Introduction: Despite adverse drug reactions (ADRs) being responsible for 10% of outpatient visits and 3.5-10% of hospital admissions the widespread phenomenon of underreporting by health care professionals persists (1). Clinicians could encounter barriers to report ADRs such as time constraints, competing priorities, causal uncertainty, reporting form accessibility, form length, limited awareness, misconceptions about reporting requirements and attribution challenges in ADR reporting (1,2). Aim: to introduce a pilot project that supports healthcare professionals in spontaneous reporting activities at the University Hospital of Pisa. Additionally, we will assess its impact during the initial three months of implementation. Methods: The Adverse Drug Reaction Monitoring Unit (ADRMU) at the University Hospital of Pisa is undertaking a pilot project to enhance the number and quality of reports on spontaneous suspected adverse reactions. The project includes two main components. Firstly, the ADRMU staff provides direct support in the outpatient clinics. Secondly, medical records management system has been implemented to enable the inpatient wards to directly seek assistance from the ADRMU. The outpatient clinics currently participating in the project are the Unit of Immuno-allergology and the Unit of Neurology. As for the inpatient wards, the Unit of Emergency Medicine and the Unit of Metabolic Diseases and Diabetology are presently involved. Results: Between March 1st, 2023, and May 31st, 2023, the staff at the University Hospital of Pisa generated a total of 129 Individual Case Safety Reports (ICSRs), 39 (30.2%) originated from a noninterventional study. Among the remaining 90 spontaneous reports, 45 (50%) were directly attributed to the support activity provided by the ADRMU, effectively doubling the overall number of spontaneous reports for the entire hospital. Of the 45 reports resulting from the ADRMU’s support activity, 22 (48.9%) were from the Unit of Immuno-allergology, 19 (42.2%) were from the Unit of Neurology. Four reports (8.9%) were from the inpatient wards, 2 from the Unit of Metabolic Diseases and Diabetology and 2 from the Unit of Emergency Medicine. Between March, 1st, 2022 and May 31st, 2022, the University Hospital of Pisa had generated a total of 63 spontaneous ICSRs. Therefore, the number of spontaneous reports in 2023 showed a 42.9% increase when compared to the corresponding period of the previous year. Conclusions: Despite the project’s limited duration and the involvement of only four departments, the results clearly indicate that the support provided by dedicated pharmacovigilance units in hospitals can effectively address the barriers to underreporting by healthcare professionals.
Supporting the Spontaneous Reporting by Health Care Professionals of the University Hospital of Pisa, Italy: a Pilot Project from the Unit of Adverse Drug Reactions Monitoring
E Cappello;G Valdiserra;M Bonaso;I Convertino;S Ferraro;M Tuccori
2023-01-01
Abstract
Introduction: Despite adverse drug reactions (ADRs) being responsible for 10% of outpatient visits and 3.5-10% of hospital admissions the widespread phenomenon of underreporting by health care professionals persists (1). Clinicians could encounter barriers to report ADRs such as time constraints, competing priorities, causal uncertainty, reporting form accessibility, form length, limited awareness, misconceptions about reporting requirements and attribution challenges in ADR reporting (1,2). Aim: to introduce a pilot project that supports healthcare professionals in spontaneous reporting activities at the University Hospital of Pisa. Additionally, we will assess its impact during the initial three months of implementation. Methods: The Adverse Drug Reaction Monitoring Unit (ADRMU) at the University Hospital of Pisa is undertaking a pilot project to enhance the number and quality of reports on spontaneous suspected adverse reactions. The project includes two main components. Firstly, the ADRMU staff provides direct support in the outpatient clinics. Secondly, medical records management system has been implemented to enable the inpatient wards to directly seek assistance from the ADRMU. The outpatient clinics currently participating in the project are the Unit of Immuno-allergology and the Unit of Neurology. As for the inpatient wards, the Unit of Emergency Medicine and the Unit of Metabolic Diseases and Diabetology are presently involved. Results: Between March 1st, 2023, and May 31st, 2023, the staff at the University Hospital of Pisa generated a total of 129 Individual Case Safety Reports (ICSRs), 39 (30.2%) originated from a noninterventional study. Among the remaining 90 spontaneous reports, 45 (50%) were directly attributed to the support activity provided by the ADRMU, effectively doubling the overall number of spontaneous reports for the entire hospital. Of the 45 reports resulting from the ADRMU’s support activity, 22 (48.9%) were from the Unit of Immuno-allergology, 19 (42.2%) were from the Unit of Neurology. Four reports (8.9%) were from the inpatient wards, 2 from the Unit of Metabolic Diseases and Diabetology and 2 from the Unit of Emergency Medicine. Between March, 1st, 2022 and May 31st, 2022, the University Hospital of Pisa had generated a total of 63 spontaneous ICSRs. Therefore, the number of spontaneous reports in 2023 showed a 42.9% increase when compared to the corresponding period of the previous year. Conclusions: Despite the project’s limited duration and the involvement of only four departments, the results clearly indicate that the support provided by dedicated pharmacovigilance units in hospitals can effectively address the barriers to underreporting by healthcare professionals.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
