Lancet Respiratory Medicine
May 2018 Volume 6 Number 5 p315-402 e16-e18
Fake medicines: fighting on all fronts
The Lancet Respiratory Medicine
The illegal market in fake medicines is a growing threat and is harming patients the world over—this was the headline of Fight the Fakes, an event at University College London (UCL) on March 16, 2018, which aimed to provoke action on the urgent global issue of falsified and substandard medicines.
A recent WHO report estimated that about 1 in 10 medical products circulating in countries of low and middle income is either substandard or falsified. Fake drugs are being produced by organised criminals who can turn large profits. Factories are set up that can create packaging and medication inserts that perfectly resemble the real drugs; this packaging is then filled with cheaply made tablets or solutions that contain no active ingredient whatsoever, or in some cases contain dangerous substances. All too often, these harmful counterfeits find their way into pharmacies and clinics in countries of low and middle income. At the Fight the Fakes event, Michael Deats of WHO showed footage of a raid on a fake medicines factory in West Africa; glass bottles were being filled with “antimicrobials” to be dispensed to children with lung infections, but the liquid being decanted from filthy plastic canisters not only contained no active ingredient, it was also heavily contaminated with Escherichia coli.
Antimicrobials and antimalarials are the most commonly reported fake drugs. A modelling study based on data from the WHO report estimated that between 79 000 and 169 000 children might be dying each year from pneumonia because they are being treated with fake antibiotics. Data on all classes of drugs are patchy, but a 2013 study of pharmacies in 19 countries found that 9·1% of tuberculosis drugs sampled did not contain enough active ingredient or failed disintegration tests. Failure rate was 16·6% in Africa, 10·1% in India, and 3·9% in other middle-income countries.
Speaking at the Fight the Fakes event, Professor Ibrahim Abubakar (UCL) noted that in the case of tuberculosis, as well as some other infectious diseases, fake drugs do not just cause harm to the individual patient, but they also contribute to the development of resistant strains that can affect society as a whole.
A second WHO report on surveillance and monitoring of substandard and falsified drugs identified three main drivers of the problem in countries of low and middle income: constrained access to safe and affordable medical products, lack of good governance, and weak technological capacity. For these drivers to be addressed, political will and public awareness will be required.
Higher-income countries face a slightly different set of problems. Lynda Scammell of the MHRA said that the incidence of fake drugs making their way into the official supply chain in the UK (ie, being dispensed by the NHS) is very low; however, a growing number of people are buying medicines online. Often, these drugs are bought from websites that look legitimate, but the supply chain is opaque, increasing the risk of falsified or substandard drugs being taken. Additionally, prescription-only medications are frequently bought online without any consultation or appropriate medical advice.
Substandard medical devices bought online are also a problem; Scammell cited syphilis testing kits that always give a negative result or dental drills with a tendency to fall apart in the middle of procedures. Both of these are examples of products seized during Operation Pangea, co-ordinated by INTERPOL, which aims to tackle the illegal sale of medicines and devices online. As well as seizing packages as they come through customs, Pangea targets internet service providers for illegal medicine websites and the payments systems that they use.
The conversation around the complex issue of fake medicines can often be rather sterile, focusing on the need for supply chain oversight, country-level surveillance, and public awareness campaigns. Although these are all important weapons in the fight, it is important to remember that this is a human issue that brings misery and suffering to people daily. In his presentation, Michael Deats showed video footage of five children from a rural area of the Democratic Republic of Congo who were among 1000 young people admitted to hospital with the same set of symptoms: dystonia, paralysis of the upper limbs, and protruding tongue. He explained that an investigation by Medecins Sans Frontieres eventually found that all the children had been given yellow tablets labelled as diazepam, which had been prescribed to treat malarial convulsions; however, when tested, the tablets were found to contain haloperidol, an antipsychotic, which had been purposefully mislabelled as diazepam to sell it. 11 of the children died. This shocking example highlights that this is an urgent issue that is not receiving the attention it deserves.