Is less more? Patients' preferences for drug information leaflets

Schwappach, David; Mulders, Verena; Simić, Dušan; Wilm, Stefan; Thürmann, Petra A.

doi:10.1002/pds.2212

Cited by 28 publications

(28 citation statements)

References 40 publications

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“…For example, patients could have access to an electronic site to verify that they have been counselled or partake in a survey to provide feedback on awareness and understanding of safety risks. Pharmacy data can be useful in the provision of an insight into the effectiveness of safety warnings and clinical behaviour of HCPs [39, 40]. Pharmacists can be engaged in a registration process to be able to order and dispense medicines with potential safety concerns and certification upon educational courses to check that patients understand contents of all patient educational materials.…”

Section: Discussionmentioning

confidence: 99%

Additional Risk Minimisation Measures for Medicinal Products in the European Union: A Review of the Implementation and Effectiveness of Measures in the United Kingdom by One Marketing Authorisation Holder

2017

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IntroductionAdditional risk minimisation measures (aRMMs) for medicinal products are necessary to address specific important safety issues which may not be practically achieved through routine risk management measures alone. The implementation and determination of effectiveness for aRMMs can be a challenge as it involves multiple stakeholders. It is therefore important to have concise objectives to avoid undue burden on patients, healthcare professionals and the healthcare system.AimThe aim of this study was to examine how aRMMs are implemented and how effectiveness is assessed in the European Union (EU) using practical examples from Roche Products Limited in the United Kingdom (UK) (referred to as the ‘Company’).MethodsThree centrally authorised products were selected from the Company’s portfolio, each of which had aRMMs to address important safety concerns; specifically, teratogenicity, medication error and infections. The implementation of EU aRMMs, effectiveness checks and specific UK activities were analysed. Hard copy folders and electronic sites for Company aRMMs were used to assess process indicators. Periodic benefit-risk evaluation reports for specified time intervals and the Company safety database was used in checking safety outcomes for the selected products. For each product, the effectiveness of aRMMs was analysed based on specific process indicators and the subsequent safety outcomes. Literature searches were performed on scientific databases for the purposes of the broader study.ResultsThe main process indicators in measuring effectiveness of Company aRMMs were distribution metrics for educational materials, assessment of awareness and clinical actions among healthcare professionals (HCPs). Case reports of pregnancy, medication errors and progressive multifocal leukoencephalopathy (PML) were the outcome indicators for Erivedge®▼, Kadcyla®▼ and MabThera® (the latter specifically in autoimmune indications: rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis) respectively. No pregnancy, one medication error and 10 confirmed PML cases were reported for Erivedge®▼, Kadcyla®▼ and MabThera® respectively.ConclusionsFor the chosen products, a reasonable awareness of aRMMs amongst HCPs is a positive indicator of success in the use of educational materials. However, low response rates from surveys indicate that voluntary feedback may not always achieve the desired level of response in measuring effectiveness. There is a challenge in determining overall effectiveness of aRMMs due to a lack of defined success thresholds. Further regulatory guidance to outline the elements and desired outcomes of aRMMs will be useful for consistency in achieving successful outcomes.

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Section: Discussionmentioning

confidence: 99%

Additional Risk Minimisation Measures for Medicinal Products in the European Union: A Review of the Implementation and Effectiveness of Measures in the United Kingdom by One Marketing Authorisation Holder

2017

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“…We recommend, therefore, that the SFDA guideline demands the use of evidence-based best practices regarding how medication information should be written, designed, and delivered. Patient characteristics such as education and age have an effect on their understanding and usability of PIs 11,12,16,31. Thus, the SFDA should also require that PILs reflect the results of consultations with target patient groups, to understand fully the diverse needs of our patients.…”

Section: Discussionmentioning

confidence: 99%

Evaluation of medication package inserts in Saudi Arabia

Al-Aqeel¹

2012

DHPS

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PurposeThe aim of this study was to examine if package inserts (PIs) supplied with prescribed and over-the-counter medications in Saudi Arabia contain information relevant for the safe and appropriate use of these medications.MethodsSixty PIs for prescription-only medications (n = 37) and over-the-counter medications (n = 23) were evaluated against a set of safety criteria compiled from the literature.ResultsAnalyzed PIs were defective in many aspects. Particularly of concern were unclear dosage instructions, lack of measures to be taken when an administrative error was made, inappropriate presentation of side effects, and lack of measures to be taken if serious side effects occurred.ConclusionThis study indicated that information relevant to the safe and appropriate use of medications was not uniformly mentioned in the PIs analyzed. To avoid medication errors due to deficits in the current PIs, we recommend improvement in the existing PIs based on best practice for information content and design.

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“…8,12,16 Despite the cultural and literacy differences between the populations of different countries, the impact of information on the adverse reactions described in package leaflets has never been specifically evaluated in Portugal. Following the trends of other European countries, 2,20 almost all of the package leaflets in the sample included a description of adverse reactions (a compulsory regulatory issue) and more or less half of the package leaflets in the sample described the frequency of adverse reactions (an optional regulatory issue).…”

Section: Information On Adverse Reactionsmentioning

confidence: 99%

“…[6][7][8] takes into account the adoption of both Directives. In accordance with this law, the package leaflets should contain the following essential elements:…”

Section: Introductionmentioning

confidence: 99%

Package leaflets of the most consumed medicines in Portugal: safety and regulatory compliance issues. A descriptive study

2014

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CONTEXT AND OBJECTIVES: Package leaflets are necessary for safe use of medicines. The aims of the present study were: 1) to assess the compliance between the content of the package leaflets and the specifications of the pharmaceutical regulations; and 2) to identify potential safety issues for patients. DESIGN AND SETTING: Qualitative descriptive study, involving all the package leaflets of branded medicines from the three most consumed therapeutic groups in Portugal, analyzed in the Department of Pharmacoepidemiology, School of Pharmacy, University of Lisbon. METHODS: A checklist validated through an expert consensus process was used to gather the data. The content of each package leaflet in the sample was classified as compliant or non-compliant with compulsory regulatory issues (i.e. stated dosage and descriptions of adverse reactions) and optional regulatory issues (i.e. adverse reaction frequency, symptoms and procedures in cases of overdose). RESULTS: A total of 651 package leaflets were identified. Overall, the package leaflets were found to be compliant with the compulsory regulatory issues. However, the optional regulatory issues were only addressed in around half of the sample of package leaflets, which made it possible to identify some situations of potentially compromised drug safety. CONCLUSION: Ideally, the methodologies for package leaflet approval should be reviewed and optimized as a way of ensuring the inclusion of the minimum essential information for safe use of medicines. RESUMO CONTEXTO E OBJETIVO:As bulas dos medicamentos são necessárias para a sua utilização segura. Os objetivos do presente estudo foram: 1) avaliar a adequação entre o conteúdo das bulas e as especificações da regulação farmacêutica e 2) identificar os aspectos que potencialmente possam comprometer a utilização segura dos medicamentos pelos doentes. TIPO DE ESTUDO E LOCAL:Estudo descritivo qualitativo com a inclusão de todas as bulas dos medicamentos de marca dos três grupos terapêuticos mais consumidos em Portugal, analisados no Departamento de Farmacoepidemiologia da Faculdade de Farmácia da Universidade de Lisboa. MÉTODOS: Utilização de uma checklist para recolher os dados. A checklist foi validada por um processo de consenso entre peritos. O conteúdo de cada uma das bulas da amostra foi classificado em relação à adequação aos aspectos regulatórios obrigatórios, como a descrição das reações adversas, dose e frequência de administração, e à adequação dos aspectos regulatórios facultativos, como a frequência das reações adversas e sintomas e procedimentos em caso de sobredosagem. RESULTADOS: Foram identificadas 651 bulas. Em termos gerais, todas as bulas foram consideradas conformes em relação aos aspectos regulatórios obrigatórios. No entanto, os aspectos regulatórios opcionais foram descritos em apenas cerca de metade da amostra de bulas, o que permite a identificação de situações susceptíveis de comprometer a utilização segura dos medicamentos. CONCLUSÃO: Idealmente as metodologias de aprovação das bulas devem ...

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Is less more? Patients' preferences for drug information leaflets

Abstract: In general, participants preferred condensed, plain information in a clear and moderately colored design, but preferences towards drug information are affected by age and level of education.

Cited by 28 publications

References 40 publications

Additional Risk Minimisation Measures for Medicinal Products in the European Union: A Review of the Implementation and Effectiveness of Measures in the United Kingdom by One Marketing Authorisation Holder

Additional Risk Minimisation Measures for Medicinal Products in the European Union: A Review of the Implementation and Effectiveness of Measures in the United Kingdom by One Marketing Authorisation Holder

Evaluation of medication package inserts in Saudi Arabia

Package leaflets of the most consumed medicines in Portugal: safety and regulatory compliance issues. A descriptive study

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