Preventability, predictability, severity and causality assessment of adverse drug reactions reported from a teaching hospital in chhattisgarh

Keche, Yogendra; Gaikwad, Nitin; Dhaneria, Suryaprakash

doi:10.4103/jfmpc.jfmpc_2374_20

Cited by 5 publications

(2 citation statements)

References 15 publications

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“…In our study, only two cases of DHS due to dapsone, two cases of acute allergies, and one case of hepatic abnormalities due to rifampicin were not preventable, highlighting the importance of patient education in increasing awareness. 29,30 In the present study, dapsone was stopped because of 59 of 145 events (40%), rifampicin was stopped in 4 of 50 events (8%), and clofazimine was not stopped in any patient. Furthermore, dapsone was discontinued in 50% (n = 43) of 85 patients who developed haemolytic anaemia during treatment.…”

Section: Discussionmentioning

confidence: 59%

Causality, severity, and preventability of adverse drug reactions due to multi-drug therapy in leprosy: evidence from a national level institution in Sri Lanka

Hewawasam,

Wijesinghe,

Nazeer

et al. 2023

LEPROSY

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Objective This study describes the causality, severity, and preventability of adverse drug reactions (ADR) in patients affected by leprosy treated with multi-drug therapy (MDT) at the dermatology and central leprosy clinics of the National Hospital of Sri Lanka. Methods This cross-sectional analytical study consisted of two components (retrospective and prospective). Prospective cases were recruited and followed up for six months. Retrospective data collection was carried out at relevant clinics in the NHSL by extracting data from the clinical records of the patients. When an ADR was suspected, it was confirmed after discussion with the clinic medical officers/consultant dermatologist and scored according to the Naranjo ADR probability scale. The intensity of an individual ADR was evaluated using the modified Hartwig and Siegel Severity Assessment Scale, and preventability assessment was performed using the modified Schumock and Thornton scale. Results One hundred and ninety-seven patients were included for ADR attributable to MDT. Approximately 145 patients (73.6%) developed ADR associated with dapsone. Another 50 cases (25.3%) were associated with rifampicin, and 10 (5.1%) were associated with clofazimine. Of the dapsone related 145 ADRs, 59 (40.7%) were definite, 64 (44.1%) were probable, and 22 (15.2%) were possible. Of the rifampicinrelated cases, four (8%) were definite, 35 (70%) were probable, and 11 (22%) were possible. The most common adverse drug reactions detected were haemolytic anaemia

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Section: Discussionmentioning

confidence: 59%

Causality, severity, and preventability of adverse drug reactions due to multi-drug therapy in leprosy: evidence from a national level institution in Sri Lanka

Hewawasam,

Wijesinghe,

Nazeer

et al. 2023

LEPROSY

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“…For instance, anaphylactic shocks caused by penicillin or chloramphenicol-induced aplastic anaemia are type-2 ADRs. Predictability assessment of ADRs is crucial in distinguishing between these two types of reactions and helps in understanding the safety profile of a drug [52,53].…”

Section: Predictability Assessmentmentioning

confidence: 99%

Causality, Severity, Preventability and Predictability Assessments Scales for Adverse Drug Reactions: A Review

Manjhi,

Singh,

Kumar

2024

Cureus

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The pharmacovigilance program of India (PvPI), after its inception, has been reliably acquiring force in bringing issues to light among the masses, healthcare professionals, the pharma industry, and clinical staff at hospitals. Adverse drug reactions are unintended events that occur after exposure to a drug, biological product, or medical device, and they may result in morbidity and mortality. It is critical to monitor the safety of drugs during the post-marketing phase to find long-term and rare ADRs, as well as ADRs in special populations and patients with co-morbidities that are not usually included during clinical trials. The definitive objective of pharmacovigilance is to collate data and analyze it. Assessing the causality between ADRs and drugs is necessary to decrease the occurrence of ADRs and to reduce the risk of drug-related ADRs. ADRs may lead to increased morbidity, increased hospital stays, and increased cost of treatment, resulting in compromised patient safety. Causality assessment is the evaluation of the likelihood that a particular treatment is the cause of an observed adverse event and establishing a causal association between a drug and a drug reaction is necessary to prevent further recurrences. Numerous methods available for establishing a causal association between the drug and adverse events have been broadly classified into clinical judgment or global introspection, algorithms, and probabilistic methods. These include the Swedish method, World Health Organization-Uppsala Monitoring Centre (WHO-UMC) scale, Naranjo's algorithm, Kramer algorithm, Jones algorithm, Karch algorithm, Bégaud algorithm, Adverse Drug Reactions Advisory Committee guidelines, Bayesian Adverse Reaction Diagnostic Instrument, and so on. Despite various methods available, none of the causality assessment tools have been universally accepted as the gold standard. Naranjo's algorithm and WHO-UMC scales are, however, the most commonly used. Similarly, for preventability and severity assessment of ADRs, the Schumock and Thornton scale and Hartwig and Siegel's scale are most commonly used. Hence, we reviewed different tools and methods available to assess the causality, preventability, and severity of ADRs.

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Heuristic Evaluation of adverse drug reaction reporting System

Meraji

Bameri

Ebnehoseini

et al. 2023

Preprint

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Background Adverse drug reactions as an ongoing public health issue, affects various aspects of society. This study aims to conduct a comprehensive study of usability and to evaluate usability of National Adverse Drug Reactions Reporting System. Methods This study was descriptive and cross-sectional. The National Adverse Drug Reactions Reporting System was evaluated based on the Pierotti heuristic evaluation checklist by seven experts. Every experts completed a heuristic evaluation checklist. The experts also measured the overall severity of each identified heuristic violation on a scale of 0 to 4, where 0 illustrates no problems and 4 illustrates a usability difficulties. Experts' views were extracted and the severity of each problem were analyzed and determined. Results A total of 265 problems were identified in the usability of this system. The severity of the problems that were identified according to the defined criteria were: severe problems 10 (3.9%), minor problems 135 (52.7%), Improvable but not necessary 120 (46.87%), and according to the evaluators major and technical problems were zero. The mean range of difficulty was between 1.03 and 8.56. The principle of “Flexibility and minimalist design " had the highest level of severity of the problem. Conclusion It is expected that the national adverse drug reaction reporting System will be reviewed again based on the needs of users, standards and changes included in the design. Also can help system designers to overcome its system usability problems.

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Preventability, predictability, severity and causality assessment of adverse drug reactions reported from a teaching hospital in chhattisgarh

Cited by 5 publications

References 15 publications

Causality, severity, and preventability of adverse drug reactions due to multi-drug therapy in leprosy: evidence from a national level institution in Sri Lanka

Causality, severity, and preventability of adverse drug reactions due to multi-drug therapy in leprosy: evidence from a national level institution in Sri Lanka

Causality, Severity, Preventability and Predictability Assessments Scales for Adverse Drug Reactions: A Review

Heuristic Evaluation of adverse drug reaction reporting System

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