The AOUI Verona Task Force for Improvement of Post-Market Clinical Surveillance for Medical Device: An International Journal of Medical Toxicology and Drug Experience

ABSTRACT

Introduction: Post-marketing surveillance (PMS) is the practice of monitoring the safety of a pharmaceutical drug or medical device (MD) after it has been released on market and is an important part of science of pharmacovigilance. PMS is considered one of the most critical aspects of the new EU-MDR 2017/745. In AOUI Verona the pharmacist in charge of MD vigilance reports adverse events to Pharmacovigilance's Regional Service and Ministry of Health. For many years there has been a collaboration between Pharmacy and Hospital Risk Management by sharing clinical information about incidents, failures, serious deteriorations or potential deficiency related to MD safety use. This multidisciplinary collaboration is the fundamental aspect to improve protection of health and safety patients, healthcare professionals and all users reducing the likelihood of reoccurring incidents. Unfortunately during Covid-19 a lack of training and staff awareness significantly reduced spontaneous incident reporting. Objective: Aim of the present study is analyze PMS data and organize hospital staff training to increase PMS and spontaneous incident reporting. Methods: Over the years Pharmacy and Risk Management keep a database for recording and monitoring data on MD adverse events. The Cross-check analysis of databases allows to intercept all incident or failure occurred. Results: From 2019, recorded data show a decrease of 30% related to MD incidents or failures (2019 N = 120;2020 N = 67;2021 N = 45) and some Operating Units are less likely to reporting. In 2021 the clinical risk manager received 56 incident reports and only 45 of these to Pharmacy too. 22 were filled in by surgical departments, of which 4 by pediatricians and 18 by adult specialists. The total number of reports shows that 80% have reached the pharmacy office, while the percentage ratio between the two sectors is expected to be 100%. Conclusion: The PMS management in AOUI requires a strong collaboration of all figures involved in this process. For this reason, training and awareness-raising must be carried out in a widespread and continuous way. In AOUI Hospitals we are organizing training meetings to sharing information between various professional skills so that any problems arising are quickly identified. One target for 2022 is a participation to training events for at least one doctor and nurse for each hospital unit.