Approaches to assessing the environmental impact of pharmaceuticals (review)
TL;DR
A comparative analysis of environmental risk assessment methods used in the European Union, United States, and Russia is conducted to conduct a comparative analysis of modern approaches to assessing the impact of drugs on the environment in various regulatory systems.
Abstract
Introduction. The pharmaceutical industry, while ensuring public health, simultaneously creates significant environmental risks. The article discusses modern approaches to assessing the impact of drugs on the environment in various regulatory systems. This impact is manifested through emissions of pollutants into the air, wastewater discharge, solid waste generation and consumption of significant volumes of natural resources as raw materials for chemical and biological substances. In addition, drugs and their metabolites enter the environment after use by patients. The problem of safe collection and disposal of drugs in civil circulation is also relevant. The complex of environmental problems associated with drugs is the focus of international organizations such as the Organization for Economic Co-operation and Development (OECD) or the United Nations Environment Programme (UNEP). Expert groups within their framework assess the situation with environmental pollution by drugs as threatening. The problem of drug pollution requires the use of an approach covering the entire life cycle of drugs – from development and registration to consumption and disposal. The focus should be on pollution prevention measures: developing "green" drugs, limiting the use of substances with high environmental risks, creating drug disposal programs, upgrading treatment facilities, and educational campaigns. Text. The objective of this review is to conduct a comparative analysis of environmental risk assessment methods used in the European Union (EU), the United States, and Russia. The EU uses a two-stage assessment system (primary screening and detailed analysis) regulated by the European Medicines Agency (EMA). In the United States, the Food and Drug Administration (FDA) applies a categorical exclusion mechanism, which makes the system more flexible. The current environmental legislation in Russia regulates waste management and sets standards for the impact on the environment, while there is no comprehensive risk assessment of the life cycle of drugs. Conclusion. The use of international experience, including the phased implementation of regulatory requirements for the assessment of environmental risks of drugs, can contribute to the development of a more sustainable pharmaceutical industry in Russia.