The Academic Perspective: Paternalism in the Regulation of Internet Pharmacy Practice

By David B. Brushwood, JD

How far should government go to protect people from the consequences of their own risky choices in drug therapy? This is one of the most basic questions asked by any pharmacy regulator when faced with a threat to the public health, and with a choice of how to address that threat.

In the past, we in pharmacy regulation have been overly protective of the public. We have not consistently been able to accept the reality that we cannot protect everyone from every adverse drug effect all of the time. We have made decisions for people, rather than teaching them how to make good decisions for themselves. Regulators have decided what drugs are safe and effective, and whether they may be acquired with or without a prescription. By limiting public choice in drug therapy, we have denied patients the opportunity to develop good decision-making ability in self care.

Until recently, there was at least a good argument to continue the traditional paternalistic approach to pharmacy regulation. Since it was possible to know who was providing inappropriate (by that, we have meant "unscientific") care, and where they were located, it was possible also to directly regulate them to protect the public from them. The Internet has changed that. It is no longer possible to consistently know who is providing pharmaceutical services and products, or where providers are located. It is not possible to build a firewall around the country, or intercept every pharmaceutical product being sent into the country. Pharmacy regulators may try to do this, and there may occasionally be widely publicized enforcement actions in countries such as Thailand, where US and Thai officials have apparently cooperated to close down several providers recently. Ultimately, comprehensive efforts to shut down offshore providers will fail.

The Internet shifts the balance of power from the providers of information to the recipients of information. There have been other technological developments that have enhanced the ability to exchange information, but the Internet is a profound change that requires a significantly different approach to regulation. The printing press enabled providers of information to reach a larger audience than could be done with oral histories. The radio and television were significant advances in information dissemination through the written word. But as significant as these developments were, the power in information continued to reside with the provider of the information. The huge difference with the Internet is that the recipient now has millions of sources of information from which to choose, rather than scores or hundreds of sources. The recipient of information can find whatever information she or he wishes via the Internet. Power over information now resides with the recipient of information.

It is information (having it or not having it) that serves as the basis for regulation in drug therapy. In a capitalist democracy, government does not generally regulate unless there is a reason to regulate. When markets function well to protect the public, there is no need for protection by the government. However, when the market fails to protect the public, government steps in through its regulators. Information asymmetry is one classic form of market failure. It is the most frequent reason to regulate in drug therapy. Threats to the public are caused by the asymmetry of information, and those who have information are required, by regulation, to behave benevolently toward those who do not have information.

Because, through the Internet, the balance of power has shifted to the recipients of information, it is these recipients to whom regulatory activities must be directed. This is why NABP's Verified Internet Pharmacy Practice Sites^TM (VIPPS^TM) program is such a good idea. In fact, it is the only approach that has the possibility of working to protect Internet users from their own risky choices. Internet users are a sophisticated group, or they would not be able to use the Internet. It is possible to communicate with Internet users through the Internet. Although this has not yet happened, it is relatively easy to imagine a comprehensive, Internet-based campaign to inform all Internet users of the VIPPS program. By regulation, this information campaign could be required of Internet service providers.

Those of us who have grown up professionally in the traditional paternalistic drug regulatory system may have trouble accepting the fact that people should be free to make bad choices, if it is only they who will be harmed by the bad choices. Yet if we can accept that people should have such freedom of choice, we might also accept the fact that it is not a regulatory failure when a person, who knows about the VIPPS program, makes a free choice to use an Internet site that fails to display the VIPPS seal, and if that person is harmed by drugs provided through such a site. It is certainly sad and regrettable when such harm occurs, but it is not realistically possible to prevent such harm, and the patient is clearly responsible for such harm.

If any of this makes sense, then it may also make sense to ration scarce regulatory resources, and not devote huge sums of money to futile efforts directed at so-called "outlaw" Internet pharmaceutical sites. It takes little imagination to envision a decade into the future that a huge regulatory industry may be built to ferret out and punish a tiny fraction of the illegitimate domestic prescribing sites and offshore distribution sites. This activity has the potential to be as expensive, and pointless, as the "war on drugs," which has made only a small dent in illegal drug use at enormous cost.

Is there an alternative? I think so. The VIPPS seal is the best way to protect the public health, and it should be widely publicized so that any person who chooses to use an Internet provider that does not display this seal is as aware of the accompanying risks as is anyone who currently uses tobacco products or does not use seat belts. The lion's share of regulatory resources should be used to enable the positive use of dispensing sites that have the VIPPS seal. These sites have a huge potential to improve the quality of medication use, and relieve community pharmacies of some of the burdens of contemporary practice.

Regulators who want to promote the public health would do well to focus on enabling legitimate Internet sites rather than restricting illegitimate Internet sites. The recently released Institute of Medicine report, To Err is Human, provides ample evidence that there is room for improvement in medication use, and the Internet has the potential to facilitate such improvement.

How might the Internet help improve medication use, and how might regulators enable this improvement? Many of the answers to this question are, perhaps not surprisingly, related to the improved use of information. The Internet can centralize information about patients and make that information available on a need-to-know basis to those who have responsibility for patient care. The Internet can post the most up-to-date clinical practice guidelines (CPGs) and templates for care plans that are based on the CPGs.

Decision assistance about the appropriateness of care can also be made available through the Internet. Threaded discussions among health care providers (and even patients) can be hosted to promote teamwork in the provision of high quality care. Patients can provide systematic input regarding their perceptions of drug safety and efficacy (ie, "This drug makes me tired," or "This drug does not work for me."). The results of patient assessments can be aggregated to disclose general trends in drug safety and efficacy, producing improvements to CPGs based on patient perceptions.

There are many more applications of Internet pharmacy that can facilitate patient care by local pharmacists who meet face-to-face with patients who require such personal attention. Each of the applications, those listed above and those not listed, must be regulated by boards of pharmacy to assure that an appropriate standard of care is developed and maintained. Otherwise, there may be a "race to the bottom" among Internet pharmacies who are left with no choice but to emphasize low prices, and not quality, in an unregulated industry.

Few of us (perhaps none of us) who currently specialize in pharmacy regulation have had an opportunity in our careers to start fresh with regulation of a completely new approach to practice. Internet pharmacy represents such an opportunity, and it is important that we get it right. Squandering finite regulatory resources on restrictions of outlaw sites makes no sense when those resources could be put to better use enabling legitimate sites. Overemphasis on restriction of outlaw sites will have unintended effects on the legitimate sites, just as restrictions on drug diversion have interfered with the effective use of opiates for pain.

We should not miss this special once-in-a-lifetime opportunity. The VIPPS program can protect patients who choose to protect themselves from illegitimate Internet sites. Enabling regulation of legitimate Internet sites can promote the health of all patients.

Attorney David Brushwood is a professor at the University of Florida College of Pharmacy. He holds degrees from the Univeristy of Kansas, Schools of Pharmacy and Law.

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