Developing a national strategy for combating counterfeit medicines
Background Counterfeit medicines pose a worldwide problem to governments, pharmaceutical companies and patients, meaning a systemic and comprehensive approach needs to be adopted by medicines regulatory agencies. The UK’s Medicines and Health Regulatory Agency (MHRA) was one of the first national agencies to develop and implement a strategy to combat counterfeit medicines. Exploring this experience from different perspectives provides an opportunity to build knowledge and inform others considering adopting a similar approach. Aims The aim of this research is to describe and investigate the key components in developing an anti-counterfeit medicines strategy in the UK; through describing and examining agency and stakeholder views on its development, implementation and evaluation and the roles of pharmacists and GPs within this. Methods A mixed method qualitative and quantitative research design was used which comprised four separate studies. Two semi-structured interview studies of MHRA and stakeholders participants were undertaken alongside two postal survey studies of community pharmacists and GPs. Findings The significant risk to patients resulting from counterfeit medicines underpinned the decision to develop and implement a national strategy. Stakeholders have an important role in the development of the strategy and in its implementation by securing the supply chain, sharing information, educating others, being vigilant and reporting suspicions. Pharmacists and GPs reported limited experience of counterfeit medicines. Whilst GPs reported receiving no related education or training, pharmacists frequently reported supply practices which did not align with current guidance. Conclusion There was agreement that in order to effectively combat counterfeit medicines a national strategy was required. Stakeholders from the pharmaceutical industry, regulatory bodies, medical and pharmacy professions were seen to have an important role in both its drafting and implementation. Pharmacists and GPs mainly believed that they had a role in combating counterfeit medicines however it was identified that they required better underpinning education and training. The research findings provide a framework of evidence-based guidance for developing an anti-counterfeit medicines strategy.
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