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.

The overall aim of the CWPharma project is to reduce the load of active pharmaceutical ingredients (APIs) going into the aquatic environment and especially the Baltic Sea. Municipal wastewater treatment plants (WWTPs) are relevant point sources of APIs, as they treat the wastewater from public households, hospitals and industry of the connected catchment area. However, conventional "state-of-the-art" WWTPs can only remove some APIs, which are either easily biodegradable and/or absorbable to activated sludge, whereas other APIs can pass the WWTP with minor to no reduction. Therefore, reduction of a broad range of APIs can only be achieved by using targeted advanced treatment techniques such as ozonation or powdered and granular activated carbon, respectively, which have already been applied on full-scale for API removal in wastewater treatment in Germany and Switzerland and proven their practical and economical suitability. At the usual applied ozone doses, ozonation of secondary effluent does not mineralize (convert an organic substance into inorganic matter) but transforms organic compounds into smaller and (usually) more biodegradable compounds. Secondary effluent is a complex water matrix consisting of hundreds of different organic substances, and it is not feasible to determine all possible transformation products and oxidation by-products, which might be created by the ozonation process. Thus, utilities and water authorities sometimes struggle with the uncertainties of the ozonation process as they perceive difficulties to judge whether oxidation of the organic matrix is beneficial or if it is creating more problems. As chemical analysis of the water only provides quantitative data for known APIs and transformation products for which chemical standards are available, effect-based ecotoxicological test systems can be used to assess the integrated actual toxicity of the whole water matrix. Based on previous research compiled by Völker et al. (2019), ozonation has a positive impact on several toxicological endpoints. But there are also indications that ozonation can create negative effects for a few toxicological endpoints that can be reduced by a suitable post-treatment. However, only little knowledge is available regarding suitable post-treatments and which ecotoxicological test systems are appropriate to evaluate their impact. In addition, post-treatment options might also have beneficial impacts on water quality parameters, APIs and transformation products. Thus, this report will evaluate different aspects regarding the impact of ozonation and its posttreatment options on (i) water quality parameters, (ii) APIs and transformation products (TPs) and (iii) ecotoxicological effects. The evaluation was conducted at three WWTPs in Linköping (SE), Kalundborg (DK) and Berlin (DE) and different post-treatment options such as moving bed bioreactors (MBBR), deep-bed filters, and a constructed wetland.

During the last decades, it has become evident that some active pharmaceutical ingredients (API) have harmful environmental impacts on aquatic ecosystems. Therefore, there is a need to decrease the amount of pharmaceutical residues that end up in the environment. Information gaps related to increased awareness of the environmental impacts of pharmaceuticals in the health care sector and the promotion of sustainable consumption of pharmaceuticals have been identified in the Status Report on Pharmaceuticals in the aquatic environment of the Baltic Sea Region (BSR) published by UNESCO and HELCOM in 2017. The aim of the current report is to fill in some of the identified knowledge gaps identified in the HELCOM report, specifically increasing awareness about the environmental impacts of pharmaceuticals. In Sweden, there are good practices for healthcare professionals about how to consider the environmental impacts of medications already at the prescription phase, as well as guidelines for how to make the environmental information available and accessible to healthcare professionals and the public. The Swedish practices are described and evaluated, and the measures that can be implemented in the other BSR countries are formulated as recommendations. Eight recommendations were formulated through dialogues with stakeholders in Sweden. The recommendations are divided into four main areas i.e. education, databases and guidelines, dissemination of information to public, and collaboration among stakeholders. Some recommendations might be implemented without any large challenges or financial costs while other recommendations require large changes such as economic investments and changes in legislation. This report also contains information about existing practices in other countries in the Baltic Sea region (BSR), provided by the project partners in the CWPharma project. The countries in the BSR are currently at different levels when it comes to management of pharmaceuticals and their residues in the environment. Public awareness of the environmental impacts of pharmaceuticals differs, as do the systems for returning leftover medications. Basic education for health care personnel regarding the environmental consequences of different medications and pharmaceutical compounds exists in most of the BSR countries but the scope and content differs. One recommendation in the report is that environmental impacts of APIs should be compiled in a national, or ideally an EU level, database. As a first step, the Baltic Sea countries could investigate the possibility to establish national interfaces to the Swedish databases “Pharmaceutical and environment” (Janusinfo) or FASS. Although the data in “Pharmaceutical and environment” and FASS are not complete, they are existing platforms which provide valuable information and gather criteria important for classification. In Sweden, there are several channels for the dissemination of information about the environmental consequences of pharmaceuticals with the aim to raise public awareness regarding this subject. Examples of actions to be considered by other countries are information campaigns driven by pharmacies for returning unused and left over medications (Germany and Finland have similar campaigns), and distribution of leaflets with information about the environmental impacts of pharmaceuticals, which have proven to be efficient in raising awareness among pharmacists, doctors and the public. The collaboration of different stakeholders is one of the foremost reasons for the progress that has been made regarding pharmaceuticals in the environment in Sweden. The Swedish Medical Production Agency has set up a Knowledge Centre for Pharmaceuticals in the Environment, providing a platform for different actors to discuss environmental issues connected to pharmaceuticals. Among these actors there is a sense of a shared environmental vision with common goals. Hence, one recommendation for the BSR countries is to investigate the possibilities of establishing similar national knowledge centers within medicine agencies, or to use existing networks as a starting point to also involve other environmental issues related to pharmaceuticals and to find new collaboration possibilities. Finally, collaboration between the EU countries is crucial to successfully implement environmental aspects in the lifecycle of the pharmaceuticals.