scholarly journals A study of pattern of adverse drug reactions in inpatients department of medicine of tertiary care hospital in Madhya Pradesh, India

Author(s):  
Pradeep Phadnis ◽  
Shashi Marko

Background: Adverse Drug Reactions are the recognized hazards of drug therapy and they can occur with any class of drugs. The main aim of the study was to detect and analyze Adverse Drug Reactions in inpatients of medicine department in tertiarycare hospital. The study assesses the incidence and pattern of ADRs, identifying co-morbidities, past and present illness, assess causality and the offending drugs, monitoring and documenting suspected adverse drug reactions.Methods: A prospective study was conducted over a period of 6 months. The WHO definition of an ADR was adopted. Each ADR was assessed for its causality by using WHO probability scale. The severity of each ADR was assessed by using modified Hartwig et al, and Siegel scale.Results: A total 58 ADR were reported during study period out of which 28 (48.27%) were male and 30 (51.72%) were female patients. The assessment by WHO probability scale showed that out of 58 ADR 22 (37.93%) were probable and 17 (29.31%) were possible and 6 (10.34%) were certain. Most commonly involved system was gastrointestinal system with 24 (41.37%) ADRs. Severity assessment by modified Hartwig and Siegel scale showed that 22 (37.93%) were moderate, 32 (55.17%) were mild and 4 (6.89%) were severe ADRs. No lethal effects were observed or produced.Conclusions: The study concluded that Adverse Drug Reactions are common and some of them resulted in increased health care cost due to need of some interventions and increased length of hospital stay. The health system should promote the reporting of Adverse Drug Reactions, proper documentation and periodic reporting to regional pharmacovigilance centers to ensure drug safety.

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


Author(s):  
Suchitra D. Akalu ◽  
Niveditha G. Belavadi

Background: Adverse reactions are known to occur with all classes of drugs and the incidence of adverse drug reactions (ADRs) due to antibiotics has increased with rise in infectious diseases contributing significantly to the increased health care costs.Methods: This retrospective observational study analysed the ADRs due to antibiotics that were reported by spontaneous reporting to ADR monitoring centre (AMC), functioning from Department of Pharmacology, ESIC-MC and PGIMSR. The total study period was 48 months from January 2013 to December 2016. During this period, all the ADRs due to antibiotics reported to the AMC were included in the study. This study analysed the retrospective data to find out the pattern of adverse drug reactions due to antibiotic drug class. Causality, severity and preventability were assessed using standard scales.Results: During the study period, a total of 228 ADRs due to antibiotic use were reported among 179 patients. Gender-wise distribution showed that males were slightly more affected than females by the ADRs due to antibiotics [93(52%) Vs. 86 (48%)]. Out of the total 179 antibiotics administered to the patients, beta-lactam antibiotics dominated followed by nitroimidazoles, quinolones and glycopeptide antibiotics in causing ADRs. Rashes and itching were most common ADRs followed by breathlessness and hypotensive episodes. Causality was assessed by Naranjo algorithm scale and causality was definite in 16 (7%), probable in 87 (38%) and possible in 125 (55%). Severity of the ADRs was assessed by Hartwig and Siegel scale and it was found that most of the ADRs 198 (87%) were of mild severity and 30 (13%) were of moderate severity and none of them were severe or lethal. Preventability was assessed by Schumock and Thornton scale and it was found that only 24 (11%) were preventable, 74 (32%) were probably preventable and 130 (57%) were not preventable.Conclusions: The study concluded that ADRs due to antibiotics are common and few of them resulted in increased healthcare cost due to the need for some interventions and increased length of hospital stay. The health system should promote the spontaneous reporting of ADRs due to antibiotics, proper documentation and periodic reporting to regional pharmacovigilance centers to ensure drug safety.


Author(s):  
Krishnakanth K. ◽  
Jagadeesh A. ◽  
Swetha T. D.

Background: Adverse drug reactions are very common among patients on anti-tubercular treatment. Hence, the current study was done to evaluate the adverse drug reaction (ADR) profile in patients receiving anti-tubercular treatment (ATT).Methods: A 6 months prospective, cross-sectional observational study was performed in collaboration with Pulmonology Medicine department. WHO-UMC scale and Naranjo scale was used to evaluate the ADRs.Results: Ninety-two patients receiving ATT presented with 113 adverse drug events (ADE). Males were more affected than females. DOTS category-1 regimen was mostly responsible for ADE. Addition of drugs for the management of ADR events was done.Conclusions: The study results show more ADRs related to ATT demanding increased collaboration between NTEP 2020 and Pharmacovigilance Programme of India to enhance drug safety in this field.


Author(s):  
Shereen Hassan ◽  
U. Ujwal Kumar ◽  
Venessa Mascarenhas ◽  
G. Suresh ◽  
K. C. Bharath Raj ◽  
...  

The present study was carried out to determine the incidence of Adverse Drug Reactions (ADRs) in general medicine department and to assess and analyze the causality, severity, and preventability of ADRs. A prospective observational study was conducted in the general medicine department for six months. All patients receiving drug therapy are considered and are selected based on the inclusion criteria. Patient demographic details like age, gender, diagnosis, past medical history, concomitant medications, etc., are recorded from the patient data gathering form. The causality assessment is accomplished using Naranjo and WHO scales. The severity is carried out using the Modified Hartwig and Siegel scale. The preventability evaluation is accomplished using the Modified Schmock and Thornton scale. The study included 385 patients were between the age group of 18 years and, out of which 34 patients developed adverse drug effects including female and male. Patients between the age group of 40-50 years (18.1%) developed a high incidence of ADRs. The causality was assessed using Naranjo’s causality assessment scale, 44.1% reactions were probable; 29.4% reactions were certain, 23.5% reactions were possible and 2.9 % reactions were conditional. When the reactions were assessed most of them were assessed 55.1% were moderate and 61.8% were probably preventable. Appropriate observation of the drug effect is essential to ensure the safety of the patient. This also will have the advantage of reducing the incidence of the ADRs, thus deplete the complications and helps to improve the quality of life of the patients.


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.


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