First Indian study evaluating role of biochemical investigations and diagnostic tools in detection of adverse drug reactions.
OBJECTIVE
To evaluate the role of biochemical investigations (BI) and diagnostic tools (DT) in ADR detection.


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.


CONCLUSIONS
BI and DT can play very important role in ADR detection.
Postgraduate, Department of Pharmacology and Therapeutics, Govt. Medical College , Jammu- J&K, India .
Vishal R
VR
Tandon
Postgraduate, Department of Pharmacology and Therapeutics, Govt. Medical College , Jammu- J&K, India .
Vijay
V
Khajuria
Postgraduate, Department of Biochemistry, Govt. Medical College , Jammu- J&K, India .
Kapila
K
Raina
Postgraduate, Department of Pharmacology and Therapeutics, Govt. Medical College , Jammu- J&K, India .
Vivek
V
Mahajan
Postgraduate, Department of Pharmacology and Therapeutics, Govt. Medical College , Jammu- J&K, India .
Aman
A
Sharma
Postgraduate, Department of Pharmacology and Therapeutics, Govt. Medical College , Jammu- J&K, India .
Zahid
Z
Gillani
Adverse drug reaction; Biochemical investigations; Diagnostic tools