Oral Presentation: Potentially Inappropriate Medication in Older Adult's Adverse Drug Reactions Spontanueous Reports

Introduction: A medicine is considered potentially inappropriate (PIM) when the potential risk of it in the older population exceeds the potential benefit, and for which there are safer alternatives [1]. This is highly prevalent in their medication therapy [1,2], enhancing adverse reactions. PIM are already identified from various tools developed, being the most common ones the explicit Beers criteria [3], the START/STOPP, which requires additional patient data [4] and in Europe the EU-7-PIM list [5]. Objective: The aim of this study was to identify suspected medicines classified as PIM in the Adverse Drug Reactions (ADR) reports received by the Portuguese Pharmacovigilance System of the National Authority of Medicines and Health Products (INFARMED, I.P.) in older adults, analysing in dept the reports including PIM as suspected medication. Methods: A retrospective study was designed including all ADR reports received by INFARMED, IP., between January and December 2019 in 65 and more year-old patients. ADR were characterized according with MedDRA System Organs Classes (SOC), seriousness, and medication according with the Anatomical Therapeutical Classification. PIM were identified in the report's suspected medication applying the operationalization for the Portuguese reality of the EU (7) PIM list [5] as well as the Beers criteria from 2019 [3]. Results: Beers and EU (7) PIM criteria were applied in 2337 reports. PIM were found in 299 (12,8%). From the 3170 suspected medicines identified, 337 (10.6%) were classified as PIM. From the 299 reports including PIM as suspected medication, the population showed a mean age of 73.0 ± 6.6 years, being 56.5% (n = 169) female. 45.2% (n = 135) were reported by physicians. 71,4% (n = 215) of the reports were classified as serious, and hospitalization was the most common seriousness criteria identified (35.1%/n = 105). "Nervous System disorders" was the most common SOC criteria reported (49,1%/n=147). Amiodarone (C01BD01) was the most frequent PIM identified by the criteria (n = 34/10.1%), followed by dabigatran etexilat (B01AE07), (7.1%/n = 24) and Rivaroxaban (B01AF01) (6.2%/n = 21). Reports including PIM in suspected medicines had a significant higher number of ADR (p = 0.025) and number of suspected medicines per report (p < 0.001). Seriousness of the ADR report classification (p = 0.005) and hospitalization (p < 0.001) were more associated in reports including PIM. Conclusion: These results reinforce the importance o