Flow charts for the selection of gene–drug interactions are given in We grouped the European agencies EMA, FIDMD, and MEB together as the EMA/FM. 0000003044 00000 n
drug-seeking behaviour, dose escalation, development of tolerance. Such variability in judgment between the clinical and regulatory agencies can be anticipated to be inherent to the different manners by which they evaluate available information. R.S., L.S., J.S., and M.I.S. Furthermore, different decisions made in various groups of experts are partly dependent on the issue that there are no firm facts that have to be fulfilled for each type of label and many decisions are based on more subtle data and different interpretations of the published results. Based on these 126 drugs in addition to the 54 above, the consensus of actionable pharmacogenomic labeling between the FDA and the EMA/FM was only 54%. The document acts as a basis of information on the use of medicines for healthcare professionals. It is evident that the CPIC and DPWG guidelines are very thorough and constructed by many different experts in the field, showing a high level of consistency.In general, an important note to be made is that there are sometimes differences in the SmPCs of different companies or drug formulations, despite having the same active ingredient. �,��j[Z�G]xiv�7�:�� ��T�N(����_͵���;z��V��u20xݺ�� *��ҠYZò��ғ�Q.�s:�o\�8l)�]�7č��l�"�s�;�8����+�\^�l�&ۦ uճ����I��R|7'%P"]�N�&tVDGDG6�2ϓ�YG�&�t����w �p�=�t���[�X��luI7�;͓D�,�k��)]�� V|a�U�@��J�M0���t Т� �E�w���4z�'� }ʖ $��A~6q R�J�H�f������ 1)��@m��!��z�2:Ph�E"n `� D��� %� A1�&50�vXFH$��@JA�F+p�a`��2�|p�RS���s�v��B��7�U8&����*ˆ���@-��)L�OK��� =�O
We further compared 450 additional drugs, lacking CPIC or DPWG guidance, and found 126 actionable gene–drug labels by the FDA and/or the EMA/FM.
We compared pharmacogenomic guidance by Clinical Pharmacogenetics Implementation Consortium (CPIC), Dutch Pharmacogenetics Working Group (DPWG), the US Food and Drug Administration (FDA), and by the European agencies the European Medicines Agency (EMA), College ter Beoordeling van Geneesmiddelen Medicines Evaluation Board (CBG‐MEB), and Federal Institute for Drugs and Medical Devices (FIDMD), collectively assigned as EMA/FIDMD+MEB shortened as EMA/FM. Selection of drugs for comparison 1, comparing CPIC, DPWG, EMA/FM, and FDA, was based on all CPIC and DPWG guidelines that contain recommendations (55 drugs with 65 GDIs). As shown in The results presented show a considerable extent of variability in the information for different pharmacogenomics biomarkers by the CPIC, DPWG, as well as by the regulatory bodies of the EMA/FM and the FDA. The distribution of the label categories among the 191 gene–drug interactions with actionable information in the SmPCs by either the FDA and/or EMA/FM are summarized in Figure 2 a . Two comparisons were made, the first one focusing on drugs that have guidelines by the CPIC and/or DPWG, and a second screen for drugs lacking CPIC or DPWG guidelines. SmPC contains more information than a Package Leaflet. startxref
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☑ We find that there is a huge discrepancy between information given by the CPIC and DPWG and the pharmacogenomic information in drugs labels in the corresponding SmPC. 0000001313 00000 n
wrote the manuscript.
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