Local emission estimates of pharmaceuticals: case study for Lithuania

1. Local emission estimates of pharmaceuticals:case study for Lithuania Jolita Kruopienė Kaunas University of Technology, Institute of Environmental Engineering (APINI)

2. Dataon sales / consumption of pharmaceuticals • Sales data in Lithuania in 2005 – from IMS Health • Further on the data are referred to as “consumption data”.

3. Dataon sales / consumption of pharmaceuticals • Sales data in Lithuania in 2005 – from IMS Health • Further on the data are referred to as “consumption data”.

4. Consumption data Mass = (DOT x DDD) / F One substance – single ATC code & single DDD value e.g. fluoxetine ATC code: N06AB03, DDD is: 20 mg.

5. Consumption data One substance – two or more ATC codes, two or more DDD values The worst case assumption by using the biggest DDD value for calculations  possible overestimation e.g. Finasteride: ATC code D11AX10, DDD = 1 mg, ATC code G04CB0, DDD = 5 mg

6. Consumption of pharmaceuticals Use of pahamaceuticals: 517 substances. • vitamins (e.g. ascorbic acid), • microelements (e.g. calcium), • substances synthesized in human body (e.g. insuline) • 436 substances remain

7. Consumption of pharmaceuticals Aspirin: 37681 kg Paracetamol: 14101 kg Amoxicillin: 11148.5 kg Metformin: 10957.5 kg

8. Load to the environment Emission estimates are a worse worst case scenario assuming • sales figures equal consumption, • outlet from WWTP is the only gate to the environment, • no human metabolism, • no degradation in WWTP.

9. Load to the environment Emission estimates are a worse worst case scenario assuming • sales figures equal consumption, • outlet from WWTP is the only gate to the environment, • no human metabolism, • no degradation in WWTP.

10. Load to the environment Emission estimates are a worse worst case scenario assuming • sales figures equal consumption, • outlet from WWTP is the only gate to the environment, • no human metabolism, • no degradation in WWTP.

11. Load to the environment Emission estimates are a worse worst case scenario assuming • sales figures equal consumption, • outlet from WWTP is the only gate to the environment, • no human metabolism, • no degradation in WWTP.

12. Load to the environment Emission estimates are a worse worst case scenario assuming • sales figures equal consumption, • outlet from WWTP is the only gate to the environment, • no human metabolism, • no degradation in WWTP.

13. Load to the environment Emission estimates are a worse worst case scenario assuming • sales figures equal consumption, • outlet from WWTP is the only gate to the environment, • no human metabolism, • no degradation in WWTP. Total load depends on population density only.

14. Maximum load to the environment

15. Water basins and major cities in Lithuania

16. Environmental concentrations Worst case scenario: • PEC values for 147 pharmaceuticals used in Lithuania in 2005 exceed the EU action level of 0.01 mg/l, • i.e. pharmaceuticals used in amount higher than 37.5 kg/year might cause a risk to the environment.

17. Environmental concentrations Worst case scenario: • PEC values for 147 pharmaceuticals used in Lithuania in 2005 exceed the EU action level of 0.01 mg/l, • i.e. pharmaceuticals used in amount higher than 37.5 kg/year might cause a risk to the environment.

18. Environmental concentrations Worst case scenario: • PEC values for 147 pharmaceuticals used in Lithuania in 2005 exceed the EU action level of 0.01 mg/l, • i.e. pharmaceuticals used in amount higher than 37.5 kg/year might cause a risk to the environment.

19. PEC / PNEC • Availability of toxicity data • PNEC calculated for 37 substances • Only 3 pharmaceuticals exceed the PEC/PNEC ratio of 1: • amoxicillin, • ciprofloxacin • spiramycin.

20. PEC / PNEC • Availability of toxicity data • PNEC calculated for 37 substances • Only 3 pharmaceuticals exceed the PEC/PNEC ratio of 1: • amoxicillin, • ciprofloxacin • spiramycin.

21. PEC / PNEC • Availability of toxicity data • PNEC calculated for 37 substances • Only 3 pharmaceuticals exceed the PEC/PNEC ratio of 1: • amoxicillin, • ciprofloxacin • spiramycin.

22. Taking into account metabolism • Even 60-70% of amoxicillin is excreted unchanged in urine. • ~ 35% of ciprofloxacine is excreted in urine as unchanged drug • Spiramycin is mainly excreted by non renal processes. Urinary excretion accounts for ~14% of an administered dose

23. Taking into account metabolism • Even 60-70% of amoxicillin is excreted unchanged in urine. • ~ 35% of ciprofloxacine is excreted in urine as unchanged drug • Spiramycin is mainly excreted by non renal processes. Urinary excretion accounts for ~14% of an administered dose

24. Taking into account metabolism • Even 60-70% of amoxicillin is excreted unchanged in urine. • ~ 35% of ciprofloxacine is excreted in urine as unchanged drug • Spiramycin is mainly excreted by non renal processes. Urinary excretion accounts for ~14% of an administered dose

25. Taking into account treatment in WWTP - About 80% of effluents in Lithuania undergo biological treatment - No biological treatment in Kaunas yet • 60% sorption onto sewage sludge is reported for amoxicillin • 65% of ciprofloxacin was eliminated by sorption, and 30% was detected in the effluent

26. Taking into account treatment in WWTP - About 80% of effluents in Lithuania undergo biological treatment - No biological treatment in Kaunas yet • 60% sorption onto sewage sludge is reported for amoxicillin • 65% of ciprofloxacin was eliminated by sorption, and 30% was detected in the effluent

27. Taking into account treatment in WWTP - About 80% of effluents in Lithuania undergo biological treatment - No biological treatment in Kaunas yet • 60% sorption onto sewage sludge is reported for amoxicillin • 65% of ciprofloxacin was eliminated by sorption, and 30% was detected in the effluent

28. Load of amoxicillin to the environment