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Swedish environmental classification of pharmaceuticals


Background

The possible impact of pharmaceutical substances on the environment is a subject that attracts increasing attention. In June 2006 the European Medicines Agency (EMA) adopted the revised guideline called “Guideline on the environmental risk assessment of medicinal products for human use” which in detail describes how environmental risk assessments should be performed and documented before submission of a Marketing Authorisation Application for approval in the EU.


In Sweden, the MPA (MedicalProducts Agency / Läkemedelsverket) was instructed by the government to carry out a commission, and a report was presented in August 2004: ”Environmental impact from pharmaceuticals as well as cosmetics and hygienic articles”. Other actors in the Swedish health sector also contributed by proposing classification schemes. The MPA in its report concluded that EU rules apply and that it is not legally possible to request specific environmental data on pharmaceuticals (in the registration procedure). The Minister for the Environment, Ms Lena Sommestad, in September 2004 expressed a strong wish for action from the industry and other interested parties. The Swedish Association of the Pharmaceutical Industry, LIF, then took the initiative to develop a voluntary classification system for the environmental impact of pharmaceutical substances, together with interested parties in the health care sector.


A model for presenting environmental data was then designed by LIF in cooperation with the MPA, the Swedish Association of Local Authorities and Regions (SALAR /Sveriges Kommuner och Landsting), the Swedish pharmacy chain Apoteket AB and the Stockholm County Council. The model aims at presenting environmental information about pharmaceutical products so that it is easily accessible to the general public as well as to professionals in the health care system. On 10 October 2005, information on the first two groups of products (PPIs and SSRIs) was published on the web site www.fass.se (the Swedish medical products list with over 4 million hits every month). The two groups were included in the pilot test of the new model.

In october 2010, environmental information in all therapeutic groups have been reviewed and published.

Environmental impact

Information on the environmental impact of pharmaceutical substances is presented on three levels.


  1. The basic level gives short information on the environmental risk, degradation and potential for bioaccumulation of the active pharmaceutical substance (API). See table 1-3 for summary phrases. The environmental risk is based on the ratio between the predicted concentration of the substance in Swedish water systems (PEC, Predicted Environmental Concentration) and the concentration that is predicted to be safe for organisms and plants living in them (PNEC, Predicted No Effect Concentration). If the concentration in the environment is lower than the concentration that, based on tests, is regarded as safe for organisms (i.e. PEC/PNEC is lower than 1), the risk of environmental impact is low or negligible. If, on the other hand, PEC is higher than PNEC (the ratio PEC/PNEC is higher than 1), there is a risk of impact on the environment. The environmental risk is supplemented with information about the characteristics of the substance with regard to degradation and the potential for bioaccumulation of the substance, i.e. if the substance accumulates in aquatic organisms, thereby gradually increasing in concentration higher up in the food chain. A substance that degrades with difficulty and/or has the capacity to bioaccumulate could mean that exposure increases since the concentration in the environment increases, which in turn enhances the risk over time of environmental impact.

    This level of information is adapted to answer questions by the general public or patients on the environmental effects of the pharmaceuticals used. It comprises the basic level of information on Fass.se for patients.

    All background data for the previous assessment of environmental risk, degradability and bioaccumulation are presented on the in-depth level, which also details how the assessment was made. This level of information is basically intended for specialists and is available both via the patient and prescriber versions of Fass.se.

    .


How to find and translate the environmental information

The environmental classification is present in the product information on Fass.se, below the heading Miljöpåverkan, and is easily found by clicking the M-symbol located to the right of the product name. The environmental information on Fass.se is always given in Swedish in the summary phrases (i.e. Environmental risk = miljörisk, Biodegradation = nedbrytning and Bioaccumulation = bioackumulering). Table 1 helps to translate the Swedish phrases. However, the background data in Läs mer>> is quite often given in English.


You find the pharmaceuticals with environmental classification by simply choosing Miljöinformation in the search area (SÖK) located to the left. The products are sorted either in alphabetic order (alfabetiskt på läkemedel), by company name (alfabetiskt på företag) or ATC-code (ATC-kod).



Table 1. Environmental risk summary phrases in English and Swedish

Environmental risk

Miljörisk

PEC/PNEC ≤ 0.1

Use of *name of the substance* has been considered to result in insignificant environmental risk.

Användning av *substansnamnet* har bedömts medföra försumbar risk för miljöpåverkan.

PEC/PNEC ≤ 1

Use of *name of the substance* has been considered to result in low environmental risk.

Användning av *substansnamnet* har bedömts medföra låg risk för miljöpåverkan.

PEC/PNEC ≤ 10

Use of *name of the substance* has been considered to result in moderate environmental risk.

Användning av *substansnamnet* har bedömts medföra medelhög risk för miljöpåverkan.

PEC/PNEC > 10

Use of *name of the substance* has been considered to result in high environmental risk.

Användning av *substansnamnet* har bedömts medföra hög risk för miljöpåverkan.

If there is no data to calculate the PEC/PNEC.

Risk of environmental impact of *name of the substance* cannot be excluded, since no ecotoxicity data are available.

Risk för miljöpåverkan av *substansnamnet* kan inte uteslutas då ekotoxikologiska data saknas.

If there is some, but not sufficient data to calculate the PEC/PNEC.

Risk of environmental impact of *name of the substance* cannot be excluded, since there is not sufficient ecotoxicity data available.

Risk för miljöpåverkan av *substansnamnet* kan inte uteslutas då det inte finns tillräckliga ekotoxikologiska data.

When PEC/PNEC <1 but the substance is flagged as a potential PBT (Persistent, Bioaccumulative and Toxic) or vPvB (very Persistent and very Bioaccumulative).

Hazardous environmental properties.

Särskilt miljöfarliga egenskaper.


Table 2. Degradation summary phrases in English and Swedish

Degradation

Nedbrytning

*Name of the substance* is degraded in the environment.

*Substansnamnet* bryts ned i miljön.

*Name of the substance* is slowly degraded in the environment.

*Substansnamnet* bryts ned långsamt i miljön.

*Name of the substance* is potentially persistent.

*Substansnamnet* är potentiellt persistent.

The potential for persistence of *name of the substance* cannot be excluded, due to lack of data.

Det kan inte uteslutas att *substansnamnet* är persistent, då data saknas.

According to the established EU criteria, *name of the substance* should be regarded as a PBT/vPvB substance.

I enlighet med EU:s fastställda kriterier ska *substansnamnet* betraktas som en PBT/vPvB-substans.


Table 3. Bioaccumulation summary phrases in English and Swedish

Bioaccumulation

Bioackumulering

*Name of the substance* has low potential for bioaccumulation.

*Substansnamnet* har låg potential att bioackumuleras.

*Name of the substance* has high potential for bioaccumulation.

*Substansnamnet* har hög potential att bioackumuleras.

The potential for bioaccumulation of *name of the substance* cannot be excluded, due to lack of data.

Det kan inte uteslutas att *substansnamnet* kan bioackumuleras, då data saknas.

According to the established EU criteria, *name of the substance* should be regarded as a PBT/vPvB substance.

I enlighet med EU:s fastställda kriterier ska *substansnamnet* betraktas som en PBT/vPvB-substans.


Publiceringsdatum: 2013-09-24