| アブストラクト | PURPOSE: Data mining in spontaneous reporting databases generates large numbers of signals of disproportionate reporting (SDRs) that need to be prioritised for assessment. The pharmacological relevance of drug-event associations is not considered in SDR prioritisation algorithms. This aimed to propose and test a pharmacological score for SDR prioritisation. METHODS: The Pharmacological Score for SDRs Prioritisation (PS-SP) was developed using a Delphi approach. An expert group agreed that PS-SP should include general criteria concerning SDRs and criteria concerning pharmacological relevance, and that criteria should be weighted for their risk representation. Once defined, the PS-SP was tested for prioritisation of SDRs for extrapyramidal syndrome in the French Pharmacovigilance database; the SDR classification was compared to that obtained using a traditional disproportionality approach. RESULTS: For a given drug, the general criteria retained were the reporting rate of the adverse drug reaction (ADR) and value of the 95% confidence interval (CI) lower boundary of the Reporting Odds Ratio (ROR). Pharmacological criteria consisted of the ADR reporting rate without concomitant at-risk drugs or those indicated for ADR treatment, and the value of the ROR 95% CI lower boundary as estimated in the subset of reports concerning drugs from the same therapeutic and then pharmacological class. Compared with traditional disproportionality, PS-SP prioritised specific drugs within congeners: metoclopramide, indoramin, and trimetazidine appeared as outliers within their classes; conventional antipsychotics had higher prioritisation than atypical antipsychotics. CONCLUSION: The pilot evaluation of PS-SP performed in extrapyramidal syndrome advocates for the use of pharmacological criteria in SDR prioritisation algorithms. |
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| ジャーナル名 | European journal of clinical pharmacology |
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| 投稿日 | 2014/3/7 |
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| 投稿者 | Salvo, Francesco; Raschi, Emanuel; Moretti, Ugo; Chiarolanza, Anita; Fourrier-Reglat, Annie; Moore, Nicholas; Sturkemboom, Miriam; De Ponti, Fabrizio; Poluzzi, Elisabetta; Pariente, Antoine |
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| 組織名 | Univ Bordeaux, U657, F33000, Bordeaux, France, francesco.salvo@u-bordeaux.fr. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/24595599/ |
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