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| Compiled by: Karel van der Waarde March 2023 | |||
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Bibliography: European Package Leaflets
[March 18, 2023: This list is ‘work in progress’ and unlikely to be ever complete.]
This bibliography contains references to 179 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.
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.
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.
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.
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.
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..
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 .
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.
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.
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.
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.
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.
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.
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.
Pi˜nero-L´opez 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.
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.
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.
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.
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.
Pi˜nero-L´opez MA, Modamio P, Lastra CF, Marin˜o 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.
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.
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]. .
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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.
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.
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 analyzis of the discourse of package leaflets from a genre analysis theoretical framework.
Schuldt J. ‘Den Patienten informieren: Beipackzettel von Medikamenten.’. Gunter Narr Verlag, Tübingen. [ISBN-13: 978-3823345220].
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.
Bogaert M, Stichele R Vander, Kaufman JM, Leferbvre R. (1989) ‘Patient package insert as a source of drug information.’. Elsevier Science Publishers BV, Amsterdam. [ISBN-13: 9780444810793].