Translating Phenytoin Therapeutic Drug Monitoring for Potential Utilities to Pharmacovigilance: Capacity Raking an Established Tertiary Care Service
Journal Title: INTERNATIONAL JOURNAL OF SCIENTIFIC STUDY - Year 2018, Vol 6, Issue 5
Abstract
Introduction: Properly applied therapeutic drug monitoring (TDM) is a proven method of reducing adverse drug events and hence health-care costs. It involves laboratory measurement of a chemical parameter of difficult to manage therapeutic drugs at the designated interval for optimization of therapy with these drugs. Objectives: The objectives of the study were optimization of Pharmacodynamic responses by pharmacokinetic based adjustments in drug use taking phenytoin as a probe and investigation of the quality of requisitions made for TDM Materials and Methods: This was a hospital-based prospective study done in cases of idiopathic epilepsy (n = 90). Pd analysis was performed by evaluating the clinical response to phenytoin therapy, adverse drug reaction monitoring, and causality categorization using the WHO-UMC causality categories and CDSCO criteria for the seriousness of adverse events. Phenytoin PK analysis was done by enzyme immunoassay technique. An audit of 135 requisitions for the quality of the information received was done by devising a scoring scale. Results: Pd analysis of 90 patients revealed that 79% of patients responded positively to phenytoin after treatment optimization or could be tapered off phenytoin successfully after achieving seizure control and remained seizure free for the period of follow-up. A total of 8% of patients needed a second antiepileptic drug in addition to phenytoin and 13% of patients were discontinued from phenytoin either because of adverse effects or because phenytoin did not modify seizure activity in these patients. Gum hypertrophy was the most common adverse effect seen in this patient population. PK data for 87 patients revealed that mean serum phenytoin trough (C0) concentration was 12.105 ± 0.433 μg/ml, mean serum phenytoin peak (C4) concentration was 16.895 ± 0.571 μg/ml, and mean area under plasma concentration-time curve was 57.99 ± 1.76 μg/ml/h. Audit of 135 TDM requisitions revealed that 40% requisitions were graded as unacceptable, 25% requisitions were of poor quality, 26% requisitions were incomplete, 9% requisitions were satisfactory, while none of the requisitions was complete. Conclusion: TDM remains a largely underutilized tertiary care resource and best practice guidelines and professional standards of practice need to be adopted for optimum utilization of this resource.
Authors and Affiliations
Shazia Kousar, Fayaz Ahmad Wani, Zaid Ahmad Wani, Arjumand Nazir, Ahmad Tauqeer Zahid, Z A Wafai
Keywords
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