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Biologicals and Biosimilars: Gaps in the Pharmacovigilance System in Portugal


 
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1. Title Title of document Biologicals and Biosimilars: Gaps in the Pharmacovigilance System in Portugal
 
2. Creator Author's name, affiliation, country Maria da Conceição Constantino Portela; Instituto de Ciências da Saúde. Universidade Católica Portuguesa. Lisboa. Portugal.; Portugal
 
2. Creator Author's name, affiliation, country Carlos Sinogas; Acompanhamento Farmacoterapêutico, Lda. Pavia. Portugal. Departamento de Biologia. Escola de Ciências e Tecnologia. Universidade de Évora. Évora. Portugal.
 
2. Creator Author's name, affiliation, country Fernando Albuquerque de Almeida; Institute of Health Policy & Management. Erasmus University Rotterdam. Rotterdam. The Netherlands.
 
2. Creator Author's name, affiliation, country Ricardo Baptista-Leite; Instituto de Ciências da Saúde. Universidade Católica Portuguesa. Lisboa. Portugal. Faculty of Health, Medicine and Life Sciences. Maastricht University. Maastricht. The Netherlands.
 
2. Creator Author's name, affiliation, country Alexandre Castro-Caldas; Instituto de Ciências da Saúde. Universidade Católica Portuguesa. Lisboa. Portugal.
 
3. Subject Discipline(s)
 
3. Subject Keyword(s) Adverse Drug Reaction Reporting Systems; Biological Products; Biosimilar Pharmaceuticals; Drug Monitoring; Pharmacovigilance; Portugal
 
4. Description Abstract

Introduction: Biological and biosimilar medicinal products have specific characteristics that call for a closer monitoring of their safety profile. Since the current legal framework stems from both European and national regulations, some gaps in the operational field may be expected. The goal of this paper is to identify these gaps and propose changes to the current information systems and pharmacovigilance regulations.
Material and Methods: A qualitative analysis of current pharmacovigilance regulatory framework and supporting information system was conducted.
Results: Current pharmacovigilance system does not seem to vouch for the safe use of biologicals and biosimilar drugs. The gaps found in reviewed materials may be attributable to their lack of specificity for biopharmaceuticals.
Discussion: Biologicals therapy presents specific determinants related with the drugs, prescription, and traceability, without replication in any other segment of the pharmaceutical market. They are able to shape their safety profile.
Conclusion: The existing pharmacovigilance’s regulatory framework should be adjusted in order to improve the safety related with biopharmaceutical therapy. Some intervention measures are proposed.
 
5. Publisher Organizing agency, location Ordem dos Médicos
 
6. Contributor Sponsor(s) Roche Farmacêutica Química Lda.
 
7. Date (YYYY-MM-DD) 2017-03-31
 
8. Type Status & genre article
 
8. Type Type
 
9. Format File format PDF (Português), PDF
 
10. Identifier Uniform Resource Identifier https://www.actamedicaportuguesa.com:443/revista/index.php/amp/article/view/8079
 
10. Identifier Digital Object Identifier (DOI) http://dx.doi.org/10.20344/amp.8079
 
11. Source Title; vol., no. (year) Acta Médica Portuguesa; Vol 30, No 3 (2017): March
 
12. Language English=en pt
 
14. Coverage Geo-spatial location, chronological period, research sample (gender, age, etc.)
 
15. Rights Copyright and permissions Copyright (c) 2017 Acta Médica Portuguesa