Package leaflets  
               
 
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Compiled by:
Karel van der Waarde
December 2023
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Colofon & notes
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Bibliography: European Package Leaflets

[November 13, 2023: This list is ‘work in progress’ and unlikely to be ever complete.]

At the moment, it contains references to 250 publications about the mandatory European package leaflets.

Each entry is annotated and contains a DOI or website link.

Please inform waarde@glo.be if there are any omissions or mistakes.

2023

Berg LN van den, Chavannes NH, Aardoom JJ. ‘Using animated videos to promote the accessibility and understandability of package leaflets: retrospective observational study evaluating the first year of implementation’. Journal of Medical Internet Research. 25: e40914. [DOI]. The Netherlands, 4926 questionnaires: web-based library with animated videos increase the understanding and accessibility of medication information.

Bergmo TS, Sandsdalen V, Manskow US, Småbrekke L, Waaseth M. ‘Internet Use for Obtaining Medicine Information: Cross-sectional Survey.’. JMIR Form Res. 7, e40466. [DOI]. Norwegian survey (n=303): 42% used package leaflet (physician 63%, pharmacy: 47%).

Davis C, Wagner AK, Salcher-Konrad M, Scowcroft H, Mintzes B, Pokorny AMJ, Lew J, Naci H. ‘Communication of anticancer drug benefits and related uncertainties to patients and clinicians: document analysis of regulated information on prescription drugs in Europe’. BMJ. 380, e073711. [DOI]. A UK analysis of 29 package leaflets for anticancer drugs (2017-2019): Drug benefits and uncertainties were not included.

Espírito-Santo M, Nascimento T, Pinto E, Dulce Estêvão M. ‘Patient information leaflets of drugs used in cardiometabolic disorders: suitability for use by older persons.’. Portuguese Journal of Public Health [DOI]. An analysis of 69 Portuguese package leaflets: information specifically for older persons is relatively scarce.

Jarke H, Bourke S, Joyce R, Scalabrini S, Thursby K, Zalcik H, Jakob L. ‘Introducing patient-centric electronic medicine leaflets in the European Union’. Open Research Europe. 3:84. [DOI]. Benefits and risks of digital leaflets, proposal for research agenda.

Johansson M. ‘Apotekspersonalens förhållningssätt vid olika läkemedelsinformationskällor: en mystery shoppingstudie i egenvården om allergimedicin under graviditet’. [Pharmacy staff’s attitudes towards different sources of medication information: a mystery shopping study regarding allergy medication during pregnancy] [website]. Sweden: pharmacy staff follows the information in package leaflet for loratadine/cetirizine to a greater extent than 1177 when they give advice to pregnant women regarding allergy medication.

Böhm Nielsen AS, Mardov-Egvang P, Dave SK. ‘e-Labeling and digital transformation in healthcare’. Regulatory Focus. [Website]. Overview of e-labelling across globe. For centrally authorized medicines through the EMA, a follow-up pilot program on e-labeling is in progress, and the results will form the basis of a future e-label roadmap.

Otón T, Carmona L, Andreu JL. ‘What do patients on methotrexate need and expect at the clinic? An online patient survey’. Rheumatology International. (43), 735-741. [DOI]. Spain: online (n=283): methotrexate information. 80% read package leaflet, only slightly more than half of them considered it worthwhile.

Skogman-Lindqvist C, Lapatto-Reiniluoto O, Sirvïo M, Sivén M. ‘Benefits and challenges of electronic package leaflet (ePL) - review of ePL pilots in hospital settings in Europe’. European Journal of Pharmaceutical Sciences. 191. [DOI]. Commentary on ongoing ePL pilots in European hospitals.

Waarde K van der. ‘Information for patients: should we reconsider our assumptions?’. Infodesign. 20(2), 1-14. [DOI]. A shift towards a ‘digital design strategy based on healthcare outcomes’ is required.

2022

Bamberger M, De Loof H, Marstboom C, Oury S, Bonanni P, Launay O, Kojouharova M, Van Damme P. ‘Replacing vaccine paper package inserts: a multi‑country questionnaire study on the acceptability of an electronic replacement in different target groups.’. BMC Public Health. 22, 156 [DOI]. Online questionnaire: 2518 responses. Digital information is acceptable for 55-82% in four countries

Bechini A, Chiesi F, Giammarco B, Gori E, Di Tommaso M, Strambi N, Alti E, Picciolli P, Mereu G, Mori MG, Vitali Rosati G, Van Damme P, Bamberger M, Bonanni P, Boccalini S. ‘Electronic Package Leaflets for Vaccines: What Are People’s Perceptions in Italy?’. Vaccines. 10(7), 1075. [DOI]. Online questionnaire: 321 responses. Pregnant women, young partents, elderly: accept digital information

Bergman E, Sherwood K, Forslund M, Arlett P, Westman G. ‘A natural language processing approach towards harmonisation of European medicinal product information.’. PLoS ONE. 17(10), e0275386. [DOI]. Linguistic analysis of English product information of 1258 medicines.

CIOMS Working Group report. ‘Patient involvement in the development, regulation and safe use of medicines.’. Geneva, Switzerland: Council for International Organizations of Medical Sciences (CIOMS). [DOI]. Systematically involving patients throughout a medicine’s life. Chapter 6 is about labelling.

Danevska M, Pechijareva Sadikarijo I, Sekovska J, Naumovska Z. ‘Knowledge and attitudes of patients for using antibiotics.’. Macedonian pharmaceutical bulletin. 68 (Suppl 1), 491-492. [DOI]. 300 Macedonian partipants: 60,4% always reads package leaflet, 30,3% sometimes, and 9,3% never.

Kondova G. ‘Electronic Product Information (ePI) for Human Medicines: A Blockchain Solution’. Healthcare and Medical Devices. 51, 1–4. [DOI]. A blockchain-based ePI solution based on a data flow analysis.

Lambot N, Ginste M Vande. ‘Electronic leaflet pilot in Belgium and Luxembourg hospitals’. Regulatory Rapporteur. 19(4), 3-5. [Website]. Most of the respondent hospital pharmacists would agree to the removal of the paper leaflet from all hospital-only medicines.

Noble AJ, Haddad S, Coleman N, Marson AG. ‘Worth the paper they are printed on? Findings from an independent evaluation of the understandability of patient information leaflets for antiseizure medications.’. Epilepsia. (63)8, 2130-2143. [DOI]. Three studies: readability formulae, 35 online questionnaires, 262 UK university students.

Olchowska-Kotala A, Uchmanowicz I, Szczepanowski R. ‘Verbal descriptors of the frequency of side effects: implementation of EMA recommendations in patient information leaflets in Poland.’. International Journal for Quality in Health Care. 34(1), 1–7. [DOI]. Frequency descriptors in Poland: Not consistent.

Sinnemaa O. ‘Läkemedelsaktörernas perspektiv på den elektroniska bipacksedeln’. [Medicine operators’ perspective on the electronic package leaflet.] Masters thesis, University of Helsinki, Faculty of pharmacy. [website]. Package leaflets are outdated. 55 Finnish experts: Mapping perspectives for digital leaflets.

Sirkas K, Juppo A, Miettinen M, Siven M. ‘Could paper package leaflet be left out from hospital products?’. Exploratory Research in Clinical and Social Pharmacy. 7, 100176. [DOI]. Nine interviews.

Zethsen KK. ‘PILs that give you a headache? The lay-friendliness of non-pharmacy restricted, over-the-counter information leaflets.’. Qualitative Health Communication. 1(1). [DOI]. Analysis of 7 Danish OTC package leaflets.

2021

Bosma W, Janssen D, Pander Maat H. ‘Kijksluiters: kijken naar gesprekken tussen apotheker en patiënt.’. Tijdschrift voor Taalbeheersing. 43(2), 231-258. [DOI] In Dutch: an audiovisual medication instruction; observation of 16 viewers.

Brennan OC, Moore JE, Nutt TW, Moore PJ, Millar BC. ‘Improving meningococcal MenACWY and 4CMenB/meningococcal group B vaccine-related health literacy in patients: Importance of readability of pharmaceutical Patient Leaflets.’. Journal of Clinical Pharmacy and Therapeutics. 46, 1109-1116. [DOI]. 10 readability formulae used to compare 31 texts about meningitis vaccins.

Moore JE, Millar BC. ‘Improving COVID-19 vaccine-related health literacy and vaccine uptake in patients: Comparison on the readability of patient information leaflets of approved COVID-19 vaccines.’. J Clin Pharm Ther. 46(6), 1498-1500. [DOI]. 10 readability formulae used to compare 5 texts about COVID-19 vaccins.

Scaletta V. ‘Patient information leaflets: English vs Italian translation.’. [Website]. An overview of English vs Italian PILs and their translations: issues and implications.

2020

Blalock J, Dickinson R, Knapp P. ‘Risk Evaluation and Communication.’. pp 1010-1029 in: BL Strom, SE Kimmel and S Hennessy (Eds). Pharmacoepidemiology, Sixth Edition. Wiley-Blackwell. [DOI]. Risk and frequency indicators in package leaflets.

Bolislis WRR, Mortazavi C, Riccioni R, Schaeffer P-E, Kühler TC. ‘From Print to Screen: Regulatory Considerations to Adopting Innovative Approaches for Patient Information and Safety.’. Therapeutic Innovation & Regulatory Science. 54, 831–838. [DOI]. Considering the regulations and options for digital medicines information.

Fuchs J. ‘Design Science with a Focus on User-Centred Evaluation of Written Information.’. pp 333-384 in: Priya Bahri (ed.) Communicating about Risks and Safe Use of Medicines. Singapore: Adis. [DOI]. A design based approach to information: thorough review; emphasis on evaluation methods.

Gormley, M. ‘Assessing If Patients Would Benefit From Electronic Patient Information Leaflets (ePils).’. Level 3. 15(2), Article 13. [DOI]. A survey of 565 people: reading depends on age, medication type, OTC/POM and frequency. Comparing PIL and ePIL. Expert interviews.

Roberts K, Thakkar R, Autor D, Bisordi F, Fitton H, Garner C, Garvin M, Honig P, Hukkelhoven M, Kowalski R, MilliganS, O’Dowd L, Olmstead S, Reilly E, Robertson AS, Rohrer M, Stewart J, Taisey M, Van Baelen K, Wegner M. ‘Creating E-Labeling Platforms: An Industry Vision.’. Clinical Pharmacology & Therapeutics. 108(4), 716-718. [DOI]. Expectations of 13 pharmaceutical industries.

Ukkonen A. ‘Medicine users’ views on reading the package leaflet and the potential for an electronic package leaflet.’. [MA thesis. University of Helsinki, Department of Pharmacy. In Finnish.] [DOI]. 110 interviews in Finland: Medicine users feel positively about the idea of an electronic leaflet.

Zhao J, Chen Y, Han T, Westland, S. ‘Designing Effective Warnings about Addiction on the Patient Information Leaflet of Over-the-Counter Codeine Sold in England to University Students.’. Int. J. Environ. Res. Public Health. 17, 5490. [DOI]. Warnings against misuse of OTC codeine by UK students: eye tracking of 30 students, analysis of 46 inserts.

2019

Azari R, Halimi SA. ‘Translating Vague Language in Patient Information Leaflets.’. Conference: 2nd Swiss Conference on Barrier-free Communication (BFC 2018). [Website]. Translating ‘vague language’ in English and Persian, based on 5 package leaflets.

Bolislis WRR, Mortazavi C, Riccioni R, Schaeffer P-E, Kühler TC. ‘From Print to Screen: Regulatory Considerations to Adopting Innovative Approaches for Patient Information and Safety.’. Therapeutic Innovation & Regulatory Science. 54, 831–838. [DOI]. Transition to dynamic e-PIL.

Drogou F, Netboute A, Giai J, Dode X, Darmon D. Kassai B, Letrilliart L. ‘Off-label drug prescriptions in French general practice: a cross-sectional study.’. BMJ Open. 9, e026076. [DOI]. France: 18,5% of 4932 prescriptions is off-label (off-label needs to be defined).

Freeman ALJ. ‘How to communicate evidence to patients.’. Drugs and therapeutics bulletin. 57(8), 119-124.[DOI]. Risk frequency descriptors.

Lampert A, Haefeli WE, Seidling HM. ‘Informationslücken in Packungsbeilagen: fehlende Hinweise zum richtigen Umgang mit Transdermalen Therapeutischen Systemen.’. DMW Deutsche Medizinische Wochenschrift. 144, e36–e41. [Website]. 256 German package leaflets insufficiently inform about transdermal patch administration.

Menges K. ‘Readability of Package Leaflets – Update on Possible Improvements Using an Electronic Version Additionally.’. Pharmaceutical Regulatory Affairs. 7(2), 214. [Website]. Whatever improvement of the design and lay-out of paper package leaflets has been achieved – the flexibility due to the legal framework is somewhat restricted –, ... .

Mononen N, Airaksinen MSA, Hämeen-Anttila K, Helakorpi S, Pohjanoksa-Mäntylä M. ‘Trends in the receipt of medicines information among Finnish adults in 1999–2014: a nationwide repeated crosssectional survey.’. BMJ Open. 9, e026377. [DOI]. Finland, 15 year study: in 2002, 44% of patients said they received medicines information from their Package leaflets. In 2014, this decreased to 34%: still dominant.

O’Donovan B, Rodgers RM, Cox AR, Krska J. ‘Use of information sources regarding medicine side effects among the general population: a cross sectional survey.’. Primary Health Care Research & Development. 20(e153), 1–8. [DOI]. 935 UK questionnaires: package leaflet (less trustworthy) and GP (less accessible) are most used sources.

Petkova P, Grigorov E, Kirilov B. ‘Warnings and precautions in the patient information leaflet.’. Scripta Scientifica Vox Studentium, Seventh ‘Black Sea Symposium for Young Scientists in Biomedicine’. 3 (suppl. 1), 57. [Website]. Analysis of 1200 medicines looking at information about pregnancy and ability to drive: information from the PIL is not enough.

Petkova P, Kirilov B, Grigorov E. ‘The patient information leaflet as part of rational use of drugs.’. Scripta Scientifica Pharmaceutica, Sixth Pharmaceutical Business Forum and Scientific and Practical Conference, Varna, October 25-27, 2019’. 6 (suppl. 1), 22. [Website]. Analysis of 1200 medicines: consult with doctor or pharmacist (71,6%), consult pharmacist (20,77%), consult doctor (5,19%): pharmaceutical care is integral part of rational drug use.

Piñero-López MA, Figueiredo-Escribá C, Modamio P, Lastra CF, Mariño EL. ‘Readability assessment of package leaflets of biosimilars.’. BMJ Open. 9, e024837. [DOI]. Applying readability formula to 35 approved package leaflets for biosimilars.

Pires C, Rosa PJ, Vigário M, Cavaco A. ‘Validation of a new tool for evaluating subjects’ satisfaction with medicine package leaflets: a cross‑sectional descriptive study.’. Sao Paulo Med Journal. 137(5), 454-62. [DOI]. Tool to evaluate satisfaction with package leaflets in Portugal: 503 participants, 12 leaflets.

Prediger B, Meyer E, Büchter R, Mathes T. ‘Nocebo effects of a simplified package leaflet compared to unstandardised oral information and a standard package leaflet: a pilot randomised controlled trial.’. Trials. 20, 458. [DOI]. Pilot (n=102) shows that the way information on adverse effects is reported in ibuprofen package leaflets can affect the nocebo effect.

Salgueiro E, Gurruchaga C, Jimeno FJ, Martínez-Múgica C, Martín Arias LH, Manso G. ‘What can we learn from the public’s understanding of drug information and safety? A population survey.’. Int J Pharm Practice. 27(1), 96-104. [DOI]. In Spain, 402 questionnaires showed that 61% say that they read the package leaflet; 56% say that they find it (sometimes) difficult to understand.

Vervloet M, te Paske R, Bekker C, Brabers A, de Jong J, van Dijk L. ‘Vertrouwen in medicijnen. Een vragenlijstonderzoek onder burgers.’. Utrecht: Nivel. [Website]. 753 questionnaires in the Netherlands: 71% find package leaflets a reliable source of information.

Waarde K van der. ‘Information about medicines in Europe. Considering possible principles?’. Information Design Journal. 25(3), 307-313. [DOI]. Governments, organizations, and companies which do not design their information with care attain the opposite results. People lose trust, consider information as less valid, and see the originator as careless and inconsiderate.

Žalinkevičius J, Butkienė R. ‘Automatic Detection of Contraindications of Medicines in Package Leaflet.’. International Conference on Information Technology. 110-114. [DOI]. Experimental system to detect contraindications in the text of package leaflets: 56% correct.

2018

Fuchs J, Götze EA, Voigt C. ‘Should package leaflets be coloured in the future?’. Pharmazeutische Industrie. 10, 1428–1435. [Website]. 6 leaflets, 192 participants, 25 content questions: Colour did not make a difference.

Kareivaitė I. ‘Vaistinių preparatų, naudojamų pediatrijoje, pakuotės lapelio suprantamumas.’. [The comprehensibility of the package leaflet for medicinal products used in pediatric use.] MA-Thesis, Lithuanian University of Health Sciences, Faculty of Pharmacy. [Website]. In Lithuanian: 357 respondents were interviewed, pediatric use: The comprehensibility of the package leaflet of medicinal preparations used in pediatrics would be improved by the illustrations used, a shorter package leaflet, the use of colors, and a larger text font.

Kościałkowska-Okońska E. ‘Translating patient information leaflets: expectations of users and the reality.’. pp 137-159 in: O Kubinska, Kubinski W. (eds). Towards understanding medical translation and interpreting. Gdańsk: Gdańsk University Press. [Website]. Comparison of English and Polish package leaflets: The translated versions of original English materials do not meet their users’ expectations.

Martínez Motos R. ‘Análisis del efecto de la traducción (inglés-español) en la legibilidad del prospecto de medicamento.’. pp 4-71 in: V Montalt, K Zethsen, V Karwacka (eds.) Retos actuales y tendencias emergentes en traducción médica / Current challenges and emerging trends in medical translation.. MonTI. Monografías De Traducción E Interpretación (10) [DOI]. Analysis of 150 Spanish package leaflets. Leaflets translated from English cause less readability problems than original Spanish leaflets.

Mühlbauer V, Prinz R, Mühlhauser I, Wegwarth O. ‘Alternative package leaflets improve people’s understanding of drug side effects - randomized controlled exploratory survey.’. PLoS ONE. 13(9), e0203800. [DOI]. 397 responses to online survey: frequency descriptors are misleading.

Raynor, DKT. ‘Written information on medicines for patients: learning from the PIL.’. Drug and Therapeutics Bulletin. 56(12), 145-149. [DOI]. Overview of the role of package leaflets.

Rollema C, Roon EM van, Schilder AGM, Vries TW de. ‘Evaluation of instructions in patient information leaflets for the use of intranasal corticosteroid sprays: an observational study.’. BMJ Open. 9, e026710. [DOI]. An analysis of 21 package leaflets for nasal sprays in the UK. All missed steps.

Webster RK, Weinman J, Rubin GJ. ‘Positively Framed Risk Information in Patient Information Leaflets Reduces Side Effect Reporting: A Double-Blind Randomized Controlled Trial.’. Annals of Behavioral Medicine. 52(11), 920–929. [DOI]. Trial 203 UK participants: Positive risk frequency indicators.

Young A, Tordorff J, Smith A. ‘Regulatory agencies’ recommendations for medicine information leaflets: Are they in line with research findings?’. Research in Social & Administrative Pharmacy. (14)2, 196-202. [DOI]. A comparison of the regulatory design principles in New Zealand, EU, UK, and the USA.

Yuan H-CT, Raynor DK, Alsani P. ‘Comparison of International Regulations for Written Medicine Information (WMI) on Prescription Medicines.’. Therapeutic Innovation & Regulatory Science. 53, 215–226. [DOI]. A review of regulations in the European Union, the United States of America, and Australia.

Zidarič N, Kreft S. ‘The information for the dosing of medicinal products in different age intervals is ambiguous.’. Therapeutic Innovation & Regulatory Science. 53, 506–511. [DOI]. Age indicators (2-4 years), 216 people: information about the dosing of medicinal products for children is ambiguous.

Zwieten M van. ‘Een begrijpelijke(re) bijsluiter voor iedereen?’. [MA thesis, Utrecht University. In Dutch.] [Website]. 36 Dutch participants: original and revised package leaflet. Both fail EU-readability test.

2017

Academy of Medical Sciences. ‘Enhancing the use of scientific evidence to judge the potential benefits and harms of medicines.’. [Website]. Section 4.1.1. is about package leaflets. They are particularly poor at outlining the potential benefits of treatments.

Adomėnienė AJ. ‘Veiksnių, turinčių įtakos vaistų pakuotės lapelių skaitymui, tyrimas’. [An analysis of the factors influencing the reading package leaflets of the medical products]. MA thesis, Vilniaus universitetas. Medicinos fakultetas [Website]. The majority of the customers think, that the main issues with the leaflets are: too much information and the text is written in letters that are too small.

Álvarez García É. ‘Las unidades fraseológicas en los prospectos de medicamentos en inglés y español’. [Phraseological units of package leaflets for medicinal products in English and Spanish]. Paremia. 27, 69-84 [Website]. Linguistic analysis of 4 Spanish and 4 English package leaflets.

Dickinson D, Gallina S. ‘Information Design in medicine package leaflets’. pp 685-700 in: Black A, Luna P, Lund O, Walker S (eds.): Information Design: research and practice. London: Routledge . [ISBN]. Information design could help to improve uptake of instructions and advice.

Fuchs J, Kraft S, Vettermann A, Reiche M. ‘Typographic Changes in Package Leaflets of the European Union Based on the Example of German Versions Between 2005 and 2015.’. Therapeutic Innovation & Regulatory Science. 51, 431–438. [DOI]. Typographic analysis of 138 German package leaflets: suggesting changes to Guidelines.

Ge-Bu (Redactiecommissie Geneesmiddelenbulletin). ‘De bijsluiter.’ (In Dutch). Geneesmiddelenbulletin. 51, 68-72. [Website]. A detailed situation description in the Netherlands: legal requirements prevail above appropriate medicine use.

Holm SP, Fuchsberger M, Bowden G, Buisson S. ‘Patient-reported outcomes in labels and package leaflets of drugs approved by the European Medicines Agency from 2007 to 2017.’. Value in Health. 20(9), A681–. [DOI]. Analysis of 125 package leaflets: Patient-reported outcome (PRO) data are still unavailable in many of the SmPCs and package leaflets of products for the treatment of diseases known to severely affect patient daily life, especially diabetes.

Khodambashi S, Haugland D, Ellingsberg A, Kottum H, Sund JK, Nytrø Ø. ‘An experimental comparison of a co-design visualizing personal drug information and patient information leaflets: Usability aspects.’. Stud Health Technol Inform. 245, 748-752. [Website]. Norway: co-design with 13 participants: using the prototype to find information is faster than using the PILs and the prototype is more usable than the PILs.

Koehorst, I. ‘Het effect van ontkenningen in bijsluiters op subjectief begrip en waargenomen risico.’. [BA thesis, University of Utrecht, Communicatie- en Informatiewetenschappen. In Dutch.] [Website]. 151 Dutch participants: negations affect risk perception.

Mirón CE, Molina-García MJ. ‘Los Prospectos: Uso y Comprensión. Una Investigación con Ciudadanos Universitarios y no Universitarios’. [Use and comprehension of PILs: A research with citizens and university students]. Monográfico II 2017. 201-229. [Website]. Spain: University students: the collaboration of independent experts, philologists and citizens is advisable in the editorial team in order to facilitate the readability and understanding of this type of text.

Pires C, Cavaco A, Vigário M. ‘How sociodemographic features impact subjects’ opinion on packages leaflets of medicines?’. Australasian Medical Journal. 10(9), 774-784. [DOI]. Portugal: 12 package leaflets. Opinions of 503 people on likert scale.

Pires C, Martins F, Cavaco A, Vigário M. ‘Automatic quantification of abbreviations in medicine package leaflets and their comprehension assessment.’. International Journal of E-Health and Medical Communications. 8(2), 47-64. [DOI]. Analysis of 531 Portuguese package leaflets with abbreviations and symbols + 18 student questionnaires: poorly understood.

Raynor DKT. ‘Why patient information leaflets have their place in informing patients about their medicines.’. Pharmaceutical Journal. [Website]. Package leaflets have improved - might need to be used by pharmacists interventions.

Sahm L, Waarde K van der. ‘A prescription for clarity’. The Clarity Journal. 76, 30-34. [Website]. These examples show that some of the information patients receive is easy to confuse, difficult to read, unstructured, and hard to apply in a real life situation.

Schmitz J, Kamping S, Wiegratz J, Müller M, Stork J, Colloca L, Flor H, Klinger R. ‘Impact of patient information leaflets on pain medication intake behavior: a pilot study.’. PAIN Reports. 2(6), e620. [DOI]. The results suggest that package leaflets of commonly used analgesics describe more negative than positive effects.

Segura-Bedmar I, Martínez P. ‘Simplifying drug package leaflets written in Spanish by using word embedding.’. Journal of Biomedical Semantics. 8, 45. [DOI]. 306 Spanish package leaflets: substituting terminology by simplest synonyms of adverse effects .

Waarde K van der. ‘Medical information design and its legislation’. pp 715-730 in: Black A, Luna P, Lund O, Walker S (eds.): Information Design: research and practice. London: Routledge . [ISBN]. The legislation related to medical information in Europe has not resulted in artefacts that really ‘enable people to act appropriately’.

Waarde K van der. ‘Packaging for people’. Pharmaceutical Manufacturing and Packing Sourcer (PMPS). May 2017. pp 62-64. [Website]. A way forward is to consider the actual situation in which a medicine is used; cooperate with people who have to use it; set benchmark standards for performance levels; and design-test-redesign-test-redesign until the required performance is achieved.

Waarde K van der. ‘Visual information about medicines for older patients.’. pp 336-354 (Chapter 18) in Emmanuel Tsekleves, Rachel Cooper (eds.): Design for healthcare. Abingdon: Routledge. [Website]. There is a need for change in the regulatory framework to accommodate for ageing processes and to make sure that medicines can be taken correctly by older patients. An ‘information strategy’ that is based on the actions of patients might provide a suitable approach.

Webster RK, Weinman J, Rubin GJ. ‘How does the side-effect information in patient information leaflets influence peoples’ side-effect expectations? A cross-sectional national survey of 18-to 65-year-olds in England.’. Health Expectations. 20(6), 1411-1420. [DOI]. Frequency indicators in England. 1003 questionnaires: overestimation of side effect risks.

Webster RK, Weinman J, Rubin GJ. ‘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, 743–754. [DOI]. Frequency indicators in England. 1003 questionnaires. The risks conveyed were greatly overestimated by participants.

2016

Beusekom MM van, Grootens-Wiegers P, Bos MJW, Guchelaar H-J, Broek JM van den. ‘Low literacy and written drug information: information-seeking, leaflet evaluation and preferences, and roles for images.’. Int J Clin Pharm. 38, 1372–1379. [DOI]. Focus groups (44) and interviews (15) with low-literate patients in the Netherlands: Short, structured, visual/textual explanations can lower the motivational threshold.

Blalock SJ, Sage A, Bitonti M, Patel P, Dickinson R, Knapp P. ‘Communicating information concerning potential medication harms and benefits: What gist do numbers convey?’. Patient Education and Counseling. 99(12), 1964-1970. [DOI]. 999 online participants: non-numerical information biases decision making.

Dickinson R, Raynor DK, Knapp P, MacDonald J. ‘Providing additional information about the benefits of statins in a leaflet for patients with coronary heart disease: a qualitative study of the impact on attitudes and beliefs.’. BMJ Open. 6, e012000. [DOI]. 21 interviews in the UK. 3 package leaflets. Patients overestimated the benefits of statins.

Dickinson R, Raynor DK, Knapp P, MacDonald J. ‘Do patients use a headline section in a leaflet to find key information about their medicines? Findings from a user-test study.’. Therapeutic Innovation & Regulatory Science. 50, 581–591. [DOI]. UK readability test (20 participants) to evaluate headline section. 39% used it.

Dickinson R, Raynor DK, Knapp P, MacDonald J. ‘How much information about the benefits of medicines is included in patient leaflets in the European Union? – A survey.’. International Journal of Pharmacy Practice. 25(2), 147–158. [DOI]. Analysis of 100 UK package leaflets: Current PILs do not appropriately communicate information about benefit.

Dijk L van, Hendriks M, Zwikker H, Jong J de, Vervloet M. ‘Informatiebehoeften van patiënten over geneesmiddelen.’. [Information needs of patients about medicines.]. Utrecht: Nivel. [Website]. Recommendation for package leaflets: shorter, easier, and with a clearer design.

Fuchs J, Götze EA, Voigt C. ‘Landscape versus portrait format in package leaflets.’. Pharm. Ind. 78(8), 1178-1184. [Website]. Germany: 234 participants, 3 leaflets in 4 formats + 2 more leaflets: no preference for format.

Hammar T, Nilsson AL, Hovstadius B. ‘Patients’ views on electronic patient information leaflets.’. Pharmacy Practice. 14(2), 702. [DOI]. South-east Sweden: The majority (225/406) prefer the patient information leaflet in paper form.

Hedenrud T, Håkonsen H. ‘Purchase habits, use of paracetamol, and information sources on a reregulated Swedish pharmacy market: A population-based study.’. Health Policy. 121(1), 35-41. [DOI]. Web based survey of 3120 Swedes about paracetamol: The most common source of information was the patient information leaflet.

Knapp P, Gardner PH, Woolf E. ‘Combined verbal and numerical expressions increase perceived risk of medicine side-effects: a randomized controlled trial of EMA recommendations.’. Health Expectations. 19, 264–274. [DOI]. UK: 339 participants opinions about frequency indicators for Taxol (placlitaxel). The EMA should consider revising its guidance about risk expressions.

Koumoundourou M, Koutsabasis P, Darzentas JS. ‘Informing the design of mobile device-based patient instructions leaflets: the case of Fentanyl patches.’. In Lloyd P, and Bohemia E. (eds.) Future Focused Thinking - DRS International Conference 2016, 27 - 30 June, Brighton, United Kingdom. 2309-2325. [DOI]. Evaluation of a digital prototype in Greece: online survey (253 respondents), usability test (10 participants): need for information design guidelines for both digital and paper.

Lauppe LM. ‘Textverstehen und Textverständlichkeit im kompetenzorientierten Deutschunterricht der Hauptschule – Die Packungsbeilage für Arzneimittel.’. Thesis Pädagogische Hochschule Freiburg. [Website]. Germany: Use of package leaflets as teaching material for tenth grade pupils.

Mahut, S. ‘Comment les patients utilisent-ils la notice des médicaments? Enquête qualitative compréhensive réalisée auprès de patients des Yvelines et du Val-d’Oise’. [Thesis, Universite de Versailles Saint-Quentin-en-Yvelines.] [Website]. 23 French participants: Patients read the package leaflet for new medicines. Doctors could reduce fear by explaining side effects, and use it as a basis for the next consultation.

Piñero-López MÁ, Modamio P, Lastra CF, Mariño EL. ‘Readability analysis of the package leaflets for biological medicines available on the internet between 2007 and 2013: An analytical longitudinal study.’. Journal of Medical Internet Research. 18(5), e100. [DOI]. Applying 3 readability formulae to 36 Spanish package leaflets: There was no improvement in the readability of the package leaflets studied between 2007 and 2013.

Pires CMBF. ‘Readability of Portuguese Package Leaflets: developing new and innovative metrics for their evaluation and improvement.’. [PhD thesis, Universidade de Lisboa, Faculdade de Farmácia]. In English.]. [Restricted repository.]. A collection of 10 articles; 7 are about package leaflets.

Pires C, Vigário M, Cavaco A. ‘Factors influencing subjects’ comprehension of a set of medicine package inserts.’. Int J Clin Pharm. 38, 888–898. [DOI]. 503 Portuguese participants; 12 package leaflets. Education and literacy predict comprehension. 48% understood less than 75%. The evaluated PIs may thus need to be simplified.

Waarde K van der. ‘De typografische vormgeving van informatie over medicijnen: een diagnose in historisch perspectief’. Journal for Media History. 19(2), 1-11. [DOI]. The free movement of goods in Europe has led to undesirable standardisation of information on medicines that does not do justice to the variety of patients and medicines.

Waarde K van der. ‘The design of information on Ibuprofen. A minor headache?’. Information Design Journal. 22(3). pp 281-297. [DOI]. The contents are incorrectly structured, repetitive, conflicting and hard to apply; the language used is confusing, vague and at some parts inappropriate; the visual design does not enable people to find and understand information, and the information does not really help patients to make appropriate decisions.

Waarde K van der. ‘Designing Information about Medicine: The role of visual design.’. Petra Cerne Oven & Cvetka Pozar (eds.) Engelhardt, Waller, Frascara, Van der Waarde, Garrett, Schriver on Information Design. Ljubljana: The museum of Architecture and Design. [Website]. The current regulatory framework focuses only on a very limited part of the activities of visual designers, mentioning only certain issues related to textual elements and image elements.

Wolf A, Fuchs J, Schweim HG. ‘Implementation of the European QRD template in package leaflets of centralized approved medicines.’. Therapeutic Innovation & Regulatory Science. 50(1), 106-114. [DOI]. Analysis of 565 English package leaflets: length increased significantly between 2011 and 2013. QRD-template amendments must be based on sufficient research evidence.

2015

Barrenberg E, Garbe E. ‘Use of over-the-counter (OTC) drugs and perceptions of OTC drug safety among German adults.’. Eur J Clin Pharmacol. 71, 1389–1396. [DOI]. Germany, OTC-medicines, online survey of 300 participants; not all aspects of the package leaflet receive equal attention.

Burgers C, Beukeboom CJ, Sparks L, Diepeveen V. ‘How (not) to inform patients about drug use: Use and effects of negations in Dutch patient information leaflets.’. Pharmacoepidemiology and Drug Safety. 24(2), 137-143. [DOI]. Linguistic analysis of 30 Dutch Package leaflets + 80 questionnaires. To increase comprehensibility, PIL designers should refrain from using negations as much as possible.

Cutts M. ‘Making leaflets clearer for patients.’. Medical Writing. 24(1), 14-19. [DOI]. Some of the language is quirky, ambiguous, and confusing.

Dooren AA van, Bie J de, Vink M, Faber A, Dijk L van. ‘Communication between Patients and Pharmacy Staff on Patient Information Leaflets.’. Journal of Advanced Clinical Pharmacology. 2(2), 39-49. [Website]. Questionnaire for 785 Dutch pharmacy technicians: they feel that PILs are frequently difficult to read, to understand and to memorize.

Fage-Butler A. ‘Package leaflets for medication in the EU: The possibility of integrating patients’ perspectives in a regulated genre?’. Medical Writing. 24(4), 210-214. [DOI]. Consider replacing the template with a set of recommendations that integrates the findings of research and patient feedback.

Fest I. ‘De nieuwe bijsluiter? Onderzoek naar een nieuw voorstel voor de structuur van de geneesmiddelenbijsluiter.’. [BA thesis, Utrecht University. In Dutch.] [Website]. 101 online Dutch participants: modifying the structure does not make it easier to find information.

Fuchs J, Kutscha M. ‘How best to assess paper quality for package leaflets – weight or opacity?’. Pharmazeutische Industrie. 77(9), 1380-1383. [Website]. Analysis of 258 German package leaflets: opacity is more important than paper weight.

Fuchs J, Kutscha M. ‘Handling des steten Textzuwachses in Packungsbeilagen.’. [In German] Pharmazeutische Industrie. 77(10), 1438-1445. [Website]. Review of options to counter the continuously increasing length of package leaflets.

Harris K, Dickinson R, Raynor DK, MacDonald J, Knapp P. ‘Changes in side effect risk communication in patient information leaflets over the past decade: results of a survey.’. Drug Safety. 38, 721-727. [DOI]. A comparison of the risk frequency descriptors in the UK of 50 leaflets in 2012, and 50 leaflets in 2015: more consistent, but unclear how they are interpreted by patients.

Knapp P, Garnder PH, Woolf E. ‘Combined verbal and numerical expressions increase perceived risk of medicine side-effects: a randomized controlled trial of EMA recommendations.’. Health Expectations. 19, 264–274 [DOI]. 339 UK participants: the recommended risk expressions can lead to significant risk overestimations. The EMA should consider revising its guidance.

Mühlbauer V, Mühlhauser I. ‘Understanding adverse drug reactions in package leaflets – an exploratory survey among health care professionals.’. BMC Health Services Research. 15, 505. [DOI]. 379 German Health professionals. Majority had difficulties understanding frequency information on side effects in package leaflets.

Pander Maat H, Lentz L, Raynor DK. ‘How to test mandatory text templates: the European patient information leaflet.’. PLoS ONE. 10(10), e0139250. [DOI]. 64 British and 64 Dutch participants tested an alternative template: proposed template improves findability.

Pierini P. ‘On the user’s side: definitions in italian and british patient information leaflets.’. Círculo de lingüística aplicada a la comunicación (CLAC). 63, 218-239. [DOI]. An analysis of definitions in 50 Italian and 50 British package leaflets: similarities and differences.

Pines, A. ‘Patient information leaflets: friend or foe?’. Editorial. Climacteric. 18(5), 663-665. [DOI]. Israel: the patient information leaflets should be improved and become more user-friendly and less frightening.

Pires C, Cavaco A, Vigário M. ‘Using an automatic tool to identify potential readability issues in a large sample of medicinal package inserts.’. Methods of Information in Medicine. 54, 379–381 [DOI]. Analysis of the length and use of abbreviations in 531 leaflets in Portugal.

Pires C, Cavaco A, Vigário M. ‘Problems identified in the package leaflets of the Portuguese non-generic medicines.’. Acta Médica Portuguesa. 28(1), 21-28. [DOI]. Analysis of the availability of a contents list (91,2%), use for more than one strength (354/2042), and length in 2042 leaflets in Portugal.

Pires C, Vigário M, Cavaco A. ‘Readability of medicinal package leaflets: a systematic review.’. Rev Saúde Pública. 49(4). [DOI]. Systematic literature review of 22 articles: The package leaflets presented various readability problems + methodological limitations of studies.

Pires C, Vigário M, Cavaco A. ‘Graphical content of medicinal package inserts: an exploratory study to evaluate potential legibility issues.’. Health Information & Libraries Journal. 33, 121-139 [DOI]. Analysis of 651 Portuguese package leaflets: scarce use of illustrations + usability test on 45 participants.

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 Journal. 133(2), 91-100. [DOI]. Analysis of 651 Portuguese package leaflets: The methodologies for package leaflet approval should be reviewed and optimized.

Pires C, Vigário M, Martins F, Cavaco A. ‘Abbreviations and symbols in a large sample of medicinal package leaflets: automatic detection and comprehension assessment.’. Procedia Computer Science. 64, 683-690. [DOI]. Analysis of the use of abbreviations and symbols in 531 Portuguese leaflets.

Renahy J, Vuitton DA, Rath B, Thomas I, Grivel V de, Cardey S. ‘Controlled language and information on vaccines: application to package inserts.’. Current Drug Safety. 10, 41-48. [DOI]. Use controlled language to write package leaflets. Example: French leaflet for a influenza vaccine.

Rij L van. ‘Het effect van demografische factoren leeftijd en opleidingsniveau op de leesbaarheid van medicijnbijsluiters.’ [BA thesis, Utrecht University. In Dutch.] [Website]. Online Dutch questionnaire (102 participants) to find effect of age and education on finding information in package leaflets: age affects time to find answer.

Sahm L, Waarde K van der. ‘Communicating clearly about medicines.’. Irish Hospital Pharmacy News. November 2015, pp 17-19. [Website]. Making sure that the information that is provided to patients about their medicines requires clear language, a balanced visual design, and an information strategy. All three might need more attention.

Sijs, W van der. ‘De medische bijsluiter.’. [BA thesis, Utrecht University. In Dutch.] [Website]. Online Dutch questionnaire (101 participants): Knowledge of medical vocabulary does not affect finding information, nor finding time.

Waarde K van der, Spinillo C. ‘The Development of Visual Information about Medicines in Europe.’. pp 185-189 (Chapter 12) in: Jorge Frascara (editor) Information Design as Principled Action. Making Information Accessible, Relevant, Understandable, and Usable. Champaign (Illinois): Common Ground Publishing. [DOI]. In order to provide patients with information that suits their needs, it seems necessary to reconsider the prevailing assumptions and develop alternative prototypes that show that changes are required and possible.

Wolf A. ‘An Analysis and Evaluation of the Development of the QRD Human Product Information Template used in Package Leaflets.’. [PhD thesis, Rheinischen Friedrich-Wilhelms-University Bonn] [Website]. Analysis of development and user testing of QRD-template: Thirteen revisions: increased length. Further optimisation is possible.

Wolf A, Fuchs J, Schweim HG. ‘Implementation of the European QRD Template in package leaflets of centralized approved medicines.’. Therapeutic Innovation & Regulatory Science. 50, 106–114. [DOI]. 565 German package leaflets: making the current QRD template more concise is strongly recommended.

2014

Büchter RB, Fechtelpeter D, Knelangen M, Ehrlich M, Waltering A. ‘Words or numbers? Communicating risk of adverse effects in written consumer health information: a systematic review and meta-analysis.’. BMC Medical Informatics and Decision Making. 14, 76. [DOI]. Systematic review: frequency indicators: verbal descriptions lead to an overestimation of the probability of an adverse effect.

Burgers C, Beukeboom CJ, Sparks L, Diepeveen V. ‘How (not) to inform patients about drug use: use and effects of negations in Dutch patient information leaflets.’. Pharmacoepidemiology and drug safety. 24, 137-143. [DOI]. Analysis of 30 Dutch leaflets (15 OTC, 15 POM), and questionnaire to 80 participants: Refrain from using negations (no, not) in package leaflet texts.

Dickinson RJ. ‘The inclusion of a headline section and information about the benefits of medicines in written medicines information.’. [PhD thesis. The University of Leeds] [Website]. Are there benefits of including a headline section or adding benefits information in package leaflets? Literature, questionnaires, interviews.

Dijk L van, Montiero SP, Vervloet M, Bie J de, Raynor DKT. ‘Study on the Package Leaflets and the Summaries of Product Characteristics of Medicinal Products for Human use.’ (PIL-S study). Report commissioned by the European Commission. [Website]. Patients’ comprehension of the PIL and its readability can be improved.

Dost, D. ‘Lees voor gebruik de bijsluiter. De invloed van kopjes en structuur op de begrijpelijkheid van de geneesmiddelenbijsluiter.’. [BA thesis, Utrecht University. In Dutch.] [Website]. Developing an alternative heading structure for package leaflets. Tested on 141 participants: no improvements.

Hausen T. ‘Falsche Empfehlungen im Beipackzettel verhindern eine gute bronchiale Deposition!’. Pneumologie. 68(09), 635. [DOI]. Germany: Incorrect recommendations for inhalers in package leaflets.

Herber OR, Gies V, Schwappach D, Thürmann P, Wilm S. ‘Patient information leaflets: informing or frightening? A focus group study exploring patients’ emotional reactions and subsequent behavior towards package leaflets of commonly prescribed medications in family practices.’. BMC Family Practice. 15, 163. [DOI]. 35 German patients in focus groups: risk information causes emotional reactions and frightens.

Køhler Simonsen H. ‘Danglers in patient information leaflets and technical manuals: an issue for specialised translators?’. The Journal of Specialised Translation. 21, 2-18. [Website]. Analysis of ‘dangling’ (when the actor of a sentence is implied) in 123 package leaflets: Dangling participles occur not very frequent.

Lentz L, Pander Maat H, Dost D. ‘An evidence-based template proposal for patient information leaflets.’. Information Design Journal. 21(3), 225-243. [DOI]. An overview of the development of an alternative structure of the QRD-template.

Liu F, Abdul-Hussain S, Mahboob S, Rai V, Kostrzewski A. ‘How useful are medication patient information leaflets to older adults? A content, readability and layout analysis.’. Int J Clin Pharm. 36, 827–834. [DOI]. Package leaflets are inappropriate for use by older adults to manage their medications effectively.

MacDonald J. ‘Striving for better patient information on adverse drug reactions.’. BMJ. 349, g5513. [DOI]. Statement of the MRHA related to adverse drug reactions in package leaflets.

Merges F, Nasiri S, Fathi M. ‘Package insert leaflet analysis and improvement to reduce patient risk factors.’. 2014 IEEE 27th International Symposium on Computer-Based Medical Systems. 483-484. [DOI]. A German ‘readability assistance system’ to support writers of package leaflets.

Notenboom K, Beers E, van Riet-Nales DA, Egberts TCG, Leufkens HGM, Jansen PAF, Bouvy ML. ‘Practical problems with medication use that older people experience: A qualitative study.’. J Am Geriatr Soc. 62, 2339–2344. [DOI]. 59 Dutch elderly: 211 problems: 37 participants reported problems with reading and understanding the instructions for use. Type too small, too difficult, too extensive, distressing.

Piñero-López MA. ‘Evaluación de la comprensibilidad y legibilidad de prospectos de medicamentos biotecnológicos.’. [PhD Thesis, in Spanish. Facultat de Farmàcia, Universitat de Barcelona.] [Website]. Readability assessment of 36 Spanish package leaflets in 2007, 2010, and 2013 through Readability formula. Increase in length, no change in readability: none was easy to understand.

Piñero-López MÁ, Modamio P, Lastra CF, Mariño EL.‘Readability assessment of package inserts of biological medicinal products from the European Medicines Agency website.’. Drug Safety. 37, 543–554. [DOI]. Application of Readability formulae to 33 Spanish leaflets between 2007 and 2010. Differences between sections.

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. 70, 583-588. [DOI]. Exploratory study of Portuguese diclofenac package leaflet. 63 participants: consumers, pharmacists, doctors. Pharmacists and doctors suggested improvements, patients struggled with technical terms.

Poplas-Susič T, Klemenc-Ketis Z, Kersnik J. ‘Usefulness of the patient information leaflet (PIL) and information on medicines from professionals: A patients’ view. A qualitative study.’. Zdrav Vestn. 83(5), 368-375. [Website]. Four focus groups in Slovenia: Package leaflets are too scientific, not easy to understand, and too complex.

Vázquez y del Arbol E. ‘Prospectos medicamentosos: macroestructura comparada aplicada a la traducción.’. [In Spanish] Skopos. 4, 207-221. [DOI]. A comparison of 20 Spanish and 20 English package leaflets: results show striking macrostructural divergences.

Vázquez y del Árbol E. ‘Modern user information leaflet frente al prospecto medicamentoso moderno: el orden de los factores ¿no altera? el valor del producto (segunda parte).’. Panace. XV, 118-127. [Website]. A comparison of 20 Spanish and 20 English package leaflets: differences after translations.

Verplaetse H, Wermuth C. ‘Keys for reader response to written healthcare communication: A contrastive study of English and translated German patient information leaflets (PILs).’. Turjuman. 23(2), 11-45 [Website]. Linguistic comparison of 10 package leaflets in English and German. Focus on uncertainty avoidance.

Waarde K van der. ‘Information about medicines for patients in Europe: To impede or to empower?’. In: Marcus A. (ed): Design, User Experience, and Usability. User Experience Design for Everyday Life Applications and Services. DUXU 2014. Lecture Notes in Computer Science, vol 8519. 132–140. [DOI]. As long as legal arguments and profits prevail, patients will have to coop with visual information about medicines that does not really fulfil its potential.

Wolf A, Fuchs J, Schweim HG. ‘Readability of the European QRD Template.’. Pharm. Ind.. 76(8), 1312–1322. [Website]. Test of QRD-template version 7.3.1 and 8 on 172 German and 69 British participants: template improved, but needs to be shorter.

2013

Ballesteros-Peña S, Fernández-Aedo I. ‘Análisis de la legibilidad lingüística de los prospectos de los medicamentos mediante el índice de Flesch-szigriszt y la escala inflesz. [Legibility analysis of drug package leaflets using Flesch-Sszigriszt index and Inflesz score].’. Anales del Sistema Sanitario de Navarra. 36(3), 397-406. [DOI]. 30 Spanish package leaflets: Legibility could be improved: grammatical structures are usually convoluted; comprehension by general public is difficult.

Fage-Butler A. ‘Including patients’ perspectives in patient information leaflets: A polyocular approach.’. Fachsprache. 3–4, 140-154. [DOI]. Perspectivist and polyocular theories discussing the absence of patients’ perspectives in mandatory PILs.

Foster CS. ‘An analysis of volunteer age and level of education on performance in ‘readability’ testing for patient information leaflets (PILs).’. Journal of Health & Medical Informatics. 4, 115. [DOI]. To increase power and reliability, readability test shoud focus on those over 70 or those who left school at 16.

Fuchs J. ‘Patientenfreundliche Packungsbeilagen unter ökonomischen und regulatorischen Gesichtspunkten’. Regulatory Affairs Newsletter FORUM Institut. [Website]. The larger the volume of text, the more patients become demotivated to read the package inserts and their confidence in using the drugs decreases.

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. 36, 673-680. [DOI]. North West England survey (1218 participants): Patients feel knowledgeable about side effects, no effect on experience of side effects.

Mira JJ, Lorenzo S, Pérez-Jover V, Navarro I, Martín de Rosales AM, Lara C. ‘Assessment of the quality of medication information for patients in Spain.’. Expert Opin. Drug Safety. 12(1), 9-18. [DOI]. Spain: applying Redability formula to information about medicines in 54 package leaflets and 77 websites.

Nisbeth Jensen M. ‘Translators of Patient Information Leaflets: Translation experts or expert translators? A mixed methods study of lay-friendliness.’. [PhD thesis, Aarhus University, School of Business and Social Sciences]. [Website]. The lack of lay-friendliness is linked to contextual constraints such as tight deadlines for translation, poor mandatory templates and authoritative bodies and reviewers with limited interlingual and intralingual translation knowledge.

Raynor DK. ‘User testing in developing patient medication information in Europe.’. Research in Social and Administrative Pharmacy. 9, 640-645. [DOI]. Reviewing the strengths and weaknesses of the readability test.

Vázquez y del Arbol E. ‘Traditional patient information leaflet frente al prospecto medicamentoso tradicional: el orden de los factores ¿no altera? el valor del producto.’. [In Spanish] Panace. XIV (37), 89-97. [Website]. A comparison of 20 Spanish and 20 English package leaflets: differences after translations.

Ziegler A, Hadlak A, Mehlbeer S, König IR. ‘Verständnis von Nebenwirkungsrisiken im Beipackzettel: Eine Umfrage unter Ärzten, Apothekern und Juristen.’. Dtsch Arztebl Int. 110(40), 669-673. [DOI]. 1000 doctors, pharmacists, and lawyers in German interpreted risk frequencey indicators: the definitions do not correspond to the everyday use of the terms.

2012

Arts N. ‘The optimal text structure in a patient information leaflet.’. [MA thesis, University of Utrecht, Faculty of Humanities.] [Website]. 64 Dutch and 64 UK Participants: results show the strengths and weaknesses of both the revised and current PIL.

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...’. Pharmaceutical Regulatory Affairs. 1, 102. [Website]. 100 German package leaflets: The new European legislation in force by the end of 2005 induced a trend towards better usable package leaflets. This effect is barely recognisable.

Berkel J van, Gerritsen M. ‘Patient information leaflets in Flanders and the Netherlands: Unnecessary differences?’. pp 151-174 in: P Heynderickx, S Dieltjens, G. Jacobs, P Gillaerts, E de Groot (Eds.) The Language Factor in International Business: New Perspectives on Research, Teaching and Practice.. Bern: Peter Lang. [Website]. Five Dutch and five Flemish package leaflets + test on 21 Flemish and 25 Dutch elderly. Package leaflets are unsuitable for elderly.

Blanck A, Nyblom K. ‘Package leaflets today: a betrayal of Europe’s patients.’. Scrip. August 2012, 16-17. [Website]. Swedish pilot study: It is not enough to amend existing regulations. We need to start from the beginning.

Calamusa A, Di Marzio A, Cristofani R, Arrighetti P, Santaniello V, Alfani S, Carducci A. ‘Factors that influence Italian consumers’ understanding of over-the-counter medicines and risk perception.’. Patient Education and Counseling. 87, 395-401. [DOI]. Italian questionnaire for 1206 adults: respondents who cited PIL among information sources had significantly higher knowledge scores. The results show gaps in understanding the vocabulary of package leaflets.

Cavaco A, Pires C. ‘Improving package leaflet information: potential users and physicians opinions.’. Research in Social and Administrative Pharmacy. 8, e50-e51. [DOI]. Portugal: 42 patients, 42 physicians: Simple lexical modifications produced favorable results in users’ acceptance of package leaflet information.

Cavaco A, Santos AL. ‘Evaluation of health literacy and the readability of information leaflets.’. Revista de Saúde Pública. 46(5) 918-922. [DOI]. Portugal: 53 participants, diclofenac package leaflet: it is questionable whether the readability test proposed by the guideline has adequate sensitivity and specificity to variations in literacy of potential users of the drug.

Edwards B, Chakraborty S. ‘Risk Communication and the pharmaceutical industry. What is the Reality?’. Drug Safety. 35(11), 1027-1040. [DOI]. No evaluation of user testing has been conducted at European level since the introduction of new requirements. The use of templates restricts the flexibility of companies to adapt their risk messages to their targets.

Elderenbosch M. ‘Leest u de bijsluiter? Een kwalitatief onderzoek naar het gebruik van geneesmiddelenbijsluiters door laaggeletterden.’ [BA thesis, University of Groningen, the Netherlands. In Dutch.] [Website]. 12 interviews with low-literate Dutch citizens: length, small type, difficult words.

Ezpeleta Piorno P. ‘An example of genre shift in the medicinal product information genre system.’. Linguistica Antverpiensia, New Series – Themes in Translation Studies. 11, 167-187. [DOI]. Genre systems descriptions: genre shift.

Frost T. ‘Patient and prescriber communication: The role of the SmPC.’. Regulatory Rapporteur. 9(1), 24-27. [Not online]. PIL and SmPC: the usefulness and comprehensibility of these documents remains questionable.

Fuchs J, Scheunpflug C, Götze EA. ‘The influence of the European Union’s QRD Template on the use of package inserts compared with a shorter model template.’. Pharm. Ind. 74(1), 1-12. [Website]. Advantages and disadvantages for package inserts using the QRD template, in comparison to a shorter model version. 192 participants.

Gröber-Grätz D, Waldmann U-M, Knaus W, Gulich M, Zeitler H-P. ‘Der Einfluss des Beipackzettels auf die medikamentöse Adhärenz bei hausärztlichen Patienten.’. [Influence of package inserts on adherence to medication in primary care patients] Dtsch Med Wochenschr. 1370, 1395–1400. [DOI]. 71 interviews iin Germany: Reading the package insert may have fewer consequences than is often assumed. It does not appear to have a major impact on drug adherence.

Gudde-Kuiper P, Brabers A, Reitsma-van Rooijen M, Zijlstra C, Jong J de. ‘Angst: een bijwerking van de bijsluiter? Het effect van twee verschillende presentaties van bijwerkingen op angst, veronderstelde vatbaarheid en ernst.’. [Anxiety: a side effect of the package insert? The effect of two different presentations of adverse events on anxiety, presumed susceptibility and severity.] Stichting Health Base en NIVEL. [Website]. Questionnaire to 217 Dutch participants: Side effects in an advisory classification elicit less anxiety than side effects in the frequency classification.

Hamrosi K, Dickinson R, Knapp P, Raynor DK, Krass I, Sowter J, Aslani P. ‘It’s for your benefit: exploring patients’ opinions about the inclusion of textual and numerical benefit information in medicine leaflets.’. International Journal of Pharmacy Practice. 21(4), 216–225. [DOI]. 23 Australian and 22 UK participants in focus groups: the provision of numerical benefit information appeared to shake participants’ faith in drug treatments.

Holappa M, Ahonen R, Vainio K, Hämeen-Anttila K. ‘Information sources used by parents to learn about medications they are giving their children.’. Research in Social and Administrative Pharmacy. 8, 579–584. [DOI]. 4032 questionnaires in Finland. Parents considered the leaflets very reliable. The quality of the leaflets varies and is not always high. Relying on information provided by PILs may be problematic.

Knapp P, Gardner P, McMillan B, Raynor DK, Woolf E. ‘Evaluating a combined (frequency and percentage) risk expression to communicate information on medicine side effects to patients.’. International Journal of Pharmacy Practice. 21, 226-232. [DOI]. 129 UK participants, online: no influence on participants’ ratings of the information or their side-effect estimates.

Nisbeth Jensen M. ‘Patient information leaflet translators in the EU: Mapping the hypothetical competences of professional translators and pharmacists-cum- translators.’. pp 237-257 in: B Fischer and M Nisbeth Jensen (eds): Translation and the reconfiguration of power relations. Revisiting role and context of translation and interpreting. [Website]. Translations of English package leaflets into Danish. The required competences of translators.

Nisbeth Jensen M, Korning Zethsen K. ‘Translation of patient information leaflets: Trained translators and pharmacists-cum-translators – a comparison.’. Linguistica Antverpiensia, New Series – Themes in Translation Studies. 11, 31-49. [DOI]. Analysis of translations issues of 54 Danish leaflets: translated by pharmacists (27) or translators (27): Effects on the use of Greek and Latin words and nominalization.

Pander Maat H. ‘De lange weg naar een serieuze leesbaarheidsindex.’. [‘The long road to a serious readability index’. In Dutch.] Tekstblad. [Website]. Developing a tool to analyse text complexity.

Raynor DKT. ‘Medicines information for patients: Insights into research and practice for medical writers.’. Medical Writing. 21(2), 123-127. [DOI]. Writing, designing, and testing information about medicines.

Twomey C. ‘An analysis of patient information leaflets supplied with medicines sold by pharmacists in the United Kingdom.’. Library & Information Research. 25(80), 3-12. [Website]. Evaluating the design of package leaflets for OTC-products in the UK.

Wolf A, Fuchs J, Schweim HG. ‘QRD template texts intended for package inserts.’. Pharm. Ind. 74(9), 1540-1549. [Website]. Keeping the QRD-template as concise as possible. A discussion of versions 7.3.1 and 8.

2011

Dickinson D, Teather J, Gallina S, Newsom-Davis E. ‘Medicine package leaflets – does good design matter?’. Information Design Journal. 18(3), 225–240. [DOI]. Testing 2 leaflets in UK on 10 participants each. Good design makes the difference between a “pass” and a “fail”, and assists readers in searching for key information.

Dolk S, Knapp P, Pander Maat H, Lentz L, Raynor T. ‘Headline section in patient information leaflets. Does it improve reading performance and perception?’. Information Design Journal. 19(1), 46–57. [DOI]. User test (40 Dutch adn 40 UK participants): headline section has no effect on finding or understanding, but affects preference.

Fage-Butler AM. ‘The Discursive Construction of Risk and Trust in Patient Information Leaflets.’. Hermes – Journal of Language and Communication Studies. 46, 61-74. [Website]. A Foucauldian discourse analysis of 9 package leaflets to investigate the discursive construction of risk and trust in PILs.

Fage-Butler AM. ‘Towards a new kind of Patient information leaflet? Risk, trust and the value of Patient-centered communication.’. [PhD Thesis, School of Business and Social Sciences, Aarhus University] [Website]. Discourse analysis to evaluate trust, risks, and needs of patients. Practical implication: The appropriateness of including greater patient centeredness in PILs seems contingent on the nature of the condition the medication is treating.

Franck MCJ, Foulon V, Vaerenbergh L van. ‘ABOP, the automatic patient information leaflet optimizer: Evaluation of a tool in development.’. Patient Education and Counseling. 83, 411–416. [DOI]. Two Dutch package leaflets: Using ABOP as a revision tool for PILs can optimize PIL quality.

Fuchs J, Götze EA, Scheunpflug C. ‘Update des QRD-Templates und daraus resultierende Änderungen in Packungsbeilagen und Fachinformationen.’. Pharm. Ind. 73(4), 670–678. [Website]. A discussion of the changes in version 8 of the QRD-template.

Garner M, Ning Z, Francis J. ‘A framework for the evaluation of patient information leaflets.’. Health Expectations. 15, 283-294. [DOI]. A detailed discussion about leaflet evaluation aiming to establish the degree of convergence between instigator and readers about both the importance and appropriateness of responses.

Haw C, Stubbs J. ‘Patient information leaflets for antidepressants: Are patients getting the information they need?’. Journal of Affective Disorders. 128, 165–170. [DOI]. Study of 42 UK package leaflets: Further guidance and tightening of the approval process for PILs are needed: more standardised in content and contain more information that is wanted by and is useful to patients.

Kasesnik K, Kline M. ‘Analyzing readability of medicines information material in Slovenia.’. Southern Med Review. 4(2), 80-87. [DOI]. Applying readability formulae to Slovenian texts: None of researched items, not even for the general public, were close to primary school grade readability levels and therefore could not be described as easily readable.

Leemans L, Heylen N, Quanten A, Deferme S. ‘Etude sur l’utilisation des notices destinées aux patients [Consumer study on the use of patient information leaflets].’. [In French] J Pharm Belg. (4), 109-16. [Website]. Belgium: 800 responsdents: taking patients’ needs into account should be a priority.

Luk A, Aslani P. ‘Tools used to evaluate written medicine and health information: document and user perspectives.’. Health Education & Behavior. 38(4), 389–403. [DOI]. A systematic review of evaluation methods: Further studies should investigate patient information produced on the basis of consumer evaluation, in particular information on medicine.

Merges F, Fathi M. ‘A new method for readability testing of drug consumer information to increase drug safety.’. i-KNOW ’11: Proceedings of the 11th International Conference on Knowledge Management and Knowledge TechnologiesS. 32, 1-4. [DOI]. A new readability test designed to optimise the readability of package leaflets for drugs.

Paech T, Ihnken B, Menges K, Dobmeyer T. ‘Readability of Package Leaflets According to Age and Level of Education.’. Pharmind. 8, 1387. [Website]. Analysis of 529 German Readability interviews: especially elderly people and readers with a low level of academic education had particular difficulty in finding and understanding medical information in package leaflets.

Pander Maat H, Lentz L. ‘Using sorting data to evaluate text structure: An evidence-based proposal for restructuring patient information leaflets.’. Technical Communication. 58(3), 197-216. [Website]. Two card sorting studies (n=46, n=78) in the Netherlands: The European template does not match users’ expectations concerning the leaflet’s structure.

Piñero-López MA, Modamio P, Lastra CF, Mariño EL. ‘Readability levels of patient package inserts for biopharmaceuticals.’. [Abstracts 7th PCNE working conference Manchester, UK, 23–26 March 2011]. Int J Clin Pharm. 33, 715–716. [DOI]. An analysis of 40 Spanish package leaflets with SMOG and Flesch Readability formula: Too difficult.

Räuscher E, Hiemer U, Schaefer M, Palissa H, Szotowski B. ‘Packungsbeilage, Booklet oder Film – welches Informationsmedium ist für die sichere Anwendung von Arzneimitteln am besten geeignet?’. Pharm. Ind.. 73(8), 1378–1386. [Website]. Germany: use of plaster (n=60): Leaflet, booklet, film. None out of 20 leaflet readers could apply the plaster correctly.

Schwappach DLB, Mülders V, Simic D, Wilm S, Thürmann PA. ‘Is less more? Patients’ preferences for drug information leaflets.’. Pharmacoepidemiology and Drug Safety. 20, 987–995. [DOI]. Testing 1000 Swiss participants over 50 about their preferences for medicines information: influence of age and level of education.

2010

Brazauskas P. ‘Patient’s attitude to the package leaflet as a source of pharmaceutical information.’ Master Thesis, Kaunas medical university, Faculty of pharmacy, Department of drug technology and social pharmacy. [Website]. 360 participants in Lithuania: Women read the leaflet more often, but the comprehensibility of package leaflet is too low, caused by incomprehensible medical terms.

Brazauskas P, Dauksiene J, Radziunas R. ‘Lithuanian patients’ attitude to the package leaflet as a source of pharmaceutical information.’. European Journal of Medical Research. 15(supplement 1), 202-203. [DOI]. Survey (n=360) in Lithuania: Doctor first, pharmacist second, leaflet (49,7%) third. 78,9% alwasys reads. Opinion of 44,3%: not always understandable.

Dickinson D, Teather J, Gallina S, Newsom-Davis E. ‘Medicine package leaflets – does good design matter?’. Information Design Journal. 18(3), 225–240. [DOI]. A-B test in UK on 2x10 participants: Good design makes the difference between a “pass” and a “fail”, and assists readers in searching for key information.

Fuchs J. ‘The Way Forward in Package Insert User Tests from a CRO’s Perspective.’. Drug Information Journal / Therapeutic Innovation and Regulatory Science. 44, 119–129. [DOI]. Germany, 1105 and 1057 participants: Precise, comprehensible, concise, and realistic rules can be better put into practice to achieve shorter and more understandable package inserts.

Fuchs J, Heyer T, Langenhan D, Hippius M. ‘New font size requirements in package inserts of medicines.’. Pharm. Ind. 72 (12), 2032–2036. [Website]. Germany: 205 participants: The minimum font size will improve readability and usability.

Fuchs J, Finke A, Hippius M. ‘Ambivalent Dosage Instructions for Children.’. Pharmazeutische Industrie. 72(4), 602–606. [Website]. Germany, 205 participants: the dosage instructions for children in package inserts should be provided by one system only – age or body weight.

Fuchs J, Werner S, Scheunpflug C, Götze EA, Elstermann K, Scheffel K, Domnowski A, Peter G, Hertzsch C, Hippius M. ‘Excessive medical information increase in package inserts.’. International Journal of Clinical Pharmacology and Therapeutics. 48(12), 781-790. [DOI]. Analysis of 271 German package leaflets: increase in length, increase of difficult words.

Hertzsch C. ‘Möglichkeiten und Grenzen einer patientenfreundlicheren Gestaltung von Packungsbeilagen im Hinblick auf Inhalte, formale Gestaltung und Textumfang’. [PhD thesis, Rheinischen Friedrich-Wilhelms-Universität, Bonn, Germany] [Website]. A thorough PhD study investigating the legal requirements, medical contents, and patient expectations in different countries.

Jay E, Alsani P, Raynor DK. ‘User testing of consumer medicine information in Australia.’. Health Education Journal. 70(4), 420–427. [DOI]. Some critical notes about user testing in UK and Australian contexts.

Lentz LR, Pander Maat H. ‘Een leesbare bijsluiter.’. Tijdschrift voor Taalbeheersing. 32(2), 128-151. [DOI]. In Dutch: 3 package leaflets, 268 participants: all three failed to reach 81% EU-norm. Revisions were effective.

Luk A, Tasker N, Raynor DKT, Aslani P. ‘Written medicine information from English-speaking countries — How does it compare?’. The Annals of Pharmacotherapy. 44, 285-294. [DOI]. A comparison of 157 documents in 6 English speaking countries, 22 UK and Irish package leaflets: too difficult.

March Cerdá JC, Prieto Rodríguez MA, Ruiz Azarola A, Lorda PS, Barrio Cantalejo I, Danet A. ‘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.] Atención Primaria. 42(1), 22–27. [DOI]. Spain, 40 participants: insufficient legibility, technical language, and small font size.

Menges K. ‘Don’t forget the fine print.’. World Pharmaceutical Frontiers. 2010. 123-127. [Trade journal] Package leaflet text cannot be short and simple, but to make it legible, clear and easy to use, it should be.

Pander Maat H, Lentz L. ‘Improving the usability of patient information leaflets.’. Patient Education and Counseling. 8, 113–119. [DOI]. The current EU regulations for patient information leaflets do not guarantee leaflet usability, the leaflets can be improved somewhat within the regulations.

Symonds T, Dean J, Coyne KS, Margolis MK, Hackett G, Edwards D, Marfatia A, Schnetzler G. ‘The ability of men to assess their suitability to take a phosphodiesterase type 5 inhibitor: an assessment of the comprehension of patient information materials.’. J Sex Med.. 7(6), 2217-2225. [DOI]. 183 UK men, Erectile dysfunction: Package leaflet was easy to understand (1,8 and 1,3 on 5-point Likert scale.

Thürmann PA, Mülders V, Simic D, Herber O, Schwappach D, Wilm S. ‘Patients’ preferences for written information about effects and undesirable side effects of drugs’. Posters. Basic & Clinical Pharmacology & Toxicology. 107, 616. [DOI]. Germany: 6 focus groups. Leaflets cause emotional reactions such as anxiety, uncertainty or dissatisfaction. Reactions range from seeking for help to non-compliance.

Valverde JL. ‘New challenges for the information on medicines in the EU.’. Pharmaceuticals Policy and Law. 12, 193–204. [DOI]. Review of different legal perspectives, Some about the border between information and promotion.

Wolschrijn H, Pijl B van der, Blom L. ‘Hoe gebruiken patiënten geneesmiddelbijsluiters?’. Farmaceutisch Tijdschrift voor België. 3, 75-80. [Website]. In Dutch: Questionnaire, 160 participants. 40% hard to understand, frequency descriptors for side effects are misunderstood.

2009

Bah N. ‘Kakovost ‘navodila za uporabo’ in preverjanje njegove jasnosti in razumljivosti’. [Quality of package leaflet, its clarity and comprehensibility]. Thesis. Fakulteta za farmacijo, Univerza v Ljubljani. [Website]. Slowenia: the analysis showed that 9 leaflets on our market did not meet the set requirements.

Delaere I, Hoste V, Peersman C, Vaerenbergh L van, Velaerts P. ‘ABOP, Automatic Optimization of Patient Information Leaflets.’. In: S. Cardey (ed.) Proceedings of the International Symposium on Data and Sense Mining, Machine Translation and Controlled Languages. 74-81. [Website]. ABOP, an Automatic optimizer for Patient Information Leaflets (PILs), aims to improve the readability of Dutch PILs. Replacing scientific terms.

Dolk S. ‘Patient Information Leaflets. Evaluation of the European translation policy and the MHRA suggestion to increase user’s awareness of key safety issues.’. MA-thesis, University of Utrecht, Faculty of Humanities. [Website]. Netherlands/UK: 80 participants: Investigating the headline section (no benefit), translations (faithful is ok), and single test (one language is ok).

Fuchs J. ‘The way forward in package insert user tests from a CRO’s perspective.’. Drug Information Journal. 44, 119–129. [DOI]. Five German package leaflets: length affects ability to locate information. Reducing the amount of text in package inserts is essential.

Fuchs J, Götze EA. ‘Patientengerechte Arzneimittelinformation in Packungsbeilagen’. Pharm. Ind.. 71(7), 1094–1100. [Website]. Updated Readability Guideline: Frequency descriptions and typesize are better, but recommendations remain imprecise.

Horwitz A, Reuther L, Andersen SE. ‘Patienters vurdering af medicinpakningernes indlægssedler’. Ugeskrift for Laeger. 171(8), 599-602 [Website]. In Danish: A total of 35 patients (32%) stated that they had stopped medication because of information about side effects on the package insert.

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.’. British Journal of Health Psychology. 14, 579–594. [DOI]. UK: Two experiments: 148 and 137 people: patients estimate risks of side effects based on frequency indicators in words and percentage.

Knapp P, Raynor DK, Woolf E, Gardner PH, Carrigan N, McMillan B. ‘Communicating the Risk of Side Effects to Patients. An Evaluation of UK Regulatory Recommendations.’. Drug Safety. 32(10), 837-849. [DOI]. UK: 187 participants. Frequency descriptors: combined descriptors (verbal and frequency bands) versus absolute descriptors.

Kohler C, Salès-Wuillemin E, Guéraud S, Masse L, Richard J-F. ‘Le rôle des connaissances dans l’utilisation d’une notice de médicament’. [The part of knowledge in the use of a patient information leaflet]. Revue européenne de psychologie appliquée. 59, 279–290. [DOI]. France: 178 people, 2 studies: participants explain the leaflet information relying on prior knowledge about medication use.

Lindström M, Tärning E, Ekedahl A. ‘Overestimation of the risk for ADR's due to the presentation in the package leaflets’. Pharmacy World & Science. 31(1), 53-54. [Website, DOI]. Sweden: 162 package leaflets: side effect frequencies. Varied descriptions may lead to confusion and impaired trust for the dispensed drug, an impaired trust that may contribute to decreased compliance.

Liukinevičiūtė V. ‘Translation problems in package leaflets for human medicine (from english to lithuanian)’. MA Thesis, Department of English Philology, Vytautas Magnus University. [website]. Lithuania, 20 package leaflets: Translations of package leaflets from English to Lithuanian are inconsistent and inadequate.

March Cerdá JC, Prieto Rodríguez MA, Ruiz Azarola A, Simón Lorda P, Barrio Cantalejo I, Daneta A. ‘Mejora de la información sanitaria contenida en los prospectos de los medicamentos: expectativas de pacientes y de profesionales sanitarios’. Atención Primaria. 42(1), 22–27. [DOI]. Spain: Flesch Readability Test: Leaflets must be adapted to the needs of the patients and professionals.

McManus J. ‘The ideology of patient information leaflets: a diachronic study’. Discourse & Communication. 3(1), 27–56. [DOI]. United Kingdom: comparing language of two sets of package leaflets (1900-1930 and 2000-2005) to show changing relation between patients and health carers.

Neubach C. ‘Deutsche und französische Packungsbeilagen: Vergleichende Fachtextanalyse von Packungsbeilagen der deutschen und französischen Sprache zwischen 1991-2007’. Dr Kovac Verlag. ISBN-13: 978-3830044857 [Website]. A comparison of German and French package leaflets within the Regulatory framework.

Nicolson DJ, Knapp P, Raynor DK, Spoor P. ‘Written information about individual medicines for consumers (Review)’. Cochrane Database of Systematic Reviews 2009. (2), CD002104. [DOI]. Evidence was not strong enough to say whether written medicines information is effective in changing knowledge, attitudes and behaviours related to medicine taking.

Nüdling S. ‘Compliance-Verbesserung durch patientenfreundliche Packungsbeilage’. Pharmazeutische Zeitung. (18). [Website]. Germany: Comprehensibility and legibility are opposed to the medical correctness and completeness of the text for the legal protection of the pharmaceutical company.

Raynor DK, Dickinson D. ‘Key Principles to Guide Development of Consumer Medicine Information—Content Analysis of Information Design Texts’. The Annals of Pharmacotherapy. 43(4), 700-706. [DOI]. Ten ground rules for good practice in writing and designing medicines information.

2008

Barrio-Cantalejo I, Simón-Lorda P, March Cerdá JC, Prieto Rodríguez A. ‘Legibilidad gramatical de los prospectos de los medicamentos de más consumo y facturación en España en 2005’. [Grammatical Readability of the Package Leaflets of the Medicinal Products most Widely Consumed and Generating the Highest Expense in Spain during 2005] Revista Española de Salud Pública. 82, 559-566. [Website]. Spain: 60 medicines: Readability formulae: Results show a low level of linguistic and grammatical readability; use of long words.

Carrigan N, Raynor DK, Knapp P. ‘Adequacy of Patient Information on Adverse Effects. An Assessment of Patient Information Leaflets in the UK’. Drug Safety. 31(4), 305-312. [DOI]. UK: Frequency indicators. 50 leaflets: Very few presented verbal descriptions alongside numerical information in the form of natural frequencies, e.g. ‘rare (affects less than 1 in 1000 people)’. .

Colledge A, Car J, Donnelly A, Majeed A. ‘Health information for patients: time to look beyond patient information leaflets’. J R Soc Med. 101, 447–453. [DOI]. Alternative format resources are an effective and viable alternative to the printed patient information leaflet.

Kohler C. ‘Rôle des connaissances sur le médicament et des objectifs de traitement dans la compréhension et l’utilisation de notices pharmaceutiques’. Thèse de doctorat en Psychologie, Université Paris 8, Saint-Denis. [Website]. The processing of information in leaflets depends on which background knowledge is activated in relation to the user’s goal.

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2004

López Marínez MI, Hernández Sánches E y. ‘Los prospectos de los fármacos como paradigma de una comunicación inefectiva.’ [Package leaflets as a paradigm of ineffective communication]. [In Spanish] Revista de Investigación Lingüística. 7, 217-230. [Website]. Analysis of package leaflets: language is not specific enough and extralinguistic mistakes.

Waarde K van der. ‘Patients, medicines and information.’. Intercom Online. 51(7), 16-18+42. [Trade journal].

2003

Mercado López S. ‘Estructura y relación de poder en los prospectos de medicamentos vendidos en España. [Structure and power relation in the written instructions of medicines sold in Spain].’. Estudios Filológicos. 38, 93-110. [DOI]. An analysis of the discourse of package leaflets from a genre analysis theoretical framework.

1992

Schuldt J. ‘Den Patienten informieren: Beipackzettel von Medikamenten.’. Gunter Narr Verlag, Tübingen. [ISBN-13: ‎978-3823345220].

1991

Mann RD. ‘Patient information in medicine.’. Parthenon Publishing, New Jersey. [ISBN-13: 9781850703679].

Rupf R. ‘Evaluation patientengerechter Arzneimittel-Information: Die Beurteilung von Packungsprospekten und das Therapieverhalten von ambulanten Patienten.’. PhD-thesis, Universität Basel.

Earlier

Joossens L. (1990) ‘De Geneesmiddelenbijsluiter in de twaalf landen van de Europese gemeenschap’. Brussel: OIVO.

Bogaert M, Stichele R Vander, Kaufman JM, Lefebvre R. (1989) ‘Patient package insert as a source of drug information.’. Elsevier Science Publishers BV, Amsterdam. [ISBN-13: 9780444810793].