Prospective observational study to evaluate adverse drug reactions pattern in a tertiary level teaching hospital (original) (raw)
Related papers
National Journal of Physiology, Pharmacy and Pharmacology, 2021
Background: In terms of morbidity and death, adverse drug reactions (ADR) have been highlighted as a worldwide burden. Determining the origin of ADRs remains a tough issue and no one approach for determining causation has been adopted as the gold standard throughout the world. Aim and Objectives: The objectives of the present study were (1) to evaluate the causality of ADRs using World Health Organization-Uppsala Monitoring Center (WHO-UMC) and Naranjo Algorithm ADRs causality assessment tools and (2) to evaluate the agreement and correlation between two universally used approaches for causality assessment of ADRs viz. WHO-UMC system and Naranjo algorithm. The secondary objective was to assess the reported ADRs in a tertiary care hospital in Northern India. Materials and Methods: The present study was a retrospective cross-sectional study. A total of 180 patients of ADRs from different departments of tertiary care hospital which were reported by Pharmacovigilance unit over a period of April 2018 to May 2019 were assessed. The causality assessment for these reported ADRs were done by WHO-UMC system and Naranjo algorithm. The agreement between these two methods calculated by Cohen's kappa (κ) statistics and Spearman's correlation was used to evaluate the correlation between these two methods. Results: According to WHO-UMC criteria, 55.5% of adverse event instances were of the probable type, 34.4% were possible, 9.4% of cases were improbable, and 0.5% of cases were definite. According to the Naranjo methodology, 80.5% of adverse outcomes were likely, while 19.4% were feasible. The WHO and Naranjo causality comparisons had a positive and fair agreement (= 0.29), according to Cohen's kappa test. Between the WHO-UMC scale and the Naranjo algorithm, the Spearman's correlation coefficient was determined to be 0.409. Conclusion: "Probable" was the most common causality category observed by the WHO-UMC scale and the Naranjo algorithm. The WHO-UMC scale and the Naranjo algorithm have a good and reasonable agreement.
Status of documentation grading and completeness score for Indian individual case safety reports
Indian Journal of Pharmacology, 2015
The quality of individual case safety reports (ICSRs) generated under Pharmacovigilance Programme of India (PvPI) plays a pivotal role in detecting a signal from Indian drug safety data. Currently, more than hundred thousand ICSRs were generated under PvPI and reported to Uppsala Monitoring Centre. The documentation grading and completeness score of Indian ICSRs were rapidly increasing, and the current score was 0.94 out of 1.0. Periodical training on emphasizing the quality ICSRs is need of the hour.
International Journal of Basic & Clinical Pharmacology
Background: India as an important clinical trial hub in the world. In clinical trials, many of the drug issues related to the safety are inadequately studied in highly selected and limited number of patients. Due to introduction of many new drugs in the country, it has become essential to have an effective Pharmacovigilance system nationwide. Under reporting of ADRs is widespread and a daunting challenge in Pharmacovigilance programme of India (PvPI).Methods: A cross sectional study was conducted for two months with the objective to study the pattern of ADRs reporting in two teaching hospitals of Tripura. The data were collected in “Suspected ADR reporting forms” of Indian Pharmacopoeia Commission (IPC). Suspected ADRs were assessed for causality using Naranjo ADR probability scale.Results: 44 ADR reporting forms were received with 58 ADRS. Among them, Gastrointestinal System ADRs were the highest (25.86%). More ADRs were seen in males than females (52.27% vs 47.72%). 68.18% cases h...
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.
Innovative Publication, 2016
Objectives: The present study was conducted with the objectives to analyze the ADRs reported to the ADR Monitoring Centre at a tertiary care hospital in Dakshina Kannada district, South India. Methods: Adverse drug reaction (ADRs) reports were collected over a span of two years for assessing an agreement between two causality assessment tools; WHO-UMC criteria and Naranjo algorithm. Results: There were 30 (46%) males and 36 (54%) females reported which were categorized into Type A (Augmented) and Type B (Bizarre) ADRs having 24 (36.4%) and 42 (63.6%), respectively, based on Modified Rawlins and Thompson Scale where majority of cases were 'Probable', followed by 'Possible' categories. Criteria for avoidability were determined to be 44(66.7%) as Not avoidable and 22 (33.3%) as possibly avoidable. Severity of ADRs were determined to be 54(81.8%) for moderate, and 6 (9.1%) for each of mild and severe categories. Amongst the drug classes concerned, 28 (42.4%) cases were attributed to Anti-infective followed by Anti-Diabetic and Radiocontrast Media constituting 18(27.3%) and 7(10.6%) cases respectively. Cephalosporins were the most common class of drugs associated with ADRs constituting 16 (24.2%) cases. Kappa test was utilized to assess the comparison of agreement between the two causality assessment criteria of WHO-UMC scale and Naranjo Algorithm and the value was 0.2. Conclusions: This study is indicative of 'poor' agreement between the two widely used criteria of WHO-UMC scale and Naranjo Algorithm.
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.
A study on adverse drug reactions in a tertiary care hospital in Bangalore
innovative publication
Objectives: The study was conducted to assess the frequency of incidence of ADRs in our hospital, its causality with the suspected drug, severity of the ADR, preventability of ADRs and its relation to the duration of stay. Method: A prospective study was conducted in a tertiary care hospital in Bangalore for a period of 12 months. Standard procedure was followed in reporting the ADRs by all healthcare personnel. Naranjo and Hartwig scales were used to assess the causality and severity of ADRs reported. Further analysis was made to evaluate the preventability and effect of duration of hospitalization on occurrence of ADRs. Results: A total of 160 ADRs were reported during the study period from various specialties. Males comprised of 102(63.75%) and females were 58(36.25%). The assessment by Naranjo scale showed that relationship of ADR and the suspected drug was definite in 12 cases, probable in 45 cases, possible in 88 cases and doubtful in 15 cases. Hartwig scale classified 84 cases to be mild, 44 to be of moderate in severity and 20 to be severe. Preventability assessment was made that showed that 44 cases of ADR were definitely preventable, 12 probably preventable and 104 ADRs not preventable. Length of stay in the hospital showed a positive correlation with the occurrence of ADRs. Conclusion: Adverse drug reactions are a significant health issue in India due to noncompliance and advent of polypharmacy. But majority of the ADRs can be avoided by the knowledge and awareness among all health care professionals. Standardized training of health professionals and reporting of ADRs not only helps in the prevention of ADRs in the hospitals, but also reduces the number of admissions related to ADRs.
A Prospective Study of Adverse Drug Reactions in a Tertiary Care Hospital in South India
Asian Journal of Pharmaceutical and Clinical Research, 2019
Objective: The objective of this study was to determine the prevalence of adverse drug reactions (ADRs) in a tertiary care teaching hospital in South India and to analyze the causality according to the Naranjo scale. Methods: This study was carried out at the SRM Medical College, Chennai, a tertiary care hospital, which is an ADR monitoring center under Pharmacovigilance Programme of India, over a period of 1 year, from September 2017 to August 2018, after approval by the Institutional Ethics Committee. These ADRs were reported by the clinical pharmacy team of our hospital to the department of pharmacology. The relevant data were collected from the patient case notes, treatment charts, laboratory data reports, ADR notification forms, patient interview, and reporter interviews after written informed consent was obtained from each patient. Patients of either sex of all ages who developed ADR within the hospital were included in the study. Patients who developed ADR outside the hospita...
International Journal of Basic & Clinical Pharmacology, 2019
Background: Adverse drug reactions (ADRs) are one of the prime causes of morbidity and mortality, increase in hospital stay and socioeconomic burden on the patients. Periodic monitoring aids in formulating methods for safe usage of medicines in hospitals. This study was undertaken to study the patterns, assessment of causality, severity, preventability, body systems affected from ADRs received by the Pharmacovigilance cell, Department of Pharmacology between April 2018 to June 2019.Methods: The present study is an observational, retrospective, non-interventional analysis of voluntarily reported ADRs. Demography of patients, causative drugs, reactions, outcome, and severity are recorded. Data were analysed and expressed in numbers, percentages.Results: A total of 180 ADRs were spontaneously reported. Dermatology (42.8%), psychiatry (23.9%) and general medicine (18.3%) are the major departments reporting ADRs in our hospital. 60.6% reports were in males. The body system with maximum r...