Are consumers ready to take part in the Pharmacovigilance System?—a Portuguese preliminary study concerning ADR reporting

Detalhes bibliográficos
Autor(a) principal: Matos, Cristiano
Data de Publicação: 2015
Outros Autores: van Hunsel, Florence, Joaquim, João
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
Texto Completo: http://hdl.handle.net/10400.26/24271
Resumo: BACKGROUND: New pharmacovigilance legislation allows consumers to report adverse drug reactions (ADRs) directly to competent authorities in all European Union countries. Consumer reporting is available in Portugal since July 2012. In 2013, the National Pharmacovigilance System (SNF) had received 3461 spontaneous ADR reports, of which only 1.4% (n = 50) were from consumers. Consumer reporting could be one opportunity to reduce underreporting. AIM: The aim of this study was to describe the attitudes and knowledge of the general public regarding spontaneous reporting and the reasons and opinions that can influence consumers' ADR underreporting. METHODS: A descriptive-correlational study was performed looking for consumers' attitudes and knowledge regarding spontaneous reporting. A 6-month survey was conducted from June to November 2013 in general adult consumers from a community pharmacy in Coimbra, Portugal, who used prescribed medicines or over-the-counter (OTC) drugs. Attitudes and opinions were surveyed by personal interview in a closed-answer questionnaire using a Likert scale. Questionnaires from healthcare professionals or incomplete ones were not considered. Data were analyzed using descriptive statistics, chi-square (χ(2)) tests, and Spearman's correlation coefficients. RESULTS: One thousand eighty-four questionnaires were collected (response rate of 81.1%) and 948 completed were selected for analysis. Of the respondents, 44.1% never heard about SNF. Younger people and those with a higher education were significantly more likely to be aware of SNF. Only one consumer had previously reported directly an ADR. Reporting ADRs indirectly through a healthcare professional (HCP) was preferred by 62.4%. The main reasons for consumers reporting spontaneous ADR would be the severity of reactions (81.1% agreed or strongly agreed) and worries about their situation (73.4% agreed or strongly agreed). Only weak and moderate correlations were found between studied statements.. CONCLUSIONS: Consumers are more likely to do spontaneous report about severe reactions or if they are worried about the symptoms. Tailored and proactive information on ADR reporting and educational interventions on consumers could increase the number of reports from consumers in Portugal.
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spelling Are consumers ready to take part in the Pharmacovigilance System?—a Portuguese preliminary study concerning ADR reportingPharmacovigilanceDirect consumer’s reportingADR reportingAttitudes and knowledgeFarmacovigilânciaRelato de reações adversas relacionadas com medicamentosAtitudes e conhecimentoBACKGROUND: New pharmacovigilance legislation allows consumers to report adverse drug reactions (ADRs) directly to competent authorities in all European Union countries. Consumer reporting is available in Portugal since July 2012. In 2013, the National Pharmacovigilance System (SNF) had received 3461 spontaneous ADR reports, of which only 1.4% (n = 50) were from consumers. Consumer reporting could be one opportunity to reduce underreporting. AIM: The aim of this study was to describe the attitudes and knowledge of the general public regarding spontaneous reporting and the reasons and opinions that can influence consumers' ADR underreporting. METHODS: A descriptive-correlational study was performed looking for consumers' attitudes and knowledge regarding spontaneous reporting. A 6-month survey was conducted from June to November 2013 in general adult consumers from a community pharmacy in Coimbra, Portugal, who used prescribed medicines or over-the-counter (OTC) drugs. Attitudes and opinions were surveyed by personal interview in a closed-answer questionnaire using a Likert scale. Questionnaires from healthcare professionals or incomplete ones were not considered. Data were analyzed using descriptive statistics, chi-square (χ(2)) tests, and Spearman's correlation coefficients. RESULTS: One thousand eighty-four questionnaires were collected (response rate of 81.1%) and 948 completed were selected for analysis. Of the respondents, 44.1% never heard about SNF. Younger people and those with a higher education were significantly more likely to be aware of SNF. Only one consumer had previously reported directly an ADR. Reporting ADRs indirectly through a healthcare professional (HCP) was preferred by 62.4%. The main reasons for consumers reporting spontaneous ADR would be the severity of reactions (81.1% agreed or strongly agreed) and worries about their situation (73.4% agreed or strongly agreed). Only weak and moderate correlations were found between studied statements.. CONCLUSIONS: Consumers are more likely to do spontaneous report about severe reactions or if they are worried about the symptoms. Tailored and proactive information on ADR reporting and educational interventions on consumers could increase the number of reports from consumers in Portugal.Springer-Verlag Berlin HeidelbergRepositório ComumMatos, Cristianovan Hunsel, FlorenceJoaquim, João2018-10-15T10:47:08Z2015-07-01T00:00:00Z2015-07-01T00:00:00Zinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleapplication/pdfhttp://hdl.handle.net/10400.26/24271engMatos, C., van Hunsel, F. & Joaquim, J. Eur J Clin Pharmacol (2015) 71: 883. https://doi.org/10.1007/s00228-015-1867-21432-1041 (Online)10.1007/s00228-015-1867-2info:eu-repo/semantics/openAccessreponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãoinstacron:RCAAP2022-09-05T15:40:27Zoai:comum.rcaap.pt:10400.26/24271Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-19T15:16:16.788639Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãofalse
dc.title.none.fl_str_mv Are consumers ready to take part in the Pharmacovigilance System?—a Portuguese preliminary study concerning ADR reporting
title Are consumers ready to take part in the Pharmacovigilance System?—a Portuguese preliminary study concerning ADR reporting
spellingShingle Are consumers ready to take part in the Pharmacovigilance System?—a Portuguese preliminary study concerning ADR reporting
Matos, Cristiano
Pharmacovigilance
Direct consumer’s reporting
ADR reporting
Attitudes and knowledge
Farmacovigilância
Relato de reações adversas relacionadas com medicamentos
Atitudes e conhecimento
title_short Are consumers ready to take part in the Pharmacovigilance System?—a Portuguese preliminary study concerning ADR reporting
title_full Are consumers ready to take part in the Pharmacovigilance System?—a Portuguese preliminary study concerning ADR reporting
title_fullStr Are consumers ready to take part in the Pharmacovigilance System?—a Portuguese preliminary study concerning ADR reporting
title_full_unstemmed Are consumers ready to take part in the Pharmacovigilance System?—a Portuguese preliminary study concerning ADR reporting
title_sort Are consumers ready to take part in the Pharmacovigilance System?—a Portuguese preliminary study concerning ADR reporting
author Matos, Cristiano
author_facet Matos, Cristiano
van Hunsel, Florence
Joaquim, João
author_role author
author2 van Hunsel, Florence
Joaquim, João
author2_role author
author
dc.contributor.none.fl_str_mv Repositório Comum
dc.contributor.author.fl_str_mv Matos, Cristiano
van Hunsel, Florence
Joaquim, João
dc.subject.por.fl_str_mv Pharmacovigilance
Direct consumer’s reporting
ADR reporting
Attitudes and knowledge
Farmacovigilância
Relato de reações adversas relacionadas com medicamentos
Atitudes e conhecimento
topic Pharmacovigilance
Direct consumer’s reporting
ADR reporting
Attitudes and knowledge
Farmacovigilância
Relato de reações adversas relacionadas com medicamentos
Atitudes e conhecimento
description BACKGROUND: New pharmacovigilance legislation allows consumers to report adverse drug reactions (ADRs) directly to competent authorities in all European Union countries. Consumer reporting is available in Portugal since July 2012. In 2013, the National Pharmacovigilance System (SNF) had received 3461 spontaneous ADR reports, of which only 1.4% (n = 50) were from consumers. Consumer reporting could be one opportunity to reduce underreporting. AIM: The aim of this study was to describe the attitudes and knowledge of the general public regarding spontaneous reporting and the reasons and opinions that can influence consumers' ADR underreporting. METHODS: A descriptive-correlational study was performed looking for consumers' attitudes and knowledge regarding spontaneous reporting. A 6-month survey was conducted from June to November 2013 in general adult consumers from a community pharmacy in Coimbra, Portugal, who used prescribed medicines or over-the-counter (OTC) drugs. Attitudes and opinions were surveyed by personal interview in a closed-answer questionnaire using a Likert scale. Questionnaires from healthcare professionals or incomplete ones were not considered. Data were analyzed using descriptive statistics, chi-square (χ(2)) tests, and Spearman's correlation coefficients. RESULTS: One thousand eighty-four questionnaires were collected (response rate of 81.1%) and 948 completed were selected for analysis. Of the respondents, 44.1% never heard about SNF. Younger people and those with a higher education were significantly more likely to be aware of SNF. Only one consumer had previously reported directly an ADR. Reporting ADRs indirectly through a healthcare professional (HCP) was preferred by 62.4%. The main reasons for consumers reporting spontaneous ADR would be the severity of reactions (81.1% agreed or strongly agreed) and worries about their situation (73.4% agreed or strongly agreed). Only weak and moderate correlations were found between studied statements.. CONCLUSIONS: Consumers are more likely to do spontaneous report about severe reactions or if they are worried about the symptoms. Tailored and proactive information on ADR reporting and educational interventions on consumers could increase the number of reports from consumers in Portugal.
publishDate 2015
dc.date.none.fl_str_mv 2015-07-01T00:00:00Z
2015-07-01T00:00:00Z
2018-10-15T10:47:08Z
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format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv http://hdl.handle.net/10400.26/24271
url http://hdl.handle.net/10400.26/24271
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv Matos, C., van Hunsel, F. & Joaquim, J. Eur J Clin Pharmacol (2015) 71: 883. https://doi.org/10.1007/s00228-015-1867-2
1432-1041 (Online)
10.1007/s00228-015-1867-2
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Springer-Verlag Berlin Heidelberg
publisher.none.fl_str_mv Springer-Verlag Berlin Heidelberg
dc.source.none.fl_str_mv reponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
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