Modern healthcare delivery has experienced a rapid and unprecedented contextual change due to COVID-19, placing staff, services, and supply chains under increasing pressure. Our recent comment in the Lancet Global Health addresses the knock-on effect of COVID-19 on medicine quality, and the risks the virus now poses to the safe supply of tests, drugs, and vaccines. Major, rapid contextual shifts due to war or disease outbreaks have been proven to adversely affect medicine quality. COVID-19 has generated supply chain issues, contributed to medicine shortages and created weaknesses in healthcare systems, which are now at an increased risk of quackery.
As CJS Thompson’s book Quacks of London (1928) makes clear, quackery has been around for centuries in the UK. Quackery has also been linked to major context shifts; During the Great Plague quackery was widespread, and during World War II a shortage of penicillin contributed to an increase in its falsification, as was made infamous in the film The Third Man. The war on COVID-19 is creating a context in which quackery is likely to thrive and has - according to a recent WHO alert - resulted in the falsification of essential medical products to combat the virus, including medicines, vaccines, and diagnostics .
Now is the time, more than ever, for healthcare organisations, professionals and consumers to be vigilant in their verification of medicines.
Falsified medicines are, according to a 2017 study published by the World Health Organisation, ‘any medical products that deliberately/fraudulently misrepresent […] their identity, composition or source’. This may include medicines manufactured in unlicensed premises and/or packaged in misleading containers. These medicines can contain the wrong ingredients, the wrong strength, or they may be legitimate products made by a licenced manufacturer which have been stolen and reintroduced into the supply chain. Substandard medicines on the other hand are those which ‘do not meet quality standards or specifications’. These could, for example, include products which have been made by a licenced manufacturer, but contain a genuine manufacturing error. Alternatively substandard medicines may become ‘out of specification’ after manufacturing due to poor storage conditions by healthcare providers or patients.
Low income threat
How the problem is tackled depends on the affluence of the country in question. Substandard and falsified (SF) medicines have an estimated prevalence of 10.5% in low to middle income countries.. The problem is often viewed through the lens of supply and demand, with key demand factors including cost, convenience, and access. When these demand factors are amplified, a market for falsified and substandard medicine coincides. These demand factors can be precipitated by a disruption to the regular legal supply chain due to local contextual changes which may include war, disease or virus outbreaks, geography, or extreme weather. Indeed, we have seen this play out as a result of the current Covid-19 pandemic.
Robust regulatory systems are central to tackling SF medicines in low- and middle-income countries, however 30% of the world’s countries do not have the correct regulatory infrastructure needed to deal with the issue. For example, it wasn’t until 2018 that the Food and Drug Agency in Tanzania became the first in an African country to be recognised as a maturity level 3 agency by the WHO, the second highest on the UN organisation’s scale and the target for regulatory systems globally. Improving regulatory infrastructure and building resilience within it, is, therefore, paramount: both in terms of curbing criminal activity (supply) and ensuring fair access to quality medicines (demand).
Affluent not exempt
There is little published evidence which estimates the extent of falsified and substandard medicine in high income countries. However, there are millions of substandard medicines recalled annually in these areas due to genuine manufacturing errors which can be detected using digital drug screening technologies. The main risk from SF medicines in high income countries is the illegal sale of medicines online. Illegal vendors thrive due to lower cost, increased convenience, and perceived availability. Strategies looking at tackling SF medicines bought online would benefit from advances in artificial intelligence to rapidly identify and efficiently shut down illegal online drug vendors. Educating patients and consumers about how they can verify the status of online ‘pharmacies’ themselves, is also crucial.
Those in healthcare with access to digital drug screening tools should be prioritising the verification of medicine prior to supply. All European pharmacies have access to digital medicine verification systems and should be scanning the 2D barcode found on legitimate medicine packages to verify medicines before supply to patients. When buying products online in the EU, consumers can verify the legal status of the pharmacy website they are buying products from by searching for the EU’s common logo. This logo guarantees the authenticity of the websites and the safety of the products.
Considering the rapid context shift due to COVID-19, now is the time, more than ever, for healthcare organisations, professionals and consumers to be vigilant in their verification of medicines and vendors wherever they possibly can. Transparency and accurate information exchange are vital in the fight against SF medicines and will help us to differentiate between quality and quackery.
Learn more about Bernard Naughton's work.