Rogue Online Drugstores

There are, of course, legitimate online pharmaceutical sites that comply with state and federal laws governing the practice of pharmacy. Some Web sites, however, do not require a prescription to dispense drugs. They may require a medical questionnaire, but it may or may not be reviewed by a licensed doctor. Researchers Bernard Bloom, PhD, 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. Bloom BS, Iannacone RC: “Internet Availability of Prescription Pharmaceuticals to the Public,” Ann. Internal Med, Dec. 7, 1999, Vol. 131, Issue 11. 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. On March 2, The Houston Chronicle reported that in a 1-week study of 495 Web sites, 41% stated that no prescription was needed and 49% offered an online consultation. Only 6% required that a prescription be either mailed or faxed.

Web search engine Google has decided to stop accepting ads from unlicensed online pharmacies. A similar approach is being taken by Overture (owned by Yahoo!). As of November 2003, it stopped accepting advertisements from online pharmacies unless they could show that they were licensed. These are steps in the direction of helping the consumer identify legitimate pharmacies.

Government Oversight

In March 2004, the House Committee on Government Reform convened to discuss the dangers of websites selling medication without the requirement of a valid prescription. Although states provide regulatory control over medical practices and pharmacies, there are ways to circumvent established procedures meant to protect consumers. William K. Hubbard, the FDA's associate commissioner for policy, planning and legislation, acknowledged the benefits of online pharmacies — convenience, privacy, and the provision of more accessible health care and pharmaceuticals. Statement of William K. Hubbard to the Committee on Government Reform, U.S. House of Representatives, March 18, 2004. He cautioned, however, that the safeguards of traditional procedures for prescribing drugs are at risk. Statement of William K. Hubbard to the Committee on Government Reform, U.S. House of Representatives, March 18, 2004.

The American framework for pharmaceutical safety allocates among a number of federal and state agencies the responsibility of ensuring a drug is safe, effective and appropriate. It's a violation of the Food, Drug, and Cosmetic Act to sell a prescription drug without a valid prescription or authorized prescription refill. Federal Food, Drug & Cosmetic Act, 21 U.S.C. ' 353(b)(1). The drug to be dispensed must be approved by the Food and Drug Administration (FDA), and the prescription must be filled by a registered pharmacist working in a licensed pharmacy that meets state standards. 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 only 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 advantage of FDA involvement is that states have difficulty enforcing their laws across state boundaries. Some commentators have predicted that this “partnership approach” (state role in pharmacy regulation and federal role in prescription drug regulation) will survive and that “coordination between the states, the federal government, and the pharmacy industry, is the key to ensuring safety standards and education of the consumer.” Stolfi P: “Caveat Emptor: Regulating the On-Line Medicine Man in the New Frontier,” 17 J. Contemp. Health L. & Pol'y 377 (Winter 2000). In addition to the federal and state regulations, before making a prescription, a licensed health care practitioner must follow certain safeguards and protocol to determine the appropriate treatment. These should include direct medical supervision and a physical evaluation performed by a licensed health professional.

This regulatory scheme provides the checks and balances to support, but not ensure, safety.

In next month's newsletter, we will discuss methods courts, legislators, doctors and pharmaceutical firms are proposing and, in some cases, already using to deal with rogue online pharmacies.

Part One of a Two-Part Article

Widespread use of the Internet is barely a decade old, and already its use and abuse have increased dramatically. While the Web provides companies with new outlets for their products, it also provides a larger outlet for rogue entities to harm the consumer and damage manufacturers' reputations. Indeed, the Internet has created an opportunity for a whole new class of fraudulent activity, with rampant identity theft the best known. In the context of drug outlets, if a purchaser buys his or her prescription from a “rogue” pharmaceutical site, that consumer may be buying expired, substandard, contaminated, counterfeited and, in some cases, unsafe products. The lack of medical oversight, which can result in administration of incorrect dosages, wrong or contra-indicated drugs, or medication without adequate directions for use are among the concerns to be addressed as we enter this new world of Internet pharmacies.

The Problem

There are, of course, legitimate online pharmaceutical sites that comply with state and federal laws governing the practice of pharmacy. Some Web sites, however, do not require a prescription to dispense drugs. They may require a medical questionnaire, but it may or may not be reviewed by a licensed doctor. Researchers Bernard Bloom, PhD, 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. Bloom BS, Iannacone RC: “Internet Availability of Prescription Pharmaceuticals to the Public,” Ann. Internal Med, Dec. 7, 1999, Vol. 131, Issue 11. 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. On March 2, The Houston Chronicle reported that in a 1-week study of 495 Web sites, 41% stated that no prescription was needed and 49% offered an online consultation. Only 6% required that a prescription be either mailed or faxed.

Web search engine Google has decided to stop accepting ads from unlicensed online pharmacies. A similar approach is being taken by Overture (owned by Yahoo!). As of November 2003, it stopped accepting advertisements from online pharmacies unless they could show that they were licensed. These are steps in the direction of helping the consumer identify legitimate pharmacies.

Government Oversight

In March 2004, the House Committee on Government Reform convened to discuss the dangers of websites selling medication without the requirement of a valid prescription. Although states provide regulatory control over medical practices and pharmacies, there are ways to circumvent established procedures meant to protect consumers. William K. Hubbard, the FDA's associate commissioner for policy, planning and legislation, acknowledged the benefits of online pharmacies — convenience, privacy, and the provision of more accessible health care and pharmaceuticals. Statement of William K. Hubbard to the Committee on Government Reform, U.S. House of Representatives, March 18, 2004. He cautioned, however, that the safeguards of traditional procedures for prescribing drugs are at risk. Statement of William K. Hubbard to the Committee on Government Reform, U.S. House of Representatives, March 18, 2004.

The American framework for pharmaceutical safety allocates among a number of federal and state agencies the responsibility of ensuring a drug is safe, effective and appropriate. It's a violation of the Food, Drug, and Cosmetic Act to sell a prescription drug without a valid prescription or authorized prescription refill. Federal Food, Drug & Cosmetic Act, 21 U.S.C. ' 353(b)(1). The drug to be dispensed must be approved by the Food and Drug Administration (FDA), and the prescription must be filled by a registered pharmacist working in a licensed pharmacy that meets state standards. 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 only 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 advantage of FDA involvement is that states have difficulty enforcing their laws across state boundaries. Some commentators have predicted that this “partnership approach” (state role in pharmacy regulation and federal role in prescription drug regulation) will survive and that “coordination between the states, the federal government, and the pharmacy industry, is the key to ensuring safety standards and education of the consumer.” Stolfi P: “Caveat Emptor: Regulating the On-Line Medicine Man in the New Frontier,” 17 J. Contemp. Health L. & Pol'y 377 (Winter 2000). In addition to the federal and state regulations, before making a prescription, a licensed health care practitioner must follow certain safeguards and protocol to determine the appropriate treatment. These should include direct medical supervision and a physical evaluation performed by a licensed health professional.

This regulatory scheme provides the checks and balances to support, but not ensure, safety.

In next month's newsletter, we will discuss methods courts, legislators, doctors and pharmaceutical firms are proposing and, in some cases, already using to deal with rogue online pharmacies.