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  • 1.
    Agerstrand, Marlene
    et al.
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Kuester, A.
    Bachmann, J.
    Breitholtz, M.
    Ebert, I.
    Rechenberg, B.
    Ruden, Christina
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Reporting and evaluation criteria as means towards a transparent use of ecotoxicity data for environmental risk assessment of pharmaceuticals2011In: Environmental Pollution, ISSN 0269-7491, E-ISSN 1873-6424, Vol. 159, no 10, p. 2487-2492Article in journal (Refereed)
    Abstract [en]

    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.

  • 2.
    Molander, Linda
    et al.
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Rudén, Christina
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Ågerstrand, Marlene
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    WikiPharma: A database with environmental effect data for pharmaceuticals2010In: Towards sustainable pharmaceuticals in a healthy society, Stockholm: MistraPharma , 2010, p. 98-147Chapter in book (Other academic)
  • 3.
    Molander, Linda
    et al.
    KTH, School of Architecture and the Built Environment (ABE), Philosophy.
    Ågerstrand, Marlene
    KTH, School of Architecture and the Built Environment (ABE), Philosophy.
    Rudén, Christina
    KTH, School of Architecture and the Built Environment (ABE), Philosophy.
    WikiPharma - A freely available, easily accessible, interactive and comprehensive database for environmental effect data for pharmaceuticals2009In: Regulatory toxicology and pharmacology, ISSN 0273-2300, E-ISSN 1096-0295, Vol. 55, no 3, p. 367-371Article in journal (Refereed)
    Abstract [en]

    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.

  • 4.
    Rudén, Christina
    et al.
    Philosophy and History, KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Ågerstrand, Marlene
    Philosophy and History, KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Göransson, M.
    Breitholtz, M.
    Standard and non-standard tests for risk assessment purposes2010In: Towards Sustainable Pharmaceuticals in a Healthy Society / [ed] C Rudén, K Liljelund, H Hagerman, Elanders Sverige AB , 2010Chapter in book (Other academic)
  • 5.
    Ågerstrand, Marlene
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    From Science to Policy: Improving environmental risk assessment andmanagement of chemicals2012Doctoral thesis, comprehensive summary (Other academic)
    Abstract [en]

    A complex process like risk assessment and the subsequent risk management decision makingshould be regularly evaluated, in order to assess the need to improve its workings. In this thesisthree related matters are addressed: evaluation of environmental risk management strategies,evaluation of environmental risk assessments, and how ecotoxicity data from the open scientificliterature can be used in a systematic way in regulatory risk assessments. It has resulted in thefollowing: a publically available database with ecotoxicity data for pharmaceuticals (Paper I); anevaluation and review of the Swedish Environmental Classification and Information System forpharmaceuticals (Papers II and III); a comparison of current reliability evaluation methods and areliability evaluation of ecotoxicity data (Paper IV); and an improved reliability and relevancereporting and evaluation scheme (Paper V).There are three overall conclusions from this thesis:(1) Ecotoxicity data from the open scientific literature is not used to the extent it could be inregulatory risk assessment of chemicals. Major reasons for this are that regulators prefer standarddata and that research studies in the open scientific literature can be reported in a way that affectstheir reliability and the user-friendliness. To enable the use of available data more efficiently actionsmust be taken by researchers, editors, and regulators. A more structured reliability and relevanceevaluation is needed to reach the goal of transparent, robust and predictable risk assessments.(2) A risk assessment is the result of the selected data and the selected methods used in theprocess. Therefore a transparent procedure, with clear justifications of choices made, is necessaryto enable external review. The risk assessments conducted within the Swedish EnvironmentalClassification and Information System for pharmaceuticals vary in their transparency and choice ofmethod. This could come to affect the credibility of the system since risk assessments are notalways consistent and guidelines are not always followed.(3) The Swedish Environmental Classification and Information System for pharmaceuticalscontribute, in its current form, to data availability and transparency but not to risk reduction. Thesystem has contributed to the general discussion about pharmaceuticals’ effect on the environmentand made data publicly available. However, to be an effective risk reduction tool this is not sufficient.

  • 6.
    Ågerstrand, Marlene
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Improving the transparency and predictability of environmental risk assessments of pharmaceuticals2010Licentiate thesis, comprehensive summary (Other academic)
    Abstract [en]

    The risk assessment process and the subsequent risk management measures need tobe constantly evaluated, updated and improved. This thesis contributes to that workby considering, and suggesting improvements, regarding aspects like userfriendliness,transparency, accuracy, consistency, data reporting, data selection anddata evaluation.The first paper in this thesis reports from an empirical investigation of themotivations, intentions and expectations underlying the development andimplementation of a voluntary industry owned environmental classification systemfor pharmaceuticals. The results show that the purpose of the classification systemis to provide information, no other risk reduction measures are aimed for.The second paper reports from an evaluation of the accuracy and the consistency ofthe environmental risk assessments conducted within the classification system. Theresults show that the guideline recommendations were not followed in several casesand consequently alternative risk ratios could be determined for six of the 36pharmaceutical substances selected for evaluation in this study. When additionaldata from the open scientific literature was included the risk ratio was altered formore than one-third of the risk assessments. Seven of the 36 substances wereassessed and classified by more than one risk assessor. In two of the seven cases,different producers classified the same substance into different classificationcategories.The third paper addresses the question whether non-standard ecotoxicity data couldbe used systematically in environmental risk assessments of pharmaceuticals. Fourdifferent evaluation methods were used to evaluate nine non-standard studies. Theevaluation result from the different methods varied at surprisingly high rate and theevaluation of the non-standard data concluded that the reliability of the data wasgenerally low.

  • 7.
    Ågerstrand, Marlene
    et al.
    Philosophy and History, KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Breitholtz, M.
    Rudén, Christina
    Philosophy and History, KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Comparison of four different methods for reliability evaluation of ecotoxicity data: A case study of non-standard test dataused in environmental risk assessments of pharmaceutical substances2011In: Environmental Sciences Europe, ISSN 2190-4707, E-ISSN 2190-4715, Vol. 23, no 17Article in journal (Other academic)
  • 8.
    Ågerstrand, Marlene
    et al.
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Breitholtz, Magnus
    Stockholm Univ, Stockholm, Sweden .
    Hansson, Sven Ove
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Rudén, Christina
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Regulatory perspectives on pharmaceuticals in the environment2012In: Toxicology Letters, ISSN 0378-4274, E-ISSN 1879-3169, Vol. 211, p. S31-S31Article in journal (Other academic)
  • 9.
    Ågerstrand, Marlene
    et al.
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Rudén, Christina
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Evaluation of the accuracy and consistency of the Swedish Environmental Classification and Information System for pharmaceuticals2010In: Science of the Total Environment, ISSN 0048-9697, E-ISSN 1879-1026, Vol. 408, no 11, p. 2327-2339Article in journal (Refereed)
    Abstract [en]

    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.

  • 10.
    Ågerstrand, Marlene
    et al.
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Rudén, Christina
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Risk assessment of pharmaceuticals in the environment: The Swedish environmental classification system for pharmaceuticals2011Conference paper (Other academic)
  • 11.
    Ågerstrand, Marlene
    et al.
    Philosophy and History, KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Rudén, Christina
    Philosophy and History, KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    The Swedish environmental and classification system for pharmaceuticals: An evaluation of the system’s achievements so far2010In: Towards Sustainable Pharmaceuticals in a Healthy Society / [ed] C Rudén, K Liljelund, H Hagerman, Elanders Sverige AB , 2010Chapter in book (Other academic)
  • 12.
    Ågerstrand, Marlene
    et al.
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Rudén, Christina
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Wester, Misse
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    The Swedish environmental information and classification scheme for pharmaceuticals - An empirical investigation of the motivations, intentions and expectations underlying its development and implementation2008In: Toxicology Letters, ISSN 0378-4274, E-ISSN 1879-3169, Vol. 180, p. S177-S178Article in journal (Refereed)
  • 13.
    Ågerstrand, Marlene
    et al.
    KTH, School of Architecture and the Built Environment (ABE), Philosophy.
    Wester, Misse
    KTH, School of Architecture and the Built Environment (ABE), Philosophy.
    Rudén, Christina
    KTH, School of Architecture and the Built Environment (ABE), Philosophy.
    The Swedish Environmental Classification and Information System for Pharmaceuticals: An empirical investigation of the motivations, intentions and expectations underlying its development and implementation2009In: Environment International, ISSN 0160-4120, E-ISSN 1873-6750, Vol. 35, no 5, p. 778-786Article in journal (Refereed)
    Abstract [en]

    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.

1 - 13 of 13
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