Assessment of the quality of medication information for patients in Spain

Expert Opin Drug Saf. 2013 Jan;12(1):9-18. doi: 10.1517/14740338.2013.744965. Epub 2012 Dec 10.


Objective: To analyze the extent to which Spanish leaflets and drug information on the Net met quality criteria.

Research design and methods: A descriptive study was conducted comparing readability (REA) and comprehensibility (COM) criteria of a random sample of 77 marketed products of the 12 active ingredients most frequently sold in 2010 in Spain. Leaflets were approved by the Spanish Agency for Medication (AEMPS). Flesch index, DISCERN, ELF, MIDAS and CIRF scales were used to evaluate quality criteria.

Results: COM assessment yielded between 63 and 77% of the maximum possible scores on the scales. None of the websites or leaflets met all the quality criteria of the DISCERN, CIRF or MIDAS scales. Four (3%) leaflets met all the 22 quality criteria of ELF. The leaflets showed shortcomings regarding: medication benefits (17 required substantial improvements, 31.5%), correct forms of storage (13, 24.1%), contraindications (12, 22.2%), side effects (11, 20.4%) and precautions to be taken (9, 16.7%).

Conclusions: The quality of the information approved by the AEMPS is superior to that which can be found by surfing the Net. More specific information on precautions, complications and how to avoid common patient errors would allow patients the best chance to contribute to their own clinical safety.

Publication types

  • Evaluation Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Access to Information*
  • Comprehension
  • Drug Information Services / standards*
  • Drug Interactions
  • Drug Storage / standards
  • Drug Therapy / standards
  • Drug-Related Side Effects and Adverse Reactions
  • Health Literacy
  • Humans
  • Internet
  • Pamphlets
  • Patient Education as Topic / methods
  • Patient Education as Topic / standards*
  • Patient Safety
  • Practice Guidelines as Topic / standards
  • Quality Indicators, Health Care / standards*
  • Reading
  • Spain