October 2005
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:
- 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 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
- The Pharmaceuticals AG is a consensus-based group, and uses a consensus based decision making process
- The steering committee for the Pharmaceuticals AG has established ground rules to address how the steering committee and full AG agree to work together
- An effort will be made to maintain an equal balance on the Pharmaceuticals AG among academia, government, business, and non-profit sectors.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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:
- 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
- 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
- Operate effectively
- Do not over promise and under produce
- Follow-through on meeting action items
- 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:
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.
