Reporting and evaluation criteria as means towards a transparent use of ecotoxicity data for environmental risk assessment of pharmaceuticals. Environmental Pollution

Ågerstrand, M.; Küster, A.; Bachmann, J.; Breitholtz, M.; Ebert, I.; Rechenberg, B.; Rudén, C.
2011 | Environ. Pollut. | 159 (2487-2492)
pharmaceuticals

Comparison of four different methods for reliability evaluation of ecotoxicity data – A case study of non-standard test data used in environmental risk assessments of pharmaceutical substances.

Ågerstrand, M.; Breitholtz, M.; Rudén, C.
2011 | Environ Sci | 23
pharmaceuticals

Reporting and evaluation criteria as means towards a transparent use of ecotoxicity data for environmental risk assessment of pharmaceuticals

Agerstrand, M; Kuster, A; Bachmann, J; Breitholtz, M; Ebert, I; Rechenberg, B; Ruden, C
2011 | Environ. Pollut. | 159 (10) (2487-2492)
chronic tests , classification , data evaluation , data quality , data reporting , endocrine active-chemicals , information-system , life stage test , minnow pimephales-promelas , non-standard data/studies/tests , relevance , reliability , trichloroethylene

Ecotoxicity data with high reliability and relevance are needed to guarantee the scientific quality of environmental risk assessments of pharmaceuticals. The main advantages of a more structured approach to data evaluation include increased transparency and predictability of the risk assessment process, and the possibility to use non-standard data. In this collaboration, between the research project MistraPharma and the German Federal Environment Agency, a new set of reporting and evaluation criteria is presented and discussed. The new criteria are based on the approaches in the literature and the OECD reporting requirements, and have been further developed to include both reliability and relevance of test data. Intended users are risk assessors and researchers performing ecotoxicological experiments, but the criteria can also be used for education purposes and in the peer-review process for scientific papers. This approach intends to bridge the gap between the regulator and the scientist's needs and way of work. (C) 2011 Elsevier Ltd. All rights reserved.

Evaluation of the accuracy and consistency of the Swedish Environmental Classification and Information System for pharmaceuticals

2010 | Sci. Total Environ. | 408 (11) (2327-2339)

The Swedish environmental and classification system for pharmaceuticals is a voluntary, industry-owned system with the purpose to provide environmental information about active pharmaceutical ingredients in the Swedish market. In this paper we report the results from a detailed evaluation of the accuracy and consistency of the risk assessments conducted within this system. The evaluation focused on the following three aspects: 1) comparison of the companies' risk assessments with the classification system's own guidance document, 2) how the risk assessments are affected if additional effect data is used, and 3) the consistency of different risk assessments for the same pharmaceutical substance. The analyses show that the system's guidance gives no criteria for when to consider a study “long-term” or “short-term”, and that this confusion affected the outcome of the risk assessments in some cases. Furthermore, when the system's guidance document is followed and the risk assessment was supplemented with effect data from the open scientific literature, then the risk classification for a substantial number of the evaluated substances was altered. Our analyses also revealed that in some cases risk assessors disagree on the outcome of the assessment for the same active pharmaceutical ingredient. Finally we list some recommendations to improve the classification system. The recommendations include clarifying concepts and instructions in the guidance document, introduction of a standardized way of reporting data to the website, and promotion of use of non-standard test data when considered the most relevant.

Standard and non‐standard tests for risk assessment purposes

Rudén, C.; Ågerstrand, M.; Göransson, M.; Breitholtz, M.
2010 (Towards Sustainable Pharmaceuticals in a Healthy Society) | ISBN: 978-91-978836-0-3

Evaluation of the accuracy and consistency of the Swedish Environmental Classification and Information System for pharmaceuticals.

Ågerstrand, M.; Rudén, C.
2010 | Sci. Total Environ. | 408 (11) (2327-2339)

The Swedish environmental and classification system for pharmaceuticals is a voluntary, industry-owned system with the purpose to provide environmental information about active pharmaceutical ingredients in the Swedish market. In this paper we report the results from a detailed evaluation of the accuracy and consistency of the risk assessments conducted within this system. The evaluation focused on the following three aspects: 1) comparison of the companies' risk assessments with the classification system's own guidance document, 2) how the risk assessments are affected if additional effect data is used, and 3) the consistency of different risk assessments for the same pharmaceutical substance. The analyses show that the system's guidance gives no criteria for when to consider a study "long-term" or "short-term", and that this confusion affected the outcome of the risk assessments in some cases. Furthermore, when the system's guidance document is followed and the risk assessment was supplemented with effect data from the open scientific literature, then the risk classification for a substantial number of the evaluated substances was altered. Our analyses also revealed that in some cases risk assessors disagree on the outcome of the assessment for the same active pharmaceutical ingredient. Finally we list some recommendations to improve the classification system. The recommendations include clarifying concepts and instructions in the guidance document, introduction of a standardized way of reporting data to the website, and promotion of use of non-standard test data when considered the most relevant

Evaluation of the accuracy and consistency of the Swedish Environmental Classification and Information System for pharmaceuticals

2010 | Sci. Total Environ. | 408 (11) (2327-2339)
accuracy , antibiotics , classification , consistency , diclofenac , ecotoxicity , impact , nontarget organisms , pharmaceuticals , risk assessment , risk assessments , toxicity , voluntary

The Swedish environmental and classification system for pharmaceuticals is a voluntary, industry-owned system with the purpose to provide environmental information about active pharmaceutical ingredients in the Swedish market. In this paper we report the results from a detailed evaluation of the accuracy and consistency of the risk assessments conducted within this system. The evaluation focused on the following three aspects: 1) comparison of the companies' risk assessments with the classification system's own guidance document, 2) how the risk assessments are affected if additional effect data is used, and 3) the consistency of different risk assessments for the same pharmaceutical substance. The analyses show that the system's guidance gives no criteria for when to consider a study "long-term" or "short-term", and that this confusion affected the outcome of the risk assessments in some cases. Furthermore, when the system's guidance document is followed and the risk assessment was supplemented with effect data from the open scientific literature, then the risk classification for a substantial number of the evaluated substances was altered. Our analyses also revealed that in some cases risk assessors disagree on the outcome of the assessment for the same active pharmaceutical ingredient. Finally we list some recommendations to improve the classification system. The recommendations include clarifying concepts and instructions in the guidance document, introduction of a standardized way of reporting data to the website, and promotion of use of nonstandard test data when considered the most relevant. (C) 2010 Elsevier B.V. All rights reserved.

WikiPharma–A freely available, easily accessible, interactive and comprehensive database for environmental effect data for pharmaceuticals

2009 | Regul. Toxicol. Pharmacol. | 55 (3) (367-371)

A significant number of Active Pharmaceutical Ingredients (APIs) have been identified in the environment and in surface waters. Data on the environmental hazards associated with these substances are emerging but are still scarce. We have compiled publicly available ecotoxicity data for APIs into a database called WikiPharma. The use of the database is free of charge. It can be accessed and updated continuously as a “wiki”. The aim of WikiPharma is to provide an easily accessible, comprehensive and up-to-date overview of effects caused by pharmaceuticals on non-target organisms. The database currently contains basic information, i.e. substance name, ATC code(s) and pharmaceutical group(s), for 831 APIs representing 35 different drug classes. Effect data have been identified and included for 116 of these substances. These ecotoxicity test data have been extracted from 156 different sources. The development of a comprehensive database on ecological hazard of APIs can facilitate identification of data gaps and promote environmental risk assessment of these substances. The database is available at www.wikipharma.org.

The Swedish Environmental Classification and Information System for Pharmaceuticals—An empirical investigation of the motivations, intentions and expectations underlying its development and implementation

2009 | Environ Int | 35 (5) (778-786)

In 2005 the Swedish Association of the Pharmaceutical Industry (LIF) initiated a national environmental classification and information system for pharmaceuticals. This investigation reports the results from a survey, conducted among the persons involved in the start-up process. The aim of this study is to generate knowledge contributing to the clarification of the motivations, expectations, and intentions underlying the development and implementation of the system. The decision to implement a classification and information system for pharmaceuticals was the result of a combination of several driving forces, mainly political pressure and a possibility to increase the industries' goodwill, while at the same time keeping the process under the industries' control. The expected possible effects of the system, other than increased goodwill, are according to this survey assumed to be low. The system offers little guidance for end-users in the substitution of one pharmaceutical for another. One possible reason for this could be that LIF needs to observe the interests of all its members' and should not affect competition. The affiliation of the involved actors correlates to how these actors view and value the system, but this has not hampered the collaborative process to develop and implement it.

The Swedish Environmental Classification and Information System for Pharmaceuticals – An empirical investigation of the motivations, intentions and expectations underlying its development and implementation

2009 | Environ Int | 35 (5) (778-786)
classification , ecotoxicity , environmental hazard and risk assessment , performance , pharmaceuticals , secis , self-regulation , survey study , the swedish environmental classification and information system for pharmaceuticals , unilateral commitment , voluntary agreement , voluntary approach

In 2005 the Swedish Association of the Pharmaceutical Industry (LIF) initiated a national environmental classification and information system for pharmaceuticals. This investigation reports the results from a survey, conducted among the persons involved in the start-up process. The aim of this study is to generate knowledge contributing to the clarification of the motivations, expectations, and intentions underlying the development and implementation of the system. The decision to implement a classification and information system for pharmaceuticals was the result of a combination of several driving forces, mainly political pressure and a possibility to increase the industries' goodwill, while at the same time keeping the process under the industries' control. The expected possible effects of the system, other than increased goodwill, are according to this survey assumed to be low. The system offers little guidance for end-users in the substitution of one pharmaceutical for another. One possible reason for this could be that LIF needs to observe the interests of all its members' and should not affect competition. The affiliation of the involved actors correlates to how these actors view and value the system, but this has not hampered the collaborative process to develop and implement it. (C) 2008 Elsevier Ltd. All rights reserved.

WikiPharma – a freely available, easily accessible, interactive and comprehensive database for environmental effect data for pharmaceuticals.

Molander, L.; Ågerstrand, M.; Rudén, C.
2009 | Regul. Toxicol. Pharmacol. | 55 (367-371)

A significant number of Active Pharmaceutical Ingredients (APIs) have been identified in the environment and in surface waters. Data on the environmental hazards associated with these substances are emerging but are still scarce. We have compiled publicly available ecotoxicity data for APIs into a database called WikiPharma. The use of the database is free of charge. It can be accessed and updated continuously as a “wiki”. The aim of WikiPharma is to provide an easily accessible, comprehensive and up-to-date overview of effects caused by pharmaceuticals on non-target organisms. The database currently contains basic information, i.e. substance name, ATC code(s) and pharmaceutical group(s), for 831 APIs representing 35 different drug classes. Effect data have been identified and included for 116 of these substances. These ecotoxicity test data have been extracted from 156 different sources. The development of a comprehensive database on ecological hazard of APIs can facilitate identification of data gaps and promote environmental risk assessment of these substances. The database is available at www.wikipharma.org.

The Swedish environmental classification and information system for pharmaceuticals – an empirical investigation of the motivations, intentions and expectations underlying its development and implementation.

Ågerstrand, M.; Wester, M.; Rudén, C.
2009 | Environ Int | 35 (5) (778-786)

In 2005 the Swedish Association of the Pharmaceutical Industry (LIF) initiated a national environmental classification and information system for pharmaceuticals. This investigation reports the results from a survey, conducted among the persons involved in the start-up process. The aim of this study is to generate knowledge contributing to the clarification of the motivations, expectations, and intentions underlying the development and implementation of the system. The decision to implement a classification and information system for pharmaceuticals was the result of a combination of several driving forces, mainly political pressure and a possibility to increase the industries' goodwill, while at the same time keeping the process under the industries' control. The expected possible effects of the system, other than increased goodwill, are according to this survey assumed to be low. The system offers little guidance for end-users in the substitution of one pharmaceutical for another. One possible reason for this could be that LIF needs to observe the interests of all its members' and should not affect competition. The affiliation of the involved actors correlates to how these actors view and value the system, but this has not hampered the collaborative process to develop and implement it. © 2008 Elsevier Ltd. All rights reserved.

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