Evaluation of the accuracy and consistency of the Swedish Environmental Classification and Information System for pharmaceuticals

Science of the Total Environment

Volumn 408, Issue 11, 2010, Pages 2327-2339

  Ågerstrand, Marlene ^a   Rudén, Christina ^a  

^a ROYAL INSTITUTE OF TECHNOLOGY   (Sweden)

Author keywords

Accuracy; Classification; Consistency; Ecotoxicity; Pharmaceuticals; Risk assessment; Voluntary

Indexed keywords

ACTIVE PHARMACEUTICAL INGREDIENTS; CLASSIFICATION; CLASSIFICATION CONSISTENCY; CLASSIFICATION SYSTEM; ECOTOXICITY; ENVIRONMENTAL INFORMATION; GUIDANCE DOCUMENT; RISK CLASSIFICATION; SCIENTIFIC LITERATURE; STANDARD TESTS; SWEDISH MARKETS;

DRUG PRODUCTS; INFORMATION RETRIEVAL SYSTEMS; RISK MANAGEMENT;

RISK ASSESSMENT;

AMITRIPTYLINE; AMLODIPINE; AMOXICILLIN; ATORVASTATIN; CARBAMAZEPINE; CEFTRIAXONE; CEFUROXIME; CIMETIDINE; DICLOFENAC; DOXORUBICIN; ENALAPRIL; ERYTHROMYCIN; ESTRADIOL; ETHINYLESTRADIOL; FLUOXETINE; FLUVOXAMINE; FUROSEMIDE; FUSIDIC ACID; GEMFIBROZIL; HYDROCHLOROTHIAZIDE; IBUPROFEN; LEVOFLOXACIN; LIDOCAINE; METFORMIN; METOPROLOL; METRONIDAZOLE; OFLOXACIN; PROPRANOLOL; UNINDEXED DRUG; VERAPAMIL;

ACCURACY ASSESSMENT; CLASSIFICATION; DRUG; ENVIRONMENTAL ASSESSMENT; GUIDELINE; RISK ASSESSMENT;

ACCURACY; ARTICLE; CONTROLLED STUDY; DECISION SUPPORT SYSTEM; DRUG CLASSIFICATION; ECOTOXICITY; ENVIRONMENTAL IMPACT ASSESSMENT; EVALUATION RESEARCH; INTERNAL CONSISTENCY; MEDICAL INFORMATION SYSTEM; OUTCOME ASSESSMENT; PRACTICE GUIDELINE; PRIORITY JOURNAL; RISK ASSESSMENT; RISK MANAGEMENT; SCIENTIFIC LITERATURE; STANDARD; SWEDEN; TROPHIC LEVEL;

ENVIRONMENTAL EXPOSURE; ENVIRONMENTAL MONITORING; ENVIRONMENTAL POLLUTANTS; NATIONAL HEALTH PROGRAMS; PHARMACEUTICAL PREPARATIONS; REPRODUCIBILITY OF RESULTS; RISK ASSESSMENT; SWEDEN; VOLUNTARY PROGRAMS;

SWEDEN;

EID: 77950062513     PISSN: 00489697     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.scitotenv.2010.02.020     Document Type: Article

References (28)

1. Adams W.J., Rowland C.D. Aquatic toxicology test methods. Handbook of ecotoxicology 2003, Lewis Publishers, Section 1, chapter 2.3. Second edition. D.J. Hoffman, B.A. Rattner, G.A. Burton, J. Cairns (Eds.).
2. Backhaus T., Grimme L.H. The toxicity of antibiotic agents to the luminescent bacterium Vibrio fischeri. Chemosphere 1999, 38:3291-3301.
3. Christensen A.M., Faaborg-Andersen S., Ingerslev F., Baun A. Mixture and single-substance toxicity of selective serotonin reuptake inhibitors toward algae and crustaceans. Environ Toxicol Chem 2007, 26:85-91.
4. Dzialowski E.M., Turner P.K., Brooks B.W. Physiological and reproductive effects of beta adrenergic receptor antagonists in Daphnia magna. Arch Environ Contam Toxicol 2006, 50:503-510.
5. European Commission. European Commission Technical Guidance Document in Support of Commission Directive 93/67/EEC on Risk Assessment for New Notified Substances and Commission Regulation (EC). 2003; No 1488/94 on Risk Assessment for Existing Substances, Part II. http://ecb.jrc.it/home.php?CONTENU=/Technical-Guidance-Document/sommaire.php.
6. European Medicines Agency (EMA). Committee for Proprietary Medicinal Products (CPMP); Note for Guidance on Environmental Risk Assessment of Non-Genetically Modified Organism (Non-GMO) Containing Medicinal Products for Human Use. Draft Document dated 27 June 2002, Ref CPMP/SWP/4447/00.
7. European Medicines Agency (EMA). Committee for medicinal products for human use (CHMP). Guideline on the environmental risk assessment of medicinal products for human use. 1 June 2006. Ref EMEA/CRMP/SWP/4447/00.
8. Ferrari B., Paxéus N., Lo Giudice R., Pollio A., Garric J. Ecotoxicological impact of pharmaceuticals found in treated wastewaters: study of carbamazepine, clofibric acid, and diclofenac. Ecotoxicol Environ Saf 2003, 55:359-370.
9. Ferrari B., Mons R., Vollat B., Fraysse B., Paxéus N., Giudice R.L., et al. Environmental risk assessment of six human pharmaceuticals: are the current environmental risk assessment procedures sufficient for the protection of the aquatic environment?. Environ Toxicol Chem 2004, 23:1344-1354.
10. Isidori M., Lavorgna M., Nardelli A., Pascarella L., Parrella A. Toxic and genotoxic evaluation of six antibiotics on non-target organisms. Sci Total Environ 2005, 346:87-98.
11. Isidori M., Nardelli A., Parrella A., Pascarella L., Previtera L. A multispecies study to assess the toxic and genotoxic effect of pharmaceuticals: furosemide and its photoproduct. Chemosphere 2006, 63:785-793.
12. Isidori M., Nardelli A., Pascarella L., Rubion M., Parrella A. Toxic and genotoxic impact of fibrates and their photoproducts on non-target organisms. Environ Int 2007, 33:635-641.
13. Kaza M., Nalecz-Jawecki G., Sawicki J. The toxicity of selected pharmaceuticals to the aquatic plant Lemna minor. Fresenius' Environ Bull 2007, vol.16:524-531.
14. Keil F., (Ed.). Pharmaceuticals for human use: options of action for reducing the contamination of water bodies. A practical guide. 2008. http://www.start-project.de/downloads/start_Practical_Guide.pdf.
15. Kendall R.J., Anderson T.A., Baker R.J., Bens C.M., Carr J.A., Chiodo L.A., et al. Ecotoxicology. Casarett & Doull's toxicology: the basic science of poisons 2001, 1013-1045. The McGraw-Hill Companies. Sixth ed. C.D. Klaasen (Ed.).
16. Kümmerer K., Al-Ahmad A., Mersch-Sundermann V. Biodegradability of some antibiotics, elimination of the genotoxicity and affection of wastewater bacteria in a simple test. Chemosphere 2000, 40:701-710.
17. Metcalfe C.D., Metcalfe T.L., Kiparissis Y., Koenig B.G., Khan C., Hughes R.J., et al. Estrogenic potency of chemicals detected in sewage treatment plant effluents as determined by in vivo assays with Japanese medaka (Oryzias latipes). Environ Toxicol Chem 2001, 20:297-308.
18. Molander L., Ågerstrand M., Rudén C. WikiPharma-a freely available, easily accessible, interactive and comprehensive database for environmental effect data for pharmaceuticals. Regul Toxicol Pharmacol 2009, 55:367-371.
19. Nentwig G. Effects of pharmaceuticals on aquatic invertebrates. Part II: The antidepressant drug fluoxetine. Arch Environ Con Tox 2007, 52:163-170.
20. Nordic Ecolabelling Board. Regulations for Nordic Ecolabelling. 2001. Available at http://www.svanen.nu/pdf/Regelverk_eng.pdf.
21. Quinn B., Gagné F., Blaise C. An investigation into the acute and chronic toxicity of eleven pharmaceuticals (and their solvents) found in wastewater effluent on the cnidarian, Hydra attenuata. Sci Total Environ 2008, 389:306-314.
22. Rudén C. The use of mechanistic data and the handling of scientific uncertainty in carcinogen risk assessment-the trichloroethylene example. Regul Toxicol Pharmacol 2002, 35:80-94.
23. Rudén C. Science and policy in risk assessments of chlorinated ethenes. Ann N Y Acad Sci 2006, 1076:191-206.
24. Sanofi-aventis. Environmental classification assessment at LIFs webpage 2009-07-09. http://www.fass.se/LIF/produktfakta/artikel_produkt.jsp?NplID=19980320000202&DocTypeID=5#IDE4POFNUB4A0VERT1.
25. Schmitt-Jansen M., Bartels P., Adler N., Altenburger R. Phytotoxicity assessment of diclofenac and its phototransformation products. Anal Bioanal Chem 2007, 387:1389-1396.
26. Swedish Medical Product Agency (Läkemedelsverket). Report in Swedish, to the Swedish government: Miljöpåverkan från läkemedel samt kosmetiska och hygieniska produkter. 2004. Available at http://www.lakemedelsverket.se/upload/om-lakemedelsverket/publikationer/040824_miljouppdraget-rapport.pdf.
27. The European Parliament and the council of the European Union. Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32008R1272:EN:NOT.
28. The Swedish Association of the Pharmaceutical Industry (LIF). Environmental classification of pharmaceutical in fass.se-guidance to pharmaceutical companies. 2007. Available at: http://www.fass.se/LIF/lakarbok/lakemedelhalsa_artikel.jsp?articleID=76074.