An audit of drug package insert: a survey based study in India

Background: The primary source of drug information is a Package Insert. It is a printed leaflet that contains information based on regulatory guidelines for the safe and effective use of a drug. It is also known as prescription drug label or prescribing information. Regulatory requirements for drug package inserts or leaflets vary across nations. United States-Food and Drug Administration (US-FDA) and European Medicines Agency (EMA) amend their regulations governing the content and format of labelling for drug products from time to time. US-FDA has published a revised guideline in the Federal Register of January 2006, which is being followed by pharmaceutical industry of the country.Methods: Around 192 package inserts were collected from pharmacies located at different areas. They were analyzed according to Sections 6.2 and 6.3 of Schedule D of Drugs and Cosmetics Rules, 1945.Results: Out of 192 package inserts, most available information in therapeutic indications is Posology and method of administration (97.3%) followed by Contra-indications(93.2%) in pharmaceutical information, it is Special precautions for storage (77%) followed by Shelf life in the medical product as packaged for sale (33.8%).Conclusions: Contents of the package inserts should be complete, reliable and up to date. This can be a step forward for ethical and effective dissemination of healthcare services in our growing society. Therefore, recommended to update the existing package inserts based on criteria mentioned in the Schedule D of Drug and Cosmetic Act, 1945

Erratum to: Distribution and trends in mesothelioma mortality in Italy from 1974 to 2006

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Prevalence of gastroschisis at birth: Retrospective study

[No abstract available

Stargardt disease: clinical features, molecular genetics, animal models and therapeutic options

Stargardt disease (STGD1; MIM 248200) is the most prevalent inherited macular dystrophy and is associated with disease-causing sequence variants in the gene ABCA4 Significant advances have been made over the last 10 years in our understanding of both the clinical and molecular features of STGD1, and also the underlying pathophysiology, which has culminated in ongoing and planned human clinical trials of novel therapies. The aims of this review are to describe the detailed phenotypic and genotypic characteristics of the disease, conventional and novel imaging findings, current knowledge of animal models and pathogenesis, and the multiple avenues of intervention being explored

Prediction of preterm labour by cervical length

Background: Preterm birth is one of the commonest causes of perinatal mortality. Cervical length is one of the major determinants of preterm delivery.Methods: This prospective observational study of 100 pregnant women attending ANC OPD was carried out at D.Y. Patil Hospital, Kolhapur. The pregnant women were scanned for cervical length between 11-14 weeks and 20-22 weeks of gestation, using USG machine with TVS probe (mindray DC-7).Results: The mean value of cervical length in pregnant women at 11-14 weeks was 3.94 cm and at 20-22 weeks of gestation it was 3.38 cm. There was shortening in the pregnant cervix from first to second trimester. In the study 12% of patients delivered prematurely who had reduction in cervical length from first trimester to second trimester. The inverse relation between the cervical length during pregnancy and frequency of preterm delivery was confirmed. The decrease in cervical length at 11-14 weeks of gestation and 20-22 weeks of gestation was useful for identifying patients at increased risk for pre-trerm.Conclusions: Our findings confirm those of previous studies that have found an inverse relation between the length of the cervix, as measured by transvaginal ultrasonography during pregnancy, and the frequency of preterm delivery. We found that the cervical length measured at 11-14 weeks and 20-22 weeks gestation was decreased in asymptomatic women with single to n pregnancies was useful for identifying patients at increased risk for preterm delivery

A Statistical Model to Analyze Clinician Expert Consensus on Glaucoma Progression using Spatially Correlated Visual Field Data

We developed a statistical model to improve the detection of glaucomatous visual field (VF) progression as defined by the consensus of expert clinicians

Infrared spectral studies of Zn-substituted CuFeCrO4 spinel ferrite system

The spinel solid solution series Znx Cu1–x FeCrO4 with x = 0.0,0.2,0.4 and 0.6 has been studied by infrared absorption spectroscopy. The IR-spectrum showed two main absorption bands ν1 and ν2 in the range 400-600 cm-1 arising from tetrahedral (A) and octahedral (B) interstitial sites in the spinel lattice. The absence of ν4 band suggests that lattice vibrations are insignificant. No shoulder or splitting is observed around ν1 and ν2 bands confirming absence of Fe+2 ions in the system. The sharpening of band with Zn- content (x) is due to the fact that the system changes from inverse to normal spinel structure. The structural and optical properties are correlated and the bulk modulus, compressional and shear velocity values determined through IR spectral analysis are in good agreement to those obtained through ultrasonic pulse transmission technique.Author Affiliation: M C Chhantbar, U N Trivedi, P V Tanna, H J Shah, R P Vara, H H Joshi and K B Modi Department of Physics, Saurashtra University, Rajkot-360 005, Gujarat, India E-mail : [email protected] of Physics, Saurashtra University, Rajkot-360 005, Gujarat, Indi

Prospective Cohort Study of Childhood-Onset Stargardt Disease: Fundus Autofluorescence Imaging, Progression, Comparison with Adulthood-Onset Disease, and Disease Symmetry

Purpose To determine the reliability and repeatability of quantitative evaluation of areas of decreased autofluorescence (DAF) from fundus autofluorescence (FAF) images and track disease progression in children with Stargardt disease (STGD1), and investigate clinical and genotype correlations, disease symmetry and intra-familial variability. Design Prospective Cohort Study. Methods Children and adults with molecularly confirmed STGD1 (n=90) underwent longitudinal FAF imaging with subsequent semi-automated measurement of the area of DAF and calculation of the annual rate of progression. The age of disease onset was recorded for all subjects, as well as the electroretinography (ERG) group at baseline (n=86). Patients were grouped for analysis based on the age at baseline and age of onset, into children (n=56), adults with childhood-onset STGD1 (n=15), and adults with adulthood-onset (n=19). Fifty FAF images were selected randomly and analysed by two observers to evaluate repeatability and reproducibility. Differences between groups, interocular symmetry, genotype-phenotype correlations and intrafamilial variability were also investigated both for baseline measurements as well as progression rates. Results Visual acuity, molecular genetics, ERG group, FAF metrics and their correlations. Results Mean age of onset ± SD was 9.6 ± 3.4 years for childhood-onset (n=71) and 28.3 ± 7.8 years for adulthood-onset STGD1 (n=19). The intra-observer and inter-observer reliability of DAF quantification was excellent (ICC; 0.995 and 0.987). DAF area was symmetric between eyes and the mean rate of progression (SD) was 0.69 (0.72), 0.78 (0.48) and 0.40 (0.36) mm2/year for children, adults with childhood-onset, and adults with adulthood-onset disease respectively. Patients belonging to a group 3 ERG phenotype (generalised cone and rod dysfunction) had a significantly greater progression rate. Limited intrafamilial variability was observed. Conclusions This is the first large prospective study of FAF in a cohort of molecularly confirmed children with STGD1. DAF area quantification was highly reliable and may thereby serve as a robust structural end-point. A high rate of progression was observed in childhood-onset disease, making this subtype of STGD1 ideally suited to be considered for prioritisation in clinical trials