[Pharmwaste] Cleaning Up Medical Waste article

[Tenace, Laurie]

This article is by Lynn Rubenstein of the Northeast Recycling Council
(http://www.nerc.org/  - check out their web site for more info) 

(Sorry it loses some formatting - Laurie)

http://mswmanagement.com/mw_0606_cleaning.html


By Lynn Rubinstein
 
You bet! That's the conclusion of several important US and international
studies. Notably, the United States Geological Survey (USGS) conducted a
national reconnaissance of streams during 1999-2000, looking for
pharmaceuticals, hormones, and other organic wastewater contaminants.
Unfortunately, the USGS found them in 80% of the sampled streams. (See
"Pharmaceuticals, Hormones, and Other Organic Wastewater Contaminants in U.S.
Streams, 1999-2000: A National Reconnaissance".)

A recent study by Environment Canada's National Water Research Institute
"found nine different drugs in water samples taken near 20 drinking water
treatment plants across southern Ontario. The drugs were mainly from a class
known as 'acidic pharmaceuticals,' and included the painkillers ibuprofen and
neproxin, and gemfibrozil, a cholesterol-lowering medication.... The worst
contamination came from treatment plants located near rivers or downstream
from sewage treatment plants, as opposed to those plants sourcing water from
lakes or groundwater" ("Prozac and painkillers found in tap water," Vancouver
Sun, November 14, 2004). There are also studies that indicate a potential
correlation between human medication and the phenomenon of male fish
producing eggs.

"'Our impression is that they are males that are being feminized [because] of
the nature of the chemicals that are in the water, and most of them are
estrogenic [meaning they stimulate development of female sex
characteristics],' [David O. Norris, a professor in the University of
Colorado's Department of Integrative Physiology, told National Geographic
News in 2004 (see "Male Fish Producing Eggs in Potomac River". 'Some of [the
estrogenic chemicals] are natural urinary estrogenic products from humans,
and some of them are pharmaceuticals-birth control pills.'

"Norris has also found large concentrations of compounds called
alkylphenols-common substances often associated with household detergents and
personal-care products. 'They're the same sort of compounds that have been
associated with fishes in England and Europe,' he said. 'The main difference
here is the source is domestic sewage, as opposed to industrial sewage. This
is one of the first observations, certainly in the US, of a domestic sewage
factor alone being connected with this [intersex phenomenon].'"

The Solid Waste Solution
So, what can the solid waste community do? Unfortunately, the norm has been
for us to recommend that unwanted medicines be flushed. Clearly, this is no
longer a sound recommendation. Well-publicized best management practice
recommendations and opportunities for collecting unwanted medications for
safe disposal are needed. 

Thanks to funding from the EPA's innovative solid waste grant program and the
US Department of Agriculture (USDA) Rural Utilities Service's solid waste
management grant program, the Northeast Recycling Council Inc. (NERC) has
recently developed best management recommendations and implemented two pilot
collections for unwanted medications. 

The collection of unwanted medications is largely unexplored in the United
States, and only a limited number of such collections have been held to date.
The two pilots that this article reports on were the first of their kind in
the Northeast: one in a senior center in Montague, MA, and the other in a
CVS/pharmacy in South Portland, ME.

An important reason more unwanted medication collections haven't taken place
is that there are significant legal barriers to conducting one. Among the
tasks in the NERC's grant was to research these legal considerations and
develop a both effective and legal strategy. 

Federal agencies that regulate the handling and disposal of prescription
medications include the Drug Enforcement Administration (DEA), the EPA, and
the US Department of Health & Human Services. 

 
Each participant tended to bring in multiple types of drugs. So while
participation in the pilot studies was low, the volume collected was
signifcant.  
In addition, state laws regulate prescription drugs, and solid and hazardous
waste. Because this is a new issue and one that has yet to fully evolve, the
federal laws are not always compatible with each other, and state laws
introduce an additional level of complication. 

While there have been unwanted medication collections in the United States,
these pilots through the NERC's USDA and EPA grants were the first projects
to squarely tackle the legal issues and specifically design a strategy that
fully complies with all federal and state laws, as well as ensures that all
medications are properly destroyed.

A complete report and guidance document on how to set up and implement these
types of pilots will be available at the end of 2005. In the meantime, we can
share some important "work in progress" information:

The best management practice for disposal of unwanted medication is
hazardous-waste incineration. In some instances, MSW incineration may be
acceptable, but the incinerator must meet certain pollution control
standards. 
You need to be prepared to manage controlled, non-controlled, and
over-the-counter medications. Each has a different federal and state
management standard that must be met. 

Background
The federal grants included several critical tasks:

Identify strategies for collection and end-of-life management that comply
with state and federal solid waste, hazardous-waste, and drug laws. 
Determine and implement best management practices for disposal of unwanted 
medications. 
Test various collection strategies. 
 
Unwanted medications are best disposed of through designated collection
programs.  
Each of these was carefully researched and implemented. There were three key
elements to the legal and safe success of the pilots:

By segregating controlled from non-controlled substances it was possible to
comply with federal and state law. The strategy designed and implemented
under this pilot was to rely on the expertise of a pharmacist to determine
which medications are regulated as controlled substances and to separate
those from the other medications.

The best management practices for disposal of unwanted medications is
dedicated collection and incineration in a licensed hazardous-waste facility.
Underlying this grant project is a multistakeholder advisory committee that
includes individuals with extensive experience in the management and disposal
of medications, as well as solid waste and environmental professionals. The
committee has determined that the best management practice-and in fact the
only acceptable disposal practice-is to collect this wastestream through
dedicated collection (versus flushing or throwing it in the garbage) and then
incineration in a licensed hazardous-waste facility.

Among the reasons for this determination were decreasing ready access to
medications that might otherwise go in the trash, thus preventing diversion
and inappropriate usage of medications; more secure destruction with greater
environmental controls on air emissions than in a solid waste combustor; the
presence of medications with hazardous-waste characteristics in the waste
mix, and the lack of information about the hazardous characteristics in the
solid wastestream of most medications; sending a message about the importance
of safe end-of-life management of these materials; and avoiding potential
leachate contamination from medications in landfills. Also, physical
destruction of the medications for the purpose of rendering them
unrecoverable, as required by federal drug law, is considered to be
essentially a practical impossibility in most settings (per a conversation
with Vicky Seeger, DEA, October 2004). One technique that has been used in
other programs is to dissolve the medications in a dilute solution of
hydrochloric acid. According to the DEA a "determined" person could still
recover drugs.

Test various collection strategies, including senior centers, household
hazardous-waste events, and in retail settings. This article chronicles the
senior center and retail setting pilots. The household hazardous-waste pilot
has not yet been tested.

In several other countries (e.g., Australia, Poland, and Canada) there are
well--established unwanted medication collection opportunities-and they are
all through pharmacies. In the United States this is not a legally acceptable
solution. Nevertheless, many people have an active relationship with their
pharmacist and often turn to him or her for advice, including how to dispose
of their unwanted medications. Because of the association in the public's
mind between pharmacies and medical advice, and because drugstores are a
frequent shopping destination, it was determined that one model to test would
be based on ease of access: a convenient location based on regular errands,
and an expectation that the pharmacist can provide advice about all aspects
of medication, including proper disposal of unused medication. 

In addition, there is growing interest in involving the pharmaceutical
industry in paying for the end-of-life management of unwanted medications.
Retail pharmacies are one of the players in that industry.

The Law
Federal Drug Law
The DEA prohibits the transfer of dispensed controlled substances from an
individual to a pharmacist, or to any other entity registered with the DEA to
handle or manage controlled substances. The only exceptions are for drug
recalls or a dispensing error (21 CFR 1307.21). Examples of controlled
substances include:

Oxycontin 
Codeine 
Valium 
Darvocet 
The sole exception is that controlled substances may pass into the control
and custody of law enforcement officials.

Thus, in order to legally collect unwanted controlled substances, it is an
absolute necessity that law enforcement officials be onsite, participate in
the collection, and take physical control and custody of all controlled
substances.

The same restrictions do not apply for non-controlled substances, but federal
law makes it illegal to transfer possession of any prescribed medication to
someone other than the person to whom it was prescribed. The sole exception
to this is for the purpose of disposal. 

In addition, the DEA has made it clear that reverse distributors-the industry
that manages out-of-date and unsalable pharmaceuticals-may not accept already
dispensed controlled substances.

When a controlled substance is ready for disposal it must be incinerated or
otherwise rendered non-recoverable in a process approved by the DEA. The
incineration must be witnessed by the law enforcement agency, the DEA, or its
authorized agent. The DEA recommends that the disposal method be
incineration. 

Federal Hazardous-Waste Law
The EPA Resource Conservation and Recovery Act exempts household waste,
including consumer prescription and over-the-counter medications, from
hazardous-waste regulation. 

 
Five-gallon pails were used in the roundup, and a label was placed on one for
controlled substances.  
This exemption applies at the federal level even if an organization collects
these items from consumers for disposal, as long as they are not commingled
with waste generated by the organization in the normal course of its
business. 

Some prescribed and over-the-counter medications are known to require
management as a hazardous waste when they come from an entity other than an
individual. Hazardous waste may not be disposed of in solid waste facilities
(landfills, incinerators, or waste-to-energy facilities). 

Hazardous-waste disposal facilities are the sole legally acceptable
destination for this type of waste.

In addition, the EPA has made it clear that reverse distributors-the industry
that manages pharmaceutical waste for pharmacies-may not accept already
dispensed medications as part of that wastestream. It would be a violation of
federal hazardous-waste laws. 

State Law
Although federal law exempts unwanted medications from management as a
hazardous waste, individual state laws may be stricter than federal law. 

For example, in Maine when an individual disposes of a material that would be
considered a hazardous waste under federal law (when it comes from a
business), it is required to be managed as a hazardous waste. It may not be
disposed of in a solid waste landfill or combustor. It must be disposed of at
an authorized hazardous-waste facility.

Not all unwanted medications are hazardous waste, but in the absence of
specific knowledge, the Maine Department of Environmental Protection has
expressed the policy position that when unwanted medications are combined for
disposal, the presumption shall be that they are hazardous waste. MSW

Lynn Rubinstein is executive director of the Northeast Recycling Council in
Brattleboro, VT. She can be contacted at lynn at nerc.org.


Laurie J. Tenace
Environmental Specialist
Florida Department of Environmental Protection
2600 Blair Stone Road, MS 4555
Tallahassee, Florida 32399-2400
PH: (850) 245-8759
FAX: (850) 245-8811
Laurie.Tenace at dep.state.fl.us  
 
view our mercury web pages at: 
http://www.dep.state.fl.us/waste/categories/mercury/default.htm 

Please Note:  Florida has a very broad public records law.  Most written
communications to or from state officials regarding state business are public
records available to the public and media upon request.  Your e-mail is
communications and may therefore be subject to public disclosure.