The U.S. Environmental Protection Agency (EPA), aiming to keep pharmaceuticals out of the nation’s waterways, is soliciting public comments about proposed guidelines on how medical facilities should manage unused drugs.

The 45-page draft “best management practices” document is posted on the agency’s website. Comments are due by Nov. 8.

The guidelines are meant to provide an alternative to disposing of drugs by washing them down a sink or flushing them in a toilet, which has been a standard practice in health care historically.

The draft guidelines outline several steps to managing unused pharmaceuticals. They include:

— Conducting an inventory of all pharmaceuticals on the premises.
— Tracking unused drugs for a period of two weeks to one month to quantify commonly wasted drugs and identify reasons they go unused.
—  Reducing the volume of unused drugs by reviewing purchasing practices and buying in smaller quantities and/or limiting the number of doses dispensed at a time.
— Requesting drug salespeople to provide vouchers for drug samples redeemable at pharmacies rather than actual drug samples; or requiring salespeople to retrieve unused samples before they expire.
— Routinely rotating stock to make sure drugs nearing expiration are used first.
— Donating unused pharmaceuticals when possible, or returning them to pharmacies.
— Training staff in proper disposal methods.

The document describes disposal methods, which vary depending upon the nature of the drug (hazardous waste, non-hazardous waste, controlled substance, non-controlled substance, chemotherapy treatment). It provides resources such as a listing of states that run drug donation programs, and a sample form for tracking unused pharmaceuticals.

In posting draft guidelines now, the EPA streamlined its process for addressing unused-drug disposal practices in health care. Originally, the agency proposed surveying 3,544 medical facilities, including 296 veterinary offices, to learn how health-care workers handle leftover pharmaceuticals.

As initially envisioned, the survey would have required respondents to report their drug-disposal practices for a period of 30 days. Those who received the survey would have been required to complete it.

But health-care practitioners and professional organizations representing them, including the American Veterinary Medical Association, protested that the survey would take too much time and money to complete. The EPA had calculated that the survey would cost participants an average of 41 hours and $1,463.

In response to the criticism, the agency said it would scale back the survey from 28 pages to one or two pages.

Ultimately, the EPA scrapped the survey altogether. Meghan Hessenauer, an environmental scientist in the EPA’s Office of Water, said agency officials decided they had enough information to move directly to proposing best-management practices.

Quoting from a report titled “Health Care Industry Unused Pharmaceuticals Detailed Study 2007-2009 Data Collection and Outreach,” Hessenauer said in an e-mail to the VIN News Service: “The survey would be an effective but potentially time-consuming tool for gathering facility-specific data on the management of unused pharmaceuticals. EPA estimates it has gathered sufficient data from its site visits and outreach to begin the development of best practices for unused pharmaceutical management at health care facilities.”

The agency stated that it visited 12 health-care facilities, reviewed disposal data from 20 hospitals and long-term care facilities and consulted with more than 700 stakeholders as part of its research and outreach.

The best management practices are proposed not as a regulation but as guidelines for industry, Hessenauer said.