For this summary information, data on bioaccumulation comes from the Plenadren (hydrocortisone) assessment report and risk comes from the report from Goodpoint.
Persistence. It cannot be excluded that hydrocortisone is persistent, due to the lack of data.
Bioaccumulation. Hydrocortisone has low potential for bioaccumulation.
Toxicity. It cannot be excluded that hydrocortisone is toxic, due to the lack of data.
Risk. Although both exposure and efficacy data are incomplete for hydrocortisone and prednisolone, there are no strong indications of environmental risk for these two substances. On the contrary, the fish plasma model and reported levels in the environment indicate low risk.
Since 2006, an Environmental Risk Assessment (ERA) for the active pharmaceutical substance shall accompany an application for a marketing authorisation in EU for a medicinal product for human use. Parts of environmental data can be found in the public investigation report (PAR/EPAR for medicinal product through a centralized procedure). Since the benefit/risk assessment for human medicinal products at present does not include environmental effects, an update of the environmental risk assessment is not required for renewals of marketing authorizations. There is thus no requirement for companies to stay informed about the development of their substances from an environmental point of view and consequently to update the environmental risk assessment as new data are published.
"The PECsurfacewater has been calculated to be 0.00662 µg/L using a DOSEai of 40 mg.inh-1.d-1 and default values for WASTEWinhab and DILUTION and this is below the EMEA action limit of 0.01µg/l. The Fpen value has been refined based on the following assumptions: The incidence of the disease i.e. the maximum number of patients that can be treated by Plenadren are 33.1 in a population of 100,000 inhabitants. Thus, out of a population of 500,000,000 in Europe (EU27) a maximum number of 165,500 can be treated with Plenadren per year. The maximum daily dose is 40 mg/day over 365 days. Therefore the total amount of Plenadren used over a year in the EU is 2416.6 kg. Using the calculation in the Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use (CHMP/SWP/4447/00) an Fpen value of 0.00031 % is calculated. Therefore, a Phase II assessment is not considered necessary. The logKOW of hydrocortisone is below the threshold of 4.5 and consequently further investigation of the potential for persistence and bioaccumulation are not necessary. No other environmental concerns are apparent."
Fass environmental information for Ficortril (hydrocortisone) from Pfizer (downloaded 2021-04-20).
Persistence: No data.
Bioaccumulation: No data.
Toxicity: No data.
Risk of environmental impact of hydrocortisonecannot be excluded, due to the lack of environmental toxicity data.
Comparative assessment of environmental risk when using the corticosteroids betamethasone, budesonide, hydrocortisone and prednisolone from a Swedish perspective.
The use of both betamethasone and budesonide poses an environmental risk, and exchange with synthetic glucocorticoids with a lower environmental risk is to be advocated in cases where it is possible from a clinical perspective. Hydrocortisone and prednisolone have a lower environmental risk but are rarely medically interchangeable alternatives to betamethasone and budesonide. Note that corresponding environmental risk assessments have not been made for other synthetic glucocorticoids that are available on the Swedish market, and which could possibly constitute exchange alternatives. No actions are recommended with regard to replacement of hydrocortisone and prednisolone as their use poses a low environmental risk given the current state of knowledge.
Author: Health and Medical Care Administration, Region Stockholm