Individual case safety reports by nursing staff: a retrospective pharmacovigilance analysis

Background: The burden of adverse drug reactions is high and accounts for considerable morbidity which can be prevented if healthcare professionals have proper knowledge. Early and spontaneous reporting of ADRs is the mainstay of pharmacovigilance program. Since staff nurses are closely involved in direct patient care, they can easily identify ADRs in the early stage. This study was done to assess the extent of participation of nurses in pharmacovigilance program in our institution.Methods: Retrospective observational study was conducted by analyzing the 210 Individual Case Safety Reports (ICSR) of 2years duration. Causality assessment in the ICSR was analyzed. Severity of the reactions was categorized into mild, moderate and severe according to Modified Hartwig and Siegel scale. Descriptive statistics were used.Results: There were 177 cases reported by faculties and 33 were by the staff nurses.19 nurses reported 33 adverse effects (1:1.7) whereas 41 faculties 177 events (1:4). On analyzing the severity of reactions, 188 cases were categorized as moderate (89.5%), 20 mild (9.5%) and 2 severe (1%). In moderate category of 188 reports, 82 % reporting was by faculties and 18% by staff nurses. All the 33 reports by nurses were of moderate category (100%). In the mild and severe category, 100% reporting was by faculties. Causality analysis showed that 194 were classified as probable (92%), 14 as Possible (7%) and 2as certain (1%). In probable category 85% of reporting was by faculties and 15% by nurses, in possible group 71 % by faculties and 29% by nurses and 100% by faculties in severe category.Conclusions: Training and dedicated participation of nurses can improve reporting of ICSR

PROTEIN BINDING STUDY OF FELODIPINE USING VALIDATED LIQUID CHROMATOGRAPHIC METHOD

Objective: The aim of present study was to develop and validate a new simple, easy, selective, precise, accurate reverse phase high-performance liquid chromatography for the estimation of felodipine in bulk and pharmaceutical dosage form.Methods: The separation was carried on HPLC system consisting C18 column (150 mm ×4.6 nm, 5 µm) at room temperature coupled with a phenomenixcolumn silica with flow rate 1 ml/min. The mobile phase used was methanol: acetonitrile in the ratio of 50: 50. The drug was detected using UV-visible detector at the wavelength of 230 nm and run time was 10 min.Results: The retention time was 3.138 min. Linearity was observed in the concentration range of 5-25μg/ml. The accuracy of the method was assessed by percentage recovery studies at three different levels at 80%, 100% and 120% of its working concentration. The percentage recovery of felodipine in the developed method was found to be in the ranges of from 99.81-100.00% that indicates the good accuracy of the method. The percentage % RSD of precision was found to be less than 2%. The method was validated as per ICH guidelines. The developed method was employed in in vitro protein binding studies using semi permeable membrane and performed by plotting calibration curve (peak area vs concentration) the % drug release of felodipine was calculated.Conclusion: The proposed method was found to be simple, precise, accurate and consistent. The validated parameters are statistically validated for linearity, precision and limit of detection, limit of quantification, robustness, ruggedness were concluded.Â

BIOEQUIVALENCE STUDIES OF MARKETED CLOZAPINE TABLETS BY USING OPTIMIZED VALIDATED LIQUID CHROMATOGRAPHIC METHOD

Objective: A simple, selective, precise and accurate method was developed for the estimation of Clozapine by RP-HPLC technique.Methods: Chromatographic conditions used are stationary phase, Phenomenex BDS (150 mm x 4.6 mm, 5µ), Mobile phase was methanol and water in (80:20) ratio and flow rate was maintained at 1.0 ml/min, column temperature was set at 25 °C, detection wavelength was 240 nm, and diluent was mobile phase. These conditions were finalized for the optimized method.Results: Linearity study was carried out between 10-60 µg/ml, the R2 value was found to be as 0.995. Precision was found to be as follows for system precision 1.052, method precision 1.662, and intraday precision 1.02 and for interday precision 0.93. The % Recovery was found to be 98.60%. LOD and LOQ were found to be 2.7 µg/ml and 8.4 µg/ml respectively. By using the above method assay of the marketed formulation was carried out and the % purity was found to be 99.28 %. Stability studies of Clozapine were done, in all conditions degradation was found to be within the acceptable range.Conclusion: The current validated method was finally applied in bioequivalence studies of four different brands of Clozapine by using dissolution apparatus and percentage drug release was found to be 99.48%, it was within the acceptable limit (NLT 85 %) as per USP

Is rehabilitation of Olfaction necessary in patients undergoing Total Laryngectomy

INTRODUCTION : Laryngeal malignancy is the second most common malignancy in the upper aero-digestive tract. In India, the incidence rate is about 2.63% of all malignancy. 85 to 95 percentage of the laryngeal malignancy is the squamous cell carcinoma type, majority of which arises from the glottis. Hypopharyngeal malignancy is not very common. It accounts for 4% of all head and neck malignancy and 7% of all upper aero-digestive tract malignancy. 95% of the malignancy is squamous cell carcinoma and pyriform sinus being the most common site involved. The treatment of choice for the carcinoma of the larynx and hypopharynx depends on the stage at the time of presentation. Early stage of disease is managed by Radiotherapy alone or Endoscopic transoral excision with negative margins. Advanced stages of the disease will need radical surgery followed by radiotherapy. OBJECTIVES : 1. To compare the olfactory acuity of patients prior to and after total laryngectomy. 2. Assess effectiveness of nasal airflow inducing maneuver technique for olfaction and the quality of life in laryngectomised patients. METHODS : A prospective study was done recruiting patients who were planned for total laryngectomy from September 2014 to July 2015. They were subjected to olfaction testing prior to surgery. Olfaction testing was done using Butanol threshold test and Odour identification test. Composite score was calculated which gave the olfaction score. Patient was followed up 2 weeks after surgery when a quality of life assessment was done using Appetite, Hunger and Sensory Perception (AHSP) questionnaire and repeat olfaction testing was done. Following this polite yawn technique was taught to the patient and the olfaction testing was repeated with the maneuver. RESULTS : Twenty eight patients were recruited in this study. There was significant loss in sense of smell in all the 28 patients following total laryngectomy. After a therapy session for polite yawn technique the olfaction score showed a significant improvement in the olfaction score of all the 28 patients. Quality of life assessment was done using AHSP questionnaire. The internal coefficient of this questionnaire was high in all the five domains and hence can be used as an effective questionnaire for quality of life assessment in total laryngectomy patients. CONCLUSION : In this study of 28 patients after total laryngectomy, there was a loss in the sense of smell in all the 28 patients, which was tested using Butanol threshold test and Odour identification score. The olfaction score after a 15 minute session of Nasal Airway Inducing Maneuver, the polite yawn technique showed significant improvement. Quality of life assessment was done using Appetite, Hunger and Sensory Perception questionnaire. The internal coefficient of this questionnaire was high and hence can be used as an effective questionnaire for quality of life assessment in total laryngectomy patients with respect to smell, taste, hunger feelings and appetite

Capacity Behaviour using WSDV Scheme over WiMAX

The objective of this project is to create Mobile Worldwide Interoperability for Microwave Access (WiMAX) for 4th generation mobile wireless networks in which it is foreseen that mobile Television (TV) services will reproduce rapidly. In television applications are bandwidth hogs that cause a challenging capacity problem in wireless networks. To address this challenge, a novel scheme for mobile Television services over WiMAX network, called the Wireless Switched Digital Video (WSDV) scheme, is proposed. Compared with the conventional broadcast or unicast schemes, the hybrid approach introduced in the proposed WSDV approach exploits the merits of two conventional schemes and mitigates their demerits, which enables it to increase wireless capacity for mobile Television services. The analytical model can capture the details of WiMAX resource allocation and take into consideration the popularity of the mobile Television contents being viewed by users enabling it to provide an accurate estimate of the amount of bandwidth required for WiMAX TV services and also enabling a designer to optimally select the number of channels via the WSDV service while meeting a desired level of blocking probability. The proposed optimized scheme outperforms the conventional schemes with respect to blocking probability. Finally, an end-to-end solution to the WSDV scheme is also presented

DNA barcodes can distinguish species of Indian mosquitoes (Diptera: Culicidae

ABSTRACT Species identiÞcation of mosquitoes (Diptera: Culicidae) based on morphological characteristics remains often difÞcult in Þeld-collected mosquito specimens in vector-borne disease surveillance programs. The use of DNA barcodes has been proposed recently as a tool for identiÞcation of the species in many diverse groups of animals. However, the efÞcacy of this tool for mosquitoes remains unexplored. Hence, a study was undertaken to construct DNA barcodes for several species of mosquitoes prevalent in India, which included major vector species. In total, 111 specimens of mosquitoes belonging to 15 genera, morphologically identiÞed to be 63 species, were used. This number also included multiple specimens for 22 species. DNA barcode approach based on DNA sequences of mitochondrial cytochrome oxidase gene sequences could identify 62 species among these, in conÞrmation with the conventional taxonomy. However, two closely related species, Ochlerotatus portonovoensis (Tiwari & Hiriyan) and Ochlerotatus wardi (Reinert) could not be identiÞed as separate species based on DNA barcode approach, their lineages indicating negligible genetic divergence (Kimura two-parameter genetic distance ϭ 0.0043)

Faunal richness and the checklist of Indian mosquitoes (Diptera: Culicidae)

A review of published studies revealed that the Indian mosquito fauna comprises 393 species in 49 genera and 41 subgenera. The subfamily Anophelinae contains 61 species in one genus followed by Culicinae with 332 species in 11 tribes and 48 genera. The tribe Aedini (subfamily Culicinae) contains the highest number of species (176 species in 33 genera and two groups of incertae sedis; i.e., “Aedes” sensu auctorum and “Ochlerotatus” sensu auctorum). With the recent taxonomic changes in tribe Aedini, the Indian mosquito genera have gone up from 22 to 49. Changes to the Indian Aedini fauna subsequent to the reclassification of tribe Aedini are discussed. A total of 31 species are currently recognized in India for transmitting various mosquito-borne agents of human diseases. A checklist for the Indian mosquito species is presented and the need for a comprehensive study is emphasized