SciELO - Scientific Electronic Library Online

vol.37 issue6Analysis of the implementation of safety practices in the automated medication dispensing cabinetsSafety in the clinical practica of the triple teraphy with telaprevir in chronic hepatitis C author indexsubject indexarticles search
Home Pagealphabetic serial listing  

Services on Demand




Related links

  • On index processCited by Google
  • Have no similar articlesSimilars in SciELO
  • On index processSimilars in Google


Farmacia Hospitalaria

On-line version ISSN 2171-8695Print version ISSN 1130-6343


GONZALEZ BERMEJO, D. et al. Ethical and methodological quality of non-interventional post-authorization studies promoted by hospital pharmacy departments. Farm Hosp. [online]. 2013, vol.37, n.6, pp.482-488. ISSN 2171-8695.

Objectives: To describe the ethical and methodological quality of non-interventional post-authorization studies promoted by Hospital Pharmacy Departments (HPD). Methods: HPD promoted studies in the 2009-2011 period included in the Spanish Agency of Medicines and Medical Devices (AEMPS) registry and/or published in "Farmacia Hospitalaria" were identified. The most relevant ethical and methodological characteristics were analyzed. Studies promoted by HPD were also compared with studies not promoted by HPD. Results: Twenty two studies promoted by HPD, and registered in the AEMPS were identified. Within the registered studies HPD promoted studies had lower sample size estimation (41,5% vs 80%) and international scope (0% vs 24%) compared to non HPD promoted studies with significant differences (p < 0,05). None of the published studies in the journal Farmacia Hospitalaria have been registered in the AEMPS and had lower methodological quality than the registered studies promoted by HPD in characteristics such as presence of control group (3,8% vs 27,3%) (p = 0,0072) and the sample size estimation of (19,2% vs 42,8%) (p < 0,05). Conclusion: The management and the methodological and ethical characteristics of the studies promoted by HPD should be improved according to the regulation. The registration in the AEMPS might have a positive impact on the quality of these research protocols.

Keywords : Non-interventional; Post-authorization; Research.

        · abstract in Spanish     · text in Spanish     · Spanish ( pdf )


Creative Commons License All the contents of this journal, except where otherwise noted, is licensed under a Creative Commons Attribution License