This document discusses ways to reduce unused pharmaceuticals entering the environment. It argues that usage control through prudent healthcare practices that minimize unnecessary prescribing and dispensing can significantly reduce pharmaceutical residues more than disposal practices alone. Usage control can eliminate the need for disposal and also reduce residues released through excretion and bathing. The document also notes several collateral benefits to pollution prevention and usage control, such as reduced healthcare costs, improved treatment outcomes, and fewer poisonings from unused drugs.
2. Actions can be directed not just at prudent alternatives for disposal, but also (and more significantly) to reducing the contributions from excretion and bathing. Reducing Leftover Drugs Actions can be directed at improvements to any part of the life cycle of medicationssuch as those spanning the vast, complex chain beginning with design/discovery, manufacturing, packaging, and advertising, and proceeding to prescribing (as also modified by practices of healthcare insurers) and dispensing, and ending with whether the medications are eventually consumed or used by the consumer.
3. Stewardship and Pollution Prevention Disposal control vs. Usage control (or Down-stream vs. Up-stream):two basic approaches for reducing the entry of APIs to the environment. Disposal control: prudent andenvironmentally sound engineered practices for disposal of unwanted medications. Usage control:prudent healthcare practices to minimize or optimize prescribing and dispensing of medications by eliminating unnecessary or imprudent customs and practices. Significantly, usage control perhaps has greater potential for reducing overall entry of APIs to the environment. It can eliminate the need for disposal PLUS also minimize the residues that would otherwise be released by excretion and bathing.
4. Aspects of Sources/OriginsImportant to Design of Stewardship Programs Fate of APIs and creation of by-products during non-optimized incineration The creation and fate of toxicologically significant by-products during manufacture, wastewater treatment, metabolism/biotransformation, and physicochemical processes in the environment The extent of occurrence and fate of PPCPs in biosolids and in recycled water (especially when applied to arable land) Whether the nanomaterialsused in the expanding field of nanomedicine pose risks once they enter the environment The extent to which plant-made pharmaceuticals pose a hazard if released to the environment Proactive environmental monitoring for new molecular entities at the time they are introduced into commerce Apportioning the sources from which APIs gain entry to the environment
5. Collateral Benefits toPollution Prevention & Usage Control In addition to reducing environmental contamination by APIs, stewardship actions aimed at ensuring prudent, efficacious usage of medications might also: lessen healthcare costs(via more effective treatment, reduced purchase costs, fewer prescribing/dispensing errors) improve therapeutic endpoints and healthcare outcomes(via better patient adherence/compliance) reduce morbidity and mortalitycaused by poisonings of infants, children, adults, pets, and sometimes wildlife by unused stored drugs or by drugs improperly disposed in trash.
6. Dogma Masquerading as Knowledge Drug disposal is a significant source of APIs in the environment Trace levels of antibiotics in the environment serve as a driver of selection for antibiotic-resistant human pathogens Use of antibiotics in confined animal feeding operations pose a risk with regard to the selection of antibiotic resistant bacteria and genetic transfer of resistance to human pathogens Manufacturer waste streams are a minor source of APIs in the environment APIs are generally not subject to comparable bioconcentrationbecause of their lower lipophilicity and ionizability Excipients do not need to be considered since they are not “active” ingredients
7. Final Thoughts The types and trends in levels of chemical contaminants in the environment serve as direct measures of our progress toward sustainability, spanning green and virtual chemistry, to smart manufacturing and intelligent consumption. Sustainability could be advanced from consumers understanding more fully their individual roles in both causing (via combined miniscule inputs) and preventing the release of chemicals to the environment. PPCPs serve to highlight that the environment and humans are intricately interconnected in a complex system that would benefit from examination as an integral whole:Humans and the environment as a single patient.
