A cross sectional study to assess knowledge, attitude and practices of pharmacovigilance by interns in a tertiary care hospital in North Karnataka

Background: Adverse drug reactions (ADRs) are an important contributor to morbidity and mortality burden in modern health care system. Continuous monitoring of drug after entering into market is necessary as it helps in improving care and safety of patient. In India, there is ongoing National Pharmacovigilance program to monitor ADRs. However, there is marked under-reporting of ADRs due to various reasons. Hence this study was taken to evaluate the knowledge, attitude and practices by the next generation doctors i.e., interns working in a tertiary care hospital, Bagalkot, Karnataka.Methods: After ethics committee approval, a pretested questionnaire containing 15 questions was given to 80 interns. Finally, 60 sets were used for analysis, as 20 were incomplete.Results: In our study it showed interns have good knowledge about pharmacovigilance as 67.4% correct responses were seen in knowledge domain and similarly 79% responses related to attitude were correct. However, there was a marked difference in the practice of ADR reporting as only 9.6% participants have reported an ADR. This study highlights that in-spite of having knowledge and awareness there was lesser ADR reporting practices. Major reasons for hindering ADR reporting found were difficulty in identifying an ADR, lack of time, not knowing how and where to report, lack of incentives and no compulsion.Conclusions: Under reporting issues can be addressed by conducting more educational activities especially at undergraduate and intern’s level, including continuous medical educations, workshops, problem-based learning about pharmacovigilance in detail in curriculum. These activities will increase reporting culture and sensitize interns to inculcate it in their future clinical practice also

Efficacy and safety comparison of topical loteprednol and topical non-steroidal anti-inflammatory drugs in seasonal allergic conjunctivitis: a prospective open label comparative study

Background: Seasonal allergic conjunctivitis (SAC) one of the most common ocular immunological disorder affecting wide population. Various classes of drugs are been used to control allergic inflammation. Traditionally topical glucocorticoids have been used for SAC. However, repeated and continuous use of steroids is associated with various complications like increase in intraocular pressure, posterior sub capsular cataract, increased susceptibility for infections and delayed wound healing. Hence the current emphasis is to prefer topical NSAIDs as they are free from various steroid related complications. As there is paucity of information regarding the comparative efficacy of topical steroids and NSAIDs, the present study was taken up. The main objective was to study the comparative efficacy and safety of three topical NSAIDs: flurbiprofen, diclofenac, ketorolac and the topical steroid loteprednol, in SAC.Methods: A prospective, comparative study enrolled 40 patients for SAC. All study drugs were instilled 4 times daily for 4 weeks. Patients were assessed for objective and subjective parameters of inflammation at baseline and weekly intervals for 4 weeks using four point scales, and also observed for any side effects. The anti-inflammatory action was assessed by the change in mean scores from basal and at various intervals.Results: Loteprednol was more effective than the three NSAIDs, only ketorolac comparable to loteprednol in relieving ocular itching. Study drugs showed good safety and tolerability, with only minimal local side effects.Conclusions: SAC the topical steroid loteprednol was found superior to NSAIDs

Evaluation of changes in rat fatigability and biochemical parameters after oral and intra-peritoneal administration of adenosine tri phosphate: an experimental study

Background: Adenosine tri phosphate (ATP) is an important intracellular energy source and has many extracellular functions meadiacating through purine receptors. Currently ATP is available in the market as oral dietary supplement. However there are inconclusive studies regarding its efficacy through oral route. Hence this study was carried out to evaluate efficacy of oral and intraperitoneal administration of ATP in experimental rats by comparing swim exhaust time and associated biochemical changes.Methods: 18 Swiss albino rats of either gender were grouped randomly into three groups, consisting of group -1 control group which receive distilled water (5ml/kg body weight) whereas group 2 and 3 received oral and intraperitoneal ATP (60mg/kg body weight) for 8 days. On 8th day all rats all rats were evaluated for extent of physical fatigue by using exhaustive swimming test time required to attain immobility status is noted. Under aseptic precautions blood samples were drawn from rat tail vein and biochemical parameters like uric acid, triglycerides, total cholesterol, random blood sugar and c-reactive protein levels were measured.Results: There was a significant (p<0.05) increase in serum uric acid, blood sugar and urea in Group 2and3 compared control group 1. There was no statistically significant increase in physical strength in group 2 and 3 as compared to group 1.Conclusions: Oral and intraperitoneal administration of ATP may lead to hyperglycaemia, hyperuricemia and dyslipidaemia without significant increase in muscle strength

Availability and use of magnesium sulphate at health care facilities in two selected districts of North Karnataka, India

Background: Pre-eclampsia and eclampsia are major causes of maternal morbidity and mortality. Magnesium sulphate is accepted as the anticonvulsant of choice in these conditions and is present on the WHO essential medicines list and the Indian National List of Essential Medicines, 2015. Despite this, magnesium sulphate is not widely used in India for pre-eclampsia and eclampsia. In addition to other factors, lack of availability may be a reason for sub-optimal usage. This study was undertaken to assess the availability and use of magnesium sulphate at public and private health care facilities in two districts of North Karnataka, India. Methods: A facility assessment survey was undertaken as part of the Community Level Interventions for Pre-eclampsia (CLIP) Feasibility Study which was undertaken prior to the CLIP Trials (NCT01911494). This study was undertaken in 12 areas of Belagavi and Bagalkote districts of North Karnataka, India and included a survey of 88 facilities. Data were collected in all facilities by interviewing the health care providers and analysed using Excel.Results: Of the 88 facilities, 28 were public, and 60 were private. In the public facilities, magnesium sulphate was available in six out of 10 Primary Health Centres (60%), in all eight taluka (sub-district) hospitals (100%), five of eight community health centres (63%) and both district hospitals (100%). Fifty-five of 60 private facilities (92%) reported availability of magnesium sulphate. Stock outs were reported in six facilities in the preceding six months – five public and one private. Twenty-five percent weight/volume and 50% weight/volume concentration formulations were available variably across the public and private facilities. Sixty-eight facilities (77%) used the drug for severe pre-eclampsia and 12 facilities (13.6%) did not use the drug even for eclampsia. Varied dosing schedules were reported from facility to facility.Conclusions: Poor availability of magnesium sulphate was identified in many facilities, and stock outs in some. Individual differences in usage were identified. Ensuring a reliable supply of magnesium sulphate, standard formulations and recommendations of dosage schedules and training may help improve use; and decrease morbidity and mortality due to pre-eclampsia/ eclampsia

Efficacy and safety comparison of topical loteprednol and topical non-steroidal anti-inflammatory drugs in seasonal allergic conjunctivitis: a prospective open label comparative study

Background: Seasonal allergic conjunctivitis (SAC) one of the most common ocular immunological disorder affecting wide population. Various classes of drugs are been used to control allergic inflammation. Traditionally topical glucocorticoids have been used for SAC. However, repeated and continuous use of steroids is associated with various complications like increase in intraocular pressure, posterior sub capsular cataract, increased susceptibility for infections and delayed wound healing. Hence the current emphasis is to prefer topical NSAIDs as they are free from various steroid related complications. As there is paucity of information regarding the comparative efficacy of topical steroids and NSAIDs, the present study was taken up. The main objective was to study the comparative efficacy and safety of three topical NSAIDs: flurbiprofen, diclofenac, ketorolac and the topical steroid loteprednol, in SAC. Methods: A prospective, comparative study enrolled 40 patients for SAC. All study drugs were instilled 4 times daily for 4 weeks. Patients were assessed for objective and subjective parameters of inflammation at baseline and weekly intervals for 4 weeks using four point scales, and also observed for any side effects. The anti-inflammatory action was assessed by the change in mean scores from basal and at various intervals. Results: Loteprednol was more effective than the three NSAIDs, only ketorolac comparable to loteprednol in relieving ocular itching. Study drugs showed good safety and tolerability, with only minimal local side effects. Conclusions: SAC the topical steroid loteprednol was found superior to NSAIDs. [Int J Basic Clin Pharmacol 2016; 5(3.000): 956-961

Evaluation of changes in rat fatigability and biochemical parameters after oral and intra-peritoneal administration of adenosine tri phosphate: an experimental study

Background: Adenosine tri phosphate (ATP) is an important intracellular energy source and has many extracellular functions meadiacating through purine receptors. Currently ATP is available in the market as oral dietary supplement. However there are inconclusive studies regarding its efficacy through oral route. Hence this study was carried out to evaluate efficacy of oral and intraperitoneal administration of ATP in experimental rats by comparing swim exhaust time and associated biochemical changes.Methods: 18 Swiss albino rats of either gender were grouped randomly into three groups, consisting of group -1 control group which receive distilled water (5ml/kg body weight) whereas group 2 and 3 received oral and intraperitoneal ATP (60mg/kg body weight) for 8 days. On 8th day all rats all rats were evaluated for extent of physical fatigue by using exhaustive swimming test time required to attain immobility status is noted. Under aseptic precautions blood samples were drawn from rat tail vein and biochemical parameters like uric acid, triglycerides, total cholesterol, random blood sugar and c-reactive protein levels were measured.Results: There was a significant (p&lt;0.05) increase in serum uric acid, blood sugar and urea in Group 2and3 compared control group 1. There was no statistically significant increase in physical strength in group 2 and 3 as compared to group 1.Conclusions: Oral and intraperitoneal administration of ATP may lead to hyperglycaemia, hyperuricemia and dyslipidaemia without significant increase in muscle strength

A Comparison of Colorimetric Assessment of Vaginal pH with Nugent Score for the Detection of Bacterial Vaginosis

Background. A Nugent score > 7 has been defined as the gold standard for the diagnosis for bacterial vaginosis (BV), though it is resource intensive and impractical as point of care testing. We sought to determine if colorimetric assessment of vaginal pH can accurately predict the occurrence of BV. Methods. We performed a planned subanalysis of 1,216 pregnant women between 13 0/7 and 19 6/7 weeks who underwent vaginal examination as part of a randomized controlled trial. Using a standardized technique, specimens were obtained for colorimetric assessment and two separate slides for Gram staining. These slides were subsequently evaluated by two independent blinded microbiologists for Nugent scoring. Results. Interrater reliability of the interpretation of the Nugent score was excellent (intraclass correlation-individual 0.93 (95 CI 0.92 to 0.94) and average 0.96 (95% CI 0.95 to 0.97)). The sensitivity of an elevated pH > 5 for a Nugent score > 7 was 21.9% while the specificity was 84.5%. The positive predictive value in our population was 33.7% with a negative predictive value of 75.0%. Conclusion. Though the Nugent score is internally accurate, the prediction of BV using vaginal pH alone has poor sensitivity and specificity

Availability and use of magnesium sulphate at health care facilities in two selected districts of North Karnataka, India

Background: Pre-eclampsia and eclampsia are major causes of maternal morbidity and mortality. Magnesium sulphate is accepted as the anticonvulsant of choice in these conditions and is present on the WHO essential medicines list and the Indian National List of Essential Medicines, 2015. Despite this, magnesium sulphate is not widely used in India for pre-eclampsia and eclampsia. In addition to other factors, lack of availability may be a reason for sub-optimal usage. This study was undertaken to assess the availability and use of magnesium sulphate at public and private health care facilities in two districts of North Karnataka, India. Methods: A facility assessment survey was undertaken as part of the Community Level Interventions for Pre-eclampsia (CLIP) Feasibility Study which was undertaken prior to the CLIP Trials (NCT01911494). This study was undertaken in 12 areas of Belagavi and Bagalkote districts of North Karnataka, India and included a survey of 88 facilities. Data were collected in all facilities by interviewing the health care providers and analysed using Excel. Results: Of the 88 facilities, 28 were public, and 60 were private. In the public facilities, magnesium sulphate was available in six out of 10 Primary Health Centres (60%), in all eight taluka (sub-district) hospitals (100%), five of eight community health centres (63%) and both district hospitals (100%). Fifty-five of 60 private facilities (92%) reported availability of magnesium sulphate. Stock outs were reported in six facilities in the preceding six months – five public and one private. Twenty-five percent weight/volume and 50% weight/volume concentration formulations were available variably across the public and private facilities. Sixty-eight facilities (77%) used the drug for severe pre-eclampsia and 12 facilities (13.6%) did not use the drug even for eclampsia. Varied dosing schedules were reported from facility to facility. Conclusions: Poor availability of magnesium sulphate was identified in many facilities, and stock outs in some. Individual differences in usage were identified. Ensuring a reliable supply of magnesium sulphate, standard formulations and recommendations of dosage schedules and training may help improve use; and decrease morbidity and mortality due to pre-eclampsia/ eclampsia. Trial registration: The CLIP trial was registered with ClinicalTrials.gov ( NCT01911494 ).Medicine, Faculty ofNon UBCObstetrics and Gynaecology, Department ofReviewedFacult

Additional file 1: of Availability and use of magnesium sulphate at health care facilities in two selected districts of North Karnataka, India

Questionnaire used in this study. (PDF 607 kb