scholarly journals A study of adverse drug reactions to iodinated contrast agents in tertiary care teaching hospital

2019 ◽  
Vol 8 (11) ◽  
pp. 2440
Author(s):  
Dhara Patel ◽  
Ajita Pillai ◽  
Farah Kausar
Keyword(s):  
Adverse Reaction ◽  
Contrast Agents ◽  
Adverse Drug Reactions ◽  
Teaching Hospital ◽  
Tertiary Care ◽  
Radiology Department ◽  
Drug Reactions ◽  
Cross Sectional ◽  
Iodinated Contrast ◽  
Iodinated Contrast Agents

Background: Contrast agents have long been used for the imaging of anatomic boundaries and to explore normal and abnormal findings in X-ray based imaging technique. These agents are not completely devoid of risk. Adverse effects from administration of contrast media vary from minor physiological disturbance to rare life threatening situation.Methods: A cross-sectional retrospective observational study over one-year duration from 1st August 2015 to 31st July 2016 was conducted at radiology department of a Pandit Deendayal Upadhyay Government Medical College and Teaching hospital, Rajkot, Gujarat. Adverse drug reactions were analyzed to study the nature of reactions caused by iodinated contrast agents. The temporal relationship of time of administration of contrast agents to the occurrence of adverse reaction was analyzed and classified as immediate or delayed type of reaction.Results: Out of 868 patients that were analysed 15 out of 497 male patients and 11 out of 371 female patients developed adverse reaction. Age range of patients that developed reactions was 20-55 years. Most common adverse drug reaction occurred in our study was nausea and vomiting which was treated by parenteral Ondansetron. All the reactions were found to be ‘probable’ in causality as per WHO causality assessment scale and Naranjo’s algorithm.Conclusions: Physicians performing diagnostic or therapeutic procedures with contrast agents must be aware of the risk, preventability & treatment so that reactions can be prevented. Sensitization of physicians is required to increase reporting of adverse drug reactions occurred due to radiocontrast agents.

scholarly journals PATTERN OF ADVERSE DRUG REACTIONS IN A TERTIARY CARE TEACHING HOSPITAL: A CROSS-SECTIONAL STUDY

2017 ◽  
Vol 10 (3) ◽  
pp. 170 ◽  
Author(s):  
Sangeetha Raja ◽  
Jamuna Rani R ◽  
Kala P
Keyword(s):  
Adverse Drug Reactions ◽  
Teaching Hospital ◽  
Antimicrobial Agents ◽  
Tertiary Care ◽  
Cross Sectional Study ◽  
Sectional Study ◽  
Drug Reactions ◽  
Cross Sectional ◽  
Tertiary Care Teaching Hospital ◽  
Care Teaching

ABSTRACTObjective: The aim of this study was to carry out adverse drug reactions (ADRs) monitoring in various departments of a tertiary care teaching hospital.Methods: A cross-sectional study was conducted on ADRs reported in the hospital from December 2012 to May 2013 after obtaining InstitutionalEthics Committee approval.Results: A total of 40 ADRs were reported, 47.50% were males and 52.50% were females. The female adult population was 45%. The majority of ADRswere due to antimicrobial agents especially beta-lactam antibiotics (42.5%) followed by NSAIDs (7.50%). A maximum number of patients (75%)were reported with dermatological manifestations. The department of medicine reported the highest number of ADRs (37.5%). As per Naranjo’sprobability scale, 62.5% reports were assessed as probable. 62.5% reports were documented as mild according to Modified Hartwig’s criteria forseverity assessment.Conclusion: This study was done to sensitize the practicing physicians on the importance of adverse drug monitoring and reporting.Keywords: Pharmacovigilance, Adverse drug reactions, Tertiary care teaching hospital, Antimicrobial agents.

Adverse Drug Reactions to Radiographic Contrast Media in a Teaching Hospital in North India: An Observational Study

2019 ◽  
Vol 14 (2) ◽  
pp. 122-126
Author(s):  
Deepti Chopra ◽  
Abhinav Jain ◽  
Richa Garg ◽  
Shreya Dhingra
Keyword(s):  
Observational Study ◽  
Contrast Media ◽  
Adverse Drug Reactions ◽  
Teaching Hospital ◽  
Adverse Reactions ◽  
North India ◽  
Drug Reactions ◽  
Iodinated Contrast ◽  
Radiographic Contrast ◽  
Radiographic Contrast Media

Background: Radiocontrast media are used extensively nowadays to visualize internal organs. Currently, non-ionic iodinated contrast media are used which are generally considered to be safe but some adverse reactions have been reported. Thus, the present study was carried out to analyze the nature and incidence of adverse drug reactions (ADRs) to radiographic contrast media in a teaching hospital. Methods:An observational study carried out for a period of six months in a teaching hospital. Contrast media induced adverse reactions were analyzed in terms of affected organs, rate, causality assessment, severity and preventability. The treatment and outcomes of adverse events were also recorded. Naranjo Probability Scale was used to evaluate the relationship between the contrast agent used and the suspected ADR. The severity of the suspected ADRs was determined using Hartwig Scale and preventability was assessed using modified Schumock and Thornton criterion. Results:A total of 15 suspected ADRs occurred in 11 patients with an incidence of 1.4%. It included 5 (45.4%) males and 6 (54.5%) females (p < 05). The highest percentage (72.7 %) of ADRs was seen in adult patients, the mean age being 40.8 years. Vomiting (33.3%) was the most common ADR noted followed by severe nausea and rashes. 64.7 % of ADRs were categorized as probable and 35.3 % were possible. Adverse reactions required treatment in 46.6% patients. There was no fatality reported. Conclusion:The reactions observed were mild to moderate in severity and occurred within 30 minutes of the administration of the contrast.

scholarly journals An observational study of adverse drug reactions reported in a rural tertiary care hospital

2019 ◽  
Vol 8 (11) ◽  
pp. 2367
Author(s):  
Ravi D. Mala ◽  
D. M. Ravichand ◽  
B. V. Patil ◽  
B. S. Payghan ◽  
Anurag Yadav
Keyword(s):  
Adverse Drug Reactions ◽  
Antimicrobial Agents ◽  
Tertiary Care ◽  
Cross Sectional Study ◽  
Care Hospital ◽  
Unintended Effects ◽  
Drug Reactions ◽  
Cross Sectional ◽  
Physician Visits ◽  
Medical College

Background: Adverse drug reactions (ADRs) are noxious and unintended effects of a drug that occurs at doses normally used in humans. ADRs may also result in diminished quality of life, increased physician visits, hospitalizations, and even death. The objectives of this study are to analyze and assess the causality and severity of reported ADRs.Methods: A cross sectional study of ADRs reported to Pharmacovigilance cell of MNR Medical College and Hospital Sangareddy in a year. The details of the various ADRs were statistically analyzed to find out pattern of ADRs. The WHO-UMC causality category and Hartwig-Seigel Scale were used to assess causality and severity of ADRs respectively.Results: The study shows, out of 60 suspected ADRs, the majority of ADRs were adults (68.3%) and out of whom 56% were females. According to the WHO-UMC Causality categories, 43.3% of the ADRs were categorized under Probable/likely, followed by possible (35%). The Hartwig-Siegel severity assessment scale shows that the majority (90%) of suspected ADRs were of mild category.Conclusions: The pattern of ADRs reported in our study is comparable to other studies. The commonest organ system affected was gastrointestinal tract, nervous and cutaneous system. Antimicrobial agents were causing maximum ADRs and medicine and allied departments have more number of ADRs. This study provides a valuable database for ADRs due to all commonly used drugs at hospitals and also helps in creating awareness regarding safe & judicious use of drugs to prevent ADRs.

scholarly journals Analysis of the Adverse Drug Reactions and Associated Cost Burden on the Patients in a South Indian Teaching Hospital

2020 ◽  
pp. 88-98
Author(s):  
Meda Venkatasubbaiah ◽  
P. Dwarakanadha Reddy ◽  
Suggala V. Satyanarayana
Keyword(s):  
Indirect Cost ◽  
Adverse Drug Reactions ◽  
Teaching Hospital ◽  
Economic Burden ◽  
Adult Population ◽  
Tertiary Care ◽  
Healthcare Sector ◽  
Cost Burden ◽  
Drug Reactions ◽  
South Indian

Objectives: To analyse the adverse drug reactions (ADR) and related economic burden on the health care system and health seekers Methods: A prospective observational study was conducted in a South Indian tertiary care teaching hospital from July 2016 – December 2018.ADRs were analyzed for their causality, severity, predictability, and preventability through standard scales and were reported to the Pharmacovigilance Program of India (PvPI) through a specified updated Indian Pharmacopoeia Commission (IPC) suspected ADR reporting form. The total cost burden including both direct and indirect were calculated by assessing the ADR management including the clinical investigations done. The indirect cost was calculated based on the per capita analysis by using the Gross Domestic Product (GDP) of our study area. Results: Among 458 ADRs, 81.88% were reported in Adult population with an almost same incidence in both the genders, majority were probable (41.70%) and Antibiotics were most commonly involved (16.18%). Around 60% ADRs were treated with at least one drug, 27% ADRs required either hospitalization or increased length of Hospitalization. A total of 989164.5 Indian Rupee (INR) was spent by the hospital and the patients for the management of ADRs, of which 79% was direct cost and 21% was indirect cost. Conclusion: In this hospital, 26.88% of patients were identified with ADRs that were associated with high direct costs, due to hospitalization/extended hospitalizations, which resulted in an extra economic burden to the healthcare sector and seekers for the management of ADRs.

scholarly journals An analysis of the pattern and profile of adverse drug reactions reported at a tertiary care teaching hospital in Kerala, India: a retrospective record based observational study

2018 ◽  
Vol 7 (9) ◽  
pp. 1715
Author(s):  
Abdul Aslam P. ◽  
Sangeetha Purushothaman ◽  
Jihana Shajahan
Keyword(s):  
Adverse Drug Reactions ◽  
Tertiary Care ◽  
Care Hospital ◽  
Drug Reactions ◽  
Cross Sectional ◽  
Important Concern ◽  
Post Marketing ◽  
The Individual ◽  
Prolonged Hospital ◽  
Sectional Analysis

Background: Adverse drug reactions (ADRs) are an important concern in modern therapeutics. Due to limitations in identifying ADRs during research phase, organized post marketing studies are essential. However, there are only few recent studies on this subject available in India. Hence this study was done in a tertiary care hospital in South Kerala to evaluate the profile and causality of ADRs.Methods: The details of patients who developed ADRs during the period from October 2016 to November 2017 were collected. Data collection was done using the suspected drug reactions monitoring form by CDSCO used under PvPI and a retrospective observational cross-sectional analysis was done. The profile and causality of ADRs were evaluated.Results: The total number of ADR events reported was 300. 179 ADRs were hypersensitivity reactions (Aronson Type B) and the remaining 121 reactions were Type A reactions. The individual drug class causing majority of the ADRs was antibiotics (36%). Commonest significant dose related ADR was bleeding (7%) caused by combined use of antiplatelets and anticoagulants. The organ system most affected as per SOC classification was skin and appendages (56%). Causality assessment revealed that majority (76%) belonged to “probable” category, whereas 23.6% were of “possible” type.Conclusions: The development of ADRs can significantly affect treatment course – interruption of drug therapy, use of additional drugs and prolonged hospital stay. Employing monitors dedicated to ADR detection and education of prescribers to closely monitor patients can help manage ADRs effectively.

scholarly journals Knowledge, attitude and practice towards adverse drug reactions reporting in post graduate students of a tertiary care hospital

2019 ◽  
Vol 8 (6) ◽  
pp. 1320
Author(s):  
Aparna S. Chincholkar ◽  
Alisha Naik
Keyword(s):  
Adverse Drug Reactions ◽  
Health Care Professionals ◽  
Tertiary Care ◽  
Care Hospital ◽  
Drug Reactions ◽  
Microsoft Excel ◽  
Cross Sectional ◽  
Adr Reporting ◽  
Microsoft Office ◽  
Knowledge Attitude And Practice

Background: Adverse Drug Reactions (ADRs) are a major cause of morbidity and mortality. Under reporting of ADRs by health care professionals is a very common problem worldwide. So, the present study was planned to assess the knowledge, attitude and practices of postgraduate (PG) students towards ADR reporting and suggest possible ways for improvement.Methods: It was a cross sectional questionnaire-based study conducted among 44 PG students using a questionnaire with questions on knowledge (21), attitude (13) and practices (15) of ADR reporting. The questionnaire was analyzed question wise and the percentage was calculated using Microsoft Excel spreadsheet in Microsoft Office 2010 software.Results: Most of them were aware of the term pharmacovigilance (PV) (95.45%). 54.55% agreed to be trained on how to report an ADR. 88.63% knew about the existence of pharmacovigilance committee in the institute.93% of participants knew that Central Drug Standard Control Organization (CDSCO) is responsible for monitoring of ADRs. 56.82% were aware about VIGIBASE an online software to report ADR. 81.82% of participants had agreed to witness ADRs in patients but only 38.64% reported them. The main reason behind it was non – availability of ADR forms. 42.55% opine that mobile based app would be the most preferred method to send ADR information to an ADR reporting center.Conclusions: There exists a huge gap between ADR experienced and ADR reported by PG students. Participants agreed upon necessity of reporting ADR and periodic briefing about PV.

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