To the Editor. In the August 2004 issue of the Mayo Clinic Proceedings, Lineberry and Bostwick1 provided some excellent case studies of clinical problems associated with Internet purchases of medications. We concur with their comments and offer the following additional suggestions.
We propose that the US Food and Drug Administration (FDA) develop or recommend a reliable Web site for the purchase of drugs and for accurate drug information. The National Association of Boards of Pharmacy (NABP) developed the Verified Internet Pharmacy Practice Sites (VIPPS) program to help patients choose legitimate Internet pharmacy Web sites (www.nabp.net/vipps/intro.asp). Fung et al2 provided a detailed description of the VIPPS program in the February 2004 issue of the Mayo Clinic Proceedings. We recommend that all physicians be educated about purchasing medications via the Internet and share information about the VIPPS program Web site or an FDA-approved Web site with their patients. The system developed by the FDA to report unlawful sales of medical products on the Internet (www.fda .gov/oc/buyonline/buyonlineform.htm) should be used by physicians, other health care professionals, and consumers to report adverse events associated with Internet drug purchases. Once the FDA receives such information, it can investigate and shut down these sites. To aid in these investigations, the FDA can use the radiofrequency identification (RFID) technology that it recommended recently3 to trace counterfeit products to their source. It will be much easier to trace products that are sold illegally on the Internet when the RFID system is implemented universally. This system should serve as a deterrent to abusers of the Internet system, and pharmaceutical manufacturers should try to comply with this policy as soon as possible. Ultimately, the issue of medication purchases via the Internet may not be resolved until aggressive legal action is taken against rogue Internet pharmacies.
Another important consideration is the credibility of health information available on the Internet. Many sites provide such brief presentations on pharmaceuticals that it is difficult for physicians to determine if the information is evidence based. If highly trained physicians have such problems, how can the average patient evaluate the credibility and quality of the information on such sites?4 The FDA should develop guidelines to ensure the credibility of the information provided to physicians on the Internet. In addition, with such poor-quality information currently available for consumers, the FDA and the National Library of Medicine should develop a service that provides better criteria for rating information on Web sites. Examples from the DISCERN Project can be used effectively. DISCERN is an evaluative instrument developed in recognition of the need for a general set of quality criteria to evaluate written consumer health information on treatment choices.5
We hope that our suggestions help advance the safe and effective distribution of medications and drug information via the Internet.
Paresh Amrutkar, BS Pharm, MBA
Sujit S. Sansgiry, PhD
University of Houston College of Pharmacy
Houston, Tex
1. Lineberry TW, Bostwick JM. Taking the physician out of "physician shopping": a case series of clinical problems associated with Internet purchases of medication. Mayo Clin Proc. 2004;19:1031-1034.
2. Fung CH, Woo HE, Asch SM. Controversies and legal issues of prescribing and dispensing medications using the Internet. Mayo Clin Proc. 2004;79:188-194.
3. FDA News. FDA announces new initiative to protect the U.S. drug supply through the use of radiofrequency identification technology. Available at: www.fda.gov/bbs/topics/news/2004/new01133.html. Accessed November 18, 2004.
4. Lanier WL. Near-death experiences delivered to your home by your friends on the Internet. Mayo Clin Proc. 2004;79:979-982.
5. Charnock D. The DISCERN Handbook: Quality Criteria for Consumer Health Information on Treatment Choices. Oxfordshire, England: Radcliffe Medical Press; 1998. Available at: www.discern.org.uk/Discern%20HB&10L .pdf. Accessibility verified March 11, 2005.
In reply. We agree with the concerns raised by Amrutkar and Sansgiry. The challenges for both patients and physicians in evaluating the safety of medications purchased through the Internet are profound. A June 2004 report by the US General Accounting Office1 cited problems with the handling, authenticity, and FDA approval status of medications obtained from Internet pharmacies. The General Accounting Office (the audit, evaluation, and investigative arm of the US Congress) purchased 11 different medications from 68 Internet pharmacy Web sites. It found fewer problems overall among pharmacies identified as being based in Canada or the United States. However, 45 of the 68 sites did not require a patient-provided prescription. The medications often came without instructions or warning information, and those requiring special handling did not always receive it.
Congress continues to try to regulate the Internet pharmaceutical industry. First introduced on May 20, 2004, the Internet Pharmacy Consumer Protection Act was reintroduced on February 16, 2005.2 This legislation would "require internet pharmacies to identify their business, pharmacist and physician for consumers; prohibit internet pharmacies from distributing drugs to consumers with a prescription based solely on an online questionnaire; and give state Attorneys General the ability to shut down rogue websites nationwide, rather than just in their individual jurisdictions." Amrutkar and Sansgiry's recommendations, combined with the proposed congressional legislation, could be important elements in improving safety. We continue to believe that proactively educating patients about the potential dangers of purchasing medications via the Internet is an essential first step.
Timothy W. Lineberry, MD
J. Michael Bostwick, MD
Mayo Clinic College of Medicine
Rochester, Minn
1. US General Accounting Office. Internet Pharmacies: Some Pose Safety Risks for Consumers. Washington, DC: US General Accounting Office; 2004. Publication GAO-04-820. Available at: www.gao.gov/new.items/d04820.pdf. Accessibility verified March 11, 2005.
2. Senators Coleman and Feinstein to continue effort to make using internet pharmacies safer [press release]. Washington, DC: February 16, 2005. Available at: www.coleman.senate.gov/index.cfm?FuseAction=PressReleases .Detail&PressRelease_id=556&Month=2&Year=2005. Accessibility verified March 11, 2005.
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