Programmaleider Zorg en Participatie bij Chronische aandoeningen; bijzonder hoogleraar 'Farmaceutisch zorgonderzoek', Rijksuniversiteit Groningen
Publicatie
Publicatie datum
Feasibility and value of a possible “key information section” in patient information leaflets and summaries of product characteristics of medicinal products for human use: the PILS-BOX study.
Dijk, L. van, Vervloet, M., Monteiro, S.P., Burgt, S. van der, Raynor, D.K.T. Feasibility and value of a possible “key information section” in patient information leaflets and summaries of product characteristics of medicinal products for human use: the PILS-BOX study. Nivel: Utrecht, 2014. 91 p.
Download de PDF
The objective of this study is to provide the European Commission with an assessment of the current evidence with regard to:
- the potential effects of the introduction of "key information" sections to rapidly identify key safety messages balanced with information on the benefit of medicines in patient information leaflets (PIL) and Summaries of Product Characteristics (SmPC);
- the feasibility of such a tool in the context of the European Union legislation on authorisation of medicinal products for human use and, if possible:
- to assess the potential cost/efficacy of adding a key information in the context of the EU legislation.
The assessment included an extensive literature search, a European-wide stakeholder survey and a SWOT-analysis (see box on page 8). It should be noted that the evidence found was limited and that the stakeholders – of whom only a minority responded to the survey – hold mixed opinions on the topic. Based upon the assessment we derive three major conclusions.
- the potential effects of the introduction of "key information" sections to rapidly identify key safety messages balanced with information on the benefit of medicines in patient information leaflets (PIL) and Summaries of Product Characteristics (SmPC);
- the feasibility of such a tool in the context of the European Union legislation on authorisation of medicinal products for human use and, if possible:
- to assess the potential cost/efficacy of adding a key information in the context of the EU legislation.
The assessment included an extensive literature search, a European-wide stakeholder survey and a SWOT-analysis (see box on page 8). It should be noted that the evidence found was limited and that the stakeholders – of whom only a minority responded to the survey – hold mixed opinions on the topic. Based upon the assessment we derive three major conclusions.
The objective of this study is to provide the European Commission with an assessment of the current evidence with regard to:
- the potential effects of the introduction of "key information" sections to rapidly identify key safety messages balanced with information on the benefit of medicines in patient information leaflets (PIL) and Summaries of Product Characteristics (SmPC);
- the feasibility of such a tool in the context of the European Union legislation on authorisation of medicinal products for human use and, if possible:
- to assess the potential cost/efficacy of adding a key information in the context of the EU legislation.
The assessment included an extensive literature search, a European-wide stakeholder survey and a SWOT-analysis (see box on page 8). It should be noted that the evidence found was limited and that the stakeholders – of whom only a minority responded to the survey – hold mixed opinions on the topic. Based upon the assessment we derive three major conclusions.
- the potential effects of the introduction of "key information" sections to rapidly identify key safety messages balanced with information on the benefit of medicines in patient information leaflets (PIL) and Summaries of Product Characteristics (SmPC);
- the feasibility of such a tool in the context of the European Union legislation on authorisation of medicinal products for human use and, if possible:
- to assess the potential cost/efficacy of adding a key information in the context of the EU legislation.
The assessment included an extensive literature search, a European-wide stakeholder survey and a SWOT-analysis (see box on page 8). It should be noted that the evidence found was limited and that the stakeholders – of whom only a minority responded to the survey – hold mixed opinions on the topic. Based upon the assessment we derive three major conclusions.
