Medical Writing Medical Writing in Paediatrics Medicines information for patients: Insights into research and practice for medical writers
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Volume 21, Issue 2 - Medical Writing in Paediatrics

Medicines information for patients: Insights into research and practice for medical writers

Abstract

Many people do not take their medicines as prescribed, and medicines can cause harm if not used appropriately. In addition, in most health systems there is increasing discussion about involving patients in decisions about their health – including decisions about the medicines they use. In addressing these issues, medicine information for patients can play a key role in supporting patients to get the best out of their medicines. For the information to work, it needs to be both accessible and understandable – this is easy to say, but less easy to put into practice. This article draws on research and practice to help answer the questions:

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Why is medicines information for patients so important?

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What sort of medicines information do people want?

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How can we write and deliver such information?

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References

  1. Haynes RB, Ackloo E, Sahota N, et al. Interventions for enhancing medication adherence. Cochrane Database Syst Rev 2008;(2):CD000011.
  2. Raynor DK, Blenkinsopp A, Knapp P, Grime J, Nicolson DJ, Pollock K, et al. A systematic review of quantitative and qualitative research on the role and effectiveness of written information available to patients about individual medicines. Health Technol Assess 2007;11:1–160.
  3. Liberating the NHS: Greater choice and control. A consultation on proposals. London: Department of Health; 2010.
  4. Directive 93/27 European Commission. Council Directive. The labelling of medicinal products for human use and on package leaflets. Brussels: European Commission; 1992.
  5. Directive 2001/83 European Commission. Council Directive. Community code relating to medicinal products for human use. Brussels: European Commission; 2001.
  6. European Commission. Guidance concerning consultations with target patient groups for the package leaflet. Brussels: European Commission; 2006
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  10. Raynor DK, Savage I, Knapp P, Henley J. We are the experts: people with asthma talk about their medicine information needs. Patient Educ Couns 2004;53:167–74.
  11. Raynor DK, Dickinson D. Key principles to guide development of consumer medicines information. Ann Pharmacother 2009;43:700–6.
  12. Berry DC, Knapp PR, Raynor D. Provision of information about drug side-effects to patients. Lancet 2002;359:853–4.
  13. Knapp P, Gardner PH, Raynor DK, Woolf E, McMillan B. Perceived risk of tamoxifen side effects: a study of the use of absolute frequencies or frequency bands, with or without verbal descriptors. Patient Educ Couns 2010;79:267–71.
  14. European Commission. Guidance concerning consultations with target patient groups for the package leaflet. Brussels: European Commission; 2006.
  15. Medicines and Healthcare Products Regulatory Agency. Always read the leaflet: getting the best information with every medicine. Report of the Committee on Safety of Medicines Working Group on Patient Information. London: The Stationery Office; 2005.
  16. Amending Directive 2001/83/EC, as regards information to the general public on medicinal products subject to medical prescription and as regards pharmacovigilance. Brussels: European Commission; 2011.
  17. Quality Review of Documents Group. Human product information template v8.00. London: European Medicines Agency; 2011.
  18. Raynor DK, Knapp P, Silcock J, Parkinson B, Feeney K. “User-testing” as a method for testing the fitness-for-purpose of written medicine information. Patient Educ Couns 2011;83:404–10.
  19. Knapp P, Raynor DK, Silcock J, Parkinson B. Can user testing of a clinical trial patient information sheet make it fit-for-purpose? – a randomized controlled trial. BMC Med 2011;9: Article number 89.
  20. Directive 2010/84 European Commission. Pharmacovigilance directive. Brussels: European Commission; 2010.

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