Fohs.bgu.ac.il

Journal of Medical Internet Research 2001;3(1):e1 behind these pages (the affiliate programs sponsored by Viagra purveyors provide a financial incentive to Web Editorial
sites which advertise their services). A very conservative estimate would be that at least 150 distinct companies Online prescriptions of pharmaceuticals: Where is the evidence for
exist on the Web which prescribe Viagra every day [3].
harm or for benefit?
Studies evaluating cyberpharmacies from the outside
A call for papers - and for reflection.
A number of studies have shown that prescription drugs are easily available online. The bad reputation of onlinepharmacies may also come from research evidence which suggests that many sites selling prescription drugs This issue of JMIR features a provocative study which will almost certainly lead to great controversies: A supply consumers with drugs when, for medical reasons, they shouldn't have.
"cyberdoctor" who prescribed sildenafil online compared the collected data and outcomes of his online patientswith those from a traditional clinic [1]. His conclusions, based on more than 2,000 online encounters: "the At least two studies [3,4] attempted to determine the quality of the service provided by Internet consulting Internet-based prescribing physician has more, not less, clinically relevant and useful information than was physicians by actually ordering drugs through these services. The two studies looked whether drugs are supplied typically obtained and utilized in a specific hospital clinic setting", and there is no evidence to believe that to people for whom they are not suitable. They did so by posing as a patient with contraindications; for example, by posing as a 69-year-old female with coronary artery disease [3], or a 45-year-old male with a history of heart However - to avoid any misunderstandings - it should be stressed right up front that the study is subject to attack and currently taking nitrate [4], both ordering Viagra. Despite clear contraindications, 3 out of 10 (30%) considerable limitations, as no prospective and active follow up of the "clients" could be performed, and the [3] and 1 out of 5 (20%) [4] of the services actually delivered Viagra to these patients. In another scenario, the outcomes of the patients who didn't volunteer any follow-up information are unknown. Larger prospective weight-loss drug Xenical was delivered in 5 out of 5 tested services to a fictitious patient with lifestyle-related studies with a more rigorous design, such as cohort studies, are urgently needed. Still, we believe that the study obesity and a BMI of 28, which is not considered an indication for Xenical [4]. Other issues criticized by these is groundbreaking, in a sense that this is the first study providing any sort of data about online prescribing.
studies include: some of the services did not gave an accurate reason for not delivering the drug; some of theservices did not obtain an appropriate medical history; and some of the services used inappropriate medical In many areas of the world, online prescribing of drugs without a prior personal doctor-patient relationship is terminology or used only the brand names of drugs (without generic names).
still considered unethical or even unlawful. The accompanying article by J. Henney outlines the current situationand debate in the US. The FDA is "concerned about the proliferation of sites that substitute a simple online Some studies also only looked at the information offered on these sites [3,5,6]. The three studies dealing with questionnaire for a face-to-face examination and patient supervision by a health care practitioner" and believes drug information on e-commerce sites were all conducted between February and May 1999 and all focussed on that "the risk of negative outcomes such as harmful drug interactions, contraindications, allergic reactions or sildanefil sites (one in addition looked at sites selling finasteride [5]). To evaluate the quality of these sites, authors extracted prices [3,5], checked for completeness of online-history taking and/or information provided onthe site e.g. pertaining to contraindications [3,6], and the presence/absence of disclaimers and/or liability waivers 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 ananachronism.
Paternalism (alluding to a child-parent relationship) has been defined as (1) being primarily intended to benefitthe recipient, and (2) the recipient's consent or dissent is not a relevant consideration for the initiator [2]. Tojustify paternalistic medical practice and legislation, which affects to a certain degree patients' autonomy andtheir right to decide, we have to ask ourselves whether these actions really benefit the recipient, and whether -in the age of openness and free information - the free will of patients (to make an informed choice not to see adoctor in person but to order pharmaceuticals after an online assessment) is something which can be easilyignored.
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 createsmore harm than benefit, or vice versa. More research is urgently needed to address questions such as whichdrugs can be prescribed safely and to which kinds of patients, and which safeguards we can install to monitoradverse events.
The FDA evidence
FDA evidence for the alleged risks of online prescribing to date merely consists of a few anecdotal cases. Themost frequently cited case is the story of a 52-year-old Illinois man with episodes of chest pain and a familyhistory of heart disease, who died of a heart attack in March 1999 after buying Viagra (sildenafil citrate) from anonline source that required only a completed questionnaire to qualify for the prescription. Though there is noproof linking the man's death to the drug, FDA officials say that a traditional doctor-patient relationship, alongwith a physical examination, may have uncovered any health problems such as heart disease and could haveensured that proper treatments were prescribed. However, it should be noted that there have been several similarcases where patients with a comparable history have died while taking Viagra, despite receiving theirprescriptions at the doctor's office.
This scarcity of reports of adverse events is surprising, given that millions of pills are prescribed on the Web Figures 1-4. Pills by mail: Video captures (Video AVI 1.2 MB) from test orders of different e-pharmacies. 3 out
each year. Leading online pharmacies report that they issue more than 1,000 prescriptions a day. It has been of 10 e-pharmacies delivered to the hypothetical obese 69-years old woman claiming to have "orgasm problems" estimated that Viagra is advertised on 4,500-15,000 Web pages, with an unknown number of distinct companies Eysenbach G. Online prescriptions of pharmaceuticals: Where is the evidence for harm or for benefit? A call for papers - and for reflection Journal of Medical Internet Research 2001;3(1):e1 bypass physicians completely) provided that such services are appropriately monitored, and the right drugs forthis new form of prescribing are chosen.
Quality criteria for online prescribing
In addition to some "good practice" standards for any type A online doctor-patient relationship, [3,7,8] several Thus, I would argue that we should consider the introduction of a new class of drugs which we may call OTI: quality criteria for online consultations and online prescribing should be taken into account, and should over-the-Internet drugs, which are safe enough to be prescribed over the Internet, but not safe enough for OTC potentially be a prerequisite for any certification program: use. They may in the future constitute a middle ground between OTC and Rx (prescription) drugs. For drugs toqualify as OTI, a preexisting patient-physician relationship and/or a thorough physical examination must not be Informed consent: Patients must be fully informed about the risks of online prescribing in general, and crucial, an online assessment or email interaction may be considered sufficient, and the benefits should greatly the risks and side-effects of the prescribed drug in particular.
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.
A thorough medical history should be taken, especially as cyberdoctors don't have the patient's recordsin front of them and must rely on the information volunteered by the patient. In one study, only 3 out of A standing call for papers and case reports
10 online pharmacies prescribing Viagra on the Internet asked about retinitis pigmentosa as a potential We are interested in getting feedback from professionals as well as from patients on this issue. We welcome all contraindication, and in 8 out of 10 services the history obtained was judged inadequate [3]. In another sorts of papers, including short letters to the editor, informed comments, or full original research studies. We are study, an expert panel of two general practitioners (GPs) and a pharmacist judged that in one of four inviting a look at all aspects of this topic, including but not limited to surveys of patient preferences, case reports tested cyberdoc sites, the history taken was inadequate, and that those services prescribed a anti- or controlled studies of patient outcomes, legal commentaries or cost-effectiveness studies. We would also like hypertension drug without making sufficient steps to arrive at a diagnosis [4].
to hear from consumers who have had positive or negative experiences with such services, who have been Patient-understandable language: Advice should be provided in a patient-understandable language. One harmed or benefited from online prescriptions or - more broadly - online therapy in general. We also hope to study said that in one of four tested cyberdoc sites, the answer given was "much too full of medical hear from physicians who have encountered patients who have been harmed or who have benefited from this jargon" and "read more like an extract from a medical text rather than advice for this specific patient," practice. Finally, we would also like to hear proposals or implementations of informatics, policy solutions or and in addition used "poor English" [4]. Sites selling Viagra to consumers used, in 70% of cases, other mechanisms to monitor adverse reactions, and the dissemination of the collected information.
inappropriate medical terminology in the medical history forms [3]. One study also evaluated thefriendliness of responses [9].
Continuity of care: Ss 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 Journal of Medical Internet Research Accountability: Consumers should know who is giving the advice and what that person's qualifications References
are. Armstrong noted that none of the 77 sites offering Viagra provided specific information about the Jones MJ. Internet-based prescription of sildenafil: a 2104-patient series. J Med Internet Res 2001;3:e2.
qualifications of the physician [6]; and Bloom noted that the address of the consulting physician, and his or her specialty, location, and qualifications were given in none of the sites reviewed [5,6]. Anotherstudy said that only on 1 out of 10 visited sites selling Viagra or Xenical revealed the name or Hershey PT. A definition for paternalism. J Med Philos 1985 May;10(2):171-82. [Medline] qualifications of the doctor on the Web [4]. Even when the consumer actually ordered the drug and Eysenbach G. Online Prescribing of Sildanefil (Viagra) on the World Wide Web. J Med Internet Res received a "prescription" or is notified that the prescription was declined, this information is given only in a minority of the cases. In one study, only in 2 out of 10 sites which issued or declined a Viagra Net benefits? Health Which. 2000;16-19.
presciption revealed the identity of the consulting doctor [3].
Bloom BS, Iannacone RC. Internet availability of prescription pharmaceuticals to the public. Ann Intern Response/delivery time. Varying response times of a few hours to several days were measured in studies [10,11] Viagra was delivered in 6, 10, and 34 days [3].
Armstrong K, Schwartz JS, Asch DA. Direct sale of sildenafil (Viagra) to consumers over the Internet.
N Engl J Med 1999 Oct 28;341(18):1389-92. [Medline] Security and patient confidentiality: As e-pharmacies store large amounts of highly sensitive data Eysenbach G. Towards ethical guidelines for dealing with unsolicited patient emails and giving (including the results of online-assessment forms containing personal medical data, as well as the name teleadvice in the absence of a pre-existing patient-physician relationship - systematic review and expert and address of the purchaser), security is a particular concern.
survey. J Med Internet Res 2000;2(1):e1 [Full text] Childress CA. Ethical Issues in Providing Online Psychotherapeutic Interventions. J Med Internet Res 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.
Sandvik H. Health information and interaction on the internet: a survey of female urinary incontinence.
BMJ 1999; 319(7201):29-32.[Medline] Conclusion: From Rx and OTC (over-the-counter) to OTI (over-the-Internet) drugs?
10. Eysenbach G, Diepgen TL. Responses to unsolicited patient e-mail requests for medical advice on the Online prescribing of pharmaceuticals is - much as other forms of online interventions such as online World Wide Web. JAMA 1998;280(15):1333-5. [Medline] 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 11. Eysenbach G, Diepgen TL. Evaluation of cyberdocs. Lancet. 1998;352(9139):1526.[Medline] potential benefits against their risks. In order to balance the risks and the benefits, we need scientific evidencefor the probabilities of certain outcomes, and need to estimate the "utility" patients and society put on certainoutcomes.
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 Eysenbach G. Online prescriptions of pharmaceuticals: Where is the evidence for harm or for benefit? A call for papers - and for reflection This is a non-peer-reviewed article. Published 31.01.2001. Please cite as:Eysenbach G. Online prescriptions of pharmaceuticals: Where is the evidence for harm or forbenefit? A call for papers - and for reflection.
Journal of Medical Internet Research 2001;3(1):e1<URL:.jmir.org/2001/1/e1/>

Source: http://fohs.bgu.ac.il/supercourse/jmir/2001/1/e1/e1.pdf