Can the use of clinical decision support system (CDSS) affect the number of adverse drug reaction (ADR) reports in the oncological patient? A preliminary evaluation of the status quo in Reggio Emilia Oncological Center (CORE) and future perspectives

Abstract

Introduction: The new legislation (DMS 4/30/2015) reaffirmed the obligation to report suspected adverse drug and vaccine reactions promptly and set strict time limits within which healthcare operators are required to report to the local network and agency. An internet site (www.vigifarmaco.it) was developed (AIFA n.519 10/7/16). Objective: Monitoring of ADRs is a challenging research issue. Our belief is that there is little attention and information about this subject. We evaluate the state of reporting ADR in both oncologic and non-oncologic settings. Methods: On 5/22/2017 we collected the data from a survey sent to 400 medical doctors in our Hospital, by e-mail on 5/11/2017. The survey included 8 questions in Italian language: age, sex, department, number of total ADR reports in 2016, number of ADR reports due to oncological drugs in 2016, number of ADR reports due to biological oncological drugs in 2016, the kind of reactions to report on and the knowledge of www.vigifarmaco.it site. Results: 165 doctors completed the survey (41%), of whom 39 in the oncological departments (24%); 88 female (53.7%) and 76 male (46.3%); the most represented age range was from 31 to 40 (n = 63 41.2%). The number of reports/year was 0 (75.8%),1(8.7%), 2-5 (10.5%), 6-10(3.1%), 11-15(1.9%), 16-20(0%), >20 (0%); the number of reports/year for oncologic drugs was 0 (88.1%), 1 (5.6%), 2-5 (4.4%), 6-10 (1.9%), >11 (0%); the number of reports/year for biological oncologic drugs was 0 (93.6%),1-10(6.4%), >10(0%). No difference in the oncological or general doctors group. To the question “What kind of reactions are to be reported?” the right answer “mild and severe, known and unknown” was chosen by 38%, only “if severe” by 41.7% and only “if unknown” by 20.3%. 80.1% do not know the official site, 13.9% knows it but do not use it, only 6% knows and uses it. Conclusion: Despite a strong commitment to awareness and information of doctors, adherence to ADRs is unacceptably low; doctors do not know the criteria for sending reports and are not up to date on new tools created to encourage the delivery of ADRs. It is essential to develop a simple and automated tool that will enable doctors to send all ADRs reports. Our next step will be to set up an instrument with these characteristics and to study its impact in clinical practice.