Under-reporting of Adverse Drug Reactions among Healthcare Professionals in Brazil: An Estimate Based on National Pharmacovigilance Survey

Autor:	Marcelo Vogler de Moraes, Elisabeth Carmen Duarte, Paulo Sérgio Dourado Arrais, Karla de Araújo Ferreira, Yannie Silveira Gonçalves, José Romério Rabelo Melo
Rok vydání:	2020
Předmět:	medicine.medical_specialty Health professionals business.industry Public health Logistic regression medicine.disease Under-reporting Environmental health Pharmacovigilance Health care Medicine General Pharmacology Toxicology and Pharmaceutics Risk factor business Adverse drug reaction
Zdroj:	Journal of Young Pharmacists. 12:360-365
ISSN:	0975-1505 0975-1483
Popis:	Background: Adverse Drug Reaction (ADR) is a public health problem with an impact on health care costs. Spontaneous reporting comprises the primary method for detection ADR’s. However, high levels under-reporting represents a barrier in pharmacovigilance. Objectives: The present study aims to estimate the prevalence of under-reporting ADR professionals in Brazil and to analyze the factors associated with under-reporting. Methods: Used a cross-sectional study based on an online survey for healthcare professionals conducted by the Brazilian Health Regulatory Agency (Anvisa). Unconditional logistic regression was performed and adjusted odd ratios (OR) were estimated. Results: In total 789 questionnaires were analyzed and based on the criteria, 67.5% of professionals were considered under-reporters. The main reason for under-reporting was the lack of access to vital data for notification (33.8%). 52.7% of the participants stated that the existence of a simpler system to notify motivated its use. It was found that residents in the Southern region of Brazil have 2.3 times the chance of under-reporting an ADR than those in the Southeast region (OR = 2.3; IC 95%:1.3-4.2). Having advanced knowledge in pharmacovigilance (OR=0.5; IC 95%: 0.4-0.7) and performing notification even without the causal certainty of the event (OR = 0.5; IC 95%:0.3-0.7) were protective factors for under-reporting, while not applicating knowledge routinely was considered a risk factor for under-reporting (OR = 4.4; IC 95%:2.1-9.2). Conclusion: A high rate of professionals considered as under-reporters of ADRs in Brazil has been detected. This study will make an important contribution to health managers and drug regulators for strengthen the national pharmacovigilance system.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_________::3d3bfa5b58621bddf747ef81b9da56eb https://doi.org/10.5530/jyp.2020.12.92 Zobrazit plný text záznamu Plný text ve formátu PDF