effluents, explaining that it is not a common practice internationally. Nonetheless, the Australian National Guidelines for Water Recycling (Phase 2) provides
guidelines about concentrations that are applicable to potable water supplies
[33]; in the other hand, Drinking Water Guideline provides a recommended
drinking water concentration for 86 pharmaceuticals, with agricultural and
veterinary applications [40], and in two programs, in Western Australia and
Queensland, three pharmaceutical indicators are monitored regularly: carbamazepine, estrone, and diclofenac. Carbamazepine and diclofenac are monitored
monthly and estrone quarterly, with testing frequency determined by the Department of Health based on estimated risk levels; also, 13 hormones and pharmaceuticals (including estriol, 17 a-estradiol, 17 b-estradiol, testosterone,
androstenedione, etiocholanolone, equilenin, ethinyl estradiol, estrone, equilin,
mestranol, norethindrone, and progesterone) are measured once a year in line
with the standard water quality testing [41–43]. Another example is Singapore,
where the National Water Agency has a Water Monitoring Program which
includes a range of pharmaceuticals in the treated wastewater effluent such as
ibuprofen, naproxen, ketoprofen, triclocarban, gemfibrozil, and diclofenac since
2007, and nowadays the capacity for monitoring has expanded and includes
carbamazepine, trimethoprim, salicylic acid, and paracetamol [44].
(c) Level 3. Sporadic monitoring and small-scale mechanisms: where pharmaceutical residues are monitored intermittently, with little or no formal statutory
foundation. There are many examples of studies of the occurrence of pharmaceuticals in different countries and in different bodies of water; however there
are still more studies that can lead us to generate a regulation of the concentrations that do not produce toxic effects in the environment.
As can see, some NSAIDs have already been considered in levels 1 and 2 of the
regulations, but it is worth mentioning the particular case of diclofenac, which in
2013, in the Directive 2013/39/EU that talks about priority substances in the field of
water policy, in the article 16(4) in which is cited: “The Commission shall review the
adopted list of priority substances at the latest four years after the date of entry into
force of this Directive and at least every six years thereafter, and come forward with
proposals as appropriate,” and in accordance with this article, the commission
carried out a review of the list of priority substances and concluded that the list
should be amended in the light of scientific progress and the establishment of
environmental quality standards for biota substances (with 11 additional substances
added), it should be noted that this context was very useful, since it allow the
inclusion of emerging pollutants to the list of priority substances based on the results
obtained by various investigations, and in the case of pharmaceuticals specifically,
for the first time are mention as contaminants of emerging concern; in section 15
of the Directive 2013/13/EU refers to them textually: “The contamination of water
and soil with pharmaceutical residues is an emerging environmental concern. In
evaluating and controlling the risk to, or via, the aquatic environment from medicinal
products, adequate attention should be paid to Union environmental objectives. In
order to address that concern, the Commission should study the risks of
Risk Evaluation and Legal Framework of the Nonsteroidal Anti-inflammatory Drugs. . .
333
guidelines about concentrations that are applicable to potable water supplies
[33]; in the other hand, Drinking Water Guideline provides a recommended
drinking water concentration for 86 pharmaceuticals, with agricultural and
veterinary applications [40], and in two programs, in Western Australia and
Queensland, three pharmaceutical indicators are monitored regularly: carbamazepine, estrone, and diclofenac. Carbamazepine and diclofenac are monitored
monthly and estrone quarterly, with testing frequency determined by the Department of Health based on estimated risk levels; also, 13 hormones and pharmaceuticals (including estriol, 17 a-estradiol, 17 b-estradiol, testosterone,
androstenedione, etiocholanolone, equilenin, ethinyl estradiol, estrone, equilin,
mestranol, norethindrone, and progesterone) are measured once a year in line
with the standard water quality testing [41–43]. Another example is Singapore,
where the National Water Agency has a Water Monitoring Program which
includes a range of pharmaceuticals in the treated wastewater effluent such as
ibuprofen, naproxen, ketoprofen, triclocarban, gemfibrozil, and diclofenac since
2007, and nowadays the capacity for monitoring has expanded and includes
carbamazepine, trimethoprim, salicylic acid, and paracetamol [44].
(c) Level 3. Sporadic monitoring and small-scale mechanisms: where pharmaceutical residues are monitored intermittently, with little or no formal statutory
foundation. There are many examples of studies of the occurrence of pharmaceuticals in different countries and in different bodies of water; however there
are still more studies that can lead us to generate a regulation of the concentrations that do not produce toxic effects in the environment.
As can see, some NSAIDs have already been considered in levels 1 and 2 of the
regulations, but it is worth mentioning the particular case of diclofenac, which in
2013, in the Directive 2013/39/EU that talks about priority substances in the field of
water policy, in the article 16(4) in which is cited: “The Commission shall review the
adopted list of priority substances at the latest four years after the date of entry into
force of this Directive and at least every six years thereafter, and come forward with
proposals as appropriate,” and in accordance with this article, the commission
carried out a review of the list of priority substances and concluded that the list
should be amended in the light of scientific progress and the establishment of
environmental quality standards for biota substances (with 11 additional substances
added), it should be noted that this context was very useful, since it allow the
inclusion of emerging pollutants to the list of priority substances based on the results
obtained by various investigations, and in the case of pharmaceuticals specifically,
for the first time are mention as contaminants of emerging concern; in section 15
of the Directive 2013/13/EU refers to them textually: “The contamination of water
and soil with pharmaceutical residues is an emerging environmental concern. In
evaluating and controlling the risk to, or via, the aquatic environment from medicinal
products, adequate attention should be paid to Union environmental objectives. In
order to address that concern, the Commission should study the risks of
Risk Evaluation and Legal Framework of the Nonsteroidal Anti-inflammatory Drugs. . .
333