Buying Drugs Online:
It's Convenient and Private, but Beware of 'Rogue Sites'
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 Web sites
selling prescription drugs and other
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. 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 direct medical supervision and a 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
Skirting the system this way sets
the stage for problems that include
dangerous drug interactions and harm
from contaminated, counterfeit or
outdated drugs. "Web sites 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, the FDA has received only a few reports of adverse events related
to Internet drug sales, but there are potential dangers in buying prescription
drugs on the basis of just a questionnaire. Many drugs should not be used in
certain people or in combination with certain other drugs, or they require special
monitoring. Bypassing the physician can lead to a failure to assure safe use
of drugs. 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.
The FDA is investigating numerous
pharmaceutical Web sites 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 2000, 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 compared
to purchasing drugs from a local
the privacy and convenience of
ordering medications from their
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
greater convenience and variety
easier access to written product
information and references to other
sources than in traditional storefront
Internet drug shopping is said 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 Web sites
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 the antibiotic Cipro (ciprofloxacin), 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. Whether
new legislation will improve oversight
of online pharmacies remains to be
seen. For the moment, regulators
have entered what the FDA's Shuren
calls "a whole new ball game" that
cuts across the limited jurisdictions
of several federal and state agencies.
Overseeing Online Sales
State medical boards regulate medical
practice, while state pharmacy boards
oversee pharmacy practice. The 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.
The 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 the FDA being involved is that states
have difficulty enforcing their laws across state boundaries. If one state successfully
shuts down sales of products by an illegal Web site 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 Web site, that operation is
out of business in all states.
In July 1999, the 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, the
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 the 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. The FDA is
working closely with the FTC on Operation Cure.All by issuing "cyber letters"
to advise and educate operators of Web sites that may not know that the products
they are marketing may not be in compliance with federal law. In addition to
sending warning letters, the FDA has also taken more serious regulatory actions
by seeking permanent injunctions against the marketing of four unapproved drug
products being illegally promoted as treatments for cancer.
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.
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 an NABP-sanctioned team to inspect its operations, given reasonable
displaying and maintaining the VIPPS seal with a link to the VIPPS Web
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."
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.
The FDA has launched a public education campaign to increase consumer awareness
of the risks and benefits of buying prescription drugs online. The campaign
uses several different approaches--including the FDA Web site, radio and print
public service announcements, a newspaper article, a brochure, and outreach
by public affairs specialists based in the FDA's field offices around the country--to
broadcast the FDA's message.
"Consumers need to know the risks of buying prescription drugs online so they
can remain vigilant," says the 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."
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 e-mail it, or users can
deliver it to the pharmacy by fax
or mail. The site then verifies
each prescription before dispensing
the medication. A written verification
policy is usually posted on the
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
Web sites 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 the 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 check the place out."
The 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.
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 the FDA.
Use sites that provide convenient access to a licensed pharmacist who can
answer your 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 those that 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" medical results.
Talk to your health-care practitioner before using any medication for the