Coordinator research program Care Demand of the Chronically Ill and Disabled; honorary professor 'Pharmacy health services research', University of Groningen, the Netherlands
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Study on the package leaflets and the summaries of product characteristics of medicinal products for human use.
Dijk, L. van, Monteiro, S.P., Vervloet, M., Bie, J. de, Raynor, D.K.T. Study on the package leaflets and the summaries of product characteristics of medicinal products for human use.: , 2015.
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The objective of this study is to provide the European Commission with:
1. An analysis of positive points and possible shortcomings of PILs and SmPC as a source of information about medicines for healthcare professionals and the public;
2. An analysis of the causes of identified shortcomings, and their (potential) consequences for the health of patients;
3. Recommendations to improve the SmPC and the PIL in order to increase their value for health care professionals and the general public, as well as their contribution to patient safety and the rational use of medicine.
The assessment included an extensive literature search, a European-wide stakeholder survey and an online discussion forum (see box, page 12). Before going into the conclusions of the assessment we summarise the legal context of the PIL and SmPC.
1. An analysis of positive points and possible shortcomings of PILs and SmPC as a source of information about medicines for healthcare professionals and the public;
2. An analysis of the causes of identified shortcomings, and their (potential) consequences for the health of patients;
3. Recommendations to improve the SmPC and the PIL in order to increase their value for health care professionals and the general public, as well as their contribution to patient safety and the rational use of medicine.
The assessment included an extensive literature search, a European-wide stakeholder survey and an online discussion forum (see box, page 12). Before going into the conclusions of the assessment we summarise the legal context of the PIL and SmPC.
The objective of this study is to provide the European Commission with:
1. An analysis of positive points and possible shortcomings of PILs and SmPC as a source of information about medicines for healthcare professionals and the public;
2. An analysis of the causes of identified shortcomings, and their (potential) consequences for the health of patients;
3. Recommendations to improve the SmPC and the PIL in order to increase their value for health care professionals and the general public, as well as their contribution to patient safety and the rational use of medicine.
The assessment included an extensive literature search, a European-wide stakeholder survey and an online discussion forum (see box, page 12). Before going into the conclusions of the assessment we summarise the legal context of the PIL and SmPC.
1. An analysis of positive points and possible shortcomings of PILs and SmPC as a source of information about medicines for healthcare professionals and the public;
2. An analysis of the causes of identified shortcomings, and their (potential) consequences for the health of patients;
3. Recommendations to improve the SmPC and the PIL in order to increase their value for health care professionals and the general public, as well as their contribution to patient safety and the rational use of medicine.
The assessment included an extensive literature search, a European-wide stakeholder survey and an online discussion forum (see box, page 12). Before going into the conclusions of the assessment we summarise the legal context of the PIL and SmPC.
