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By Robert G. Bell

Robert BellA recent paper by Christian Daughton of the EPA discusses preventing pollution from active pharmaceutical ingredients (APIs). Traditionally, reducing API entry to the environment has relied solely on conventional end-of-use pollution control measures such as wastewater treatment and take-back collections to prevent disposal by flushing to sewers. The focus on these traditional approaches has ignored the main source of the problem and may have slowed progress in minimizing the environmental footprint of the healthcare industry. Perhaps a more effective and less-costly upstream pollution prevention approach includes modifications of established clinical prescribing such as reducing the dose or usage of certain select medications.

Another suggested approach by Daughton is to examine the excretion profiles of APIs. The implementation of prudent prescribing and ranking the excretion profiles in terms of API residual amounts in the aquatic environment is termed eco-directed sustainable prescribing (EDSP) and may hold the best potential for reducing API entry into the environment. This would be accomplished by guiding the prescriber’s drug selections in terms of patient efficacy versus the environmental impact of the drug. EDSP could reduce the API entry to the environment by minimizing the need for disposal and reducing the excretion of unmetabolized APIs by preferentially prescribing APIs that are more extensively metabolized.

Daughton also examines the potential utility of the Biopharmaceutics Drug Disposition Classification System (BDDCS) for the first time as a guide for API prescribing decisions by revealing relative API quantities entering sewage via excretion. These two approaches combined could be termed eco-directed sustainable prescribing (EDSP) and may hold the potential for achieving the largest reductions in API entry to the environment—largely by guiding prescribers’ decisions regarding drug selection. EDSP could reduce API entry to the environment by minimizing the need for disposal (as a consequence of avoiding leftover, unwanted medications) and reducing the excretion of unmetabolized APIs (by preferentially prescribing APIs that are more extensively metabolized). The potential utility of the BDDCS is examined for the first time as a guide for API prescribing decisions by revealing relative API quantities entering sewage via excretion. EDSP would provide prescribers, dispensers, and patients with pollution prevention information to consider in their selection of medications or dosages. The EDSP concept would serve to raise awareness that while excretion may represent the major source of most APIs in the environment, these levels can be actively reduced with no added infrastructure costs (such as entailed with improved wastewater treatment) and could mesh well with the emerging clinical movement of “conservative prescribing”.

Changing the prescribing behavior of physicians and patient expectations for treatment would certainly be a major challenge.

Should the health of the environment be a major factor when considering health treatment options for you? What are your thoughts on the matter?

Robert G. Bell, Ph.D., is president and owner of Drug and Biotechnology Development LLC, a consultancy to the pharmaceutical industry and academia for biological, drug, and device development.