In case you missed the news, the Environmental Protection Agency passed new rules in December concerning the management of hazardous waste pharmaceuticals. The new regulations are in response to a 2015 study that estimated health care facilities were disposing of thousands of tons of pharmaceutical drugs by flushing them down sinks and toilets, creating a hazard for wastewater facilities ill equipped to remove discharged pharmaceuticals and thereby exposing fish and aquatic wildlife to dangerous chemicals.
Guidelines for HW Pharmaceuticals
The EPA’s new rules call for stricter regulations on the management of HW pharmaceuticals, specifically prohibiting disposal of these drugs in sewage systems. Up until now, it has been customary to flush unused pharmaceuticals down the toilet or drain. While the Clean Water Act was established to clamp down on the discharge of pollutants into waterways, it never addressed the treatment of pharmaceuticals in wastewater – a problem, given that publicly-owned wastewater treatment plants were never designed to treat active pharmaceutical ingredients (APIs). As a result, antibiotics and antidepressant compounds are finding their way into rivers, lakes, and drinking water supplies, creating a hazard for aquatic species and posing a potential threat to humans.
All health care facilities that generate, accumulate, and handle HW pharmaceuticals are bound to the EPA’s new regulations, as are all businesses tasked with “reverse distribution,” which is defined as a system for managing any unsold retail pharmaceuticals. Retail stores generally set up arrangements with pharmaceutical manufacturers to establish a process for disposing these drugs. Under the new rules, reverse distributors will need to ensure the drugs are either reused or destroyed at a permitted disposal facility. A partial list of entities affected includes hospitals, pharmacies and drug stores, physician’s offices, dental clinics, and veterinarians. The rule does not apply to pharmaceutical manufacturers, who must abide by a separate set of regulations already in place.
It is up to the health care facility to differentiate between hazardous and nonhazardous drugs and to take the appropriate action. They may choose to work with their waste service provider to ensure proper controls are in place. Having expert professionals onsite will also help with packaging, labeling, storage, recordkeeping, and transportation issues.
Because of the inherent environmental risks HW pharmaceuticals pose, the EPA recommends incineration as the primary means of disposal. Consumer-generated pharmaceutical waste is exempt from the new regulations; waste generated in the home should be collected through community programs and treated as hazardous waste.