ArticleBMJ open2013
Shaping medicinal product information: a before and after study exploring physicians' perspectives on the summary of product characteristics.
Article in BMJ open, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.
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Who cites it
14 citing papers in PubMed.
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- Impact of pandemic mobility restrictions on kidney transplant patients' experience: lessons on quality of care.Journal of nephrology · 2024Article
- [Patient-centered radiology : What patients want from radiologists].Radiologie (Heidelberg, Germany) · 2023Review
- Communication of anticancer drug benefits and related uncertainties to patients and clinicians: document analysis of regulated information on prescription drugs in Europe.BMJ (Clinical research ed.) · 2023Article
- Factors influencing cancer survivors' experiences with follow-up cancer care: results from the pan-Canadian Experiences of Cancer Patients in Transition Study survey.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2022Article
- Comprehensibility of Contraindications in German, UK and US Summaries of Product Characteristics/Prescribing Information-A Comparative Qualitative and Quantitative Analysis.Journal of clinical medicine · 2022Article
- Review of Clinical Questions Submitted to Norwegian Drug Information Centres Concerning Administration and Dosage to Older Patients of Relevance to Patient-Centric Care.Pharmaceutics · 2021Article
- An inventory of medicinal products causing skin rash: Clinical and regulatory lessons.Experimental and therapeutic medicine · 2019Article
- Ethnicity-Specific Drug Safety Data in European Medicines Agency Registration Dossiers, European Public Assessment Reports, and European and Singapore Drug Labels: Lost in Translation?Pharmaceutical medicine · 2019Article
- Evaluation of clarity of presentation and applicability of monitoring instructions for patients using lithium in clinical practice guidelines for treatment of bipolar disorder.Bipolar disorders · 2018Article
- Comparing cytochrome P450 pharmacogenetic information available on United States drug labels and European Union Summaries of Product Characteristics.The pharmacogenomics journal · 2017Article
- Quality assessment of structure and language elements of written responses given by seven Scandinavian drug information centres.European journal of clinical pharmacology · 2017Article
Corrections and comments
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Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo establish, in the context of the revised European Pharmacovigilance Directive and based on physicians' perspectives, how Summaries of Product Characteristics (SmPCs) could be more user friendly and better support physicians' interactions with patients, thereby improving patients' own understanding of their medicines.
designQualitative focus group discussions (step 1), development of an alternative SmPC (step 2) and an online quantitative survey (step 3) comparing the alternative SmPC to the currently approved version.
settingOffice-based physicians (n=218) from all federal states of Germany.
participants218 German physicians participated, with an equal representation of office-based general practitioners and specialists. For step 1 (n=18), physicians were recruited who frequently consulted SmPCs. OUTCOME MEASURES: Planned and performed: Mayring's qualitative content analysis of focus group discussions (step 1), rating on a five-point Likert scale of preference of current versus alternative SmPCs (step 3).
resultsPhysicians confirmed the importance of SmPCs as a comprehensive source of medicinal product information, but were moderately satisfied with the current SmPCs, utilised it infrequently and were more likely to engage additional sources of information. The alternative SmPC was consistently preferred. It differed in the way information for particular patient groups was presented, included additional sections (synopsis, checklist for patient information) and used a tabular format. Physicians indicated that SmPCs should be available with search and hyperlink functions, as well as be automatically updated and integrated in available practice software or similar solutions.
conclusionsThis research contributes to the development of an official, reliable medicinal product information system meeting the needs of a modern information society while providing the reliability of an officially authorised source. In the context of health literacy, SmPCs should be established as the primary information source for healthcare professionals to ensure compliant and safe utilisation of medicinal products.
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