AIM OF STUDY: To evaluate the role of biochemical investigations (BI) and diagnostic tools (DT) in ADR detection. MATERIALS AND METHODS: An observational prospective cross-sectional study was done using suspected ADR data collection form. RESULTS: A total of 2381 ADR related events were recorded in two years. Total number/percentage of biochemical abnormalities (BA) related ADR detection rate was 14.57% and of DT was 1.091% in contrast to 84.33% recorded with clinical presentation. Maximum cases were inward patients (87.13%), 67.02% were recorded by active surveillance. ADR detection rate at one point & detection on follow up was 56.31% Vs 46.38%. ADR detection rate of ECG, endoscopy, X-ray were 0.57%, 0.22%, 0.22% and of CT scan, MRI, DEXA scan, USG and biopsy was 0.04% each. Maximum ADRs were severe/serious, latent and Type-A in nature. Anemia (4.6%), followed by liver dysfunction (2.8%), renal dysfunction, electrolyte imbalance, hyperglycemia (1.1% each), abnormal coagulation profile (1%), decrease platelet count (0.8%), hypoglycemia (0.7%) were the most common BAs. Anti retroviral drugs (ART), tirofiban and methotrexate accounted for anemia, ART and anti tubercular drugs for liver & renal dysfunction, insulin for hypoglycemia, tirofiban, paclitaxel, capecipabine and ifosfamide for thrombocytopenia, hematuria by enoxaparin & dyslipidemia with ART were common ADRs. CONCLUSION: BI and DT can play very important role in ADR detection.
AIM OF STUDY: To evaluate the role of biochemical investigations (BI) and diagnostic tools (DT) in ADR detection. MATERIALS AND METHODS: An observational prospective cross-sectional study was done using suspected ADR data collection form. RESULTS: A total of 2381 ADR related events were recorded in two years. Total number/percentage of biochemical abnormalities (BA) related ADR detection rate was 14.57% and of DT was 1.091% in contrast to 84.33% recorded with clinical presentation. Maximum cases were inward patients (87.13%), 67.02% were recorded by active surveillance. ADR detection rate at one point & detection on follow up was 56.31% Vs 46.38%. ADR detection rate of ECG, endoscopy, X-ray were 0.57%, 0.22%, 0.22% and of CT scan, MRI, DEXA scan, USG and biopsy was 0.04% each. Maximum ADRs were severe/serious, latent and Type-A in nature. Anemia (4.6%), followed by liver dysfunction (2.8%), renal dysfunction, electrolyte imbalance, hyperglycemia (1.1% each), abnormal coagulation profile (1%), decrease platelet count (0.8%), hypoglycemia (0.7%) were the most common BAs. Anti retroviral drugs (ART), tirofiban and methotrexate accounted for anemia, ART and anti tubercular drugs for liver & renal dysfunction, insulin for hypoglycemia, tirofiban, paclitaxel, capecipabine and ifosfamide for thrombocytopenia, hematuria by enoxaparin & dyslipidemia with ART were common ADRs. CONCLUSION: BI and DT can play very important role in ADR detection.
Entities:
Keywords:
Adverse drug reaction; Biochemical investigations; Diagnostic tools
Authors: Joanna E Klopotowska; Peter C Wierenga; Susanne M Smorenburg; Clementine C M Stuijt; Lambertus Arisz; Paul F M Kuks; Marcel G W Dijkgraaf; Loraine Lie-A-Huen; Sophia E de Rooij Journal: Eur J Clin Pharmacol Date: 2012-06-07 Impact factor: 2.953
Authors: Z Bárzaga Arencibia; A López Leyva; Y Mejías Peña; A R González Reyes; E Fernández Manzano; I Choonara Journal: Eur J Clin Pharmacol Date: 2012-02-08 Impact factor: 2.953