SciELO - Scientific Electronic Library Online

vol.91Calidad de vida relacionada con la salud en una población de gestantes sanas tras un programa de actividad física en el medio acuático (PAFMAE)Epidemiología de la Osteogénesis Imperfecta: una enfermedad rara en la Comunitat Valenciana índice de autoresíndice de assuntospesquisa de artigos
Home Pagelista alfabética de periódicos  

Serviços Personalizados




Links relacionados

  • Em processo de indexaçãoCitado por Google
  • Não possue artigos similaresSimilares em SciELO
  • Em processo de indexaçãoSimilares em Google


Revista Española de Salud Pública

versão On-line ISSN 2173-9110versão impressa ISSN 1135-5727


GRAU RUBIO, María Antonia et al. Description of postauthorisation observational prospective studies with drugs in the valencian region between 2010 and 2015. Factors associated with their authorisation. Rev. Esp. Salud Publica [online]. 2017, vol.91, e201711043.  Epub 24-Nov-2017. ISSN 2173-9110.


Postauthorisation observational studies are crucial source of information on drug effectiveness and safety. The objectives of this work were to describe the characteristics of the postauthorisation observational prospective studies (EPA-SP) for which authorisation was requested in the Valencian region, as well as to explore which factors influenced the aforementioned authorisation.


We performed a retrospective analytical study comprising all the EPA-SP for which authorisation was requested in the Valencian region between 2010 and 2015.The variables associated to the studies (e.g., objectives, studied drug, target disease) as well as those concerning the authorisation process itself (e.g., authorisation status, reason for authorisation refusal, current status of the study) were obtained from relevant databases. The analysis was divided into descriptive and analytical stages.


We included a total of 249 studies, out of which 192 (77,1%) aimed at estimating effectiveness or quality of life. The most frequent types of drugs involved in the studies were the antineoplastic and immunomodulating agents (42%). Only 57% of the studies were granted authorisation, with prescription induction and unusual practice being the most common causes for refusal (40.1% and 39.3%, respectively). The authorisation was linked to the diagnosis (circulatory system OR 10,7, IC95% 2,3 to 49,1), ATC L group (OR 4,2, IC95% 1,9 to 49,1) as well as to whether it had been advocated by the industry (OR 0,5, IC95% 0,3 to 0,9).


Given the importance of having information on effectiveness and safety in usual practice, it is a priority for EPA-SP to be directed towards these aims and to promote independent research.

Palavras-chave : Epidemiology; Pharmacoepidemiology; Observational Study; Outcome assessment.

        · resumo em Espanhol     · texto em Espanhol     · Espanhol ( pdf )