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Pharmaceuticals and Personal Care Products in the Canadian Environment: Research and Policy Directions

3.5 International and Industry Activities

Dr. Joanne Parrott of the Aquatic Ecosystem Protection Research Division of Environment Canada provided a summary of environmental risk assessment of pharmaceuticals (ERAPharm) in the European Union (EU).

ERAPharm is an EU funded project comprised of over forty scientists from 13 research institutions in 8 countries. The group is collaborating on a 3-year multi-million dollar research project to determine the data needs to assess the environmental risks of pharmaceuticals. The objectives of the project are to contribute to the improvement of knowledge and procedures for the environmental risk assessment of human and veterinary pharmaceuticals. ERAPharm will assess two model compounds, the human pharmaceutical atenolol (beta-blocker drug used to reduce heart rate) and the veterinary pharmaceutical ivermectin (an anti-parasitic drug used in cattle, horses, and sheep, as well as in aquacultures).

The scientists are assessing the biological fate, exposure pathways and ecotoxicological effects of the selected pharmaceuticals. Data from ERAPharm researchers will be used to fill out the current proposed environmental risk assessment frameworks (from the European Agency for the Evaluation of Medicinal Products (EMEA) and the International Cooperation on Harmonization of Technical Requirements for the Registration of Veterinary Medicinal Products (VICH) in Europe) which will predict the potential environmental risks of these compounds under the current guidelines. Then, additional data will be generated in the ERAPharm project under the categories of 'exposure assessment’ (fate processes and exposure modeling) and 'effects assessment’ (bioanalytical tests, and bioassays with microorganisms, aquatic and terrestrial invertebrates, and fish) that may better predict the potential environmental risks of these compounds. The goal is to provide a more complete picture of the risk assessment for these chemicals, and to recommend tools for exposure assessment and effects assessment that will enhance our ability to predict environmental effects of these pharmaceuticals. Unique sets of data will be generated in the ERAPharm Project, and assembled to form complete example environmental risk assessments for these model pharmaceuticals.

The ultimate aim of ERAPharm is to develop improved guidance on the environmental risk assessment of pharmaceuticals. Tools generated in the project will include a web database containing information on fate and effects of pharmaceuticals, and a web screening-level risk assessment tool. Recommendations from the project will be used to refine the environmental risk assessment of human and veterinary pharmaceuticals, and will be of use to regulators, industry and the scientific community.

Dr. Mary Buzby, director of Global Safety and Environmental Technology for Merck Co. Inc., provided a summary of research and risk assessment activities by the Pharmaceutical Research and Manufacturers of America (PhRMA).

Improved analytical testing technology has made it possible to detect trace amounts of pharmaceuticals and other compounds in water at low concentrations. The pharmaceutical industry is using a science based approach to understand and address concerns resulting from detection of pharmaceutical compounds in the environment.

The PhATE (Pharmaceutical Assessment and Transport Evaluation) model was developed as a tool to estimate concentrations of active pharmaceutical ingredients (APIs) in United States surface waters that result from patient use (or consumption) of medicines. PhATE uses a mass balance approach to model predicted environmental concentrations (PECs) in 11 watersheds selected to be representative of most hydrologic regions of the United States. PhRMA has also developed the PhACT (Pharmaceutical Assessment and Characterization Tool) database to compile all of the peer-reviewed literature about aquatic effects, treatment, and environmental depletion of APIs. This information will be used to understand the potential for effects of APIs on aquatic organisms.