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

Int J Clin Pharm. 2014 Aug;36(4):827-34. doi: 10.1007/s11096-014-9973-2. Epub 2014 Jul 2.


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.

Publication types

  • Evaluation Study

MeSH terms

  • Aged
  • Aged, 80 and over
  • Aging*
  • Cardiovascular Agents / administration & dosage
  • Cardiovascular Agents / adverse effects
  • Cardiovascular Agents / pharmacokinetics
  • Cardiovascular Agents / therapeutic use
  • Cardiovascular Diseases / drug therapy
  • Comprehension
  • Diabetes Mellitus, Type 2 / drug therapy
  • Drug Administration Schedule
  • Drug Industry / methods
  • Drug Packaging* / standards
  • England
  • Humans
  • Hypoglycemic Agents / administration & dosage
  • Hypoglycemic Agents / adverse effects
  • Hypoglycemic Agents / pharmacokinetics
  • Hypoglycemic Agents / therapeutic use
  • Medical Writing / standards
  • Patient Education as Topic* / standards
  • Practice Guidelines as Topic
  • Prescription Drugs / administration & dosage
  • Prescription Drugs / adverse effects
  • Prescription Drugs / pharmacokinetics
  • Prescription Drugs / therapeutic use*
  • Quality of Health Care* / standards


  • Cardiovascular Agents
  • Hypoglycemic Agents
  • Prescription Drugs