Predicting Environmental Risks of Pharmaceuticals from Wholesale Data: An Example from Norway

Area of Science:

• Environmental Science
• Ecotoxicology
• Pharmaceuticals

Background:

• Environmental risk assessment (ERA) of pharmaceuticals often lacks sufficient measured environmental concentration data.
• Predicted environmental concentrations (PECs) derived from sales data are a viable alternative, though often limited to prescription sales.

Purpose of the Study:

• To rank approximately 200 active pharmaceutical ingredients (APIs) by environmental risk in Norway using sales-based PECs (2016-2019).
• To evaluate the added value of wholesale and veterinary data on exposure and risk predictions.
• To characterize the persistence, mobility, and bioaccumulation of APIs.

Main Methods:

• Calculated PECs from sales data for ~200 APIs in Norway (2016-2019).
• Compared PECs with available Norwegian measurements.
• Calculated risk quotients (RQs) using predicted-no-effect concentrations and assessed API persistence and bioaccumulation.
• Analyzed the impact of including wholesale, veterinary, and over-the-counter sales data.

Main Results:

• The PEC calculation method generally overestimated environmental concentrations compared to measurements.
• Seventeen APIs exhibited mean RQs > 1, indicating potential environmental risk, notably driven by sex hormones, antibiotics, abiraterone, and painkillers.
• High-risk APIs like levonorgestrel and ciprofloxacin showed potential persistence or bioaccumulation.
• Prescription sales accounted for 70% of PEC magnitude, and human sales 85% compared to veterinary sales.

Conclusions:

• Sales-based PECs provide an efficient initial approach for identifying and ranking pharmaceutical environmental risks.
• Despite limitations in data availability and uncertainty quantification, this method is valuable for prioritizing APIs for ERA.
• The study highlights the potential environmental risks posed by specific APIs and the importance of comprehensive sales data.