Monitoring of Adverse Drug Reactions of Anti- Epileptic Agents in the Neurology Department (original) (raw)
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Objective: The purpose of this study was to assess the incidence and pattern of adverse drug reactions (ADRs) reported from the department of neurology of a tertiary care hospital in Karnataka, India. Methods: It is a hospital-based prospective, observational study, conducted among the inpatients of all age groups of either sex for a period of 6 months. ADRs were reported by the clinical pharmacists and physicians of this hospital. ADRs obtained were categorized based on its causality, severity, preventability, predictability, and outcomes. Binary logistic regression was carried out to identify the predictors of ADR and Kaplan-Meier analysis was performed for survival analysis. Results: A total of 250 patients were enrolled for the study in which 108 (43%) patients were presented with at least one ADR and a total of 212 ADRs were observed. The highest rate of ADRs was observed with antiepileptics 61 (29.5%). The most commonly reported ADRs were skin reactions 23 (10.8%). Causality was assessed using three different scales which showed that most of the ADRs were probable. Severity, preventability, and predictability were assessed, of which 125 (59%) ADRs were moderate, 192 (90.6%) ADRs were probably preventable, and 156 (73.6%) ADRs were predictable, respectively. The outcomes showed that 150 (70.1%) patients recovered from the reactions. Predictors such as polypharmacy and duration of stay were found to be significant. Conclusion: The study concluded that the prevalence of ADRs in the department of neurology is high. Thus, early detection and management of ADRs are essential to avoid further complications of the reaction.
IOSR Journals , 2019
Introduction: All drugs have therapeutic effects and none are absolutely devoid of adverse effects and prescription of them should be judicious and with a satisfactory risk/benefit ratio. Pharmacovigilance has perceived several advancements throughout the world, over the past few decades. The WHO defines "Pharmacovigilance as the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other possible drug-related problems, including herbal materials." Materials and Methods: This study was done in Kurnool Medical College, Kurnool, AP as a retrospective observational study. After getting ethical committee approval and consent from the pharmacovigilance committee of ADR monitoring centre KMC Kurnool, without revealing the identity of the patients, a retrospective data collection was done by collecting different types of ADR reported in this hospital for the previous six months (May 2018-October 2018). Those included were only inpatients from the hospital for whom ADR was reported for the pharmacovigilance program of India. Results: Out of the 313 cases reported, major ADR were for antibiotics (55.5%). The antibiotics which were causing ADR were, antituberculous drugs, cefixime, ceftriaxone, ampicillin, amoxicillin, amoxicillin with clavulunic acid etc. Among the antibiotics the most common adverse drug reaction was rash caused by antituberculous drugs. The second commonest was anticancer agents (18.2%). The anticancer agents which caused adverse drug reactions were carboplatin, paclitaxol, and methotrexate. The ADR were minor and probable in anticancer agents. This result shows that the majority reported ADR were for chemotherapy agents. The analgesics with ADR were 6.6% and the psychiatric drugs were 4.4%. This shows that the next common ADR were the NSAID and the psychiatric drugs. The offending drugs were Diclofenac and lithium respectively for NSAIDs and Psychiatric drugs. These adverse effects were also causality assessed as probable. Conclusion: From this study, it is concluded that the antibiotics has the major ADR pattern. It's also known that the probable and possible causalities are more common when ADR are reported.
Pharmacovigilance also known as drug safety is defined as the science and activities relating to the collection, detection, assessment, monitoring and prevention of adverse effects or any other drug- related problems. The World Health Organization (WHO) defines an ADR as ‘a response to a drug that is noxious, unintended and occurs at doses normally used in man for the prophylaxis, diagnosis, therapy of disease, or for modification of physiological function’. The study conducted was a cross sectional retrospective study using modified ADR form from Central Drugs Standard Control Organization (CDSCO) and assessment was performed using different scales. This is a retrospective observational study, conducted on reported ADRs at a quaternary care hospital from 2009 – 2014. The main aim of this study is to assess the incidence, pattern of ADRs, causality, offending drugs, and to prevent the occurrence. Each reported ADR was assessed for its causality by using Naranjo’s scale. The severity of each reported ADR was assessed using modified Hartwig & Siegel scale and preventability of ADRs by modified Schumock & Thornton scale. The adverse drug reactions which occur in this quaternary care hospital reaction had a large number of reactions but most of which were in mild to moderate range. The prescribing of large number of medications causing low intensity of ADRs indicates the use of cautious responsibility due to direct liability and awareness.
Spontaneous Adverse Drug Reaction Reporting in a Tertiary Care Hospital in Calicut
Asian Journal of Pharmaceutical and Clinical Research, 2018
Objective: The study was conducted to assess the adverse drug reactions (ADRs) reported in a tertiary care hospital in Calicut. Methods: Spontaneous ADR reporting method was followed for the study. The ADRs reported by the health-care professionals, or the patients were confirmed with the physician-in-charge. Further, the assessments of type, severity, and preventability of reported ADRs were done using Wills and Brown classification, modified Schumock and Thornton severity scale, and modified Hartwig and Siegel preventability scale. Results: A total of 30 ADRs were reported. A study found that the incidence of ADRs was more in males (1.14%) when compared to females (0.79%). Geriatric patients showed more incidences of ADRs (1.04%) when compared to pediatrics (0.69%) and adults (1.02%). More number of ADRs was associated with antibiotics (23.33%) and anticonvulsants (23.33%) than another category of drugs. Based on type or mechanism involved 80% of ADRs were pharmacologically related (Augmented) ADRs. Severity assessment showed that 50% were mild, 46.67% were moderate, and 3.33% were severe. Assessment of preventability showed that 63.33% of ADRs were not preventable, 30% were preventable, and 6.67% were probably preventable. Conclusion: The study was useful in finding the age category and drugs that were more prone to ADRs. This will render precautions and monitoring in the future. The importance of ADR monitoring unit and aid of clinical pharmacist in the monitoring and assessment were very well considered during the study.
IP Innovative Publication Pvt. Ltd., 2017
Introduction: Adverse Drug Reactions (ADRs) are a great cause of concern to the general public, medical profession, the patients and the pharmaceutical industry. For this reason Pharmacovigilance, which is an evolving science dedicated for reducing medicine related harm to patients, is a good tool for ensuring safe and effective use of medicine. The information may be useful in identifying and minimizing preventable ADRs, while generally enhancing the knowledge of the prescribers to deal with them more efficiently. There are hardly any studies regarding ADR patterns in North East India. Hence a study was undertaken to record and analyze the pattern of adverse drug reaction in a Tertiary Care Hospital of North East India. Materials and Methods: All the ADRs that were collected in ADR monitoring centre of Department of Pharmacology of our Institute during the period of January 2015 to July 2016 were analysed according to demographic distribution, organ system wise distribution, most commonly involved drugs associated with ADRs and causality analysis was done by using WHO causality analysis scale. Results: Only 272 ADRs were reported during the 18 months study period. Females were affected more than males. Skin and subcutaneous tissue was the most commonly affected system followed by GIT and CNS. Among drug classes anticancer agents were responsible for highest number of ADRs followed by 3 rd generation Cephalosporin and NSAID Aceclofenac. Conclusion: The ADR reporting rate is very less in our study. So there is an urgent need streamlining of hospital based ADR reporting and monitoring system to create awareness and to promote the reporting of ADR among Healthcare Professionals.
International Journal of Basic & Clinical Pharmacology, 2020
Background: The objective of the study was to study the pattern and trends of adverse effects of drugs used in department of neurology in a tertiary care hospital.Methods: A prospective, observational study was carried out for a duration of 12 months from November 2018 to October 2019 at Department of Neurology and Department of Pharmacology and Therapeutics, G.S.V.M. Medical College, Kanpur after getting an approval from institutional ethical committee. Data was collected by analyzing OPD prescription slip, treatment charts and investigation reports. All relevant information regarding adverse drug reactions (ADRs) were collected as per norms of Indian Pharmacopoeia commission (IPC).Results: During the study period, a total of 130 ADRs reported. Most of the ADRs were reported due to antiepileptic drugs followed by antiparkinsonian drugs. Dizziness was the most frequent ADR reported. Most of the ADRs were reported due to phenytoin. Other ADRs observed were drowsiness, nausea/vomiting...
Adverse drug reactions Is a worldwide public health problem and an important cause of death and hospitalizations in developed countries. An adverse drug reaction is a major cause of patient morbidity and mortality, Increase in hospital stay and unnecessary economic burden to the patient. To study the incidence of ADRs in tertiary care teaching hospital, in Tamil Nadu at Southern part of India. An analytical cross sectional, observational study was carried over a period of 6 months. A total of 40 cases were reported to have ADRs from 500 patients. ADRs were monitored by using standard developed and designed by CDSCO, India. Data thus obtained were analyzed by using casualty assessment. The WHO scale and Naranjo Algorithm score were used to evaluate ADRs. In this study overall Incidence of ADR found to be 8% and male to female ratio was 3.6 and 4.4% respectively. Maximum number of ADRs were reported from the GIT 37.5% followed by Skin 25% and CNS 12.5%. Different types of ADRs were studied in which rashes (35.13%) the most commonly ADR. Then reported followed by vomiting (13.51%), dizziness (10.81%) and with respect to outcome attributed to ADRs 15 patient got hospitalized due to ADRs. When causality of ADRs was assessed by Naranjo algorithm scale and it is found to be 42.5% probable, 37.5% possible, 7.5% definite and doubtful 12.5% and WHO scale certain 15%, probable 30%, possible 32.5%, unlikely 10%, conditional 7.5% and unassessable 5%. The result of our study is similar to other studies. All ADRs were not toxic reactions and they were unpredictable.
International Journal of Health Sciences (IJHS), 2022
Abstract---Introduction: World Health Organization defines adverse drug reactions (ADRs) as any noxious, unintended, and undesired effect of a drug, which occurs at doses used in humans for prophylaxis, diagnosis, or therapy. For evaluating the incidence and outcome of adverse drug reactions (ADRs) to assist in minimizing the deleterious effects, the present study was planned to find the incidence of ADR, its severity, and outcomes among patients. Material and Methods: The spontaneous ADR reporting technique and the Suspected Adverse Drug Reaction Reporting Form were used for the data collection and reporting. All patients who developed an ADR during the study period has included. By using Expanded Rawlins and Thompson’s classification, all patients were categorized into types A to F and classified according to the severity levels (mild, moderate, severe) by applying the Modified Hartwig severity scale. The classification of outcomes of the ADRs was done as per WHO criteria as fatal, continuing, recovering, recovered, unknown, or any other.Results: Type B (Bizarre) ADRs were found to be the most frequently occurring ADRs (51%) followed by type A (Augmented) 29%. Maximum ADR cases were found in the 12-45 years age group (58%). On the severity scale, the majority of ADRs were found of moderate severity (64% moderate v/s 35% mild). Only 15 % of reactions were serious in nature and the maximum burden (61%) of serious ADRs was found with type B. The best outcome has been found in type B ADRs while type-D and type-C ADRs have more protracted courses. Conclusion: In the present study the incidence of ADRs was clinically significant among study patients. ADRs increase patients’ morbidity, mortality, cost of health care, and duration of hospital stay. Although, further studies are needed with a more focused approach.
Asian Journal of Pharmacy and Pharmacology
Background The World Health Organization defines a "adverse drug reaction," which has been in use for about 30 years, as "a response to a drug that is toxic and unexpected and occurs at levels commonly employed in man for the prevention, diagnosis, or treatment of disease, or for altering physiological function." ADRs should be carefully considered and managed right away in order to shield patients from undesirable pharmacological side effects. Objective: To evaluate the degree of association between suspected ADR and pharmacological therapy, the WHO Probability assessment scale was applied. To establish the causative link between a drug and a suspected reaction, the Naranjo's causality assessment scale was applied. Methodology: The study was carried out at a quaternary care super speciality hospital. The study was carried out for a period of 2 month where the previous ADR reported forms were considered for the review from the year 2019-2022. A total 106 ADR are reported from 2019 to 2021 in Results: quaternary super speciality hospital in southern India. Among that majority were females 51.9% and males are 48.1%, maximum number of ADRs were reported from the general medicine 49(46.3%), followed by general surgery 16(15.2%), Orthopaedics 12(11.3%), Neurology 11(10.4%), Nephrology 8(7.5%), Oncology 5(4.7%), Gastroenterology 3(2.8%), Paediatrics 1(0.9%) and Cardiology 1(0.9%). 33% of the population experienced rashes and itching as the ADR. 80.2% of the ADR were minor and all were treated and recovered. The Conclusion: occurrence of adverse events, which raises healthcare expenditures, is influenced by adverse medication responses, which are a major cause of morbidity and mortality. Continuous encouragement is required for ADR reporting. It is crucial to foster a supportive attitude toward pharmacovigilance among medical practitioners, including pharmacists, so that reporting ADRs becomes a common and acknowledged practise.
Pharmacological Research, 2006
Hospital-based adverse drug reaction (ADR) monitoring and reporting programs aims to identify and quantify the risks associated with the use of drugs. The present study was undertaken to characterize the pattern of ADRs reported in a tertiary care teaching hospital (Kasturba Hospital, Manipal) in South India. The study was conducted based on the ADRs reported between March 2004 and February 2005 (12 months) to the ADR reporting unit of the hospital. Evaluation of the data was done for various parameters which included patient demographics, drug and reaction characteristics, and outcome of the reactions. Assessment was also done for causality, severity, preventability, and predisposing factors. A total of 408 ADRs which were reported during the 12 months period were evaluated. The overall incidence of ADR calculated from the patient population was 0.15%. At least one ADR was reported in 1.14% of the hospitalised patients and in 0.012% of the outpatients. No significant difference was seen in the overall incidence of ADRs observed in males and females. Incidence of ADRs among elderly adults and older adults (0.23%) were significantly higher than other age groups. Type A reactions (72.5%) accounted for majority of the reports and a greater share of the ADRs were described to be very common (43.4%) in the literature. Dermatological system (23.5%) was the most commonly affected organ system with skin rash (10.5%) as the most frequently reported reaction. Antineoplastic agents (21.8%) was the drug class most commonly involved, while phenytoin (7.8%) was the individual drug most frequently reported. The suspected drug was withdrawn for the management of the ADR in majority (56.6%) of the reports. In 74.8% of the reports the patient recovered from the reaction at the time of evaluation. Upon causality assessment, majority of the reports were rated as probable (53.7%). Mild and moderate reactions accounted for 50.5 and 43.9%, respectively. In 28.7% of the reports, the reaction was considered to be preventable. At least one predisposing factor was present in 79.9% of the reports and the most common predisposing factors associated were polypharmacy and multiple disease state. Evaluating the relationship between patient characteristics and reaction characteristics, type A reactions were more common among elderly adults (85.92%) and type B reactions more common in adults (35.01%) compared to other age groups. In conclusion, the pattern of ADRs reported in our hospital is comparable with the results of studies conducted in hospital set up elsewhere. Our evaluations revealed opportunities for interventions especially for the preventable ADRs to ensure safer drug use.