Assessment of impact of medication counseling on patients' medication knowledge and compliance in an outpatient clinic in South India

The primary aim of this study was to assess the impact of patient medication counseling by comparing the levels of patient's medication knowledge and adherence achieved by medication counseling in an outpatient clinic. Ninety patients were randomized in the ratio of 1:2 into either counseled or usual care group. Their medication knowledge was assessed by a questionnaire and adherence was assessed by pill count method and self-assessment by the patients. Their medication knowledge was assessed at baseline and during their subsequent appointments. The average medication knowledge score of the counseled group versus usual care group was 13.82+/-1.8064 and 11.78+/-3.5037. Compliance score of the patients during their follow-up period was 92.29+/-4.5 and 84.71+/-11.80 for the counseled and control group, respectively. Statistical analysis of medication knowledge was carried out and all the demographic characters and number of medication were individually correlated with medication knowledge score and the difference observed was statistically significant. Compliance score of the patients was 92.29+/-4.5 and 84.71+/-11.8 % for the counseled and usual care group, respectively.     

Population pharmacokinetics of lamotrigine in Indian epileptic patients

Purpose

The aim of this analysis was to describe the pharmacokinetics of oral lamotrigine (LTG) in Indian epileptic patients using a population pharmacokinetic (PPK) modeling approach to confirm that the PK is similar to that of the Caucasian population, and to evaluate and confirm the impact of covariates predictive of inter-individual variability using a simulation platform.

Methods

Blood samples were obtained from 95 patients, and LTG plasma concentrations were determined. Population PK modeling was performed using NONMEM. A one-compartment PK model with first-order absorption and elimination was used to describe the LTG PK. Log-likelihood profiling and normalized prediction distribution errors (NPDE) were used for model evaluation. A simulation study was performed to investigate dose regimens.

Results

Clearance (CL) was estimated to be 2.27 L/h with inter-individual variability (IIV) of 29 CV%. Volume of distribution (V) was estimated to be 53.6 L (31 CV% IIV). Body weight and concurrent use of carbamazepine and valproate were identified as significant covariates on clearance. Log-likelihood profiling indicated that parameters could be estimated with adequate precision, and NPDE indicated that the model adequately described the data observed. The simulation study illustrated the impact of carbamazepine and valproate on LTG PK, and negligible differences in PK between Indian and Caucasian patients.

Conclusions

This is the first PK analysis of LTG in Indian patients. The population PK model developed adequately described the data observed. Comparison of identified PK parameters with previous PK analyses in Caucasian patients indicates that CL of LTG is similar, while V is somewhat lower compared with Caucasian patients, but this is not expected to lead to relevant differences in PK profiles during steady state.     

Preparation,validation and user-testing of pictogram-based patient information leaflets for hemodialysis patients

Background: Patient information leaflets are universally-accepted resources to educate the patients/users about their medications, disease and lifestyle modification. Objectives: The objective of the study was to prepare, validate and perform user-testing of pictogram-based patient information leaflets (P-PILs) among hemodialysis (HD) patients. Methods: The P-PILs are prepared by referring to the primary, secondary and tertiary resources. The content and pictograms of the leaflet have been validated by an expert committee consisting of three nephrologists and two academic pharmacists. The Baker Able Leaflet Design has been applied to develop the layout and design of the P-PILs. Results: Quasi-experimental pre- and post-test design without control group was conducted on 81 HD patients for user-testing of P-PILs. The mean Baker Able Leaflet Design assessment score for English version of the leaflet was 28, and 26 for Kannada version. The overall user-testing knowledge assessment mean scores were observed to have significantly improved from 44.25 to 69.62 with p value <0.001. Conclusion: The overall user opinion of content and legibility of the leaflets was good. Pictogram-based patient information leaflets can be considered an effective educational tool for HD patients.     

Cost of adverse drug reactions in a South Indian tertiary care teaching hospital

In India, very few reports on the cost of adverse drug reactions (ADRs) are available. There is a need to study this aspect of health care in order to understand the economic burden imposed by ADRs. The aim of the current work was to study the costs associated with documented ADRs in a tertiary care teaching hospital. This study was conducted in medical wards of a south Indian tertiary care teaching hospital over a 6-month period. The study protocol was assessed and approved by the institutional ethics committee. A total of 317 ADRs from 246 patients were identified during the study period. The present study used an intensive monitoring method to detect ADRs and assessed an incidence of 32.7% adverse reactions in the monitored group. The causality, severity, predictability, and preventability of the documented ADRs were assessed. The total cost to the hospital due to ADRs was found to be Rs. 1,567,397 (US$36 451). The average cost per patient hospitalized with an ADR was Rs. 4,945 (US$115). The cost per reaction was found to be higher in the Indian context, as the per capita annual expenditure on health in this country is around US$109.     

Fluorimetric determination of rivastigmine in rat plasma by a reverse phase--high performance liquid chromatographic method. Application to a pharmacokinetic study

A sensitive and selective high performance liquid chromatographic (HPLC) method was developed and validated for the rapid quantification of rivastigmine (CAS 123441-03-2) in micro quantity in rat plasma samples. The chromatographic separation was achieved with a reverse phase monomeric column C18 (4.6 x 250 mm, 5 microm) and the mobile phase consisted of acetonitrile and 20 mmol/L phosphate buffer pH 3.0 (25:75) with a flow rate of 1 mL/min. The effluents were measured by fluorimetric detection with excitation and emission wavelengths at 220 nm and 293 nm, respectively. The calibration curve was linear (r2 > 0.99) ranging from 25-3000 ng/mL and the lower limit of quantification was 25 ng/mL. The method was validated with excellent sensitivity, selectivity, accuracy, precision, recovery and stability. The method has been successfully applied in a pharmacokinetic study of rivastigmine in rats.