De toekomst van de geneesmiddelenbewaking vanuit een wetenschappelijk perspectief. Bert Leufkens, voorzitter CBG. Gefeliciteerd!!!

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1 De toekomst van de geneesmiddelenbewaking vanuit een wetenschappelijk perspectief Bert Leufkens, voorzitter CBG Gefeliciteerd!!!

2 Wetenschappelijke fundering farmacovigilantie Klinische farmacologie Farmacovigilantie Farmacoepidemiologie Lareb 25 years

3 Weber JCP. Epidemiology of adverse reactions to nonsteroidal antiinflammatory drugs. Adv Inflamm Res 1984; 6: Lareb 25 years

4 Meest geciteerde papers (>200) pharmacovigilance Evans, SJW; Waller, PC; Davis, S. Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports. PHARMACOEPIDEMIOLOGY AND DRUG SAFETY 2001; 10: Rodriguez, LAG; Gutthann, SP. Use of the UK General Practice Research Database for pharmacoepidemiology. BRITISH JOURNAL OF CLINICAL PHARMACOLOGY 1998;45: DuMouchel, W. Bayesian data mining in large frequency tables, with an application to the FDA spontaneous reporting system. AMERICAN STATISTICIAN 1999; 53: Brown, EG; Wood, L; Wood, S. The Medical Dictionary for Regulatory Activities (MedDRA). DRUG SAFETY 1999; 20: van Puijenbroek, EP; Bate, A; Leufkens, HGM; et al. A comparison of measures of disproportionality for signal detection in spontaneous reporting systems for adverse drug reactions. PHARMACOEPIDEMIOLOGY AND DRUG SAFETY 2002; 11: Lareb 25 years

5 Lareb Kwartaalbericht (2001, 2) Lareb 25 years

6 Lareb Kwartaalbericht (2011, 2) Lareb 25 years

7 Lareb Kwartaalbericht (2015, 2) Lareb 25 years

8 EU PV wetgeving: de kerngebieden Collection of key information on medicines Risk management plans Periodic safety update reports (PSURs) Post-authorisation safety and efficacy studies (PASS/PAES) Electronic submission of core medicine information by pharmaceutical industry Reporting by patients Regulatory action to safeguard public health Scientific committees and decisionmaking Strengthening referral procedures Better analysis and understanding of data and information EudraVigilance and signal detection Additional monitoring IT systems to support processing and analysis of data Communication with stakeholders Online publishing of information Coordination of safety messages Public hearings Lareb 25 years

9 Belangrijke functies geneesmiddelenbewaking Learning over hoe een geneesmiddel zich in de praktijk gedraagt. Fine-tuning van productkenmerken/informatie (PSURs, PASS, etc.). Signaleren van issues naar aanleiding interventies (biosimilars, generieke substitutie, andere verpakkingen, etc.). Lareb 25 years

10 Het aangeharkte NL landschap Lareb 25 years

11 BMJ 1994; 309: Crommelin D, Stolk P, Besancon L, Shah V, Midha K, Leufkens H. Pharmaceutical sciences in Nat Drug Discov 2010; 9: Lareb 25 years

12 Structuur-effect relaties levertoxiciteit NSAIDs Jesserun et al. Drug Saf 2015 DOI /s z. Lareb 25 years

13 EU Risk Management Plans (RMP) after 5 years Lareb 25 years Total of 48 products; 17 biologicals and 31 small molecule drugs. 20.7% of the uncertain-ties existing at approval had been resolved 5 years after approval However, new uncertainties were included in the RMP at a similar rate. Vermeer NS et al. Clin Pharmacol Ther 2014; 96:

14 CV ziekte van invloed op CV risico sibutramine Hayes JF et al. Int J Obes 2015 May 14. doi: /ijo Lareb 25 years

15 Adaptive licensing : verschuiving van preapproval naar post-approval Eichler HG et al. Clin Pharmacol Ther 2012; 91: ISPE Lareb EHR 25 years pragmatic 2016trial

16 Toekomst geneesmiddelenbewaking Farmacovigilantie mainstream wetenschap, methodologische verdieping, voorbij de ROR. Bijwerkingen steeds meer farmacologisch/biologisch te duiden, begrijpen, etc. Meer onderzoek effectmodificatie biomarkers/genetica. Exposure landschap zal veranderen (meer ziekenhuis, specialistische settings, interventies betalers). Big data voor verborgen associaties en testen a prior hypotheses. Relevantie van en voor klinische praktijk blijft belangrijk, dichtbij de patient (voorbij Weber). >>>>> Bright Future Lareb Lareb 25 years