ABSTRACT
Background: An adverse drug reaction (ADRs) is determined as response to a drug that is noxious unintended excludes therapeutic failures, overdose, drug abuse, noncompliance, and medication errors. The main aim of the study is to detect, understand and report ADR扴.Methods: This study is prospective observational study conducted for 6 months in in-patient setting in a tertiary care hospital. Naranjo抯, WHO causality scale, Siegel scale, Schumock and Thornton scale are used to assess ADR. Graph Pad Prism and SAS software抯 are used.Results: Data was collected from a total of 1000 patients of which 121 (12.1%) patients were effected with 150 ADRs. Among 121 patients AdrAd was 60.66% and AdrIn was 39.33%. Of 121 patients 97 patients with single ADR, 28 patients with 2 ADRs, 10 patients were with three ADRs. ADR onset divides acute (10%), Latent (39%) and sub-acute (51%). ADR occurred are recovered (54%), Recovering (13%). Naranjos scale interprets definite (0.9%), probable (50.9%), possible (42.97%). According to WHO scale certain (2.7%), unlikely (2.7%), possible (38.84%). Hartwig and Siegel scale results are mild (12.4%), moderate (66.12%) and severe (12.4%). Schumock and Thornton preventability results are definitely (25.45%), probably (68.18%) and not preventable (6.36%).Conclusions: Every health care professional should be aware of the Pharmacovigilance principles and also should be aware of suspected ADR reporting form of PVPI. By applying the above scales it is easy for health care professionals to assess an ADR.
ABSTRACT
Background: Adverse drug reactions are common with multidrug therapy in tuberculosis, if detected early can improve patient compliance and prevent emergence of resistance.Methods: A prospective observational study as a part of Pharmacovigilance Program under Central Drugs Standard Control Organisation was conducted in Kasturba hospital, Manipal to collect adverse drug reactions (ADR). Data of patients reported with antitubercular treatment (ATT) related ADRs from September 2012 to August 2013 was evaluated for patient demography, type of tuberculosis, ATT regimen, organ/ system affected and time of onset of ADR. ADRs were then subjected to causality assessment as per WHO scale.Results: A total of 65 ADRs were reported in 60 patients during the study period, of which 46.7% were in males and 53.3% in females. 85% of ADRs were reported in patients with pulmonary tuberculosis. 77% of ADRs were observed with daily regimen. Common ADRs were hepatitis (40%), gastritis (15%), skin reactions (15%), peripheral neuropathy (14%), gout (6%) and nephritis (3%). Median duration for the onset of ADR was 31 days each for hepatitis, gout, nephritis and 20, 11, 9 days for gastritis, peripheral neuropathy and skin reactions respectively. As per causality assessment, 80% of ADRs were assigned “possible”, 11% “probable” and 9% “certain”. As per severity scale 27.7% of ADR were severe, 36.9% were moderate.Conclusions: Early detection and management of ADRs is vital for the success of ATT and patient adherence.
ABSTRACT
Background: Tuberculosis is fundamentally a disease of the lungs, however, it can influence any organ in the body. Objectives: Primary objective was to improve the patient compliance or medication adherence and to identify, detect, monitor ADRs induced by anti-tubercular drugs and report them. A secondary objective was to prevent the emergence of drug resistance and treatment of prolongation/failure in TB patients. Methods: A prospective, observational, cohort study was carried out for 6-months in tertiary care hospital. There were 60 patients included in the study. The data were evaluated for patients’ demographic profile, type of TB, medication adherence and occurrence of ADRs. Adverse drug reactions were observed and recorded. The causality of ADRs was assessed using WHO-causality assessment scale and Naranjo causality assessment scale. The severity of ADRs was determined using Hartwig’s severity assessment scale. Results and Discussion: Total of 60 patients were included in the study. Results showed that among 60 patients included in the study, 44 patients experienced ADRs. Among all age groups, the highest numbers of ADRs were seen in the age group 19-30 (43.1%) years. The occurrence of ADRs was noticed more in females (77.7%). The majority of ADRs occurred in patients was general (28.4%), and gastrointestinal effects (23.8%). Conclusion and Scope of the Study: Adherence to treatment is crucial for the cure of individual patients, controlling the spread of infection, minimizing the development of drug resistance and to reduce the chances of re-infection. Proper therapeutic monitoring of regimen, dose management, and pharmacovigilance activities are necessary. Such approaches will not only improve the treatment outcomes but also minimizes the chances of treatment prolongation/failure. All the health care professionals should interpret their responsibility in this domain of the health care profession.
ABSTRACT
Background: Adverse drug reactions (ADRs) are one of the major causes of hospital admissions. The objective of this study was to ascertain the various ADRs occurring in a tertiary care teaching hospital at Dehradun, Uttarakhand. Methods: The ADRs were collected from January 2010 to June 2014 by the Department of Pharmacology in Shri Guru Ram Rai Institute of Medical & Health Sciences, Dehradun, Uttarakhand. A total of 123 ADRs were collected, analyzed and assessed on WHO causality assessment scale. Results: A total of 123 ADRs were assessed. Male:female ratio was 1.5:1. Age-wise distribution of ADRs was done: 0-15 years had 15 (12.19%), 16-30 had 50 (40.65%), 31-45 showed 25 (20.32%), 46-60 years 22 (17.88%) and >60 years had 11 (8.94%). 112 (91.05%) ADRs were serious, and 11 (8.94%) were non-serious. As per the WHO causality assessment scale, 91 (73.98%) ADRs were probable, 30 (24.39%) were possible, and 2 (1.62%) were certain. Most commonly occurring ADRs were fixed drug eruption in 42 (34.14%) patients, erythematous maculopapular rash in 20 (16.26%) patients and urticarial rash in 15 (12.19%) patients, followed by others. The drugs most frequently associated with ADRs were non-steroidal antiinflammatory drugs (NSAIDs), fluoroquinolones, penicillins, cephalosporins and phenytoin sodium, followed by others. Conclusions: Majority of ADRs were probable according to WHO causality assessment scale. Most common ADR was fixed drug eruption. Most frequent drugs associated with ADRs were NSAIDs. ADRs contribute to increased morbidity and mortality in patients; thereby pose a huge burden on the society.