1. Use of EVDAS for monitoring purposes Piotr Nowicki, MD Warsaw, 06-Oct-2011

2. Presentation Content Job Definition Challenges Use of the EVDAS system Further Questions / Solution Proposal Outlook / Further Development Points to Consider Q&A Piotr Nowicki, MD pnow@pragmalog.com2

3. Job Definition The scope of work is to monitor the SDRs (signals of disproportionate reporting) over time The monitoring reports are sent every month There are about 20 products to be monitored The report format provided: pdf – files Piotr Nowicki, MD pnow@pragmalog.com3

4. PDF Report Sample - Header Piotr Nowicki, MD pnow@pragmalog.com4

5. PDF Report Sample – Marked SDRs Piotr Nowicki, MD pnow@pragmalog.com5

6. Initial Feasibility Calculations AllSDRSDR % ALBENDAZOLE2010-03-28 399287,02 AMINOLEVULINIC ACID2010-03-28 2100,00 BICALUTAMIDE2010-03-28 775182,32 FINASTERIDE2010-03-28 1033676,49 FLUTICASONE2010-03-28 654314,74 HUMAN THROMBIN, HUMAN CLOTTABLE PROTEIN CONTAINING MAINLY FIBRINOGEN AND FIBRONECTIN2010-03-28 9222,22 HYOSCINE2010-03-28 232198,19 LOPERAMIDE2010-03-28 363133,58 METAMIZOLE2010-03-28 480234,79 METRONIDAZOLE2010-03-28 1266473,71 MONTELUKAST2010-03-28 1083353,23 NITRENDIPINE2010-03-28 26962,23 OLANZAPINE2010-03-28 28701635,68 OMEPRAZOLE2010-03-28 1882432,28 ORLISTAT2010-03-28 1455644,40 PERINDOPRIL2010-03-28 349226,30 RISEDRONATE SODIUM2010-03-28 194419910,24 RISPERIDONE2010-03-28 25371134,45 RIVASTIGMINE2010-03-28 1282634,91 ROSUVASTATIN2010-03-28 1427412,87 THIAMAZOLE2010-03-28 618284,53 Total 2094810254,89 Piotr Nowicki, MD pnow@pragmalog.com6

7. Challenges The pdf reports provided have to be reviewed manually The numbers of drug-events combinations is relatively high - approx. 20000 a month ; number of SDRs approx. 1000 (~5%) The drug – event combinations are provided cumulatively Piotr Nowicki, MD pnow@pragmalog.com7

8. Challenges Cont. Emerging Issues: – How to get more information - case details? – How to see trends ? – How to track the data (i.e. see the differences over time for the drug-events pairs of interest) ? – How to document the decisions taken ? Piotr Nowicki, MD pnow@pragmalog.com8

9. Performing Data Analysis with EVDAS Variety of Online Reports SDR over time charts Drill down possibilities (from SDR to Case level) Piotr Nowicki, MD pnow@pragmalog.com9

10. Reaction Monitoring Report Piotr Nowicki, MD pnow@pragmalog.com10

11. Case List Piotr Nowicki, MD pnow@pragmalog.com11

12. Case Details Piotr Nowicki, MD pnow@pragmalog.com12

13. Dynamic PRR Report – SDR over Time Piotr Nowicki, MD pnow@pragmalog.com13

14. PRR Monitor report displaying the PRR Confidence Intervals Piotr Nowicki, MD pnow@pragmalog.com14

15. PRR Monitor (CHI^2) report Bold lines represent the thresholds of PRR =2 and chi^2 = 4 Piotr Nowicki, MD pnow@pragmalog.com15

16. Further Questions/Solution Proposal Outstanding questions – How to monitor the data for each pdf report provided every month? – partially solved with EVDAS – How to document the decisions taken and track them over time? Piotr Nowicki, MD pnow@pragmalog.com16

17. Reaction Monitoring Report (simple format export) Piotr Nowicki, MD pnow@pragmalog.com17

18. Reaction Monitoring Report Export ( drill down with additional counts ) Piotr Nowicki, MD pnow@pragmalog.com18

19. Conversion of the files (Extract data from the header and create columns: Product name, Retrieval date, Remove number separators etc.) Piotr Nowicki, MD pnow@pragmalog.com19

20. Imported Data Piotr Nowicki, MD pnow@pragmalog.com20

21. Filtered view of the imported data Piotr Nowicki, MD pnow@pragmalog.com21

22. Monitoring Charts Piotr Nowicki, MD pnow@pragmalog.com22

23. Monitoring Charts with assessment fields Piotr Nowicki, MD pnow@pragmalog.com23

24. Outlook / Further development Add case details – import of cases needed Additional charts: – Monitor the changes in the „process” Common sense approach definition of rules – Effective use of available Product data: – SPC and Mapping Algorithms (further issues to be solved e.g. coding) Piotr Nowicki, MD pnow@pragmalog.com24

25. Process in Control? Piotr Nowicki, MD pnow@pragmalog.com25

26. Common sense approach - Rules Piotr Nowicki, MD pnow@pragmalog.com26

27. Points to Consider Support from EVDAS? Reports in text file format e.g. (CSV) Files with case list but with different/additional columns? Full case details in another format ? Better performance to be expected? Other solutions? Piotr Nowicki, MD pnow@pragmalog.com27

28. Q & A Piotr Nowicki, MD pnow@pragmalog.com28

29. Piotr Nowicki, MD pnow@pragmalog.com29

30. Overview Piotr Nowicki, MD pnow@pragmalog.com30

31. Overview Piotr Nowicki, MD pnow@pragmalog.com31