Giunchi Valentina, Fusaroli Michele, Cangini Agnese, Fortinguerra Filomena, Zito Simona, Pierantozzi Andrea, Lunghi Carlotta, Poluzzi Elisabetta, Trotta Francesco
Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy.
Italian Medicines Agency (AIFA), Rome, Italy.
Br J Clin Pharmacol. 2025 May;91(5):1297-1305. doi: 10.1002/bcp.70046. Epub 2025 Mar 18.
This study builds on the environmental risk analysis presented in the 2022 National Report on Medicines Use in Italy by the Italian Medicines Agency and aims to assess the environmental risk posed by medicines in Italy and its regions.
The analysis selected 90 medicines based on three criteria: high utilization, low predicted no effect concentration (PNEC), and inclusion or candidacy for the European Watch List. For each medicine, the environmental risk was computed as the ratio between the predicted environmental concentration (PEC) and the PNEC. The PEC was derived following the approach of the Swedish Association of Pharmaceutical Industries and Italian drug utilization data. The risk was classified high if the ratio was greater than 10 and moderate if greater than 1.
Overall, 13 medicines were identified as posing a high risk, including cardiovascular agents, antibiotics, analgesics, antidepressants and antiparasitic agents. The high risk was driven by either a very low PNEC (eg, estradiol and lacidipine) or high utilization (eg, amoxicillin, ibuprofen and diclofenac). Regional analysis showed higher risk due to high consumption for azithromycin and ofloxacin in central and southern Italy, and for levonorgestrel in northern Italy.
This study points to the need for prioritizing targeted sampling in surface waters for medicines estimated at high risk. To prevent and mitigate the risk, a more conscious clinical practice coupled with appropriate waste management are required.
本研究以意大利药品管理局发布的《2022年意大利药品使用国家报告》中提出的环境风险分析为基础，旨在评估意大利及其各地区药品所造成的环境风险。
该分析基于三个标准选择了90种药品：高使用率、低预测无效应浓度（PNEC）以及被列入或有资格列入欧洲观察清单。对于每种药品，环境风险通过预测环境浓度（PEC）与PNEC的比值来计算。PEC是根据瑞典制药工业协会的方法和意大利药品使用数据得出的。如果该比值大于10，则风险被分类为高风险；如果大于1，则为中等风险。
总体而言，有13种药品被确定为具有高风险，包括心血管药物、抗生素、镇痛药、抗抑郁药和抗寄生虫药。高风险是由极低的PNEC（如雌二醇和拉西地平）或高使用率（如阿莫西林、布洛芬和双氯芬酸）导致的。区域分析显示，由于意大利中部和南部阿奇霉素和氧氟沙星的高消费量，以及意大利北部左炔诺孕酮的高消费量，导致风险更高。
本研究指出，有必要对估计具有高风险的药品在地表水中进行有针对性的采样。为了预防和减轻风险，需要更有意识的临床实践以及适当的废物管理。
