Abstract
Introduction
Patients’ perceptions of side effect risks are important influences on their medicine-taking behaviour. A previous survey of Patient Information Leaflets (PILs) showed considerable variation in the terms used to communicate risks.
Objective
Our objective was to assess the methods used to describe risk of side effects in recent PILs and to compare them with PILs sampled in 2006.
Method
We sampled PILs for the 50 most frequently dispensed medicines in England and Wales in 2012 and PILs for the 50 most recently licensed medicines. We assessed the use of risk frequency terms or numbers, and the use of the risk format recommended by the European Medicines Agency (EMA).
Results
A majority (76 %) of PILs for the most frequently dispensed medicines included a risk frequency descriptor, with 66 % using the recommended format. No difference was seen between PILs for branded and generic medicines. All 50 PILs for the most recently licensed medicines used the EU recommended risk format. PILs from the 2012 sample were much more likely than those from the 2006 sample to include risk descriptors and to use a consistent approach.
Conclusion
The increased use and consistency of risk descriptors in PILs should benefit patients, particularly those using multiple medicines produced by different market authorisation holders. A need remains for further research evaluating the risk format recommended by the EMA. There is also a need for research evaluating spoken information and other sources of printed risk information about medicines that is available to patients.
This is a preview of subscription content, log in via an institution to check access.
References
European Commission. Council Directive. The labelling of medicinal products for human use and on package leaflets. Brussels: European Commission; 1992.
European Commission. Guideline on the readability of the labelling and package leaflet of medicinal products for human use. 2009. Available at: http://ec.europa.eu/health/files/eudralex/vol-2/c/2009_01_12_readability_guideline_final_en.pdf. Accessed Jan 2015.
Krska J, Morecroft CW. Patients’ use of information about medicine side effects in relation to experiences of suspected adverse drug reactions: a cross-sectional survey in medical in-patients. Drug Safety. 2013;36:673–80.
Raynor DK, Blenkinsopp A, Knapp P, Grime J, Nicolson D J, Pollock K, Dorer G, Gilbody SM, Dickinson D, Maule AJ, Spoor PA. A systematic review of quantitative and qualitative research on the role and effectiveness of written information available to patients about individual medicines. Health Technol Assess. 2007;11(5):1–160.
Fried TR, Tinetti ME, Towle V, O’Leary JR, Iannone L. Effects of benefits and harms on older persons’ willingness to take medication for primary cardiovascular prevention. Arch Intern Med. 2011;171:923–8.
Commission European. A guideline on the readability of the label and package leaflet of medicinal products for human use. Brussels: European Commission; 1999.
Knapp P, Gardner PG, Woolf E. Combined verbal and numerical expressions increase perceived risk of medicine side effects: a randomized controlled trial of EMA recommendations. Health Expect. 2015. doi:10.1111/hex.12344.
Knapp P, Raynor DK, Berry DC. Comparison of two methods of presenting risk information to patients about the side effects of medicines. Qual Saf Health Care. 2004;13:176–80.
Knapp P, Gardner PH, Carrigan N, Raynor DK, Woolf E. Perceived risk of medicine side effects in users of a patient information website: a study of the use of verbal descriptors, percentages and natural frequencies. Br J Health Psychol. 2009;14:579–94.
Carrigan N, Raynor DK, Knapp P. Adequacy of patient information on adverse effects. Drug Saf. 2008;31:305–12.
Medicines and Healthcare products Regulatory Agency. Always read the leaflet: getting the best information with every medicine. http://www.mhra.gov.uk/home/groups/pl-a/documents/publication/con2018041.pdf. Accessed 8 June 2015.
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. Pharm Regul Aff. 2012;1:102.
Haw C, Stubbs J. Patient information leaflets for antidepressants: are patients getting the information they need? J Affect Disord. 2011;128:165–70.
Author information
Authors and Affiliations
Corresponding author
Ethics declarations
Research ethics
The manuscript does not contain clinical studies or patient data, and so Research Ethics committee approval was not required.
Declarations of interest
Katherine Harris has no conflicts of interest that are directly relevant to the content of the study. Rebecca Dickinson has no conflicts of interest that are directly relevant to the content of the study. David K. Raynor is co-founder and academic advisor to Luto Research, which develops, refines and tests health information materials. Jan MacDonald has no conflicts of interest that are directly relevant to the content of the study. Peter Knapp has no conflicts of interest that are directly relevant to the content of the study.
Funding
Katherine Harris’ work on this study was supported by an Undergraduate Summer Research Scholarship funded by the Hull York Medical School, UK. Rebecca Dickinson’s work on this study was supported by a doctoral studentship funded jointly by the UK Medicines and Healthcare products Regulatory Agency and the School of Healthcare, University of Leeds, UK.
Rights and permissions
About this article
Cite this article
Harris, K., Dickinson, R., Raynor, D.K. et al. Changes in Side Effect Risk Communication in Patient Information Leaflets over the Past Decade: Results of a Survey. Drug Saf 38, 721–727 (2015). https://doi.org/10.1007/s40264-015-0307-7
Published:
Issue Date:
DOI: https://doi.org/10.1007/s40264-015-0307-7