Intensive monitoring studies for assessing medicines : a systematic review
| Autor(a) principal: | |
|---|---|
| Data de Publicação: | 2019 |
| Outros Autores: | , , , , , , |
| Tipo de documento: | Artigo |
| Idioma: | eng |
| Título da fonte: | Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
| Texto Completo: | http://hdl.handle.net/10451/39830 |
Resumo: | Copyright © 2019 Torre, Cary, Borges, Ferreira, Alarcão, Leufkens, Costa and Martins. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. |
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Intensive monitoring studies for assessing medicines : a systematic reviewAdverse drug reaction reporting systemsClinical practice patternDrug monitoringPharmacovigilanceSystematic reviewCopyright © 2019 Torre, Cary, Borges, Ferreira, Alarcão, Leufkens, Costa and Martins. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.Introduction: Intensive monitoring (IM) is one of the methods of post-marketing active surveillance based upon event monitoring, which has received interest in the current medicines regulatory landscape. For a specific period of time, IM involves primary data collection and is actively focused on gathering longitudinal information, mainly safety, since the first day of drug use. Objectives: To describe IM systems and studies' data published over 11-years period (2006-2016). Specifically, we reviewed study population/event surveillance, methodological approaches, limitations, and its applications in the real-world evidence generation data. Methods: We completed a systematic search of MEDLINE and EMBASE to identify studies published from 2006 to 2016, that used IM methodology. We extracted data using a standardized form and results were analyzed descriptively. The methodological quality of selected studies was assessed using the modified Downs and Black checklist. Results: From 1,400 screened citations, we identified 86 papers, corresponding to 69 different studies. Seventy percent of reviewed studies corresponded to established IM systems, of which, more than half were prescription event monitoring (PEM) and modified-PEM. Among non-established IM systems, vaccines were the most common studied drugs (n = 14). The median cohort size ranged from 488 (hospitals) to 10,479 (PEM) patients. Patients and caregivers were the event data source in 39.1% of studies. The mean overall quality score was similar between established and non-established IM. Conclusions: Over the study period, IM studies were implemented in 26 countries with different maturity levels of post-marketing surveillance systems. We identified two major limitations: only 20% of studies were conducted at hospital-level, which is a matter of concern, insofar as healthcare systems are facing a lack of access to new medicines at ambulatory care level. Additionally, IM access to data of drug exposure cohorts, either at identification or at follow-up stages, could somehow constitute a barrier, given the complexity of managerial, linkable, and privacy data issues.The publication fee was supported by the Center for Health Evaluation and Research (CEFAR), National Association of Pharmacies, Lisbon, Portugal.Frontiers MediaRepositório da Universidade de LisboaTorre, CarlaCary, MariaBorges, Fábio CardosoFerreira, Paula S.Alarcão, JoanaLeufkens, Hubert G.Costa, JoãoMartins, Ana Paula2019-10-14T11:27:58Z20192019-01-01T00:00:00Zinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleapplication/pdfhttp://hdl.handle.net/10451/39830eng2296-858X10.3389/fmed.2019.00147info: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:RCAAP2023-11-08T16:38:43Zoai:repositorio.ul.pt:10451/39830Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-19T21:53:35.488439Repositório 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 |
Intensive monitoring studies for assessing medicines : a systematic review |
| title |
Intensive monitoring studies for assessing medicines : a systematic review |
| spellingShingle |
Intensive monitoring studies for assessing medicines : a systematic review Torre, Carla Adverse drug reaction reporting systems Clinical practice pattern Drug monitoring Pharmacovigilance Systematic review |
| title_short |
Intensive monitoring studies for assessing medicines : a systematic review |
| title_full |
Intensive monitoring studies for assessing medicines : a systematic review |
| title_fullStr |
Intensive monitoring studies for assessing medicines : a systematic review |
| title_full_unstemmed |
Intensive monitoring studies for assessing medicines : a systematic review |
| title_sort |
Intensive monitoring studies for assessing medicines : a systematic review |
| author |
Torre, Carla |
| author_facet |
Torre, Carla Cary, Maria Borges, Fábio Cardoso Ferreira, Paula S. Alarcão, Joana Leufkens, Hubert G. Costa, João Martins, Ana Paula |
| author_role |
author |
| author2 |
Cary, Maria Borges, Fábio Cardoso Ferreira, Paula S. Alarcão, Joana Leufkens, Hubert G. Costa, João Martins, Ana Paula |
| author2_role |
author author author author author author author |
| dc.contributor.none.fl_str_mv |
Repositório da Universidade de Lisboa |
| dc.contributor.author.fl_str_mv |
Torre, Carla Cary, Maria Borges, Fábio Cardoso Ferreira, Paula S. Alarcão, Joana Leufkens, Hubert G. Costa, João Martins, Ana Paula |
| dc.subject.por.fl_str_mv |
Adverse drug reaction reporting systems Clinical practice pattern Drug monitoring Pharmacovigilance Systematic review |
| topic |
Adverse drug reaction reporting systems Clinical practice pattern Drug monitoring Pharmacovigilance Systematic review |
| description |
Copyright © 2019 Torre, Cary, Borges, Ferreira, Alarcão, Leufkens, Costa and Martins. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. |
| publishDate |
2019 |
| dc.date.none.fl_str_mv |
2019-10-14T11:27:58Z 2019 2019-01-01T00:00:00Z |
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info:eu-repo/semantics/publishedVersion |
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info:eu-repo/semantics/article |
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article |
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publishedVersion |
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http://hdl.handle.net/10451/39830 |
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http://hdl.handle.net/10451/39830 |
| dc.language.iso.fl_str_mv |
eng |
| language |
eng |
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2296-858X 10.3389/fmed.2019.00147 |
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info:eu-repo/semantics/openAccess |
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openAccess |
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application/pdf |
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Frontiers Media |
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Frontiers Media |
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reponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação instacron:RCAAP |
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Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação |
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RCAAP |
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RCAAP |
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Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
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Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
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Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação |
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