Design of Medicines Packaging

Research Theme: Healthcare Design

The packaging and labelling of medicines provide safety-critical information to a range of users, including warehouse stockists, pharmacists, nurses, patients and carers. This information must be located, understood and remembered, with great accuracy.

However, manufacturers of medicines have traditionally seen packaging and labelling design as primarily a vehicle for advertising, rather than for clearly conveying critical information.

Motivation

The design of medicines packaging and labelling has been implicated in as many as 10,000 injuries and deaths each year in the USA (Kenagy and Stein, 2001), through issues such as mix-ups between medicines and misunderstood instructions. Manufacturers are now starting to recognise the need to improve such design, and a number of changes are starting to appear on pharmacy shelving. However, it is not always clear whether such "improvements" really result in increased patient safety.

Objectives

  • The ultimate aim of the project is to improve the design of medicines packagingand labelling through:Identifying problems and their causes.
  • Developing and evaluating solutions, in partnership with user groups andcompanies.

Method

In this project it is critical that we engage with a wide variety of stakeholders. This is being achieved through interviews, observations and workshops with representatives from the National Health service, patients, manufacturers and regulators.

Findings

Research for the National Patient Safety Agency (NPSA) resulted in several national publications (e.g. NPSA, 2004 and WARD, 2004), which have had an impact across the UK, resulting in many changes and subsequent improvement to patient care.

Research for Almus Pharmaceuticals Ltd. is nearing completion. This has involved evaluating the impact of a new range of packaging and labelling (see Figure 2) on medicines users.

Details

Research began in 2003, and focused on the use of a medicine called methotrexate, which over the years had been implicated in the deaths or serious injuries of many patients. It was suspected that the design of the packaging and labelling was linked to a proportion of these incidents.

Research was carried out in partnership with the NPSA, healthcare practitioners in primary and secondary care, patients and the key manufacturers of methotrexate in the UK. It identified a number of problems for patients that were caused by inapproprite design of packaging and labelling.

In response to these problems, a workshop with designers produced a number of packaging and labelling design concepts, aimed at improved safety. Problems and concepts were presented to the manfuacturers, who undertook to improve packaging and labelling design. Across the UK, the NHS made many changes to their practice, which have resulted in measurable improvements in patient safety.

More recently, research with Almus Pharmaceuticals has investigated the impact of their new range of packaging and labelling (see Figure 2). It is envisaged that the research will be complete by summer 2006.

Research continues with the UK's National Health Service (NHS), who also manufacture custom-made medicines packaging and labelling. However, even the NHS lags behind commercial manufacturers in its use of good design practice in medicines packaging and labelling. We are now working with various representatives to develop a plan for improvements.

Acknowledgements

We would like to thank Almus Pharmaceuticals and the NPSA for providing funding for this research, as well as the many healthcare professionals and patients who have provided their valuable insights.

Selected Publications

  • KENAGY, J. W. and STEIN, G. C. (2001). 'Naming, labeling, and packagingof pharmaceuticals.' American Journal of Health-System Pharmacy, 58(1), 2033-2041.
  • NPSA (2004), Towards the safer use of oral methotrexate, Patient SafetyAlert, National Patient Safety Agency, London.
  • WARD, J.R., CLARKSON, P.J. and BUCKLE, P. (2004) 'The packagingand labelling of solid oral medicines: a study to identify the needs and functionalityfor safe administration of solid oral medicines using oral Methotrexate asan example', University of Cambridge Engineering Design Centre / National PatientSafety Agency internal report
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