The Way Forward in Package Insert User Tests from a CRO’s Perspective

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A significant increase in the amount of text in package inserts has been observed over the last years. This study investigated the consequences of this increase. Method: Five package inserts available on the German medicine market in 2002 and five developed model versions were investigated in a crossover procedure using the written readability test.


The more extensive the package inserts, the worse patients feel informed. Increasing the amount of text significantly decreases the ability to locate information, thus putting people off from reading the contents (P ≤ 0.021).


The results suggest that decreasing the amount of text is a key factor, whereby a maximum of 1,500 words per package insert should be the aim. Conclusion: The way forward in package insert user testing is to concentrate on patient requirements and package insert improvements. Appropriate solutions are required for the further development of guidelines, templates, and directives.

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  1. 1.

    European Parliament and the Council of the European Union. Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use. Off J Eur Communities. 2004:(L136):34–57.

  2. 2.

    European Commission. Guidance concerning consultations with target patient groups for the package leaflet. May 2006. Accessed December 10, 2008.

  3. 3.

    Sless D. Wiseman R. Writing About Medicines for People: Usability Guidelines for Consumer Medicine Information. Canberra: Department of Health and Family Services; 1997

  4. 4.

    Fuchs J. Hippius M. Inappropriate dosage instructions in package inserts. Patient Educ Counsel 2007;67:157–168.

  5. 5.

    US Food and Drug Administration. An introduction to the improved FDA prescription drug labeling. Accessed April 27, 2009.

  6. 6.

    Chin-Quee D. Wong E, Cuthbertson C. Evaluating information on oral contraceptive use: a randomized controlled trial to access missed pill instructions. Hum Reprod. 2006;21:3137–3145.

  7. 7.

    Hubal R, Day R. Understanding the frequency and Severity of Side Effects: Linguistic, Numeric and Visual Representations. American Association for Artificial Intelligence; 2006.

  8. 8.

    Svarstad B, Mount J. Evaluation of written prescription information provided in community pharmacies, 2001. Final report to the US Department of Health and Human Services and the Food and Drug Administration, Accessed April 27, 2009.

  9. 9.

    Bernardini C, Ambrogi V, Fardella G, Perioli L, Grandolini G. How to improve the readability of the patient package leaflet: a survey on the use of colour, print size and layout, Pharmacol Res. 2001;5:437–443.

  10. 10.

    PAINT-Consult, Jena, Germany, 2008.

  11. 11.

    Fuchs J, Banow S, Görbert N, Hippius M. The importance of package insert information in the European Union. PharmInd. 2007;69(2):165–172.

  12. 12.

    Fuchs J. Hippius M, Schaefer M. Analysts of German package inserts. Int J Clin Pharmacol Ther. 2006;44(1):8–13.

  13. 13.

    Dickinson D, Raynor DK, Duman M. Patient information leaflets for medicines: using consumer testing to determine the most effective design. Patient Educ Counsel. 2001;43:147–159.

  14. 14.

    EMEA. QRD template centralised procedure version 7.2 and MR/DC/referral procedures 1.2. Accessed November 25, 2008.

  15. 15.

    US Food and Drug Administration. FDA News. FDA announces new prescription drug information formal to improve patient safety. January 18, 2006. Accessed December 10, 2008.

  16. 16.

    Commission of the European Communities. Proposal for a directive of the European Parliament and of the Council amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use. Accessed December 22, 2008.

  17. 17.

    Fuchs J, Schweim H. Packungsbeilagen—Text muss kürzer werden. Pharmazeutische Zeitung. 2006;151:3864–3869.

  18. 18.

    European Commission. A guideline on the readability of the label and package leaflet of medicinal products for human use. Brussels, 29 September 1998. Accessed December 10, 2008.

  19. 19.

    European Commission. Guideline on the readability of the labelling and package leaflet of medicinal products for human use. Revision 1, January 12, 2009. Accessed January 16, 2009.

  20. 20.

    EMEA. Regulatory and procedural guidance: product information. file:///C:/Dokumente%20und%20Einstellungen/fuchs/Desktop/productinformation%20documents%20EMEA.htm. Accessed December 10, 2008.

  21. 21.

    Sless D, PIL testing: misapplied and out of context. Regul Rapporteur J. 2007;(11): 14–15.

  22. 22.

    Döbert M. Hubertus P. Ihr Kreuz ist die Schrift. Munster: Bundesverband Alphabetisierung: 2000.

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Correspondence to Dr. Joerg Fuchs.

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Fuchs, J. The Way Forward in Package Insert User Tests from a CRO’s Perspective. Ther Innov Regul Sci 44, 119–129 (2010) doi:10.1177/009286151004400203

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Key Words

  • User test
  • Readability test
  • Package insert
  • Amount of text
  • Guidelines