Appropriate collection and disposal of medicine-related waste has been identified as one of the main ways to decrease the emission of active pharmaceutical ingredients (APIs) into the environment. Improvement to the take-back and treatment of collected pharmaceutical waste may be considered lowhanging fruit when one is considering measures to reduce API emissions. However, comparable information that would enable estimating the potential impact of these efforts has not been available. Directive 2004/27/EC, related to medicinal products for human use, mandates that EU member states implement appropriate collection schemes for unused or expired human-use medicinal products. However, it does not provide any guidelines on practical implementation of these schemes. Several studies have pointed out significant differences among Member States in this regard. In March 2019, the European Commission published the European Union Strategic Approach to Pharmaceuticals in the Environment. The actions specified therein cover all stages of the pharmaceutical life cycle, from design and production to disposal and waste management. It emphasizes such elements as sharing good practices, co-operating at international level, and improving understanding of the risks. This report is aimed at filling knowledge gaps and proposing good practices for take-back and disposal of unused human and veterinary medicines and other pharmaceutical waste. The report is targeted to e.g. ministries, environment and medicines agencies, supervisory authorities, municipalities, hospitals, NGOs, pharmacists, doctors, and veterinarians. For the report, current national practices for take-back and disposal of unused medicines and other pharmaceutical waste in Denmark, Estonia, Finland, Germany, Latvia, Lithuania, Poland, Russia, and Sweden were evaluated. The pharmaceutical waste originating from households, hospitals and other health care institutions, the pharmaceutical industry, and veterinary use was considered. The proportion of citizens who return unused pharmaceuticals via designated collection points varies greatly between Baltic Sea countries, from about 10% to 70%, with 16–80% disposing of them of as mixed household waste and 3–30% flushing them down the drain. The most commonly cited reason for improper disposal of medicines on households’ part is lack of information about their environmental impacts and how to get rid of them in an environmentally sound manner. Separate collection of unused household pharmaceuticals does not exist in Russia, and the collection mechanism functions poorly in Latvia, Lithuania and Poland. Information on the take-back schemes for unused human medicines is more readily available than is corresponding information on veterinary medicines. We identified, all told, 21 good practices and recommendations for take-back and disposal of unused pharmaceuticals and other pharmaceutical waste and for promoting the rational use of pharmaceuticals in the Baltic Sea region. Nevertheless, implementing them at national level requires particular consideration due to differences in national legislation and other characteristics of the EU Baltic Sea countries and Russia. The good practices identified in this report answer the call issued in the EU strategic approach for an efficient risk-reduction strategy.

Elevated levels of active pharmaceutical ingredients (API) have been detected in the Baltic Sea for many years. These APIs are often discharged from hospitals, households, pharmaceutical manufacturing plants, and animal farms, among other sources. As APIs are not completely degraded in municipal wastewater treatment plants (WWTP), they are then transported to the Baltic Sea. Although research on the effects of APIs in the Baltic Sea has been ongoing, the consequences of API discharges on the environment, in terms of potentially risky ecological effects, have not yet been fully evaluated. The European Union’s Interreg Baltic Sea Region programme funded the Clear Waters from Pharmaceuticals (CWPharma) project, which quantified API loading into the Baltic Sea from six river basin districts. Seven Baltic Sea Region (BSR) countries were involved as CWPharma partners (Denmark, Estonia, Finland, Germany, Latvia, Poland and Sweden). Surface water, soil, and sediment samples were collected from coastal, rural, and agricultural locations and analysed for up to 80 APIs. By comparing the API concentrations detected in rivers with predicted no-effect levels (PNEC), the environmental risk of individual APIs was quantified. A GIS-based model was developed which allowed illustration and assessment of API loads into the Baltic Sea coming from the project partner countries, as well as evaluation of the impacts of various emission reduction scenarios. Different types of emission reduction measures were proposed. Reductions of API emission from WWTPs through the application of advanced wastewater treatment (AWT) technologies were experimentally validated at full- and pilot-scale. AWT technologies tested in CWPharma included full-scale ozonation and various post-treatment technologies, such as moving bed bioreactors, constructed wetlands, deep bed filters using sand/anthracite, and granular activated carbon. Additionally, 21 recommendations for other reduction measures focused on improving collection and disposal of unused pharmaceuticals and pharmaceutical waste, targeting various groups and emitters, were also developed. By simulating the variety of API reduction methods within the API loading model, the most effective measures for reducing API emissions could be determined. Similarly, both the costs and global warming potential of upgrading various classes of WWTPs with AWT in the form of ozonation or activated carbon were calculated for each CWPharma project partner country. This report summarizes the most important recommendations elicited from the CWPharma project.

This report describes the contamination by pharmaceuticals and the environmental risks associated with their environmental levels in the Baltic Sea Region. Data were collected within the three-year project Clear Waters from Pharmaceuticals (CWPharma) funded by the EU’s Interreg Baltic Sea Region Programme. Sampling was performed in the river basin districts of Vantaanjoki in Finland, Pärnu in Estonia, Lielupe and Daugava in Latvia, Vistula in Poland, Warnow-Peene in Germany and Motala ström in Sweden. Analyses were performed on surface water, coastal water, sediment and soil that was fertilized with sewage sludge or manure. Analyses were also performed on emissions from municipal wastewater treatment plants, hospitals, pharmaceutical manufacturing facilities, landfills, and fish and livestock farms. In total, the study covered 13 365 data points from 226 samples as well as collection of human and veterinary consumption data of selected active pharmaceutical ingredients (APIs). Samples were screened for up to 80 APIs, representing antibiotics, antiepileptics, antihypertensives, asthma and allergy medications, gastrointestinal disease medications, hormones, metabolic disease medications, non-steroidal anti-inflammatory drugs (NSAIDs) and analgesics, other cardiovascular medicines, psychopharmaceuticals, veterinary medicines and caffeine. The measured APIs were selected based on analytical capacity, consumption rates, identified data gaps and potential environmental risks. Literature and databases were screened for ecotoxicological information. Acute toxicity tests were performed for two APIs, nebivolol and cetirizine, for which ecotoxicological data were lacking. Measured environmental concentrations were compared with predicted no-effect concentrations (PNEC) to assess environmental risks of the selected APIs.