Legislators question cybermedicine

Four members of the House of Representatives submitted a letter to the General Accounting Office requesting a formal review of Internet sites that reportedly fill and dispense prescription medicines.

Reps. Henry Waxman (D-CA), John Dingell (D-MI), Ron Klink (D-PA) and Sherrod Brown (D-OH) sent the letter. The House members wrote that they were concerned that "the rapidly exploding trend of online pharmacies may be outpacing formal state and federal controls."

Sites such as ThePillBox.com, Drugstore.com, Soma.com and PlanetRx.com offer Internet users the opportunity to request and receive prescription medicines at what the sites promote as wholesale prices. In many ways, the virtual pharmacies operate much like real pharmacies do. They offer copayment options through major insurers, claim to be licensed and accept major credit cards. However, their very existence raises serious questions, which the House members have asked the GAO to investigate.

A host of concerns

The House members presented three major concerns: patient privacy, patient safety and the potential for fraud and abuse.

When patients visit physicians face to face and share personal medical histories, their information is added to their confidential medical records. However, when online pharmacy users submit highly sensitive personal and medical data in hopes of receiving a prescription, it is unclear just how secure their information is. Can online pharmacies sell the information they collect about patients in the same way that retailers in other industries sell demographic and customer profile information?

In regard to patient safety, how can online pharmacies be certain they are giving a patient the proper medication? Although some sites reportedly offer "online physician visits," in which patients fill out health questionnaires that are later reviewed by physicians, it is unclear how the online pharmacies verify the accuracy of the information. How can they be sure that patients who fill out the questionnaires are telling the truth? And how can they verify that the patients don't have pre-existing conditions that would cause serious or even fatal interactions with a prescription product? Without ever seeing the patients in person or establishing a physician-patient relationship, it is impossible to say.

Finally, the House members pointed out that "it remains murky how online pharmacies will process (if at all) controlled substances and not be susceptible for fraud and abuse by hackers or other criminal elements." Furthermore, because the Internet allows for international commerce, can Americans legally obtain non-FDA-approved medicines from online pharmacies operating in other countries?

"A host of serious regulatory concerns are indeed raised by online pharmacies," the House members concluded. They requested that the General Accounting Office determine the following:

•Â How many online pharmacies are there? How much commerce are they conducting?

•Â What are the differences between online pharmacies? Do some sites require a patients' physician to be involved in prescribing and approving fulfillment of a prescription while others offer prescriptions without anything more than completion of an online form?

•Â Who has the authority to regulate online pharmacies? Do current state and federal agencies have the responsibilities, resources and jurisdiction to regulate these businesses?

•Â Do current laws encompass the complexity of online pharmacy commerce? If not, what are the discrepancies and do changes need to be made?

•Â How do online pharmacies deal with medical records privacy and protection, the selling of controlled substances and drug interactions - and are their practices effective enough?

•Â How do online pharmacies prevent unqualified persons from receiving prescriptions? Are online pharmacies more susceptible to fraud and abuse than their face-to-face counterparts?

•Â What quality assurances protect patients who order prescriptions online? For example, if a patient orders eight 200 mg tablets of a particular product, who monitors that the tablets are truly formulated in the stated dose and are appropriately effective?

The date by which the General Accounting Office will release its findings had not been determined at press time.

Industry supports review

The American Medical Association, the Food and Drug Administration, the World Health Organization, the National Association of Boards of Pharmacy and many others are equally concerned with the current growth and future direction of online pharmacy.

The AMA and FDA are concerned with the lack of face-to-face, patient-physician interaction and have expressed worries that unregulated online pharmacies are prime candidates for indulging in illegal or medically unethical practices.

The National Association of Boards of Pharmacy announced a plan to draft standards for online pharmacies; those that meet the association's standards will be formally recognized on the association's own Web site. The plan, tentatively known as the Verification of Internet Pharmacy Practice Sites and conceived by representatives of various state medical boards and the FDA, will offer its findings free as a public service to consumers.

According to the association, the first list will be posted by the end of the year. PR