Adverse drug reaction profile of microtubule-damaging antineoplastic drugs: A focused pharmacovigilance study in India.

OBJECTIVES: The aim of the study was to analyze the adverse drug reaction (ADR) profile of microtubule-damaging antineoplastic drugs (taxanes and vinca alkaloids) and to look for unexpected ADRs among the local population. Focused study on these drugs, rampantly used in oncology department for a wide variety of tumors including early and advanced malignancies, would enable better treatment care by physicians. MATERIALS AND METHODS: Data on ADRs were collected from the cancer patients belonging to both gender and of all ages, on taxanes- or vinca-based cancer chemotherapy and reported in the Indian Pharmacopoeia Commission form. Causality was assessed using the WHO criteria and Naranjo's Algorithm. Preventability and severity of ADRs were also assessed. RESULTS: A total of 97 ADRs were reported among 488 patients on microtubule-damaging anticancer drugs admitted over a period of 1 year. The incidence rate was 19.87%. Gastrointestinal system (40.2%) was the most affected followed by bone marrow (33%) and skin (8.2%). The highest incidence of ADRs was reported among paclitaxel (54.6%), and vincristine (39.2%). Most of the reported ADRs were of milder nature and preventable. The WHO causality assessment scale indicated 71.1% possible reactions. CONCLUSIONS: This study showed that most ADRs are preventable with effective ADR monitoring. There is a great need to create awareness among healthcare professionals regarding the importance of the pharmacovigilance system. Judicious use of the preventive measures will lead to a reduction in the incidence of ADRs due to the drug armamentarium, thereby enabling additional economic benefit to the patient and society.

Perceptions and practices of self-medication in healthcare and nonhealthcare university students in South India.

BACKGROUND: The aim was to study and compare knowledge, attitude and practices regarding self-medication in healthcare and nonhealthcare university students. METHODS: Suitably constructed, structured and pretested questionnaires were distributed to 350 students in each group; data were documented in SPSS software version 20.0 and analyzed using χ2-test and multivariate logistic regression analysis. RESULTS: Completed questionnaires only were analyzed, which were 314 and 310 in healthcare and nonhealthcare groups, respectively. The majority of students practiced self-medication (84.4% vs. 68.1%; p<0.001) with the most common indications being fever (46.4% vs. 37.9%; p<0.001) and cough and common cold (30.9% vs. 37%; p=0.004). Most commonly self-medicated drugs were antipyretics (67.9% vs. 52.6%; p=0.03) and multivitamins (28.7% vs. 16.8%; p<0.001). A few of them experienced adverse drug reactions due to self-medication (6.8% vs. 1.9%; p<0.001). Independent risk factors for self-medication were younger age group (OR=2.93, CI 95% 1.09-7.85), storage of medicines at home (OR=2.49, CI 95% 1.21-5.12), healthcare students (OR=2.54, CI 95% 1.72-3.74), higher knowledge scores (OR=1.65, CI 95% 1.08-2.52), those consuming homeopathic preparations (OR=9.19, CI 95% 1.24-68.11), multivitamins (OR=6.7, CI 95% 2.88-15.6) or health supplements (OR=6, CI 95% 2.15-16.74), participants who strongly agreed that self-medication is a part of self-care (OR=3.97, CI 95% 1.56-10.09), and those self-medicating with an old prescription for same illness (OR=0.04, CI 95% 0.01-0.15) or over advice from home (OR=0.11, CI 95% 0.04-0.3). CONCLUSIONS: Though self-medication is common in university students, there is a dearth in their knowledge regarding the same. This highlights the need for increasing awareness among students regarding hazards of self-medication.

Pattern of adverse drug reactions due to cancer chemotherapy in a tertiary care hospital in South India.

PURPOSE: Studies regarding pattern of adverse drug reactions (ADRs) in cancer chemotherapy patients are scarce in India. This study was conducted to evaluate the pattern of occurrence of ADRs due to cancer chemotherapy in hospitalized patients and to assess the causality, severity, predictability, and preventability of these reactions. MATERIALS AND METHODS: This was a retrospective, descriptive study and the occurrence and nature of ADR, suspected drug, duration of hospital stay and outcome were noted from case records. These ADRs were assessed for causality using both World Health Organization (WHO) causality assessment scale and Naranjo's algorithm. The severity and preventability of the reported reactions were assessed using modified Hartwig and Siegel scale and modified Schumock and Thornton scale respectively. RESULTS: Five hundred ADRs were recorded from 195 patients. Most common ADRs were infections (22.4%), nausea/vomiting (21.6%) and febrile neutropenia (13%). Platinum compounds, nitrogen mustards, taxanes, antibiotics and 5-fluorouracil were the most common drugs causing ADRs. WHO causality assessment scale showed 65% of the reactions to be "probable" and 35% to be "possible", while Naranjo's algorithm indicated that 65.6% of ADRs were "probable" and 34.4% were "possible". Modified Hartwig and Siegel scale showed most reactions (41.4%) to be of "moderate level 4(a)" severity, while 30.6% of reactions were of "mild level 1" severity. About 30.8% of the ADRs were "definitely preventable" according to the modified Schumock and Thornton scale. CONCLUSION: ADRs are most important causes of morbidity and mortality and increase the economic burden on patient and society. By careful ADR monitoring, their incidence can be decreased.

Clinical Manifestations and Predictors of Thrombocytopenia in Hospitalized Adults with Dengue Fever.

BACKGROUND: India is one of the seven identified Southeast Asian countries reporting frequent outbreaks of dengue fever (DF). AIMS: This study was to analyze clinical and laboratory profile and predictive markers of thrombocytopenia and length of hospital stay in DF. MATERIALS AND METHODS: This record-based retrospective study conducted in a coastal district of Karnataka, South India, included all dengue cases in adults aged >18 years, admitted during period of January 2011 to December 2014. Multivariate logistic regression analysis was carried out to compute odds ratio (OR) and 95% confidence interval (CI) to assess independent associations of variables with low platelet count and longer duration of hospital stay. RESULTS: Among 207 dengue immunoglobulin M (IgM) antibody confirmed cases (mean age of 36.94 ± 14.61 years), 143 (69.1%) were males and 64 were females. The mean duration of illness and hospital stay were 4.94 ± 3.58 days and 5.98 ± 2.58 days, respectively. Abdominal symptoms included nausea and vomiting (53.6%), abdominal pain (25.1%), and diarrhea (13.5%). Bleeding manifestations were seen in 24 (11.6%) cases and fluid accumulation was revealed in 18 (8.7%) cases. The mean platelet count was 110,159.42 ± 68,397.32 (cells/mm(3)). Low platelet count on admission was associated with the presence of rash (OR = 0.43, 95% CI 0.23-0.81), high aspartate aminotransferase (AST) levels (OR = 3.14, 95% CI 1.58-6.23), high alanine aminotransferase (ALT) levels (OR = 2.91, 95% CI 1.55-5.47), and low albumin levels (OR = 4.48, 95% CI 1.02-19.75). The duration of hospital stay was associated with diarrhea (OR = 0.4, 95% CI 0.18-0.9), abdominal pain (OR = 0.52, 95% CI 0.27-1.00), ascites (OR = 0.26, 95% CI 0.09-0.69), and low hemoglobin (OR = 0.46, 95% CI 0.25-0.86) level on admission. CONCLUSIONS: Though thrombocytopenia on admission was associated with the presence of rash, high AST and ALT levels, and low albumin levels, it was not predictive of length of hospitalization. Duration of hospital stay was longer with the presence of diarrhea, abdominal pain, ascites, and low hemoglobin level on admission.

Comparing the efficacy and influence on the quality of life of three classes of drugs used in bronchial asthma - a prospective study.

OBJECTIVES: To compare the efficacy of formoterol, montelukast and acebrophylline when used in combination with budesonide in patients with bronchial asthma and to determine their role in the improvement of the quality of life of patients. MATERIALS AND METHODS: A total of 75 patients were divided into 3 groups based on treatment given - formoterol 6 mcg/puff + budesonide 100 mcg/puff combination inhaler, 2 puffs twice daily; oral montelukast 10 mg once daily + budesonide 100 mcg/puff, 2 puffs twice daily and oral acebrophylline 100 mg twice daily + budesonide 100 mcg/puff, 2 puffs twice daily. The patients were followed-up for 4 wk after initiating treatment. Spirometry values - forced expiratory volume in 1 second (FEV1) and peak expiratory flow rate (PEFR), before and after treatment were recorded. The quality of life was assessed before and after treatment using Asthma Quality of Life Questionnaire (AQLQ). Analysis was done using repeated measures ANOVA followed by Bonferroni's post-hoc test. RESULTS: As compared to baseline values, FEV1, PEFR and Quality of Life showed significant improvement in all 3 groups after 4 wk of treatment (p-value < 0.01). Three patients in acebrophylline-treated group reported gastric irritation while no adverse effects were reported in the other groups. CONCLUSION: Formoterol, montelukast or acebrophylline combined with inhaled corticosteroids have similar efficacy in the treatment of asthma.

Knowledge, attitude and practices related to dietary supplements and micronutrients in health sciences students.

OBJECTIVES: Little is known about supplement users and their dietary behavior in India. This study was conducted with the following objectives: 1. To determine the usage of dietary supplements in health sciences students. 2. To determine their knowledge, attitudes and beliefs regarding micronutrients. MATERIALS AND METHODS: Cross-sectional, questionnaire based study conducted at a University in south India, which included second year students pursuing medical, dental and nursing courses. Data was analysed using SPSS version 19. RESULTS: The commonest reasons for consuming supplements were to maintain good health (136, 40.1%) and ensure adequate nutrition (125, 36.9%). The respondents' opinions about dietary supplements were generally between 'unsure' and 'agree'. Medical students scored the highest percentage (44.84%) in their knowledge about micronutrients as compared to nursing (43.17%) and dental (37.8%). There was a significant difference between the scores of medical and dental students (p=0.005) while the scoring of students of medical and nursing did not vary significantly. There was no significant difference between the scoring percentage of males and females in medical and dental groups while in the nursing group female students scored a better percentage as compared to males (p=0.036). CONCLUSION: Although, the usage of dietary supplements in health sciences students is high, there is a dearth of knowledge, especially regarding role of micronutrients in health and disease. Hence, it is crucial this information must be highlighted in the health sciences curriculum with the objective of producing well-informed professionals who can later on have a positive impact on the health of society.

Effect of ethanolic extract of Acacia auriculiformis leaves on learning and memory in rats.

BACKGROUND: The effects and benefits of Acacia auriculiformis on health are not well established. This study was planned to evaluate the effect of ethanolic extract of Acacia auriculiformis leaves on learning and memory in rats. MATERIALS AND METHODS: Learning and memory were evaluated using passive avoidance paradigm and rewarded alternation test (T-maze) after the oral administration of two doses (200mg/kg and 400mg/kg) of ethanolic extract of Acacia auriculiformis with rivastigmine as positive control. Forty eight rats were divided into 4 groups in each study model. Estimation of brain cholinesterase activity was done to substantiate the results of the above mentioned tests. Data was analyzed using one way Analysis of Variance (ANOVA) followed by Tukey's post-hoc test using GraphPad InStat software, version 3.06. RESULTS: The extract produced a dose-dependent improvement in the memory score namely the step through latency in passive avoidance model (P < 0.001) and the percentage of correct responses in rewarded alternation test (P < 0.05). Dose-dependent inhibition of brain cholinesterase activity (P < 0.001) was also noted. CONCLUSION: The acetylcholinesterase inhibiting property of Acacia auriculiformis contributes to its memory enhancing potential. Further large scale studies are required to elucidate its benefits on cognitive function. This may offer a promising new option for the treatment of dementia and other cognitive deficits.