Assessing the environmental impact of medicines in Italy using data from the Italian Medicines Agency

Aim: 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. Methods: 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. Results: 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. Conclusion: 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.