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Evaluation of the accuracy and consistency of the Swedish Environmental Classification and Information System for pharmaceuticals
KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
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.

Place, publisher, year, edition, pages
2010. Vol. 408, no 11, 2327-2339 p.
Keyword [en]
Risk assessment, Classification, Pharmaceuticals, Consistency, Accuracy, Voluntary, Ecotoxicity
National Category
Philosophy
Identifiers
URN: urn:nbn:se:kth:diva-24885DOI: 10.1016/j.scitotenv.2010.02.020ISI: 000277109600007Scopus ID: 2-s2.0-77950062513OAI: oai:DiVA.org:kth-24885DiVA: diva2:353979
Note

QC 20100929

Available from: 2010-09-29 Created: 2010-09-29 Last updated: 2017-12-12Bibliographically approved
In thesis
1. Improving the transparency and predictability of environmental risk assessments of pharmaceuticals
Open this publication in new window or tab >>Improving the transparency and predictability of environmental risk assessments of pharmaceuticals
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
environmental risk assessment, pharmaceuticals, transparency, predictability, accuracy, consistency, voluntary initiatives, reliability evaluation, non-standard test data.
National Category
Philosophy
Identifiers
urn:nbn:se:kth:diva-24832 (URN)978-91-7415-737-6 (ISBN)
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
2. From Science to Policy: Improving environmental risk assessment andmanagement of chemicals
Open this publication in new window or tab >>From Science to Policy: Improving environmental risk assessment andmanagement of chemicals
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
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:nbn:se:kth:diva-105225 (URN)978-91-7501-507-1 (ISBN)
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

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