The presence and potential hazards of pharmaceuticals in the environment have received increasing international attention in the academic and popular press, as well as within the regulatory community. The increased focus on potential ecological effects from pharmaceuticals largely began as a result of a growing number of technical papers published from the late 1990s until the present that reported low levels of pharmaceuticals in Wastewater Treatment Plant effluent and surface water and, to a more limited extent, groundwater, drinking water, and sediment.

Environmental concerns about pharmaceuticals have consistently been linked to two factors:

• The bioactive property of pharmaceuticals, which is the basis of their therapeutic (pharmacological) activity.
• The potential for pharmaceuticals to be routinely present, albeit at low concentrations, from ongoing use.

Concerns have been raised about whether the current environmental risk assessment scientific methodology may need to be revised or replaced to evaluate the potential environmental impact of pharmaceuticals appropriately.

The Society of Environmental Toxicology and Chemistry (SETAC) Pharmaceuticals Advisory Group (AG) was established to advance the science and understanding of pharmaceuticals in the environment. It is a formally recognized forum within SETAC and was established by the SETAC World Council (SWC) in October 2005. Membership of the Pharmaceuticals AG is open to all SETAC members, as well as to all professionals interested in the topics addressed by the Pharmaceuticals AG.

We intend to develop this part of the website over the coming months so that it becomes a useful forum for researchers and others interested in pharmaceuticals in the environment. Currently our web pages include:

• The scope, purpose and operating guidelines of the Pharmaceuticals AG
• Membership of the Pharmaceuticals AG Steering Committee
•  A Powerpoint presentation on the background and purpose of the Pharmaceuticals AG from the 2005 SETAC North America Annual Conference.

Scope, Purpose and Guidelines:

Introduction

The presence and potential hazards of
pharmaceuticals in the environment have received increasing
international attention in the academic and popular press, as well as
within the regulatory community. The increased focus on potential
ecological effects from pharmaceuticals largely initiated as a result
of a growing number of technical papers published from the late 1990s
until the present that reported low levels of pharmaceuticals in WWTP
effluent and surface water, and to a more limited extent, groundwater,
drinking water, and sediment.

Environmental concerns about pharmaceuticals have consistently been linked to two factors:

1. The bioactive property of pharmaceuticals, which is the basis of their therapeutic (pharmacological) activity
2. The potential for pharmaceuticals to be routinely present, albeit at low concentrations, from ongoing use

Concerns have been raised about whether the current environmental risk
assessment scientific methodology may need to be revised or replaced to
appropriately evaluate the potential environmental impact of
pharmaceuticals.

The
Society of Environmental Toxicology and Chemistry (SETAC)
Pharmaceuticals Advisory Group (AG) was established to advance the
science and understanding of pharmaceuticals in the environment. It is
a formally recognized forum within SETAC and was established by the
SETAC World Council (SWC) in October 2005. Membership to the
Pharmaceuticals AG is open to all SETAC members, as well as to all
professionals interested in the topics addressed by the Pharmaceuticals
AG.

Scope

The scope of the SETAC Pharmaceuticals
AG is human and veterinary pharmaceuticals. Personal Care Products
(PCP) and other emerging contaminants are not included since it is
specifically pharmacological bioactivity that has called into question
the adequacy of the existing environmental risk assessment science for
pharmaceuticals. Scientific coverage of the Pharmaceuticals AG includes
all fields pertinent to conducting effective environmental risk
assessments for pharmaceuticals, such as transport, fate, exposure,
effect, and impact analysis. All environmental compartments, such as
aquatic, terrestrial, and biomass are included.

The following are accepted characteristics of a pharmaceutical:

The US Food and Drug Administration definition of a drug includes the following concepts:

• A substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease
• A substance (other than food) intended to affect the structure or any function of the body

The EU definition of a medicinal product includes the following
concepts of pharmaceutical substances or combinations of substances:

• Having properties for treating or preventing disease
• Administered with a view to restoring, correcting or modifying
  physiological functions by exerting a pharmacological, immunological or
  metabolic action, or to making a medical diagnosis.

Mission and Purpose

The Pharmaceutical AG exists to serve
as a scientific resource to all stakeholders impacted by the topic of
pharmaceuticals in the environment, and fulfills the following mission
and purpose:

• Serve as a focal point within SETAC as a means of involving the membership in research and discussions
• Stimulate critical assessment in order to establish the best available science
• Encourage the worldwide incorporation of the best available science and strategic approaches
• Advance the overall understanding of the fate, effects, and potential environmental consequences of pharmaceuticals
• Provide scientific support to ensure effective regulatory decision making
• Provide a neutral platform and focal point for collaborative identification, evaluation, and resolution of scientific issues

Roles and Responsibilities of the Pharmaceuticals AG

To
achieve its mission and purpose, the roles and responsibilities of the
Pharmaceuticals AG include developing and implementing a long-range
strategic plan for stimulating and participating in the advancement of
Pharmaceuticals AG-related environmental science. Roles and
responsibilities focus on identification of research needs and
fostering scientific exchange. In specific, the steps the
Pharmaceuticals AG may take to meet its mission and purpose include,
but are not necessarily limited to:

• Preparation of technical papers (general information, issue specific)
• Developing a specific area of the SETAC web site for the Pharmaceuticals AG
• Developing a discussion forum on the SETAC web site
• Sponsoring general pharmaceuticals technical sessions at meetings
• Holding targeted (subject specific) discussion groups at meetings
• Implementing short courses, for example in advance of either SETAC or other conferences (i.e., DIA/ILSI-HESI)
• Presentations to government agencies
• Communication of updates in the SETAC Globe
• Developing guidelines for conducting studies with pharmaceuticals
• Providing educational materials for the public and school systems

Roles and Responsibilities of the Pharmaceuticals AG Steering Committee Members

• Identify and utilize opportunities to advance the Pharmaceutical
  AG’s mission and purpose through generating ideas, making decisions,
  and taking action
• Aspire to establish the Pharmaceuticals AG as being recognized and sought as an authoritative expert body
• Communicate with external thought leaders and decision makers to advance the effectiveness of the Pharmaceuticals AG
• Monitor progress in achieving the Pharmaceutical AG scientific objectives and elevate the AG scientific performance as needed
• Monitor performance of the Pharmaceuticals AG and AG steering committee as teams and elevate performance as needed
• Ensure the Pharmaceutical AG operating principles are consistently applied
• Report to the SETAC World Council at least annually on AG activities and plans
• Coordinate with and/or inform the SETAC office on all Group activities

Operating principles

1. The Pharmaceuticals AG is a consensus-based group, and uses a consensus based decision making process
2. The steering committee for the Pharmaceuticals AG has established
   ground rules to address how the steering committee and full AG agree to
   work together
3. An effort will be made to maintain an equal balance on the
   Pharmaceuticals AG among academia, government, business, and non-profit
   sectors.
4. While meetings of the full Pharmaceuticals AG may be scheduled as
   needed, the AG plans to hold at least 2 meetings per year. One will
   coincide with the SETAC North America Annual Meeting and the second
   with the SETAC Europe Annual Meeting.
5. The Pharmaceuticals AG steering committee will hold at least 2
   face-to-face meetings per year. One will coincide with the SETAC North
   America Annual Meeting and the second with the SETAC Europe Annual
   Meeting. In addition, the steering committee will hold conference calls
   on a regular basis, with the frequency being agenda driven, determined
   by the nature of projects under consideration.
6. An agenda will be prepared for each meeting of the Pharmaceuticals
   AG steering committee or the full AG and circulated at least 1 week in
   advance. Any items for the agenda should be submitted to the
   Pharmaceuticals AG chair at least 2 weeks prior to a meeting. Minutes
   from an AG meeting will be distributed through the SETAC office.
7. The Pharmaceuticals AG encourages the volunteer nature of SETAC.
   SETAC believes that, in order to progress, it is important to have
   individuals present at meetings. As such, SETAC recognize that
   individuals occasionally might need to obtain subsistence on a
   case-by-case basis. Approval of such will be granted on a need basis
   subject to funds being available and granted by the SETAC office.
8. Success of the Pharmaceuticals AG depends, in part, on the active
   participation of its members. Any Pharmaceuticals AG steering committee
   member who misses 3 consecutive meetings or conference calls without
   acceptable justification will be released from the Pharmaceuticals AG
   steering committee.
9. Any materials to be distributed to the entire Pharmaceuticals AG or
   to the SETAC membership should be forwarded first to the
   Pharmaceuticals AG chair. Following review, materials then will be sent
   to the SETAC Executive Director or designee, who will assemble
   materials and periodically distribute them. The Pharmaceuticals AG
   steering committee may communicate amongst itself without a direct
   connection through the SETAC office, although all communications will
   be copied to the SETAC office.
10. All members of the AG will adhere to the SETAC Constitution and By-Laws.

Ground Rules

The Pharmaceuticals AG steering
committee and AG itself agree to work together in the following manner
in order to accomplish the AG mission and purpose:

1. Maintain Respect for People
   -   Listen fully
   -   Test your understanding of assumptions
   -   Problem solve together
   -   Be tolerant of each other's perspective
   -   Be open, honest, and candid
   -   Respect confidentiality
   -   Be mindful of the complexities presented by conference calls
   -   Work to be inclusive of the full membership
2. Conduct organized meetings
   -   Utilize a written agenda (old business, new business, ongoing   business)
   -   Start and end meetings on time.
   -   Come to meetings prepared - - review pre-meeting reading materials
   -   Publish minutes as soon as possible following meetings
   -   Stay focused on the topic
   -   Utilize a reminder system to return to issues that arise
3. Operate effectively
   -   Do not over promise and under produce
   -   Follow-through on meeting action items
4. Decision-Making: Use consensus as the primary decision making approach
   -   Test for consensus before moving ahead with the agenda
   -   Manage challenges consistently. Use the following process:
       *   Identify the issues
       *   Identify and verify the basis of any conflicts
       *   Focus on the science to seek consensus
       *   In cases where consensus cannot be achieved, clearly indicate the issue and outcome in the minutes

Connections

The SETAC Pharmaceuticals AG will establish and maintain connections to:

• ERAPharm http://www.erapharm.org/summary.html
• American Chemical Society (ACS)
• Society of Risk Analysis
• Society of Toxicology (SOT)
• Regulatory initiatives/agencies
• Others

Funds

Funding for the various activities is through
SETAC, which is a non-profit 501(c)(3) organization. The
Pharmaceuticals AG, under the auspices of SETAC, will manage the funds
of the Pharmaceuticals AG.

Budget

An annual budget
will be prepared by the SETAC Pharmaceuticals AG. This budget will be
submitted for inclusion in the overall annual budget for SETAC.

Oversight

The
SETAC World Council will provide regular review of the Pharmaceuticals
AG, including the Steering Committee structure and activities and, if
necessary, will offer guidance to ensure compliance with established
policy.

The Pharmaceuticals AG will regularly report the activities of the Pharmaceuticals AG to the SETAC World Council.

SETAC Relationship

SETAC
is a nonprofit professional society founded to promote the use of
multi–disciplinary approaches in the study of environmental issues.
SETAC represents nearly 6000 environmental toxicologists, chemists,
risk assessors, and engineers worldwide. The Society was founded on the
principle that it is important to have a membership comprised of equal
representation of persons from academia, industry, NGOs, and government
agencies. SETAC members are involved in diverse areas, such as
education, research, environmental management, manufacturing and
distribution of products in commerce, and regulatory activities.

In
addition to serving its members, a primary goal of SETAC is to provide
balanced, scientific information to planners, legislators, managers,
regulators, and others, and to assist in the development of technically
sound environmental policies, laws, and regulations.

SETAC has
achieved its goal of providing a forum for the examination of
environmental issues by environmental professionals from academia,
industry, and government. This forum includes two international
journals, technical workshops, special publications, a bimonthly
newsletter (the Globe), and meetings—regional, national and global.

The
SETAC Pharmaceuticals AG reports to the SETAC World Council through the
Pharmaceuticals AG chair. The Pharmaceuticals AG is committed to
advancing the purposes of SETAC while fulfilling its primary mission
and purpose. The Pharmaceuticals AG represents a balance among
academia, industry, government, and non-profit organizations; is
multi-disciplinary in representation; and is international in scope.

Program, Task Forces, and Working Committees

Specific
activities such as workshops, conferences, and educational materials or
“white” papers undertaken by the Pharmaceuticals AG are approved by the
SETAC World Council.

The Pharmaceuticals AG can, as needed,
solicit assistance from various SETAC committees to help
Pharmaceuticals AG activities. For example, technical activities are
conducted through the SETAC Technical Committee, educational activities
through the SETAC Education Committee, and publication and
dissemination of technical information through the SETAC Publication
Advisory Council.

The SETAC Office serves as a coordinator and disseminator of AG activities.

The
Pharmaceuticals AG will maintain a liaison with other SETAC groups
performing Pharmaceuticals AG-related environmental activities.

Advisory Group Steering Committee Membership

Membership
in the Steering Committee is intended to achieve balance and will
follow the basic SETAC guidelines, with representation from academia,
industry, government, and non-profit organizations. The Steering
Committee will be comprised of no less than eight and no more than
fifteen individuals. Balanced representation from the various SETAC
geographic units should be made to the extent possible.

The SETAC Executive Director or designee will serve as an ex officio member of the Pharmaceuticals AG Steering Committee.

The
President of the SETAC World Council, based on consultation with
Pharmaceuticals AG members, appoints the chair of the Pharmaceuticals
AG Steering Committee from among the Steering Committee members.

Pharmaceuticals AG Steering Committee members must be national or regional SETAC members.

Pharmaceutical
AG Steering Committee members will serve two-year terms. Any steering
committee member can serve only for two consecutive terms, after the
term of the founding Pharmaceuticals AG Steering Committee.

The
founding Pharmaceuticals AG Steering Committee will serve a two-year
term starting in January 2006. At the end of two years, the founding
Pharmaceuticals AG Steering Committee will begin to stagger their
leaving the AG Steering Committee to ensure a turnover of approximately
one-third members per year. The term on the AG Steering Committee will
be tied to calendar years.

When new members are to be appointed
to the Steering Committee, the SETAC office will announce the vacancy
at least four (4) months prior to the appointment date. Anyone who fits
(1) sector category (academia, industry, NGO, government), (2) has
institutional or personal support, (3) has expertise or interest in
Pharmaceuticals AG-related environmental issues, and (4) has a
commitment to the mission and operating guidelines of the AG can
express their interest in being considered for appointment to the AG
Steering Committee. A name must be placed into consideration at least
one (1) month prior to the appointment of new members.
In instances
where an AG steering committee member must leave before completing
his/her term, and when there are more than six months remaining in the
term, the AG Steering Committee will identify individuals from the
departing member’s sector to fulfill the term. Individuals will be
identified to the AG steering committee at least two weeks prior to the
appointment of the replacement.

Steering Committee:

Katie Barrett - Huntingdon Life Sciences, UK
Alistair Boxall - York University, UK
Bryan Brooks - Baylor University, US
Dan Caldwell - Johnson & Johnson, US
Mark Crane - Watts & Crane Associates, UK
Suzanne Fitzpatrick - Food & Drug Administration, US
Jan Koschorreck - Federal Environmental Agency, Germany
Jim Lazorchak - Environmental Protection Agency, US
Hans Sanderson - Danish National Environmental Research Institute, DK
Jane Staveley - ARCADIS G&M Inc., US
John Sumpter - Brunel University, UK
Rich Williams - Chair – Pfizer Inc, US

Background and Purpose:

Click HERE
for a PowerPoint presentation on the background and purpose of the
Pharmaceuticals AG from the 2005 SETAC North America Annual Conference.