Abstract

Counterfeit pharmaceuticals are a serious and ever-growing threat to public safety. Monitoring the trade is difficult, resulting in the precise scale of the problem being unknown, however evidence shows that it is not just lifestyle drugs that are targeted nowadays. Adverse health problems, including fatalities, have resulted from consumers self-medicating with counterfeit products. Without efforts to enhance the public's knowledge, the problem will continue to persist. The internet is facilitating the trade by providing counterfeiters with a large consumer base and limited risks. The dark net within it allows for anonymous transactions between manufacturer, distributer and consumer. While some online pharmacies are legitimate, there are a growing number of those that are unverified which sell dangerous counterfeit products. Both the packaging and medication are becoming increasingly sophisticated, making it difficult for consumers and law enforcement to identify them without chemical analysis. Counterfeit batches have also been detected in established legal trade routes whereby they are able to, if undetected, end up in high street pharmacies and hospitals. Multiple organisations have set up worldwide operations to dismantle the trade however this is a complex and evolving problem that without significant changes to legislation may never be fully.

Highlights

  • Substandard, spurious, falsely labelled, falsified and counterfeit (SSFFC) medical products[1] are each year becoming an increasing threat to consumers’ health and the problem remains largely underreported.[2]

  • Investigation into a covert or ‘invisible’ approach is underway whereby trace amounts of an inactive ingredient is added. This is known as a taggant and their aim is to allow for product authentication and easier detection of counterfeit products.[67]

  • Dismantling the counterfeit market remains a challenge and despite more investigations and spot checks being undertaken, it is a complex market with grey areas that remain ambiguous to officials.[22]

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Summary

Introduction

Substandard, spurious, falsely labelled, falsified and counterfeit (SSFFC) medical products[1] are each year becoming an increasing threat to consumers’ health and the problem remains largely underreported.[2]. Strained resources and implications of ethics, including patient privacy, have limited the efforts to tackle this consistently growing and evolving issue.[35] The International Criminal Police Organisation (INTERPOL) have undertaken multiple large scale operations in order to tackle pharmaceutical crime but have confirmed that there is a vital need for continued intervention.[63] Operation Pangea, launched in 2008, was the first of its kind dealing with targeting internet pharmacies on an international scale.[64] To date it has gained a significant following and is active in over 100 countries.[58] Operation Mamba followed, with the goal being to intercept the trafficking activities of counterfeit medical products in Eastern Africa before they could reach developed countries whilst raising awareness.[65] The MHRA launched a threepronged strategy in the same year, as summarised, to tackle the problem.[17] Success of this strategy was found to be problematic to quantify as the initial scale was unknown and the level of risk to consumers remains undetermined. The knowledge of this logo is limited, with many consumers not understanding the significance

Method Communication
Conclusion
50. Fake Medicine
63. Pharmaceutical Crime
Findings
67. Guidance for Industry
Full Text
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