PMID- 24634163 OWN - NLM STAT- MEDLINE DCOM- 20150309 LR - 20211021 IS - 1179-1942 (Electronic) IS - 0114-5916 (Print) IS - 0114-5916 (Linking) VI - 37 IP - 4 DP - 2014 Apr TI - Dose-specific adverse drug reaction identification in electronic patient records: temporal data mining in an inpatient psychiatric population. PG - 237-47 LID - 10.1007/s40264-014-0145-z [doi] AB - BACKGROUND: Data collected for medical, filing and administrative purposes in electronic patient records (EPRs) represent a rich source of individualised clinical data, which has great potential for improved detection of patients experiencing adverse drug reactions (ADRs), across all approved drugs and across all indication areas. OBJECTIVES: The aim of this study was to take advantage of techniques for temporal data mining of EPRs in order to detect ADRs in a patient- and dose-specific manner. METHODS: We used a psychiatric hospital's EPR system to investigate undesired drug effects. Within one workflow the method identified patient-specific adverse events (AEs) and links these to specific drugs and dosages in a temporal manner, based on integration of text mining results and structured data. The structured data contained precise information on drug identity, dosage and strength. RESULTS: When applying the method to the 3,394 patients in the cohort, we identified AEs linked with a drug in 2,402 patients (70.8 %). Of the 43,528 patient-specific drug substances prescribed, 14,736 (33.9 %) were linked with AEs. From these links we identified multiple ADRs (p < 0.05) and found them to occur at similar frequencies, as stated by the manufacturer and in the literature. We showed that drugs displaying similar ADR profiles share targets, and we compared submitted spontaneous AE reports with our findings. For nine of the ten most prescribed antipsychotics in the patient population, larger doses were prescribed to sedated patients than non-sedated patients; five antipsychotics [corrected] exhibited a significant difference (p<0.05). Finally, we present two cases (p < 0.05) identified by the workflow. The method identified the potentially fatal AE QT prolongation caused by methadone, and a non-described likely ADR between levomepromazine and nightmares found among the hundreds of identified novel links between drugs and AEs (p < 0.05). CONCLUSIONS: The developed method can be used to extract dose-dependent ADR information from already collected EPR data. Large-scale AE extraction from EPRs may complement or even replace current drug safety monitoring methods in the future, reducing or eliminating manual reporting and enabling much faster ADR detection. FAU - Eriksson, Robert AU - Eriksson R AD - NNF Center for Protein Research, Department of Disease Systems Biology, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200, Copenhagen, Denmark. FAU - Werge, Thomas AU - Werge T FAU - Jensen, Lars Juhl AU - Jensen LJ FAU - Brunak, Soren AU - Brunak S LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't PL - New Zealand TA - Drug Saf JT - Drug safety JID - 9002928 RN - 0 (Antipsychotic Agents) SB - IM EIN - Drug Saf. 2014 May;37(5):379 MH - Adolescent MH - Adverse Drug Reaction Reporting Systems MH - Aged MH - Aged, 80 and over MH - Antipsychotic Agents/*administration & dosage/*adverse effects MH - Data Collection/methods MH - Data Mining MH - Drug-Related Side Effects and Adverse Reactions/*etiology MH - Electronic Health Records MH - Female MH - Humans MH - Inpatients MH - Male MH - Mental Disorders/*drug therapy MH - Middle Aged MH - Young Adult PMC - PMC3975083 COIS- Thomas Werge has previously received consulting fees from H. Lundbeck A/S. Robert Eriksson, Thomas Werge, Lars Juhl Jensen and Soren Brunak have no other conflicts of interest that are directly relevant to the content of this article. EDAT- 2014/03/19 06:00 MHDA- 2015/03/10 06:00 PMCR- 2014/03/15 CRDT- 2014/03/18 06:00 PHST- 2014/03/18 06:00 [entrez] PHST- 2014/03/19 06:00 [pubmed] PHST- 2015/03/10 06:00 [medline] PHST- 2014/03/15 00:00 [pmc-release] AID - 145 [pii] AID - 10.1007/s40264-014-0145-z [doi] PST - ppublish SO - Drug Saf. 2014 Apr;37(4):237-47. doi: 10.1007/s40264-014-0145-z.