Local emission estimates of

pharmaceuticals:case study for Lithuania

Jolita Kruopienė

Kaunas University of Technology,Institute of Environmental Engineering

(APINI)

Dataon sales / consumption of pharmaceuticals

• Sales data in Lithuania in 2005 – from IMS Health

• Further on the data are referred to as “consumption data”.

Dataon sales / consumption of pharmaceuticals

• Sales data in Lithuania in 2005 – from IMS Health

• Further on the data are referred to as “consumption data”.

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.

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 overestimatione.g. Finasteride:ATC code D11AX10, DDD = 1 mg,ATC code G04CB0, DDD = 5 mg

Consumption of pharmaceuticals

Use of pahamaceuticals: 517 substances.

• 436 substances remain

• vitamins (e.g. ascorbic acid),• microelements (e.g. calcium),• substances synthesized in human body

(e.g. insuline)

Consumption of pharmaceuticals

Aspirin: 37681 kg

Paracetamol: 14101 kg

Amoxicillin: 11148.5 kg

Metformin: 10957.5 kg

< 0.001 kg

(< 1 g)

0.001 – 1 kg

1 – 100 kg 100 – 1000 kg

1000 – 10000 kg (1-10 t)

> 10000 kg (>10 t)

Number 22 108 211 72 19 4

Frequency, %

5.0 24.8 48.4 16.5 4.4 0.9

Load to the environment

Emission estimates are a worse worst case scenario assuming

1) sales figures equal consumption,2) outlet from WWTP is the only gate to the

environment,3) no human metabolism, 4) no degradation in WWTP.

Load to the environment

Emission estimates are a worse worst case scenario assuming

1) sales figures equal consumption,2) outlet from WWTP is the only gate to the

environment,3) no human metabolism, 4) no degradation in WWTP.

Load to the environment

Emission estimates are a worse worst case scenario assuming

1) sales figures equal consumption,2) outlet from WWTP is the only gate to the

environment,3) no human metabolism, 4) no degradation in WWTP.

Load to the environment

Emission estimates are a worse worst case scenario assuming

1) sales figures equal consumption,2) outlet from WWTP is the only gate to the

environment,3) no human metabolism, 4) no degradation in WWTP.

Load to the environment

Emission estimates are a worse worst case scenario assuming

1) sales figures equal consumption,2) outlet from WWTP is the only gate to the

environment,3) no human metabolism, 4) no degradation in WWTP.

Load to the environment

Emission estimates are a worse worst case scenario assuming

1) sales figures equal consumption,2) outlet from WWTP is the only gate to the

environment, 3) no human metabolism, 4) no degradation in WWTP.

Total load depends on population density only.

Maximum load to the environment

Water basins and major cities in Lithuania

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.

DWinhabP

APECSW

365

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.

DWinhabP

APECSW

365

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.

DWinhabP

APECSW

365

PEC / PNEC

• Availability of toxicity data– PNEC calculated for 37 substances

• Only 3 pharmaceuticals exceed the PEC/PNEC ratio of 1: – amoxicillin,

– ciprofloxacin – spiramycin.

PEC / PNEC

• Availability of toxicity data– PNEC calculated for 37 substances

• Only 3 pharmaceuticals exceed the PEC/PNEC ratio of 1: – amoxicillin,

– ciprofloxacin – spiramycin.

PEC / PNEC

• Availability of toxicity data– PNEC calculated for 37 substances

• Only 3 pharmaceuticals exceed the PEC/PNEC ratio of 1: – amoxicillin,

– ciprofloxacin – spiramycin.

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

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

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

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

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

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

Load of amoxicillin to the environment