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France is one of the top ten consumers of pharmaceuticals worldwide and the largest consumer in Europe. Currently, more than 3,000 pharmaceuticals for human use and 300 veterinary medicines are available on the French market.
Pharmaceutical drugs are manufactured to be highly biologically active. They fall into a variety of chemical structure categories, including:
Like pesticides, drugs intended for human or animal use can be released into the environment in three ways:
To address this emerging issue, the National Plan on Drug Residues in Water (PNRM) was implemented between 2010 and 2015. This initiative was part of a general strategy to reduce the pollution of aquatic environments by micropollutants, in line with the objectives set by the Grenelle Environment Forum.
The plan was structured around three main areas of focus:
Assessing risks (including taking measurements from water, soil, and waste water treatment station discharges).
Establishing short-term management measure
Developing knowledge on the subject.
This study notably led to a Commission Implementing Decision published on 20 March 2015 (2015/495), establishing a watch list of substances for European Union-wide monitoring in the field of water policy pursuant to Directive 2008/105/EC of the European Parliament and of the Council.
This list contains 11 substances or groups of substances:
Additionally, the opinion on the limits of quantification of parameter-matrix pairs for the accreditation of laboratories conducting analyses on water and aquatic environments was updated to include a list of pharmaceutical residues.
Where analysis methods are concerned, in France a standard was established with a list of 26 substances: XP T 90-223, concerning the detection and measurement of certain pharmaceutical residues in the dissolved fraction of water. This method uses solid-phase extraction and liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS).
CTC is COFRAC-accredited for this internal method, which is specifically adapted for fresh water.
The analysis involves directly injecting a filtered sample into an LC/MS/MS instrument.
LC stands for liquid chromatography, whereby molecules are separated in a liquid mobile phase (solvents) using a solid stationary phase called a chromatographic column.
Once separated, the molecules are ionised via an electrospray interface (ESI) and enter a first mass spectrometer (MS).
An ion is selected in this first mass spectrometer, then fragmented in the collision cell. The second mass spectrometer is then used to track the resulting fragments on a mass spectrum.
As part of a project with regulatory authorities, we searched for pharmaceutical residues in 94 samples of various origins (30% from fresh water sources and 70% from waste water). We tested for 70 molecules and 61 one of them were detected at least once.
The most frequently detected compound was cotinine, which is classified as a miscellaneous pharmaceutical agent and an anthropogenic marker of smoking. The next three were metformin (a miscellaneous pharmaceutical agent and antidiabetic agent), niflumic acid and paracetamol (an anti-inflammatory agent).
By category and across all matrices, 25% of detections were of anti-inflammatory agents. At the other end of the scale, only 3% of detections were of steroids and preservatives.
The maximum concentration level in fresh water remains below 1 µg/L.
In the waste water matrix, however, which includes industrial and sewage treatment station effluents, metformin had the highest concentration (700 µg/L) of the 20 most frequently detected molecules. This was followed by erythromycin and paracetamol.
It should be noted that oxazepam was detected in around 40 out of 68 samples. It is a neuroleptic agent and a metabolite of other neuroleptic agents, such as lorazepam and diazepam. This suggests that there are a large number of consumers in France.
We took the opportunity to compare the occurrences of the detected molecules with the list of the 30 best-selling active substances in urban areas in France (source: ANSM, 2013).
Paracetamol was detected around 50 times in the waste waters tested, and it was the top-selling active substance.
Yet, despite ranking seventh in terms of sales, aspirin (or acetylsalicylic acid) was never detected. Therefore, there is no established correlation. The persistence of these molecules in the environment depends on their stability or their half-life in the natural environment.