concentrations (50.6 and 27.8 μg L
À1 ). To estimate the RQ values in the effluent
wastewater and digested sludge, the highest concentrations found were taken and
used as MEC; as for the RQ values in the receiving streams and in the soils modified
with digested sludge, they were applied the highest PEC values. The greatest
ecotoxicological risk in wastewater and in digested sludge was ibuprofen (RQ: 3.2
and 4.4, respectively).
Bouissou-Schurtz et al. [24] focused on the list of 33 chemicals that was
established through a French national prioritization strategy. The assessment of the
potential risks to the environment was a gradual procedure: (1) the expected environmental concentration (PEC) of all the molecules evaluated in the national survey
was determined based on the highest recommended dose used and, (2) the concentration used Average Measured Environmental Concentration (MEC) and the
predicted no-effect concentration (PNEC) to establish the risk quotient (RQ) based
on the PEC/PNEC (estimated risk) or MEC/PNEC (real risk). The risk assessment
was performed using a binary ecological classification that suggests that an appreciable risk is likely (RQ 1). In this study, the environmental risk was estimated likely
for the following nonsteroidal anti-inflammatory drugs: acetaminophen (RQ ¼ 1.6),
ibuprofen (RQ ¼ 600), and diclofenac (RQ ¼ 15). Only ibuprofen was identified
with a real environmental risk based on its MEC (RQ ¼ 1.9).
Lolić et al. [15] conducted a study where the presence of seven drugs and two
metabolites belonging to the therapeutic classes of nonsteroidal anti-inflammatory
drugs and analgesics were evaluated. A total of 101 samples covering 14 beaches
and 5 cities on the north coast of Portugal were evaluated. Acetaminophen,
ketoprofen, and the hydroxyibuprofen metabolite were detected in all seawater
samples at maximum concentrations of 584, 89.7, and 287 ng L
À1 , respectively.
Carboxyibuprofen had the highest concentration in seawater (1,227 ng L
À1 ). The
temporal distribution of the selected pharmaceutical products showed that, in general, higher concentrations were detected in August and September. The environmental risk represented by these pharmaceutical products detected in marine waters
at different trophic levels (fish, daphnids, and algae) was also evaluated, with respect
to their hazard quotient (HQ), which was calculated according to the guideline of the
European Union. The result was obtained from the quotient between the mean
environmental concentration (MEC) which was obtained from the different beaches
evaluated and the expected concentration without effect (PNEC), which was estimated using the acute ecotoxicological data of lesser magnitude reported in the
literature (EC 50 or LC 50 ) for acute toxicity studies at the three trophic levels and
applying an evaluation factor (usually 1,000), to establish the “worst-case” scenario.
If HQ is equal to or greater than 1, there is a possible environmental risk situation,
while when it is less than 1, no risk is expected. The fish were the species that
showed the highest HQ values and were the only species that had HQ 1 values, while
the daphnia and the algae showed a similar sensitivity to the detected pharmaceutical
products and never exceeded the threshold value of one. Diclofenac was the pharmaceutical product that recorded the highest HQs for fish at two of the sampling
points. Ibuprofen also showed a high HQ for fish, although the threshold limit was
never exceeded. For daphnids, the highest HQs for acetaminophen were obtained,
Risk Evaluation and Legal Framework of the Nonsteroidal Anti-inflammatory Drugs. . .
327
À1 ). To estimate the RQ values in the effluent
wastewater and digested sludge, the highest concentrations found were taken and
used as MEC; as for the RQ values in the receiving streams and in the soils modified
with digested sludge, they were applied the highest PEC values. The greatest
ecotoxicological risk in wastewater and in digested sludge was ibuprofen (RQ: 3.2
and 4.4, respectively).
Bouissou-Schurtz et al. [24] focused on the list of 33 chemicals that was
established through a French national prioritization strategy. The assessment of the
potential risks to the environment was a gradual procedure: (1) the expected environmental concentration (PEC) of all the molecules evaluated in the national survey
was determined based on the highest recommended dose used and, (2) the concentration used Average Measured Environmental Concentration (MEC) and the
predicted no-effect concentration (PNEC) to establish the risk quotient (RQ) based
on the PEC/PNEC (estimated risk) or MEC/PNEC (real risk). The risk assessment
was performed using a binary ecological classification that suggests that an appreciable risk is likely (RQ 1). In this study, the environmental risk was estimated likely
for the following nonsteroidal anti-inflammatory drugs: acetaminophen (RQ ¼ 1.6),
ibuprofen (RQ ¼ 600), and diclofenac (RQ ¼ 15). Only ibuprofen was identified
with a real environmental risk based on its MEC (RQ ¼ 1.9).
Lolić et al. [15] conducted a study where the presence of seven drugs and two
metabolites belonging to the therapeutic classes of nonsteroidal anti-inflammatory
drugs and analgesics were evaluated. A total of 101 samples covering 14 beaches
and 5 cities on the north coast of Portugal were evaluated. Acetaminophen,
ketoprofen, and the hydroxyibuprofen metabolite were detected in all seawater
samples at maximum concentrations of 584, 89.7, and 287 ng L
À1 , respectively.
Carboxyibuprofen had the highest concentration in seawater (1,227 ng L
À1 ). The
temporal distribution of the selected pharmaceutical products showed that, in general, higher concentrations were detected in August and September. The environmental risk represented by these pharmaceutical products detected in marine waters
at different trophic levels (fish, daphnids, and algae) was also evaluated, with respect
to their hazard quotient (HQ), which was calculated according to the guideline of the
European Union. The result was obtained from the quotient between the mean
environmental concentration (MEC) which was obtained from the different beaches
evaluated and the expected concentration without effect (PNEC), which was estimated using the acute ecotoxicological data of lesser magnitude reported in the
literature (EC 50 or LC 50 ) for acute toxicity studies at the three trophic levels and
applying an evaluation factor (usually 1,000), to establish the “worst-case” scenario.
If HQ is equal to or greater than 1, there is a possible environmental risk situation,
while when it is less than 1, no risk is expected. The fish were the species that
showed the highest HQ values and were the only species that had HQ 1 values, while
the daphnia and the algae showed a similar sensitivity to the detected pharmaceutical
products and never exceeded the threshold value of one. Diclofenac was the pharmaceutical product that recorded the highest HQs for fish at two of the sampling
points. Ibuprofen also showed a high HQ for fish, although the threshold limit was
never exceeded. For daphnids, the highest HQs for acetaminophen were obtained,
Risk Evaluation and Legal Framework of the Nonsteroidal Anti-inflammatory Drugs. . .
327