School of Computing Science, Middlesex University, UK.
The growth of the Internet over the last 10 years as a medium of information and as a communication technology has, not unsurprisingly, provided a foundation for the growth of direct-to-the-public online sales. Amongst the many commercial activities that are now flourishing in this environment are Internet Pharmacies, providing a variety of products (e.g. health and beauty products) as well as prescription drugs. Some pharmacies only dispense drugs with a valid prescription, some provide online consultations for prescribing and dispensing medicines, and some dispense medications without a prescription. This paper reports on how technology has facilitated the practice of medicine online, and discusses the benefits to consumers in terms of access and convenience, together with the problems that have arisen as a result of remote consultations and lack of professionalism. It discusses legal, ethical and social issues of concern regarding online medical consultation and prescribing, and highlights how these present concerns are relevant to looking forward into the future. It also identifies how advances in technology can impact on online healthcare, both in terms of providing solutions to present difficulties and in creating further ethical concerns. Finally it offers some suggestions on how consumers can be safeguarded in light of this evolving phenomenon.
The growth of the Internet over the last 10 years as a medium of information and as a communication technology has, not unsurprisingly, provided a foundation for the growth of direct-to-the-public online sales. Amongst the many commercial activities that are now flourishing in this environment are Internet Pharmacies (e-Pharmacies, Cyber Pharmacies), providing a variety of products (e.g. health and beauty products) as well as prescription drugs. Some pharmacies only dispense drugs with a valid prescription, some provide online consultations for prescribing and dispensing medicines, and some dispense medications without a prescription (Radatz, 2004).
Internet Pharmacies provide various benefits to consumers but also bring many problems for regulators and consumers (George, 2005). Benefits include: the ease and convenience of 24 hour shopping; increased consumer choice of products; increased consumer information and information exchange between patient and pharmacist; generally lower costs; privacy; and availability of alternative treatments. Problems include: uncertainty about the purity and quality of drugs sold; risks of buying drugs online, for example, related to foreign labels and use of different drug names in different countries; dispensing prescription drugs without a prescription; and the issuing of prescriptions through online consultations but without prior physical examination by a licensed physician. This latter aspect provides the focus of this paper.
The paper will first discuss online consultations, identifying various concerns. It will outline the regulation of online consultations in the United States (US) and the United Kingdom (UK), and comment on whether current regulations provide sufficient safeguards for society. It will then discuss the various legal, social and ethical questions raised by this emerging practice. The role of Information Technology both in terms of creating such problems but also possibly facilitating solutions will be examined. Finally, the paper provides some suggestions on how consumers can be safeguarded in the future.
Many Internet pharmacies provide online consultations as a first step towards selling prescription medicines online. These consultations usually require that a potential customer fill out an online questionnaire. A typical online consultation questionnaire (obtained by first registering then placing an order for drugs at: https://meds4yourhealth.com) may consist of three parts. The first part asks for personal details such as name, address, contact telephone numbers, date of birth, height, body weight and gender. The second part of the questionnaire asks about medical history including: whether a particular drug requested has been used before; what drugs are currently being taken; a history of allergies and side-effects to certain medicines; what complaint is the drug requested for; and whether the customer has suffered from a range of conditions such as heart disease, kidney disease, liver disease, diabetes, epilepsy, hypertension, asthma, and chronic bowel disorders. The third part asks for payment details and shipping information.
After the questionnaire is completed, it is then reportedly evaluated by a licensed physician affiliated to the pharmacy in order to either approve or decline a prescription request. If a request is approved, a prescription is written by the physician then sent to the pharmacy for dispensing and shipping of the medication. In addition to the medication, a customer will received contact information for the pharmacy and information on usage, dosage and precautions relating to the medication.
Consultations made online, by their very nature, do not involve a physical examination in person by a licensed physician. Therefore, they may be dangerous both in terms of making a correct diagnosis and determining drug interactions among other problems (Henney, 2000). If online questionnaires are not completed truthfully then medications may be prescribed on false information. Patients also run the risk that a legitimate consulting physician may not be present to evaluate the online questionnaire. Further, use of general questionnaires may not provide the necessary information for the determination of a number of important issues such as whether a particular drug (FTC, 2001): (i) will work for an individual; (ii) is safe to use; (iii) is more appropriate than another treatment; (iv) may cause adverse reactions if an individual is taking another medication; or (v) may be harmful due to an underlying medical condition such as an allergy.
In some cases, doctors who issue online prescriptions (cyberdoctors) are either not licensed to practice medicine in the consumer’s state/country or are not credible. A US study (BDA, 2003) into the background of cyberdoctors, found that most either: had financial problems; were sued for malpractice; had their licence revoked; or were recovering from drug addiction. Another 2003 US study reported that many cyberdoctors recruited by Internet Pharmacies were previously unemployed, semi-retired or had declining practice incomes (Crawford, 2003).
In 2002, the US Federation of State Medical Boards (consisting of members of medical boards of all US states) published, ‘Model Guidelines for the appropriate use of the Internet in Medical Practice’ (FSMB, 2002). Two of the guidelines specifically addressed the issue of remote prescription practices, referring to “documented patient evaluation” (including a patient history and physical evaluation) and stating that “Issuing a prescription based solely on an online questionnaire or consultation does not constitute an acceptable standard of care” (FSMB, 2002). Further, guidelines issued by the American Medical Association in 2003 (regarding the prescribing of medicines to patients via the Internet) state that a physician who prescribes medications via the internet must establish or have an established a valid patient-physician relationship (AMA, 2003). This includes among other things: obtaining a reliable medical history and performing a physical examination of the patient; having sufficient dialogue with the patient regarding treatment options, and risks and benefits of the treatment; and having follow-ups with the patient where appropriate.
In 2004 the General Medical Council (GMC) in the United Kingdom issued new practice guidelines which have similar regulatory goals to the US position but some noticeable differences (GMC, 2004). The GMC details conditions to be met for remote prescribing in situations where a practitioner is either: continuing to care for a patient; deputising for another doctor responsible for the patient; or has prior knowledge and understanding of the patient’s condition and medical history and has access to the patient’s medical records. In the absence of these situations, however, the GMC does not expressly forbid remote prescribing but gives additional conditions to be satisfied if remote prescribing is to be used. These additional conditions include (GMC, 2004): having appropriate dialogue with the patient to assess the patient’s current medical conditions and any medications being taken; being able to adequately assess the patient’s condition and the cause of such condition; being able to justify medicines/treatment proposed and discuss alternative treatments with the patient; being able to assess any contra-indication effects of medicines/treatments proposed; and keeping a record of all medicines prescribed.
In both the US and UK, doctors have been prosecuted for using online consultations to prescribe drugs. In January 2002, Dr Richard Franklin was found guilty of serious professional misconduct by the GMC after prescribing drugs online (BBC, 2004). Patients were required to fill out an online questionnaire which was then reviewed by Dr Franklin and used to prescribe drugs. The GMC stated that the questionnaire was closed and did not allow for a dialogue between doctor and patient. Also, that Dr Franklin did not carry out an adequate assessment of his patients’ conditions, and therefore did not act in the best interests of his patients (BBC, 2004). In August 2004, Dr Shreelal Shindore, of Florida (US) was forced to relinquish his medical license after “prescribing a Schedule IV controlled substance to a patient who completed an Internet questionnaire without conducting a physical examination, obtaining a complete history, without making a diagnosis and without establishing a treatment plan” (NYSBPM, 2004).
The writing of prescriptions via online consultation may raise important legal issues, especially related to confidentiality and civil liability for medical malpractice should something go wrong (Kahan et al, 2000). Confidentiality issues may arise because information given for online consultations may be prone to be seen by people other than the consulting doctor, unless strict security and protocols are in place (Kahan et al, 2000). This has important implications within the European Union/United Kingdom (EU/UK) with regard to obligations under data protection law. In the EU/UK medical data is treated as ‘sensitive personal data’ and acknowledged as a special category (amongst others such as ethnic origin, religious belief) which requires a higher level of protection compared to ordinary personal data. Civil liability issues may arise since liability for malpractice may not be clearly established where an online prescription is issued (Kahan et al, 2000). This is because whereas in a traditional doctor-patient relationship a clear duty of care exists, it is debatable whether a doctor who prescribes medication online (without any direct verbal or physical contact with a patient), forms a doctor-patient relationship and therefore attracts the same duty of care.
The Internet crosses geographic and state boundaries and hence creates a global market for commerce. It is thus relatively easy for a medical practitioner to be located within one jurisdiction and to administer an online consultation to a patient located in a different jurisdiction, without being licensed to practice medicine in either of the jurisdictions. The practice of medicine within any jurisdiction without an appropriate licence is a criminal offence, since it places citizens at a serious risk. It may, however, be difficult to successfully prosecute a medical practitioner located in a jurisdiction different to that of the patient. This is especially true where the appropriate legal agreements between jurisdictions (especially countries) are not present, or where it is prohibitively expensive to do so.
The ethical issues are closely related to the legal concerns expressed above. In the cases reported in the previous section, national legislation serves to protect patients and uphold the established ethical practices of the medical profession. The foundation for the ethical principles of the medical profession (in the western world) is the Hippocratic Oath (Nova, 2001a). The principles enshrined in this code, as with many ethical codes, are high level principles that take into account the power imbalance between the expert and the ill-informed. Key principles are the prevention of harm and injustice, and maintaining patient confidentiality.
It is hard to see how the questionnaire approach to medical consultations can adequately address the prevention of harm, and the imbalance between expert and non-expert. The dialogue between doctor and patient that is traditionally conducted face-to-face is an important aspect of a doctor’s practice especially with regard to his duty to prevent harm (as far as is reasonably possible). In this context the doctor makes an assessment of the condition that is presented at that time, based on a number of factors that give an overall picture of the health of the patient – such things as skin tone and texture, condition of eyes, tongue, reaction to touch, and many others. This rich picture is built from experience and comes largely from tacit knowledge. Doctors in this familiar setting are also in a position to share information with the patient, and are in a much better position to establish that the patient understands what they are saying – whether it be information about the condition, or, vitally, information concerning drug use. Thus some measure of informed consent (an underlying principle of an ethical action) can be achieved. When completing an online questionnaire, the level of language competence and understanding within the medical context (discussed later) has serious implications for this generally held principle of informed consent – how informed is the consumer under such circumstances?
We have questioned the legal status of patient confidentiality, and raise it again as an ethical issue. Doctors who prescribe drugs online could argue that the precautions they take to ensure confidentiality are at least as good as the measures used in more traditional settings. We cannot say that patient files are totally secure in either the off-line or online environment. However, it would be safe to say that there is an increased opportunity to gain access to confidential material online, with much less risk of being caught, even where the best security measures are in place. If security measures are not in place, then patient confidentiality is not provided for. What is more, if access to this information is inadequately protected online, the extent of the spread of this information is potentially on a ‘massive’ scale. Once leaked it would be impossible to contain, or conduct any damage limitation. Whilst the vulnerability of personal data is a general concern in online activities, and not exclusive to online medical practices, personal medical information is highly sensitive and warrants special care (under data protection legislation). We would argue that because this information is valuable to third parties (pharmaceutical and insurance companies, for instance) it is especially at risk online.
Finally, the practice of prescribing drugs online favours the assumption that drugs are the best solution to the problem, and this may not necessarily be the case. There is already a questionable cultural trend in the US and the UK to use drugs as the first line of attack for many conditions. Patients visit their doctor and expect a solution to their condition in the form of pill, and it is often easier for doctors under pressure to prescribe drugs than investigate other possible causes (such as living conditions or life style for example). McCoy (2005) refers to this trend as the “over-biomedicalisation of healthcare”, that is, the lack of attention to life context, and reduction of illness to something that can be solved by prescription. This trend, according to McCoy, is as a result of pressure exerted by pharmaceutical companies, directly and indirectly through advertising (McCoy, 2005).
It may be worth noting at this point the following extract from the modern version of the Hippocratic Oath:
“I will remember that there is art to medicine as well as science, and that warmth, sympathy, and understanding may outweigh the surgeon’s knife or the chemist’s drug” (Nova, 2001b),
The two cases reported above raise a number of social issues. In general terms, buying prescription drugs remotely encourages a culture of independence from recognised institutional practices and undermines the ethos of risk associated with such drugs. Drugs that are designated prescription-only are considered to carry risk under certain conditions - if they were not they would be available for anyone to buy. The issuing of a prescription implies that an expert has taken the medical characteristics of the patient into account, the risks and benefits of prescribing the drug, and has recommended a course of treatment based on those factors. By offering an “easy” route to buying drugs, it could be argued that the practitioner prescribing online is complicit in undermining the best practice advice of recognised professional bodies. There is also a wider social implication to bypassing the traditional route and using an e-commerce model, and this is the issue of patient protection. One of the purposes of a professional medical body (or other professional body) is to provide protection for those seeking expertise, that is, those who are less expert and therefore vulnerable in their lack of knowledge (Duquenoy, 2003). The case above, of Dr. Franklin, illustrates this aspect where the GMC stated that Dr. Franklin did not act in the best interests of his patients. Whilst the law has taken action in this particular case it may become increasingly difficult to monitor the activities of doctors practicing in this way – and in particular in areas where either no medical body exists, or where a medical body does not have the weight of established professional bodies such as the GMC in the UK, and FSMB in the US.
At the individual level, the online questionnaire takes no account of the level of literacy of the patient – either in terms of understanding terminology used in the context of health, competence in the language used in the questionnaire, or specific cultural interpretations. When completing an online medical questionnaire, a respondent may not completely understand a question and may “guess” an answer, or may misinterpret a question and give an invalid answer. These issues are extremely relevant where drugs are bought and sold in a global market-place, where language competence and understanding of medical terminology can vary. A lack of understanding of the medical context, and particularly familiar medical culture, could have drastic effects.
To illustrate our point, the following questions (below) are taken from an actual online consultation questionnaire at https://meds4yourhealth.com. Notice that some of the questions are expressed in medical terms which are not immediately obvious to a non-medical person.
Do you suffer from or currently have Cardiac or (ischemic) heart disease?
Do you suffer from or currently have Transient ischemic attack(s) (TIA’s)?
Do you suffer from or currently have Diabetes?
Do you suffer from or currently have Epilepsy?
Do you suffer from or currently have Hypertension (exceeds either value of 80/120 mm Hg)?
Do you use MAO-inhibitors like phenelzine or moclobemide?
Do you use NSAID’s (nonsteroidal anti-inflammatory drug - f.i. salicylates, diclofenac, naproxen)?
While terms such as ‘Diabetes’ and ‘Epilepsy’ are familiar to most people, we suggest that it is doubtful that someone would know whether they had a “transient ischemic attack” or whether they suffered from Hypertension that “exceeds either value of 80/120 mm Hg”. Also medical terms such as ‘MAO-inhibitors’ and ‘NSAID’ are not commonly used amongst the general population. It is also interesting that the following disclaimer is included in the questionnaire (note: this is only the first of a total of four clauses):
I declare without any restriction:
(a) that I have read the terms and conditions and the disclaimer on this website and agree with their content and applicability
This approach is surely very different from the type of doctor/patient interaction that takes place in a surgery – patients in the traditional role are not asked to agree to any “disclaimer”.
Another important issue concerns the authenticity of the patient request – does this person really have the symptoms the drug will alleviate, are they buying for someone else, or buying to sell on to others? Also it is possible for a minor (under 18 years old) to buy drugs. In a 2003 briefing to the US Congress, an investigator reported that his 9 year old daughter successfully ordered a prescription weight-loss drug on the US Drug Enforcement Administration (DEA) controlled substance list (Lueck, 2003). In addition, his 13 year old son ordered and received Prozac, a drug on the US Food and Drug Administration’s (FDA) Import Alert list (Lueck, 2003).
Finally there is the issue of follow-up treatment once a medication has been prescribed. In the case of Dr. Shindore it was reported that no treatment plan was established. One wonders whether some purchasers are choosing to get the drugs online because they prefer a one-off interaction, and whether they appreciate the potentially harmful implications of such a one-off deal. Even if advice is given as to the period of time the drug should be taken, when a reassessment is due, what contra-indications may appear, the purchaser may not (a) take any notice, or (b) not fully understand. Furthermore, the purchaser of online drugs may find it difficult to effectively communicate concerns, developments or changes in symptoms, since he/she cannot be physically assessed by a medical practitioner.
In this paper we have provided an overview of the practice of selling drugs online, highlighting some of the benefits and problems associated with this phenomenon. We then focused on the use of online consultations to facilitate the sale of prescription drugs, and outlined the related regulatory frameworks which exist in the US and UK. Further, we discussed some legal, ethical and social issues of concern which may arise with regard to the use of online consultations.
Some legal issues of concern discussed were: confidentiality of patent information especially in light of EU/UK data protection law; civil liability for medical malpractice, in light of the extent to which a duty of care in an online consultation is comparable to that which exists in the traditional doctor-patient relationship; whether a medical practitioner is licensed to practice medicine within the jurisdiction where he/she is located, and also in the jurisdiction where the patient is located (if different).
In our discussion of ethical issues we questioned the reasons for buying online. One reason may be that someone may want large quantities of a particular drug – much easier to get online by visiting different sites. The purchaser may be contemplating suicide, or may be planning to sell the drugs on at a profit and bypassing any regulations that protect the user. Other issues were patient confidentiality; informed consent; and finally, the implicit assumption that prescribing drugs is the most appropriate form of treatment for the patient.
With regard to social issues, the subtle but clear move from a face-to-face interaction towards a simple “form-filling” exercise is likely to encourage a casual and less informed approach to drugs that carry some risk, and has an added impact in undermining the status of the medical profession. We are also concerned about the level of understanding on the part of the purchaser, the verification of authenticity of the patient request and the potential for a lack of continuous monitoring and advice concerning the patient’s medical condition. Finally we suggest that with online consultations, the risks to the consumer are greater and the level of protection less, compared to the traditional off-line medical consultation.
All of the present concerns discussed above are relevant to future developments. Technology is moving on, and the Internet has brought with it an irrevocable cultural change. Opportunities have arisen that allow consumers more choice in how they purchase goods, and from whom. With developments in mobile technologies and increased access to the Internet, the preponderance and use of online pharmacies is likely to grow. Many of the concerns we have raised will continue to be relevant. These include:
at the medical level: issues related to disassociation of remedy from cause, disassociation from personal expert advice and the consequent clinician/patient relationship that is formed over time (which includes knowledge of the patient’s personality, medical history, and social context)
at the purchaser level: language competence and understanding in multi-cultural states, and cross-national transactions.
at the technological level: issues of confidentiality and security of personal data
at the legal level: issues of confidentiality, data protection, civil liability for malpractice, and enforcement of inter-jurisdictional offences.
Advances in technology can impact on the provision of online healthcare, both in terms of providing solutions to present difficulties and in creating further legal, ethical and social concerns. Technology can provide solutions by aiding doctors in making better diagnoses at a distance, for example: use of video for examining patients and use of medical instruments that can be used to carry out various medical tests on a patient. Technology can also provide better security for information, aid regulatory bodies and enforcement authorities in their duties and help promote public awareness of important issues. Unfortunately technologies are also likely to be abused or subject to malfunction or failure. This further raises: legal concerns such as where legal liability for failure of a technology lies; ethical concerns such as the potential for misuse of a new technology; and social concerns such as how a technology impacts on current norms and practices.
The discussions above imply a need for continuing regulatory and ethical scrutiny of the evolving social phenomenon of online medical practice. Present regulatory frameworks and ethical codes of conduct may not adequately address the future scenarios that could develop. Although legitimate Internet pharmacies appear to adhere to the provisions of the existing regulatory frameworks, as discussed earlier, the problem really lies with rogue pharmacies that are driven by commercial profits and operate without regard to either regulatory or ethical guidance.
Having seen the rather futile efforts to dissuade Internet users from utilising its resources (for example, by the music industry to prevent the sharing of music files), we argue that the medical profession will need to consider how they can best adapt to Internet practices using technology, policy and legislation, and consumer education, to adequately protect the patient. Any adaptation, however, should not lower the established medical standards and hence put patients at potential risk. The global risk to the health and well-being of everyone dictate that ethical codes of conduct and regulatory frameworks need to be constantly reviewed and updated not only to address online medical practitioners, but also other players that facilitate this commercial activity. Thus appropriate ethical guidance and regulation should be aimed at technologists, delivery specialists and credit card companies among others in the stream of online medical commerce. The need to protect consumers from the potential harmful consequences of online consultations should be a core principle, guiding the conduct of all commercial entities. We argue, finally, that perhaps the only way forward into the future is for more international consensus, cooperation and agreement to establish global ethical and regulatory standards for online medical practice, to safeguard us all.
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