A pattern of serious adverse drug reactions reported in a tertiary care hospital, Rangaraya Medical College, Kakinada, Andhra Pradesh

Background: Serious adverse drug reactions (ADRs) constitute a major limitation in clinical development of a drug thus necessitating close monitoring. Studies regarding the pattern of serious ADRs are limited in southern India. The present study was conducted in tertiary care hospital in Andhra Pradesh with an objective to evaluate the pattern of severe cutaneous and non-cutaneous ADRs in our hospital and to assess the causality, severity, and preventability of these reactions.Methods: A retrospective observational study was conducted over two years, from January 2016 till January 2018 in our ADR monitoring center. The pattern of serious adverse drug reactions, the nature of ADR, suspected drug, the outcome and preventability were analyzed using Modified Hartwig and Siegel scale, and modified Schumock and Thorton scale.Results: Out of 734 ADRs reported, 42 were serious, while 692 were non-serious. Out of 42, 22 were dermatological in origin while the others were acute kidney injury, acute psychosis, febrile neutropenia, gynecomastia, and lipodystrophy. According to WHO causality assessment scale, 27 were probable while 15 were possible. The majority were reported in the age group of 16 to 65 years with female (34) preponderance. The most common drug category responsible was antimicrobials, followed by antiretrovirals, anti-epileptics, and analgesics.Conclusions: Antimicrobial, anti-epileptics, and analgesics contributed to serious ADRs. Although non-cutaneous ADRs did not result in hospitalization, they caused social inhibition and mental stress in the patient.

Assessment of patient satisfaction in a tertiary and secondary hospitals of east Godavari district: a comparative study

Background: Satisfaction is an important element in the evaluation of services rendered by a hospital. Patient satisfaction is as important as other clinical health measures and is a primary means of measuring the effectiveness of health care delivery. It refers to the patient's state of being adequately rewarded. Patient satisfaction is a measure of success of the services being provided by the hospitals. Objective of the study was to assess the satisfaction levels of the people utilizing various services provided in secondary and tertiary health care delivery settings.Methods: Observational hospital based comparative study conducted among Inpatients aged 18 yrs and above from different wards who are discharged during the study period and are willing to participate in the study at Secondary and tertiary health care centres of East Godavari District during May 2015 to April 2016. Sample size was calculated using n-master version 2.0. Sample size calculation was based on assumption that the prevalence of patient satisfaction as 50% with mean difference of satisfaction of 15%, confidence interval of 95%, α - error of 5%, power 90%, with effect size 0.3, sample size estimated was 234 in each setting resulting in a cumulative sample size of 702.Results: It was found that 64.52% of inpatients of District Hospital, Rajahmundry, have expressed neutrality or dissatisfaction regarding overall admission services as compared to 49.14% in Government General Hospital, Kakinada and 14.52% in Area Hospital, Rampachodavaram.Conclusions: The overall patient satisfaction was observed to be around 80% for all the three hospitals.

Evaluation of safety and efficacy of intravenous iron sucrose therapy for moderate anaemia in antenatal women

Background: Prevalence of iron deficiency anaemia is high in developing countries like India. Treatment of iron deficiency anaemia in pregnancy is very important to bring down maternal mortality rate as blood loss during delivery can lead to death of the patient. The aim and objective of our study is to evaluate the efficacy and safety of intravenous iron sucrose infusions in antenatal women admitted in hospital suffering from moderate iron deficiency anaemia. Special emphasis was given to observe adverse drug effects.Methods: This was a prospective observational study conducted in Obstetrics and Gynaecology department, Government General Hospital, Rangaraya Medical College, Kakinada, Andhra Pradesh. Study period was two months and study population included antenatal women with gestational age less than 37 weeks with moderate iron deficiency anaemia. Peripheral smear was examined for microcytic hypochromic anaemia and they were treated with intravenous infusion of iron sucrose. Haemoglobin levels were checked before and 5 weeks after iron infusions. Monitoring was done for adverse reactions.Results: Out of 322 admissions, 95% were found to be anaemic. 72 patients were suffering from moderate anaemia from which 25 have been included and treated with intravenous iron sucrose infusions. They were observed for efficacy and safety parameters. Two minor adverse events were reported (fever with chills and angioedema of lips) and they were excluded from study. Mean haemoglobin concentration was found to be raised from 7.08±0.73 (SD) to 11.33±0.48 (SD) within 5 weeks for 23 patients.Conclusions: Iron sucrose infusion is safe and effective for anaemia in pregnancy.

Schwannoma arising from hypoglossal nerve in the submandibular triangle: a case report.

Hypoglossal schwannomas usually develop in the intracranial portion of the brain. The incidence of hypoglossal schwannomas of the submandibular region is extremely rare. Here we report a case of schwannoma arising from the extracranial hypoglossal nerve in the left submandibular region.

Antioxidant and Radical Scavenging Properties of β-Carotene on Cisplatin Induced Cardiotoxicity.

Objective: To investigate the protective role of β-Carotene against cisplatin induced cardiotoxicity in male albino rats. Methods: Various biochemical parameters such as Creatine kinase-MB, Lactate dehydrogenase (LDH), Alkaline phosphatase (ALP), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Triglycerides (TG) and Total cholesterol (TC) are being assessed. Also the levels of the in vivo antioxidants such as Reduced glutathione (GSH), Catalase (CAT), and Malondialdehyde (MDA) in the post mitochondrial supernatant of heart were measured. In addition, the histopathological studies were performed to study the protective activity of β-carotene. Results: Cisplatin administration has shown the elevated levels of the cardiac markers and diminished the endogenous antioxidant levels when compared with the normal rats. β-carotene treatment showed the inhibitory effect on the free radicals showing decreased levels of the cardiac markers like CK-MB, LDH, AST, ALT and ALP. The β-carotene treated rats showed significant (p<0.001) decrease in lipid peroxidation in both prophylactic and curative groups when compared to the cisplatin group. Also showed a significant (p<0.05, p<0.001) increase in the levels of GSH in prophylactic and curative group respectively when compared with the cisplatin group. Both prophylactic and curative groups have shown a significant (p<0.001) increase in the levels of CAT. Further, the histopathological studies confirm the protective effect of β-carotene. Conclusion: These findings justify the biological and traditional uses of β-carotene as confirmed by its promising radical scavenging activity against cisplatin induced cardiotoxicity.

Tobacco cessation in India: A contemporary issue in public health dentistry.

In India, tobacco use is incredibly linked to poverty and accounts for the high public health costs of treating tobacco-related diseases. Dental public health programs aid in detecting the tobacco-related periodontal diseases, oral cancers, etc., where the majority belongs to the submerged portion of iceberg, which otherwise leads to substantial morbidity and mortality. Moreover, public health dentists plays a key role in identifying both clinical and subclinical cases and aid in tobacco use cessation through various modes of health education and counseling. Therefore, the community-based measures are deemed to be the most cost-effective tool for tobacco cessation.

Efficacy of two commercially available dentifrices in reducing dentinal hypersensitivity.

Objective: A parallel design clinical study evaluated reduction in hypersensitivity after brushing for 12 weeks with Anchor toothpaste (containing potassium citrate, zinc citrate, triclosan and sodium monofluorophosphate) (test) and Colgate Total (sodium fluoride, silica, triclosan and copolymer) (control) dentifrices. Materials and Methods: Sixty adults with sensitivity to hot and cold stimulus in at least two tooth surfaces were stratified at the baseline examination by tactile, hot and cold stimuli scores in two balanced groups. Subjects were randomly allocated the test and control dentifrices and evaluated after 6 and 12 weeks of dentifrice use for hypersensitivity. Results: The two teeth that were selected in each patient were designated as two different sets. The 12 th -week scores as compared to baseline scores for tactile, heat and cold tests in the test group showed a reduction in tooth hypersensitivity by 36.67% (P < 0.01), 20.35% (P < 0.01) and 53.64 % (P < 0.01), respectively, in the first set of teeth and 43.75% (P < 0.01), 24.48% (P < 0.01) and 59.78% (P < 0.01), respectively, in the second set of teeth. The 12 th -week scores as compared to baseline scores for tactile, heat and cold tests in the control group showed a reduction in tooth hypersensitivity by 42.86% (P < 0.01), 13.02% (P < 0.01) and 45.14% (P < 0.01), respectively, in the first set of teeth and 40% (P < 0.01), 16.59% (P < 0.01) and 44.16% (P < 0.01), respectively, in the second set of teeth. Conclusions: Both the products reduced dentinal hypersensitivity in the study subjects at the end of the 12-week period. However, there was no statistically significant difference in reduction in hypersensitivity between the two products.

Pulmonary function tests in Indian girls--prediction equations.

OBJECTIVE: The present study was conducted to evaluate pulmonary functions and develop prediction equations in Indian girls. METHODS: 1038 normal healthy schoolgirls in the age group of 5 to 15 years were selected for the present study. The anthropometrical parameters like height, weight, sitting height and chest circumference were measured and body surface area (BSA) and fat free mass (FFM) were derived using equations. The pulmonary functions such as FEV1, FVC, FEV1/FVC% and PEFR were studied. RESULTS: The height, sitting height, weight, BSA, chest circumference, body fat as well as FEV1, FVC, FEV1/FVC% and PEFR were comparable with Indian standards. Multiple regression equations were developed to predict FEV1, FVC and PEFR using anthropometrical indices like height, fat free mass and age or chest circumference in view of significantly high correlation of these parameters with lung function variables [height and FEV1 (r-0.90), height and FVC (r-0.899), height and PEFR (r-0.891), chest and FEV1 (r-0.868), chest and FVC (r-0.867), chest and PEFR (r-0.83)]. CONCLUSION: The regression equations to predict the pulmonary functions were presented using the independent variables like height, fat free mass and chest circumference or age, since these variables have shown very strong predictability for FEV1, FVC and PEFR. The equations presented in this study can be considered as referral standards for Indian girls.

Study on lung function tests and prediction equations in Indian male children.

OBJECTIVE: The present study was carried out to evaluate lung functions and develop prediction equations in Indian boys. SUBJECTS: 1555 normal healthy schoolboys from Hyderabad city who were in the age group of 5 to 15 years were selected for the present study. DESIGN: The anthropometric parameters such as height, sitting height, weight, and chest circumference were measured and body surface area (BSA) and percent body fat (% Fat) were derived. The lung functions studied were FEV1, FVC, FEV1% and PEFR. RESULTS: The height, sitting height, weight, BSA, chest circumference, body fat as well as FEV1, FVC, FEV1 % and PEFR were comparable with Indian boys. The height for age, weight for age and weight for height were found to be lower than 50th percentile of NCHS standards in the subjects studied. Similarly the lung function values of the study population were found to be lower than the values of corresponding western population. CONCLUSION: Regression equations were derived to predict FEV1, FVC and PEFR using physical characteristics. Height, chest circumference and fat free mass were the best predictors for FEV1, FVC, and PEFR. Age, height, sitting height, weight, chest circumference and fat free mass showed significant association with lung functions.

Proximate determinants of demand for oral health care in the surveyed households of Dharwad city, Karnataka India.

The study was undertaken to identify the factors influential in determining the demand for oral health care in the surveyed households of Dharwad city. Karnataka during May-July 2001. Dharwad city was divided into nine divisions in 1991 census, in which four divisions were selected at random. A sample of 70 households was selected randomly from each division. A total of 1381 persons from 280 households only 208 persons were reported with various oral health problems during reference period of study. A significant positive relationship was observed between oral health care expenditure with the total number of visits (r = 0.4160, P < 0.01), the education of the sick person (r = 0.1983, p < 0.05), and the highest level of education among females (r = 0.1475, P < 0.05) and a significant negative relationship was observed between time gap between onset of disease and contact of health care centre (r = -0.1449, P < 0.05) and family size (r = -0.1518, P < 0.05) with expenditure. Path analysis results showed that, the duration of illness episode, the total number of visits to source of care during the reference period and distance between health care from the residence of the households (in km) are important variables in explaining increased oral health care expenditure.

Comparison of effects of yoga & physical exercise in athletes.

The effect of pranayama a controlled breathing practice, on exercise tests was studied in athletes in two phases; sub-maximal and maximal exercise tests. At the end of phase I (one year) both the groups (control and experimental) achieved significantly higher work rate and reduction in oxygen consumption per unit work. There was a significant reduction in blood lactate and an increase in P/L ratio in the experimental group, at rest. At the end of phase II (two years), the oxygen consumption per unit work was found to be significantly reduced and the work rate significantly increased in the experimental group. Blood lactate decreased significantly at rest in the experimental group only. Pyruvate and pyruvate-lactate ratio increased significantly in both the groups after exercise and at rest in the experimental group. The results in both phases showed that the subjects who practised pranayama could achieve higher work rates with reduced oxygen consumption per unit work and without increase in blood lactate levels. The blood lactate levels were significantly low at rest.

Evaluation of Ammannia baccifera Linn. for antiurolithic activity in albino rats.

Ethanolic extract of A. baccifera was tested for its antiurolithic activity in male albino rats. Urinary stones were induced by implantation of zinc discs in the urinary bladder. The stones formed were mainly of magnesium ammonium phosphate with traces of calcium oxalate. Ethanolic extract of A. baccifera (2g/kg/day, po) was found to be effective in reducing the formation of stones as also in dissolving the pre-formed ones. There was a significant increase in the urinary excretion of calcium, magnesium and oxalate, four weeks after implantation of zinc discs. Treatment with A. baccifera has significantly reduced calcium and magnesium levels in the prophylactic group while it has reversed the levels of these ions to normal values in the curative group.

Evaluation of Musa (Paradisiaca Linn. cultivar)--"Puttubale" stem juice for antilithiatic activity in albino rats.

The fresh juice of Musa stem (Puttubale) was tested for its antilithiatic activity. Zinc discs were implanted in the urinary bladder of albino rats to induce urolithiasis. The stones formed were mainly of magnesium ammonium phosphate with traces of calcium oxalate. Musa stem juice (3 mL/rat/day orally) was found to be effective in reducing the formation and also in dissolving the pre-formed stones.

Pharmacokinetics of norethisterone from two different combination contraceptive pills in Indian women.

In view of our previous studies that the plasma elimination of norethisterone (NET) from mini pill is faster in low socio-economic group Indian women, the present studies were contemplated to find the least effective dosage of NET from combination pills. Pharmacokinetics of NET were evaluated in a total of twenty women of low socio-economic group taking pills containing NET-acetate (500 micrograms or 1 mg) and ethinyl estradiol (30 or 50 micrograms respectively) on empty stomach. Blood samples were drawn at different time intervals from 0.5 to 24 hr and plasma NET was estimated by a specific radio-immunoassay. In the women taking 1 mg NET-acetate containing pills peak plasma levels ranging from 6.2 to 20.8 ng/ml were observed at 1 hr whereas with 500 micrograms pill they ranged from 2.0 to 6.5 ng/ml and the peak was noted at 4 hr. Pharmacokinetic parameters of NET were more or less comparable between the two pills. The results suggest that pills containing 500 micrograms NET-acetate and 30 micrograms ethinyl estradiol provide adequate levels of NET even in low-socio-economic group women.