatory agencies and law enforcement
groups to combat illegal domestic sales of prescription drugs.
The agency signed agreements with
the National Association of Boards of Pharmacy and the Federation of State
Medical Boards. These organizations have made a commitment to help enforce
federal and state laws against unlawful Internet sellers and prescribers
of drugs in the United States.
Though regulating Internet sales
of health products is still fairly new, FDA has successfully taken action
in the past against illegal sites.
For example, a California company
called Lei-Home Access Care in 1996 and 1997 used the Internet to sell
a home kit advertised as a blood test for the AIDS virus.
Not only was the kit unapproved,
but the maker also fabricated test results given to users who submitted
a drop of blood. After an extensive FDA investigation, the site was shut
down, and its operator, Lawrence Greene, was sentenced to more than five
years in prison.
In July 1999, the Federal Trade Commission
announced a program called "Operation Cure.All," which aims to stop bogus
Internet claims for products and treatments touted as cures for various
diseases. Over two years, the FTC identified about 800 sites and numerous
Usenet newsgroups containing questionable promotions.
"Miracle cures, once thought to be
laughed out of existence, have found a new medium," says Jodie Bernstein,
director of FTC's Bureau of Consumer Protection. "Consumers now spend millions
on unproven, deceptively marketed products on the Web."
As part of the program, four companies
settled FTC charges of deceptive health claims. These included sites that
claimed to cure arthritis with a fatty acid derived from beef tallow, to
treat cancer and AIDS with a Peruvian plant derivative, and to treat cancer
and high blood pressure with magnetic devices. FDA is working closely with
FTC on Operation Cure.All and has taken its own regulatory actions, such
as sending warning letters to
help ensure that false and misleading
statements are removed from the Internet.
More than a dozen states also have
taken some kind of action against Internet pharmacies, including Kansas,
which in 1999 prohibited several pharmacies from operating illegal Web-based
businesses within the state.
Industry
Polices Itself
At the same time that regulatory
agencies are stepping up enforcement efforts against illegal online drug
sales, professional organizations are launching programs with the goal
of cleaning house from within.
In late 1999, the National Association
of Boards of Pharmacy (NABP) unveiled its Verified Internet Pharmacy Practice
Sites (VIPPS) program, which provides consumers valuable information about
the credentials of online pharmacies.
VIPPS is a voluntary certification
program. The fairly rigid conditions the online pharmacy must agree to
for acceptance into the program include:
-
maintaining all state licenses in good
standing
-
allowing information about the pharmacy
to be posted and maintained on the VIPPS Website (http://www.nabp.net/vipps/intro.asp)
-
allowing an NABP-sanctioned team to
inspect its operations, given reasonable notice
-
displaying and maintaining the VIPPS
seal with a link to the VIPPS Website
VIPPS officials say the program is especially
beneficial to seniors. "There is particular concern among the elderly population,
which is often the target of unscrupulous marketing ploys," says Kevin
Kinkade, NABP executive committee chairman.
"VIPPS will be of tremendous benefit
to consumers who need to be certain that the prescription medications they
receive are from legitimate online pharmacies."
To date, six businesses have been
awarded VIPPS certification: drugstore.com, Merck-Medco Managed Care L.L.C.,
planetRx.com, familymeds.com, CVS Washington Inc., and Tel-Drug Inc.
At its June 1999 annual meeting,
the American Medical Association adopted guidelines for doctors that specifically
address Internet prescriptions.
These voluntary principles recommend
that doctors who prescribe over the Internet follow minimum standards of
care. This includes examining a patient to determine the medical problem,
discussing the risks and benefits of a drug with the patient, and following
up to ensure the patient does not experience serious side effects.
Many in the pharmaceutical industry
back the AMA's action. "The relationship between physician and patient
is critically important, " says Martin Hirsch, public affairs director
for Roche Laboratories Inc., maker of Xenical. "We support guidelines that
will ensure that this relationship continues."
With regulatory and voluntary actions
in full swing, it still will be hard to stay on top of illegal Internet
drug sales.
"Even if the state boards, FDA, and
others do their jobs, consumers are going to need to be educated about
the issue," says Wagner of the National Association of Chain Drug Stores.
FDA plans to help increase public
awareness with an education campaign that informs consumers about the health,
economic and legal risks of online sales of medical products. The campaign
also will target health-care practitioners and industry. Other federal
and private groups are conducting similar outreach.
"Consumers need to know the risks
of buying prescription drugs online so they can remain vigilant," says
FDA's Shuren.
" The public also needs to know,"
he adds, "that there's a price to pay for operating an illegal Internet
pharmacy. Even bringing a few highly publicized cases into the public eye
will send a powerful message that these illegal sites will not be tolerated."
John Henkel is a member of FDA's
Website Management Staff.
How Online
Sales Work
In general, legitimate online pharmacies
operate this way:
Users open an account with the pharmacy,
submitting credit and insurance information. The pharmacy is licensed to
sell prescription drugs by the state in which it operates and in those
states to which it sells, if an out-of-state license is required.
After establishing an account, users
must submit a valid prescription. Doctors can call it in or in some states
email it, or users can deliver it to the pharmacy by fax or mail.
Some online pharmacies send products
from a central spot, while others allow users to pick the prescription
up at a local drugstore. Prescriptions usually are delivered within three
days, often for no shipping charge. For an extra fee, many sites will deliver
overnight.
Sites typically have a mechanism
for users to ask questions of the pharmacist, either through e-mail or
a toll-free number.
What Consumers
Can Do
With hundreds of drug-dispensing
Websites in business, how can consumers tell which sites are legitimate
ones, especially when it is very easy to set up a site that is very professional-looking
and promises deep discounts or a minimum of hassles?
"Consumers need to be cautious,"
says Jeffrey Shuren, M.D., medical officer in FDA's Office of Policy, Planning
and Legislation. "You should use the same kind of common sense you use
when buying from any business. You look for a reputable dealer. You get
recommendations from friends. You check the place out."
FDA offers these tips to consumers
who buy health products online:
-
Check with the National Association
of Boards of Pharmacy to determine if the site is a licensed pharmacy in
good standing (visit the Website at http://www.nabp.net/, or call 847-698-6227).
-
Don't buy from sites that offer to prescribe
a prescription drug for the first time without a physical exam, sell a
prescription drug without a prescription, or sell drugs not approved by
FDA.
-
Don't do business with sites that do
not provide access to a registered pharmacist to answer questions.
-
Avoid sites that do not identify with
whom you are dealing and do not provide a U.S. address and phone number
to contact if there's a problem.
-
Beware of sites that advertise a "new
cure" for a serious disorder or a quick cure-all for a wide range of ailments.
-
Be careful of sites that use impressive-sounding
terminology to disguise a lack of good science or thosethat claim the government,
the medical profession, or research scientists have conspired to suppress
a product.
-
Steer clear of sites that include undocumented
case histories claiming "amazing" results.
-
Talk to your health-care professional
before using any medication for the first time.
-
If you suspect a site is illegal, you
can report it to FDA by visiting the agency's website at http://www.fda.gov/default.htm
and using the online reporting form.
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