scholarly journals Oral Provocation Testing in Cutaneous Adverse Drug Reactions to Antiretroviral and Antitubercular Therapy: A Study at a Tertiary Care Hospital in South India

Author(s):  
Sowmya Kaimal ◽  
Jithendriya Madhukara

Aim: To collect data pertaining to oral drug provocation testing (DPT) in hospitalized patients with antiretroviral (ARV)/antitubercular agent–induced rashes. Methods: Patients with cutaneous adverse drug reactions (ADRs) to ARV/antitubercular drugs and who underwent oral DPT during a 5-year period were included in this study. Results: Data were collected from the records of 21 patients. Of the 21, 19 had HIV infection. The most commonly implicated drug was nevirapine (NVP), followed by cotrimoxazole and antitubercular agents. Of the 11 ADRs that occurred on rechallenge, the ADR on rechallenge was similar in clinical presentation to the initial ADR in 6 patients, while a different rash was elicited in 5 patients. Conclusion: Oral DPT is a safe and effective tool to accurately diagnose ADRs, especially in patients on multiple drugs and in situations such as HIV infection and tuberculosis where second-line agents are expensive and/or not easily available through the national AIDS control/tuberculosis programs.

2017 ◽  
Vol 9 (4) ◽  
pp. 593-597 ◽  
Author(s):  
Sapan Kumar Behera ◽  
Chenchu Reddy Kishtapati ◽  
Vikneswaran Gunaseelan ◽  
Biswajit Dubashi ◽  
Adithan Chandrasekaran ◽  
...  

2015 ◽  
Vol 6 (2) ◽  
pp. 109 ◽  
Author(s):  
Ajitha Sharma ◽  
Joseph Thomas ◽  
KL Bairy ◽  
KMeena Kumari ◽  
HasithaDiana Manohar

2020 ◽  
Vol 1 (1) ◽  
pp. 6-9 ◽  
Author(s):  
Baijayanti Rath ◽  
Manas Ranjan Naik ◽  
Bhabagrahi Rath ◽  
Renuka Bhoi ◽  
Jai Prakash

Introduction: Cutaneous adverse drug reactions (CADRs) are one of the most common ADRs caused by drugs causing a lot of morbidity and mortality. The overall incidence of CADRs in developed countries is 1-3 %, while that in the developing countries is reported to be higher between 2 % and 5 %. Changes in drug metabolism drug interactions, oxidative stress, and various cytokines are the various factors that cause cutaneous adverse drug reactions. Aim and objective: This study aims to evaluate the patterns of CADRs, the causative drugs along with causality and severity assessment. Methods: A total of 50 Patients with cutaneous adverse drug reactions who were included in our last study attended skin OPD, VIMSAR Burla, from June 2018 to September 2018 and were analyzed for causality assessment using the WHO-UMC scale and severity assessment using  Hartwig and Siegel's scale. Results: Out of 50 patients, 48 % belong to the age group 21-40 years. Around 44 % of CADRs were fixed drug eruptions. NSAID was found to be the most offending drug and it contributed to a maximum of 32 % of ADRs. 16 % of ADRs were found to be caused by antitubercular drugs. Paracetamol was the key NSAID, contributing 87.5 % of ADRs. Causality was certain, probable, and possible for 8 %, 24 %, and 60 % of ADRs respectively. Severity was mild for 64 % and moderate for 34 % of ADRs. Conclusions: NSAID and antitubercular drugs are the commonest drugs causing CADRs. Fixed drug eruption is the most common CADRs and the commonest drug was paracetamol. Causality grade was possible and the severity grade was mild.


2021 ◽  
Vol 14 (02) ◽  
pp. 701-708
Author(s):  
Kiran M ◽  
Nagabushan H

Background: Tuberculosis is one of the major public health concerns in India. Treatment of tuberculosis need multidrug combinations, which is associated with increased incidence of adverse drug reactions (ADRs). Hence there is a need of active monitoring for adverse effects in patients who are on antitubercular treatment (ATT). Objectives: To study the pattern of ADRs caused by antitubercular drugs and to assess causality, severity and predisposing factors. Methodology: A prospective observational study was conducted for 6 months in tertiary care hospital of Mandya. A total of 74 patients of tuberculosis who experienced ADRs were included in the study after obtaining informed consent. Their demographic, treatment and ADR data were collected and analysed. Causality was assessed using WHO scale and Naranjo’s algorithm, whereas severity was assessed by Modified Hartwig and Siegel scale. Results: Among 74 patients, 55(74.32%) were males and 19 (25.67%) were females. A total of 86 ADRs were recorded amongst 74 patients, as 11 patients experienced two ADRs. During intensive and continuation phase of treatment, 65 (87.63%) and 9 (12.16%)patients experienced ADRs respectively. Gastrointestinal side effects and hepatotoxicity were the most frequently observed ADRs with 23 (26.7%) each, followed by pruritus and rashes in 18 (20.93%) patients.63.51% of ADRs had an association with fixed dose combination (FDC) of isoniazid, rifampicin, pyrazinamide and ethambutol. As per WHO scale and Naranjo’s algorithm majority of ADRs were probable with 44 (59.45%) and 58 (78.37%) respectively. Most of the ADRs belonged to mild (67.56%) category as per Modified Hartwig and Siegel scale. Conclusion: ADRs induced by ATT are common. Hence counselling of patients regarding their life style along with early detection and management will minimize the occurrence of ADRs and improvethe adherence to treatment.


2019 ◽  
Vol 12 (3) ◽  
pp. 1079-1083
Author(s):  
Hemanthkumar Shanmugam ◽  
Nithya Panneerselvam ◽  
Arul Amutha Lawrence

Cardiovascular diseases are prevalent in developing countries like India. Patients with cardiovascular diseases are prescribed multiple drugs, hence polypharmacy may attribute to higher incidence of adverse drug reactions in these patients. To monitor and to analyze the pattern of occurrence of adverse drug reactions reported with cardiovascular drugs in intensive cardiac care unit of a tertiary care hospital, Chennai. This was a prospective surveillance study carried out for a period of 6 months. Analysis of various adverse drug reactions reported were done using various assessment scales. Descriptive statistics was used and values were expressed in numbers and percentage. During the study period, 282 adverse reactions were reported from 389 patientsat includes 232 males and 157 females. The average age of the patients included in this study was 58.1± 16.8 years . The most common ADRs observed were electrolyte imbalance (14.89%), headache (13.12%) and gastritis (12.41%). Assessment using WHO Causality assessment scale revealed 60.28% were possible, 18.43% probable, 12.76% certain and 8.51% unlikely. According to Schumock and Thornton scale 65.9% of ADRs were preventable and 34% non preventable. Analysis with Hartwig and Seigel’s scale 62.05% of ADRs were moderate in severity, 27.95% mild and 10.99% severe. Drugs attributing to highest ADRs were Digoxin and Furosemide. The common ADRs due to cardiovascular drugs can be reduced by improving the prescription pattern. Intense monitoring and reporting of ADRs could help in minimizing the preventable ADRs, among the health care professionals.


Author(s):  
JERIN JAMES ◽  
JAMUNA RANI

Objective: The objective of this study was to determine the prevalence of adverse drug reactions (ADRs) in a tertiary care teaching hospital in South India and to analyze the causality according to the Naranjo scale. Methods: This study was carried out at the SRM Medical College, Chennai, a tertiary care hospital, which is an ADR monitoring center under Pharmacovigilance Programme of India, over a period of 1 year, from September 2017 to August 2018, after approval by the Institutional Ethics Committee. These ADRs were reported by the clinical pharmacy team of our hospital to the department of pharmacology. The relevant data were collected from the patient case notes, treatment charts, laboratory data reports, ADR notification forms, patient interview, and reporter interviews after written informed consent was obtained from each patient. Patients of either sex of all ages who developed ADR within the hospital were included in the study. Patients who developed ADR outside the hospital were excluded from the study. The collected ADRs were subjected to the Naranjo causality assessment scale. Hartwig’s scale was used to assess the severity of the reaction. The causalities and other aspects of the ADRs were analyzed in detail. Results: A total of 80 ADRs were reported during this study period. The ADRs were most frequently reported in the adult age group (75%) with slight female preponderance (60%). Antibiotics contributed to the maximum number of ADRs which accounted for 52.5% of the total, of which beta-lactams were the highest (37.5%) followed by analgesics. Causality assessment of ADRs by the Naranjo scale showed that the maximum reactions could be categorized as probable (85%) followed by the possible category (15%). The most common presentation of ADR was itching (45%) followed by rashes (30%). Three cases of severe adverse reactions were reported, one case each of anaphylaxis to pantoprazole and diclofenac and one case of Steven–Johnson syndrome to cotrimoxazole. Conclusion: ADRs are a common occurrence but are often not recognized. Even if recognized, they are underreported as many physicians are unaware that all ADRs should be reported to ADR monitoring centers. ADRs are an important cause of morbidity and mortality all over the world and are an important public health concern. It inflicts a negative impact on the treatment and exerts a greater economic burden on the patient if it results in prolongation of the duration of hospitalization or other comorbidities. Therefore, the practicing physicians, as well as the nursing staff, should be sensitized of the importance of ADR reporting to their respective pharmacovigilance centers.


Author(s):  
Tauseef Nazir ◽  
Sameena Farhat ◽  
Mohd Adil ◽  
Zuryat Asraf

Background: Treatment of tuberculosis involves giving multiple drugs to the patient which is done to prevent development of resistance besides targeting all bacterial sub-populations. The objective of the present study was to find out the adverse drug reactions (ADRs) of the first line anti-tubercular drugs and to calculate prevalence and causality of these drugs.Methods: The study was conducted by the Department of Pharmacology, Government Medical College, Srinagar in association with the department of Chest medicine. All patients of tuberculosis on directly observed treatment-short course (DOTS) of either sex or age group were enrolled. An assessment of the causality and allocation of ADRs was done using Naranjo’s monitoring scale and WHO-UMC scale.Results: A total of 57 ADRs with 13 different types were observed in 164 patients, with an overall prevalence of about 34.7%. Thirty seven (64.9%) ADRs were categorized as having a ‘probable’ causal relationship while 17 (29.8%) was categorized as ‘possible’ as per the Naranjo’s scale. As per the WHO-UMC monitoring scale fifty two (91.2%) were categorized as ‘possible’ while three (5.3%) were categorized as ‘certain’.Conclusions: Occurrence of ADRs generally results in non-adherance. Timely detection of ADRs through an effective pharmacovigilance programme is the need of hour. The establishment of an active pharmacovigilance centre which was set up in our institution has paved the way to improve the quality of patient care by ensuring safer use of drugs and has helped us to identify and report the various ADR’s encountered.


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