Pharmaceuticals have been singled out for specific attention as environmental pollutants but this is irrational. Pharmaceuticals , once in the environment, are similar to other emerging pollutants and should be treated on a case by case basis Attempts to regulate pharmaceuticals as a class of pollutants are unwarrented.

1. Chemical RiskAssessment & Environmental Consultancy
1
Demonizing human pharmaceuticals
is an inappropriate therapy resulting
from a flawed diagnosis.
David Taylor - wca environment

2. SETAC PAG Workshop – Basel May 2014 Slide 2
 Advances in analytical science enable us to see residues of
pharmaceuticals in the environment that used to be invisible.
 Most are <1 µg l-1, many are <0.1 µg l-1, Drinking Water <0.01 µg l-1
 The principle source of most pharmaceuticals to the
environment is from the excretion products of patients.
 At the levels currently present in the environment:
 Risks to human health are considered to be very unlikely
 Acute effects on aquatic life are considered to be insignificant
 Data on the potential long term impacts is increasing, and
varied, however some significant impacts on some
aquatic life forms cannot be ruled out.
What do we now know about
Pharmaceuticals in the Environment?
N J Ayscough, J Fawell, G Franklin and W Young 2000
Environment Agency R&D Technical Report P390
Review of Human Pharmaceuticals in the Environment

3. SETAC PAG Workshop – Basel May 2014 Slide 3
Plasticisers
Pesticides Biocides
Flame Retardants
Fragrances
Personal Care
Products
Detergents
PAHsPCBs
Perfluorooctanes
BPA
PharmaceuticalsPharmaceuticals
We are suffering from tunnel vision

4. SETAC PAG Workshop – Basel May 2014 Slide 4
The Challenge of Emerging Pollutants
 The number of substances that we couldn’t previously see
but can now detect is increasing exponentially.
Presence
is not
synonymous
with harm

5. SETAC PAG Workshop – Basel May 2014 Slide 5
Advances in Analytical Science
Decade Detection Limit Ratio Description
1900s 1 gram / litre (0.1%) 1 in 103
Parts per thousand
1930s 1 milligram / litre 1 in 106
Parts per million
1960s 1 microgram / litre 1 in 109
Parts per billion
1980s 1 nanogram / litre 1 in 1012
Parts per trillion
1990s 1 picogram / litre 1 in 1015
Parts per quadrillion
2010s 1 femtogram / litre 1 in 1018
Parts per quintillion
???? 100 molecules / litre 1 in 1021
???? 1 molecule / litre 1 in 1023
With a big enough sample analytical chemists can
now find anything, anywhere if they look hard enough.

6. SETAC PAG Workshop – Basel May 2014 Slide 6
What defines a pharmaceutical?
Pharmaceuticals cannot
be defined by any of
their chemical, physical,
structural or biological
properties
A pharmaceutical is simply any substance
that is used for a pharmaceutical purpose.

7. SETAC PAG Workshop – Basel May 2014 Slide 7
Pharmaceuticals in the environment:
The ‘Problem’ in perspective
Taylor & Senac (2014) [Doi: 10.1016/j.chemosphere.2014.01.011]
 Pharmaceuticals can only be differentiated from other substances
as a consequence of their use.
 Pharmaceuticals are ‘discovered’ not designed ab initio
 Compared to other micropollutants pharmaceuticals are:
 Neither more widely distributed nor found at higher concentrations
 Not more prone to mixture, metabolite or endocrine disruption effects
 Not necessarily more biologically active.
– Likely to be less toxic and accumulative in mammals
 There is thus no reason to treat the pharmaceutical group
differently to other groups of micropollutants
 However individual pharmaceuticals, like any other micropollutant, might
be of environmental significance e.g. Ethinylestradiol fish feminisation &
diclofenac on Asian vultures.

8. SETAC PAG Workshop – Basel May 2014 Slide 8
Pharmaceuticals are data rich
substances and are getting richer
More information is probably available on the toxicology
of pharmaceuticals than all other substances put together
Data on toxicology (including mutagenicity, carcinogenicity,
cytotoxicity, histopathology, teratogenicity …), kinetics,
metabolism, mode of action… for humans AND animals.

9. SETAC PAG Workshop – Basel May 2014 Slide 9
Faulty diagnosis can produce
inappropriate therapies

10. SETAC PAG Workshop – Basel May 2014 Slide 10
Beware the Policy Syllogism
“Something must be done!,
This is something,
Therefore we must do this”
Actions need to address actual
problems and be proportionate
BBC “Yes Minister” 1988

11. SETAC PAG Workshop – Basel May 2014 Slide 11
Pharmaceuticals in Drinking Water
Risk to HumanConsumers in Perspective

12. SETAC PAG Workshop – Basel May 2014 Slide 12
TREATED SEWAGE DISCOVERED
IN OUR DRINKING WATER
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THE DAILY NEWS
www.dailynews.com THE WORLD’S FAVOURITE NEWSPAPER - Since 1879

13. SETAC PAG Workshop – Basel May 2014 Slide 13
Any additional treatment technology should be
aimed at the global reduction of ALL those
micropollutants which indicate significant
environmental risk, not just pharmaceuticals
Removal of pharmaceuticals in wastewater
An expensive way to solve the wrong problem

14. SETAC PAG Workshop – Basel May 2014 Slide 14
What does the industry need to do?
 Minimise Environmental Exposure
 Ensure discharges of pharmaceuticals from
manufacturing are controlled.
 Optimise drug use by patients
 Actively promote and facilitate the safe
disposal of life expired & unused pharmaceuticals.
 Improve Understanding of Environmental Impact
 Publish ERAs for all existing pharmaceuticals.
 Establish active ecopharmacovigilance programmes.
 Continue to support research into the ecotoxicological
effects of chronic exposure to pharmaceuticals.

15. SETAC PAG Workshop – Basel May 2014 Slide 15
The societal risk benefit balance is
very different for pharmaceuticals
 Society will usually tolerate a higher level of risk to man
& the environment to gain significant patient benefit.
 Risk benefit assessment of pharmaceuticals is complex.
 Not all side effects will be known when the product is approved.
 Pharmacovigilance is used to update the assessment
 Trade offs will need to be made between + ve and – ve aspects.
 A balance will be needed between benefit and uncertainties.
 Pharmaceuticals receive a comprehensive in depth risk benefit
evaluation before they receive a marketing authorisation.
 A single regulator is needed to balance ALL the evidence.
 Authorised use of the drug may result in damage to the environment

16. SETAC PAG Workshop – Basel May 2014 Slide 16
Some degradation of the
natural environment may be
an acceptable price to pay
for significant human benefit
Another Inconvenient Truth
Apologies to President Gore
This has been socially acceptable since time immemorial
(We just don’t like to admit it)

17. SETAC PAG Workshop – Basel May 2014 Slide 17
SOCIALLY ACCEPTABLE AREAS OF VERY POOR
ECOLOGICAL QUALITY

18. SETAC PAG Workshop – Basel May 2014 Slide 18
SOCIALLY ACCEPTABLE AREAS OF EXTREME
BIOLOGICAL IMPACT

19. SETAC PAG Workshop – Basel May 2014 Slide 19
Conflict with the EU Water
Framework Directive
 Regulatory Approval for Marketing Authorisation of an NME
is based on a difficult balance of risks and benefits.
 Consequently pharmaceuticals are exempt from a lot of legislation to
avoid conflicting decisions being taken by different regulators.
 e.g. Art 2.5a of REACH provides an exclusion for medicinal products.
 Note Art 68 of REACH provides a reserve power for the Commission
 There is no exemption in the EU Water Framework Directive
 ALL waters to be of “good ecological quality”
 This is already causing problems as one regulator seeks to eliminate
potential environmental damage that a different regulator is prepared
to tolerate.

20. SETAC PAG Workshop – Basel May 2014 Slide 20
Potential consequences of requiring
compliance with WFD Quality Standards
 End of pipe treatment
 Upgrading effluent & water treatment plants is costly & uses energy.
 Estimated cost to remove Ethinylestradiol in the UK was €M36,000
 Selective targeting of ‘hot spots’ might limit costs.
 Source control (Restriction of drug availability)
 Reduced number of ‘over the counter’ (OTC) drugs available.
 e.g. Ibuprofen & Diclofenac could revert to prescription only.
 Increases GP consultations & increases health care costs.
 Replacement of old generics with newer products.
 Spreads total drug load across more compounds
 Increases health care costs.
 “Improved” prescribing
 More rigorous prescribing of antibiotics
 2% drop in ethinylestradiol input by not prescribing to girls below age of consent

21. SETAC PAG Workshop – Basel May 2014 Slide 21
Conclusions
 Pharmaceuticals as a group are no more of a problem than
any other micropollutant ‘group’.
 Individual pharmaceuticals may pose specific problems but
these should be dealt with on a case by case basis.
 Antibiotics may be a special case
 A satisfactory ERA is needed for all micropollutants
including all existing pharmaceuticals.
 A proportionate ‘no-regrets’ approach should be applied to
reducing inputs of all micropollutants to the environment
including pharmaceuticals.
 Faulty problem diagnosis can lead to inappropriate actions,
unhelpful regulatory conflicts and aggrieved citizens.

22. wca-consulting.com