 
During phase 1, MistraPharma generated several significant results; Sensitive and streamlined analytical protocols were developed for more than 120 APIs (Active Pharmaceutical Ingredients) in different matrices. MistraPharma also contributed, along with other research groups, to identifying progestins as a new group of APIs that can pose a risk to aquatic species. By combining bioconcentration studies and read-across between mammals and fish, several additional APIs were identified as being of potential concern. The evolutionary conservation of human drug targets in non-target organisms was described, identifying limitations for extrapolating between species. Different effluent treatment technologies were evaluated, both chemically and based on effects on exposed organisms. Pollution from manufacturing was identified as a source for the highest concentrations of drugs in the environment, leading to promotion of antibiotic resistance genes in polluted aquatic environments. The use of non-standard data for regulatory risk assessment has been scrutinized and recommendations to improve EU test requirements are discussed. Finally, the engagement from and interaction with stakeholders in the Swedish society have been and are extensive, for example leading to a Government commission on ways to reduce pollution from drug manufacturing globally.
In MistraPharma 2 we propose to continue to test APIs identified as being of concern during phase 1, combining more conclusive endpoints with standard tests. Factors determining bioconcentration, degradation and the kinetics of APIs will also be explored. Novel, powerful DNA sequencing approaches will be applied to compare risks for antibiotic resistance promotion in environments with different degrees of pollution. Substitution processes and suggestions for novel regulatory testing requirements will be further developed. Advanced effluent treatment technologies will be more fine-tuned and brought closer to potential implementation. Different types of up-stream risk management will also be explored including improved test requirements, risk assessments for groups of APIs, and the feasibility of substitution. Finally, MistraPharma will continue to serve stakeholders and deliver scientifically founded advice. |
