Package Leaflets

Anytime patients pick up a drug from a pharmacy, they are also given an official package leaflet. The question is whether this procedure fulfils the purpose for which it was once introduced, viz. to promote the correct use of drugs. If a package leaflet is to be effective in terms of optimising the efficacy and minimising the risks of a drug, it will need to satisfy certain conditions. First of all, the leaflet must be shown to be sufficiently readable and comprehensible. It turns out, however, that the methods recommended by the regulatory authorities to assess this feature certain obstacles that make it difficult to meet this requirement.

The obstacles inherent in the current legislation and guidelines make it likely that many patients will find it difficult to understand the leaflets. The examples of unintelligible information given in the article reinforce the notion that the readability tests applied to these leaflets fail to achieve their purpose. The drive towards improving readability and comprehensibility is however impeded by the fact that the guidelines and templates provided by the regulatory authorities are as yet far from satisfactory and actually stand in the way of readable package leaflets. Progress is further hampered by the fact that the results of the readability tests are not published. In addition, unnecessarily elaborate tests, which attach greater importance to quantitative than qualitative requirements, do not contribute to greater readability and comprehensibility.

Research into the effectiveness of package leaflets has been scarce and has limited itself to the effect of the verbal and/or numerical presentation of side-effects. Research into attitudes and behaviour provides clues as to possible and already implemented improvements, but does not offer concrete leads. There has been no research using the hard outcome measure of health effects, and such research is not easily realised.

Package leaflets offer ample information about risks and side-effects of a drug, whereas its efficacy is usually only very briefly presented. It turns out that the information as currently presented in the leaflets results in patients greatly overestimating the risk of experiencing certain side-effects. Hence, the leaflet appears to deter patients rather than supporting drug treatment. It has never been studied whether patients discontinue certain drugs, or do not even start using them, because of the information presented in the package leaflet.

No research has been published on the effectiveness of package leaflets in terms of improving the efficacy and reducing the risks of drugs. Randomised trials involving a fully non-informed control group is impossible because of the unrestricted availability of information and the many ethical and legal objections to not providing patients with information. This does not mean that giving patients package leaflets is useless. Without such ‘instructions for use’, drugs will be dangerous and potentially even fatal. It will be clear, however, that expert advice could produce considerable improvement as regards patient education and information design. As it is, the legal aspects (meeting the requirements stated in the law) and the manufacturers’ desire to cover themselves against liability appear to prevail over the Dutch Medicine Evaluation Board’s stated objective of these leaflets, to ‘promote the responsible use of medicines.’

  1. Geneesmiddelenwet augustus 2016, artikel 69, lid 2. Via:
  2. Informatie website College ter beoordeling van Geneesmiddelen, geraadpleegd 15 september 2017. Via:
  3. Regeling geneesmiddelenwet juli 2017, artikel 4a.3. Via:
  4. European Commision. Directive 2001/83/EC of the European parliament and of the council. November 2001. Via:
  5. European Commission. Guideline on the summary of product characteristics September 2009. Via:
  6. European Commission. Guideline on the readability of the labelling and package leaflet of medicinal products for human use. November 2009. Via:
  7. College ter beoordeling van Geneesmiddelen. MEB 14 - Parallelimport: handelsvergunning en onderhoud. 25 juli 2016. Via:
  8. van Dijk L, Patrício Monteiro S, Vervloet M, de Bie J, Raynor DK. Study on the package leaflets and the summaries of product characteristics of medicinal products for human use – PIL-S study. Europese Unie: 2014.
  9. Garner M, Ning Z, Francis J. A framework for the evaluation of patient information leaflets. Health Expect 2011; 15: 283-294.
  10. QRD Human product information template. Februari 2015. Via:
  11. College ter beoordeling van Geneesmiddelen. Beleidsdocument: Bijsluiter van farmaceutische producten. Augustus 2015. Via:
  12. Lijst met patiëntvriendelijke termen. Maart 2015. Via:
  13. Pander Maat H, Lentz L, Andriesen S. Schrijfadviezen voor de geneesmiddelenbijsluiter. December 2012. Via:
  14. Pander Maat H. Hoe (on)leesbaar zijn geneesmiddelenbijsluiters? Een test van drie veel gebruikte bijsluiters. Universiteit Utrecht, maart 2008.
  15. Algemene rekenkamer. Rapport aanpak van laaggeletterdheid 2016.
  16. Europese Commissie. The European Health Literacy Project 2009-2012.
  17. Young A, Tordoff J, Smith A. Regulatory agencies’ recommendations for medicine information leaflets: are they in line with research findings? Res Soc Admin Pharm 2017; xxxx
  18. Sless D, Shrensky R. Writing about Medicines for People 3174 ed. Australian Self-Medication Industry.
  19. Dickinson D, Raynor DK, Duman M. Patient information leaflets for medicines: using consumer testing to determine the most effective design. Pat Edu Couns 2001; 43: 147-159.
  20. Tyers A. Performance based design. Information Design Journal 2008; 16: 202-215.
  21. Faulkner L. Beyond the five-user assumption: Benefits of increased sample sizes in usability testing. Behavior Res Methods, Instr Comp 2003; 35: 379-383.
  22. Raynor DK, Dickinson D. Key principles to guide development of consumer medicine information - content analysis of information design texts. Ann Pharmacother 2009; 43: 700-706.
  23. Pander Maat H, Lentz L. Improving the usability of patient information leaflets. Pat Edu Couns 2010; 80: 113-119.
  24. Dickinson D, Teather J, Gallina S, Newsom-Davis E. Medicine package leaflets - does good design matter? Information Design Journal 2010; 18: 225-240.
  25. van der Waarde K. Measuring the quality of information in medical package leaflets: harmful or helpful? Information Design Journal 2008; 16: 216-228.
  26. Lentz L, Pander Maat H, Dost D. An evidence-based template proposal for patient information leaflets. Inform Design J 2014; 21: 225-243.
  27. Pander Maat, Lentz L, Raynor DK. How to test mandatory text templates: The European patient information leaflet. PLoS ONE 2015; 10: e0139250.
  28. Europese Commissie. Verslag van de commissie aan het Europees parlement en de raad Brussel 22 maart 2017. Via:
  29. Burgers C, Beukeboom CJ, Sparks L, Diepeveen V. How (not) to inform patients about drug use: use and effects of negations in Dutch patient information leaflets. Pharmacoepidemiol Drug Saf 2015; 24: 137-143.
  30. Beime B, Menges K. Does the Requirement of Readability Testing Improve Package Leaflets? Evaluation of the 100 Most Frequently Prescribed Drugs in Germany Marketed before 2005 and First Time in 2007 or After. Pharmaceut Reg Affairs 2012; 1: 102.
  31. College ter beoordeling van geneesmidddelen. Geneesmiddeleninformatiebank. Geraadpleegd 15 september 2017. Via:
  32. Dickinson R, Raynor DK, Knapp P, MacDonald J. Providing additional information about the benefits of statins in a leaflet for patients with coronary heart disease: a qualitative study of the impact on attitudes and beliefs. BMJ Open 2016; 6: e01202000.
  33. Berry DC, Knapp P, Raynor DK. Expressing medicine side-effects: Assesing the effectiveness of absolute risk, relative risk, and number needed to harm, and the provision of baseline risk information. Pat Edu Couns 2006; 63: 89-96.
  34. Knapp P, Raynor DK, Woolf, E, Gardner PH, Carrigan N, McMillan B. Communicating risk of side effects to patients. An evaluation of UK regulatory recommendations. Drug Saf 2009; 32: 837-849.
  35. Knapp P, Gardner P, McMillan B, Raynor DK, Woolf E. Evaluating a combined (frequency and percentage) risk expression to communicate information on medicine side effects to patients. Int J Pharm Practice 2013; 21: 226-232.
  36. Blalock SJ, Sage A, Bitonti M, Patel P, Dickinson R, Knapp P. Communicating information concerning potential medication harm and benefits: What gist do numbers convey? Pat Edu Couns 2016; 99: 1964-1970.
  37. Knapp P, Raynor DK, Berry DC. Comparison of two methods of presenting risk information to patients about the side effects of medicine. Qual Saf Health Care 2004; 13: 176-180.
  38. Knapp P, Gardner PH, Woolf E. Combined verbal and numerical expressions increase perceived risk of medicine side-effects: a randomized controlled trial of EMA recommendations. Health Expect 2015; 19: 264-274.

*The literature refers to the Dutch text