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Adequacy of Patient Information on Adverse Effects

An Assessment of Patient Information Leaflets in the UK

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Abstract

Background: One of the most important categories of information that patients want to know about the drug they are taking is the likelihood or probability of adverse effects. All patients should receive such information in the patient information leaflet that is supplied with all drugs. Anecdotal evidence suggests that most leaflets give little indication of the likelihood of adverse effects. The UK Medicines and Healthcare products Regulatory Agency (MHRA) suggests using a combination of words and numbers to convey this information. However, an EU guideline suggests using five verbal descriptors on a scale from common to rare, the use of which has been shown to lead to gross overestimation of the risk of adverse effects.

Methods: We assessed the leaflets supplied with the 50 most frequently prescribed drugs in England, to determine the extent to which the likelihood of adverse effects was described, and whether it met the requirements of the EU guidance and/or best practice. We examined both the method used to describe the likelihood of adverse effects, and the format of this information in the leaflet.

Results: Twenty of the 50 leaflets (40%) gave no indication of the likelihood of adverse effects occurring. Six (12%) used the recommended EU terms and a further 20 (40%) used a wide range of other verbal descriptors. Only four leaflets (8%) provided any form of numerical indication of risk. Over half (52%) presented long lists of adverse effects in paragraphs of continuous text.

Conclusions: Patient need is not being met in terms of the provision of usable information about the likelihood of adverse effects. Most patients receive no information, whereas some are given verbal descriptors, both of which lead to overestimation of the risk. Very few of the patient information leaflets assessed used currently described best practice, i.e. to present verbal descriptions alongside numerical information in the form of natural frequencies, e.g. ‘rare (affects less than 1 in 1000 people)’.

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References

  1. Berry DC, Gillie T, Banbury SP. What do patients want to know about their medicines? An empirical study. Expert Systems with Applications 1995; 8: 419–28

    Article  Google Scholar 

  2. Raynor DK, Savage I, Knapp P, et al. We are the experts: people with asthma talk about their medicine information needs. Patient Educ Couns 2004; 53: 167–74

    Article  PubMed  Google Scholar 

  3. Ziegler DK, Mosier MC, Buenaver M, et al. How much information about adverse effects of medication do patients want from physicians? Arch Intern Med 2001; 161: 706–13

    Article  PubMed  CAS  Google Scholar 

  4. European Commission. EEC Directive 92/27/EEC on labelling of medicinal products for human use and on package leaflets (OJ No. L1 13 of 30 April 1992). 1992

  5. Raynor DK, Knapp P, Moody A, et al. Patient information leaflets: impact of European regulations on safe and effective use of medicines. Pharmaceutical J 2005; 275: 609–11

    Google Scholar 

  6. Grime J, Blenkinsopp A, Raynor DK, et al. The role and value of written information for patients about individual medicines: a systematic review. Health Expect 2007; 10: 286–98

    Article  PubMed  Google Scholar 

  7. European Commission. A guideline on the readability of the label and package leaflet of medicinal products for human use. B ussels: EC Pharmaceuticals Committee, 1998

    Google Scholar 

  8. Bryant GD, Norman GR. Expressions of probability: words and numbers. N Engl J Med 1980; 302: 411

    PubMed  CAS  Google Scholar 

  9. Berry DC, Knapp P, Raynor DK. Provision of information about drug side effects to patients. Lancet 2002; 359: 853–4

    Article  PubMed  CAS  Google Scholar 

  10. Berry DC, Raynor DK, Knapp P. Communicating risk of medication side effects: an empirical evaluation of EU recommended terminology. Psychol Health Med 2003; 8: 251–63

    Article  Google Scholar 

  11. Berry DC, Raynor DK, Knapp P. Is 15% very common? Informing people about the risks of medicine side effects. IJPP 2002; 10: 145–51

    Google Scholar 

  12. Knapp P, Raynor DK, Berry DC. Comparison of two methods of presenting risk information to patients about the side effects of medicines. Qual Saf Health Care 2004; 13: 176–80

    Article  PubMed  CAS  Google Scholar 

  13. Raynor DK, Blenkinsopp A, Knapp P, 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 (5)

  14. 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

    Google Scholar 

  15. Information Centre for Health and Social Care. Prescription cost analysis: England 2005 online]. Available from URL: http://www.centralservicesagency.com/display/statistics Accessed 2006 Nov 10]

  16. Electronic medicines compendium online]. Available from http://www.medicines.org.uk/ Accessed 2008 Feb 5]

  17. Paling J. Strategies to help patients understand risk. BMJ 2003; 327: 745–8

    Article  PubMed  Google Scholar 

  18. Doyal L. Informed consent: moral necessity or illusion? Qual in Health Care 2001; 10: 29–33

    Article  Google Scholar 

  19. Miller GA. The magical number seven, plus or minus two: some limits on our capacity for processing information. Psychol Rev 1956; 63: 81–97

    Article  PubMed  CAS  Google Scholar 

  20. Finucane ML, Alhakami A, Slovic P, et al. The affect heuristic in judgements of risk and benefits. J Behave Dec Making 2000; 13: 1–17

    Article  Google Scholar 

  21. Lloyd AJ. The extent of patients’ understanding of the risk of treatments. Qual Saf Health Care 2001; 10(90001): 14–8

    Article  Google Scholar 

  22. Barber N. Ensuring patients’ satisfaction with information about their medicines. Qual Saf Health Care 2001; 10: 130–1

    Article  CAS  Google Scholar 

Download references

Acknowledgements

No sources of funding were used to assist in the preparation of this study. Dr Carrigan has no conflicts of interest directly relevant to this study. Professor Raynor and Dr Knapp are directors of LUTO Research Ltd (www.luto.co.uk), a Leeds University spin-out company that tests the readability of drug information leaflets for the pharmaceutical industry.

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Authors and Affiliations

  1. School of Healthcare, University of Leeds, Baines Wing, Leeds, LS2 9LN, UK

    Neil Carrigan, D. K. Raynor &  Peter Knapp

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  1. Neil Carrigan
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  2. D. K. Raynor
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  3. Peter Knapp
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Correspondence to Peter Knapp.

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Carrigan, N., Raynor, D.K. & Knapp, P. Adequacy of Patient Information on Adverse Effects. Drug-Safety 31, 305–312 (2008). https://doi.org/10.2165/00002018-200831040-00004

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