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Risperidone

Information

This summary information about persistence, bioaccumulation and toxicity comes from Fass. The information on risk comes from the report by Goodpoint.

Persistence. Risperidone is potentially persistent.
Bioaccumulation. Risperidone has low potential for bioaccumulation.
Toxicity. Risperidone has high acute toxicity.
Risk. See the report from Goodpoint.

Detailed information

Fass environmental information

Fass environmental information for Risperdal (risperidone) from Janssen (downloaded 2020-11-13).

Hazard

Persistence: "Based on the measurements of CO2 produced and DOC analysis, the percentage biodegradation calculated for Risperidone was 5%. Based on the measurements of CO2 produced and DOC analysis, the percentage biodegradation calculated for the reference substance glucose was > 60%. Consequently, it can be concluded that Risperidone is not readily biodegradable."

Bioaccumulation: "The average apparent partition coefficient (total solute measured, regardless of from) of R064766 in 1-octanol/aqueous solution at 25°C as determined by UV spectrometry is:

  • in 1-octanol/buffer pH 5: log P = 0.22
  • in 1-octanol/buffer pH 7: log P = 1.67
  • in 1-octanol/buffer pH 9: log P = 2.91"

Toxicity: There are data for 3 trophic levels, most sensitive Bluegill sunfish (Lepomis macrochirus) LC50 96 h = 5.8 mg/L (Survival).

Risk

PEC/PNEC is based on sales data in Sweden in year 2018. PEC/PNEC = 0.000388914 which gives the risk insignificant, i.e. consideration has not been given to measured levels in the environment.

Report Goodpoint

Concentrations found in wild fish in Sweden correspond to therapeutic concentrations in human, which seem reasonable due to the liposolubility of risperidone and concentrations detected in wastewater treatment plants.

Risperidone is included in Region Stockholm's table of pharmaceuticals with risk for negative environmental impact according to the environmental program 2017–2021. Risperidone has been detected in treated wastewater in Region Stockholm.

The Wise list

Risperidone is recommended in the Wise list. The Wise list is the drug formulary of essential medicines for common diseases in Region Stockholm from the Drug and Therapeutics Committee. Environmental classification of pharmaceuticals is taken into consideration, sometimes with other environmental aspects, when selecting pharmaceuticals for the Wise list. When comparable pharmaceuticals are equivalent to medical effects, safety and pharmaceutical efficacy, environmental impact and price are considered.

Suggestions on how to reduce the emissions of risperidone

Concrete proposals on how to work to reduce emissions of environmentally harmful pharmaceuticals on the list have been developed in close cooperation with the Stockholm Drug and Therapeutics Committee's expert groups. The action proposals were developed from an environmental perspective. The patient's best always goes first and several pharmaceuticals on the list are also included in the Wise list. However, for such pharmaceuticals, there may be measures that could reduce the environmental impact.

Concrete proposal for risperidone

  • Risperidone is recommended in the Wise list.
  • An option for new administration to patients with schizophrenia may be aripiprazole (recommended in the Wise list and is better from an environmental point of view than risperidone).
  • Only recommended as short term treatment in case of psychotic symptoms or severe aggression to the elderly.
  • Starter pack of certain strengths is available within the reimbursement system.

Author: Health and Medical Care Administration, Region Stockholm