Gomes Daniel, Herdeiro Maria Teresa, Ribeiro-Vaz Inês, Ferreira Pedro Lopes, Roque Fátima
Research Unit for Inland Development, Polytechnic of Guarda (UDI-IPG), 6300-559 Guarda, Portugal.
Centre for Health Studies and Research, University of Coimbra, 3004-512 Coimbra, Portugal.
J Clin Med. 2022 Apr 15;11(8):2229. doi: 10.3390/jcm11082229.
Criteria have been developed to identify potentially inappropriate medications that can enhance adverse reactions, highly prevalent in older patient’s therapy. This study aimed to identify potentially inappropriate medications within the adverse drug reactions reported in the Portuguese pharmacovigilance system, characterizing the reports where inappropriate medications were identified. INFARMED, I.P. provided all adverse drug reactions reported from January to December 2019 in 65-year-old and older patients. Adverse drug reactions were characterized according to the System Organs Classes, seriousness, and medications with the Anatomical Therapeutical Classification. Potentially inappropriate medications were identified by applying the EU-(7)-PIM and the Beers criteria. A p value < 0.05 was considered statistically significant. From the 2337 reports considered for the analysis, PIMs were found in 12.8% of these, and 64.7% of all adverse reaction reports were classified as serious. Within the group of reports including at least one PIM, 71.4% were classified as serious, with hospitalization the most common criteria (35.1%). From the 3170 suspected medicines identified, 10.6% were classified as PIMs. Amiodarone was the most frequent PIM identified in the study (10.1%). Reports including at least one PIM were more associated with a higher number of ADRs (p = 0.025) reported in the same record, higher number of suspected medicines identified (p < 0.001), seriousness (p = 0.005), and hospitalization (p < 0.001). Potentially inappropriate medications are important enhancers of serious adverse drug reactions, increasing the likelihood of hospitalizations. This reinforces the importance of improving medication appropriateness in the older population.
已制定标准来识别可能会增加不良反应的潜在不适当药物，这些药物在老年患者治疗中非常普遍。本研究旨在识别葡萄牙药物警戒系统报告的药物不良反应中潜在不适当的药物，并对识别出不适当药物的报告进行特征描述。葡萄牙药品和医疗器械监管局（INFARMED, I.P.）提供了2019年1月至12月65岁及以上患者报告的所有药物不良反应。根据系统器官分类、严重程度以及采用解剖治疗学分类的药物对药物不良反应进行了特征描述。通过应用欧盟（7）-PIM标准和Beers标准来识别潜在不适当的药物。p值<0.05被认为具有统计学意义。在纳入分析的2337份报告中，有12.8%发现了潜在不适当药物，所有不良反应报告中有64.7%被分类为严重不良反应。在至少包含一种潜在不适当药物的报告组中，71.4%被分类为严重不良反应，住院是最常见的标准（35.1%）。在识别出的3170种可疑药物中，10.6%被分类为潜在不适当药物。胺碘酮是该研究中最常识别出的潜在不适当药物（10.1%）。至少包含一种潜在不适当药物的报告与同一份记录中报告的更高数量的药物不良反应（p = 0.025）、识别出的更高数量的可疑药物（p < 0.001）、严重程度（p = 0.005）和住院情况（p < 0.001）更相关。潜在不适当药物是严重药物不良反应的重要促成因素，增加了住院的可能性。这强化了提高老年人群用药合理性的重要性。
