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Screening for Adverse Reactions in Eudravigilance

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Screening for Adverse Reactions in Eudravigilance 19 December 2016 EMA/849944/2016 Inspections, Human Medicines, Pharmacovigilance and Committees Division Screening for adverse reactions in EudraVigilance Table of contents 1. Introduction ............................................................................................ 3 2. Scope....................................................................................................... 4 3. An integrated approach to signal detection ............................................. 5 3.1. Considerations related to performance .................................................................... 5 4. Screening for adverse reactions in the total population .......................... 6 4.1. Disproportionality methods .................................................................................... 6 4.1.1. Components of the statistical signal detection system based on disproportionality methods .................................................................................................................... 6 4.1.2. Selection of a disproportionality method ............................................................... 7 4.1.3. Thresholds defining SDRs in EudraVigilance .......................................................... 9 4.1.4. Subgroup analyses and stratification .................................................................. 11 4.1.5. Some operational choices ................................................................................. 15 4.2. Alternatives to SDR based on clinical information ................................................... 15 4.2.1. Characterisation of additional methods ............................................................... 16 4.3. Conclusions on screening methods for the general population .................................. 17 5. Interpretation of screening results based on spontaneous report data . 18 5.1. Review of ICSRs ................................................................................................. 19 5.2. Review of other evidence .................................................................................... 19 6. Methods aimed at specific patient populations ...................................... 20 6.1. Paediatric population .......................................................................................... 20 6.1.1. Disproportionality methods ............................................................................... 20 6.1.2. Clinical based methods ..................................................................................... 21 6.1.3. Conclusions .................................................................................................... 21 6.2. Geriatric population ............................................................................................ 22 6.2.1. Disproportionality methods ............................................................................... 22 6.2.2. Clinical based methods ..................................................................................... 23 6.2.3. Conclusions .................................................................................................... 23 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5520 Send a question via our website www.ema.europa.eu/contact An agency of the European Union © European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged. 7. Other areas of interest .......................................................................... 23 7.1. Abuse, misuse, overdose, medication error or occupational exposure ........................ 23 7.2. Positive re-challenge ........................................................................................... 23 7.3. Literature cases ................................................................................................. 24 7.4. Conclusions ....................................................................................................... 24 8. Application to other reporting systems .................................................. 24 9. Areas for further development .............................................................. 24 10. Conclusion ........................................................................................... 26 11. List of abbreviations ............................................................................ 27 12. Reference ............................................................................................ 28 13. Appendix ............................................................................................. 30 13.1. ROR calculation ................................................................................................ 30 13.2. Methodological considerations for subgroup analysis and stratification ..................... 31 13.3. Additional information for Figure 1 and 3 and summary table ................................. 33 Screening for adverse reactions in EudraVigilance EMA/849944/2016 Page 2/34 1. Introduction When a pharmaceutical product is first authorised for use in clinical practice the information regarding its use is usually only that obtained from the programme of clinical trials supporting the marketing authorisation application. While these trials will have demonstrated a positive benefit-risk under carefully monitored conditions, adverse reactions that are rare, only emerge after prolonged exposure, or affect types of patients under-represented in clinical trials may remain undetected. To identify such reactions an elaborate system of post-authorisation surveillance is conducted by pharmaceutical companies, regulators and the World Health Organisation. Many sources of data are used to detect adverse drug reactions (ADRs) but one kind of data collection in particular, the collection of individual case safety reports (ICSR) concerning suspected ADRs in people exposed to medicines, is specifically performed for this purpose. The data processing system for ICSRs used by the EU regulatory network is called EudraVigilance (EV) and includes a management system for reporting and evaluating suspected ADRs of medicinal products marketed in the European Economic Area (EEA). The first version was launched in December 2001. When EV was first set up, direct access to the data was limited to regulatory authorities. At the current time (2016) plans are under way to extend routine access to Marketing Authorisation Holders (MAH) and the Uppsala Monitoring Centre. Moreover, access is granted in various forms to research groups and the public. Hence, there is increased interest in how the processes of signal detection are performed in EV. Regulatory guidance is provided concerning signal detection in spontaneous report data in the Annex to Good Pharmacovigilance Practice Module IX. The purpose of this guidance is to give a more discursive account of the potential uses of EV in screening for ADRs and to clarify the changes implemented and the rationale behind them based on evidence from recent research activities, including the IMI PROTECT project (http://www.imi-protect.eu/). Thus, this guidance should be viewed as a scientific discussion, not as providing regulatory requirements. This guidance also updates and supersedes the previous guideline on the use of statistical signal detection in EV (EMEA/106464/2006 rev. 1) The focus of the document is, where possible, on evidence based recommendations; therefore the structure followed throughout is to provide results of studies or empirical evidence first and then detail how these have been translated in recommendations and actual implementation in EV. A section is dedicated to each of the populations for which specific methods are implemented: total population, paediatric and geriatric. In each section the approach is first to discuss the more classical disproportionality methods that are the starting points of most of the signal detection systems and then alternative rule-based methods using clinical information. Finally, a simple approach is proposed to integrate the disproportionality and alternative methods efficiently. After the different populations are described, a section is dedicated to other approaches that can potentially influence the decision of the pharmacovigilance experts to further investigate a drug-event combination (DEC). When the screening methods identify a DEC for further investigation, it can be evaluated in a number of ways that will be discussed in section 5. Only after such evaluation can a DEC be considered as a signal related to the safety of the medicinal products. It should also be noted that, when a signal has been identified from other sources of evidence, the absence of a positive screening result in EV does not refute the signal. Two tools are used in EV for signal detection. The electronic Reaction Monitoring Report (eRMR) is a standard report that provides summarised signal detection data from EV. The EudraVigilance Data Analysis System (EVDAS), which operates on the EudraVigilance Data Warehouse, is used in Screening for adverse reactions in EudraVigilance EMA/849944/2016 Page 3/34 conjunction with the eRMR to enhance signal detection1. It contains many predefined tables and graph formats for report presentation and has a variety of functions useful in the later stage of the signal management activities. The eRMR and the reports providing statistical information in EVDAS incorporate many of the principles discussed in this guidance;
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