International Journal of Clinical Pharmacy

, Volume 36, Issue 4, pp 827–834 | Cite as

How useful are medication patient information leaflets to older adults? A content, readability and layout analysis

  • Fang LiuEmail author
  • Sarah Abdul-Hussain
  • Shams Mahboob
  • Vijay Rai
  • Andrzej Kostrzewski
Research Article


Background Patient information leaflets (PILs) are the most important information source for older patients to effectively manage their drug therapy. Objective The objective of this study is to evaluate the appropriateness of current available PILs for use by older adults. Methods The content of the PILs were assessed by checking the availability of information relevant to older patients including pharmacokinetics, safety and dose instructions. The layout of the PILs was evaluated using criteria derived from the relevant regulatory guidelines on the design of PILs. The Gunning Fog Index was used to determine the readability of the PILs to older adults. Results Total of 48 PILs were analysed involving 25 drug substances for the treatment of cardiovascular disease and type 2 diabetes. One out of the 48 PILs contained information on pharmacokinetic changes in older patients and only 15 % of the PILs specified the age of the older person. Thirty-one percent of the PILs provided nonspecific warnings to the older population, while only 15 % included specific side effects that could occur in the older generation. Text font sizes of the PILs were generally too small for older adults to read, with only 9 % of the PILs used type size 12 or over. The readability of 63 % of the PILs had a score above 12, which is considered difficult for older people to understand. Conclusion Currently available medication PILs are inappropriate for use by older adults to manage their medications effectively, which could adversely affect patient safety and adherence to drug therapy.


Elderly Geriatric information Layout Older Patient information leaflet PIL Readability United Kingdom 




Conflicts of interest



  1. 1.
    United Nations, World Population Ageing: 1950–2050. 2001. Accessed 06 May 2014.
  2. 2.
    Borgsteede SD, Westerman MJ, Kok IL, et al. Factors related to high and low levels of drug adherence according to patients with type 2 diabetes. Int J Clin Pharm. 2011;33:779–87.PubMedCentralPubMedCrossRefGoogle Scholar
  3. 3.
    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.PubMedCrossRefGoogle Scholar
  4. 4.
    European Commission. Directive 2004/27/EC of 31 March 2004 amending Directive 2001/83/EC on the community code relating to medicinal products for human use. 2004. Accessed 06 May 2014.
  5. 5.
    European Commision. A guideline on summary of product characteristics (SmPC). 2009. Accessed 06 May 2014.
  6. 6.
    Briggs R, Robinson S, O’Neill D. Ageism and clinical research. Ir Med J. 2012;105:311–2.PubMedGoogle Scholar
  7. 7.
    Crome P, Lally F, Cherubini A, et al. Exclusion of older people from clinical trials: professional views from nine European countries participating in the PREDICT study. Drugs Aging. 2011;28:667–77.PubMedCrossRefGoogle Scholar
  8. 8.
    International Conference on Harmonization (ICH). E7–studies in support of special populations: geriatrics. 1993. Accessed 06 May 2014.
  9. 9.
    European Medicines Agency (EMA). ICH topic E7-Studies in support of special populations: geriatrics; questions and answers. 2010. Accessed 06 May 2014.
  10. 10.
    Beers E, Egberts TC, Leufkens HG, Jansen PA. Information for adequate prescribing to older patients: an evaluation of the product information of 53 recently approved medicines. Drugs Aging. 2013;30:255–62.PubMedCrossRefGoogle Scholar
  11. 11.
    Davis TC, Wolf MS, Bass PF 3rd, et al. Literacy and misunderstanding prescription drug labels. Ann Intern Med. 2006;145:887–94.PubMedCrossRefGoogle Scholar
  12. 12.
    Shrank W, Avorn J, Rolon C, Shekelle P. Effect of content and format of prescription drug labels on readability, understanding, and medication use: a systematic review. Ann Pharmacother. 2007;41:783–801.PubMedCrossRefGoogle Scholar
  13. 13.
    European Commission. Guideline of the readability of the labelling and package leaflet of medicinal products for human use. 2009. Accessed 06 May 2014.
  14. 14.
    Medicines and Healthcare products Regulatory Agency (MHRA). Always read the leaflet: getting the best information with every medicine. 2004. Accessed 06 May 2014.
  15. 15.
    NHS information Center for Health and Social care. Prescription cost analysis—England. 2012. Accessed 06 May 2014.
  16. 16.
    British Medical Association and the Royal Pharmaceutical Society. The British National Formulary (BNF). 65th ed. London: BMJ Group and Pharmaceutical Press; 2013.Google Scholar
  17. 17.
    Datapharm Communications Limited. The electronic medicines compendium (eMC). Accessed 06 May 2014.
  18. 18.
    Petterson T. How readable are the hospital information leaflets available to elderly patients? Age Ageing. 1994;23:14–6.PubMedCrossRefGoogle Scholar
  19. 19.
    Cheng YJ, Imperatore G, Geiss LS, et al. Secular changes in the age-specific prevalence of diabetes among US Adults: 1988–2010. Diabetes Care. 2013;36:2690–6.PubMedCrossRefGoogle Scholar
  20. 20.
    Hanlon JT, Schmader KE, Koronkowski MJ, et al. Adverse drug events in high risk older outpatients. J Am Geriatr Soc. 1997;45:945–8.PubMedGoogle Scholar
  21. 21.
    Steinmetz KL, Coley KC, Pollock BG. Assessment of geriatric information on the drug label for commonly prescribed drugs in older people. J Am Geriatr Soc. 2005;53:891–4.PubMedGoogle Scholar
  22. 22.
    Perrie Y, Badhan RK, Kirby DJ, et al. The impact of ageing on the barriers to drug delivery. J Control Release. 2012;161:389–98.PubMedCrossRefGoogle Scholar
  23. 23.
    Hanlon JT, Sloane RJ, Pieper CF, Schmader KE. Association of adverse drug reactions with drug–drug and drug–disease interactions in frail older outpatients. Age Ageing. 2011;40:274–7.PubMedCentralPubMedCrossRefGoogle Scholar
  24. 24.
    Wright D. Medication administration in nursing homes. Nurs Stand. 2002;16:33–8.PubMedCrossRefGoogle Scholar
  25. 25.
    Boulton DW, Fawcett JP, Woods DJ. Stability of an extemporaneously compounded levothyroxine sodium oral liquid. Am J Health Syst Pharm. 1996;53:1157–61.PubMedGoogle Scholar
  26. 26.
    Twomey C. An analysis of patient information leaflets supplied with medicines sold by pharmacists in the United Kingdom. Libr Inf Res. 2001;25:3–12.Google Scholar
  27. 27.
    Bernardini C, Ambrogi V, Fardella G, et al. How to improve the readability of the patient package leaflet: a survey on the use of colour, print size and layout. Pharmacol Res. 2001;43:437–44.PubMedCrossRefGoogle Scholar
  28. 28.
    Wogalter MS, Vigilante WJ Jr. Effects of label format on knowledge acquisition and perceived readability by younger and older adults. Ergonomics. 2003;46:327–44.PubMedCrossRefGoogle Scholar
  29. 29.
    Carrigan N, Raynor DK, Knapp P. Adequacy of patient information on adverse effects: an assessment of patient information leaflets in the UK. Drug Saf. 2008;31:305–12.PubMedCrossRefGoogle Scholar
  30. 30.
    Bond C, Blenkinsopp A, Raynor DK. Prescribing and partnership with patients. Br J Clin Pharmacol. 2012;74:581–8.PubMedCentralPubMedCrossRefGoogle Scholar
  31. 31.
    News Team. Medicines safety experts call for rewrite of packaging regulations. Pharm J. 2013;291:424.Google Scholar
  32. 32.
    European Medicines Agency (EMA). Ensuring safe and effective medicines for an ageing population: workshop proceedings. 2012. Accessed 06 May 2014.

Copyright information

© Koninklijke Nederlandse Maatschappij ter bevordering der Pharmacie 2014

Authors and Affiliations

  • Fang Liu
    • 1
    Email author
  • Sarah Abdul-Hussain
    • 1
  • Shams Mahboob
    • 1
  • Vijay Rai
    • 1
  • Andrzej Kostrzewski
    • 1
  1. 1.Department of Pharmacy, School of Life and Medical SciencesUniversity of HertfordshireHatfieldUK

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