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Background: Cardiovascular diseases are one of the leading causes of morbidity and mortality worldwide. Anticoagulants are the most commonly implicated drugs, used in cardiology unit and they are responsible for a majority of adverse drug reactions (ADRs). The objective of the present study was to evaluate the pattern of ADRs reported with anticoagulant drugs used in the cardiology unit of a tertiary care hospital.Methods: This observational prospective study was undertaken from September 2017 to August 2018. Causality assessment of ADRs was assessed using the WHO and Naranjo scale of probability. The severity was assessed by modified Hartwig and Siegel scale, and preventability of ADRs was assessed by Schumock and Thornton scale.Results: Out of the total forty-one ADRs recorded, 40 (97.56%) were mild and 1 (2.44%) was reported as severe on the Hartwig and Siegel severity scale. Hematuria (68.29%) was the most common ADR followed by hemoptysis (14.63%). Among all anticoagulants, low molecular weight heparin was associated with the majority of ADRs (85.37%). The WHO causality and Naranjo Scale revealed that maximum of the ADRs (~80%) were possible. All ADRs reported was Type 揂� reactions according to Wills and Brown classification of ADRs. Majority of ADRs (97.56%) were probably preventable.Conclusions: In the present study, hematuria was the most common ADR reported. Among all anticoagulants, Low molecular weight heparin accounted for the majority of ADRs followed by acenocoumarol and heparin. Intensive monitoring and frequent reporting need to be done in cardiac units to improve patient safety.
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Background: Cognitive decline with AEDs (Anti-epileptic drugs) is associated with learning and memory deficits especially in the younger age group. The data regarding the impact of levetiracetam and valproic acid as monotherapy on cognition in epileptic patients is scarce. The present study was done for evaluation of cognitive decline associated with the use of AEDs.Methods: Present study was a prospective study on 60 patients on AEDs for a period of 12 weeks. Patients were enrolled from the Department of Neurology, Swami Rama Himalayan University, Dehradun, Uttarakhand, India and divided into group A (levetiracetam) and group B (valproic acid) with 30 patients in each group. Permission from the institutional ethics committee and written informed consent was taken from all the patients. They were analyzed for cognitive impairment using MMSE and MoCA scales at baseline and 12 weeks.Results: The mean duration of disease was 2.13�1 years and 2.08�1 years and mean age of the patients was 14.67�9 years in group A and 16.20�6 years in group B. GTCS was present in 31 patients (52%) followed by partial seizures in 29 patients (48%). The mean change in the MMSE scores from baseline to 12 weeks was significant in group A 1.30�1 (p value <0.05) and change group B was -0.20�4 not statistically significant. The mean change was observed in MoCA scores from baseline to 12 weeks was significant in both groups A and B by 1.17�1 and -0.70�1 respectively (P value <0.05).Conclusions: Patients on levetiracetam showed cognitive improvement, whereas patients on valproic acid showed a decline in the MMSE and MoCA scores.
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Background: Neuropathic pain is associated with prolonged disability and is usually not responsive to conventional analgesics like NSAIDs and opioids. Even the recommended first-line drugs are effective in less than 50% patients. Thus, drugs with different mechanisms of action are needed. Baclofen, a GABA-B agonist has shown benefit in different types of neuropathic pains and is compared against pregabalin.Methods: The sciatic nerve was ligated in 2 groups of 6 rats each as per the chronic constriction injury model of neuropathic pain on day 0. After 14 days the effect of single doses of pregabalin (30mg/kg) and baclofen (5mg/kg) intraperitoneally were assessed over a 2 hours period. Thermal and mechanical hyperalgesia were assessed as measures of neuropathic pain by the hotplate and pin-prick method respectively.Results: Significant thermal and mechanical hyperalgesia was produced 14 days after sciatic nerve ligation in both the groups (p <0.05). Both pregabalin (p <0.001) and baclofen (p <0.01) were effective in decreasing thermal hyperalgesia throughout the two hours study period, but pregabalin was more effective as compared to baclofen (p <0.05) at 30, 60 and 120minutes. Both the drugs produced a significant decrease in mechanical hyperalgesia (p <0.01) throughout the study period. Again, pregabalin was the more effective drug (p <0.05) at all time points.Conclusions: Significant thermal and mechanical hyperalgesia was seen 14 days after sciatic nerve ligation. Both pregabalin and baclofen were effective in reversing the hyperalgesia, but pregabalin was the more effective of the two drugs at all time points.
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Background: Children constitute one-third of the population and they suffer from a variety of infectious diseases and are commonly prescribed antibiotics. Most of the antibiotics lack sufficient information on safety and efficacy in children and are thus prescribed off-label. This study was envisaged to assess the off-label use of antibiotics in hospitalized children.Methods: Total 120 patients were included in the study. Off-label use was determined on the basis of product literature and National Formulary of India. Descriptive statistics was used to present the data i.e. percentage; proportions, frequency, mean and standard deviation using Microsoft excel worksheet.Results: A total of 791 drugs from different classes were prescribed to 120 patients with a mean of 6.6±2.68 drugs described per patient during their stay in the hospital. 100 out of 120 (83%) patients were prescribed at least one antibiotic during their stay in the hospital. Out of the 204 antibiotics prescribed, 43(21%) were prescribed off-label. Antibiotic dose was the most common reason followed by age (1month-1 year more than 2-6 years of age) and frequency in off-label use.Conclusions: Antibiotics are commonly prescribed to children with substantial off-label use. The same must be seriously addressed by the policy makers and stakeholders in order to promote their rational use.
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Background: Antimicrobials are a major class of drugs prescribed in Intensive Care Unit (ICU). Widespread use of empirical antibiotic therapy has facilitated the emergence of drug resistance, since empirical therapy is very often initiated at the outset, even before culture and sensitivity reports are available. The problem of drug resistance is on a rise, therefore, this study was planned to assess the drug resistance and sensitivity patterns of the blood isolates recovered from ICU.Methods: An observational- prospective study was conducted in the Tertiary care teaching hospital over a period of twelve months to assess antibiotic resistance and sensitivity pattern. A total of 104 consecutive patients receiving antibiotics in the ICU and having blood cultures with significant growth were included in the study. Blood sample was collected and after obtaining a culture growth, the identification and antimicrobial sensitivity testing was done.Results: Blood stream infection by Gram-negative bacteria (50.96%) was more common than Gram-positive bacteria (49.04%). Coagulase negative Staphylococci (CoNS) was the predominant single blood culture isolate (35.58%). Klebsiella pneumoniae (13.46%), Escherichia coli (12.50%), Acinetobacter baumannii complex (7.69%) were commonly isolated gram negative organisms. Gram positive isolates were resistant to beta lactams in maximum patients whereas Tigecycline, Linezolid, Daptomycin, Vancomycin, Nitrofurantoin and Teicoplanin were sensitive against them. Common gram negative isolates were sensitive to Colistin and Tigecycline but resistant to most of the antibiotics.Conclusions: A preponderance of gram negative bacteria over gram positive bacteria was noted with a higher degree of resistance to most of the first line antimicrobial agents.
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Background: Quality of life plays an important role in patients of epilepsy and is the most neglected part during management. The antiepileptic drugs treatment results in seizure control but adversely affect the quality of life in patients.Methods: An observational analytical study was conducted in the Department of pharmacology with Department of Neurology of Himalayan Institute of Medical Sciences, Dehradun over 12 months. 85 patients fulfilling the inclusion criteria with diagnosis of generalized tonic clonic seizures (GTCS) were enrolled and divided into two groups based on physicians discretion and followed up for 12 weeks. Patients were evaluated for quality of life by QOLIE-10 self administered questionnaire at 0 and 12 weeks, assessed for seizure control and drug related adverse effects.Results: 85 patients were enrolled and divided into two treatment arms as per physician discretion, levetiracetam (41) and valproic acid group (44). Study drugs showed significant improvement in quality of life, levetiracetam showed mean change that was significantly greater than valproic acid (p=0.003) at 12 weeks. Patients who failed to achieve seizure control at 6 weeks were 17% patients in levetiracetam and 20% in valproic acid group, reason being non-adherence which was 17% and 20% respectively. Adverse events recorded with Levetiracetam (10), most common being increased sleep and with valproic acid (18), with most common being increased sleep and weight gain.Conclusions: Levetiracetam treatment resulted in better quality of life, with similar seizure control but decreased number of adverse effect then Valproic acid.
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Background: The aim of this study was to know the pattern & rationality of antimicrobial prescription by dental practitioners. Methods: It was questionnaire based cross sectional study. A total of 175 questionnaires were distributed to dental practitioners working in a tertiary care Dental College & Hospital and private practitioners in Jaipur (Rajasthan). The questionnaire contained questions about years of practice, diagnosis for which antimicrobial were prescribed, dosage and duration of antimicrobial drugs for prophylaxis, acute and chronic conditions, patient compliance & adverse effects. Data was expressed as counts and percentages. Results: Out of 175 questionnaires distributed, 150 were included in the study. 78% dentists had practices less than 5 years duration. Most common indications for which antimicrobials were prescribed were abscess, cellulitis, irreversible pulpitis, and acute gingivitis. Most common antimicrobials used for prophylaxis were Amoxycillin and Metronidazole. For the treatment of acute and chronic conditions, Amoxycillin, Metronidazole, Ofloxacin and Ornidazole alone or in combination were used. Only 20% dentist advised culture & sensitivity tests. 74% patients completed the recommended course of antimicrobials. 56% patients reported adverse drug reactions (ADRs) with the most common being nausea and vomiting, but only 13% dentists reported them to proper authorities. Conclusions: In this study, Amoxycillin and Metronidazole were the most common drugs used for the management of oral diseases, but were prescribed without culture & sensitivity in most cases. 56% patients reported ADRs, but only 13% dentists reported them to proper authorities. Appropriate measures need to be taken to promote rational prescribing and ADR reporting.