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Establishing good authentication practice (GAP) in secondary care to protect against falsified medicines and improve patient safety
  1. Bernard D Naughton1,
  2. James A Smith2,3,
  3. David A Brindley2,3,4,5,6
  1. 1Oxford University Hospitals NHS Trust, Oxford, UK
  2. 2Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK
  3. 3The Oxford—UCL Centre for the Advancement of Sustainable Medical Innovation (CASMI), The University of Oxford, Oxford, UK
  4. 4Centre for Behavioural Medicine, UCL School of Pharmacy, University College London, London, UK
  5. 5Harvard Stem Cell Institute, Cambridge, Massachusetts, USA
  6. 6USCF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI), USA
  1. Correspondence to Bernard D Naughton, Oxford University Hospitals NHS Trust, Headley Way, Headington, Oxford OX3 9DU, UK; bernardnaughton{at}

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Sustained growth of falsified and counterfeit medicines in the legal supply chain is a critical threat to patients, (bio)pharmaceutical companies, caregivers, payers and pharmacists.1 ,2 The European Union (EU) Falsified Medicines Directive (FMD) is a tractable opportunity to mitigate this threat and optimise healthcare delivery, including through the optimisation of pharmacy workflows and support of patient adherence. In order to deliver these benefits, and ensure FMD compliance, the production and regular review of Good Authentication Practice (GAP) guidelines is an essential step.

Falsified medicines

‘Falsified medicines’ are ‘fake medicines that pass themselves off as real, authorised medicines’, according to the European Medicines Agency (EMA).3 They may contain incorrect ingredients, low-grade ingredients or incorrect doses and may have suspicious distribution histories or unofficial packaging.4 These products may be mislabelled, misleading and dangerous to the consumer.

In recent years, there has been an increase in falsified and counterfeit medicines, which increases the risk of inadvertent administration and can result in detrimental patient effects. Such effects include failed treatment, adverse side effects and, in some cases, death.5–7

The distribution of falsified medicine is not restricted to on-line purchases or developing countries; the problem spans the entire global market and a variety of distribution chains, from medicines sourced online to treatments supplied through the UK National Health Service (NHS)1 ,5 ,6 ,7 (table 1).

View this table:
Table 1

Examples of recent global incidents of falsified medicine use5 ,6

In response to this growing problem, the European Parliament and the Council of the European Union have published the EU FMD (Directive 2011/62/EU), which requires complete implementation by 2018.8 The Directive states that each eligible medicinal product must have a unique identifier and tamper-evident seal to allow for the authentication of each medicine pack at the point of dispensing …

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