Effect of Vaccine-related Reports on Pediatric Safety Signal Detection
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1 Effect of Vaccine-related Reports on Pediatric Safety Signal Detection Sandra de Bie 1,2 ; Katia Verhamme 1 ; Sabine J Straus 1,2 ; Bruno Hh Stricker 1 ; iriam J Sturkenboom 1 1 Department of edical Informatics, Erasmus, Rotterdam, Netherlands 2 Department of Pharmacovigilance, edicines Evaluations Board, the Hague, Netherlands 27th International onference on Pharmacoepidemiology & Therapeutic Risk anagement 17 August 2011
2 onflict of interest As employees of Erasmus, JS and KV have been involved as project leaders and in analyses contracted by various pharmaceutical companies and received unconditional research grants from Pfizer, erck, Johnson&Johnson, Amgen, Roche, GSK, Boehringer, Yamanouchi and Altana. None of which are related to the subject of this study. JS has been consultant to Pfizer, Servier and Lundbeck > 3 yrs ago on issues not related to this study. The opinions and conclusions expressed in this presentation are not necessarily those of the Uppsala onitoring entre, the various national centres, or the WHO.
3 Introduction Increasing demand for pediatric safety data Pediatric Regulation; SmP guideline; List of Pediatric Needs Role of signal detection within pharmacovigilance is expanding Signal detection can play a role within pediatric pharmacovigilance Special topic in pediatrics: vaccine safety Around 45-70% of ADR-reports in children on vaccines Types of ADRs differ between vaccines and non-vaccines
4 Research hypothesis & Objective Hypothesis Pediatric signal detection is influenced by the large proportion of vaccine-related ADRs Objectives To study the influence of vaccines on disproportionality analysis, using the Reporting Odds Ratio, within pediatric ADR data Is there a change in the number of detected signals of disproportionate reporting (SDRs)?
5 Signal detection using data mining Based on disproportionate reporting do we observe what we expect? Statistics to calculate: signal of disproportionate reporting (SDRs) Frequentist approach Reporting Odds Ratio (ROR) Proportional Reporting Ratio (PRR) Bayesian statistics Information component Empirical Bayes Geometric ean (EGB) Based on 2x2 table Drug + Drug - ADR + A ADR - B D ROR= (A*D) / (*B)
6 ethods
7 ethods VigiBase data WHO-U (Uppsala onitoring entre) Established : >3.7 million Individual ase Safety Reports (ISRs) For this study we included All pediatric ISRs (0-18 years) Study period Spontaneous reports only Only ISRs with suspected causality
8 ethods 1. Reporting Odds Ratio alculated ROR for each drug-adr pair 1. Using all records 2. Subgroup analyses restriction to either vaccines or nonvaccines Vaccine-ADR pairs: Non-vaccine ADR pairs: ADR+ ADR- ADR+ ADR- Drug + Drug + Drug - Drug -
9 ethods 2. Proportional change in ROR alculated proportional change in ROR after subgroup analysis: ROR subgroup - ROR crude ROR crude x100% ROR crude: using all records ROR subgroup: after restriction to either vaccines or non-vaccines
10 ethods 3. Signal of disproportionate reporting (SDR) Definition Pairs of interest N 3 95% confidence interval ROR > 1 omparison of number of SDRs before and after subgroup analyses
11 Results
12 Pediatric drug-adr pairs within WHO-U database Drug-ADR pairs 218,840 ISRs containing 812,415 drug-adr combinations 63.7% vaccines Number of SDRs rude analyses 90,441 unique drug-adr pairs Vaccine-ADR pairs (N=11,478) 1,637 SDRs 14.3% Non-vaccine-ADR pairs (N=78,963) 13,375 SDRs 16.9%
13 hange in ROR (%) Proportional change of ROR Increase Decrease Decrease Increase Vaccine-ADR pairs Non-vaccine-ADR pairs ADRs mainly reported for non-vaccines, e.g. QT prolongation, withdrawal syndrome ADRs mainly reported for vaccines, e.g. fever convulsions, injection site reactions % vaccines in ADR (cell )
14 hange in ROR (%) hange in number of SDRs SDRs SDRs Vaccine-ADR pairs Non-vaccine-ADR pairs - 2,271 SDRs SDRs Intersection: % vaccines in cell = % vaccines in cell D Subgroup analysis beneficial harmful for for ADRs mostly reported for non-vaccines SDRs Subgroup analysis beneficial harmful for for ADRs mostly reported for non-vaccines -2, SDRs % vaccines in ADR (cell )
15 Summary After subgroup analysis based on % vaccine-related reports for ADR of interest (intersection in graph): In total 1,315 additional SDRs were detected [+9%] Vaccine-related SDRs: 1,637 2,131 [+30%] Non vaccine-related SDRs: 13,375 14,196 [+6%] No signals were lost
16 Proposed algorithm Drug-ADR pair of interest Vaccine-related? Yes No % vaccines in ADR < % vaccines in cell D % vaccines in ADR > % vaccines in cell D Yes No Yes Analyse whole dataset Subgroup analysis
17 onclusions Vaccine-related reports have a large impact on signal detection within pediatric ADR data Subgroup analyses by restriction to either vaccines or non-vaccines is beneficial when: Non-vaccines: ADR of interest is reported mainly for vaccines Vaccines: ADR of interest is reported mainly for non-vaccines Subgroup analysis based on % vaccine-related reports for ADR of interest reveals SDRs that previously were masked while no SDRs are missed
18
19
20 % Vaccines in ADR <64% % Vaccines in ADR >64%
21 % Vaccines in ADR <64% % Vaccines in ADR >64%
22 Real signals? 10% sample of the newly detected SDRs listed in SP? 60% of the new vaccine-related SDRs 74% of the new non-vaccine related SDRs
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