PIL of the Month – a Study of Best Practice in Patient Information Leaflets


  • Karen Korning Zethsen Aarhus School of Business, University of Aarhus
  • Inger Askehave Aalborg University




patient information leaflets, best practice, user-friendliness, patient-centeredness


Patient empowerment has become increasingly important within the health sector and an important patient information document like the Patient Information Leaflet (PIL) has been the subject of an ongoing discussion for more than a decade. The PIL has often been heavily criticized for its lack of userfriendliness in spite of legal (EU) requirements that the PIL be easy to read, understand, and act upon. In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) has introduced a new best-practice initiative called the PIL of the month, the aim of which is to further the improvement of the userfriendliness of PILs. This initiative focuses on positive aspects of PILs, however, the published quality criteria on which the selection builds hardly mention linguistic features at all. We have analyzed a corpus consisting of 10 PILs of the month in order to find out whether the PILs of the month constitute best-practice examples of userfriendliness from a linguistic point of view and if so how? In general we found many positive features and improvements on more traditional solutions, though we also still found many features which have a negative impact on userfriendliness. Only one leaflet could be said to constitute a real best-practice example, six leaflets were a mixture of positive and negative features, whereas three leaflets were very far from constituting best practice from a linguistic point of view.

Author Biographies

Karen Korning Zethsen, Aarhus School of Business, University of Aarhus

Karen Korning Zethsen, PhD, is professor in Translation Studies and Head of the Research Group for Translation and Interpreting at the Aarhus School of Business, University of Aarhus, Denmark. Her primary research interests include translation studies, expert-lay communication and lexical semantics. She has published numerous articles within her fields of interest in journals such as Target, the Translator, Meta, TTR, JoSTrans, Document Design, Text & Talk and The Journal of Pragmatics. Address for correspondence: Department of Language and Business Communication, Aarhus School of Business, University of Aarhus, Fuglesangs Allé 4, 8210 Aarhus V, Denmark. Email: [email protected]

Inger Askehave, Aalborg University

Inger Askehave, Ph.D., is professor in Professional Communication and Pro-Vice- Chancellor at Aalborg University, Denmark. Her primary research interests include expert–lay communication, PR and business communication, and organizational communication. She has published several articles on genre theory, language and discourse, translation, business communication, and expert–lay communication in journals such as Applied Linguistics, Text & Talk, Perspectives, Document Design, Discourse Studies and Discourse & Society. Address for correspondence: University of Aalborg, Fredrik Bajers Vej 5, 9220 Aalborg Ø, Denmark. Email: [email protected] dk


Aarva, P. and Tampere, M. P. (2006) Studying the striving and opposing forces in newspaper journalism: The actantial model of health promotion. Health Promotion International 21 (2): 160–168. doi:10.1093/heapro/dal010

Askehave, I. and Zethsen, K. K. (2000) The Patient Package Insert of the Future. Aarhus: The Aarhus School of Business.

Askehave, I. and Zethsen, K. K. (2002) Translating for laymen. Perspectives: Studies in Translatology 10 (1): 15–29.

Askehave, I. and Zethsen, K. K. (2003) Communication barriers in public discourse – the patient package insert. Document Design 4 (1): 22–41. doi:10.1075/dd.4.1.03ask

Askehave, I. and Zethsen, K. K. (2008) Mandatory genres: The case of European Public Assessment Report (EPAR) summaries. Text & Talk 28 (2): 167–191. doi:10.1515/ TEXT.2008.008

Askehave, I. and Zethsen, K. K. (2010) ‘Check it out’ – the construction of patient empowerment in health promotion leaflets. In M. F. R. Garrido, I. Fortanet and J. C. Plamer (eds) English for Academic and Professional Purposes, 107–122. Utrecht: Rodopi.

Askehave, I., Holmgren, L., Lassen, I. and Strunck, J. (2010) At styrke patienten i en New Public Management verden: En udredning af betydnings-potentialet i begrebet patient empowerment. In A. Horsboel, M. B. Sørensen and H. S. Wentzer (eds) Sundhedskommunikation i Sygehusvæsenet, 147–182. Aalborg: Aalborg University Press.

Clerehan, R. and Buchbinder, R. (2006) Toward a more valid account of functional text quality: The case of the patient information leaflet. Text & Talk 26 (1): 39–68. doi:10.1515/ TEXT.2006.003

Dickinson, D., Raynor, D. K. and Duman, M. (2001) Patient information leaflets for medicines: Using consumer testing to determine the most effective design. Patient Education and Counselling 43 (2): 147–159. doi:10.1016/S0738-3991(00)00156-7

Dickinson, D. K., Raynor, T., Kennedy, J. G., Bonaccorso, S. and Sturchio, J. L. (2003) What information do patients need about medicines? British Medical Journal 328 (7419): 861– 864.

Flower, L., Hayes, J. R. and Swarts, H. (1983) Revising functional documents: The Scenario Principle. In P. V. Anderson, R. J. Brockmann and C. R. Miller (eds) New Essays in Technical and Scientific Communication: Research, Theory, Practice, 41–58. Farmingdale, NY: Baywood.

Halliday, M. (1994) An Introduction to Functional Grammar (2nd ed). New York: Edward Arnold.

Hall, D. R. (2006) Medical leaflets, empowerment and disempowerment. In M. Gotti and F. Salager-Meyer (eds) Advances in Medical Discourse Analysis: Oral and Written Contexts, 271–288. Bern: Peter Lang.

Hirsh, D., Clerehan.R., Barber, M., Staples, M., Osborne, R. and Buchbinder, R. (2009) Patient assessment of medication information leaflets: A reader-focused strategy to validate an analytic linguistic framework. Patient Education and Counselling 77 (2): 248– 254. doi:10.1016/j.pec.2009.03.011

Horwitz, A., Reuther, L. and Andersen S. E. (2009) Patienters vurdering af medicinpakningernes indlægssedler. Ugeskrift for Læger 171 (8): 599–602.

Hvas, A. C. and Thesen, J. (2002) At styrke patientens egne kræfter og at modvirke undertrykkende kræfter: ‘Empowerment’ i et medicinsk perspektiv. Ugeskrift for Læger 164: 5361–5365.

Jensen, L. B. (2001) Den sproglige dåseåbner – om at formidle faglig viden forståeligt. Roskilde: Roskilde Universitets Forlag.

Johnson, A. (1999) Do parents value and use written health information? Neonatal, Paediatric and Child Health Nursing 2: 3–7.

Killingsworth, M. J. (1987) Guest editorial: Thingishness and objectivity in technical style. Journal of Technical Writing and Communication 17 (2): 105–113.

Kimble, J. (1994–1995) Answering the critics of plain language. The Scribes Journal of Legal Writing 5: 51–85.

Larsen, E. L. and Manderson, L. (2008) ‘A good spot’: Health promotion discourse, healthy cities and heterogeneity in contemporary Denmark. Health & Place 15 (2): 606–613. doi:10.1016/j.healthplace.2008.10.001

Løj, M., Holm, L., Hansen, J., Hesselbæk, B. and Hagel, A. (2004) Brugsanvisninger til medicin er svære at forstå. København: Lægemiddelstyrelsen.

McManus, J. (2009) The ideology of patient information leaflets – a diachronic study. Discourse & Communication 3 (1): 27–56.

Pander Maat, H. and Lentz, L. (2010) Improving the usability of patient information leaflets. Patient Education and Counselling 80 (1): 113–119. doi:10.1016/j.pec.2009.09.030

Roberts, L. (2006) First impressions: an information leaflet for patients attending a musculoskeletal outpatient department. Physiotherapy 92: 179–186. doi:10.1016/j. physio.2006.02.009

Sager, J. C., Dungworth, D. and McDonald, P. F. (1980) English Special Languages: Principles and Practice in Science and Technology. Wiesbaden: Oscar Brandstetter Verlag.

Sless, D. and Wiseman, R. (1997) Writing about Medicines for People – Usability Guidelines for Consumer Medicine Information. Canberra: Communication Research Institute of Australia.

Stuart, M. C. (2007) The Complete Guide to Medical Writing. London: Pharmaceutical Press.


Bekendtgørelse nr. 1210 af 07/12 2005 om mærkning m.m. af lægemidler.http://lms-lw. lovportaler.dk/ShowDoc.aspx?docId=bek20051210-full (accessed 7 October, 2010).

Guideline on the Readability of the Labelling and Package Leaflet of Medicinal Products for Human Use, Revision 1, 12 January 2009, The European Commission. http://ec.europa. eu/enterprise/pharmaceuticals/eudralex/vol-2/c/2009_01_12_readability_guideline_ final.pdf (accessed 15 January, 2010).

Product Information Template, version 7.3, 10/2009, EMEA http://www.ema.europa.eu/ htms/human/qrd/qrdtemplate.htm (accessed 15 January, 2010).

Directive 2001/83/EC of The European Parliament and of the Council of 6 November 2001 on the Community Code Relating to Medicinal Products for Human Use http://www. ema.europa.eu/pdfs/human/pmf/2001-83-EC.pdf (accessed 15 January, 2010).

Quality criteria for patient information leaflets http://www.mhra.gov.uk/ Howweregulate/Medicines/Labelspatientinformationleafletsandpackaging/ Patientinformationleaflet(PIL)ofthemonth/index.htm (accessed 13 November, 2009).

‘Always Read the Leaflet’: getting the best information with every medicine http://www.mhra.gov.uk/Howweregulate/Medicines/Labelspatientinformationleafletsandpackaging/ Patientinformationleaflet(PIL)ofthemonth/index.htm (accessed 13 November, 2009).

Corpus of 10 PILs of the Month: http://www.mhra.gov.uk/Howweregulate/Medicines/ Labelspatientinformationleafletsandpackaging/Patientinformationleaflet(PIL) ofthemonth/index.htm (accessed 13 November, 2009).



How to Cite

Zethsen, K. K., & Askehave, I. (2011). PIL of the Month – a Study of Best Practice in Patient Information Leaflets. Journal of Applied Linguistics and Professional Practice, 7(1), 97–120. https://doi.org/10.1558/japl.v7i1.97