scholarly journals Evaluation of adverse drug reactions of anti-tubercular drugs in the treatment of tuberculosis in tertiary care hospital

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):  
Manik Chhabra ◽  
Manjeet Singh Jangra ◽  
Muhammed Rashid ◽  
Puneet Sharma ◽  
Kota Vidyasagar

Abstract Objectives Study aim to describe the spontaneous reporting of the adverse drug reactions (ADRs) among the patients admitted to medicine department of a tertiary care hospital. Methods A prospective observational study was conducted over a period of four months at the medicine department. On the daily basis, all the patients aged >18 years admitted to the internal medicine department were followed and analyzed for occurrence of ADRs. Naranjo scale was used to determine causal relationship between the ADRs and suspected drugs. The nature of ADRs and its severity was assessed using the Hartwig scale. Results A total of 4,530 patients were screened for the ADRs, out of which 90 ADRs were developed in the 89 patients. The overall incidence of ADRs was found to be 1.96% in the studied population. The most common ADRs encountered during the study period were type A (augmented). The least number of ADRs were observed in the age group of 31–40 years. Furthermore, the more significant number of male patients suffered from a severe type of ADRs as compared to females. Sixteen ADRs were of the mucocutaneous type of reaction followed by dizziness in 12 cases. The higher number of patients recovering from the ADRs was in the age group 41–60 years. The outcomes of ADRs were not found to be statistically significant with gender and age groups. Conclusions There is a strong need to extend the monitoring and reporting of the ADRs to ensure the patient safety. However, the overall incidence of ADRs appeared to be less in our study, highlighting the need for strengthening reporting system of ADRs. The results indicate that elderly patients are at significant risk of developing ADRs.


Author(s):  
Jayendra R. Gohil ◽  
Aniket B. Sarwade ◽  
Hardik R. Chauhan ◽  
Jay R. Jasani ◽  
Hinal R. Gujrati

Background: Objective was to study the occurrence of adverse drug reactions in pediatric age group in a tertiary care hospital setting.Methods: A retrospective study was undertaken to analyze adverse drug events in pediatrics wards of a tertiary care hospital. Any event marked as ‘suspected adverse drug reaction’ was included in the study and ADR forms were analyzed for causality and severity. Other parameters like age and sex, class of drug, types of ADR, commonly involved systems and polypharmacy were studied.Results: Total 74 cases of admitted patients (13 deaths: 11 infants, 6 neonates) with severe ADR were studied of whom 39% were females. Antimicrobials were the commonest drug class (54%) with Skin most commonly involved. 77% cases were of probable category according to Naranjo’s scale of causality assessment. 11% cases were prescribed polypharmacy.Conclusions: Antibiotics were the class of drug causing maximum ADRs. The commonest system involved was skin. Redness, itching & rashes were the common symptoms. Antimicrobials should be used judiciously. Polypharmacy should be avoided. ADR reporting should be strengthened. Extra vigilance is required for infants and neonate’s prescriptions.


Author(s):  
LIMA KORUTHARA MOHANAN ◽  
DHANYA THIROOKARAN HARICHANDRAN ◽  
SANALKUMAR KB

Objective: The objective of the study was to study the pattern of suspected adverse drug reactions (ADRs) in a tertiary care hospital. Methods: This is a cross-sectional study conducted in the Department of Pharmacology of a Tertiary Care Teaching Hospital, Kerala. As part of pharmacovigilance activities, the ADRs were collected in Central Drug Standard Control Organization Suspected ADR reporting form from various departments during a period of 3 months and recorded in Pharmacovigilance register maintained by the pharmacology department. As part of our study, we collected the details such as patient’s initials, age, gender, reporting department of hospital, description of the ADR, duration of the reaction, name of suspected ADRs, and outcome from the Pharmacovigilance register. Descriptive statistics will be used for data analysis by statistical package for the social science for windows 16. Results: Two hundred and twenty-two ADR from 141 patients obtained during a period of 3 months. The maximum ADR reports were in age group more than 50 years of age. The skin and appendages were most affected followed by gastrointestinal tract. Antineoplastic drugs accounted for 59.7% of drug class suspected for ADRs followed by use of more than one drug (14.1%). Among antineoplastic drugs, cyclophosphamide and carboplatin accounted for majority causes of ADR. The antibiotics accounted for 12.7% of all drugs. Among the antibiotics penicillin and cephalosporins caused most of the ADRs. Conclusion: The maximum number of ADR reported in our study was with the use of antineoplastic drugs and most common ADR reported was alopecia.


Author(s):  
Santosh B. Godbharle ◽  
Sudhir L. Padwal

Background: The objectives of the study were to evaluate incidence and preventability of adverse drug events (ADEs) and potential ADEs and to analyse preventable events to develop prevention strategies.Methods: The study was retrospective observational study conducted at a rural tertiary care hospital at Maharashtra, for 12 months. Patients of both gender and all age group were included in the study. These entire adverse drug reactions were reported either by the PVPI assistance and/or hospital staff and their severity and causality assessments was performed as per Naranjo’s and Hartwig’s assessment criteria respectively. Data was analyzed by using Microsoft Excel.Results: There were total 256 ADR (adverse drug reactions) were reported in 12 months from January 2018 to December 2018 in various departments of the study center. Most of the adverse drug reactions were reported among age group of 21–40 years patients. Rash and itching (69) were most commonly reported ADR’s. ART (31.25%), antibiotics (28.90%) were reported to induce maximum number of ADRs. Most of the adverse drug reactions were possible (194, 75.78%) and mild (208, 81.25%) in nature.Conclusions: The antibiotics, ART drugs were most common drugs to reported ADRs. The commonly reported reactions were rash and itching.


2021 ◽  
Vol 8 (2) ◽  
Author(s):  
Mudasir Maqbool ◽  
Dinka Dugassa ◽  
Ginenus Fekadu

Background: Epilepsy is a disorder that affects 1% of the global population. It is the second most common serious neurologic disorder after stroke, affecting humans. Since antiepileptic drugs have a narrow therapeutic index and their adverse effects can affect any organ, their widespread use has significant safety implications. Objectives: The study assessed adverse drug reactions (ADRs) using antiepileptic drugs in the Department of Neurology at a Tertiary Care Hospital, Srinagar, Jammu & Kashmir, India. Methods: This prospective observational study was conducted in the Department of Neurology of a Tertiary Care Hospital, Srinagar, Jammu & Kashmir, India, for eight months. It was a spontaneous reporting of ADRs by practicing physicians in the outpatient and inpatient settings that were included in the study. Results: Of the 3,300 patients who were on the anti-epileptic drug (AED), 92 (3.07%) had AED-related ADRs. A total of 18 cases were reported in the inpatient department and 74 cases in the outpatient setting. The most common ADRs were loss of appetite (34.78%), skin rashes (17.39%), and gum hypertrophy (9.78%). Of 80 ADRs, 42.5% were related to valproate, followed by phenytoin, carbamazepine, and levetiracetam. The suspected drug was changed in 22 patients with ADRs. Conclusions: For the early diagnosis and avoidance of ADRs, the frequent follow-up of patients on AEDs is needed to improve patient compliance with drug therapy and provide better drug therapy for avoiding associated morbidity and mortality.


Author(s):  
Syed Hussain F. ◽  
Sathyanarayanan V. ◽  
Jamuna Rani R.

Background: Adverse drug reactions are due to hazards of drug therapy and can occur with any class of drugs. The aim of this study was to evaluate and record adverse drug reactions reported from various departments of a tertiary care hospital.Methods: A Cross Sectional study conducted in a tertiary care hospital for a period of 4 months from March to June 2017 after Institutional Ethics Committee approval. ADRs reports collected and analyzed for causality, severity and preventability by international standardized scales.Results: A total of 38 ADR’s were reported during the study period with male predominance (58%). Most of the ADR’s (42%) were common in patients in the age group 19-39 years. More number of ADR’s were from Medicine (29%). Most commonly affected organ systems were skin (45%). The drugs mostly accounted were antibiotics (55%) especially Cephalosporins (33%). According to Naranjo’s causality assessment scale 74% of reactions were probable, 26% were possible, Modified Hartwig and Seigel severity assessment scale revealed 45% ADRs to be moderate, 42% were mild and 13% were severe, Modified Schumock and Thorton Preventability assessment scale which revealed 61% ADRs were not preventable, 32% were probably preventable,7% were definitively preventable.Conclusions: Adverse Drug Reactions are common and some of them resulted in increased healthcare cost due to need of some interventions and increased length of hospital stay. The health system should promote the spontaneous reporting of ADR’s. The proper documentation and periodic reporting to Pharmacovigilance Centres is required to ensure drug safety.


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