buying drugs online

FDA Consumer, Jan, 2000 by John Henkel

It's Convenient and Private, but Beware of `Rogue Sites'

One way consumers can ensure the quality of an online pharmacy is to look for the VIPPS seal, which is proof that the site has passed the rigid criteria of the Verified Internet Pharmacy Practice Sites program. Because VIPPS certification is fairly new and voluntary, only a few sites have been certified so far.

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 druggist. 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, they 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way sets the stage for problems that include dangerous drug interactions and harm from contaminated, counterfeit or outdated drugs. "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. 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 last March 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. Industry figures predicted that 2.97 billion prescriptions would be 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 last fall 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 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.