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Improving the transparency and predictability of environmental risk assessments of pharmaceuticals
KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
2010 (English)Licentiate 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.

Place, publisher, year, edition, pages
Stockholm: KTH , 2010. , viii, 22 p.
Series
Theses in Risk and Safety from the Division of Philosophy at the Royal Institute of Technology, ISSN 1654-627X
Keyword [en]
environmental risk assessment, pharmaceuticals, transparency, predictability, accuracy, consistency, voluntary initiatives, reliability evaluation, non-standard test data.
National Category
Philosophy
Identifiers
URN: urn:nbn:se:kth:diva-24832ISBN: 978-91-7415-737-6 (print)OAI: oai:DiVA.org:kth-24832DiVA: diva2:353518
Presentation
2010-10-15, 231, Teknikringen 78B, KTH, Stockholm, 13:00 (English)
Opponent
Supervisors
Note
QC 20100929Available from: 2010-09-29 Created: 2010-09-27 Last updated: 2012-02-08Bibliographically approved
List of papers
1. 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
2. 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
3. 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

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Marlene Ågerstrand(141 kB)469 downloads
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