D. Maine’s new program to prevent pharmaceuticals from entering Maine’s waters and aquatic environments

This session is approved for training contact hours (TCH) through Maine’s Wastewater Operator Certification Program. Sign-up sheets will be located in the session room.

Morning Session – 8:30AM-10:30AM
Capital Room (2nd floor, North Wing)

Session Chair:

Active Pharmaceutical Ingredients (API’s) enter Maine’s groundwaters, streams, lakes, rivers and coastal areas via flushing and trash disposal of unused prescription drugs through both septic systems, public water treatment systems, and landfills. These APIs can alter the ecosystems of our native waters, alter the DNA in our native species, bioaccumulate in target fish and invertebrates, and ultimately expose the public.

A new program is intended to prevent such exposures to our native waters, ecology, and public through a new campaign and collection system funded by the manufacturers of the pharmaceutical products distributed in Maine. The program will outline impacts of APIs on:

  • Aquatic food chain
  • Impacts to recreational and commercial fisheries
  • Exposure to Maine Public through drinking water and consumption of fish/seafood and wildlife

Session Overview

  • 8:30AM-8:55AM – Introduction of new program designed to prevent active pharmaceutical ingredients (APIs) from entering water resources in Maine. Robert R. Burks
  • 9:00AM-9:25AM – Connecting Environmental Toxicology with Pharmaceutical Sciences Through the Study of a Type 2 Diabetes Medication. Katie Edwards
  • 9:30M-9:55AM – Do some over-the-counter antimicrobials do more harm than good? The unexpected cellular and mitochondrial toxicity of triclosan and cetylpyridinium chloride. Julie Gosse
  • 10:00AM-10:25AM – Drugs in our water. Are pharmaceuticals a threat? Jenn Rehage

Session Abstracts

Presenters are indicated in bold font.

8:30AM-8:55AM
Introduction of new program designed to prevent active pharmaceutical ingredients (APIs) from entering water resources in Maine

A pdf of this presentation is available. Please contact Robert Burks with any questions.

Robert R. Burks
Program Lead, Aquatic ecologist/toxicology, Maine Department of Environmental Protection

Unused and unwanted pharmaceuticals acquired by residents of the state are typically flushed into a septic system or into a Wastewater Treatment Plant, where there is currently no technology to remove the active pharmaceutical ingredients (APIs) from the wastewater stream before emitting into local waters.    Disposal in landfills creates another issue where APIs can contaminate leachate generated by the landfill which can also enter native waters.   As a result, API’s may enter groundwater and the aquatic environment of Maine’s streams, rivers, lakes, and coastal waters, creating an adverse impact to the aquatic ecosystem and subsequently wildlife and human exposure.

This introduction describes the procedures designed to protect Maine’s waters, ecosystem, and reduce human exposure to APIs.  Maine is one of the few states in the US to establish such a program.

9:00AM-9:25AM
Connecting Environmental Toxicology with Pharmaceutical Sciences Through the Study of a Type 2 Diabetes Medication

A pdf of this presentation is available. Please contact Katie Edwards with any questions.

Katie Edwards
School of Pharmacy and Pharmaceutical Sciences, University of Binghamton

As of 2019, approximately 11.3% of the U.S. population (~28.5 million people) have diagnosed diabetes, with another 8.5 million U.S. adults remaining undiagnosed and 96 million U.S. adults estimated to have pre-diabetes. Projections suggest that the number of people with diabetes will triple by 2060. Metformin is a small molecule biguanide drug used as a first-line treatment for Type 2 diabetes and is prescribed to ~150 million people each year worldwide. The prescription prevalence, coupled with the high doses needed for efficacy (up to 2,000 mg/day) and lack of metabolism of this orally administered drug, contributes to significant release in wastewater. These factors prompted our interest in understanding its subtherapeutic effects in various systems ranging from bacteria to amphibians to human cells. Our focus has primarily been on how low concentrations of metformin impact thiamine (vitamin B1)-mediated processes. Thiamine is an essential cofactor in carbohydrate metabolism. Thiamine deficiency in aquatic organisms is a recurring concern in bodies of water ranging from the Great Lakes to the Baltic Sea, causing neurological symptoms and reproductive declines.

Aside from experiments that yield information across different concentration regimes and disciplines, another unique aspect of conducting environmental toxicology research in a pharmacy school is the opportunity to disseminate findings and expand environmental outreach to the pharmacy profession. Often motivated by preventing the misuse and diversion of drugs, our PharmD students actively participate in and organize local drug take-back events, educate patients, and advocate for legislation affecting drug policies at the state level. Aside from presenting our results, this conference provides an exciting forum to consider leveraging connections with the pharmacist community to improve drug disposal and recycling practices.

9:30M-9:55AM
Do some over-the-counter antimicrobials do more harm than good? The unexpected cellular and mitochondrial toxicity of triclosan and cetylpyridinium chloride

A pdf of this presentation is available. Please contact Julie Gosse with any questions.

Dr. Julie Gosse
Associate Professor of Biochemistry, University of Maine

A wide swath of humanity is exposed to high concentrations of over-the counter (OTC) antimicrobials via numerous workplace, personal care product, and agricultural applications. Some of these drugs have been in use for decades, even for a century, and were “grandfathered in” for continual use approval rather than ever being subject to scientific study of their toxicological effects on eukaryotes (including humans). Two of these chemicals include triclosan (TCS) and cetylpyridinium chloride (CPC). The benefits of any widespread, high dose chemical must be weighed with potential risks by gathering toxicology data. CPC may have additional beneficial effects beyond its known antibacterial properties, including anti-influenza and anti-SARS-CoV-2 activities. However, we have discovered adverse effects of both TCS and CPC, at low doses, on mammalian immune cell signaling and mitochondrial function. Ironically, these antibacterial agents, employed to fight microbial disease, may inhibit immune function. We have determined the effective dose ranges and underlying molecular mechanisms, which aid in prediction of toxic effects in other systems or with similarly-structured chemicals. Along with other researchers’ data and a raft of epidemiological findings, this research led to the recent banning or removal from TCS from most consumer products. CPC is far less-studied than TCS and remains in numerous OTC products. We employ molecular, biochemical, and biophysical tools, including super-resolution fluorescence microscopy, to unravel the mechanisms by which these chemicals modulate immune cell and mitochondrial function. Our work provides insights into impacts on public health and will point to either pharmacological uses for or toxic impacts of this ubiquitous chemicals.

10:00AM-10:25AM
Drugs in our water. Are pharmaceuticals a threat?

Dr. Jenn Rehage
Florida International University, Institute of Environment

Pharmaceuticals have been acknowledged as an important contaminant of emerging concern with the potential to cause adverse effects in exposed fauna. This study investigates the prevalence of pharmaceutical exposure to a recreational sportfish, bonefish (Albula vulpes), in South Florida, USA and evaluates the relative risk of adverse effects. We sampled blood plasma from 93 bonefish across five distinct regions and analyzed them for 102 commonly prescribed pharmaceuticals. The influence of sampling region, season of collection (within or outside spawning season) and bonefish length on pharmaceutical assemblage, detection frequency, and risk was assessed. To quantify risk, we compared the measured concentrations to a threshold of 1/3rd the human therapeutic plasma concentration (HTPC) for each pharmaceutical. A total of 53 different pharmaceuticals were detected with an average of 6.3 pharmaceuticals per bonefish and a maximum of 17 in an individual bonefish. Across all bonefish, 52.3% had at least one pharmaceutical exceeding the 1/3rd HTPC threshold of effect, with a maximum of 11 pharmaceuticals exceeding the threshold in an individual. The presence of pharmaceutical cocktails at concentrations capable of eliciting an effect is of particular concern considering the potential for unknown interactions and additive effects. For both exposure and risk, region was the only significant factor, and no effect was detected for spawning season or bonefish length. We found that exposure and risk was highest in the most remote sampling region, indicating the ubiquitous nature of pharmaceuticals and that their presence is not limited to urbanized and populous areas. Our results establish pharmaceuticals’ widespread prevalence in subtropical coastal marine ecosystems, exposure and risk to biota, and the necessity for further research beyond freshwater systems.

About Our Session Chair

Robert R. Burks earned a Marine Biology degree from the University of North Carolina and is currently pursuing a master’s in environmental epidemiology. He has worked in the private environmental science and engineering sector in the US , 28 countries on 5 continents in the international sector, and with more than 30 local, state, federal, international agencies and NGOs. His expertise in aquatic ecology and toxicology brought him to DEP Maine in January of 2022, where he heads the drug take back program, designed to keep unwanted and unused pharmaceuticals out of Maine’s waters.