Approaches on management for pharmaceutical and personal care products in water.

Sirbu, Dana ; Curseu, Daniela ; Popa, Monica 等

Abstract: Pharmaceutical and Personal Care Product (PPCPs) are organic contaminants ubiquitous in aquatic ecosystems throughout the world. The occurrence of these pollutants in wastewater, rivers, groundwater and drinking water is a European wide problem. There are only few researches in our country about the extent of environmental occurrence, and the risks for human health. This paper focuses on the current status of PPCPs in surface water in some European countries and the opportunities for managing risk and to develop a management strategy which describes the current policies and procedures to protect public health and to minimize the environmental risks associated with PPCPs in the Romanian environment.

Key words: pharmaceutical, personal care products, surface water, management, environmental risk.

1. INTRODUCTION

Pharmaceuticals and personal care products are a diverse group of thousands of chemical substances (generally synthetic organic compounds) that are consumed by people (or animals) for health or cosmetic reasons including: pharmaceuticals, diagnostic agents (X-ray contrast media) fragrances, cosmetics, sunscreens agents (e.g., methylbenzylidene camphor), skin anti-aging preparations (e.g., retinoid)., personal hygiene products, and nutritional supplements.

PPCPs can enter the environment (in surface water, groundwater and even in drinking water) when PPCP residues in treated sewage effluent (or in terrestrial run-off or directly discharged raw sewage) are released from sewage treatment systems. Major sources for PPCPs that have been identified include: wastewater effluents of municipal sewage treatment plants (STPs), hospital wastewater effluents, animal production facilities, animal wastes, manure application, aquaculture practices, biosolids disposal management applications (STPs and manures), disposal practices for unused drugs and cosmetics.

They are emerging pollutants of concern which can affect reproductive and developmental processes in humans, wildlife, and laboratory animals (endocrine disruptors). Due to the low extent of biodegradation and high lipophilicity tend to accumulate in biological tissues, in aquatic and terrestrial organisms. The human risk of long-term exposure to very low concentrations of PPCPs in drinking water is essentially unknown. There is potential concern specifically for infants, fetuses, and people with enzyme deficiencies. (Daughton & Ternes 1999)

2. OCCURRENCE DATA OF PPCPs

Approximately 3000 different pharmaceutical ingredients and a lot of personal care products are used in the EU today. Several studies in Europe reported that concentrations generally range from the low ppt--to ppb--levels (ng/l to [micro]g/l) (Ricking et al., 2003; Moldovan, 2005). The highest concentration levels of investigated pharmaceuticals seem to occur in Germany.

For some of the PPCPs such as carbamazepine and diclofenac the concentrations are comparable for most of the countries. For other PPCPs such as the macrolide antibiotic roxithromycin significant differences were found, for instance between Germany (560 ng/l) and France (9ng/l). Diazepam was detected in Germany (40 ng/l) and also in Romania (60 ng/l in Somes River). In Romania, in Somes River an important quantity of compounds used as Personal Care Products such as: polycyclic musk fragrance (Galaxolide (HHCB) and Tonalide (AHTN)) were detected around 300 ng/l. The unchanged quantity of these fragrances, detected in different places along of the river is according with the stability of these compounds as reported by many studies (Moldovan, 2005; Ricking et al., 2003).

Analytical approaches for monitoring PPCPs in European countries showed that PPCPs do occur in sewage influent but in most cases are removed by various wastewater treatment processes and sewage treatment works (table 2). Comparisons between concentrations of drugs in influent and final effluent samples are consistent with efficient removal of most drugs during sewage treatment, but some drugs, such as Carbamazepine may be relatively resistant to degradation. For Finland the situation seems to be a little bit different, since the wastewater concentrations of diclofenac and bezafibrate are lower and those of ibuprofen are higher than in central Europe. In the Polish WWTP, tonalide (AHTN) and roxithromycin, and in the Spanish WWTP diclofenac and roxithromycin were not found.

3. STRATEGY IN THE PROCESS OF PPCPs' MANAGEMENT

In order to be able to reduce the possibility of the environment getting contaminated by the elimination of PPCPs we propose the following strategy in the process of management:

3.1 Identifying danger through quantitative and qualitative evaluation of all the PPCPs used during a given period of time (one year). Robust analyses on a regional basis of volume use data for pharmaceuticals, natural health products and cosmetics and personal care products is essential to focus on priority substances.

3.2 Evaluating the potential risk for PPCPs present on the environment. This should be based on the risk assessment framework proposed by the European Medicines Agency in 2 phases (EMEA, 2005; Thomas et al., 2006). In the first phase the extent of environmental exposure is estimated while in the second phase the fate and effects of the active residue (parent and/or metabolites) are assessed. In Phase I the Predicted Environmental Concentration (PEC) calculation is restricted to the aquatic compartment ([PEC.sub.surface water]). If this [PEC.sub.surface water] value is above 0.01[micro]g/l a Phase II environmental effect analysis should be performed. The keys determinants of environmental exposure are the loading rate of PPCPs into the environment (the volume use of human and veterinary pharmaceuticals, cosmetics and personal care products and survey data for PPCPs in effluents of municipal STPs and in wastewater effluents of hospital) and the environmental fate including bioaccumulation potential that is governed according to the physical-chemical properties of the introduced substance. In Phase II, it is important to make use of physico--chemical data, relevant pharmacological-toxicological and toxicokinetic studies and information on degradability, persistence or the potential for bioaccumulation of the active substance and/or relevant metabolites.

Based on risk assessment results it will be selected the interventions in the process of PPCPs management, which will include more information from:

--municipal wastewater treatment (the PPCPs of concern, their ionic form, removal rates, need for a life-cycle assessment of products). Most pharmaceuticals are high soluble in water. (Daughton & Ternes, 1999). For many pharmaceuticals that are synthetic organic compounds, granular activated carbon, powdered activated carbon, reverse osmosis, and nanofiltration are likely to be more effective.

--agriculture evaluation of the effectiveness of odor and nutrient control measures under current agricultural best management practices for manure, sewage, biosolids disposal via spreading on agricultural land to determine whether they are protective for PPCPs, persistence and effect of PPCPs in agricultural soils, the potential for PPCPs to leach to groundwater or enter surface waters via agricultural runoff).

--drinking water: to establish the type and the level of PPCPs present in drinking water, to choose the best available management strategy for drinking water - e.g. activated carbon filtration to know its effectiveness for the removal of PPCPs).

--pharmaceuticals use and disposal practices: prevention of over-prescription and inappropriate use requires by communication with physicians, environmental stewardship programs to keep unused pharmaceutical products out of landfills and sewers through industry supported collection programs via local pharmacies (Sirbu et al., 2005).

3.3 Taking decisions--according to the character of the information gathered previously must be stated: the ways of eliminating liquid effluents, the control sites, the frequency of gathering samples and the special indicators which have to be monitorized. Risk management options need to be developed and could include a public education and risk communication strategy, environmental research strategy, national wastewater treatment, and agriculture management strategy.

4. CONCLUSIONS

PPCPs have been detected in some Rumanian rivers, but little is known about the extent of environmental occurrence, transport, and ultimate fate of many synthetic organic chemicals after their intended use. Environmental effects monitoring studies and surveillance programs with clear objectives are required. Long-term monitoring studies need to be conducted that are statistically meaningful in order to observe temporal trends in data.

5. REFERENCES

Daughton, C.G. &Ternes, T.A. (1999). Pharmaceutical and personal care products in the environment: Agents of subtle change? Environ.Health. Perspect., 107 (supl 6), 907-938

European Medicines Agency (EMEA) (2005). Guideline on the environmental risk assessment of medicinal products for human use. Available from: http://www.emea.europa.eu/pdfs/human/swp/444700en.pdf Accessed: 2007-03-12

Moldovan Z. (2005). Structure of organic pollutants detected in surface waters from Romania. Proceedings of Sustainability for humanity and environment in the extended connection field science--economy--policy. pp 157-160, ISBN 973-625-205-1, febr. 2005, Ed Politehnica, Timisoara.

Ricking, M.; Schwarzbauer, J.and Franke. S. (2003). Molecular markers of anthropogenic activity in sediments of the Havel and Spree Rivers (Germany). Wat Res 37 pp. 2607-2617.

Sirbu, D.; Popa, M.; Curseu, D. & Hegedus, L. (2005) Hospital Waters--A Management Plan in Order to Prevent the Nosocomial Infections. Proceedings of Sustainability for Humanity & Environment in the Extended Connection Field Science-Economy-Policy. pp. 325-329. ISBN 973-625-206-X. febr. 2005. Ed. Politehnica, Timisoara.

Thomas, K.; Kallqvist, T. & Grung, M. (2006) Initial assessment of eleven pharmaceuticals using the EMEA guidelinein Norway. Available from: http://www.sft.no/publikasjoner/2216/ta2216.pdf. Accessed: 2007-04-15.

Table 1. Median concentrations (in ng/l) of PPCPs in rivers of
some European countries.

PPCPs Romania Germany Austria

 Pharmaceuticals

Diclofenac d 150 20
Ibuprofen d 70 n.d.
Bezafibrate n.dt 350 20
Diazepam 60 40 n.d.
Carbamazepine n.dt. 250 75
Roxithromycin n.dt. 560 n.d.
Iopromide n.dt. 100 91

 Musks

Tonalide 300 n.dt. n.dt.
Galaxolide n.dt. n.dt.

PPCPs France Switzerland Finland

 Pharmaceuticals

Diclofenac 18 20-150 15
Ibuprofen 23 150 10
Bezafibrate 102 n.a. 5
Diazepam n.d. n.d. n.d.
Carbamazepine 78 150 70
Roxithromycin 9 n.a. n.a.
Iopromide 7 n.a n.a.

 Musks

Tonalide n.dt n.dt n.dt.
Galaxolide n.dt n.dt n.dt.

* d detected; n.d- non detectable < detection limit;
n.a non available; n.dt non determinate

Table 2. Median concentrations of PPCPs (in ng/l)

 Germany Austria Poland

 Diclofenac

Influent 3500 3100 1750
Effluent 810 1500 n.a

 Ibuprofen

Influent 5000 1500 2250
Effluent 370 22 n.a

 Bezafibrate

Influent 4900 2565 780
Effluent 2200 103 n.a.

 Diazepam

Influent n.d. n.d. n.a
Effluent 40 n.d. n.a

 Carbamazepine

Influent 2200 960 1150
Effluent 2100 916 n.a.

 Roxithromycin

Influent 830 66 n.d.
Effluent 100 43 n.a.

 Iopromide

Influent 1300 n.d. 1330
Effluent 750 n.d. 680

 Tonalide (AHTN)

Influent 400 970 n.d
Effluent 90 140 n.a

 Galaxolide (HHCB)

Influent 1500 2800 610
Effluent 450 470 n.a

 Spain Switzerland Finland

 Diclofenac

Influent n.d. 1400 350
Effluent n.d 950 250

 Ibuprofen

Influent 2750 1980 13000
Effluent 970 50 1300

 Bezafibrate

Influent n.d. n.a 420
Effluent n.d. n.a. 205

 Diazepam

Influent n.d. n.d. n.d.
Effluent n.d. n.d. n.d.

 Carbamazepine

Influent n.a 690 750
Effluent n.a 480 400

 Roxithromycin

Influent n.d. 20 n.a.
Effluent n.d. 15 n.a.

 Iopromide

Influent 9300 810 n.a.
Effluent 6600 790 n.a.

 Tonalide (AHTN)

Influent 1530 545 200
Effluent 160 410 40

 Galaxolide (HHCB)

Influent 3180 1660 750
Effluent 500 1150 120