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From Science to Policy: Improving environmental risk assessment andmanagement of chemicals
KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
2012 (English)Doctoral 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.

Place, publisher, year, edition, pages
Stockholm: KTH Royal Institute of Technology, 2012. , 43 p.
Series
Theses in Risk and Safety from the Division of Philosophy at the Royal Institute of Technology, ISSN 1654-627X ; 8
Keyword [en]
environmental risk assessment, chemicals, pharmaceuticals, transparency, predictability, accuracy, consistency, voluntary initiatives, ecotoxicity data, reliability evaluation, relevance evaluation, non-standard test data, CSR, risk management.
National Category
Environmental Sciences
Identifiers
URN: urn:nbn:se:kth:diva-105225ISBN: 978-91-7501-507-1 (print)OAI: oai:DiVA.org:kth-105225DiVA: diva2:570429
Public defence
2012-12-07, E3, Osquars Backe 14, KTH, Stockholm, 10:00 (English)
Opponent
Supervisors
Projects
MistraPharmaFormas - Evaluation of the Swedish Environmental Classification and Information System for Pharmaceutcals.
Funder
FormasMistra - The Swedish Foundation for Strategic Environmental Research
Note

QC 20121119

Available from: 2012-11-19 Created: 2012-11-19 Last updated: 2012-11-19Bibliographically approved
List of papers
1. WikiPharma - A freely available, easily accessible, interactive and comprehensive database for environmental effect data for pharmaceuticals
Open this publication in new window or tab >>WikiPharma - A freely available, easily accessible, interactive and comprehensive database for environmental effect data for pharmaceuticals
2009 (English)In: Regulatory toxicology and pharmacology, ISSN 0273-2300, E-ISSN 1096-0295, Vol. 55, no 3, 367-371 p.Article in journal (Refereed) Published
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.

Keyword
Pharmaceuticals, Ecotoxicity, Database, Environmental effects, MistraPharma, WikiPharma, chemicals
Identifiers
urn:nbn:se:kth:diva-18961 (URN)10.1016/j.yrtph.2009.08.009 (DOI)000271771100015 ()2-s2.0-70350394844 (Scopus ID)
Note
QC 20100525Available from: 2010-08-05 Created: 2010-08-05 Last updated: 2017-12-12Bibliographically approved
2. The Swedish Environmental Classification and Information System for Pharmaceuticals: An empirical investigation of the motivations, intentions and expectations underlying its development and implementation
Open this publication in new window or tab >>The Swedish Environmental Classification and Information System for Pharmaceuticals: An empirical investigation of the motivations, intentions and expectations underlying its development and implementation
2009 (English)In: Environment International, ISSN 0160-4120, E-ISSN 1873-6750, Vol. 35, no 5, 778-786 p.Article in journal (Refereed) Published
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.

Keyword
Pharmaceuticals, Ecotoxicity, Environmental hazard and risk assessment, Classification, The Swedish Environmental Classification and, Information System for Pharmaceuticals, SECIS, Unilateral commitment, Voluntary agreement, Voluntary approach, Self-regulation, Survey study, self-regulation, performance
National Category
Philosophy
Identifiers
urn:nbn:se:kth:diva-18493 (URN)10.1016/j.envint.2008.12.001 (DOI)000266770200005 ()2-s2.0-67349272605 (Scopus ID)
Conference
International Conference on Pharmaceutical Products in the Environment Nimes, FRANCE, FEB 19-20, 2008
Note
QC 20100525Available from: 2010-08-05 Created: 2010-08-05 Last updated: 2017-12-12Bibliographically approved
3. Evaluation of the accuracy and consistency of the Swedish Environmental Classification and Information System for pharmaceuticals
Open this publication in new window or tab >>Evaluation of the accuracy and consistency of the Swedish Environmental Classification and Information System for pharmaceuticals
2010 (English)In: Science of the Total Environment, ISSN 0048-9697, E-ISSN 1879-1026, Vol. 408, no 11, 2327-2339 p.Article in journal (Refereed) Published
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.

Keyword
Risk assessment, Classification, Pharmaceuticals, Consistency, Accuracy, Voluntary, Ecotoxicity
National Category
Philosophy
Identifiers
urn:nbn:se:kth:diva-24885 (URN)10.1016/j.scitotenv.2010.02.020 (DOI)000277109600007 ()2-s2.0-77950062513 (Scopus ID)
Note

QC 20100929

Available from: 2010-09-29 Created: 2010-09-29 Last updated: 2017-12-12Bibliographically approved
4. 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 substances
Open this publication in new window or tab >>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 substances
2011 (English)In: Environmental Sciences Europe, ISSN 2190-4715, E-ISSN 2190-4715, Vol. 23, no 17Article in journal (Other academic) Published
National Category
Philosophy
Identifiers
urn:nbn:se:kth:diva-24898 (URN)2-s2.0-79960611586 (Scopus ID)
Note
QC 20100929Available from: 2010-09-29 Created: 2010-09-29 Last updated: 2017-12-12Bibliographically approved
5. Reporting and evaluation criteria as means towards a transparent use of ecotoxicity data for environmental risk assessment of pharmaceuticals
Open this publication in new window or tab >>Reporting and evaluation criteria as means towards a transparent use of ecotoxicity data for environmental risk assessment of pharmaceuticals
Show others...
2011 (English)In: Environmental Pollution, ISSN 0269-7491, E-ISSN 1873-6424, Vol. 159, no 10, 2487-2492 p.Article in journal (Refereed) Published
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.

Keyword
Reliability, Relevance, Data evaluation, Data reporting, Non-standard data/studies/tests
National Category
Ecology
Identifiers
urn:nbn:se:kth:diva-47992 (URN)10.1016/j.envpol.2011.06.023 (DOI)000295493100036 ()2-s2.0-80052305439 (Scopus ID)
Funder
Formas
Note
QC 20111116Available from: 2011-11-16 Created: 2011-11-15 Last updated: 2017-12-08Bibliographically approved

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