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Biosimilars are being marketed in India since 2000. Like biologics, biosimilars have a large size, complex structure, and complicated manufacturing process, and they are produced in a living organism. It requires specialized delivery devices for administration and needs tighter temperature control to prevent degradation. As biosimilar development follows abbreviated pathway, adverse events (AEs) previously unknown during a clinical trial may be detected postmarketing. In India, the awareness on pharmacovigilance has increased significantly after implementation of the pharmacovigilance guidance in January 2018. However, biologics require tighter monitoring to ensure their safety and efficacy. This review article discusses the importance of pharmacovigilance for biosimilars, how it is different from generics, and provides recommendations to sensitize clinicians and researchers about the requirement of a different approach to improve pharmacovigilance for biosimilars. Pharmacovigilance for biosimilars is as important as it is for innovator biologics and more important than that for generics.

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Background: There are multiple economic, psychological, and physical consequences of high job stress, low job satisfaction and burnout in faculty of a teaching hospital in South India. Data from developing countries on these domains are sparse. Materials and Methods: In a cross-sectional study we assessed the prevalence and sources of perceived job stress, job satisfaction and burnout in faculty, as well as ways of coping with stress among consenting faculty of a large, private, charitable, teaching hospital in India using standardized, self-rated questionnaires. Results: A total of 304 respondents, 156 (51.3%) were Assistant Professors; 71 (23.4%) were Associate Professors, and 77 (25.3%) were Professors. The majority (175; 58%) were male, younger than 45 years (235; 76%) and from clinical departments (248; 81.5%) A third (96; 31%) reported high overall levels of perceived job stress. In multivariate analyses, age less than 45 years, designation as Assistant or Associate Professor, and working in a clinical department were associated with perceived high job stress; reporting high perceived job satisfaction was protective. Nearly two-thirds (217; 71.4%) of faculty reported high levels of job satisfaction. In multivariate analysis, age less than 45 years and reporting high job stress were associated with low perceived job satisfaction. Causes of stress and satisfaction differed by age, gender and designation. On the Maslach Burnout Inventory (MBI), 88 (29%) had high scores on the emotional exhaustion subscale, 63 (20.8%) had high scores on the depersonalization subscale, and 90 (29.7%) had low scores on the personal achievement subscales. High job stress and low job satisfaction were significantly associated with burnout on the three domains. Conclusions: High job stress and low job satisfaction were inversely related in this survey of medical faculty and were significantly associated with levels of burnout. The sources of job stress and job satisfaction identified provide insights that could inform formal institutional mechanisms to prevent burnout in doctors.

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Pigmented villonodular synovitis (PVNS) is a rare benign disorder of a joint which affects its synovium, tendon sheaths and bursas. While most cases of PVNS are adult patients aged between 20-50 years, few afflicted children have also been reported. Clinical signs of PVNS are insidious and non-specific. Pain, swelling and stiffness are the major symptoms. Magnetic Resonance Imaging (MRI) is the best radiological method for diagnosis of PVNS, as the initial X-ray is normal in early phase of disease in most cases. Therefore, diagnosis is often delayed or confused with mechanical disorders, haemophilic arthropathy, tuberculosis, juvenile idiopathic arthritis (JIA), and other disorders. Four paediatric PVNS cases are being reported in this case series with the aim to highlight that PVNS should be considered in the differential diagnoses of chronic monoarthritis. Two of our cases were initially misdiagnosed as JIA and the remaining two as Familial Mediterranean fever (FMF). They did not respond to conventional anti-inflammatory treatment and eventually only benefited from surgery. These four cases emphasize that the radiologist and clinician should collaborate carefully while managing any child with monoarthritis to ensure that the diagnosis of PVNS is not missed.

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Background/Objectives: Gastroesophageal reflux disease (GERD) is one of the common gastrointestinal disorders worldwide. Recent epidemiologic studies have suggested that use of statins may lower the risk of GERD although the results from different studies were inconsistent. This systematic review and meta-analysis were conducted with the aim to summarize all available data. Methods: A systematic literature review was performed using MEDLINE and EMBASE database from inception to December 2017. Cohort, case-control, and cross-sectional studies that compared the risk of GERD among statin users versus nonusers were included. Pooled odds ratio (OR) and 95% confidence interval (CI) were calculated using a random-effect, generic inverse variance method. Results: A total of 4 studies (1 case control, 1 cohort, and 2 cross-sectional studies) with 14,505 participants met the eligibility criteria and were included in the meta-analysis. The risk of GERD among statin users was numerically lower than nonusers with the pooled OR of 0.89 but the result did not achieve statistical significance (95% CI, 0.60–1.33). The statistical heterogeneity in this study was moderate (I² = 54%). Conclusions: The current meta-analysis found that the risk of GERD was numerically lower among statin users although the pooled result did not reach statistical significance. Therefore, more studies are still needed to further clarify this potential benefit of statins.

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Context: Globally, around half of all under-5 deaths are attributable to undernutrition. The magnitude of child undernutrition in India is one of the highest in the world. Responsive feeding that has the potential to optimize nutrition and development depends on a “healthy mother”. Objectives: The objective of this study was to find out the magnitude and determinants of maternal depression among mothers of infants who attended immunization clinic in a rural medical college in central India and observe its association with infant-feeding practices and nutritional status of infants. Study Design: This was an analytical cross-sectional study. Materials and Methods: Study was conducted among consecutively chosen 300 mothers and their infants who visited the immunization clinic of hospital during May-September, 2016. Data were collected individually by interviewing each mother, and anthropometry of her infant was done. The mothers with depression were diagnosed according to the 10-item Edinburgh Postnatal Depression Scale. Magnitude of depression has been reported using frequency and percentage, whereas association has been studied using prevalence odds ratio with 95% confidence interval (CI) and logistic regression at 0.05 significance level. Results: The magnitude of maternal depression was 19% (95% CI 14.4-23.5). Mothers with depression had significantly higher odds for not indulging in responsive feeding. Maternal education had significant association with maternal depression after adjusting for other variables. Conclusions: Burden of maternal depression is high among mothers of infants who attended immunization clinic in a rural medical college in central India and is significantly associated with nonresponsive feeding practices.

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Aims: The primary objective of this study was to evaluate the economic burden of slow learners (students with “borderline intellectual functioning”) by estimating its direct, indirect, and intangible costs. The secondary objective was to assess the impact of variables on the economic burden. Settings and Design: Cross-sectional, single-arm descriptive study. Setting: Learning disability clinic in a public medical college in Mumbai. Materials and Methods: The study cases (age ≥5 - 18 years) were recruited by nonprobability sampling. A structured questionnaire was used to interview the parent to collect data related to direct and indirect costs. Intangible costs data were collected by documenting the willingness-to-pay value using the contingent valuation technique. Statistical Analysis Used: A quantile regression model was used to assess the impact of predictor variables on the costs. Results: The direct, indirect, and intangible costs of slow learners were INR 6,065,915, 10,298,613, and 145,172,800, respectively. Indirect costs comprised 62.9% of the total costs. Expenditure on tuitions, medications, and remedial education comprised 57.38%, 16.18%, and 10.30% of the direct costs, respectively. The average annual total costs of slow learners were INR 3,544,880. The average annual learning disability clinic costs were INR 2,250,194. The average annual total costs per student were INR 57,951. Longer duration of poor school performance was predictive of higher direct and total costs. Conclusion: The economic burden of slow learners is enormous (intangible > indirect > direct costs). Tuitions are the most costly component of direct costs. Parental loss of earnings is the most costly component of indirect costs.

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Dipeptidyl peptidase-4 inhibitors (DPP-4i) are one of the mainstay drugs in the management of type 2 diabetes mellitus. It has been well-documented that these class of drugs cause allergic reactions. Bullous pemphigoid (BP) is a blistering skin condition commonly associated with many drugs. Here, we report a case of probable DPP-4i-induced BP in an elderly man, which resolved on discontinuation of the drug. Although this adverse drug reaction has been documented in Western world and Japanese ethnicity, this seems to be the first case report of such occurrence in Indian ethnicity.

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A 66-year-old female underwent preoperative evaluation for primary hyperparathyroidism. Ultrasound (US) neck and technetium (Tc)-99m-sestamibi planar scintigraphy were negative, but single photon emission computed tomography/computed tomography (SPECT/CT) demonstrated a tracer-avid retropharyngeal nodule compatible with parathyroid adenoma (PTA). A retrospective review of CT neck angiogram (CTA) and neck magnetic resonance imaging (MRI) performed 4 months earlier for stroke evaluation revealed arterial phase hyperenhancing retropharyngeal tissue, which had been dismissed as a nonpathological lymph node. “Polar vessel sign” seen in two-thirds of PTA was also present on retrospective review of the CTA. The concordant findings between SPECT/CT and CTA were indicative of a solitary undescended ectopic PTA in the retropharyngeal space, an uncommon location. A successful surgical cure was achieved after minimally invasive parathyroidectomy. This case highlights the retropharyngeal space as an important ectopic site of PTA, limitation of US, and Tc-99m-sestamibi planar scintigraphy in identifying retropharyngeal PTA. We also discuss the role of CT and MRI and the challenge in differentiating retropharyngeal PTA from a lymph node.

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We report a 24-year-old female with early-onset and persistent mild fasting hyperglycemia due to glucokinase-maturity-onset diabetes of the young (GCK-MODY). A c.505A>G (p. Lys169Glu) missense mutation of the GCK gene was identified. In silico analysis indicated that the mutation affected a conserved amino acid and is disease-causing. This report describes GCK-MODY in a Chinese family and stresses that in managing this condition it is important to avoid unnecessary drug treatment and excessive anxiety about mild hyperglycemia.

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