title: An audit of therapeutic drug monitoring services of anticonvulsants at a tertiary care hospital in India.
abstract: BACKGROUND
  Therapeutic drug monitoring (TDM) is an important adjunct to the treatment of epilepsy. However, few studies have actually correlated plasma levels of antiepileptic drugs (AEDs) with treatment response. The present audit aimed to study (i) the association between seizure control and number of AEDs, plasma AED concentration, and concomitant use of antitubercular drugs; (ii) the pattern of indications for TDM requisitions; and (iii) the association between referral for toxicity and plasma AED concentration.
  
  
  METHODS
  This observational and retrospective study was carried out to analyze the TDM data of patients referred between January 2008 and December 2011. As per the International League Against Epilepsy Task Force 2009, patients were categorized into responders and nonresponders. Plasma AED levels were interpreted as below, within, and above the reference range.
  
  
  RESULTS
  Of 3206 TDM requisitions, 67% were monotherapy and 33% were 2 or more AEDs. Only 8% were responders as against 92% nonresponders. Of 95 patients on concomitant antituberculosis treatment, 72 were nonresponders, with odds ratio (95% confidence interval) 3.71 [2.19 to 6.23]. Breakthrough seizure (37%) was the most common indication followed by suspected toxicity and routine monitoring in 22% each and suspected nonadherence in 11% of the total requests. In 52% of patients, plasma levels were below the reference range, and they were equally distributed amongst responders and nonresponders. Among patients referred for suspected phenytoin toxicity, only 59% (50.6 to 67.8) had plasma concentrations above the reference range.
  
  
  CONCLUSIONS
  TDM continues to remain an important tool to support dose individualization when the patient is receiving multiple AEDs or other drugs such as antitubercular medicines, to assess compliance, and to monitor and treat toxicity.
authors: Department of Clinical Pharmacology, Seth GS Medical College and KEM Hospital, Mumbai, Maharashtra, India.
authors: Santosh R
authors: SR
authors: Taur
authors: Namrata B
authors: NB
authors: Kulkarni
authors: Nithya J
authors: NJ
authors: Gogtay
authors: Urmila M
authors: UM
authors: Thatte
mesh_terms: D000927:Anticonvulsants / Q000097:blood* / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D003430:Cross-Sectional Studies; D016903:Drug Monitoring / Q000379:methods*; D004827:Epilepsy / Q000097:blood / Q000188:drug therapy / Q000453:epidemiology; D005260:Female; D006801:Humans; D007194:India / Q000453:epidemiology; D008297:Male; D008485:Medical Audit / Q000379:methods*; D012189:Retrospective Studies; D062606:Tertiary Care Centers
chemical_list: D000927:Anticonvulsants