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Environmental Toxicology and Chemistry 21 (1): 47-54 The Swedish Environmental Classification and Information System for Pharmaceuticals.

An Evaluation of the System's Achievements so hydrocodone no perscription overseas far Marlene Agerstrand and Christina Ruden.

KTH According to the pharmaceuticals legislation in Europe, ecotoxicity testing and environmental risk assessment is required for new marketing notifications, but the marketing of a pharmaceutical cannot be denied based on its hydrocodone no perscription overseas ecotoxicological properties. Therefore, given the current situation, other risk management options might be considered. One way to reduce emissions of a particular pharmaceutical substance, if considered motivated, is to reduce prescriptions of products that contain that substance. One way to potentially affect prescriptions is to provide information about the pharmaceuticals' ecotoxicity and promote environmentally benign alternatives when available. A major initiative with the purpose to provide such information is the Swedish Environmental Classification and Information System for pharmaceuticals (SECIS). In this chapter we report the results from a detailed evaluation of the environmental risk assessments conducted within SECIS so far. The results reported concern the use of environmental toxicity data for the purpose of risk assessment and classification.

For results concerning additional aspects and the full analyses see Agerstrand and Ruden, 2010. Background The Swedish Environmental Classification and Information System for pharmaceuticals (henceforth called SECIS) is a voluntary system for classification of pharmaceuticals based on their effect in non-target environmental species. The system was initiated in 2005 by the Swedish Association for the Pharmaceutical Industry (LIF).

In addition to LIF, several other stakeholders within the healthcare sector participated in the development of the system. The stakeholders are the Stockholm County Council, the Swedish Medical Products Agency, Apoteket AB (the Swedish pharmacy chain) and the Swedish Association of Local Authorities and Regions (Mattson, 2007). According to LIF's webpage (www.fass.se), is oxycodone making me irritable the purpose of the classification system is to provide the public new phentermine phentermine 37 and health care sectors with environmental information about all active pharmaceutical ingredients on the Swedish market by 2010. Environmental risk assessment according to SECIS According to the SECIS guidance document the risk assessment within this system should follow the basic principle of environmental risk assessment, namely to combine information about the hazardous properties of an active pharmaceutical ingredient hydrocodone no perscription overseas with its estimated (or measured) environmental concentrations to determine the PEC/PNEC ratio (Predicted Environmental Concentration / Predicted No Effect Concentration). The processes for environmental risk assessment for general chemicals and for pharmaceutical substances respectively are introduced in chapter 5. Within SECIS the PEC/PNEC ratio is used to classify each pharmaceutical product according to pre-defined criteria into a risk category an a risk phrase. The system has four categories for environmental risk and two categories for indicating lack of data.

For an overview and summary of these criteria see Table 1. (The Swedish Association of the Pharmaceutical Industry, 2007). SECIS classification criteria and the corresponding risk categories/risk phrases.

SECIS Criteria Risk category PEC/PNEC 10 Use of the medicine has been considered to result in high environmental risk Data is lacking Risk of environmental impact cannot be excluded, since no ecotoxicity data are available Data availability is hydrocodone no perscription overseas insufficient Risk of environmental impact cannot be excluded, however some ecotoxicity data are available The PEC value shall be calculated by using the formula and the basic principles specified by European Medicines Agency (EMA) (EMA, 2002). It is also possible to use measured environmental concentrations (MEC) if sufficient data is available (The Swedish Association of the Pharmaceutical Industry, 2007). For the PNEC, the SECIS guidance document allows both for effect data originating from the companies' own studies and for data generated by other pharmaceutical companies or by independent research groups. All data should, ideally, be generated by methods supported by appropriate standards such as those issued by OECD (Organisation for Economic Co-operation and Development) or the FDA (United States Food and Drug Administration).



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