ADVERSE DRUGREACTIONS IN RURAL FIELD PRACTICE AREA OF A TERTIARY TEACHING HOSPITAL (original) (raw)
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IP Innovative Publication Pvt. Ltd. , 2018
Introduction: Adverse events can lead to admission in hospital, prolongation of hospitalization, increase in investigations as well as treatment costs, deformities, danger to life and even death. Objective: The aim of this study was to conduct adverse drug reactions (ADRs) monitoring in various departments of a tertiary care teaching hospital. Methods: A retrospective observational study was conducted on ADRs reported in adverse drug monitoring center of our hospital from April, 2016 to December, 2016. Data such as age, gender, diagnosis, drug intake, types of ADRs, treatment and outcome of the reactions were collected. Each reported patient was assessed individually. Causality assessment was done on Naranjo's probability scale. Modified Hartwig's criteria were used to assess the severity of ADRs. Results: A total of 173 reports were studied. 65 (38%) patients were males and 108 (62%) were females. The majority of ADRs were due to cancer chemotherapy agents in 87 (50%), followed by anti-tubercular drugs in 22(13%), antimicrobial agents in 22 (13%) and anti-retroviral drugs in 16(9%). Out of total 574 events, 192 (34%) complaints comprised of gastro-intestinal manifestations. On Naranjo's probability scale, 111 (64%) reactions were probable, 54 (31%) as possible and 8 (5%) as certain. According to Modified Hartwig's criteria 130 (75%) reactions were mild, 29 (17%) were moderate and 14(8%) were severe. Conclusion: Health-care providers will have to do vigilant monitoring and reporting of ADR´s.
International Journal of Basic & Clinical Pharmacology, 2018
Background: Drug safety information about children is scarcely available. This study aims to describe the ADRs in hospitalized paediatric patients under 12 years of age in paediatrics wards of DM WIMS Hospital, Wayanad, Kerala, a tertiary care center in southern part of India. Methods: A retrospective study based on data collected as per the ongoing pharmacovigilance program of India (PvPI) was conducted for twelve months period in order to study the ADRs in hospitalized paediatric patients under 12 years of age with at least one medication prescribed. The study was conducted in paediatrics wards of DM WIMS Hospital, Wayanad. WHO-UMC scale and Naranjo´s Algorithm was used to evaluate causality, the modified Hartwig and Siegel assessment scale was used to establish severity and the Schumock and Thornton criteria was used to determine preventability. Results: Forty-two children (42) who experienced 55 ADRs were included in the study. The frequency was higher in children under 1 year of age (47.62%). Emergence of ADRs was higher in male patients (59.52%), in those used three or more medicines together (71.43%) and in those with systemic antibiotics (58.18%). Conclusions: Being the first study from Kerala in paediatric patients, it is an important contribution to drug safety profile in children from this region of India. ADRs frequency and other descriptive characteristics are provided for the enrolled children under 12 years of age. ADRs are an additional burden of morbidity and risk, particularly in those who used several medicines, including antibiotics.
Initiation of a pharmacovigilance programme at a tertiary care hospital in South India
International Journal of Pharmacy Practice, 2007
Objective India is a country with the availability of a large number of pharmaceutical preparations as branded generics. At the time of this study there was no established pharmacovigilance system at the national level except a co-ordinating centre at the national capital. The study site was a tertiary care teaching hospital with a bed capacity of 500 and with an average of 200 outpatient visits and 50 inpatient admissions per day. The hospital did not have any system of monitoring and documenting adverse drug reactions. The objective of the study was to introduce an adverse drug reaction (ADR) monitoring programme at a tertiary care teaching hospital and assess ADR-related issues in both inpatient and outpatient departments.Method All departments willing to report ADRs were included in the study, which was carried out for one year. Physicians and nurses filled in the notification forms when they encountered suspected ADR cases. These cases were then assessed by a panel of four judges. According to Naranjo's algorithm, the ADRs were assessed and classified based on World Health Organization (WHO) classification.Key findings A total of 288 suspected cases were reported and 264 ADRs were confirmed by the panel. According to Naranjo's probability scale, 83 cases were categorized as ‘probable’, 181 cases were classified as ‘possible’, and none were classified as ‘unlikely’ or ‘definite’. The most common classes of drugs involved were antibiotics (25%), psychotropics (20%), analgesic and cardiovascular agents (14% each). Generalised itch and rash, tremors, urticarial drug reaction, oral ulcer, gastritis and akathesia and extrapyramidal symptoms were found to be the most common ADRs observed; 2.1% of the patients in the studied departments had ADRs.Conclusion The ADR reporting system was initiated at the hospital and was well received by the physicians. Appreciable participation of physicians was noted during the study in reporting ADRs. The study also gave an insight into the awareness of physicians about ADR-related issues. The number of ADRs reported was reasonably comparable with the findings of other authors from India.
Analysis of adverse drug reactions in a tertiary care teaching hospital in Southern India
International Journal of Basic & Clinical Pharmacology, 2019
Background: Medication use has been there since time immemorial. Also, it was well known that all medications carry risk of adverse drug events. Hence regular and periodic monitoring of medications for adverse events has assumed importance. With this background pharmacovigilance has an important role to play in monitoring of adverse events to medications. Hence the present study was undertaken to analyze the pattern of adverse events reported to a tertiary care teaching hospital in Southern India (Shivamogga Institute of Medical Sciences (SIMS), Shimoga).Methods: This study is a retrospective observational study of 150 adverse drug events reported at McGann teaching hospital, SIMS, Shimoga. The adverse events reported were analyzed for their age and gender distribution, drugs causing ADRs, organ systems affected, causality, type, severity and preventability of ADRs.Results: Patients in age groups of 21-40 were most commonly affected by ADRs with a slight increase in male population ...
Cureus, 2021
Background and objective The incidence of adverse drug reactions (ADRs) in hospitalized children varies from 0.6-16.8%. There is a lack of uniformity and an absence of quality reporting with respect to the collection of data on ADRs worldwide, resulting in a scarcity of data regarding ADRs in children. In light of this, we aimed to analyze various factors related to ADRs in the pediatric population in the ADR Monitoring Center (AMC) of a teaching hospital in Odisha, India. Methods This was a record-based study conducted by the department of pharmacology in collaboration with the department of pediatrics. Detailed information regarding all ADR cases in children (<14 years of age) was collected in a format designed by the Indian Pharmacopoeia Commission (IPC). A total of 105 ADRs reported during a five-year period (2015-20) were subjected to analysis. Results The largest number of ADRs were reported in the age group zero to five years (41%). Males were affected more compared to females (1.7:1). Cutaneous ADRs were the most common type (86.5%) followed by the involvement of the gastrointestinal system (10%); 21% of cases were serious in nature, i.e., they required either hospitalization or led to a prolonged hospital stay. Antibiotics were the major drug category involved in causing drug reactions (66%) and among them, ceftriaxone (24.6%) was the most common causative agent. Conclusions One-fifth of the pediatric cases of ADRs were serious in nature. The most common causative agent was antibiotics, especially beta-lactams. There is an urgent need to raise awareness among healthcare professionals by conducting training programs to encourage the spontaneous reporting of ADRs, which will help to ensure drug safety in the pediatric population.
A profile of adverse drug reactions in a rural tertiary care hospital
National Journal of Physiology, Pharmacy and Pharmacology, 2016
background: Adverse drug reactions are the fourth leading cause of mortality and a great concern in therapeutics. Atleast one adverse drug reaction has been reported to occur in 10 to 20% of hospitalized patients. The present study was conducted with the aim of analyzing the pattern of adverse drug reactions occurring in our institution and to identify the common drugs, their manifestations and severity. Methods: An observational prospective study was conducted over a year. The red boxes for dropping the filled yellow adverse drug reactions forms were installed in all the wards and outpatient departments. Additional information and missing data was obtained personally by either consulting the physician or through case sheets. Results: The most common class of drugs implicated in causation of adverse drug reactions was antimicrobials (52%), followed by drugs acting on central nervous system. The most commonly observed adverse drug reactions were dermatological (66.67%) and type B reactions. Majority of the adverse drug reactions belonged to possible (60%) or probable (33.33%) category. Conclusion: Dermatological reactions are the most common adverse drug reactions occurring in our hospital and antimicrobials are the most common causative drugs. There is a need for increasing the awareness and knowledge about adverse drug reactions reporting system for promoting the safe use of drugs.
International Journal of Basic and Clinical Pharmacology, 2016
WHO-UNICEF report 2006 quotes, "children are not small adults when taking a drug". 4 Children are a highly varied group of different physiologies. Drug pharmacokinetics and pharmacodynamics alter with respect to various stages of growth and development from neonates to adolescents. E.g., metabolism of paracetamol is by sulfate conjugation in infants and children, whereas ABSTRACT Background: Adverse drug reactions (ADRs) are a major source of concern in adult and paediatric population. Monitoring ADRs in children is vital as they differ from adults in pharmacokinetic and pharmacodynamics responses. Strict ethical guidelines in clinical trials result in extrapolation of data from studies done in adults. Further, ADRs reported in adults do not predict those in children. Incidence of ADRs in children is 2.9% emphasizing the need for systematic monitoring. Studies at institutional level can generate valuable data among paediatric population. Hence, the current study was taken up to assess the clinical pattern of ADRs, their causality, severity and preventability. Methods: This is a prospective observational single centre study. Suspected cases of ADRs were collected and assessed for the clinical pattern, causality, severity and preventability factors along with gender-wise distribution. Results: A total of 118 ADRs were reported in our study. Most of the ADRs (46.67%) occurred below 1 year of age with male preponderance (53.4%). Skin was the most common organ involved (91.5%). Majority (78.8%) of ADRs were due to anti-infectives for systemic use (J). Vaccines were the most commonly implicated agents (55.9%) followed by antibiotics (22.9%). Severe reaction like DRESS syndrome was reported due to antiepileptics (including levetiracetam) requiring hospitalisation. Majority of ADRs were probable (92.4%), moderate (73.7%) and definitely preventable (61%). Conclusions: A wide range of ADRs are possible in paediatric population. Adequate knowledge about ADRs is essential and caution has to be exercised even while prescribing drugs which are considered safe in children.
Evaluation of Adverse Drug Reactions in teaching hospital in Kumoun Region
2016
Objective: The main aim of the study was to assess the occurrence and pattern of ADRS , assess causality and documentation of Suspected ADRS, inteaching hospital in Kumoun Region. Methods: It is a retrospective study about the occurence, nature, pattern and outcome of ADR monitoring from Aug 2015 to July 2016. The ADRS were assessed for casualty using world health organization (WHO) casualty assessment Scale and Naranjo’s algorithm. Result: 466 ADRS were recorded from 251 ADRs form, Male: Female ratio was 1:1.6. Antibiotics / Antimicrobial (32.06%) followed by Anti-viral (23.76%), Anti-tubercular (19.50%) and NSAIDS (6.05%). The common drugs causing ADR were Albendazole 15.24%, Duloutine 8.52%, Pyrizenamide 6.95%, and Metronidazole 4.48%. The most common system involved were gastro intestinal tract 31.16% of ADR, followed by central and peripheral nervous system 27.35%, skin and appendages 22.42% and hormonal system 8.07%. Out of the total ADRs, 62% were possible, 30% were probable ...
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...
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.