by Lisa Sugiura (@lisa_sugiura)
Following the recent tragic death of Eloise Parry from ‘diet pills’ she purchased online, there has been a flurry of media attention highlighting the risks of buying medicine from the Web. However this is not a new issue. The dangers of purchasing medicines online have been reported over the past decade in: harrowing media cases; in governmental campaigns; and, to a lesser extent, in academic studies. The Guardian article ‘Should I buy prescription drugs over the internet?’ Sunday 26 April 2015 reports that: the majority of prescription medicines available to purchase online are fake, substandard or unapproved; that one in four GPs have treated patients for adverse reactions to medicines bought online; and that it is illegal for UK based websites to sell prescription medicine unless they are registered pharmacies. We, as consumers, are told that the main things we need to be concerned with are: whether medicines are counterfeit; whether they are safe to consume; and whether or not they are being sold legally. Except it is not that simple. These ‘risks’ are presented in the rhetoric of online medicine purchasing but are not fully explained or disentangled from the confusion over what is legitimate or illegitimate when obtaining medicine from the Web.
In the first instance, ‘counterfeit medicine’ is an ambiguous term. Although debates over counterfeit medicines have been ongoing for almost the same length of time that medicine has been available to buy online, there is still no universal definition as to what they are (Attaran et al. 2012). The Guardian article refers to fake, substandard and unapproved medicines, and all have been associated with the counterfeit medicine trade. Often these terms are used interchangeably. However, they are distinct from each other and placing them all under the same umbrella implies that they share the same deficiencies. Fake medicines are: deliberately and fraudulently mislabelled with respect to identity and/or source; may include the wrong ingredients or inactive ingredients; or have imitation packaging. Substandard medicines are those that do not meet the legally required quality specifications of a country’s regulations (for example, here in the UK the sale and provision of medicine is controlled by the Medicine Act 1968, which is now encompassed within the Human Medicines Regulations 2012) due to the quality of the raw ingredients, or (unintentional?) errors in manufacturing or handling. Unapproved medicines mean that they have not been registered. They do not have the obligatory legal authorisation (of a country’s regulators) to be imported or sold in a particular country. Such medicines are often untested and so their safety and efficacy are unknown.
It is clear that when considering counterfeit medicines there are issues related to the deliberate intention to mislead, which are distinct from contrasting production methods in different countries, but, from a patient perspective, not all counterfeit medicines are dangerous to health. Whilst some are undeniably dangerous containing illicit substances or are ineffective, others provide legitimate treatment. The quality of medicines is also conflated with commercial and economic interests. Counterfeiting can occur with both branded and generic medicine products and this has financial implications for pharmaceutical companies. A brand name is a name given to a drug by the manufacturer. The use of the name is reserved exclusively for its owner. Alternatively a generic medicine is a pharmaceutical product, usually intended to be synonymous with a brand product, which is manufactured without a licence from a company and marketed after the expiry date of the patent or other exclusive rights. They are marketed under a non-proprietary or approved name rather than a proprietary or brand name. Generic medicines are frequently as effective as, but much cheaper than, brand name medicines. Because of their low price, generic medicines are often the only medicines that the poorest can access.
When considering whether medicines bought online are safe to consume, it should be noted that there no reliable statistics on side effects or harms resulting from medicines bought online. In 2007 it was reported that the FDA did not have accurate figures on “adverse events” resulting from online medicine purchases (Easton, 2007). A UK survey reported that one in four general practitioners said that they had treated patients for adverse reactions to medicines bought online, while a further 8% suspected they had treated side effects of web-bought medicines (Moberly, 2009). However, the survey did not ask whether the medicines that caused these reactions were purchased abroad or from unregistered outlets, or whether the reactions were the result of fake drugs, or a failure in the instructions provided or an interaction with another medication.
Nevertheless, there have been reported deaths occurring from the consumption of counterfeit medicines bought online (Kao et al., 2009; Dondorp et al., 2004; Hanif et al., 1995). In China, during 2001, it was reported in the Shenzhen Evening News that 200,000 people were alleged to have died from consuming fake medicines (Satchwell, 2004:44; Humble, 2005). Furthermore, the harrowing case of Eloise Parry is also not unique. In 2013, a young British woman named Sarah Houston died after taking slimming pills that she had purchased from the Web. In both cases it is significant that the product taken was not sold for human consumption in the US or UK. This opens up a whole other can of worms concerning substances that escape medicine regulation provided they are not marketed for human consumption. Often they are often sold under the guise of bath salts or plant food, though the design of their packaging and marketing may suggest otherwise.
UK based websites must be registered pharmacies to sell prescription medicine, if not they can be prosecuted. These online pharmacies operate in the same manner as offline establishments, where a valid prescription procured from a doctor is needed before the medicine can be dispensed. This issue is uncomplicated when dealing with websites trading from the UK; however UK citizens can access international online pharmacies, with different medicine regulations and standards. Medicine that ordinarily requires prescription in the UK might be obtainable over-the-counter elsewhere, and less regulation might mean a reduced quality of ingredients. With no global standards to govern the online sale of medicine, domestic laws can easily be circumnavigated. Policing and control of the movement of medicines across borders is problematic. The Web allows people to view websites outside of national and legislative jurisdiction and enables access to unregulated and unauthorised substances within the home country sent from abroad.
Before the Web there were limited options for people to purchase medicine. Nowadays people can choose to undertake the traditional practice of visiting a doctor or pharmacy or go online for their healthcare needs. Given the attention that this issue has and is currently receiving, more needs to be done to deconstruct the problem of being able to buy medicine from the Web. Specifically, for people to manage the risks associated with purchasing medicine online there needs to be a clearer distinction between buying medicines from legitimate online pharmacies as opposed to illegitimate online sources.
References
Attaran, A., Barry, D., Basheer, S., Bate, R., Benton, D., Chauvin, J.,& McKee, M. (2012). How to achieve international action on falsified and substandard medicines. BMJ, 345.
Dondorp, A. M., Newton, P. N., Mayxay, M., Van Damme, W., Smithuis, F. M., Yeung, S., Petit, A., Lynam, A. J., Johnson, A., Hien, T. T., McGready, R., Farrar, J. J., Looareesuwan, S., Day, N. P. J., Green, M. D. & White, N. J. (2004). “Fake antimalarials in Southeast Asia are a major impediment to malaria control: Multinational cross-sectional survey on the prevalence of fake antimalarials.” Tropical Medicine & International Health, 9(12), 1241–6.
Hanif, M., Mobarak, M., Ronan, A., Rahman, D., Donovan, J. et al. (1995). “Fatal renal failure caused by diethylene glycol in paracetamol exlixir: The Bangladesh epidemic.” British Medical Journal, 311, 88–91.
Human Medicine Regulations 2012 http://www.legislation.gov.uk/uksi/2012/1916/contents/made
Humble, C. (2005). “Inside the fake Viagra factory.” Sunday Telegraph, 21 August. Available at: http:// www.telegraph.co.uk/news/uknews/3322770/ Inside-the-fake-Viagra-factory.html.
Kao, S. L., Chan, C. L., Tan, B., Lim, C. T., Dalan, R., Gardner, D. & Lee, K. O. (2009). “An unusual outbreak of hypoglycemia.” New England Journal of Medicine, 360(7), 734-6.
Medicines Act 1968
Satchwell, G. (2004). A Sick Business: Counterfeit Medicines and Organised Crime. Stockholm Network.