scholarly journals Pattern of adverse drug reactions reported at a tertiary care teaching hospital in northern India

Author(s):  
Arpita Singh ◽  
Atul Jain ◽  
Maneesh Soni ◽  
Pooja Shukla ◽  
Joonmoni Lahon ◽  
...  

Background: Adverse drug reactions (ADRs) are among the leading cause of morbidity and mortality in hospital setup. This study was conducted with the aim of understanding the pattern and occurrence of ADRs to minimize their risk and safeguard public health.Methods: This study is a retrospective analysis of pattern of ADRs reported at ADR monitoring centre (AMC) in a tertiary care hospital. A total of 207 spontaneous ADR reports collected over a period of 18 months were analysed for pattern and type of reactions, demographic profile of patients, organ system affected by ADRs, causative drugs, route of drug administration, severity of reaction, their outcome, management and causality assessment.Results: Most common age group affected by ADRs was 41-50 years with almost equal involvement of male and female gender. Cutaneous reactions involving skin like rashes and itching were most common ADRs. The most common causative drug for ADRs were antimicrobials agents like Penicillin and Cephalosporin group of antibiotics. Orally administered drugs were most commonly involved in causing ADRs. Most of the ADRs belonged to Type A category, were non-serious and moderate in severity. Most of the patients recovered from the ADRs on stopping the suspected drug. On assessing the causality, most of the ADRs were probable with the suspected drugs.Conclusions: Most of the patients recover from ADRs with appropriate and timely intervention, but it is important to understand the pattern and occurrence of ADRs for patient safety and this is possible only with an effective and robust pharmacovigilance system.

Author(s):  
Gajanan P. Kulkarni ◽  
Lokesh V. Patil

Objective: To assess ADRs with reference to causative drugs, organ systems involved and seriousness of reactions.Methods: A prospective study conducted over a period of 1 y. The spontaneous adverse drug reactions reported between July 2016 and July 2017 at AMC centre BRIMS, Bidar were analyzed using Naranjo’s scale. Causality assessment of suspected drugs involved, system affected, and seriousness of reactions was assessed.Results: GIT system was most commonly involved, followed by generalized features, skin and appendages, CNS i. e, extrapyramidal system and dizziness, hearing and vestibular systems.Conclusion: Majority of the ADRs reported were mild to moderate severity and 20% can be categorized as severe reactions, which needed to treat under hospitalization


2019 ◽  
Vol 12 (7) ◽  
pp. 3517
Author(s):  
Sumit Kumar ◽  
Badruddeen ◽  
S. P. Singh ◽  
Akhtar Juber ◽  
Mohammad Irfan Khan

Author(s):  
Dinesh K. Badyal ◽  
Bimal Kanish ◽  
Gaurav Gulrez

Background: Adverse drug reactions (ADRs) have become frequent cause for hospitalization and are coming up as an economic burden on health systems. Identification of ADRs and their reporting pattern can provide useful information for their management. Hence, this study was planned to evaluate causality and pattern of ADRs in a tertiary care hospital.Methods: The present study was undertaken in a tertiary care teaching hospital. A total of 200 ADRs reports collected in the ADR monitoring centre were analysed. The WHO definition of an ADR was adopted as well as WHO scale for causality assessment was used. Evaluation of the data was done for various parameters which included drug groups causing ADRs, body systems affected in ADRs, reporters and seriousness of reactions.Results: Overall occurrence of ADRs was slightly more in males (58%). Skin (72%) was the most commonly affected organ system. Antimicrobials (47%) were the drug group most commonly involved in ADRs. The causative drug was withdrawn for the management of the ADR in the majority (86%) of the patients. Upon causality assessment, majority of the ADRs were rated as probable (83.5%). Almost all of the reports were contributed by clinicians (99%).Conclusions: The causality assessment and pattern of ADRs reported in our hospital is comparable with the results of studies conducted in hospital set up elsewhere, although there are few differences. The study results revealed opportunities for interventions in ADR management especially for the preventable ADRs to ensure safer drug use.


Author(s):  
Leeyasid Shaik ◽  
Vasundhara Krishnaiah ◽  
Girish K.

Background: Adverse drug reactions (ADRs) are the main leading causes of hospitalization which leads to morbidity and mortality worldwide. Reporting of ADRs to national databases is necessary. To strengthen this system, consumers apart from health-care professionals have also been empowered to report any ADRs directly to the regulatory agencies. Direct and spontaneous patient or consumer reporting offers various benefits beyond pharmacovigilance (PV). Consumer reporting of ADRs has existed in several countries for decades, but in India, with the inclusion of consumer reporting of ADR, the data on the same is valuable and limited. Hence the present study is taken up. The aim of this study was to explore the knowledge, perceptions and practice of ADR reporting among consumers in KIMS hospital and research center, Bangalore.Methods: The data was collected from Patients attending OPD’s, admitted in wards and at pharmacy in KIMS Hospital and Research Center, Bangalore. It is a cross sectional descriptive study. Study period is for six months from 1st April to 31st September 2018 and sample size is 200. A structured questionnaire in English and Kannada was used as a tool.Results: Of the 200 patients from the surveyed, in males the knowledge scores were better when compared to females and attitude, perception scores were same (statistically not significant). Most of the patients opined for the establishment of consumer pharmacovigilance system at hospitals and local pharmacies.Conclusions: Knowledge about ADR reporting and pharmacovigilance is less in consumers. So that there is a need to increase awareness in consumers.


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 6 (4) ◽  
pp. 1557
Author(s):  
Veereswara Rao Kurma ◽  
Triveni Manchu ◽  
Meena Kumari Amancharla ◽  
Kalyani Manchu ◽  
Pavan Kumar Kandula

Background: Adverse drug reactions (ADRs) are an important cause of morbidity and mortality across the world and contribute to a significant economic burden on healthcare resources and community. In children, monitoring ADRs is essential as adequate clinical trials are lacking in this group. So, this study was undertaken to assess the ADR pattern in a paediatric population in a tertiary care hospital.Methods: A cross sectional, retrospective study was done at ADR monitoring centre (AMC) for a period of 3 years in a tertiary care hospital. All the ADRs reported by the Department of Paediatrics to AMC were collected and analyzed for age group affected, demographic profile, ADR pattern, drug group, systems affected, causality and severity of the ADR.Results: During the study period, a total of 102 ADRs were reported to the AMC from the paediatric department. Out of 102 ADRs reported, males represented 60.8% and females represented 39.2%. Maximum number of ADRs were seen in the age group of 1-5 years (43.3%). Most common ADR reported was maculopapular rash (27.5%) followed by diarrhoea (14.7%). The most common drug class causing ADRs are antibiotics (36.3%) followed by anticonvulsants (18.6%). Vaccines contributed to 14.7% of all reported ADRs. Majority of the ADRs were of probable (70.6%) causality and moderate (52%) in severity.Conclusions: ADRs were reported more among under 5 years of age and antibiotics were the common implicated causative agents. Most of the reactions were of moderate severity. Information acquired through ADR reporting may be useful in identifying and minimizing preventable ADRs and augmenting the knowledge of the prescribers to deal with ADRs more efficiently.


2019 ◽  
Vol 9 (1) ◽  
pp. 195-198
Author(s):  
B. Prashanthi ◽  
Hepsibha Modi ◽  
Dharmateja Kalagara

The observational and brief cross section study was conducted in the ADR monitoring centre, department of pharmacology, SVS MEDICAL HOSPITAL. The adverse drug reactions (ADR) reported by physician of dermatology department of SVSMH were collected and then causality, severity and preventability assessment was done. The results were presented as number and percentage. Total of 544 patients were observed with 15 suspected ADRs. The incidence of dermatological ADR was 3.78%. Maximum incidence of dermatological ADRs were observed with anti-inflammatory agents and immunosuppressive (33.30%) followed by antibiotic drugs (13.3%).Dermatological adverse drug reactions were a common occurrence and awareness about them was found to be essential for early detection and prevention. The healthcare system can promote the spontaneous reporting of dermatological ADR top Pharmacovigilance centre's for ensuring safe drug use and patient care. . Most of the reported ADRs were possible, definitely preventable and mild in nature. Our study suggests that there is a need of intensive monitoring for ADRs in tertiary care hospital for early detection and to ensure the patient safety. Keywords: adverse drug reaction, casualty, severity, probability.


2013 ◽  
Vol 7 (5) ◽  
pp. 384-388
Author(s):  
Harmeet S. Rehan ◽  
Deepti Chopra ◽  
Ravinder K. Sah ◽  
Ritu Mishra

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