Serious adverse events following immunization after ChAdOx1 nCov-19 vaccination in India: a single center experience

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Evaluation of nephroprotective effect of Bryonia lacinosa on streptozotocin induced diabetic nephropathy in rats

Background: Ayurvedic literature indicated use of Bryonia laciniosa (BL) for metabolic abnormalities. However only one study evaluated Bryonia laciniosa seed ethanolic extract in streptozotocin-induced diabetes in rats and was found to have anti-hyperglycemic and anti-hyperlipidemic effects. The authors looked at the renal function test in addition and found that it prevents deterioration of renal function in rats. Hence it was interesting to find if Bryonia laciniosa had any protective action in streptozotocin induced diabetic nephropathy in rats.Methods: Streptozotocin induced diabetic nephropathy model in wistar rats was standardised in phase 1. In phase 2 animals were divided into 4 groups and diabetic nephropathy was induce with STZ. Vehicle Control group animals received CMC 0.5%, Positive control group received enalapril 5 mg/kg, Test group 1 received ethanolic extract of Bryonia laciniosa (EEBL) 250 mg/kg and Test group 2 received (EEBL) 500 mg/kg from 3rd day onwards till 6 weeks. Renal function, morphology and histopthological changes were evaluated.Results: There was a significant reduction (p <0.001) in the serum creatinine and BUN in both low and high dose EEBL groups. High dose of EEBL lowered raised MDA values significantly (p<0.001) and raised the GSH values (p<0.001). On histopathology, the high dose EEBL reversed nephropathic changes which were equivalent to enalapril.Conclusions: Bryonia lacinosa in high doses 500 mg/kg has potential to reverse diabetic nephropathic changes induced in wistar rats

Drug-Induced Severe Cutaneous Adverse Reactions, Diagnostics and Management

Severe cutaneous Adverse Reactions (SCAR) are rare drug hypersensitivity reactions but can be life-threatening if not appropriately and timely managed. Many research studies have shed light on its pathomechanism and triggers that have helped us better understand SCAR. The presence of viral fever and genetics such as HLA genotype with certain drugs have been associated with the occurrence of SCAR. However, the basis of interaction of these causative agents needs further evaluation to understand the predisposition to the reaction occurrence. The different spectrum of SCAR needs to be clinically diagnosed appropriately which includes Drug Reactions with Eosinophilia and Systemic Symptoms (DRESS), Steven Johnson Syndrome/Toxic Epidermal Necrolysis (SJS/TEN), Acute Generalized Exanthematous Pustulosis (AGEP), and generalized bullous fixed drug eruptions (GBFDE). However, due to the rare occurrence of this reaction, there is not sufficient evidence for the best treatment for patients suffering from SCAR. Our review provides detailed information about the disease type, manifestation, pathophysiology, diagnostics, and current treatment aspects of SCAR

Impact of Educational Intervention on the Knowledge, Attitude, and Practice of Pharmacovigilance Among Nurses at a Tertiary Care Public Hospital

Background: Nursing students and employees remain the first point of contact in case a patient develops an adverse drug reaction in hospital settings. Thus, it is important for nurses to understand the importance of pharmacovigilance activity and implement the same in their practice. They can also contribute to drug safety by reducing medication errors and adverse drug reaction reporting. Methods: After ethics approval, an observational questionnaire-based study was conducted in 2017 that involved nursing students and nursing employees (N=390) to assess their baseline knowledge, attitude, and practice toward pharmacovigilance. Participants who consented were enrolled and a pre-training survey was conducted. Pharmacovigilance sensitization/ training sessions were conducted in the same year after getting their baseline data. Three years later in 2021, the same questionnaire was distributed to a subset of nursing students and employees (N=299) to analyze any change in their knowledge, attitude, and practice towards the pharmacovigilance activity as a posttest. Pre and post sensitization session questionnaire-based survey data was analyzed to confirm the long-term impact of conducting such pharmacovigilance awareness training. Results: The nurses’ overall performance before and after training in each of the domains of knowledge, attitude and practice were 17.53%, 72.86%, 39.69% in the pretest group, respectively, and post test scores were 30.77%, OR-3.04, p=0.0 (Knowledge), 85.92%, OR-0.14, p=0.0 (Attitude) and 37.21%, OR-0.08, p=0.08 (Practice) in the corresponding domain. Overall, there was a declining trend in the practice domain of the nurses response between the pre-test and post intervention groups however this decline was not statistically significant (p=0.08). Conclusion: Pharmacovigilance awareness training and sensitization programs had an impact on the knowledge and attitude of nurses but there is a need to ensure that it is implemented in clinical practice. </jats:sec

A cross-sectional survey to assess the drug disposal practices of unused and expired medicines among lay public visiting a tertiary care hospital in an urban metropolis

Objectives: A cross-sectional survey was conducted to evaluate the knowledge, awareness and practice among the lay public regarding storage and disposal of unused and expired medicines. Materials and Methods: This was an observational, cross-sectional, single-centre and questionnaire-based survey. After obtaining Institutional Ethics Committee approval, the study was conducted using a pre-validated structured questionnaire distributed among the lay public visiting a tertiary care hospital located in an urban metropolitan city. Results: Four hundred of 720 individuals visiting the tertiary care hospital participated in the survey. The results revealed that 75% had never referred to any sources to get the correct information about the proper and safe disposal of medicines and had no knowledge regarding the same. About 12.75% of study participants reported that they were educated regarding the disposal of medicines by their treating physicians (RR: 0.71 [95% CI: 0.51–0.99]) when compared with the other sources of information (18%) with statistically significant contribution made by the physicians (p&lt;0.05). About 67% of the public stored their medicines at room temperature. Majority (83.75%) of the study participants reported that they disposed unused and expired drugs in the dustbin. Only 42.5% of the public knew the detrimental effect of improper drug disposal on human health and our ecosystem. In addition, 80% (320/400) of the participants confirmed that, given the option, they would prefer to return the unused or expired drugs to the pharmacy shops from where the medicines were purchased. Conclusion: There is a need to educate drug consumers/general public about safe and proper disposal of unused/ expired medicines. Health-care professionals, governments and policymakers should offer training to educate the general public about Indian regulations for safe disposal of unused/expired medicines. </jats:sec

Public Awareness and Perception about Drug Safety in the Population Residing in Western India - A Questionnaire Based Cross Sectional Survey.

Drug safety is an important health concern for every individual on medications. Pharmacovigilance programme focuses on the reporting, evaluation and prevention of any adverse drug reactions and needs the equal support from every stakeholder that includes health care professionals, pharmacists and public patients as well. Public participation for reporting Adverse Drug Reactions [ADR] is quite low in developing country, India. Therefore, this study was planned with objective to evaluate awareness and perception about drug safety practice and adverse drug reactions reporting system among the lay population. A validated and ethics committee approved questionnaire was distributed to consenting participants residing in the Mumbai region by reaching to the lay public through the community centers and the responses were collected from year 2019 to 2021 to assess awareness and understanding about drug safety and adverse drug reaction reporting among lay public. A total of 1876 questionnaires were collected with a response rate of 75%. 86.7% of the participants believed drugs can have both benefit and adverse effects. 62.41% participants were unaware of any common drug related side effects. Only 8.04% of the public were aware of adverse drug reactions and reporting same to adverse event Monitoring Centre and 98.3% participants never heard of adverse event monitoring center. 66.57% participants learnt about the Pharmacovigilance program through our survey. Also, it was the patient asking the doctor about potential drug related side effects [37.58%] rather than the other way round [24%]. Although the educational survey created awareness among all participants, a greater impact was seen among the younger generation [18-30 years’ age group] irrespective of their literacy status [p&lt;0.001]. We concluded that the Pharmacovigilance program of any nation needs health care professionals to sensitize the lay public to participate in ADR reporting thereby promote patient safety.</jats:p