Reporting of suspected adverse drug reactions by nursing in Spain. An observational-descriptive retrospective study.

Objective: This study aimed to gain knowledge of the nurses' involvement in the spontaneous report of suspected adverse drug reactions (ADR) in the Spanish Pharmacovigilance System for Medicinal Products for Human Use (SEFV-H), describing the principal characteristics of the reported cases, identifying points of improvement.

Methods: A descriptive observational retrospective study was based on the data from FEDRA, the database created by the SEFV-H. The sample taken was the spontaneous adverse drug reactions reported to SEFV-H by nurses during the first 6 months of the 2018.

Results: Complete data was provided by 6,370 suspicions of ADR reported to SEFV-H by all healthcare professionals. Only 4,8% of the samples were taken by nurses, 62,7% came from medical centers. The majority of the ADR were not considered a serious disease (78%). The most frequently adverse drug reactions reported by nurses were local reactions. The patients most involved were children and vaccines were the most reported drugs (58,3%), followed by the intravenous contrast agents used in diagnostic tests.

Conclusions: Nurses report very few cases to SEFV-H and are mostly related to the administration of vaccines and are sent by nurses working in the out-of-hospital setting. Most cases are not serious and usually report known adverse reactions to the suspected drug. This observed under-notification raises the need to promote increased pharmacovigilance training among these notifying nurses so that they can continue to report, and also for those who do not do so in their daily practice, so that they can begin to do so.