scholarly journals Profile of serious adverse drug events in a tertiary care hospital of South India - a five years experience

Author(s):  
Jayanthi C. R. ◽  
Mohammed Yaqub Pasha ◽  
Sushma M.

Background: Adverse drug event (ADE) is said to be serious, when it is life-threatening, leads to hospitalization, disability, congenital anomaly, death or requires intervention to prevent permanent impairment or damage. The present study aimed to determine the pattern, causality, preventability of serious ADEs.Methods: This retrospective study was carried out to profile serious ADEs reported from Bangalore Medical College and Research Institute to Adverse Drug Reaction (ADR) Monitoring Centre, under Pharmacovigilance Programme of India from 2012 to 2016. Patient demographics, clinical and drug data, details of the ADE, onset time, causal drug details, outcome and severity were collected as per CDSCO form. Causality was assessed by WHO-ADR probability scale, preventability by modified Schumock and Thornton scale.Results: A total of 809 ADEs were reported, of which 50 (6.18%) were serious in nature. Male preponderance (74%) was observed, with 42% among patients aged 20-40 years. 56% of serious ADEs were reported from department of Dermatology. Steven Johnson Syndrome (SJS) (20%) contributed for most of the ADEs. Antiepileptics caused maximum number of serious ADEs (32%). 76% of the ADEs were found to be ‘probable’ and 4% were definitely preventable. 56% of them was life threatening and 86% required intensive interventions. 16% patients experienced serious ADEs during hospital stay.Conclusions: Serious ADEs constituted 6.18% of all ADEs reported. SJS was commonly seen with antimicrobials and hepatotoxicity with ATT. Antiepileptics and ATT contributed for majority of them. This study highlights the importance of monitoring and timely management of serious ADEs to commonly prescribed medications.

2019 ◽  
Vol 6 (7) ◽  
pp. 2533
Author(s):  
Ramanuj Mukherjee ◽  
Vaibhav Agarwal ◽  
Arup Mohanta ◽  
Gouri Mukhopadhyay ◽  
Sudipta Samanta

Background: Being one of the most commonly performed surgery in the modern era, post-operative complications following laparoscopic cholecystectomy deserve special mention. Though not very life threatening, they are quite common. Considering these aspects, this study aims to identify them and possibly a potential remedy for decreasing the incidence in the future.Methods: This is a retrospective, institution-based, observational and cross-sectional analysis conducted in R.G. KAR Medical College and Hospital over 5 years on 1000 patients undergoing surgery. Here we intend to observe the adverse events following laparoscopic cholecystectomy in the post-operative period.Results: Most of the complications were seen in the age group greater than 40 years(63%) followed by the age group 30-40 years (26%).Adverse events were much more common in females (85%) followed by males (15%). The symptoms appeared mostly during 3-7 days post operatively (57%) followed by 20% within the first 6 hours. Non-specific abdominal pain (28%) was the most common adverse event followed by port-site infection in 16.5% cases.Conclusions: Proper pre-anaesthetic check-up with proper instrument handling with proper caution and before closing confirmation of proper placement of clip and no other unintentional injury anywhere can decrease the post-operative complication.


2017 ◽  
Vol 15 (2) ◽  
pp. 6-9
Author(s):  
Husneyara Haque ◽  
Kalpana Kumari Thapa

Introduction: Eclampsia is an acute and life-threatening complication of pregnancy associated with elevated maternal and fetal morbidity and mortality. This study was done with the aim to evaluate the maternal and fetal outcome in eclampsia patients and to observe various factors affecting its occurrence and outcome. Methods: A retrospective cross-sectional hospital based study carried out in Nepalgunj Medical College, Nepalgunj from January 2015 to December 2016. Details and data obtained from maternity register were analysed. All patients with eclampsia were included and fetomaternal outcomes measured in terms of complications. Simple descriptive statistical method was applied for analysis. Result: Out of 6056 pregnant women, 46 had eclampsia with the incidence of 7.59 per 1000 deliveries. 58.7% of study population belonged to age group of 21-30 years followed by 36.96% from age less than 20 years. 78.26% cases were unbooked. 73.91% eclamptic patients were primi gravida and 60.87% had gestational age less than 37 weeks. Half of pregnancies with eclampsia underwent ceasarian for delivery and 30.44% required ICU care. One third women developed eclampsia related complications and 2(4.35%) died. Common complications were atonic postpartum heamorrhage (15.21%), psychosis (8.71%) acute renal failure (4.35%). 60.86% newborn were preterm and 56.52% were low birth weight. In 50% newborn, Apgar score at 5 minutes was less than 7. Fetal death was 10.85%. Conclusion: Eclampsia continues to be one of the prime etiological factors for maternal and fetal morbidity and mortality. Therefore early recognition and proper management are vital to tackle this challenge.


Author(s):  
Sujatha Sowmyanarayan ◽  
Swati Banerjee

Background: the aim of the study was to monitor all adverse drug reactions in the departments of Medicine, Paediatrics and Surgery in a Tertiary Care Hospital.Methods: It was a prospective study undertaken in a 300 bedded tertiary care hospital. Patients presenting with adverse drug reactions in Medicine, Paediatrics and Surgery Departments were studied. Causality and severity of the adverse drug reactions were analysed Other parameters such as age wise and gender wise distribution of the ADRs, types of ADRs and drugs causing ADRs were studied.Results: There were 33 cases of ADRs were enrolled for the study in the duration of Sept. 2016 to Aug. 2017. Female preponderance was seen. The largest number of ADRs were seen in the age group of 21-30 years (30.3%). The most common ADR was skin rash (30.3%) followed by periorbital edema (12%). There were two SAEs namely Anaphylaxis and Steven Johnson syndrome. The most offending class of drug was antibiotics (30.3%) followed by intravenous fluids (12.1%).Conclusions: The maximum number of cases were reported from the Medicine Department which was 11 (33.33%). The highest number of ADRs fell in the probable category (63.6%). The number of cases of mild and moderate severity were equal (42.4%). The knowledge of these adverse drug reactions is necessary while prescribing drugs to patients as patient safety is absolutely essential. Also the healthcare provided by the institution will improve. This data has been collected with a view to establish an ADR monitoring centre at our hospital.


2019 ◽  
Vol 12 (1) ◽  
pp. 13-16
Author(s):  
B Sigdel ◽  
R Nepali ◽  
Neeraj KC ◽  
T Dubey ◽  
B Neupane ◽  
...  

Introduction: Epistaxis is a common otolaryngological emergency condition. It occurs due to local and systemic cause. Local cause lies within the nose bleeding either anterior or posterior. Commonest site of bleeding anterior epistaxis is kiesselbach’s plexus. In posterior epistaxis, it is difficult to locate bleeding site. Epistaxis is controlled by simply pinching of nose, decongested nasal drop and abgel packing. Some cases become more challenging required nasal packing and arterial ligation. Objectives: To study the epidemiological pattern and management of epistaxis. Methods: This was a retrospective study on pattern of epistaxis man­aged at Gandaki Medical College Teaching Hospital over a period from April 2015 to April 2016. Information regarding demographic profile, presentation and management of epistaxis was obtained from the Hospital records, ENT Outpatient clinic, Emergency Department, ENT ward and operation theatre. Results: A total of 78 cases were managed during study period. There was a significant male preponderance with male to female ratio 1.78:1. Patients’ age varied from eight to 80 years with mean age 40.7 years. The peak age of incidence was 21 - 30 years group. Idiopathic nasal bleeding 27 (34.6%) was commonest followed by nasal trauma 23 (29.5%) cases and hypertension 16 (20.5%) cases. Seventeen (21.8%) cases managed in day care basis with decongested nasal drop, chemi­cal cautery and abgel packing. Remaining cases required nasal packing and bipolar cautery and other specific form of treatment. Five (6.4%) cases required sphenopalatine artery ligation with no recurrence of bleeding. Conclusions: Epistaxis is common ENT emergency. Most common causes are idiopathic followed by nasal trauma and hypertension. Prompt management is instituted according to cases. Most of the cas­es are managed by non-surgical method.


2016 ◽  
Vol 4 (1) ◽  
pp. 242
Author(s):  
Rajiv Jain ◽  
Vikas Gupta

Background:Acute Abdomen is a term used to encompass a spectrum of surgical, medical and gynecological conditions ranging from trivial to life threatening conditions, which require hospital admission, investigations and treatment. The purpose of this study was to identify the epidemiological pattern and to determine the spectrum of disease causing “non-traumatic acute abdomen in central India”.Methods: This is a prospective study of 98 patients of non-traumatic acute abdominal cases conducted in the Department of Surgery, Sri Aurobindo Medical College and PG Institute, Indore, Madhya Pradesh, India. In this study, preoperative detailed history and thorough physical examination was done for all acute abdominal emergencies, to arrive at pre-operative diagnosis.Results:Amongst the study of 98 patients, males have higher incidence of acute abdomen with the young age group (21-30 years) most commonly affected. Perforation peritonitis constituted the most common cause of acute abdomen (39.7%), followed by acute appendicitis (37.7%), followed by intestinal obstruction (14.2%).Conclusions: This study was conducted to evaluate the epidemiology, etiology and differential diagnosis of non-traumatic acute abdomen. At the end of the study, we had a better insight of the spectrum of the condition and we concluded that there is more scope for further work in the same field for better understanding of this topic.


2021 ◽  
Vol 11 (2) ◽  
pp. 129-132
Author(s):  
U Vivekananda Reddy ◽  

Background: Acute renal failure (ARF) refers to an abrupt and sustained decrease in renal function resulting in retention of nitrogenous (urea and creatinine) and non-nitrogenous waste products. AKI is common, harmful, treatable and largely preventable but there are very few studies available on this subject from India using various serum creatinine values.1 Hence we carried out this study to look into the varied etiology of AKI and their outcome using newer AKI definitions.Aim: To determine the cause, prognosis and outcome in patients of Acute Kidney Injury (AKI) admitted in a tertiary care hospital Materials and Methods: A Hospital based Prospective study was conducted in Department of Medicine, Santhiram medical college and general hospital for a 1 year period. Universal Sampling Technique was used for selection of study subjects. All the patients coming to medicine department during the study period with age >18 years and Patients who fulfill AKIN criteria were taken for study after taking prior informed consent. Final sample size was 69 subjects of Acute Kidney Injury of varied etiology. Results: Mean of study subjects was 48.9 years (range from 19-87 years) with M: F ratio of 4.75:1. Most common etiology for AKI was Sepsis (14.5%) and Malaria infection (14.5%) followed by Dengue, AGI and Leptospirosis (11.6% each). Multi organ dysfunction (14.5%) was observed in patients of Sepsis and Lepto. Out of total patients, 46 (66.7% %) had stage II AKI, while 23 (33.3 %) had stage III AKI according to AKIN staging. A total of 11.6% patients were on dialysis. Two out of 23 patients of AKI stage III (8.7%) and one patient out of 46 (2.2%) belonging to AKI stage II died during the study. Conclusion: AKI was observed at a relatively younger age in present study with male preponderance. Most common etiologies were Sepsis and Malaria. Most of the patient of Sepsis, MODS and Leptospirosis were having stage III AKI. Overall mortality observed was 4.34


Author(s):  
Anusha P ◽  
Bankar Nandkishor J ◽  
Karan Jain ◽  
Ramdas Brahmane ◽  
Dhrubha Hari Chandi

INTRODUCTION: India being the second highly populated nation in the world. HIV/AIDS has acquired pandemic proportion in the world. Estimate by WHO for current infection rate in Asia. India has the third largest HIV epidemic in the world. HIV prevalence in the age group 15-49 yrs was an estimate of 0.2%. India has been classified as an intermediate in the Hepatitis B Virus (HBV) endemic (HBsAg carriage 2-7%) zone with the second largest global pool of chronic HBV infections. Safety assessment of the blood supply, the quality of screening measures and the risk of transfusion transmitted infectious diseases (TTIs) in any country can be estimated by scrutinizing the files of blood donors. After the introduction of the blood banks and improved storage facilities, it became more extensively used. Blood is one of the major sources of TTIs like hepatitis B, hepatitis C, HIV, syphilis, and many other blood borne diseases. Disclosure of these threats brought a dramatic change in attitude of physicians and patients about blood transfusion. The objective of this study is to determine the seroprevalence of transfusion transmitted infections amidst voluntary blood donors at a rural tertiary healthcare teaching hospital in Chhattisgarh. MATERIAL AND METHODS: This retrospective study was carried out in Chandulal Chandrakar Memorial Medical College, Kachandur, Durg. Blood donors were volunteers, or and commercial donors who donated the blood and paid by patients, their families, or friends to replace blood used or expected to be used for patients from the blood bank of the hospital. After proper donation of blood routine screening of blood was carried out according to standard protocol. Laboratory diagnosis of HIV 1 and HIV 2 was carried out by ELISA test. Hepatitis B surface antigen was screened by using ELISA. RESULTS: A total of 1915 consecutive blood donors’ sera were screened at Chandulal Chandrakar Memorial Medical College, blood bank during study period. Of these 1914 were male and 1 female. The mean age of patients was found to be 29.34 years with standard deviation (SD) of 11.65 Years. Among all blood donors in present study, 759(39.63%) were first time donors and 1156(60.37%) were repeated donors. 1 patient was HIV positive in first donation group while 3 (75%) were positive in repeat donation group. 7 (38.9%) were HBsAg positive in in first donation group while 11(61.1%) were positive in repeat donation group. Two patients in first donation group had dual infection of HIV and HBsAg. CONCLUSION: Seropositivity was high in repeated donors as compared to first time donors. The incidence of HIV is observed to be 0.2% and that of HBsAg is 0.94%. Strict selection of blood donors should be done to avoid transfusion-transmissible infections during the window period.


2016 ◽  
Vol 1 (2) ◽  
pp. 29
Author(s):  
Rekha Bachhiwal ◽  
Rajni Sharma ◽  
Pooja Gupta ◽  
Jyotsna Shukla

Introduction: To ascertain the seroprevalence of enterically transmitted Hepatitis A (HAV) and Hepatitis E (HEV) in cases with acute/subacute hepatitis attending a tertiary care hospital in North West India. Methods: A total of 2936 cases were examined for the presence of current infection with HAV and HEV, determined by demonstration of HAV-IgM and HEV-IgM antibodies using ELISA. Results: Overall seroprevalence for enterically transmitted hepatitis was found to be 24.89%. HAV IgM was present in 7.35% and HEV IgM was present in 17.54% of total cases. HAV infection was predominantly found in pediatric age group while HEV infection was mostly seen among adults. Male preponderance was noted. Enteric hepatitis cases occurred throughout the year. No definitive seasonal pattern was observed. Conclusion: Our data demonstrated high seropositivity of enterically transmitted hepatitis indicating the need for improvement in personal and public hygiene, and development of HEV vaccine.


2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S600-S601
Author(s):  
Dong Hoon Shin ◽  
Seung-Jin Yoo ◽  
Jongtak Jung ◽  
Kang Il Jun ◽  
Hyungjin Kim ◽  
...  

Abstract Background Invasive pulmonary aspergillosis (IPA) is a life-threatening opportunistic infection which usually occurs in immunocompromised patients. Recommended duration of voriconazole therapy is a minimum of 6-12 weeks for IPA, despite the lack of any firm evidence. In addition, risk factors for relapse of IPA are still unclear. Here, we explored risk factors for IPA relapse after initial treatment. Methods All patients with proven or probable IPA who had finished voriconazole treatment between 2005 and 2019 in a tertiary-care hospital were reviewed. IPA relapse was defined as re-diagnosis of proven or probable IPA at the same site within 1 year after treatment termination. Short course of voriconazole treatment was defined as a treatment less than 9 weeks, which is a median of the recommended minimum duration of therapy from the Infectious Disease Society of America. The radiological response was defined as a reduction in IPA burden by more than 50% on chest computed tomography (CT). Results Of 87 patients who had completed voriconazole treatment, 14 (16.1%) experienced IPA relapse. Multivariable Cox regression identified that short voriconazole treatment duration (adjusted hazard ratio [aHR], 3.7; 95% confidence interval [CI], 1.1–12.3; P=0.033) and radiological non-response (aHR, 4.6; 95% CI, 1.2–17.5; P=0.026) were independently associated with relapse of IPA after adjusting for several clinical risk factors. Conclusion Less improvement in CT, and short duration of voriconazole therapy were the independent risk factors for relapse after treatment of IPA. Longer duration of therapy should be considered for those at higher risk of relapse. Disclosures All Authors: No reported disclosures


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