PMID- 29143369
OWN - NLM
STAT- MEDLINE
DCOM- 20180917
LR  - 20180917
IS  - 1472-8206 (Electronic)
IS  - 0767-3981 (Linking)
VI  - 32
IP  - 2
DP  - 2018 Apr
TI  - Detection of adverse drug reactions: evaluation of an automatic data processing 
      applied in oncology performed in the French Diagnosis Related Groups database.
PG  - 227-233
LID - 10.1111/fcp.12333 [doi]
AB  - The aim of this study was to assess an automated detection method of serious 
      adverse reactions induced by oral targeted therapy (OTT) in patients with cancer, 
      performed in the French Diagnosis Related Groups (DRG) database. Patients with 
      cancer of the Poitiers hospital who started an OTT between 2014 and 2015 were 
      included. This study focused on adverse drug reaction which required inpatient 
      hospitalization (ADR(h) ). All diagnoses coded in the DRG database for hospital 
      stays that occurred within 3 months after OTT initiation were collected 
      (potential ADR(h) ). Filters (exclusion criteria) were automatically applied on 
      potential ADR(h) to exclude diagnoses that were not adverse drug reactions (false 
      positives). A pharmacovigilance review was carried out to identify ADR(h) in the 
      medical records (reported ADR(h) ). The sensitivity and specificity of the 
      detection method were estimated for each filter combinations by comparison 
      between potential and reported ADR(h) . This study included 129 patients. The 
      medical records review led to identify 19 ADR(h) (all coded in the DRG database) 
      in 14 patients. To maintain a 100% sensitivity of the method detection, the best 
      specificity obtained was 58.3% (95% IC: [55.2-61.4]).The use of restrictive 
      filters ('drug' in the diagnostic label, specific diagnosis code for adverse 
      cancer drug reaction) resulted in a 97.8% specificity (95% IC: [96.6-98.5]) with 
      a 38.2% sensitivity (95% IC: [23.9-55.0]). Our method has detected the third of 
      ADR(h) with an excellent specificity. Complementary experimentations in 
      pharmacovigilance centers are necessary to evaluate the interest of this tool in 
      routine in addition to spontaneous reporting.
CI  - (c) 2017 Societe Francaise de Pharmacologie et de Therapeutique.
FAU - Quillet, Alexandre
AU  - Quillet A
AUID- ORCID: 0000-0001-7807-9394
AD  - Service de Pharmacologie Clinique et Vigilances, CHU de Poitiers, 2 rue de la 
      miletrie, 86021, Poitiers, France.
FAU - Colin, Olivier
AU  - Colin O
AD  - Service de Neurologie, CHU de Poitiers, 2 rue de la miletrie, 86021, Poitiers, 
      France.
FAU - Bourgeois, Nicolas
AU  - Bourgeois N
AD  - Service de Pharmacologie Clinique et Vigilances, CHU de Poitiers, 2 rue de la 
      miletrie, 86021, Poitiers, France.
FAU - Favreliere, Sylvie
AU  - Favreliere S
AD  - Service de Pharmacologie Clinique et Vigilances, CHU de Poitiers, 2 rue de la 
      miletrie, 86021, Poitiers, France.
FAU - Ferru, Aurelie
AU  - Ferru A
AD  - Service d'Oncologie Medicale, CHU de Poitiers, 2 rue de la miletrie, 86021, 
      Poitiers, France.
FAU - Boinot, Laurence
AU  - Boinot L
AD  - Service d'Information Medicale, CHU de Poitiers, 2 rue de la miletrie, 86021, 
      Poitiers, France.
FAU - Lafay-Chebassier, Claire
AU  - Lafay-Chebassier C
AD  - Service de Pharmacologie Clinique et Vigilances, CHU de Poitiers, 2 rue de la 
      miletrie, 86021, Poitiers, France.
FAU - Perault-Pochat, Marie-Christine
AU  - Perault-Pochat MC
AD  - Service de Pharmacologie Clinique et Vigilances, CHU de Poitiers, 2 rue de la 
      miletrie, 86021, Poitiers, France.
AD  - INSERM, CIC 1402, CHU de Poitiers, 2 rue de la miletrie, 86021, Poitiers, France.
LA  - eng
PT  - Comparative Study
PT  - Journal Article
DEP - 20171127
PL  - England
TA  - Fundam Clin Pharmacol
JT  - Fundamental & clinical pharmacology
JID - 8710411
RN  - 0 (Antineoplastic Agents)
SB  - IM
MH  - Administration, Oral
MH  - Aged
MH  - Antineoplastic Agents/administration & dosage/*adverse effects
MH  - Automation
MH  - Data Mining/*methods
MH  - Databases, Factual
MH  - *Diagnosis-Related Groups
MH  - Drug-Related Side Effects and Adverse Reactions/*diagnosis/epidemiology/therapy
MH  - Female
MH  - France/epidemiology
MH  - Hospitalization
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Molecular Targeted Therapy/*adverse effects
MH  - Pharmacovigilance
MH  - Time Factors
OTO - NOTNLM
OT  - Diagnosis Related Groups-based information system
OT  - adverse drug reactions
OT  - automatic data processing
OT  - molecular targeted therapy
OT  - neoplasms
OT  - pharmacovigilance
EDAT- 2017/11/17 06:00
MHDA- 2018/09/18 06:00
CRDT- 2017/11/17 06:00
PHST- 2017/03/28 00:00 [received]
PHST- 2017/11/03 00:00 [revised]
PHST- 2017/11/09 00:00 [accepted]
PHST- 2017/11/17 06:00 [pubmed]
PHST- 2018/09/18 06:00 [medline]
PHST- 2017/11/17 06:00 [entrez]
AID - 10.1111/fcp.12333 [doi]
PST - ppublish
SO  - Fundam Clin Pharmacol. 2018 Apr;32(2):227-233. doi: 10.1111/fcp.12333. Epub 2017 
      Nov 27.