AN ANALYSIS OF BANNED FIXED-DOSE COMBINATIONS IN INDIA

Objective: The objective of the study was to analyze the nonsteroidal anti-inflammatory drugs (NSAIDs) and respiratory fixed-dose combinations (FDCs) recently banned in India. Methods: This observational study was conducted at the Department of Pharmacology, B. J. Medical College, Ahmedabad, Gujarat. The data were collected from the report on the banned FDCs submitted by the drug technical advisory board subcommittee. Total 195 FDCs belonging to NSAIDs (33) and respiratory group (162) were assessed for class, number of active pharmacological ingredients, formulations, indications, and reasons for banning. Results: The mean number of drugs in FDCs of NSAIDs was 2.6, while in respiratory FDCs, it was 3.6. The most common NSAID formulation was uncoated tablet (15, 30%) while it was syrup in respiratory (49, 30%). The most common reasons for banning these FDCs were safety concerns (153, 78.4%), followed by mismatched pharmacodynamics in respiratory FDCs and mismatched pharmacokinetics in NSAIDs FDCs. The NSAIDs FDCs were marketed for pain (70%) while respiratory FDCs were marketed for cough and cold (62%). Most common NSAIDs FDCs contained NSAID with NSAID (18%), while in respiratory FDCs combinations of a cough suppressant, expectorant, and soothing agents (10%) were present. Conclusion: Evaluation of FDCs is essential to prevent the marketing of irrational FDCs

AN ANALYSIS OF CASES OF DRUG-INDUCED LIVER INJURY REPORTED TO AN ADVERSE DRUG REACTION MONITORING CENTER

Objectives: Drug-induced liver injury (DILI) is a frequent cause of liver injury and acute liver failure .We aimed to analyze the cases of DILI reported over a period of 8 years to the adverse drug reaction (ADR) monitoring center (AMC) at our institution. Methods: This observational retrospective study was conducted at the ADR monitoring center of a tertiary care hospital. Cases reported to the AMC, Pharmacovigilance Programme of India during the year 2011–2018 were analyzed as per the criteria used to analyze the ADRs. Results: A total of 5448 ADRs were reported during the study period, of which 105 (2%) were suspected to be DILI. The mean age of the patients with DILI was 39.26 years. Men (66.66%) were more commonly affected than women (33.34%). The most common drug groups causing DILI were antiretroviral (ART) (42.85%) and antitubercular (ATT) (40%). Most common single drug responsible for DILI was isoniazid (44.44%) followed by atazanavir (28%) and pyrazinamide (22.22%). Increase in serum bilirubin was the most common DILI (64.75%). About 79% of cases had a possible causality and 21% of cases had probable causal association with the suspected drugs. Majority of the ADRs (83%) were not preventable and mild in severity (21%). All ADR forms were complete in accordance with National Coordinating Center scale. Conclusion: DILI is commonly observed in patients taking ART and ATT drugs for more than a month. Regular monitoring and assessment in these patients may help in preventing DILI and manage these ADRs

Evaluation of trigger tool method for adverse drug reaction reporting by nursing staff at a tertiary care teaching hospital

Background: To sensitize nurses about Trigger Tool Method (TTM) and to evaluate the impact of TTM on adverse drug event (ADE) reporting by nurses at a tertiary care teaching hospital in India.Methods: This was prospective, interventional, single center study conducted among nursing health professionals of Civil Hospital Ahmedabad (CHA) posted in Medicine Department. They were sensitized about ADE reporting, pharmacovigilance, methods of ADRs reporting and details about TTM. Also, a list of 17 triggers was prepared by the investigator and given to nurses. They were educated to report ADEs using TTM. At the initiation and end of study, questionnaires were given to evaluate knowledge, attitude and practice of ADR reporting among participant nurses. All triggers and ADEs reported were analyzed in terms of association between them, effectiveness of trigger in detecting an ADR and in terms of Positive Predictive Value (PPV). Reported ADRs were also assessed for causality, severity and preventability.Results: A total 758 patients were admitted during the study period in the respective medicine department. List of 17 triggers consists of 9 drug triggers (DT), 1 laboratory trigger (LT) and 7 patient triggers (PT). Of these 17 triggers, 14 triggers were identified by nurses. These 14 triggers were noticed 130 times. These included DT (100 times), LT (0 times) and PT (30 times). Of the various triggers observed, 7 DT and 4 PT were related to ADRs. Hence, 11 triggers (64.70%) were positive (related to ADRs), out of 17 total triggers under evaluation. 21 ADRs were observed using TTM by nurses.Conclusions: The TTM helps to detect and report ADRs by nurses. Educational interventions about TTM help in better detection and reporting of ADRs

Estimation of thyroid profile in patients with diabetes mellitus in New Civil Hospital, Surat

Background: Diabetes mellitus (DM) and thyroid diseases are the two common endocrinopathies seen commonly in the population. There is inter-dependence between insulin and thyroid hormones for normal cellular metabolism so that DM and thyroid diseases can mutually influence the other disease process. The excess or deficit of one hormone may result in functional derangement of other. Diabetes being a most common endocrine metabolic disorder, the variety of thyroid abnormalities may co-exist and interact with DM. Early detection of thyroid dysfunction and its treatment can delay the long-term complications of DM. The present study was planned to determine prevalence of thyroid dysfunction in DM patients and therefore to provide the appropriate guidelines.Methods: The study was cross-sectional. 100 patients were enrolled for the study. Among them 50 were control (non-diabetic) and 50 were cases (diabetic). They were enrolled in the study from medicine outpatient department’s and inpatient department’s according to inclusion and exclusion criteria. Their thyroid profile (free T3, T4 and thyroid stimulating hormone) was done by chemiluminescence assay method.Results: Results were analyzed by unpaired-t-test. Prevalence of thyroid dysfunction was found significantly high in DM patients. p<0.05 value considered as statistically significant.Conclusions: Screening for thyroid disease among patients with diabetes mellitus should be routinely performed for early detection and treatment of thyroid dysfunction to delay the complications of diabetes

Dydrogesterone usage pattern in India: a knowledge, attitude and practice survey among Indian gynaecologists

Background: There is limited data about the knowledge, perception, and routine clinical usage pattern of dydrogesterone among medical practitioners in India. Therefore, the present survey was undertaken to assess attitudes and perception/practices of obstetrician and gynaecologists towards use of dydrogesterone in the real-life setting.Methods: Total 1168 gynaecologists across India participated in the KAP survey. Sixteen questions which explored indications, dosages, duration, efficacy, tolerability and comparison were asked and results were expressed as percentages.Results: Dydrogesterone has been marketed since the 1960s and has been extensively used worldwide for the treatment of threatened miscarriage (TM) and recurrent miscarriage (RM). Dydrogesterone is approved for hormone replacement therapy (HRT), as well as pregnancy and non-pregnancy-related conditions where there is a progesterone deficiency. In the present survey, dydrogesterone 10 mg twice daily was found to be the most commonly preferred dosage by 823 (73%) gynaecologists. Poor tolerability, compliance and lower efficacy were reported as major limitations of micronized progesterone by 68% of doctors. The average clinical pregnancy rate noted at 12 weeks after Dydrogesterone usage was around 40% by majority of the doctors. However, 30% of doctors noted more than 40% of clinical pregnancy rate after dydrogesterone usage. Almost 35% of doctors reported that the average live birth rate noticed after dydrogesterone usage is around 40%.Conclusions: The present KAP survey highlights that the effectiveness and the tolerability of dydrogesterone is valued by Indian gynaecologists which accounts for its robust clinical utility

Risk of secondhand smoke exposure and severity of COVID-19 infection: multicenter case–control study

IntroductionExposure to secondhand smoke (SHS) is an established causal risk factor for cardiovascular disease (CVD) and chronic lung disease. Numerous studies have evaluated the role of tobacco in COVID-19 infection, severity, and mortality but missed the opportunity to assess the role of SHS. Therefore, this study was conducted to determine whether SHS is an independent risk factor for COVID-19 infection, severity, mortality, and other co-morbidities.MethodologyMulticentric case–control study was conducted across six states in India. Severe COVID-19 patients were chosen as our study cases, and mild and moderate COVID-19 as control were evaluated for exposure to SHS. The sample size was calculated using Epi-info version 7. A neighborhood-matching technique was utilized to address ecological variability and enhance comparability between cases and controls, considering age and sex as additional matching criteria. The binary logistic regression model was used to measure the association, and the results were presented using an adjusted odds ratio. The data were analyzed using SPSS version 24 (SPSS Inc., Chicago, IL, USA).ResultsA total of 672 cases of severe COVID-19 and 681 controls of mild and moderate COVID-19 were recruited in this study. The adjusted odds ratio (AOR) for SHS exposure at home was 3.03 (CI 95%: 2.29–4.02) compared to mild/moderate COVID-19, while SHS exposure at the workplace had odds of 2.19 (CI 95%: 1.43–3.35). Other factors significantly related to the severity of COVID-19 were a history of COVID-19 vaccination before illness, body mass index (BMI), and attached kitchen at home.DiscussionThe results of this study suggest that cumulative exposure to secondhand cigarette smoke is an independent risk factor for severe COVID-19 illness. More studies with the use of biomarkers and quantification of SHS exposure in the future are needed

An evaluation of Adverse Drug Reactions with Remdesivir in patients of COVID-19 : Adverse drug reactions with remdesivir.

Background: Corona virus disease (COVID-19) is a systemic thrombo-hyperinflammatory vasculitis caused by SARS CoV2 virus, symptoms of which range from pharyngitis to severe acute respiratory illness. Remdesivir, an adenosine triphosphate analogue, was granted USFDA Emergency Use Authorization (EUA) for COVID-19 treatment. Limited data is available regarding its safety profile. This study aims to evaluate the Adverse Drug Reactions (ADRs) following remdesivir therapy in patients of COVID-19infection. &nbsp; Aim: To evaluate the Adverse Drug Reactions following Remdesivir therapy in patients of COVID-19. &nbsp; Methodology: All Patients more than 18 years of age of any gender, diagnosed with COVID-19 infection receiving remdesivir therapy and fulfilling the selection criteria were included in the study after informed consent. They were monitored for ADRs till end of treatment and analysed for characteristics of the ADRs: causality, severity and preventability. &nbsp; Results: Out of 80 patients (mean age of 49.27±16.22 years) enrolled, 51 (63.75%) developed 84 ADRs. Most common ADRs included increased aspartate transaminases (AST),(20.23%), increased bilirubin (19.04%), increased alanine transaminases (ALT) (13.09%), increased creatinine (11.90%) and increased blood urea (9.52%). Causality assessment using WHO-UMC scale showed, 85.71% possible, 13.09% probable and 1% certain causal association of the ADRs with remdesivir. A total 75% ADRs were mild in severity and 45% patients recovered from the event at the end of treatment. &nbsp; Conclusion: Hepatic and Renal dysfunctions are observed with remdesivir in COVID-19 patients. Intensive monitoring of ADRs with newer drugs with EUA such as remdesivir is warranted to ensure safer use in patients

Prescribing Pattern of Anti-epileptic drugs in Pediatric Patients at a Tertiary Care Teaching Hospital: Pattern of Anti-epileptic drugs in Pediatric Patients

&nbsp;Introduction: Epilepsy is one of the common neurological conditions worldwide. Material&amp; Methods: The observational, continuous, prospective, single center study was carried out to evaluate prescribing pattern of anti-epileptic drugs (AEDs) in pediatric patients at a tertiary care teaching hospital of Gujarat for a total duration of 18 months.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Patients were followed up monthly for the period of three months to evaluate seizure freedom, breakthrough seizure, and change in the AEDs, add-on therapy, treatment adherence and ADRs. Rationality was assessed for selection of drug and selection of right dose according to recent guidelines. Results: Majority of patients in the age group of 7 to 9 years with mean age of 6.83 ± 3.09 years.&nbsp; Male to female ratio was 1.3:1. Total 73 AEDs were prescribed to pediatric epilepsy patients after diagnosis. 37 (69.80 %) patients were prescribed AED on visit as monotherapy and 16 (30.20 %) patients were prescribed polytherapy. Sodium valproate (77.36 %) was most commonly prescribed AED followed by levetiracetam and carbamazepine .Most of AEDs were prescribed according to NICE guideline and by generic name. Conclusion: Conventional AEDs are still used as first line of treatment for pediatric epilepsy patients, although newer AEDs also frequently prescribed as add on or primary drug. Low birth weight, NICU admission and non compliance to treatment are associated with breakthrough seizures.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;&nbsp

An evaluation of the impact of antidiabetic medication on treatment satisfaction and quality of life in patients of diabetes mellitus

Aims: This study aims to measure the quality of life (QOL), treatment satisfaction, and tolerability of antidiabetic drugs in patients suffering from type 2 diabetes mellitus (DM). Methods: The prospective, observational study was conducted in consenting patients of type 2 DM attending the outpatient department of a tertiary care hospital in Western India. The QOL instrument for Indian diabetes (QOLID) patients questionnaire and the Diabetes Treatment Satisfaction Questionnaire were administered to all patients at baseline, 3 months, and 6 months of treatment. Tukey–Kramer comparison test was used to analyze the difference in QOLID scores in various domains at baseline, 3 months, and 6 months. WHO-UMC scale, Naranjo's probability scale, Hartwig and Siegel, and Schumock and Thornton modified criteria were used to analyze the adverse drug reactions. Results: A male preponderance was observed in 200 patients enrolled in the study. The mean duration of diabetes was 10.96 ± 5.99 years. The patients received metformin alone (40), metformin and glipizide (47), metformin, glipizide and other oral hypoglycemic agents (OHAs) (78), and OHAs and insulin (35). A significant improvement in fasting and postprandial blood sugar was observed at 6 months as compared to the baseline (P < 0.05). A total of 39 (19.5%) patients suffered from adverse effects to metformin and insulin. Physical health and physical endurance improved in patients receiving metformin alone or in combination with glipizide as compared to patients receiving other OHAs and/or insulin. Treatment satisfaction, highest in patients receiving metformin and least in those receiving insulin, was unaltered during the study period. Conclusions: While polypharmacy is evident, using lesser medicines offers better treatment satisfaction and QOL in DM. Periodic assessment of QOL and treatment satisfaction are recommended in DM

Steroid-induced central serous retinopathy

A-24 year-old male was prescribed prednisolone (60 mg/day) for left sided facial palsy. After three days of therapy, the patient complained of black spots in his vision in right eye. Fluorescein angiography of right eye showed evidence of central serous retinopathy (CSR). Prednisolone dose was withdrawn gradually and the patient improved within a week. There were no other systemic or ophthalmic diseases reported by the patient, which could have caused this condition. An improvement after dechallenge confirmed steroid-induced CSR. Recurrent CSR is known to cause permanent loss of vision. Hence, awareness regarding this adverse drug reaction (ADR) with steroids and its reporting can minimize this complication and help in better patient management