Advancements in materiovigilance: A comprehensive overview D. Vikas, Rajesh Venkataraman, A Hafis. Perspectives in Clinical Research, 2025 Patient safety is crucial while using medical equipment, which is, therefore, strong risk management and monitoring systems such as materiovigilance are required. Through international cooperation and technical improvements, this field which focuses on identifying and resolving adverse occurrences related to medical devices has developed. By facilitating real-time data analysis and the early detection of safety issues, as well as by enhancing patient outcomes and regulatory compliance, the combination of artificial intelligence and machine learning has greatly improved materiovigilance. The Materiovigilance Programme of India attempts to improve the infrastructure for medical device monitoring in underdeveloped nations like India, in spite of obstacles including poor data quality and infrastructure. To improve the security and efficacy of medical devices, engineers, regulators, healthcare practitioners, and technology companies must continue to collaborate. To protect public health and safety, materiovigilance will increasingly rely on advanced technologies and strict adherence to regulations.
Safety Assessment of Streptococcus salivarius UBSS-01 in Rats and Double-Blind Placebo-Controlled Study in Healthy Individuals Bindhu S. Jatoth, Ziaur Rahman, Manoj P. Dandekar, Rajesh Venkataraman, Ravi K. Shivalingegowda, Gloriya G. Manuel International Journal of Toxicology, 2024 Streptococcus salivarius is a common, harmless, and prevalent member of the oral microbiota in humans. In the present study, the safety of S. salivarius UBSS-01 was evaluated using in silico methods and preclinical and clinical studies. In an acute toxicity study, rats were administered with 5 g/kg (500 × 109 CFU) S. salivarius UBSS-01. The changes in phenotypic behaviors and hematological, biochemical, electrolytes, and urine analyses were monitored. No toxicity was observed at 14 days post-treatment. The no observable effects limit (NOEL) of S. salivarius UBSS-01 was >5 g/kg in rats. In a 28-day repeat dose toxicity study, rats were administered S. salivarius UBSS-01 once daily at doses of 0.1, 0.5, and 1 g/kg (10, 50, and 100 billion CFU/kg, respectively) body weight. S. salivarius UBSS-01 did not influence any of the hematology parameters and clinical chemistry parameters in plasma and serum samples after 28-day repeated administration. No structural abnormality was observed in the histological examination of organs. Whole genome analysis revealed the absence of virulence factors or genes that may transmit antibiotic resistance. In the double-blind study with 60 human participants (aged 18–60 years), consumption of S. salivarius UBSS-01 for 30 days was found to be safe and results were comparable with placebo treatment These findings indicate that S. salivarius UBSS-01 may be safe for human consumption.
Metronidazole Induced Cutaneous Adverse Drug Reaction- A Systematic Review of Descriptive Studies Shifa Taj, Mohammed Zuber, Vidhyashree Ballagere Hanumanthaiah, Rajesh Venkataraman, Sathish Kumar Puttegowda, Syed Afrid, Sai Kiran Current Reviews in Clinical and Experimental Pharmacology, 2024 Background: A substantial number of research studies on metronidazole-related cutaneous symptoms have recently been published. Our objective was to identify and evaluate descriptive studies that described metronidazole-related skin manifestations, therapeutic interventions, and consequences. Methods: A comprehensive literature search was carried out in the PubMed, Scopus, and grey literature databases from inception to April 2022 without any constraints, as well as a snowball search in Google and a search in Google Scholar. Descriptive articles describing metronidazole-related cutaneous manifestations were considered for the review. Two distinct reviewers carried out the research selection, data extraction, and quality assessment; any discrepancies were resolved by consensus with the third reviewer. Results: About 24 out of 4648 descriptive studies, including 26 patients (20 Female patients and 6 male patients), were included in this review. The included studies comprised a range of ages from 16 to 78 years old. Metronidazole was indicated for the treatment of bacterial vaginosis, trichomoniasis, sepsis, anti-infection therapy, perforated appendicitis, rosacea, vaginal discharge, dysentery, acne rosacea, trichomonal vaginitis, lichen planus, liver abscess, facial rosacea, intestinal amoebiasis, and gingivitis. Fixed drug eruption was the most common skin manifestation which was reported in 7 cases included in this review. Cutaneous manifestations were ameliorated by cessation of the offending drug and by apportioning antihistamines, topical steroids, parenteral corticosteroids, emollients, and topical moisturizers. Conclusion: Clinicians and healthcare professionals should be cognizant of the potential cutaneous adverse drug reactions (CADRs) induced by metronidazole to mitigate fatal circumstances. The management of the CADRs appears to respond effectively with immediate drug discontinuation and supportive therapy. Prospero No: CRD42021259364
Effect of body mass index on pregnancy outcomes: a prospective observational study from a rural South Indian tertiary care setting R. Venkataraman, S.K. Yadav, R.S. Pukal Italian Journal of Gynaecology and Obstetrics, 2023 Objective.The effect of body mass index (BMI) on pregnancy outcome is not well established especially in a South Indian population.This study aimed to assess the link between maternal BMI and pregnancy outcomes.Materials and Methods.A prospective observational study was conducted among 150 pregnant women subjects in a South Indian tertiary care centre for a period of 6 months after obtaining ethical approval.Pregnant women aged 18 or above who were accepted and willing to provide written informed consent were included in the study.The relevant data were collected from patients and analysed using SPSS version 16.Results.A higher proportion of participants (65.3%) had normal BMI, followed by overweight or obese (32%) and only 2.7% were underweight, during the pregnancy.Being overweight was significantly associated with depression (p = 0.032) and gestational diabetes (p = 0.000), but not with gestational hypertension and pre-eclampsia (p > 0.05) in the pregnant woman.Conclusions.The overweight and obesity were significantly associated with gestational diabetes and depression among pregnant women.
Social Determinants Predicting the Community Pharmacists' Workforce Preparedness for, and Response to, the Public Health Emergencies Rajesh Venkataraman, Kingston Rajiah, Meghana Anand, Gopika Surendran Disaster Medicine and Public Health Preparedness, 2023 Objectives: To identify the predicting factors that contribute to preparedness for public health emergencies among community pharmacists in India. Methods: Multistage cluster sampling was done. The geographic breakdown was done based on villages and areas and used as clusters. A simple random method was done in the first stage to select the villages as clusters. From each selected village, a simple random method was done in the second stage to select the areas. From each selected area, all the community pharmacies were selected. The survey questionnaire had 3 sections with 43 items: (A) demographic information, (B) preparedness, (C) response toward infectious diseases. The participants chose “Yes/No”, in sections B and C. A score of 1 was given for “Yes”, and a score of zero was given for “No”. Results: Multiple correlation analyses were conducted between participants’ preparedness and response (PR) scores and independent variables. The independent variables such as “More than one Pharmacist working in a pharmacy”, “Pharmacists who are trained more than once on disaster management”, and encountered more than 1 patient with the infectious disease were positively and significantly correlated with the dependent variable (PR scores). Conclusions: Community pharmacists were aware of the issues they may face in their community concerning public health emergencies. They believed that the medications available in their pharmacy are sufficient to face any emergency. They could identify the clinical manifestations of public health emergency conditions and provide counselling to the customers toward them. Community pharmacists who were trained more than once in disaster management were the strongest predicting factor.
Factors affecting the depression and impact of depression on maternal outcomes: a prospective observational study from a rural tertiary care South Indian Hospital R. Venkataraman, S.K. Yadav, R. S. Pukale Italian Journal of Gynaecology and Obstetrics, 2023 Objective. There is a dearth of evidence from lower income countries on impact of depression and mental health issues on pregnancy outcomes. This study aimed to examine the factors affecting the depression and its effect on maternal outcomes in a rural South Indian tertiary care hospital. Materials and Methods. A 9-month prospective observational study was carried out among the pregnant women in a tertiary care facility in south India. The pregnant woman aged 18 years or above were included in the study. The participants with a history of depressive symptoms and not willing to provide the informed consent were excluded from the study. The depression was measured using The Edinburgh Postnatal Depression Scale and a score of 13 and > 13 was considered to be no abnormality and possible depression. The effect of various demographics on depression and effect of depression on maternal outcomes is assessed using the chi-square and regression analysis, respectively. A P-value < 0.05 considered to be significant. Results. A total of 150 patients were included in the study and 48% (n = 72) had the possible depression. The factors such as being obese (p = 0.020) and being a housewife (p = 0.000) were significantly associated with depression. Depression was significantly associated with the gestational diabetes (p = 0.036), but not with gestational hypertension and pre-eclampsia. Conclusions. Among pregnant women, being obese, and housewife was significantly associated with depression. The depression was significantly associated with gestational diabetes.
Catheter-associated urinary tract infection: An overview Rajesh Venkataraman, Umesh Yadav Journal of Basic and Clinical Physiology and Pharmacology, 2023 CAUTIs (catheter-associated urinary tract infections) continue to be one of the most common health-care-related illnesses in the entire globe. CAUTIs are the cause of 40% of all hospital-acquired infections and 80% of all nosocomial urinary tract infections (UTIs). A urine catheter is implanted into a high percentage of inpatients at some point during their hospitalization, and indwelling urinary catheter adoption likely to be on the rise. Urinary catheters, made of plastic materials, inhibit the urinary tract’s natural defence mechanisms and enhance the bacterial colonization or biofilm formation on the catheter surface, which may cause CAUTIs. It is associated with increased burden of disease, mortality, hospital bills and length of hospital stay. Therefore, to prevent these infections, technological innovations in catheter materials that limit biofilm formation will be required. Unfortunately, many health-care practitioners are unclear of the precise indications for bladder catheterization and accurate CAUTI criteria, which can lead to unnecessary catheterization, antibiotic overuse for asymptomatic bacteriuria and the spread of resistant organisms. As a result, we discuss CAUTIs in general, including definitions, pathophysiology, causation, indications for catheterization and a variety of effective CAUTI-fighting strategies.
Tele-pharmacy and E-pharmacy equivocal in India? Technological and legal issues of tele-pharmacy in India International Journal of Current Pharmaceutical Review and Research, 2015
Social pharmacy in India: Is it emerging as a comprehensive curriculum in academia? Research Journal of Pharmaceutical Biological and Chemical Sciences, 2015
Smoking, alcohol and hypertension International Journal of Pharmacy and Pharmaceutical Sciences, 2013
Lifestyle factors: An alarm towards hypertension Asian Journal of Pharmaceutical and Clinical Research, 2013
A study of socio-demographic and behavioral risk factor in patients with cardiovascular disease visiting rural hospital in South India International Journal of Pharmaceutical Sciences Review and Research, 2013
Assessment of clinical pharmacist intervention in tertiary care teaching hospital of Southern India Asian Journal of Pharmaceutical and Clinical Research, 2013
Potential risk factors for cognitive decline in diabetic cohort International Journal of Pharma and Bio Sciences, 2011
Influence of literacy, occupation and hereditary on cognitive functioning in Diabetic individuals International Journal of Pharmacy and Pharmaceutical Sciences, 2011
