Search

The article focuses on the significance of active surveillance in ameliorating the hospital-based adverse drug event (ADE) monitoring in India. It was found out that active surveillance is more effective in detecting the adverse events to newly marketed drugs than through the spontaneous reporting (SR) system. It has been suggested that SR-based hospital ADE monitoring system should be added to the active surveillance system to supervise the safety profile of newly marketed drugs at hospitals.

Although mycophenolate is widely prescribed in India, therapeutic drug monitoring of mycophenolic acid is not performed in most centers. This could be due to many factors such as the large investment and expertise required for high performance liquid chromatography, or the high costs involved as specialized refrigeration is required when transporting patient specimens to the laboratories with the facility to analyze MPA. The Clinical Pharmacology unit of the Christian Medical College Hospital routinely monitors the area under the curve of MPA. In order to determine if this unit could act as a central laboratory for MPA monitoring, the stability of MPA in plasma under a series of storage and transport conditions was assessed. The procedures involved the analysis of plasma specimens from patients on mycophenolate mofetil and blank plasma spiked with MPA reference standard. A range of low and high concentrations were separately analyzed to confirm long term and short term stability. The measured concentrations of MPA showed no significant change over 5 months when stored at -20° or over five days under conditions encountered during transport. [ABSTRACT FROM AUTHOR]

A response by B. S. Mathew, D. H. Fleming, S. J. Chandy and Vinohar Balraj to a letter to the editor about their article "An Objective Measure of Antibiotic Use for Febrile Illness in a Rural Paediatric Population Using High Performance Liquid Chromatography," in the 2010 issue is presented.

Study design:Prospective, randomized, double-blind clinical trial.Objectives:To evaluate the efficacy of topical phenytoin solution in treating pressure ulcers among patients with spinal cord disorders and to evaluate the systemic absorption of topical phenytoin.Setting:Physical Medicine and Rehabilitation Unit, Christian Medical College, Vellore, India.Methods:Twenty-eight patients with stage 2 pressure ulcers were randomized to receive either phenytoin solution (5 mg/ml) or normal saline dressing on their ulcers once daily for 15 days. Efficacy of the treatment was determined by assessing the reduction in Pressure Ulcer Scores for Healing (PUSH 3.0), ulcer volume and ulcer size as on day 16. Serum phenytoin concentrations were estimated to determine the systemic absorption of topical phenytoin.Results:Statistically insignificant but marginally higher reduction in PUSH 3.0 scores and ulcer size were seen with topical phenytoin treatment. Systemic absorption of topical phenytoin was negligible. No adverse drug events were detected during the study.Conclusions:Phenytoin solution is a safe topical agent that accelerates healing of pressure ulcers. However, its efficacy is only slightly more than normal saline treatment.Spinal Cord (2007) 45, 739–743; doi:10.1038/sj.sc.3102029; published online 6 February 2007 [ABSTRACT FROM AUTHOR]

Background: Therapeutic drug monitoring for mycophenolic acid (MPA) is increasingly being advocated. The present therapeutic range relates to the 12-hour area under the serum concentration time profile (AUC). However, this is a cumbersome, tedious, cost restricting procedure. Is it possible to reduce this sampling period? Aim: To compare the AUC from a reduced sampling strategy with the full 12-hour profile for MPA. Settings and Design: Clinical Pharmacology Unit of a tertiary care hospital in South India. Retrospective, paired data. Materials and Methods: Thirty-four 12-hour profiles from post-renal transplant patients on Cellcept® were evaluated. Profiles were grouped according to steroid and immunosuppressant co-medication and the time after transplant. MPA was estimated by high performance liquid chromatography with UV detection. From the 12-hour profiles the AUC up to only six hours was calculated by the trapezoidal rule and a correction factor applied. These two AUCs were then compared. Statistical Analysis: Linear regression, intra-class correlations (ICC) and a two-tailed paired t-test were applied to the data. Results: Comparing the 12-hour AUC with the paired 6-hour extrapolated AUC, the ICC and linear regression (r²) were very good for all three groups. No statistical difference was found by a two-tailed paired t-test. No bias was seen with a Bland Altman plot or by calculation. Conclusion: For patients on Cellcept® with prednisolone ± cyclosporine the 6-hour corrected is an accurate measure of the full 12-hour AUC. [ABSTRACT FROM AUTHOR]

A letter to the editor is presented about an objective method for measuring antibiotic use for febrile illness in a rural paediatric population using high performance liquid chromatography.