Transcript Presentation pharma_JK 3

Local emission
estimates of
pharmaceuticals:
case study for Lithuania
Jolita Kruopienė
Kaunas University of Technology,
Institute of Environmental Engineering
(APINI)
Data
on sales / consumption of pharmaceuticals
• Sales data in Lithuania in 2005 – from
IMS Health
• Further on the data are referred to as
“consumption data”.
Data
on 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 –
e.g. fluoxetine
single ATC code &
single DDD value
ATC code:
DDD is:
N06AB03,
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 overestimation
e.g. Finasteride:
ATC code D11AX10, DDD = 1 mg,
ATC code G04CB0, DDD = 5 mg
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
Consumption of pharmaceuticals
< 0.001 kg 0.001 – 1
kg
(< 1 g)
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
Aspirin:
Paracetamol:
Amoxicillin:
Metformin:
37681 kg
14101 kg
11148.5 kg
10957.5 kg
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 SW
A

365  P  Winhab  D
• 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.
Environmental concentrations
Worst case scenario:
PEC SW
A

365  P  Winhab  D
• 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.
Environmental concentrations
Worst case scenario:
PEC SW
A

365  P  Winhab  D
• 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.
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