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Written information on medicines for patients: learning from the PIL
  1. D K Theo Raynor
  1. School of Healthcare, University of Leeds, Leeds LS2 9JT, UK
  1. Correspondence to D K Theo Raynor; d.k.raynor{at}leeds.ac.uk

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Key learning points

  • Medicine information leaflets that are well written and well designed can improve peoples’ knowledge and understanding.

  • The focus of information about medicines should be on empowering decision-making and supporting safe and effective use rather than encouraging people to take a medicine.

  • People want information that is tailored to their circumstances and needs.

  • Written information should support spoken information from a health professional—not replace it.

Introduction

Everyone should expect accurate, accessible and usable information about their medicines. A generation ago, the only source was the label on the bottle. Since then, there has been a gradual increase in regulated information provided to patients. Pharmacists began to include additional administration and safety information on the label, and then leaflets started to appear—notably with non-oral dose forms such as inhalers.

Work on developing more comprehensive leaflets began in the late 1980s, with research on a generic style of leaflet that outlined the effects of a group of medicines (eg, diuretics, benzodiazepines).1 This was overtaken in the mid-1990s with the European Union (EU) initiative to provide inside every pack what are generally called patient information leaflets (PILs). These comprehensive leaflets (covering indication, warnings and precautions, administration and adverse effects) became mandatory in 1999, and from 2005, they were required to be user-tested for readability with members of the public.2,3 Alongside, these developments has been an increase in the number of regulated and unregulated sources of information about medicines published online.

Over time, the emphasis has shifted from basic ‘how to use’ information, through to more detailed information on safe use. More recently, there has been a focus on providing patients with information to enable them to make an informed decision about whether a medicine is right for them. In 2005, the Committee of Safety of Medicines published guidance, which highlighted the variable quality …

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