The growth of the Internet in recent years has created countless opportunities for patients to access health-related information, products, and services. The Internet offers convenience and privacy for persons buying on-line while providing expanded access to prescription drugs and health care practitioners. Through the Internet, the disabled, the elderly, and patients living in remote areas can easily obtain information, products, and services that were previously acquired only with great difficulty. Bloom and Iannacone discuss the problems presented by purchasing prescription drugs over the World Wide Web. The authors identified 37 sites that sold primarily sildenafil (Viagra, Pfizer, New York, New York) and finasteride (Propecia, Merck, West Point, Pennsylvania) and required a prescription from an on-line consultant or a personal physician. Although these sites are convenient, this benefit comes with a higher price tag and limited accountability. Bloom and Iannacone found that the average cost of purchasing these drugs on-line was higher than at Philadelphia pharmacies and that the average cost of receiving an on-line consultation was higher than for a general practice visit in the Philadelphia area. In addition, fewer than 11% of the sites provided the actual location of the business, and none provided the name, specialty, location, or qualifications of the consulting physicians.
Although consumers risk paying more for a drug bought on-line, both consumers and practitioners should be aware of more ominous dangers posed by Internet drug purchases. Long before the development of the Internet, the U.S. Congress and state legislatures enacted safeguards to protect patients from injuries resulting from unsafe and counterfeit drugs and from illicit practice of medicine and pharmacy. This system of regulation has served us well. To receive a prescription drug for the first time, a patient is generally examined by a licensed health care practitioner who issues a prescription for an appropriate, Food and Drug Administration (FDA)-approved drug. The patient then receives the drug from a registered pharmacist working in a licensed pharmacy that meets state practice standards. This comprehensive system of premarket approval, prescription drug designation, practitioner evaluation, and pharmacy dispensing creates an effective safety net to protect the U.S. public from harmful or ineffective drugs, as well as improper prescribing or dispensing of pharmaceuticals.
Sale of drugs on the Internet makes it easy to bypass this risk-management system. Because of the ease with which a Web site can be created, an illegitimate site may seem to be a lawful pharmacy. Patients who buy prescription drugs from such a site are at risk for adverse effects from inappropriately prescribed medications, dangerous drug interactions, contaminated drugs, or unapproved drugs that may have been contaminated during manufacturing.
Of particular concern are Web sites that use questionnaires to determine the appropriateness of prescribing drugs that patients have not received before. Unlike in the traditional relationship between a patient and his or her physician, many on-line practitioners issue prescriptions to a patient for the first time without a physical examination or any form of direct contact. Patients are therefore more likely to receive an inappropriate drug and to place themselves at greater risk for side effects and drug interactions. By avoiding the inconvenience of an office visit or overtly seeking to obtain a drug without having to see a practitioner (for example, an anorexic patient seeking a diet drug), a patient may sacrifice the opportunity for a correct diagnosis or identification of a contraindication to the drug. To address this concern, in June 1999 the American Medical Association formally adopted the position that any health care practitioner who offers a prescription to a patient solely on the basis of an on-line questionnaire without having ever examined the patient generally has not met the appropriate medical standard of care. The FDA agrees with this position, and more than a dozen states have already taken action against practitioners who prescribed drugs in this manner.
Congress requires that the FDA classify certain medications as prescription drugs for a reason: A practitioner's supervision is essential to safe use of these drugs. Although patients can provide false or incorrect information during an office visit as well as on-line, a face-to-face encounter makes deception less feasible and allows the practitioner to examine the patient.
Additional concerns arise with respect to foreign sites. Bloom and Iannacone identified nine foreign Web sites that sold prescription medications without a prescription, which clearly violates U.S. federal and state law.
Foreign Web sites pose other potential difficulties. Drugs offered by foreign sites are more likely to raise safety concerns about contamination or subpotent strengths resulting from poor manufacturing or improper storage conditions during distribution. The limited ability of U.S. law enforcement to reach foreign sellers in their own countries creates greater incentives for these sellers to ship counterfeit products or not to deliver a product after receiving payment.
Several federal agencies, including the FDA and the U.S. Customs Service, detain illegal products when they enter the country. On its Web site, the FDA posts the names of several illegal drugs it has detained; however, the absence of a particular product or business from the detention list does not indicate that importation of the product is legal or that the FDA has not detained the product. The FDA may, in fact, be working with a foreign government to take action against the seller.
In conclusion, on-line drug sales that bypass the traditional safeguards imposed by Congress and state legislatures place the U.S. public at risk. Both practitioners and patients can help curb illegal and unethical Internet drug sales. Before buying a prescription drug over the Internet, patients should check with the National Association of Boards of Pharmacy to see if the pharmacy has a valid license and has met state practice standards. At a minimum, patients generally should not buy drugs from Web sites that offer to prescribe a drug for the first time without a physical examination, sell prescription drugs without a prescription, sell drugs that are not approved by the FDA, do not offer the opportunity to ask questions of a registered pharmacist, require that you link to another Web site to purchase the drug, or do not provide a U.S. telephone number and address to contact with questions.
Practitioners can play an important role by educating their patients about dangerous practices on the Internet and encouraging their state law enforcement and regulatory officials to take action against physicians who engage in illegal and unethical on-line practices. The FDA encourages physicians and patients to report potentially illegal Web sites to the FDA or to the National Association of Boards of Pharmacy.
The Internet can serve as an important tool for providing health-related products, services, and information. However, as with any tool, new or old, consumers must use it wisely. Until appropriate safeguards have been implemented, patients and practitioners should be cautious.
Author and Article Information
U.S. Food and Drug Administration; Office of the Commissioner; Rockville, MD 20857 (Henney)
U.S. Food and Drug Administration; Office of the Commissioner; Rockville, MD 20857 (Shuren)
U.S. Food and Drug Administration; Office of the Commissioner; Rockville, MD 20857 (Nightingale)
U.S. Food and Drug Administration; Office of the Commissioner; Rockville, MD 20857 (McGinnis)
Requests for Reprints: Jeffrey E. Shuren, MD, JD, U.S. Food and Drug Administration, HF-11, Room 14-101, 5600 Fishers Lane, Rockville, MD 20857.