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Combating substandard, spurious, falsely labelled, falsified and counterfeit drugs (SFFC)

This project has been sparked by the introduction of the EU falsified medicines directive (FMD) (2011) and the US Drug Quality and Security Act (DQSA) (2013). The team is investigating the emerging issue of medicines counterfeiting, identifying methods to detect counterfeit medicines and identifying changes to improve existing technology and its implementation. This research also includes management of change studies and aims to identify, through qualitative research, the reasons for failures in technology implementation within the NHS. The outputs from this research are intended to prepare the NHS for the incoming falsified medicines directive, to aid the detection of counterfeit medicines and therefore improve patient safety.

Themes in our research

Regulation and innovation: Researching emerging technologies which span the entire spectrum from ‘sms’ messaging to laboratory analyses, their effectiveness and the part they play in international counterfeit and falsified medicines legislation.

Drug supply chain management: Research to better understand the drug supply chain in secondary care. This will help to gain insight into the implementation obstacles facing anti-counterfeit medicine technologies in the NHS.

SFFC detection and modification: Investigating the technical and operational detection rate of Medicines Authentication Technology (MAT) across a variety of NHS hospital sites and using qualitative studies such as the Delphi method approach to gain expert operator feedback to improve authentication technologies ahead of mandated regulatory compliance.

Context and change management: Research to understand internal and external context which affect the implementation of emerging technologies and the best approaches to facilitate positive change management within the NHS.
 

Research outputs

Effectiveness of medicines authentication technology to detect counterfeit, recalled and expired medicines: a two-stage quantitative secondary care study Download research

The European Falsified Medicines Directive in Poland: background, implementation and potential recommendations for pharmacists

Download research
Establishing good authentication practice (GAP) in secondary care to protect against falsified medicines and improve patient safety Download research
Book Excerpt: Fundamentals of EU Regulatory Affairs, Seventh Edition, Chapter 8: European Union Falsified Medicines Directive: Requirements and Implications for Multi-Stakeholder Healthcare Delivery Download research
Combating Counterfeit Medicines: Legal Frameworks and Emerging Technologies Download research
EU Falsified Medicines Directive mandatory requirements for secondary care: A concise review Download research
The Falsified Medicines Directive: How to secure your supply chain Download research
BLOG: The impact of the EU Falsified Medicines Directive on secondary care Download research

Duration

October 2015 - October 2018