Green Pharmacy: Minimizing the Potential Effects of Pharmaceuticals and Personal Care Products on the Environment
Nicholas D. Anastas, Ph.D., M.S. Poseidon's Trident, Milton , MA

Do Pharmaceuticals in Water Pose a Risk to Human Health?
Edward V. Sargent, MPH, PhD, DABT, Managing Principal, EV Sargent LLC and Adjunct Professor, UMDNJ School of Public Health, Clearwater, FL

Pharmaceuticals in the Environment: Environmental Risk Assessment
Manu Sharma, M.S., P.E., Principal, Gradient Corporation, Cambridge , MA

Are APIs EDCs?
Tim Verslycke, Ph.D., Gradient Corporation and Visiting Investigator, Woods Hole Oceanographic Institution., Cambridge, MA

Green Pharmacy: Minimizing the Potential Effects of Pharmaceuticals and Personal Care Products on the Environment
Nicholas D. Anastas, Ph.D., M.S. Poseidon's Trident, 83 Sassamon Avenue , Milton , MA 02186 , Tel: 617.698.7105, E-mail: mtanastas@comcast.net  

Improvements in therapeutics and advancements in pharmacological and pharmaceutical research have increased longevity and improved the quality of life for many people.  The number of prescriptions written by physicians and veterinarians for pharmaceuticals and personal care products (PPCP), and the availability and use of over-the counter- medications, has significantly increased in response to these advancements and to increased patient demand.  

Over the past twenty years, the presence of these classes of compounds detected in the environment has become an issue of emerging concern because of the potential damage to aquatic systems and possibly humans.  Environmental regulatory agencies were not set up to incorporate PPCP risk characterization as part of a comprehensive risk reduction strategy.  Regulatory agencies, academic research laboratories and private sector enterprises have devoted significant resources towards identifying the scope of this issue. Green Pharmacy or Sustainable Medicine is a strategy to identify drivers and barriers to implementing measures to manage PPCPs in the environment.

This talk will focus on efforts that are currently underway that support the concept of green pharmacy as a core component of holistic chemistry.  Some of these topics include green chemistry and green chemical design, unused or unwanted medicine take-back programs, and Sweden ’s efforts for environmental classification of pharmaceuticals.

Do Pharmaceuticals in Water Pose a Risk to Human Health?
Edward V. Sargent, MPH, PhD, DABT, Managing Principal, EV Sargent LLC and Adjunct Professor, UMDNJ School of Public Health, 1430 Gulf Boulevard, Suite 205, Clearwater, FL, 33767, USA, Tel: 908.803.5524, Email: evsargent@gmail.com

Within the last decade, an increasing number of studies have identified pharmaceuticals in the surface waters of Europe and North America .  Advances in analytical methods allow pharmaceuticals to be identified and detected at concentrations at the low ng/L levels.  Studies have measured an even smaller number of pharmaceuticals in drinking water.  The results of these studies understandably raise questions about the potential risks to human health, however only a few risk assessments have been conducted.  Because of these and other questions, global regulatory requirements for assessing the fate and effects of pharmaceuticals in the environment have expanded.  In addition to meeting regulatory requirements, human health risk assessments have been conducted by pharmaceutical companies and industry organizations.  In addition, a model to evaluate the fate and transport of pharmaceuticals in water has been developed and used to conduct larger scale risk assessments.  The results of these risk assessments indicate that the pharmaceuticals detected in water generally pose little risk to human health.  New science based approaches are needed however to continue to explain the significance of pharmaceuticals detected in water.

 

Pharmaceuticals in the Environment: Environmental Risk Assessment
Manu Sharma, M.S., P.E., Principal, Gradient Corporation, 20 University Road , Cambridge , MA 02138 , Tel: 617.395.5000, Fax: 617.395.5001, E-mail: msharma@gradientcorp.com

Pharmaceuticals have likely been present in the environment since their use began.  However,recent advances in analytical chemistry, have allowed us to detect and quantify trace amountsof active pharmaceutical ingredients (APIs) in surface waters and drinking water, which in turn, has raised public awareness.  While there are clear regulatory drivers and well established frameworks for environmental risk assessment of new pharmaceuticals as part of the drug registration process, such frameworks might not address the breadth of public concerns regarding the presence and potential effects of APIs on our environment. 

This talk will provide a general introduction to the environmental fate and transport of pharmaceuticals and the major sources of pharmaceuticals in the Environment.  In addition, it will present the existing regulatory frameworks for assessing the environmental risks associated with the societal use of new pharmaceuticals as part of the drug registration process in the USA (FDA) and the EU (EMEA).  Environmental risks associated with manufacturing of pharmaceuticals and not covered under this framework will be highlighted through a number of case studies.  Finally, an overview of product stewardship practices that are currently implemented by global pharmaceutical companies to pro-actively address potential environmental issues will be presented.

 

Are APIs EDCs?
Tim Verslycke , Ph.D., Environmental Toxicologist, Gradient Corporation and Visiting Investigator, Woods Hole Oceanographic Institution, 20 University Road , Cambridge , MA 02138 , Tel: 617.395.5000, Fax: 617.395.5001, E-mail: verslycke@gradientcorp.com

Active Pharmaceutical Ingredients (APIs) are purposefully designed to be ‘active’ and ‘effective’ at low doses to treat or prevent a myriad of diseases, pains, anxiety or other forms of perceived discomfort in humans or animals.  Endocrine Disrupting Chemicals (EDCs) are substances that are accidentally ‘active’ when absorbed by humans and animals by mimicking or otherwise interfering with the action of natural hormones, thereby disrupting normal body functions.  Issues related to the presence of APIs and EDCs in the environment have been at the center of media attention, public concern, and government action for more than a decade.

This talk will compare several issues associated with APIs and EDCs in the environment.  First, while the societal benefits associated with both groups of compounds are clear, the unintended environmental and human risks associated with their use are the subject of ongoing controversy and research.  Second, while the regulatory framework for assessing potential environmental risks associated with APIs is well established, such frameworks are just being defined and implemented for EDCs.  Third, the roadblocks that hinder scientifically sound environmental risk assessment for APIs and EDCs are remarkably similar.  Finally, emerging issues related to APIs or EDCs now quickly become breaking news stories, and present risk communication challenges for industry, as well as decision challenges for consumers in the face of mass- and mis-communication.