[Pharmwaste] Campaign Could Boost EPA Plan To Allow Pharmaceutical Take-Back

[DeBiasi,Deborah]

This article is from InsideEPA.com


Monday, April 09, 2007                                                 
                                                                        

Campaign Could Boost EPA Plan To Allow Pharmaceutical Take-Back

The U.S. Fish and Wildlife Service (FWS) and the American Pharmacists
Association (APhA) have unveiled a public education campaign to prevent
improper disposal of medicines which could harm the environment --- a
move that could bolster EPA's recent announcement that it plans to amend
its waste rules to allow the development of pharmaceutical take-back
programs.

The groups' campaign, known as "SMARxT DISPOSAL," aims to train
consumers not to dispose of unwanted and unused medications by flushing
them down the toilet, previously a commonly advised practice.

The new effort, which will begin by focusing its message on pharmacists,
is one step in a future plan by a number of federal agencies, including
EPA, who are targeting pharmaceuticals as a source of concern for
environmental and human health.

The federal agencies have formed a strategy group known as
Pharmaceuticals in the Environment (PiE), which had an early conference
call two weeks ago, a member involved says. PiE plans to have research
strategies for human and veterinary pharmaceuticals in the environment
by December 2007, an EPA source says. The group is aiming for a strategy
for antibiotics in the environment, with a focus on antibiotic
resistance, by December 2008, the source says.

The agencies include EPA, the U.S. Geological Survey (USGS), the Food &
Drug Administration (FDA), the Center for Disease Control & Prevention,
the National Institute for Environmental Health Sciences, the National
Oceanic & Atmospheric Administration, Department of Agriculture and FWS.

The expanse of the issue makes finding a solution challenging, sources
say, noting that the Drug Enforcement Agency (DEA) is concerned about
illegal medications, wastewater treatment plants are searching for new
removal technologies, and FDA is concerned about drug labeling.

"We're all visually impaired and looking at an elephant," a PiE member
says, mentioning that neither FWS nor APhA considered the problems of
illegal acquisition of drugs until DEA raised the issue. The groups
altered guidelines to be issued as part of the SMARxt DISPOSAL project
as a result.

As part of its effort to limit pharmaceutical disposals, EPA officials
recently announced that they plan to amend its Resource Conservation &
Recovery Act (RCRA) regulations, which currently require that many
chemicals found in pharmaceuticals are subject to strict disposal,
handling and record-keeping requirements.

Observers say these rules, coupled with DEA rules on handling
"controlled substances," have hindered the development of pharmaceutical
take-back programs as an alternative to disposing of drugs in landfills
or wastewater systems. Currently, only fifteen so-called "pilot"
take-back programs are operating nationwide, with twelve more under
consideration.

Agency officials now say they plan to lift the restrictions by applying
a less stringent "universal waste" designation to drugs collected in
take-back programs, "thus making it easier for take-back programs to
operate in the future," an EPA source says.

At the same time, FWS and APhA plan to determine an effective way to
communicate with consumers, a FWS source says, noting that the front
line in achieving that is thought to be found in pharmacists. They hope
to have the program's Web site live by American Pharmacy Month in
October.

"We don't know enough about the effects" of pharmaceuticals in the
environment, Jeff Armstrong of the Orange County, CA, sanitation
department said at a March 23 congressional briefing presented by the
Water Environment Federation. There is concern, he said, but "I'm not
chicken little --- I don't think the sky is falling."

According to the panel of experts at the briefing, however, there are a
number of locations in the United States where pharmaceuticals in the
groundwater are persistent and worrisome concerns. A source involved in
PiE says wastewater treatment plants across the country are working to
improve technology for filtering for pharmaceuticals, using ultraviolet
sterilization, activated sludge, and a filtering process other than
sand. Reverse osmosis would likely be ineffective given the large
volumes most plants must filter, the source says.

"We need to get more aggressive with our pharmaceutical take-backs,"
Armstrong says.

Several states are trying out pilot programs under the eye of the DEA,
says a FWS source, but the efforts are few and far between. EPA issued a
request for proposals in September 2006, for programs to begin January
2007, but the chosen grant recipients have not yet been announced or
finalized for the public, a source familiar with the effort says.

Since 1996, the Canadian government has mandated a Medications Return
Program through pharmacies which is funded by the pharmaceutical
industry, according to a government publication. While there are no
similar plans in motion in the United States, "that's something we're
talking about with our partners," a FWS source says. "It's not off the
table."


Date: April 9, 2007
(c) Inside Washington Publishers

Deborah L. DeBiasi
Email:   dldebiasi at deq.virginia.gov
WEB site address:  www.deq.virginia.gov
Virginia Department of Environmental Quality
Office of Water Permit Programs
Industrial Pretreatment/Toxics Management Program
Mail:          P.O. Box 1105, Richmond, VA  23218 (NEW!)
Location:  629 E. Main Street, Richmond, VA  23219
PH:         804-698-4028
FAX:      804-698-4032