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The Swedish Environmental Classification and Information System for Pharmaceuticals: An empirical investigation of the motivations, intentions and expectations underlying its development and implementation
KTH, School of Architecture and the Built Environment (ABE), Philosophy.
KTH, School of Architecture and the Built Environment (ABE), Philosophy.ORCID iD: 0000-0002-4671-758X
KTH, School of Architecture and the Built Environment (ABE), Philosophy.
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.

Place, publisher, year, edition, pages
2009. Vol. 35, no 5, 778-786 p.
Keyword [en]
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: urn:nbn:se:kth:diva-18493DOI: 10.1016/j.envint.2008.12.001ISI: 000266770200005Scopus ID: 2-s2.0-67349272605OAI: oai:DiVA.org:kth-18493DiVA: diva2:336540
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: 2012-11-19Bibliographically 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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