Comparison of regulatory frameworks of environmental risk assessments for human pharmaceuticals in EU, USA, and Canada

Lee, Dongyoung; Choi, Kyungho

doi:10.1016/j.scitotenv.2019.03.372

Cited by 46 publications

(31 citation statements)

References 16 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…ECOdrug, Verbruggen et al, 2018 ; SeqPASS, LaLone et al, 2016 ). Despite these efforts, the current ERA process remains mechanistically agnostic and solidly centred on traditional fate/exposure predictions, with toxicity levels of individual compounds experimentally determined using simple tests focused on apical endpoints ( Lee and Choi, 2019 ). This limitation acquires even more significance when mixtures of drugs are considered.…”

Section: Discussionmentioning

confidence: 99%

Pharmacology-informed prediction of the risk posed to fish by mixtures of non-steroidal anti-inflammatory drugs (NSAIDs) in the environment

Marmon

Owen

Margiotta-Casaluci

2021

Environment International

View full text Add to dashboard Cite

Section: Discussionmentioning

confidence: 99%

Pharmacology-informed prediction of the risk posed to fish by mixtures of non-steroidal anti-inflammatory drugs (NSAIDs) in the environment

Marmon

Owen

Margiotta-Casaluci

2021

Environment International

View full text Add to dashboard Cite

“…This framework aims to ensure adequate control of effluent emissions from the manufacturing units (AMR Industry Alliance 2018 ). Among the measures proposed was calculating the amount of API discharge by the industries into the environment, called the predicted-no-effect concentration (PNEC) or antibiotic concentrations below which there are no adverse effects on the environment and the risk of developing resistance is minimal (Lee and Choi 2019 ). These values are expected to be protective of ecological species and incorporate assessment factors consistent with standard environmental risk methodologies (Brandt et al 2015 ).…”

Section: Stakeholders Efforts To Address Antibiotic Residues In Pharmaceutical Effluentmentioning

confidence: 99%

Pharmaceutical effluent: a critical link in the interconnected ecosystem promoting antimicrobial resistance

Kotwani

Joshi

Kaloni

2021

Environ Sci Pollut Res

View full text Add to dashboard Cite

Antimicrobial resistance (AMR) is a complex global health issue and will push twenty-four million people into extreme poverty by 2030, risking the sustainable development goals (SDGs) 2, 3, 6, 9, 12, and 17 if not addressed immediately. Humans, animals, and the environment are the reservoirs that contribute and allow AMR to propagate in interconnected ecosystems. The emergence of antibiotic-resistant bacteria and antibiotic-resistant genes in the water environment has become an important environmental health issue. One of the major influencers from environment sector is the pharmaceutical industry which is growing globally to meet the ever-increasing demand of antibiotics, especially in low-and middle-income countries. The pharmaceutical effluent has a mix of large concentrations of antibiotics and antibiotic resistance genes, and these sites act as hotspots for environmental contamination and the spread of AMR. Inadequate treatment of the effluent and its irresponsible disposal leads to unprecedented antibiotic contamination in the environment and their persistent presence in the environment significantly modulates the bacterial genomes' expression that is responsible for increase and spread of AMR. However, not much interventions are suggested in the National Action Plan developed on AMR by many countries. There are no regulations across the globe till date for the level of antibiotic residues in pharmaceutical effluent for the growing pharmaceutical industry. This review put together the work done showing several detrimental effects of the antimicrobial residues in the pharmaceutical effluent which leads to rise in development of AMR. The environment risk approach and need to have indicators to measure environment risk is a way forward for all countries engage in antibiotic manufacturing. Overall, efforts to address the problem are isolated and fragmented. Policymakers, regulators, manufacturers, researchers, civil society, and the community need to collaborate so that antibiotics are produced sustainably and continue to stay effective in treating bacterial infections.

show abstract

“…Environmental safety is another issue that is becoming increasingly challenging, for both human and animal drug production. Because of the potential impacts of pharmaceutical residues on the aquatic and terrestrial ecosystems, regulatory authorities require an environmental risk assessment (ERA) of all pharmaceutical products before marketing is allowed ( Lee and Choi, 2019 ). For livestock on pastures, the risk is considered even higher, due to a combination of ecotoxicity and persistence in soil/sediment ( Liebig et al, 2010 ; Lumaret et al, 2012 ), which is an added hurdle for livestock anthelmintics.…”

Section: Anthelmintic Discovery and Developmentmentioning

confidence: 99%

Where are all the anthelmintics? Challenges and opportunities on the path to new anthelmintics

Nixon

Welz

Woods

et al. 2020

International Journal for Parasitology: Drugs and Drug Resistan

View full text Add to dashboard Cite

Control of helminth parasites is a key challenge for human and veterinary medicine. In the absence of effective vaccines and adequate sanitation, prophylaxis and treatment commonly rely upon anthelmintics. There are concerns about the development of drug resistance, side-effects, lack of efficacy and cost-effectiveness that drive the need for new classes of anthelmintics. Despite this need, only three new drug classes have reached the animal market since 2000 and no new classes of anthelmintic have been approved for human use. So where are all the anthelmintics? What are the barriers to anthelmintic discovery, and what emerging opportunities can be used to address this? This was a discussion group focus at the 2019 8th Consortium for Anthelmintic Resistance and Susceptibility (CARS) in Wisconsin, USA. Here we report the findings of the group in the broader context of the human and veterinary anthelmintic discovery pipeline, highlighting challenges unique to antiparasitic drug discovery. We comment on why the development of novel anthelmintics has been so rare. Further, we discuss potential opportunities for drug development moving into the 21st Century.

show abstract

Comparison of regulatory frameworks of environmental risk assessments for human pharmaceuticals in EU, USA, and Canada

Cited by 46 publications

References 16 publications

Pharmacology-informed prediction of the risk posed to fish by mixtures of non-steroidal anti-inflammatory drugs (NSAIDs) in the environment

Pharmacology-informed prediction of the risk posed to fish by mixtures of non-steroidal anti-inflammatory drugs (NSAIDs) in the environment

Pharmaceutical effluent: a critical link in the interconnected ecosystem promoting antimicrobial resistance

Where are all the anthelmintics? Challenges and opportunities on the path to new anthelmintics

Contact Info

Product

Resources

About