5PSQ-109 Active pharmacovigilance in oncology: pharmacological contribution to improve reports

Background Pharmacovigilance has intrinsic limits, for example in the hospital the main problem is associated with poor doctor reporting. In addition, reports are superficial and lacking in patient history and therapy data. In thye Oncology Department, there are many adverse drug reactions (ADRs), due to the type of drugs used. Further, the use of innovative and biological drugs makes pharmacovigilance activity in oncology crucial. Purpose Improve the quality of reporting in pharmacovigilance through active monitoring and pharmacological counselling. Sensitise the clinician to inform the pharmacy about ADRs. Suggest advice to improve the therapy scheme. Material and methods Our study collected ADRs during the period from June to September 2017, through clinical reports’ analysis or through spontaneous reporting. If the report was made by the physician we asked to analyse the clinical folder. The study was conducted in the Oncology Department. The pharmacist saw and interviewed patients who manifested ADRs. For each reaction, an analysis was carried out through InterCheckWeb software to assess ADR risk score, calculate the causality by Naranjo or Drug Interaction Probability Scale (DIPS) algorithm and check for pharmacological interactions. For elderly patients (>65 years), Screening Tool of Older Persons’ Prescriptions (STOPP) and Screening Tool to Alert to Right Treatment (START) were checked. For each signal, the pharmacist has submitted a pharmacological report that was introduced in the clinical folder. Common Terminology Criteria for Adverse Events (CTCEA) were used. We excluded ADRs lower than grade 3. All grades were considered if the signal was made by the physician. Results Eighty-four clinical patient reports were analysed and we found 74 ADRs: 61 were reported according to the inclusion criteria of the study. Pharmacological analyses were done for each ADR. Twenty-nine (47.5%) were reported by the physician and 32 (52.5%) by the pharmacist. Seventeen (27.7%) were severe ADRs. Conclusion Pharmacist activity has increased the number of reports (+110.3%). However, the fundamental value is the remarkable increase in the signal quality, with causal linkage reporting and associated pharmacological analysis. Suggestions were also included to improve the therapeutic scheme. The hope is that pharmacists can collaborate with multiple departments to increase the quality and number of the signal. No conflict of interest