Purpose: The aim of this study is to compare the completeness of relevant structured fields such as age, sex, drug and reaction start dates, time to onset, outcome and drug indication, in serious spontaneous cases reported in Spain depending on whether they have been collected by regional pharmacovigilance centres or by the marketing authorization holders.
Methods: We analyzed the completeness of key variables for causality assessment related to the patient, the reaction and the suspected drug in all serious cases spontaneously reported and registered in the Spanish Pharmacovilance database, called FEDRA, from 1 January 2011 until 31 December 2018. The completeness scores were calculated according to the type of field and taking into account the VigiGrade tool. Cases were classified according to the reporting pathway, that is whether they were received and transmitted by marketing authorization holder or by regional pharmacovigilance centres.
Results: The completeness score of cases collected by regional pharmacovigilance centres was higher in all the studied variables. The main differences were found in drug and reaction start date, and time to onset.
Conclusions: This study shows a high completeness score in cases of suspected adverse reactions reported to the regional pharmacovigilance centres with regard to key elements for causality assessment, signal and duplicate detection. In contrast, marketing authorization holder cases show a low completeness score and a decreasing tendency in all the studied variables over the studied period.
Keywords: Completeness; Pharmaceutical industry; Pharmacovigilance; Quality; Regional pharmacovigilance centres.