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DI-037 Impact of spanish pharmacovigilance legislation on suspected adverse drug reactions reported by the hospital pharmacy service
  1. A Porta Sanchez,
  2. C Mondelo Garcia,
  3. N Lema Gandara,
  4. I Martin Herranz
  1. Complexo Hospitalario Universitario A Coruña, Pharmacy Service, A Coruña, Spain


Background Spanish pharmacovigilance legislation of human medicines states that healthcare professionals are obliged to report suspected adverse drug reactions (ADRs), giving priority to serious ADRs, unexpected or related to drugs under additional monitoring.

Purpose To assess the impact of the Spanish Pharmacovigilance Legislation recommendations on ADR reporting by the hospital pharmacy service (HPS).

Material and methods This was a retrospective analysis of the severity of ADRs reported by the HPS and those involving medicinal products under additional monitoring. Study period: August 2013 to March2016. Data sources: database of ADRs reported to Regional Pharmacovigilance Centre, electronic medical records and European list of medicinal products under additional monitoring. Collected data: date of spontaneous ADR reports, medical record number, demographic dates, drugs involved and communication of ADRs and severity.

Results 319 suspected ADRs were reported by the HPS. Mean patient age was 58 years (range 9 days–92 years). 75.7% of reports corresponded to serious ADRs and/or drugs on the European list of medicinal products under additional monitoring. Therapeutic groups mainly involved were: antineoplastic–immunomodulating (43.9%), systemic anti-infectives (25.1%) and the nervous system (11.6%). Drugs mainly involved were: everolimus (14/319), adalimumab (12/319), linezolid (12/319) and boceprevir (8/319). 67.4% of ADRs reported were serious. 26.5% of ADRs caused hospitalisation and 9.8% prolonged hospital stay. ADRs were the cause of death in 1.4% of cases, endangered life in 12.1% of cases and caused persistent/severe disability in 3.7%. In 46.5% of cases, ADRs were considered serious because of their importance from a medical point of view. 17.9% of ADRs belonged to the European list of medicinal products under additional monitoring, among which 35.1% were abiraterone (7), boceprevir (8) and telaprevir (5); 47.4% were serious. In 11/319 ADRs in patients under 18 years of age, 8 were considered serious, including 2 cases related to Immunoglobulin against Neisseria meningitidis group B.

Conclusion A high percentage of ADRs reported by the HPS was consistent with the pharmacovigilance legislation, highlighting the number of serious ADRs. Reporting of ADRs by the HPS contributes to increased awareness of drug safety, especially those recently marketed.

References and/or acknowledgements European list of medicinal products under additional monitoring. European Medicines Agency. September 2016.

No conflict of interest

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