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.
The next time your doctor writes you a prescription, consider this: The medication may not be approved for your specific condition or age group.
But you probably shouldn't call the medical board. The practice, called "off-label" prescribing, is entirely legal and very common. More than one in five outpatient prescriptions written in the U.S. are for off-label therapies.
"Off-label" means the medication is being used in a manner not specified in the FDA's approved packaging label, or insert. Every...
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 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way sets the stage for problems that include dangerous drug interactions and harm from contaminated, counterfeit or outdated drugs.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. 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.