When a new drug is developed, its environmental journey does not end at the pharmacy shelf. Active pharmaceutical ingredients (APIs) can enter water bodies and soils through manufacturing discharges, patient excretion, or improper disposal. If not addressed, these residues may disrupt ecosystems and pose long-term environmental risks.

Environmental Risk Assessment (ERA) has thus become an integral part of sustainable pharmaceutical development, balancing human health needs with ecological protection. This blog explores how ERA contributes to sustainability across the entire pharmaceutical life cycle — from early research and development to product disposal.

Understanding Environmental Risk Assessment (ERA)

Environmental risk analysis systematically evaluates the potential impacts of pharmaceuticals on ecosystems once they enter environmental compartments such as water or soil. It assesses how drug compounds persist, bioaccumulate, and exert toxicity on organisms. By applying scientific methodologies, developers can predict and mitigate environmental risks proactively, rather than reactively.

ERA involves laboratory and field studies designed to assess the persistence, toxicity, and bioaccumulation potential of pharmaceutical compounds. For example, companies may evaluate the biodegradability of chemicals in water or soil, test their toxicity to aquatic organisms, and model the predicted environmental concentration (PEC) of a drug. These PEC values are compared to predicted no-effect concentrations (PNEC) — the concentration at which no adverse environmental effects are expected. A PEC/PNEC ratio below 1 indicates low environmental risk, whereas a value equal to or greater than 1 suggests a potential ecological hazard.

Key Components of an ERA

A comprehensive environmental risk assessment typically includes the following elements:

• Physicochemical testing: Evaluates solubility, stability, and other intrinsic properties of the pharmaceutical compound.
• Aquatic ecotoxicology: Involves toxicity tests on species across different trophic levels, including fish, aquatic invertebrates, and algae.
• Environmental fate studies: Examine how the compound degrades in water, sediment, and soil, including processes in sewage treatment plants.
• Bioaccumulation screening: Assesses whether the compound tends to accumulate in the tissues of living organisms and move up the food chain.
• Phase-wise or tiered assessment: Regulatory agencies often apply a stepwise approach (such as Phase I/II assessments under EMA guidance) to determine the extent of testing required based on predicted exposure levels.

Read more about Regulatory Expectations and Methods Advancement in Environmental Risk Assessment here: https://resource.ddregpharma.com/uncategorized/the-role-of-environmental-risk-assessment-in-sustainable-pharmaceutical-development/