Experiences gained through the Environmental Classification System for Pharmaceuticals
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Experiences gained through the Environmental Classification System for Pharmaceuticals Andreas Woldegiorgis, Ph. D. Conference on Sustainable Development and Pharmaceuticals, Uppsala 10-11/11, 2009. Overview. Background The PEC/PNEC relationship PEC and human metabolism

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Conference on sustainable development and pharmaceuticals uppsala 10 11 11 2009

Experiences gained through the Environmental Classification System for PharmaceuticalsAndreas Woldegiorgis, Ph. D.

Conference on Sustainable Development and Pharmaceuticals,

Uppsala 10-11/11, 2009


Conference on sustainable development and pharmaceuticals uppsala 10 11 11 2009

Overview

Background

The PEC/PNEC relationship

PEC and human metabolism

PEC and STP-removal

PNEC data in the fass.se system

The role of the system reviewer

A case study from the fass.se system

Conclusions


Conference on sustainable development and pharmaceuticals uppsala 10 11 11 2009

Frogs, fish and pharmaceuticals a troubling brew

Prozac, other drugs detected in streams and their inhabitants

By Marsha Walton CNNFriday, November 14, 2003 Posted: 9:14 AM EST (1414 GMT)

Two tapdpoles after 57 days of development in the lab. The one on the right, which has yet to sprout limbs, was exposed to fluoxetine, also known as Prozac.

(CNN) --A number of aquatic and amphibian species are being exposed to small amounts of everything from Prozac to perfume to birth control pills that make their way into U.S. rivers and streams.

And scientists now have evidence that this "cocktail" of pharmaceuticals, in high enough quantities, can lead to problems that may be serious enough to prevent wildlife from reproducing. It's not yet clear how the buildup over time could affect the species.

In 2002, 80 percent of streams sampled by the U.S. Geological Survey showed evidence of drugs, hormones, steroids and personal care products such as soaps and perfumes. The U.S.G.S. tested 139 rivers in 30 states.

Background;

Effects in the environment (and in the media..)


Conference on sustainable development and pharmaceuticals uppsala 10 11 11 2009

Or;

Approximatively 550 peer-reviewed articles published on the issue

"pharmaceuticals in the environment" between 1991-2008.

...~ 65 % published rather recently, 2006 and onwards...


Conference on sustainable development and pharmaceuticals uppsala 10 11 11 2009

Thus;

Any classification system of the environmental risks of

pharmaceuticals implemented 2005 must be considered as a

'living' system in which improvements and new

methodology can easily be implemented.


Basic principles of environmental risk assessment era

Predicted No Effect Concentration

Predicted Environmental Concentration

Basic principles of Environmental Risk Assessment (ERA)

Predicted concentration of the substance in the environment is related to the toxicity of the substance towards organisms living in the environment.

PEC / PNEC


Conference on sustainable development and pharmaceuticals uppsala 10 11 11 2009

Estimation of the Surface water PEC in µg/l

"A" ; sold amount annually [kg]

Or, in a simplified way...

Consumption in kg

PEC =

Nr of liters of water that the Swedish population uses annually

Thus, the system requires an exact estimation of the sold

amount of any given pharmaceutical!!!


Conference on sustainable development and pharmaceuticals uppsala 10 11 11 2009

Refinement (reduction...) of the PEC-value possible;

Metabolism in the human body;

from the fass.se-guideline;"...Identification of the metabolites, including specification of

conjugates, which may de-conjugate to the parent compound in a sewage treatment plant.

...Pharmacological activity (or eco-toxicity, if known) of the metabolites compared with the

parent compound."

Fate of the pharmaceutical upon passage of the waste water treatment plant;

If no eco-toxicological data on the main metabolite can

be found, PEC should NOT be reduced based on metabolism!

PEC-reduction should be based on either the SimpleTreat-model, OECD 303-experiments,

or extensive measurements!

SimpleTreat

(Strujis J, 1996, TGD (Ref. 4), Part II, Chapter 3, Appendix II)

"R" = f(OECD301/302-data, logH and logKow)


Conference on sustainable development and pharmaceuticals uppsala 10 11 11 2009

The PNEC data in the fass.se system;

Data should reflect tests performed on 3 trophic levels; algae, crustaceans and fish.

In order to ensure acceptable safety margin when going from lab tests on x individuals

to an entire population in the environment; a safety factor (AF) is applied. Thus;

If only short term acute data available then AF = 1000

.

.

.

If chronic long-term data are available from all 3 trophic levels, then AF = 10


Conference on sustainable development and pharmaceuticals uppsala 10 11 11 2009

PNEC data in the fass.se-system are mostly;

1) provided by the companies from standard tests performed during the ERA process.

2) reflecting acute and short-term testing conditions (thus seldom chronic data)

3) mostly data not taking the specific mode-of-action of the pharmaceutical into

consideration

4) never 'calculated' or estimated based on structure-activity relationships (SARs/QSARs)

Consequently, PNEC data currently used leave room for improvements when more

appropriate data becomes available!!


One important remark before we continue

One important remark before we continue....

  • PEC and PNEC data on all available substances are transparently displayed at the fass.se website (for anybody to check/audit)

    (along with data on biodegradation and bioaccumulation).

    The transparency (and availability) renders the system attractive to anybody interested;

    (authorities, stake holders, other companies).

  • Which other environmental classification systems possesses this property?


The role of ivl swedish environmental research institute in the fass se project

The role of IVL Swedish Environmental Research Institute in the fass.se-project

  • To scientifically review the environmental risk-and hazard data supplied by the pharmarceutical companies.

  • To comment the supplied risk assessments submitted and recommend improvements to ensure;

    • compatibility with the fass.se guideline,

    • that data chosen seem appropriate with respect to methodology used,

    • that the overall traceability of the data meets the guideline requirements.

  • To suggest improvements of the guideline to the environmental committée of LIF.

  • To summarize the data accumulated on fass.se to some general and overall synthese, beneficial to the stakeholders (at the end of the project).


  • Important considerations of the reviewing process

    Important considerations of the reviewing process

    • No direct contact between IVL-reviewers and pharmaceutical companies, all communication and data iteration through the LIF office.

    • A self-declaration system where the pharmaceutical companies "owns" their respective data. IVL does not 'police' the published material beyond the reviewing process.

    • The system is a classification system with a broad perspective, hence sometimes difficult to implement latest scientific findings from the research frontier.


    Case study fass se data may not always be enough to make environmentally good choices

    Case study; Fass.se-data may not always be enough to make environmentally good choices!

    • Sertraline and Citalopram considered equally good on some indications of depression (therapeutic effect of treatment).

    • PNEC (Sertraline) = 0.056 µg/l

    • PNEC (Citalopram) =4.9 µg/l ("Sertraline 88 times more "toxic"..)

    • Both "have the potential to bioaccumulate" (log Kow > 3)

    • Sertraline; "slowly degraded"

    • Citalopram; "potentially persistent" (due to lack of data)

    • PEC/PNEC (Sertraline) = 6.6

    • PEC/PNEC (Citalopram) = 0.05

    • Sertraline poses a 132 times higher environmental risk, nationally...

    • Best 'choice' would be Citalopram, right?


    Ivl screening data on stp effluents

    IVL Screening data on STP effluents

    Citalopram

    detected in all

    STP effluents;

    1-120 ng/l

    Sertraline never

    detected in any of

    the 28 effluents


    Fate of sertraline

    IVL Screening data on digested sludge

    Detected in all digested

    sludge samples;

    1.6 – 310 ng/g DW

    Fate of Sertraline ?

    In Stockholm;

    Citalopram easily reaches the

    the archipelago through

    the effluent discharge in Saltsjön

    while Sertraline-contaminated

    sludge is transported 2000 km

    to Lapponia where it is used as

    landfill!

    Which is the more favourable choice for the environment?


    Conclusions

    Conclusions

    • Scientific reviewing of the fass.se-data should safeguard that data and methods are in accd. with guidelines (fass.se and TGD) and that the interpretation of data is in accd. with the precautionary principle.

    • Scientific reviewing of the fass.se-data not always straightforward, many "special cases" not entirely covered by guidelines". The guideline is thus a 'living' document.

    • Fass.se-data can perferably be combined with occurence data and some kind of scientific rationale, fass.se is not a "bible" for ERA!

    • The total transparency of the fass.se system makes it unique as a classification system.

    • The system can be transferred to other countries!


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