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Methods Inf Med 2015; 54(04): 379-381
DOI: 10.3414/ME15-04-0003
DOI: 10.3414/ME15-04-0003
Letter to the Editor
Using an Automatic Tool to Identify Potential Readability Issues in a Large Sample of Medicinal Package Inserts[*]
Further Information
Publication History
received:
06 March 2015
accepted:
29 May 2015
Publication Date:
22 January 2018 (online)
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* Supplementary online material published on our website www.methods-online.com
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References
- 1 Pires C, Vigário M, Cavaco A. Package leaflets of the most consumed medicines in Portugal: safety and regulatory compliance issues. A descriptive study. Sao Paulo Med J 2015; 133 (02) 91-100.
- 2 European Medicine Agency. Quality Review of Documents Human Product Information Annotated Template version 9. 2013. [consulted on 14/12/2014]. Available at http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2009/12/WC500029823.pdf.
- 3 Stahl C, Brauer S, Zeitler HP. et al. How important is a package insert for drug therapy in ambulatory care?. J Public Health 2006; 14: 174-177.
- 4 Wolf A, Fuchs J, Schweim HG. QRD Template Texts Intended for Package Inserts Development from the first QRD template up to the new draft of July 2012. Pharm Ind 2012; 74: 1540-1549.
- 5 Food and Drug Administration. Guidance for Industry. Labelling for human Prescription Drug and Biological Products - Implementing the PLR content and Format Requirements. 2013. [consulted on 05/01/2015]. Available at http://www.fda.gov/downloads/Drugs/GuidanceCompliance RegulatoryInformation/Guidances/ucm075082.pdf.
- 6 European Medicine Agency. Guideline on the readability of the labelling and package leaflet of medicinal products for human use. 2009. [consulted on 05/01/2015]. Available at http://ec.europa.eu/health/files/eudralex/vol-2/c/2009_01_12_readability_guideline_final_en.pdf.
- 7 Australian Commission on Safety and Quality in Health Care. National terminology, abbreviations and symbols to be used in the prescribing and administering of medicines in Australia hospitals. 2006. [consulted on 17/12/2014]. Available at http://www.countryhealthsa.sa.gov.au/LinkClick.aspx?fileticket=MrTKXCi7fEY=.
- 8 Fuchs J. The way forward in package insert user tests from a CRO’s perspective. Drug Inf J 2010; 44: 119-129.
- 9 Institute for Safe Medication Practices. List of Error-Prone Abbreviations, Symbols, and Dose Designations. 2013. [consulted on 17/01/2015]. Available at http://www.ismp.org/tools/errorproneabbreviations.pdf.
- 10 Hirsh D, Clerehan R, Staples M, Osborne RH, Buchbinder R. Patient assessment of medication information leaflets and validation of the Evaluative Linguistic Framework (ELF). Patient Educ Couns 2009; 77 (02) 248-254.
- 11 Pander Maat H, Lentz L. Improving the usability of patient information leaflets. Patient Educ Couns 2010; 80 (01) 113-119.
- 12 Barrio-Cantalejo I, Simón-Lorda P, Jiménez MM, Ruiz AM. Consensus on the legibility criteria of health education leaflets. An Sist Sanit Navar 2011; 34 (02) 153-165.
- 13 Pires CM, Cavaco AM. Exploring the perspectives of potential consumers and healthcare professionals on the readability of a package insert: a case study of an over-the-counter medicine. Eur J Clin Pharmacol 2014; 70 (05) 583-588.
- 14 Shultz J, Strosher L, Nathoo SN, Manley J. Avoiding Potential Medication Errors Associated with Non-intuitive Medication Abbreviations. Can J Hosp Pharm 2011; 64 (04) 246-251.
- 15 Mbuagbaw L, Ndongmanji E. Patients’ understanding of prescription instructions in a semi-urban setting in Cameroon. Patient Educ Couns 2012; 88 (01) 147-151.
- 16 Brunetti L, Santell JP, Hicks RW. The impact of abbreviations on patient safety. Jt Comm J Qual Patient Saf 2007; 33: 576-583.
- 17 European Medicine Agency. Tables of non-standard abbreviations. 2012. [consulted on 17/12/2014]. Available at http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500004439.pdf.
- 18 Ministry of Health. Prontuário Terapêutico -10 [Portuguese Prescribing Guide-10]. Lisboa: Infarmed. 2011. [consulted on 10/01/2015]. Available at http://www.infarmed.pt/portal/page/portal/INFARMED/PUBLICACOES/PRONTUARIO/pt10_web.pdf.
- 19 European Commission. Directive 2001/83/EC: Community Code relating to Medicinal products for human use. 2001. [consulted on 17/12/2014]. Available at http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2001:311:0067:0128:en:PDF.
- 20 Martins F, Vigario M, Frota S. PreText - Text Preprocessing. Lisbon: Phonetic Laboratory, CLUL/FLUL [consulted on 03/05/2015]. Available at. http://labfon.letras.ulisboa.pt/FreP/tools.html.
- 21 Rêgo HH, Braunstein LA, D’Agostino G. et al. When a text is translated does the complexity of its vocabulary change? Translations and target readerships. PLoS One 2014; 9 (10) e110213.
- 22 Cavaco A, Pires C, Vigário M. Medicine package inserts abbreviations and acronyms in Portuguese: exploring how difficult they are for educated people (Poster, Proceedings from 2013 ICCH. In: Medical Encounter, A Publication of the American Academy on Communication in Healthcare 2014; 27: 2.