Article Text
PDF
Statistics from Altmetric.com
Using medicines purchased online without therapeutic advice can lead to outcomes such as treatment failure, antimicrobial drug resistance, adverse drug reactions and deaths. We have reviewed the factors associated with 17 deaths, which UK coroners deemed preventable, in individuals who used medicines purchased online.
This article is part of the Coroners’ Concerns to Prevent Harms series.1 It highlights problems that can arise from using medicines purchased online, exemplified by 16 Prevent Future Death reports relating to 17 individuals.
Introduction
Coroners in England and Wales have a duty to report deaths that they have investigated when they believe that actions should be taken to prevent similar deaths. They do so in reports to prevent future deaths (PFDs).
This paper is one of a series in which we are charting the epidemiological aspects of such deaths. Here we deal with deaths that coroners have attributed to the use of medicines purchased online and the circumstances in which such deaths occur.
Methods
We have described our methods elsewhere.1 Briefly, we used web scraping2 to collect PFDs from the UK’s Courts and Tribunals Judiciary website, which is in the public domain, and created The Preventable Deaths Database and Tracker.3 We screened 3037 PFDs dated from July 2013 to September 2020 to identify cases in which the use of products purchased online were associated with deaths.
Cases
We found 17 PFDs, issued between November 2013 and December 2019, relating to 18 deaths associated with online purchase of medicines or non-medicinal chemicals, in 2 cases via the dark web, a part of the internet that allows users to remain anonymous and untraceable. In one case, death was not directly attributable to the substances purchased. Table 1 summarises the other 16 reports involving 17 deaths. Figure 1 shows the dates of the reports.
Timeline of the dates of 16 coroners’ prevent future death reports of 17 cases that raised concerns about online ordering of medicines and non-pharmacological compounds whose ingestion resulted in deaths; each arrow is aligned in the centre of the relevant quarter of the year shown (eg, coroners issued three reports in the last quarter of 2019) (created by the authors).
Sixteen reports of 17 deaths attributed to the use of medicines or non-medicinal compounds purchased online (created by the authors)
There were 7 women and 10 men; their ages, where stated, were 19–51 years (median 26 years, n=14). The most common contributory factors were mental health problems (n=8) and drug dependence/abuse (n=7) in two cases in combination. Most of the cases involved prescription-only medicines; six cases involved recreational drugs (alpha-methyltryptamine and ecstasy), designer drugs (acetylfentanyl and a synthetic opioid), and non-medicinal chemicals (dinitrophenol and cyanide). We cannot tell from the PFDs whether the products obtained online were substandard or falsified.
The 16 PFDs were addressed to 21 recipients and were written within a median of 6 (range 1–53) days after the end of the inquest. Twelve were addressed to ministers or government departments, such as the Secretary of State for Health and Social Care, the Home Office, the Department of Health, and the Ministry of Justice. Other recipients included NHS England, The Medicines and Healthcare products Regulatory Agency (MHRA), and the Advisory Council on the Misuse of Drugs. The judiciary does not post all replies to PFDs; however, 11 replies were published, received within a median of 70 days (range=52–268). The Home Office and the Department of Health gave the most detailed responses.
Discussion
Medicinal products can be purchased online from anywhere in the world from pharmacies that are accredited and regulated or from non-accredited purveyors (box 1). Untrained users cannot easily distinguish them. Websites can supply products that are authorised (licensed).4 Products unauthorised (unlicensed) in a country but authorised elsewhere and products that are not authorised anywhere may also be available without prescription or discussion with a prescriber. Recreational drugs are also available. Non-medicinal chemicals, which we define as chemicals that are not intended for medicinal use, can be legitimately purchased online and inappropriately used for therapeutic or suicidal purposes.
Online availability of medicinal products and non-medicinal chemicals4 (created by the authors)
A. Types of outlet.
Pharmacy chains dispensing medicines in both physical outlets and online.
Individual pharmacies dispensing medicines in both physical outlets and online.
Organisations dispensing medicines solely online.
Suppliers of chemical goods or products containing chemicals.
B. Types of product available.
Licensed products.
Prescription-only medicines.
OTC products, available only in pharmacies.
OTC products, available in other outlets (eg, supermarkets).
Unlicensed products.
Unlicensed in some countries but licensed in others.
Not licensed anywhere.
Therapeutic medicines.
Recreational drugs.
Non-medicinal chemicals.
C. Regulation
Complying with the laws and regulations of the country in which the outlet is operating.
Non-compliant (illicit or illegal).
Some available products are substandard or falsified. Substandard products are defined by the WHO5 as authorised products that fail to meet either their quality standards or specifications, or both. Falsified products (sometimes called fake or counterfeit products) are medical products whose identity, composition, or source is deliberately/fraudulently misrepresented. Using such products can cause harms such as treatment failures,6 antimicrobial drug resistance,7 8 and deaths.9 10
Box 2 summarises the concerns that coroners expressed. Their concerns are understandable, but solutions to them are hard to find and implement. Anyone determined to obtain medicines or recreational compounds online will do so without difficulty. Most international regulatory efforts are directed at accredited pharmacies, confirming their accreditation and warning the public about avoiding others.
Coroners’ concerns, summarised from the 16 prevent future death reports (created by the authors)
Ease of obtaining drugs, including prescription-only medicines and unlicensed medicines or toxic chemical compounds, via the internet without any contact with the patient’s regular medical practitioner or access to the patient’s records and without any regulatory framework.
Concern about the regulation of supply and importation of class A drugs and the regulation of the supply and delivery, using international shipping and the UK postal system, of drugs bought via the internet.
Regulation of the dark web, particularly in relation to supply and importation of drugs, including class A drugs.
No ability to limit the amounts of medications ordered or the frequency of ordering.
Recipients of PFDs have a legal duty to respond to the coroner within 56 days of receipt, outlining actions taken or proposed that address the concerns; the coroner can agree, if asked, to extend the deadline. That 19 of 21 recipients did not respond to the coroner within the legal limit or at all, is another cause of concern.
The UK Care Quality Commission (CQC) inspects registered online pharmacy services. While acknowledging that well-run services can offer convenient and effective treatments, it advises caution when buying medicines online.11 The CQC, with other UK bodies—the General Medical Council (GMC), the General Pharmaceutical Council (GPhC), and the MHRA—has reminded providers and healthcare professionals working for online services that they must provide safe and effective care and follow professional guidelines. The GMC advises prescribers to ask their patients about use of illegal medicines and those purchased online and to encourage patients to be open about their use of such medicines12; it does not, however, suggest asking about other substances that an individual might obtain, such as dinitrophenol, which has occasionally caused deaths.13 14 The GPhC has also issued guidance on online prescribing, highlighting safeguards.15
Accredited and non-accredited outlets are hard to tell apart, although the former tend to have shorter URLs. Pharmacies advertised on Twitter are likely to be illegal.16 Distance-selling logos, such as those introduced by the European Union (EU)17 and the GPhC,18 may help in identifying registered pharmacies; clicking on a logo should take you to a national website that confirms that a pharmacy is legitimate. However, purchasers may be unaware that logos exist and may use pharmacies that do not display them. Statements on websites that a pharmacy is, for example, ‘safe and regulated’ are meaningless unless accompanied by a regulatory logo. Furthermore, suppliers can fake logos, and pharmacies should not be trusted if clicking on their logos does not take you to the regulatory websites. However, since January 2021, UK pharmacies, except those in Northern Ireland, have not been required to display the EU logo. Moreover, use of the GPhC’s logo is voluntary; there is a case for making it compulsory under law.
Those intending to purchase medicines online without a medical consultation or a prescription that can be dispensed by a pharmacist should be discouraged from doing so and warned about the problems. Products may arrive either packeted or unpacketed, but lack identifying marks or accompanying literature. Even if they come in what looks like a proper packet, and even with accompanying literature, the formulations may not contain what the packet advertises or may contain adulterants. For example, although many websites offer to sell 'Viagra' without a prescription, their products are often counterfeit.19
Conclusions
Online prescriptions issued through regulated pharmacies do not generally raise concerns. Although this case series suggests that deaths from adverse effects of medicines purchased online are uncommon in the UK, under-reporting is likely, by both patients and coroners; coroners will not necessarily discover that drugs were obtained online, and inquests are not always held. The problem may be extensive, given the large internet market for medicines, including the dark web,20 21 and is unlikely to be limited to the UK.
Healthcare workers should note that those most at risk are those with mental health problems, those with drug dependence, and those seeking recreational use.
For the general public, the message is to be careful about ordering medicines or other chemical substances online. There are many more illegal online outlets than accredited ones, and they are not easily distinguished. Look for the logos and click on them, seeking regulatory guidance. It is better not to order drugs online without advice from a prescriber or a prescription that a qualified pharmacist will dispense.
Ethics statements
Patient consent for publication
Ethics approval
This study does not involve human participants.
Footnotes
Twitter @JKAronson, @Richards_G_C
Contributors GCR created the Preventable Deaths Database; all three authors searched it for relevant cases. JA analysed the data, wrote the first draft and edited it following comments from the other authors. All authors read and approved the final version.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests JKA has published articles and edited textbooks on adverse drug reactions and interactions, for which he has sometimes received royalties, and has often given medicolegal advice, including appearances as an expert witness in coroners’ courts, for which he has received fees. He is an associate editor of BMJ Evidence-Based Medicine and was a coauthor of the editorial that introduced the Coroners’ Concerns to Prevent Harms Series in the journal. GCR was financially supported by the National Institute for Health Research School for Primary Care Research, the Naji Foundation, and the Rotary Foundation to study for a doctor of philosophy (2017-2020), but no longer has any financial conflicts of interest; she is an associate editor of BMJ Evidence-Based Medicine, was lead author of the editorial that introduced the Coroners’ Concerns to Prevent Harms Series, and is developing (https://preventabledeathstracker.net/) a programme of research on preventable deaths.
Provenance and peer review Not commissioned; externally peer reviewed.