A retrospective analysis of adverse drug reaction reported in a tertiary care hospital

Background: The adverse drug reactions (ADRs) reported to pharmacovigilance centre in tertiary care hospital was analysed to find out the incidence and causality.Methods: This was a retrospective study to analyse the ADR reported at pharmacovigilance centre after ethical clearance from Institutional Ethic Committee (IEC). ADR data were analysed and ADRs were categorized as department-wise, system affected and causative drug. The causality of each ADR was assessed by WHO-UMC scale.Results: The majority of patients who had suffered from ADRs were between 19-64 years of age (94.2%) and male patients (58.6%) were affected more than female (41.4%). Pulmonary medicine department has reported highest number of ADR followed by dermatology department. Skin (46.5%) was most affected system followed by gastrointestinal (30.45%), CNS (21.26%), respiratory (9.0%) and remaining systems. Rifampicin (13.79%) shows the largest numbers of ADR followed by zidovudine (13.21%), nevirapine (12.64%) and diclofenac sodium (8.0%). The maximum ADRs reported were probable (94.8%) followed by possible (5.2%).Conclusions: In conclusion, the skin was most affected system followed by gastrointestinal, central nervous and respiratory system. Rifampicin has caused maximum ADRs followed by zidovudine, nevirapine and diclofenac sodium. The causality analyses showed that majority of ADRs were probable (94.8%) while remaining falls in possible (5.2%) category

A study of effect of a single dose of second generation antihistaminics on cognitive and psychomotor function in healthy human volunteers

Background: Objective of the study was to assess whether second generation antihistaminic alter psychomotor and cognitive function in comparison with promethazine (marked sedation; altered psychomotor and cognitive impairment).Methods: It was a single blind prospective study. Seventy five healthy human volunteers were registered, divided in five groups. These groups have received placebo, promethazine 25 mg, cetirizine 10 mg, fexofenadine 120 mg and loratadine 10 mg. Cognitive and psychomotor functions were assessed pretreatment and 60 minutes after single dose of drug(post treatment)by using a battery of standard tests (e.g. PST-Perceptual speed test, BVRT-Benton visual retention test,SSS- Stanford Sleepiness Scale, FTT-Finger tapping test etc.). The data were analyzed by student’s t-test and ANOVA test.Results: No significant effect was observed in any test parameter with placebo and fexofenadine. Significant difference with promethazine in PST, BVRT, SSS and cetirizine in DSST, FTT and loratadine in DSST were observed. Significant difference was observed in DSST between the placebo and promethazine, in SSS between promethazine and all other drugs. In FTT and BVRT significant difference between the groups were observed.Conclusions: Significant sedation and altered cognitive and psychomotor function were observed with promethazine. Cetirizine and loratadine do not cause sedation but both affect psychomotor functions. No significant effect was produced by fexofenadine. Thus, fexofenadine can safely be used in persons involved in activity where alertness is required while cetirizine and loratadine should be avoided

Educational intervention to improve knowledge, attitude and practice of pharmacovigilance among nursing staff in tertiary care hospital

Background: The present study was planned to assess the knowledge, attitude and practice among nursing staff and to evaluate the effect of educational intervention.Methods: The questionnaire related with knowledge, attitude and practice (KAP) were given to nursing staff before and after the educational intervention in a tertiary care hospital. The data obtained were subjected to statistical analysis.Results: The training given in different sessions has improved KAP among nursing staff. Ninety six percent of them responded correctly regarding who can report ADR as compared to pre training session (69%). Regarding pharmacovigilance as purpose of safe use of medicines was responded by 71% after training as compared to 54% before training. In questions related to PvPI, 94% of nursing staff responded correctly about the scale to be used for causality assessment in comparison to 79% before training. Majority of them were of opinion that only unknown and serious ADR should be reported whereas after training they answered that all the ADR should be reported. A significant improvement has been noticed in questions related to attitude and practice.Conclusions: The educational intervention to improve KAP among nursing staff has resulted in significant improvement

Assessment of COVID-19 vaccine hesitancy among undergraduate medical students of a tertiary care teaching hospital, Surat: a source of profound concern

Background: The discussion around COVID-19 vaccines has been in the limelight ever since the announcement was made for mass vaccination campaign in India. Less is known about undergraduate medical students’ perception and willingness towards getting COVID-19 vaccination. The aim of the study was to assess reasons for the apprehension if present towards taking the COVID-19 vaccines among medical students and to spread awareness about the ongoing issue.Methods: This was a prospective, cross sectional, survey-based study which was conducted at Surat Municipal Institute of Medical Education and Research (SMIMER), Surat, Gujarat, India. Questionnaire was distributed among medical students during lectures and exam going students were sent Google form link. Data collection was done from February to March 2021, and 550 students submitted the forms.Results: While 34.9% students had taken the vaccine voluntarily, category I (acceptance group); 18.2% students were initially hesitant to take the vaccine, but later took it, category II (hesitant group); the frequency increased to 46.9% students who are still hesitant and have not taken the vaccine, category III (refusal group). Top reasons for hesitancy were: concern regarding adverse events (69%), safety (60%) and lack of scientific data (27%) provided for the vaccines.Conclusions: This study revealed that there was lack of knowledge and positive attitude towards the COVID-19 vaccines among the non-vaccinated students. This evaluation has guided the importance and the need of targeted educational program to address the knowledge gap

Albiglutide and cardiovascular outcomes in patients with type 2 diabetes and cardiovascular disease (Harmony Outcomes): a double-blind, randomised placebo-controlled trial

Background: Glucagon-like peptide 1 receptor agonists differ in chemical structure, duration of action, and in their effects on clinical outcomes. The cardiovascular effects of once-weekly albiglutide in type 2 diabetes are unknown. We aimed to determine the safety and efficacy of albiglutide in preventing cardiovascular death, myocardial infarction, or stroke. Methods: We did a double-blind, randomised, placebo-controlled trial in 610 sites across 28 countries. We randomly assigned patients aged 40 years and older with type 2 diabetes and cardiovascular disease (at a 1:1 ratio) to groups that either received a subcutaneous injection of albiglutide (30–50 mg, based on glycaemic response and tolerability) or of a matched volume of placebo once a week, in addition to their standard care. Investigators used an interactive voice or web response system to obtain treatment assignment, and patients and all study investigators were masked to their treatment allocation. We hypothesised that albiglutide would be non-inferior to placebo for the primary outcome of the first occurrence of cardiovascular death, myocardial infarction, or stroke, which was assessed in the intention-to-treat population. If non-inferiority was confirmed by an upper limit of the 95% CI for a hazard ratio of less than 1·30, closed testing for superiority was prespecified. This study is registered with ClinicalTrials.gov, number NCT02465515. Findings: Patients were screened between July 1, 2015, and Nov 24, 2016. 10 793 patients were screened and 9463 participants were enrolled and randomly assigned to groups: 4731 patients were assigned to receive albiglutide and 4732 patients to receive placebo. On Nov 8, 2017, it was determined that 611 primary endpoints and a median follow-up of at least 1·5 years had accrued, and participants returned for a final visit and discontinuation from study treatment; the last patient visit was on March 12, 2018. These 9463 patients, the intention-to-treat population, were evaluated for a median duration of 1·6 years and were assessed for the primary outcome. The primary composite outcome occurred in 338 (7%) of 4731 patients at an incidence rate of 4·6 events per 100 person-years in the albiglutide group and in 428 (9%) of 4732 patients at an incidence rate of 5·9 events per 100 person-years in the placebo group (hazard ratio 0·78, 95% CI 0·68–0·90), which indicated that albiglutide was superior to placebo (p<0·0001 for non-inferiority; p=0·0006 for superiority). The incidence of acute pancreatitis (ten patients in the albiglutide group and seven patients in the placebo group), pancreatic cancer (six patients in the albiglutide group and five patients in the placebo group), medullary thyroid carcinoma (zero patients in both groups), and other serious adverse events did not differ between the two groups. There were three (<1%) deaths in the placebo group that were assessed by investigators, who were masked to study drug assignment, to be treatment-related and two (<1%) deaths in the albiglutide group. Interpretation: In patients with type 2 diabetes and cardiovascular disease, albiglutide was superior to placebo with respect to major adverse cardiovascular events. Evidence-based glucagon-like peptide 1 receptor agonists should therefore be considered as part of a comprehensive strategy to reduce the risk of cardiovascular events in patients with type 2 diabetes. Funding: GlaxoSmithKline