Study of knowledge, attitude, and practices towards current updates of pharmacovigilance and adverse drug reaction reporting among doctors in a tertiary care teaching hospital of Western India

Background: In general, adverse drug reactions (ADRs) are global problems causing both morbidity and mortality. Spontaneous ADR reporting is important to monitor adverse effects of medicines but under reporting is still very prevalent so, there is a need of constant monitoring and rectification of system of Pharmacovigilance. The objective of this study was to evaluate the knowledge, attitude, and practices (KAP) of the healthcare professionals about Pharmacovigilance and to identify the reason for under reporting of ADRs.Methods: A cross-sectional study was carried out using a pretested questionnaire among doctors with minimum qualification MBBS or B.D.S. including faculties, senior and junior residents. Subsequently, analysis of association between education and experience was done by chi square test at P-value <0.05.Results: A pretested questionnaire was distributed among 403 doctors and 240 (59.16%) responded voluntarily. In general, 131 (54.58%) participants noted lack of time to report ADR while 90 (37.50%) participants noted no benefit of reporting already known ADR. On the other hand, total 104 (43.33%) participants were aware about need to report a serious adverse event during “Clinical Trial” within 24 hours to the Ethics Committee. Only 87 (36.25%) participants noted a need of reporting of already known ADR.Conclusions: Participants had good knowledge and attitude towards pharmacovigilance, but the actual practice of ADR reporting is still deficient among them that can be improved by sensitization training and involvement of grass root level health care workers

A study of cutaneous adverse drug reactions in the dermatology department of a tertiary care teaching hospital in Gujarat

Background: Various drugs are responsible for different cutaneous adverse drug reactions (CADRs). Considering variation in drug responses and the day-to-day increasing burden of ADRs, this study was done with emphasis on the need for effective evaluation and the reporting of the ADR reporting programme. Methods: This was an observational cross-sectional study conducted for the duration of six months in the dermatology department to evaluate various clinical patterns of CADRs. Results: A total of 60 CADRs were reported. Among them, 51.67% were present in males and 48.33% were present in females. The most common CADR was FDE (35%), followed by macula-papular rash (25%). Antimicrobials were most commonly responsible for CADRs, followed by NSAIDs, antiepileptic, anti-gout, and anti-hypertensive medications. Conclusions: For better patient care, drug safety, and rational use of medicines, knowledge of various drugs responsible for CADRs can be useful for health care professionals to reduce mortality and morbidity by monitoring, reporting, and assessment of CADRs whenever detected

Sodium-glucose co-transporter-2 inhibitors as anti-diabetic agents: a review

The incidence and prevalence of Type 2 diabetes mellitus (T2DM) have been increasing worldwide. However, existing therapeutic classes of anti-diabetic drugs are not adequately effective in achieving and maintaining long-term glycemic control in the most patients. The majority of the drugs control blood sugar without addressing the basic pathology of insulin resistance and relative deficiency. Moreover, side effects such as hypoglycemia and weight gain, of both new and established drugs need to be considered prior to treating a patient. An emerging anti-hyperglycemic intervention, the sodium glucose co-transporter 2 (SGLT2) inhibitor acts by a novel mechanism. Under physiological conditions, SGLT2 accounts for 90% of the glucose re-absorption in the kidney, while the SGLT2 inhibitors result in an increase in urinary excretion of glucose and lower plasma glucose levels. Here, the pros and cons of SGLT2 inhibitors are considered, while approaching a patient with T2DM. The basic biochemistry and physiology underlying the mechanisms of SGLT2 inhibitors are discussed alongside its clinical pharmacology, with a focus on metabolic changes associated with urinary glucose loss. Finally, a consideration of Food and Drug Administration safety concerns associated with acidosis due to SGLT2 inhibitor usage is presented, to allow a complete understanding of the utility of these molecules in the light of existing T2DM therapies

Evaluation of prescription pattern of antifungal drugs in the dermatology department of a tertiary care teaching hospital

Background: In general, fungal infections are one of the contributors of disease burden in the community, but irrational use of antifungal drugs can result in unwanted adverse events or antifungal drugs resistance. The present study was designed to analyze the prescription pattern of antifungal drugs prescribed in the dermatology department of a tertiary care teaching hospital. Methods: After getting permission from the ethics committee, this prospective observational cross-sectional study was conducted by analysis of prescriptions of 900 voluntary participant patients over a period of seven months in the dermatology outpatient department of a tertiary care teaching hospital in western India. Prescribed medicines’ parameters were analyzed as per WHO/INRUD prescription indicators. Results: Overall 900 prescriptions were analyzed, and among them around 50% patients were having tinea corporis and tinea cruris, making it the most common fungal infection. The most commonly prescribed antifungals were Clotrimazole (34.59%), followed by Fluconazole (31.61%) and Luliconazole (23.52%). Percentage of drugs prescribed from the WHO model list of essential medicines was 71.22%. Average number of antifungal drugs per prescription was 2.83 ± 0.57%. Conclusions: This study indicates prescribing practices of anti-fungal drugs and supportive medicines at tertiary care hospital that can be further improved by promoting prescribing by generic names. Overall final list of essential medicines at district level, state level and national level may vary as compared to the WHO list for anti-fungal drugs and doctors can consider alternative drugs as per domestic resistant pattern

Long-COVID versus adverse event following COVID vaccination among students and staff of tertiary care teaching hospital

Background: Long COVID is an important public health concern requiring proper defining, quantifying and describing following SARS-CoV infection with differentiation from adverse events due to COVID vaccination. So, this study was planned to analyze adverse effect of COVID19 vaccination or drug for COVID treatment versus consequences of COVID19 infection. Methods: Self-reported data was collected through questionnaire-based survey by voluntary participation of healthcare staff. Percentage of participant developing various events was analyzed by enlisting sign, symptom, co-morbidity and medication history. Association between COVID-19 infection with number of doses of COVID-19 vaccine taken was analyzed by Chi Square Test with p value <0.05. Association between presence of specific sign, symptom after COVID infection or side effect after COVID vaccination was analyzed by Chi-Square Test with p value <0.05.  Results: Overall total 985 (59.58%) participants were analyzed and among them maximum number of participants (60.30%) reported as COVID-19 positive during the third wave with history of diagnosed COVID positive twice (57.87%). Participants with presence of co-morbidity were more likely to develop symptoms (p<0.001). On analysis, fever, body ache, headache, sore throat and fatigue were significantly more likely to develop after COVID infection as compared to after COVID vaccination (p<0.001).  Conclusions: This study by exploratory survey highlights heterogeneity of Long COVID sign or symptom that’s seen predominantly in person with co-morbidity and a few of them were mimicking adverse events after COVID vaccinations

The Changing Landscape for Stroke\ua0Prevention in AF: Findings From the GLORIA-AF Registry Phase 2

Background GLORIA-AF (Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation) is a prospective, global registry program describing antithrombotic treatment patterns in patients with newly diagnosed nonvalvular atrial fibrillation at risk of stroke. Phase 2 began when dabigatran, the first non\u2013vitamin K antagonist oral anticoagulant (NOAC), became available. Objectives This study sought to describe phase 2 baseline data and compare these with the pre-NOAC era collected during phase 1. Methods During phase 2, 15,641 consenting patients were enrolled (November 2011 to December 2014); 15,092 were eligible. This pre-specified cross-sectional analysis describes eligible patients\u2019 baseline characteristics. Atrial fibrillation disease characteristics, medical outcomes, and concomitant diseases and medications were collected. Data were analyzed using descriptive statistics. Results Of the total patients, 45.5% were female; median age was 71 (interquartile range: 64, 78) years. Patients were from Europe (47.1%), North America (22.5%), Asia (20.3%), Latin America (6.0%), and the Middle East/Africa (4.0%). Most had high stroke risk (CHA2DS2-VASc [Congestive heart failure, Hypertension, Age  6575 years, Diabetes mellitus, previous Stroke, Vascular disease, Age 65 to 74 years, Sex category] score  652; 86.1%); 13.9% had moderate risk (CHA2DS2-VASc = 1). Overall, 79.9% received oral anticoagulants, of whom 47.6% received NOAC and 32.3% vitamin K antagonists (VKA); 12.1% received antiplatelet agents; 7.8% received no antithrombotic treatment. For comparison, the proportion of phase 1 patients (of N = 1,063 all eligible) prescribed VKA was 32.8%, acetylsalicylic acid 41.7%, and no therapy 20.2%. In Europe in phase 2, treatment with NOAC was more common than VKA (52.3% and 37.8%, respectively); 6.0% of patients received antiplatelet treatment; and 3.8% received no antithrombotic treatment. In North America, 52.1%, 26.2%, and 14.0% of patients received NOAC, VKA, and antiplatelet drugs, respectively; 7.5% received no antithrombotic treatment. NOAC use was less common in Asia (27.7%), where 27.5% of patients received VKA, 25.0% antiplatelet drugs, and 19.8% no antithrombotic treatment. Conclusions The baseline data from GLORIA-AF phase 2 demonstrate that in newly diagnosed nonvalvular atrial fibrillation patients, NOAC have been highly adopted into practice, becoming more frequently prescribed than VKA in Europe and North America. Worldwide, however, a large proportion of patients remain undertreated, particularly in Asia and North America. (Global Registry on Long-Term Oral Antithrombotic Treatment in Patients With Atrial Fibrillation [GLORIA-AF]; NCT01468701

Study of knowledge, attitude, and practices towards current updates of pharmacovigilance and adverse drug reaction reporting among doctors in a tertiary care teaching hospital of Western India

Background: In general, adverse drug reactions (ADRs) are global problems causing both morbidity and mortality. Spontaneous ADR reporting is important to monitor adverse effects of medicines but under reporting is still very prevalent so, there is a need of constant monitoring and rectification of system of Pharmacovigilance. The objective of this study was to evaluate the knowledge, attitude, and practices (KAP) of the healthcare professionals about Pharmacovigilance and to identify the reason for under reporting of ADRs.Methods: A cross-sectional study was carried out using a pretested questionnaire among doctors with minimum qualification MBBS or B.D.S. including faculties, senior and junior residents. Subsequently, analysis of association between education and experience was done by chi square test at P-value <0.05.Results: A pretested questionnaire was distributed among 403 doctors and 240 (59.16%) responded voluntarily. In general, 131 (54.58%) participants noted lack of time to report ADR while 90 (37.50%) participants noted no benefit of reporting already known ADR. On the other hand, total 104 (43.33%) participants were aware about need to report a serious adverse event during “Clinical Trial” within 24 hours to the Ethics Committee. Only 87 (36.25%) participants noted a need of reporting of already known ADR.Conclusions: Participants had good knowledge and attitude towards pharmacovigilance, but the actual practice of ADR reporting is still deficient among them that can be improved by sensitization training and involvement of grass root level health care workers