Background: Adverse reactions are known to occur with all classes of drugs and the incidence of adverse drug reactions (ADRs) due to antibiotics has increased with rise in infectious diseases contributing significantly to the increased health care costs.Methods: This retrospective observational study analysed the ADRs due to antibiotics that were reported by spontaneous reporting to ADR monitoring centre (AMC), functioning from Department of Pharmacology, ESIC-MC and PGIMSR. The total study period was 48 months from January 2013 to December 2016. During this period, all the ADRs due to antibiotics reported to the AMC were included in the study. This study analysed the retrospective data to find out the pattern of adverse drug reactions due to antibiotic drug class. Causality, severity and preventability were assessed using standard scales.Results: During the study period, a total of 228 ADRs due to antibiotic use were reported among 179 patients. Gender-wise distribution showed that males were slightly more affected than females by the ADRs due to antibiotics [93(52%) Vs. 86 (48%)]. Out of the total 179 antibiotics administered to the patients, beta-lactam antibiotics dominated followed by nitroimidazoles, quinolones and glycopeptide antibiotics in causing ADRs. Rashes and itching were most common ADRs followed by breathlessness and hypotensive episodes. Causality was assessed by Naranjo algorithm scale and causality was definite in 16 (7%), probable in 87 (38%) and possible in 125 (55%). Severity of the ADRs was assessed by Hartwig and Siegel scale and it was found that most of the ADRs 198 (87%) were of mild severity and 30 (13%) were of moderate severity and none of them were severe or lethal. Preventability was assessed by Schumock and Thornton scale and it was found that only 24 (11%) were preventable, 74 (32%) were probably preventable and 130 (57%) were not preventable.Conclusions: The study concluded that ADRs due to antibiotics are common and few of them resulted in increased healthcare cost due to the need for some interventions and increased length of hospital stay. The health system should promote the spontaneous reporting of ADRs due to antibiotics, proper documentation and periodic reporting to regional pharmacovigilance centers to ensure drug safety.
Background: Adverse drug reactions (ADRs) are a major cause of morbidity and mortality, and are the leading cause of hospital admission. The overall rate of ADRs is estimated to be 6.5% and 28% of these ADRs are preventable. Antiepileptic drugs (AEDs) are authorized for several therapeutic indications and are highly prescribed. ADRs due to AEDs range from minor maculopapular exanthem (MPE) to severe life-threatening reactions like Drug reaction eosinophilia and systemic symptoms (DRESS) and Stevens-Johnson syndrome (SJS). Objective of the study was to evaluate the pattern of ADRs reported with AEDs in an adverse drug reaction monitoring centre (AMC) of a tertiary care hospital.Methods: Retrospective analysis of the records was done for a period 48 months from January 2013 to December 2016. During this period, all the ADRs caused by AEDs reported to the AMC were included in the study. The study evaluated the pattern of ADRs due to AEDs. The study also assessed the gender-wise distribution, predilection for various systems, causality, severity, and preventability of ADRs. Data was analysed using descriptive statistics.Results: A total of 319 ADRs were reported by spontaneous reporting during the entire study period. Out of the total 319 ADR reports received, antiepileptic drugs related ADRs were 35 (11%). Antiepileptic drugs which caused the ADRs included phenytoin, carbamazepine, clobazam and lorazepam. The most common system affected was dermatological (60%), followed by gastrointestinal system (17.14%), vascular system (11.42%), blood (5.8%), respiratory system (5.8%) and central nervous system (2.9%). Among the dermatological ADRs, SJS accounted for 11 cases of which 10 cases were due to phenytoin and one case was due to carbamazepine. DRESS syndrome due to phenytoin was documented in one case.Conclusions: AEDs are the most commonly prescribed drugs for various indications. Uses of AEDs are accompanied by ADRs which vary from mild rashes and itching to SJS and DRESS/TEN. Post-marketing surveillance of the AEDs is important for compliance, therapeutic efficacy and ultimately safety of the patient.
Background: Antibiotic resistance is a global threat and new resistance mechanisms are emerging and spreading globally, threatening our ability to treat common infectious diseases. Reducing the incidence of drug resistant infections is crucial and is a top priority at global and national levels. A study was conducted among interns to assess the awareness related to antibiotic usage and resistance. Methods: The questionnaire was administered to a batch of 75 medical interns whereby their awareness regarding antibiotic use and resistance was assessed by a five point Likert scale, whose responses ranged from "strongly agree" to "strongly disagree", and always to never. Some questions were of true and false type. The data was analysed by using simple descriptive statistics. Results: Out of the 78 interns, 75 participated in the study and completed the questionnaires. All the 75 (100%) interns believed that indiscriminate antibiotic use leads to antimicrobial resistance and 78.6% (n=59) believed that if antimicrobials are taken too often, they are less likely to work in the future. Majority (90.6%) of the interns knew of the fact that common cold and influenza are due to viral aetiology and not bacterial. Regarding the antibiotic practices of the interns, questionnaire addressed questions related to their practices related to use of antimicrobials, 66.6% (n=50) of the interns disagreed on the question that antibiotics are safe drugs, hence can be commonly used while 62.6% (n=47) do not believe that skipping one or two doses of the drug does not lead to antibiotic resistance. Conclusions:The antibiotic resistance crisis has been attributed to the overuse and misuse of these medications. Judicious use of antibiotics is the only solution for which awareness is required at the level of both health care providers and patients. Our study provides an important insight regarding the regarding awareness of antibiotic usage and antibiotic resistance among interns.
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