This issue of JMIR features a provocative study which will almost certainly lead to great controversies: A "cyberdoctor" who prescribed sildenafil online compared the collected data and outcomes of his online patients with those from a traditional clinic [
However - to avoid any misunderstandings - it should be stressed right up front that the study is subject to considerable limitations, as no prospective and active follow up of the "clients" could be performed, and the outcomes of the patients who didn't volunteer any follow-up information are unknown. Larger prospective studies with a more rigorous design, such as cohort studies, are urgently needed. Still, we believe that the study is groundbreaking, in a sense that this is the first study providing any sort of data about online prescribing.
In many areas of the world, online prescribing of drugs without a prior personal doctor-patient relationship is still considered unethical or even unlawful. The accompanying article by J. Henney outlines the current situation and debate in the US. The FDA is "concerned about the proliferation of sites that substitute a simple online questionnaire for a face-to-face examination and patient supervision by a health care practitioner" and believes that "the risk of negative outcomes such as harmful drug interactions, contraindications, allergic reactions or improper dosing is greatly magnified."
However, ethics and law-making should be based on evidence, just as medical practice itself is; some may argue that the current paradigm and restrictive legislation is not evidence-based, but overly paternalistic and an anachronism.
Paternalism (alluding to a child-parent relationship) has been defined as (1) being primarily intended to benefit the recipient, and (2) the recipient's consent or dissent is not a relevant consideration for the initiator [
This is bottom line: Currently, we simply do not have sufficient evidence whether, and under which conditions, online prescribing of relatively safe drugs such as the impotence drug Viagra (sildenafil citrate) actually creates more harm than benefit, or vice versa. More research is urgently needed to address questions such as which drugs can be prescribed safely and to which kinds of patients, and which safeguards we can install to monitor adverse events.
FDA evidence for the alleged risks of online prescribing to date merely consists of a few anecdotal cases. The most frequently cited case is the story of a 52-year-old Illinois man with episodes of chest pain and a family history of heart disease, who died of a heart attack in March 1999 after buying Viagra (sildenafil citrate) from an online source that required only a completed questionnaire to qualify for the prescription. Though there is no proof linking the man's death to the drug, FDA officials say that a traditional doctor-patient relationship, along with a physical examination, may have uncovered any health problems such as heart disease and could have ensured that proper treatments were prescribed. However, it should be noted that there have been several similar cases where patients with a comparable history have died while taking Viagra, despite receiving their prescriptions at the doctor's office.
This scarcity of reports of adverse events is surprising, given that millions of pills are prescribed on the Web each year. Leading online pharmacies report that they issue more than 1,000 prescriptions a day. It has been estimated that Viagra is advertised on 4,500-15,000 Web pages, with an unknown number of distinct companies behind these pages (the affiliate programs sponsored by Viagra purveyors provide a financial incentive to Web sites which advertise their services). A very conservative estimate would be that at least 150 distinct companies exist on the Web which prescribe Viagra every day [
A number of studies have shown that prescription drugs are easily available online. The bad reputation of online pharmacies may also come from research evidence which suggests that many sites selling prescription drugs supply consumers with drugs when, for medical reasons, they shouldn't have.
At least two studies [
Some studies also only looked at the information offered on these sites [
Figures 1-4, Pills by mail: Video captures (
In addition to some "good practice" standards for any type A online doctor-patient relationship, [
Informed consent: Patients must be fully informed about the risks of online prescribing in general, and the risks and side-effects of the prescribed drug in particular.
A thorough medical history should be taken, especially as cyberdoctors don't have the patient's records in front of them and must rely on the information volunteered by the patient. In one study, only 3 out of 10 online pharmacies prescribing Viagra on the Internet asked about retinitis pigmentosa as a potential contraindication, and in 8 out of 10 services the history obtained was judged inadequate [
Patient-understandable language: Advice should be provided in a patient-understandable language. One study said that in one of four tested cyberdoc sites, the answer given was "much too full of medical jargon" and "read more like an extract from a medical text rather than advice for this specific patient," and in addition used "poor English" [
Continuity of care: Is the information designed to support existing patient-physician relationships? What type of follow-up is offered? Is the patient's own GP informed about any treatment given or recommended on the Internet?
Accountability: Consumers should know who is giving the advice and what that person's qualifications are. Armstrong noted that none of the 77 sites offering Viagra provided specific information about the qualifications of the physician [
Response/delivery time. Varying response times of a few hours to several days were measured in studies [
Security and patient confidentiality: As e-pharmacies store large amounts of highly sensitive data (including the results of online-assessment forms containing personal medical data, as well as the name and address of the purchaser), security is a particular concern.
The FDA requires online pharmacies to post information on their Web sites about their ownership, state licensure, name of the pharmacist in charge, and a phone number where consumers can contact the pharmacist.
Online prescribing of pharmaceuticals is - much as other forms of online interventions such as online psychotherapy or even educational interventions - a two sided coin. This of course is true for many (if not all) interventions in medicine - no treatment is without risks and side effects, and it is always crucial to balance potential benefits against their risks. In order to balance the risks and the benefits, we need scientific evidence for the probabilities of certain outcomes, and need to estimate the "utility" patients and society put on certain outcomes.
Online prescriptions may, under certain circumstances, be not more "potentially dangerous" than, for example, self-medication with OTC (over-the-counter) drugs (for which consumers do not need any prescription and bypass physicians completely) provided that such services are appropriately monitored, and the right drugs for this new form of prescribing are chosen.
Thus, I would argue that we should consider the introduction of a new class of drugs which we may call OTI: over-the-Internet drugs, which are safe enough to be prescribed over the Internet, but not safe enough for OTC use. They may in the future constitute a middle ground between OTC and Rx (prescription) drugs. For drugs to qualify as OTI, a preexisting patient-physician relationship and/or a thorough physical examination must not be crucial, an online assessment or email interaction may be considered sufficient, and the benefits should greatly outweigh the risks. To be able to decide which factors may make an OTI drug out of a Rx drug we - again - need appropriate studies.
We are interested in getting feedback from professionals as well as from patients on this issue. We welcome all sorts of papers, including short letters to the editor, informed comments, or full original research studies. We are inviting a look at all aspects of this topic, including but not limited to surveys of patient preferences, case reports or controlled studies of patient outcomes, legal commentaries or cost-effectiveness studies. We would also like to hear from consumers who have had positive or negative experiences with such services, who have been harmed or benefited from online prescriptions or - more broadly - online therapy in general. We also hope to hear from physicians who have encountered patients who have been harmed or who have benefited from this practice. Finally, we would also like to hear proposals or implementations of informatics, policy solutions or other mechanisms to monitor adverse reactions, and the dissemination of the collected information.