Fialová Daniela, Brkić Jovana, Laffon Blanca, Reissigová Jindra, Grešáková Silvia, Dogan Soner, Doro Peter, Tasić Ljiljana, Marinković Valentina, Valdiglesias Vanessa, Costa Solange, Kostřiba Jan
Department of Social and Clinical Pharmacy, Faculty of Pharmacy in Hradec Králové, Charles University, Heyrovského 1203, Hradec Králové 500 05, Czech Republic.
Department of Social and Clinical Pharmacy, Charles University, Czech Republic.
Ther Adv Drug Saf. 2019 Jun 24;10:2042098619854014. doi: 10.1177/2042098619854014. eCollection 2019.
The European Union (EU)(7)-PIM (potentially inappropriate medication) list presents the most comprehensive and up-to-date tool for evaluation of PIM prescribing in Europe; however, several country-specific studies have documented lower specificity of this list on pharmaceutical markets of some countries. The aim of our study was to describe approval rates and marketing of PIMs stated by EU(7)-PIM criteria in six EU countries [in comparison with the American Geriatric Society (AGS) Beers 2015 criteria].
Research teams of six EU countries (Czech Republic, Spain, Portugal, Serbia, Hungary and Turkey) participated in this study conducted by WG1b EU COST Action IS1402 group in the period October 2015-November 2018. Data on approval rates of PIMs and their availability on pharmaceutical markets have been obtained from databases of national drug-regulatory institutes and up-to-date drug compendia. The EU(7)-PIM list and AGS Beers 2015 Criteria (Section 1) were applied.
PIMs from EU(7)-PIM list were approved for clinical use more often than those from the AGS Beers 2015 criteria (Section 1). Approval rates for EU(7)-PIMs ranged from 42.8% in Serbia to 71.4% in Spain (for AGS criteria only from 36.4% to 65.1%, respectively). Higher percentages of approved PIMs were documented in Spain (71.4%), Portugal (67.1%) and Turkey (67.5%), lower in Hungary (55.5%), Czech Republic (50.2%) and Serbia (42.8%). The majority of approved PIMs were also currently marketed in all countries except in Turkey (19.8-21.7% not marketed PIMs) and less than 20% of PIMs were available as over-the-counter medications (except in Turkey, 46.4-48.1%).
The EU(7)-PIM list was created for utilization in European studies; however, applicability of this list is still limited in some countries, particularly in Eastern and Central Europe. The EU project EUROAGEISM H2020 (2017-2021) that focuses on PIM prescribing and regulatory measures in Central and Eastern European countries must consider these limits.
欧盟(EU)(7)-潜在不适当用药(PIM)清单是欧洲评估PIM处方最全面、最新的工具;然而,一些针对特定国家的研究表明,该清单在某些国家药品市场上的特异性较低。我们研究的目的是描述欧盟6个国家中符合欧盟(7)-PIM标准的PIM的批准率和上市情况[并与美国老年医学会(AGS)2015年Beers标准进行比较]。
6个欧盟国家(捷克共和国、西班牙、葡萄牙、塞尔维亚、匈牙利和土耳其)的研究团队参与了由欧盟COST行动IS1402小组WG1b在2015年10月至2018年11月期间开展的这项研究。PIM的批准率及其在药品市场上的可得性数据已从国家药品监管机构的数据库和最新的药品药典中获取。应用了欧盟(7)-PIM清单和AGS 2015年Beers标准(第1节)。
与AGS 2015年标准(第1节)中的PIM相比,欧盟(7)-PIM清单中的PIM被批准用于临床的情况更为常见。欧盟(7)-PIM的批准率从塞尔维亚的42.8%到西班牙的71.4%不等(AGS标准的批准率分别仅为36.4%至65.1%)。西班牙(71.4%)、葡萄牙(67.1%)和土耳其(67.5%)记录的批准PIM的百分比更高,匈牙利(55.5%)、捷克共和国(50.2%)和塞尔维亚(42.8%)的批准率较低。除土耳其外(19.8 - 21.7%的PIM未上市),大多数获批的PIM目前在所有国家都有销售,且不到20%的PIM可作为非处方药获取(土耳其除外,非处方药占46.4 - 48.1%)。
欧盟(7)-PIM清单是为在欧洲研究中使用而制定的;然而,该清单在一些国家,特别是在东欧和中欧国家的适用性仍然有限。专注于中东欧国家PIM处方和监管措施的欧盟项目EUROAGEISM H2020(2017 - 2021)必须考虑这些限制。