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      Causes for the underreporting of adverse drug events by health professionals: a systematic review Translated title: Causas del subregistro de los eventos adversos de medicamentos por los profesionales de la salud: revisión sistemática Translated title: Causas de subnotificação de eventos adversos a medicamentos por profissionais da saúde: revisão sistemática

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          Abstract

          Objective: Identifying the main causes for underreporting of Adverse Drug Reaction (ADR) by health professionals. Method: A systematic review carried out in the following databases: LILACS, PAHO, SciELO, EMBASE and PubMed in the period between 1992 and 2012. Descriptors were used in the search for articles, and the identified causes of underreporting were analyzed according to the classification of Inman. Results: In total, were identified 149 articles, among which 29 were selected. Most studies were carried out in hospitals (24/29) for physicians (22/29), and pharmacists (10/29). The main causes related to underreporting were ignorance (24/29), insecurity (24/29) and indifference (23/29). Conclusion: The data show the eighth sin in underreporting, which is the lack of training in pharmacovigilance. Therefore, continuing education can increase adherence of professionals to the service and improve knowledge and communication of risks due to drug use.


          Translated abstract

          Objetivo: Identificar las causas de la subnotificación de la Reacción Adversa a Medicamento (RAM) por profesionales de la salud. Método: Revisión sistemática realizada en las bases de datos LILACS, PAHO, SciELO, EMBASE y PubMed, cuyo período de revisión fue de 1992 a 2012. Se utilizaron descriptores para buscar los artículos. Las causas de subnotificación identificadas fueron analizadas de acuerdo con la clasificación de Inman. Resultados: Se identificaron 149 artículos, de los cuales 29 fueron seleccionados. La mayoría de los estudios fueron realizados en hospitales (24/29) para médicos (22/29) y farmacéuticos (10/29). Las principales causas relacionadas a la subnotificación observadas fueron: la ignorancia (24/29), la inseguridad (24/29) y la indiferencia (23/29). Conclusión: Los datos evidencian el octavo pecado de la subnotificación, que es la falta de formación en farmacovigilancia. Por lo tanto, la educación continua puede aumentar la adhesión de los profesionales al servicio y mejorar el conocimiento y la comunicación de riesgos del uso de medicamentos.

          Translated abstract

          Objetivo: Identificar as causas de subnotificação de Reação Adversa a Medicamento (RAM) por profissionais da saúde. Método: Revisão sistemática realizada nas bases de dados LILACS, PAHO, SciELO, EMBASE e PubMed, cujo período de abrangência foi de 1992 a 2012. Foram utilizados descritores para buscar os artigos. As causas de subnotificação de RAM identificadas foram analisadas de acordo com a classificação de Inman. Resultados: Identificaram-se 149 artigos, dos quais 29 foram considerados elegíveis. A maioria dos estudos foi conduzida em hospitais (24/29), para médicos (22/29) e farmacêuticos (10/29). As principais causas relacionadas à subnotificação observadas foram: a ignorância (24/29), a insegurança (24/29) e a indiferença (23/29). Conclusão: Os dados evidenciam o oitavo pecado da subnotificação, que é a falta de formação em farmacovigilância. Assim, a educação permanente pode aumentar a adesão dos profissionais ao serviço e melhorar o conhecimento e a comunicação dos riscos associados ao uso de medicamentos.


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          Human error: models and management

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              Attitudinal survey of voluntary reporting of adverse drug reactions.

              Voluntary adverse drug reaction (ADR) reporting schemes have operated since the early sixties in many Western countries. It is generally recognized, however, that only a small proportion of ADRs is actually reported. The current survey was conducted to assess attitudes towards reporting of ADRs, and to study which types of ADRs are reported. A questionnaire seeking reasons for nonreporting was sent to a random sample of 10% of medical practitioners in The Netherlands in October 1997. After 6 weeks, a reminder was sent to those who had not responded. One thousand four hundred and forty-two (73%) questionnaires were returned, of which 94% were complete. The percentage of GPs (51%) which had ever reported an ADR to the national reporting centre was significantly higher than the percentage of specialists (35%), who reported more often to the pharmaceutical industry (34% vs 48%). 86% of GPs, 72% of surgical specialists and 81% of medical specialists had ever diagnosed an ADR, which they had not reported. Uncertainty as to whether the reaction was caused by a drug (72%), the ADR being trivial (75%) or too well known (93%) were the most important reasons for not reporting. 18% were not aware of the need to report ADRs, 22% did not know how to report ADRs, 38% did not have enough time, 36% thought that reporting was too bureaucratic and only 26% of Dutch physicians knew which ADRs to report. A serious ADR, an unlabelled ADR, an ADR to a new drug, history of reporting of one or more ADRs, and specialty were all independently associated with reporting of 16 hypothetical ADRs. Surgical and medical specialists tended to report less often than GPs. There is a considerable degree of underreporting, which might partly be explained by lack of knowledge and misconceptions about spontaneous reporting of adverse drug reactions.
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                Author and article information

                Contributors
                Role: ND
                Role: ND
                Role: ND
                Role: ND
                Journal
                reeusp
                Revista da Escola de Enfermagem da USP
                Rev. esc. enferm. USP
                Universidade de São Paulo, Escola de Enfermagem (São Paulo )
                1980-220X
                August 2014
                : 48
                : 4
                : 739-747
                Affiliations
                [1 ] Universidade Estadual Paulista Brazil
                [2 ] Universidade Estadual Paulista Brazil
                [3 ] Universidade Estadual Paulista Brazil
                [4 ] Universidade Estadual Paulista Brazil
                Article
                S0080-62342014000400739
                10.1590/S0080-623420140000400023
                e7fcea71-6ba1-4293-af7b-d221598eec52

                http://creativecommons.org/licenses/by/4.0/

                History
                Product

                SciELO Brazil

                Self URI (journal page): http://www.scielo.br/scielo.php?script=sci_serial&pid=0080-6234&lng=en
                Categories
                NURSING

                Nursing
                Adverse Drug Reaction Reporting Systems,Pharmacovigilance,Revisión,Sistemas de Notificação de Reações Adversas a Medicamentos,Pessoal de saúde,Farmacovigilância,Vigilância de produtos comercializados,Educação continuada,Revisão,Health personnel,Product surveillance, postmarketing,Review,Sistemas de Registro de Reacción Adversa a Medicamentos,Personal de la salud,Farmacovigilancia,Vigilancia de Productos Comercializados,Educación continua,Education, continuing

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