PILs that give you a headache? The lay-friendliness of non-pharmacy restricted, over-the-counter information leaflets


  • Karen Korning Zethsen School of Communication and Culture, Aarhus University, Denmark




Lay-friendliness, non-pharmacy restricted, over-the-counter medication, patient information leaflet, readability


Background: Over-the-counter (OTC) medication, and in particular non-pharmacy restricted OTC medicines, sold in supermarkets or online, is subject to the same EU legislation as prescription medication. However, it seems that due care is often not taken to ensure maximum patient comprehension even though the Patient Information Leaflet (PIL) is potentially more important due to lack of access to the advice of pharmacy staff. Aim: The aim of this article is to explore the legislative background and practice of the PILs of non-pharmacy restricted OTC medicines in a European context. Methods: It provides a qualitative textual analysis of Danish PILs for the potentially most dangerous products with a view to finding out to which extent the PILs comply with current legislation and guidelines. Findings: The textual analysis shows that the PILs are far too complex to stand alone as a source of information. Discussion: The article discusses the nature of non-pharmacy restricted OTC medicines, the potential consequences of a lack of understandable patient information, and whether it is in the interest of consumers that these products are available outside the pharmacy. Conclusion: It is recommended that the potentially most harmful non-pharmacy restricted OTC medicines, such as analgesics, are restricted to pharmacies.


Askehave, I., & Zethsen, K. K. (2010). PIL of the month: A study of best practice in EU patient information leaflets. Journal of Applied Linguistics and Professional Practice, 7(1), 97-120. https://doi.org/10.1558/japl.v7i1.97

Askehave, I., & Zethsen, K. K. (2014). A comparative analysis of the lay-friendliness of Danish EU patient information leaflets from 2000 to 2012. Communication & Medicine - An Interdisciplinary Journal of Healthcare, Ethics and Society, 11(3), 209-222. https://doi.org/10.1558/cam.v11i3.20700

Askehave, I., & Zethsen, K. K. (2000). The Patient Package Insert of the Future: Report for the Danish Ministry of Health. Aarhus School of Business.

Bennin, F., & Rother, H-A. (2015). “But it’s just paracetamol”: Caregivers’ ability to administer over-the-counter painkillers to children with the information provided. Patient Education and Counseling, 98(3), 331-337. https://doi.org/10.1016/j.pec.2014.11.025

Calamusa, A., Di Marzio, A., Cristofani, R., Arrighetti, P., Santaniello, V., Alfani, S., & Carducci, A. (2012). Factors that influence Italian consumers’ understanding of over-the-counter medicines and risk perception. Patient Education and Counseling, 87(3), 395-401. https://doi.org/10.1016/j.pec.2011.10.003

Cavaco A. & Pires C. (2012). Improving package leaflet information: potential users and physicians opinions. Research in Social and Administrative Pharmacy, 8(6), e50-1. https://doi.org/10.1016/j.sapharm.2012.08.117

European Parliament and Council. (2001). 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. 28263005en 67..100 (europa.eu)

Foley, M., Kelly, P., Deluca, P., & Kimergård, A. (2018). Advertising of Over-the-Counter Codeine-Containing Medicines in the EU: Differences in the Regulation of Advertising Between Member States. Pharmaceutical Medicine, 32(5), 327–333. https://doi.org/10.1007/s40290-018-0245-7

Fuchs, J., & Hippius M. (2007). Inappropriate dosage instructions in package inserts. Patient Education and Counseling, 67(1-2), 157-68. https://doi.org/10.1016/j.pec.2007.03.009

Gedeborg, R., Svennblad, B., Holm, L., Sjögren H., Bardage, C., Personne, M., Sjöberg, G., Feltelius, N., & Zethelius, B. (2017). Increased availability of paracetamol in Sweden and incidence of paracetamol poisoning: using laboratory data to increase validity of a population‐based registry study. Pharmacoepidemiology and Drug Safety, 26(5), 518–527. https://doi.org/10.1002/pds.4166

Hedenrud, T., & Håkonsen, H. (2016). Purchase habits, use of paracetamol, and information sources on a reregulated Swedish pharmacy market: A population-based study. Health Policy, 121(1), 35–41. https://doi.org/10.1016/j.healthpol.2016.11.009

Hornsby, L.B., Whitley, H.P., Hester, E.K., Thompson, M., & Donaldson, A. (2010). Survey of patient knowledge related to acetaminophen recognition, dosing, and toxicity. Journal of the American Pharmacists Association, 50(4), 485-489. https://doi.org/10.1331/JAPhA.2010.08175

Horwitz, A., Reuther, L., & Andersen, S. E. (2009). Patienters vurdering af medicinpakningernes indlægssedler [Patient evaluation of PILs]. Ugeskrift for Læger, 171(8), 599-602. https://ugeskriftet.dk/videnskab/patienters-vurdering-af-medicinpakningernes-indlaegssedler

Ip, E., Tang, T., Cheng, V., Yu, J., & Cheongsiatmoy, D. (2015). Impact of Educational Levels and Health Literacy on Community Acetaminophen Knowledge. Journal of Pharmacy Practice, 28(6), 499–503. https://doi.org/10.1177/0897190014544819

Lægemiddelstyrelsen (The Danish Medicines Agency) (2014). Guideline on advertising etc. of Medicinal Products. https://laegemiddelstyrelsen.dk/en/licensing/supervision-and-inspection/guidelines-on-advertising/

Lægemiddelstyrelsen (The Danish Medicines Agency). (2019a). Salg af medicin uden for apotek [Sale of medication outside the pharmacy]. https://laegemiddelstyrelsen.dk/da/apoteker/salg-uden-for-apotek/

Lægemiddelstyrelsen (The Danish Medicines Agency). (2019b). Håndkøbsmedicin [non-prescription drugs]. https://laegemiddelstyrelsen.dk/da/apoteker/haandkoebsmedicin

Lægemiddelstyrelsen (The Danish Medicines Agency). (2020a). Indlægsseddel: Information til brugeren. HUSK Psyllium-frøskaller, hårde kapsler [HUSK Psyllium, hard capsules]. http://xnet.dkma.dk/indlaegsseddel/PdfFileServlet?formulationid=17862&lang=da

Lægemiddelstyrelsen (The Danish Medicines Agency). (2020b). Medicin til mennesker [medication for humans]. http://xnet.dkma.dk/indlaegsseddel/leaflets/leaflets.faces

Lokker, N., Sanders, L., Perrin, E.M., Kumar, D., Finkle, J., Franco, V., Choi, L., Johnston, P., & Rothman, R. (2009). Parental misinterpretations of over-the-counter pediatric cough and cold medication labels. Pediatrics, 123(6), 1464-71. https://doi.org/10.1542/peds.2008-0854

Madsen, M.H., Højgaard, B., & Albæk, J. (2009). Health literacy - Begrebet, konsekvenser og mulige interventioner [Health literacy – The concept, consequences and possible interventions]. Sundhedsstyrelsen (The Danish Health Authority) https://www.sst.dk/da/Udgivelser/2009/Health-Literacy---Begrebet-konsekvenser-og-mulige-interventioner

March Cerdá J. C., Prieto Rodríguez M. A., Ruiz Azarola A., Lorda P. S., Barrio Cantalejo I., & Danet A. (2010). Mejora de la información sanitaria contenida en los prospectos de los medicamentos: expectativas de pacientes y de profesionales sanitarios [Quality improvement of health information included in drug information leaflets. Patient and health professional expectations]. Aten Primaria, 42(1), 22-7. https://doi.org/10.1016/j.aprim.2009.04.006

Morthorst, B. R., Erlangsen, A., Nordentoft, M., Hawton, K., Groth Hoegberg, L. K., & Dalhoff, K.P. (2018). Availability of Paracetamol Sold Over the Counter in Europe: A Descriptive Cross-Sectional International Survey of Pack Size Restriction. Basic & Clinical Pharmacology & Toxicology, 122, 643–649. https://doi.org/10.1111/bcpt.12959

Morthorst, B. R., Soegaard, B., Nordentoft, M., & Erlangsen, A. (2016). Incidence rates of deliberate self-harm in Denmark 1994-2011. Crisis, 37(4), 256-264. https://doi.org/10.1027/0227-5910/a000391

Morthorst, E., Erlangsen, A., Chaine, M., Eriksson, F., Hawton, K., Dalhoff, K., & Nordentoft, M. (2020). Restriction of non-opioid analgesics sold over-the-counter in Denmark: A national study of impact on poisonings. Journal of Affective Disorders, 268, 61–68. https://doi.org/10.1016/j.jad.2020.02.043

Nielsen, S., MacDonald, T., & Johnson, J. L. (2018). Identifying and treating codeine dependence: a systematic review. The Medical Journal of Australia, 208(10), 451-61. https://doi.org/10.5694/mja17.00749

Nisbeth Jensen, M. (2013). Translators of patient information leaflets: Translation experts or expert translators?: A mixed methods study of lay-friendliness. [PhD thesis. Aarhus University, Aarhus School of Business and Social Sciences]. Pure AU. https://pure.au.dk/portal/files/55635800/Matilde_Nisbeth_Jensen_PhD_AU_final.pdf

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

Pearce, C. (2020, August 5) UK medicines regulator ‘will consider’ ban on over-the-counter codeine. PULSE. https://www.pulsetoday.co.uk/news/clinical-areas/prescribing/uk-medicines-regulator-will-consider-ban-on-over-the-counter-codeine/

Pires, C., Vigário, M., & Cavaco, A. (2015). Readability of medicinal package leaflets: a systematic review. Revista de Saúde Pública, 49, 4–13. https://doi.org/10.1590/s0034-8910.2015049005559

Raynor, D.T. (2007). The importance of medicines information for patients. Prescriber, 18(2), 60-62. https://doi.org/10.1002/psb.15

Simon, H., & Weinkle, D. (1997). Over-the-counter medications: do parents give what they intend to give? Archives of Pediatrics & Adolescent Medicine, 151(7), 654-6. https://doi.org/10.1001/archpedi.1997.02170440016003

Tong, V., Raynor, D., & Aslani, P. (2014). Design and comprehensibility of over-the-counter product labels and leaflets: a narrative review. International Journal of Clinical Pharmacy, 36(5), 865–872. https://doi.org/10.1007/s11096-014-9975-0

Webster, R. K., Weinman, J., & Rubin, G. J. (2017). People’s understanding of verbal risk descriptors in patient information leaflets; A cross-sectional national survey of 18-to 65-year-olds in England. Drug Safety, 40(8), 743-54. https://doi.org/10.1007/s40264-017-0542-1

Zethsen, K. K. (2004). Latin-based terms: True or false friends? Target, 16(1), 125-142. https://doi.org/10.1075/target.16.1.07zet

Zhao, J., Chen, Y., Han, T., & Westland, S. (2020). Designing Effective Warnings about Addiction on the Patient Information Leaflet of Over-the-Counter Codeine Sold in England to University Students. International Journal of Environmental Research and Public Health, 17(15), 5490. https://doi.org/10.3390/ijerph17155490




How to Cite

Zethsen, K. K. (2022). PILs that give you a headache? The lay-friendliness of non-pharmacy restricted, over-the-counter information leaflets. Qualitative Health Communication, 1(1), 44–60. https://doi.org/10.7146/qhc.v1i1.124084