Deriving meaningful insights from clinical trial and postmarketing safety data: Perspectives from India.

Today, drug safety data collection in India is both manual and electronic with reporting of potential overlapping and duplicate data, which is likely incomplete for further review and analysis. Furthermore, standardized data collection and timelines are not aligned with international standards. Complete coverage of safety data from all sources throughout the life of the drug cannot be ensured.

Elderly patients' participation in clinical trials.

The elderly population is a large and the fastest-growing portion of the population worldwide. The elderly make up the lion's share of patients for certain health conditions including cancer, cardiovascular disease, arthritis, and Parkinson's disease, among others in most parts of the world. Furthermore, elderly make up the majority of patients for many medications treating chronic conditions.

Potentially inappropriate medication use in Indian elderly: comparison of Beers' criteria and Screening Tool of Older Persons' potentially inappropriate Prescriptions.

Aim: To compare Beers' criteria (BC) and Screening Tool of Older Persons' potentially inappropriate Prescriptions (STOPP) for prevalence, specificity, sensitivity and predictors for potentially inappropriate medication (PIM) use.

Methods: Patients aged ≥ 60 years from medicine wards of a tertiary care hospital were included. Comparisons between BC and STOPP were made using Pearson's χ(2) -test for categorical variables and Mann-Whitney U-test for continuous variables.

Prescribing patterns and predictors of high-level polypharmacy in the elderly population: A prospective surveillance study from two teaching hospitals in India.

Background: Polypharmacy has been reported to increase the risks for inappropriate prescribing, adverse drug reactions, geriatric syndromes, and morbidity and mortality in elderly populations in the United States and Europe. Data on prescribing patterns and polypharmacy in the elderly population in India are limited.

Objectives: The aims of this study were to assess prescribing patterns and to determine the predictors of high-level polypharmacy in the elderly population in 2 tertiary care hospitals in India.

Valproic acid-induced abnormal behavior.

A 12-year-old female was admitted to hospital with complaints of abnormal behavior. She was on valproic acid 200mg twice daily and clobazam 5mg at night for the past 13 weeks for her complex partial seizures with secondary generalized seizures. On day 60 of the treatment with valproic acid she developed behavioral disturbances and initiated treatment with tablet chlorpromazine, olanzapine and risperidone.

Adverse drug reactions to antiretroviral therapy (ART): an experience of spontaneous reporting and intensive monitoring from ART centre in India.

Purpose: To assess the nature, severity, predictability and preventability of adverse drug reactions (ADRs) and to identify risk factors for antiretroviral ADRs.

Methods: Enrolled ambulatory patients were intensively monitored for ADRs. Spontaneously reported ADRs by clinicians were also included.