Causality assessment of adverse drug reactions by applying a global introspection method in a high complexity hospital
| Autor: | Antonio Luiz Pinho Ribeiro, Luna Elisabeth Carvalho Ferreira, Marcelo Martins Pinto Filho, Maria das Dores Graciano Silva, Maria Auxiliadora Parreiras Martins, Gláucia Helena Martinho, Renata Rezende de Menezes |
|---|---|
| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_specialty
business.industry Hospitalized patients Concordance media_common.quotation_subject Causality World health RS1-441 Hospital Patient safety Pharmacovigilance Pharmacy and materia medica High complexity Family medicine Medicine Introspection Drug reaction business Drug-related side effect and adverse reactions media_common |
| Zdroj: | Exploratory Research in Clinical and Social Pharmacy, Vol 3, Iss, Pp 100064-(2021) |
| ISSN: | 2667-2766 |
| Popis: | Background Causality assessment of adverse drug reactions (ADRs) is an essential approach in pharmacovigilance. The World Health Organization-Uppsala Monitoring Center (WHO-UMC) system has been considered one of the most adequate method for establishing causal relationship in hospitalized patients. Objective To describe the causality of potential ADRs in hospitalized patients assessed by the WHO-UMC system and by different healthcare professionals. Methods Three healthcare professionals, with different backgrounds, acted as judges to adjudicate the causality categories for potential ADRs according to WHO-UMC system, in a Brazilian high complexity hospital. Judges' agreement was evaluated by using Fleiss' and Cohen's kappa coefficients. Results Ninety potential ADRs identified in 300 participants were adjudicated by each judge, comprising a total of 270 assessments. Most potential ADRs were classified as probable or possible (77.8%). Fleiss´ kappa revealed slight concordance among judges (k = 0.096;CI:95%;0.01–0.18). Conclusions Diverse backgrounds may have influenced the results for causality assessment of ADRs by employing the WHO-UMC system. Despite the slight concordance found for the method, this result suggests potential opportunity to enrich the ADRs management by engaging multiprofessional teams in the process. Further studies should be considered to investigate the performance of methods for ADRs assessment in hospitalized patients in low- and middle-income countries. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|