New European database to support environmental risk assessment of human pharmaceuticals

New European database to support environmental risk assessment of human pharmaceuticals Lisa Lock Scientific Editor Andrew Zinin Chief Editor The PREMIER project, a public-private European consortium of research organizations (like Radboud University) and international pharmaceutical companies, has launched a new database to support the environmental risk assessment (ERA) of human pharmaceuticals. The data is publicly accessible, free of charge. The database was built with key user requirements in mind. The database increases the transparency of existing data and provides detailed study information, enabling stakeholders such as water managers, regulators, scientists and the pharmaceutical industry to identify relevant and reliable data for their purposes. This may include deriving safe concentration limits for human pharmaceutical residues in the environment. PREMIER's work represents a considerable step forward in environmental risk assessment (ERA) of human pharmaceuticals. The presence of these pharmaceuticals in the environment is a well-recognized issue. Ad Ragas, PREMIER coordinator at Radboud University, says, "Patients excrete a substantial fraction of the medicines that they use. The sewer system then takes these residues to the wastewater treatment plant, which can remove some, but typically not all, residues. As treated wastewater is discharged to receiving waters, some residues reach our surface waters. Here, these residues can harm aquatic life such as fish, water invertebrates and water plants." Closing the gap between new and old pharmaceuticals In 2006, the European Union implemented a new regulation requiring companies to perform an ERA on any new human pharmaceutical being introduced into the market. These ERAs address key questions including how much of the pharmaceutical residue potentially reaches the environment and how to determine maximum safe levels for algae, water invertebrates and fish. However, these assessments have their limitations. Ragas says, "Performing toxicity tests is particularly expensive. It can cost 200,000–500,000 euros per compound." However, the obligation to assess environmental risks does not apply to medicines on the European market before 2006. Ragas says, "This poses a considerable societal challenge, especially for the pharmaceutical industry. There are approximately 1,000–1,500 human pharmaceuticals on the market for which the environmental risks are poorly characterized. Testing all these substances will cost an enormous amount of time and money. That's why we developed intelligent strategies to identify APIs that are most likely to pose a significant environmental risk so we can subject these APIs to further testing and detailed assessment." For example, the PREMIER consortium identified 25 "old and potentially harmful, data-poor" pharmaceuticals and performed extensive environmental risk assessments, finding limited environmental risks for these compounds. A new resource for water managers, industry, academia and government institutions The new PREMIER database brings together data for environmental risk assessment of human pharmaceuticals in one central place, providing easy access for all stakeholders, including the wider public. The database currently contains data on more than 450 APIs, including data originating from previous European risk assessments. This will make life easier for companies, government institutions and scientists assessing the environmental risks of pharmaceuticals. "But water managers can also use the database, for example to determine safe concentration limits for the pharmaceuticals in their surface waters," explains the scientist. "The health sector is also showing interest. More and more doctors nowadays consider environmental aspects when prescribing medicines. That is a positive development." Naturally, the environmental scientist would prefer to see as few synthetic substances as possible in our surface waters. "But we should first tackle those that pose the biggest risks. This is where our database and assessment system can help. PREMIER makes it easier to identify problematic human pharmaceuticals, so we can start reducing the environmental risks of these substances first." Provided by Radboud University