Buying Drugs Online

by Food and Drug Administration (FDA)

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 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. 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 net."

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way sets the stage for problems that include dangerous drug interactions and harm from contaminated, counterfeit or outdated drugs.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 drugstore, including:

• the privacy and convenience of ordering medications from their homes
• 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
• greater convenience and variety of products
• easier access to written product information and references to other sources than in traditional storefront pharmacies

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.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.