Inclusion Criteria and Coding of Contents

Quality of Online Pharmacies and Websites Selling Prescription Drugs: A Systematic Review

Quality of Online Pharmacies and Websites Selling Prescription Drugs: A Systematic Review

Monitoring Editor: Gunther Eysenbach

Reviewed by Lana Ivanitskaya and Sara Rubinelli

Grazia Orizio, MD, PhD, ¹ Anna Merla, MD,¹ Peter J Schulz, PhD,² and Umberto Gelatti, MD¹

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Abstract

Background

Online pharmacies are companies that sell pharmaceutical preparations, including prescription-only drugs, on the Internet. Very little is known about this phenomenon because many online pharmacies operate from remote countries, where legal bases and business practices are largely inaccessible to international research.

Objective

The aim of the study was to perform an up-to-date and comprehensive review of the scientific literature focusing on the broader picture of online pharmacies by scanning several scientific and institutional databases, with no publication time limits.

Methods

We searched 4 electronic databases up to January 2011 and the gray literature on the Internet using the Google search engine and its tool Google Scholar. We also investigated the official websites of institutional agencies (World Health Organization, and US and European centers for disease control and drug regulation authorities). We focused specifically on online pharmacies offering prescription-only drugs. We decided to analyze and report only articles with original data, in order to review all the available data regarding online pharmacies and their usage.

Results

We selected 193 relevant articles: 76 articles with original data, and 117 articles without original data (editorials, regulation articles, or the like) including 5 reviews. The articles with original data cover samples of online pharmacies in 47 cases, online drug purchases in 13, consumer characteristics in 15, and case reports on adverse effects of online drugs in 12. The studies show that random samples with no specific limits to prescription requirements found that at least some websites sold drugs without a prescription and that an online questionnaire was a frequent tool to replace prescription. Data about geographical characteristics show that this information can be concealed in many websites. The analysis of drug offer showed that online a consumer can get virtually everything. Regarding quality of drugs, researchers very often found inappropriate packaging and labeling, whereas the chemical composition usually was not as expected in a minority of the studies’ samples. Regarding consumers, the majority of studies found that not more than 6% of the samples had bought drugs online.

Conclusions

Online pharmacies are an important phenomenon that is continuing to spread, despite partial regulation, due to intrinsic difficulties linked to the impalpable and evanescent nature of the Web and its global dimension. 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. The second level needs to focus on the individual. This approach should aim to increase health literacy, 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.

Keywords:Internet, pharmaceutical preparations, public health, review, online pharmacies

Background

Online pharmacies are companies that sell pharmaceutical preparations, including prescription-only drugs, on the Internet. Very little is known about this phenomenon because many online pharmacies operate from remote countries, where legal bases and business practices are largely inaccessible to international research.

Objective

The aim of the study was to perform an up-to-date and comprehensive review of the scientific literature focusing on the broader picture of online pharmacies by scanning several scientific and institutional databases, with no publication time limits.

Methods

We searched 4 electronic databases up to January 2011 and the gray literature on the Internet using the Google search engine and its tool Google Scholar. We also investigated the official websites of institutional agencies (World Health Organization, and US and European centers for disease control and drug regulation authorities). We focused specifically on online pharmacies offering prescription-only drugs. We decided to analyze and report only articles with original data, in order to review all the available data regarding online pharmacies and their usage.

Results

We selected 193 relevant articles: 76 articles with original data, and 117 articles without original data (editorials, regulation articles, or the like) including 5 reviews. The articles with original data cover samples of online pharmacies in 47 cases, online drug purchases in 13, consumer characteristics in 15, and case reports on adverse effects of online drugs in 12. The studies show that random samples with no specific limits to prescription requirements found that at least some websites sold drugs without a prescription and that an online questionnaire was a frequent tool to replace prescription. Data about geographical characteristics show that this information can be concealed in many websites. The analysis of drug offer showed that online a consumer can get virtually everything. Regarding quality of drugs, researchers very often found inappropriate packaging and labeling, whereas the chemical composition usually was not as expected in a minority of the studies’ samples. Regarding consumers, the majority of studies found that not more than 6% of the samples had bought drugs online.

Conclusions

Online pharmacies are an important phenomenon that is continuing to spread, despite partial regulation, due to intrinsic difficulties linked to the impalpable and evanescent nature of the Web and its global dimension. 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. The second level needs to focus on the individual. This approach should aim to increase health literacy, 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.

Introduction

Neo, which pill would you choose? You take the blue pill—the story ends, you wake up in your bed and believe whatever you want to believe. You take the red pill—you stay in Wonderland and I show you how deep the rabbit-hole goes[1].

Although their choice is much less metaphysical than the question posed to Neo in the science fiction movie The Matrix, but still important in terms of health care delivery, consumers nowadays can make another decision: they can choose a pill sold at their local pharmacy, as they have always done, or they can choose one from the Web, by purchasing it from a “cyberpharmacy” or “online pharmacy” [2]. An online pharmacy is a company that sells pharmaceutical preparations, including prescription-only drugs, via online ordering and mail delivery, although—as the evidence will show—very few of them behave like a proper “pharmacy” and many of them are not licensed.

The online sale of drugs started in the late 1990s and has expanded so much that the US Food and Drug Administration (FDA) has implemented an entire section on its website dedicated to “Buying medicines over the Internet” [3,4]. The World Health Organization (WHO) is faced with this issue in the context of counterfeit medicines, which “pose a public health risk” [5-7]. Another aspect that is important to consider is that the Internet can facilitate access and thus support abuse of prescription drugs [8].

It is very difficult to estimate the number of online pharmacies and people buying online, the volume of drugs traded, and the revenue and profits generated by such a hidden business. Moreover, the geographical distribution of the phenomenon seems to be very heterogeneous. With regard to the number of online pharmacies, MarkMonitor in a 2009 press release claimed to have found nearly 3000 websites selling prescription medicines, while a 2010 review by the US National Association of Boards of Pharmacy (NABP) investigated the characteristics of 5859 Internet outlets selling prescription medications [9,10]. Regarding access to drugs online, the 2006 Online Health Search, a US survey by the Pew Internet & American Life Project, showed that “prescription or over-the-counter drugs” was the fifth most widely searched health topic on the Internet [11]. Another US telephone survey concluded that 4% of Americans had purchased prescription drugs on the Internet [12]. Very few estimates regarding the revenue and profits of this phenomenon are available, there being great variability in methods and numbers [13-15]. Besides economic aspects, there is a legal issue and jurisdictional consequences: cases of law enforcement acts and legal prosecutions have been reported in the literature [16-18].

This new market has undoubted advantages for patients: access to drugs for the disabled or housebound, access 24 hours a day, a virtually unlimited number of products available, relative privacy, which may encourage patients to ask questions about embarrassing issues, and more affordable prices [19-21]. But direct access to health services, especially drugs, poses a hazard to consumers because it is difficult to determine whether drugs purchased online are counterfeit, unapproved, or illegal [22]. Besides, the inappropriate use of medicines, the limited or nonexistent opportunity for advice (which blurs the line between willful abuse and unknowing misuse), and the risk of increased antibiotic resistance arising from their misuse have also been suggested as negative consequences of online purchase of medication [23,24]. What is more, the chance to circumvent prescription boundaries can be a potential disruptor at several levels, at both an individual and a public health level. At an individual level, this phenomenon can influence the doctor–patient relationship [25,26]. At a public health level, since each country has a unique system, access to drugs from abroad can disrupt the delicate equilibrium that leads to a certain drug price on the basis of taxation, copayment, reimbursement, and negotiation with industry [27].

Previous Reviews

To our knowledge, 2 reviews about online pharmacies in general and 3 others on specific aspects related to online pharmacies are available. With regard to general reviews, Fung et al [20] searched material published between 1997 and 2002 using 3 scientific databases. They identified 139 articles, although they found that “many of the articles reported about a specific legal case involving an online pharmacy.” Although this review is wide-ranging, it is important to note that it dealt with papers issued 9 or more years ago (2002), a considerable length of time in such a dynamic world as that of the Internet and e-commerce. The most recent review, issued in 2009, is by Nielsen and Barratt [28]. They reviewed the literature on prescription drug misuse through the Internet, focusing on online supply, online monitoring of drug use trends, and electronic prescription monitoring [28]. The part relevant to our review is that on Internet supply; although the work is valuable, the article selection method was not described in detail, making it impossible to establish which databases were screened, with which keywords, and the time of publication. Since the review was submitted for publication on February 5, 2008, we can deduce it explored articles published up to 2007, as confirmed by looking at the references. Besides, the review focused only partially on online supply (referring to only 14 papers in connection with this topic).

Other reviews tackled specific issues but were unable to give an overall picture of the phenomenon. A recent review examined counterfeit phosphodiesterase type 5 inhibitors (PDE5Is) for the treatment of erectile dysfunction, similar to the 2000 review of sildenafil and the Internet [29,30]. The review by Baert and De Spiegeleer gives an overview of the different quality attributes that can be evaluated to gain a complete understanding of the quality of the pharmaceutical product traded on the Internet, as well as the current analytical techniques that serve this objective [31].

Objectives

This review sought to investigate the available evidence on the phenomenon of online pharmacies. We report data on the 3 main areas on which the literature focuses: the characteristics of the websites, the quality of pharmaceutical products purchased online, and the number of consumers and their characteristics.

Methods

Search Strategy

The literature search covered the period up to January 2011. The search was performed on 3 sources: electronic databases, search engines, and institutional websites. First, we searched, without any limitations as to publication date, the following electronic databases: PubMed [32], ISI Web of Knowledge [33], Science Direct [34], and PsycInfo [35]. Second, we searched for gray literature on the Internet using the Google search engine [36] and its tool Google Scholar [37]. We used Google because it is the most widely used search engine [38,39]. Lastly, we investigated the institutional websites of the WHO [40], the WHO European Region [41], the WHO American Region [42], the US Centers for Disease Control and Prevention [43], the FDA [44], the European Centre for Disease Prevention and Control [45], and the European Medicines Agency [46]. We investigated all the results obtained by the databases and the institutional websites but considered only the first 500 results for each keyword appearing in Google and Google Scholar, because the number of relevant articles declined substantially after the first 300 results and because this search engine displays results by relevance using a link analysis system or algorithms [47]. We used the following search terms for each website and database analyzed: “drugs and internet,” “drug/s online,” “online pharmacy/ies,” and “internet pharmacy/ies.” We scanned the reference lists for relevant articles up to the second level, and we considered the “related articles” of relevant ones in the PubMed database.

The database search identified 18,857 records, and other sources (search engines and institutional websites) gave 5893 additional records. Screening of these 24,750 records led to 730 articles, excluding duplicates and nonpertinent results. It is important to point out that such a drop in numbers depends mainly on the use of multiple key words, which are often very similar, which were used in order not to miss any pertinent studies. This resulted in a notable “noise effect,” thereby decreasing the specificity and increasing the sensitivity of our search strategy. An in-depth analysis of the 730 selected articles produced 193 eligible ones that were pertinent to the study and fit the inclusion criteria. Of these, 117 where excluded from the analysis and are listed in Appendix 1, giving a final sample of 76 full articles for study. Figure 1 shows the selection process.

Figure 1

Paper selection algorithm.

Inclusion Criteria and Coding of Contents

We included all articles relevant to the subject of the research—namely, online pharmacies, their characteristics, their products, and their consumers. We selected only articles dealing with the sale of prescription-only drugs and with websites that presented themselves as pharmacies: the purpose was to stay within the sphere of substances that are supposed to involve a doctor–patient relationship. Articles regarding only over-the-counter medicines, complementary medicines, herbal remedies, supplements, and drugs of abuse were excluded. If the researchers analyzed websites selling prescription and over-the-counter drugs, we considered websites selling prescription drugs if it was possible to identify them. We decided to deal only with prescription drugs, although over-the-counter substances can also have negative effects on people’s health, despite the no-harm claims made by their producers, as several clinical cases demonstrate [48,49]. Although examining nonprescription drugs was not an objective of this review, it should be borne in mind that some case reports showed the presence of prescription drugs even in products that did not claim to contain them [50,51]. This means that prescription-only drugs can be distributed through channels in which the active substances do not appear.

As an additional inclusion criterion, we selected articles in English that had the abstract or the full text available. We included only scientific articles, which means that we excluded popular articles published in daily newspapers, and in weekly and monthly magazines.

We classified the articles according to whether they reported original data. We selected only the articles reporting original data, which means that we excluded articles lacking original data, which means those with only a speculative discussion about the problem or only citing data from other studies; these are, for example, editorials, letters, comments, articles about regulation issues, and reviews. However, to make this debate easily available to the reader, we have listed all articles without original data inMultimedia Appendix 1. A discussion of all the reviews we found is included in the introduction.

The original data are described according to 3 main subjects: types and characteristics of online pharmacies, drugs purchased online, and online pharmacy consumer data, which included case reports on complications occurring in consumers of drugs purchased online. Some articles with original data covered more than 1 of these subjects and were consequently allocated to more than 1 group. Each of these categories is described below.

Date: 2016-03-03; view: 991