A Method for Developing Rapid Screening Values for Active Pharmaceutical Ingredients (APIs) in Water and Results of Initial Application for 119 APIs

Abstract

Americans fill upward of four billion prescriptions for pharmaceuticals each year, and many of those pharmaceuticals eventually make their way into the environment. Hundreds of different active pharmaceutical ingredients (APIs) are detected in ambient waters and source water used for drinking water in the U.S. Very few of these drugs have health-based guidance values that suggest a safe level for individuals exposed in the ambient environment through drinking water. The Minnesota Department of Health (MDH) has developed a novel method to derive screening-level human health guidance values for APIs. This method was designed for rapid evaluation and relies on Food and Drug Administration (FDA)-approved drug labels and limited additional public data resources for necessary information. MDH developed an analytical framework using traditional and novel uncertainty and adjustment factors specific to the information available for APIs. This framework, along with an estimated lowest therapeutic dose (LTD), was used to derive screening reference dose (sRfD) values. Water screening values (WSV) were then derived using the sRfD, a relative source contribution factor (RSC), and a water intake rate for infants to represent a highly exposed population. MDH used this new method to derive water screening values for 119 APIs that are commonly prescribed and/or commonly monitored in Minnesota waters, including antibiotics, antidepressants, steroids, and other classes of drugs. The derived WSVs can be used to provide context to environmental detections, prioritize APIs for further health-based guidance development, prioritize APIs for future environmental monitoring studies, and inform the development or refinement of analytical methods.

Prevalence of Pharmaceuticals in Surface Water Samples in Ghana

“…e detection of antibiotic and analgesic residues in various aquatic compartments including municipal sewage, hospital sewage, groundwater, surface water, and drinking water at various concentrations [7][8][9] has been widely reported. While several of such reviews have highlighted aquatic monitoring in the European Union [10], the USA [11], and China [12], not much is known in the literature regarding the problem in sub-Saharan Africa [13]. Again, the lack of a universal view of what happens when these pharmaceuticals are released into the environment has lately become topical [14].…”

Human health risk assessment of pharmaceuticals in the European Vecht River

“…For pharmaceuticals for which no chemical analysis data were available in drinking water(i.e., 17α-ethinylestradiol, metformin, oxazepam), an assumed LoQ of 0.05 µg/L was applied, n.a., substances for which measurement information was not available. l This study.mBull et al (2014).nCunningham et al (2010).oFourie et al (2004).pSuchomel et al (2015).qPalm et al (1997).rCal/EPA (1992).s NL (2012).tCheng et al (2012).uHou et al (2007).…”

Immobilized Enzyme-based Novel Biosensing System for Recognition of Toxic Elements in the Aqueous Environment

“…Effect of toxic pollutants on human health and symptoms during its exposure a No data related to human health risk in water sources has been found[135] Disturbances of the nervous system, convulsions, pain, numbness, tremor in extremities, motor neuron diseases, dizziness and headaches, myasthenia, memory problems, insomnia, impaired cognitive development, neurological disorders, including Alzheimer's disease, learning and behavior problems Nephrological effects: Renal disorders, edema, foamed urine, nephrotic syndrome and hematuria Respiratory effects: Shortness of breath and chest tightness, lung fibrosis, pulmonary edema Gastrointestinal effects: Garlic taste in the mouth, pain in throat, chest, or abdomen, nausea, diarrhea…”