Background information on the risk assessment criteria
The information provided on these pages is part of AstraZeneca’s ongoing programme of environmental data transparency. It has been made available to allow readers to see how AstraZeneca evaluates the possible environmental risks posed by its products in use and how it ensures that these risks are fully understood alongside the benefits our medicines bring to patients. The amount of data differs for the APIs, and generally there is more information for the newer compounds compared with the older ones. Also, more long-term (chronic) data are available for the newer APIs. AstraZeneca is continuously reviewing and updating the information as necessary.
Information is given for each individual Active Pharmaceutical Ingredient (API), and consists of the predicted environmental risk quotient (PEC/PNEC, see below), a summary of the environmental risk assessment (ERA) and a table with the environmental study results that are available. In addition, consistent with applicable regulatory guidelines (e.g. European Medicines Agency1, 2006 ), a note is made if the API is exempted from regulatory ERA because it is unlikely to result in a significant risk to the environment.
For pharmaceuticals it is primarily the aquatic compartment that is of interest, since human medicines may be excreted partly or wholly unchanged by patients, and subsequently enter the sewage system and ultimately rivers and other surface waters. The environmental risk of medicines is determined by the environmental risk quotient. The environmental risk quotient is the ratio between the Predicted Environmental Concentration (PEC) of the API in the aquatic environment and the Predicted No Effect Concentration (PNEC), i.e. the concentration, based on the available test results, predicted to cause no effect on the organisms living there. Usually a ‘worst-case’ risk quotient is presented and as such our PEC information is based on the European country with the highest per capita use2. The total patient consumption is based on the total volume of API from all human medicines containing the same active ingredient (including products marketed by other companies where applicable).
If the concentration in the environment is lower than the no effect concentration (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 potential risk of impact on the environment.
In our assessments the environmental risk is divided into four different categories, depending on the risk quotient, consistent with the system for environmental information on www.fass.se, the web version of the Swedish Prescribing guide.
The risk categories are as follows:
|PEC/PNEC ≤ 0.1 Use of the substance has been considered to result in insignificant environmental risk.|
|0.1 < PEC/PNEC ≤ 1 Use of the substance has been considered to result in low environmental risk.|
|1 < PEC/PNEC ≤ 10 Use of the substance has been considered to result in moderate environmental risk.|
|PEC/PNEC > 10 Use of the substance has been considered to result in high environmental risk.|
The ERA summary given for each API is consistent with the environmental information provided as part of our marketing applications or, where this is not available, from the currently available data. The table containing the environmental data is available by clicking on the API name, and includes the results from ecotoxicology (e.g. fish, invertebrate and alga) and fate (e.g. partition coefficient octanol/water, biodegradation and abiotic degradation) tests. Relevant literature data may be included where appropriate.
2. Based on IMS Health data for 2010, including 19 European markets (Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Netherlands, Norway, Poland, Portugal, Slovakia, Spain, Sweden, Switzerland and United Kingdom)