Clinical Case Reports

We found 12 published papers on clinical cases related to prescription drugs obtained via the Internet, which are shown in Multimedia Appendix 3. One regarded the Internet purchase and injection of gamma-butyrolactone by an 18-year-old woman that led to admission to a pediatric intensive care unit [117]. Romero et al [118] reported florid withdrawal delirium following the discontinuation of Fioricet (a combination of butalbital, which is a barbiturate, with caffeine and acetaminophen indicated for muscle contraction headaches) that a 37-year-old woman purchased online and self-administered in escalating doses for the treatment of chronic headaches in a context of a history of depression. A 40-year-old woman was treated at the emergency department for severe tetany-like spasms, probably due to the ingestion of haloperidol and bentazepam purchased on the Internet, which were displayed on the online pharmacy under “sleep aids” [119]. Neuberg et al [120] reported a case of life-threatening thyroid hormone abuse in a 56-year-old woman encouraged and enabled by unconventional health advice and nonprescribed medication obtained via the Internet. Carisoprodol (a muscle relaxant) withdrawal after Internet purchase was reported by Eleid et al [121]. Another report described a 43-year-old woman who underwent surgery for brain cancer; after hospital discharge she researched adjunctive treatments of cancer on the Internet and self-initiated a 10-day course of cesium chloride, ending up with an acquired long QT syndrome [122]. A 55-year-old man with squamous cell carcinoma of the maxillary sinus, who declined to undergo surgery, radiation, and chemotherapy, decided to treat his cancer using hydralazine sulfate, obtained online; he died from fatal hepatorenal failure, probably caused by the hydralazine sulfate [123]. A series of case studies was reported by Lineberry and Bostwick [124] regarding a suicide attempt by a 35-year-old man using amitriptyline purchased online unbeknownst to his psychiatrist, who had prescribed him paroxetine, and 3 stories of opiate and painkiller addiction in a 37-year-old man, a 42-year-old man, and a 29-year-old woman facilitated by online purchase. Levesque [125] reported tardive dyskinesia in a 67-year-old man associated with the online purchase of the older antipsychotic drugs he probably received when he requested a tranquilizer. All the cases reported so far occurred in the US, although other evidence shows that the phenomenon exists in Europe as well. A case of prolonged hypogonadotropic hypogonadism caused by anabolic steroids purchased on the Internet by a 34-year-old Italian man was reported by Pirola et al [126]. In the United Kingdom, orlistat-induced subacute liver failure was reported in a 57-year-old woman [127]. Also in the United Kingdom, acute coronary syndrome was diagnosed in a 41-year-old man who had taken Viagra for erectile dysfunction [128].

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Discussion

We synthesized the scientific literature on online pharmacies by performing an up-to-date and comprehensive review scanning several scientific and institutional databases, with no publication time limits, focusing on the broader picture of online pharmacies. We thought it was necessary to implement a new review because we found no recent summarizing material in the scientific literature, since the second of the only 2 available reviews with a general approach cited just 14 papers regarding online pharmacy supply and was up-to-date to 2007. This is quite a considerable time in a rapidly changing world such as the Internet. In addition, 63% (48/76) of all the studies we found with original data were published in or after 2005, which seems to indicate that the phenomenon of purchasing medications online is increasing.

The main challenge in conducting this review was that the works we further analyzed and report were fairly difficult to compare owing to the widely differing methods used to select and assess samples, and often the works were written in answer to multiple research questions. In order not to miss the multiple aspects of these works we elaborated different research questions—in our opinion the only way to analyze these data. This could be seen as a limit of the study in terms of coherence, but we prefer to view it as an added value of this review, since we wanted to impress on the reader the complexity of the papers’ methods and data, mirroring the complexity of the phenomenon of online pharmacies.

Despite this complexity, we made an effort to identify a common denominator in all the research questions scholars have used in tackling the issue, and we related them back to the broad issue of consumer safety in its multiple variations. Ultimately, the tangible side of this consumer safety framework is clinical reports of health damage caused by drugs purchased online, the last link in the chain, when the feared dangers have already occurred. Consumer studies have tried to estimate the number of exposed people and to identify at-risk groups. The majority of these studies focused on the general population or specific groups, and found that 6% or less of the sample had bought drugs online. As depicted in Figure 3, all the contents that we systematized in our research can be linked to consumer safety, in terms of drug misuse, denial and delay of care, transparency issues, drug accessibility, drug quality, and consumer data protection.

Figure 3

Consumer safety as a common denominator for studying online pharmacies.

One of the major risks posed by online pharmacies is drug misuse. Prescription requirement and use of online questionnaires can be linked to avoiding the physician and hence to the possible misuse of drugs. All the random samples with no specific limits regarding prescription requirements found that at least some websites sold drugs without a prescription, and that online questionnaires could be used as a substitute for prescriptions. This issue leads to the risk of one of the most feared consequences: the possible disruption of the doctor–patient relationship, which has been widely discussed. In the context of the doctor–patient relationship, drugs purchased online can have acute effects, and even chronic and irreversible ones, and nowadays doctors should always investigate the use of nonprescribed substances in their anamnesis [125]. Also connected to drug misuse is the theme of self-medication: in this context drug information displayed by online pharmacies is supposed to be a tool to help consumers be aware of the risks they are exposed to when taking a specific drug. If drug information is not available, this could minimize risk awareness. Risk awareness can also be minimized by marketing strategies, as the findings have often shown that online pharmacies tend to market their products as if they were any other commodity. Indeed, inflation of drug demand has been suggested as an effect by the papers that have analyzed aspects related to marketing strategies adopted by online pharmacies. The demand for drugs is enhanced not just by advertising economic advantages (the true nature of which appears confused and controversial when comparing works that tackled the issue), showing that there are many triggers causing a person to buy online, not just a cheaper purchase, especially in countries other than the United States where drug prices are often negotiated; the other factors probably involved are confidentiality and willingness to avoid the doctor [27,79]. Whatever the reasons, the phenomenon is likely to increase, in a context in which people are becoming increasingly accustomed to online commerce, which is increasing day by day in terms of sales volumes and the number of people engaging in it. Being more accustomed does not mean always being more aware of risks: an experimental study about risk perception in young US consumers regarding “rogue” online pharmacies showed a worrying inability to see multiple signs of danger and a tendency to be misled by online sellers that use professional design, veil untrustworthy features, and mimic reputable websites [129]. The risk of getting unnecessary drugs is also linked to pressure from marketing strategies.

Privacy issues are about the confidentiality of consumers’ data and personal data protection. The evidence suggests that online pharmacies (or ones presumed to be such) could be a tool for data fishing or fraud when they do not deliver the products (sometimes charging the consumer anyway) or send something different from what was ordered. It is not just a matter of privacy; it becomes a matter of security. This could even mean that stealing money from vulnerable consumers could lead to them not being able to afford the drug or having to wait to obtain it elsewhere, thus posing problems of denial of care and delay of care.

In terms of drug quality, when the researchers bought drugs online, they very frequently found inappropriate packaging and labeling, whereas the chemical composition was not as expected in a minority of the samples of studies, except for one [65].

Drug accessibility is a core issue regarding online pharmacies. Worldwide delivery eliminates national barriers for consumers; but the place of dispatch can be indicative of the place of production, and therefore it could be linked to drug quality. The analysis of the drugs on offer showed that an online consumer can get virtually anything, which is a matter of risk as well as accessibility, since some drugs are more intrinsically dangerous than others. Lastly, prices can modify drug accessibility and could be linked to drug quality.

Another important area associated with consumer safety is transparency in giving consumers details of the company they are buying from; this aspect can be assessed by analyzing the contact details, geographical location, time websites were accessible, quality certifications, and last website update. Geographical characteristics showed that this information is concealed on many websites, and that US-based websites tend to behave better than others. Studies that investigated the presence of quality certification found it in a minority of the websites.

Conclusions

From a policy point of view, online pharmacies are only partially regulated due to intrinsic difficulties linked to the impalpable and evanescent nature of the Web and its global dimension, with no national barriers. The legal implications are really challenging, since the virtual “brave new world” created by the Internet poses issues never faced before. The fragmentary picture of online drug trading regulations is a recognized issue, and a noteworthy attempt to regulate the phenomenon is the “Implementation of the Ryan Haight Online Pharmacy Consumer Protection Act” by the US Department of Justice in 2009 [130-132]. Liang and Mackey [133] proposed a statute that includes drug access costs, prohibition of Internet sales, a legal reform to give several federal agencies the authority to destroy contraband drugs, a pharmacy verification and licensure system, search engine accountability, and prevention of illicit transactions.

Given the technical difficulty of reducing the risks from an enforcement point of view, the role of the consumer becomes essential. The role of the patient as an active partner in health care, and not just a passive object of diagnostic testing and medical treatment, is widely accepted. As this view is accepted, providing information to patients becomes a very crucial issue. Attempts to create some sort of labeling to distinguish trustworthy from rogue websites are valuable, but they cannot be very effective as long as people are not aware of these tools and of the risks involved in buying medication online. As described by Eysenbach [134], medicine 2.0 includes the concept of a shift from an “intermediation environment” (based on the power of the experts) to an “apomediation environment” (based on the empowerment of users). The latter is “desirable by older adolescents and adults, experienced or information literate consumers”, otherwise the risks of increased autonomy can far outweigh the benefits in a context like that of free access to drugs.

In conclusion, online pharmacies are a case where major conflicts occur between the concept of individuals being able to decide their purchases in their own interests on the one hand, and on the other the demand that the state must prevent people from harming themselves and must use public resources fairly and efficiently, as well as the value of social solidarity [23]. In order to enhance the benefits and minimize the risks of online pharmacies, a 2-level approach could be adopted. The first level should focus on policy, with laws regulating the phenomenon at an international level, filling the existing legislative vacuum, although, as stated above, this would be very difficult, costly, and only partially effective. The second level needs to focus on the individual. This approach should aim to increase health literacy, which is the foundation of critical thinking, a skill required for making appropriate health choices, recognizing risks, and making the most of the multitude of opportunities offered by the world of medicine 2.0.

Acknowledgments

The authors wish to thank the anonymous reviewers for their valuable comments and insightful suggestions to improve the quality of the paper.

Date: 2016-03-03; view: 788