On April 30 from 10 a.m. to 2 p.m. agencies in selected areas within the State of Minnesota and the Drug Enforcement Administration (DEA) will give the public and long-care facilities an opportunity to destroy certain expired, unused, and unwanted prescription drugs.

Last September, Americans turned in 242,000 pounds—121 tons—of prescription drugs at nearly 4,100 sites operated by the DEA and more than 3,000 state and local law enforcement partners. This year, the DEA has authorized nursing facilities and home care agencies to participate in the April 30 drug take-back program where available. Recent discussions with representatives from the DEA indicate that this national initiative will only be available in certain areas in the northern half of Minnesota. Find out if there is a drug take-back site in your area (on that page, click on “Find a collection site near you”).

Four days after last fall’s event, Congress passed the Secure and Responsible Drug Disposal Act of 2010, which amends the Controlled Substances Act to allow an “ultimate user” of controlled substance medications to dispose of them by delivering them to entities authorized by the Attorney General to accept them. The Act also allows the Attorney General to authorize long-term care facilities to dispose of their residents’ controlled substances in certain instances. The DEA has begun drafting regulations to implement the Act.

Care Providers of Minnesota followed up on conversations with DEA representatives by contacting representatives from the Board of Pharmacy and the Division of Compliance Monitoring at the Minnesota Department of Health. To no one’s surprise, the regulatory issues surrounding long-term care businesses' utilization of take-back collection sites is a bit unclear.

On Friday the DEA sent out this letter to selected “long-term providers” in northern Minnesota. The DEA was uncertain how they “defined long-term care providers” or how many letters were sent, but they thought it went to selected nursing homes and “assisted living” providers. The intent was to send the letter to nursing homes and Class F home care agencies in areas where take-back programs were planned for the April 30th event.

The letter provides some clarification as well as some confusion:

• The DEA encourages providers to use the drug take-back program on April 30, 2011.

• The service is only for “controlled prescription drugs” (later in the letter it states the program is for all solid pharmaceutical drugs).

• The drop off will be anonymous (upon clarification this means that no receipt, manifest, or other written confirmation of acceptance of the medications will be provided by the DEA/DEA Partners).

Should providers use this drop-off service? It depends. Here are some issues providers should consider.

• At this time is appears the service will be sporadic at best for most locations. Providers are not encouraged to stockpile medications in order to utilize such drop-off services unless they are routinely scheduled. If the service is routinely scheduled, do you want people to know that on a prescribed date, for a four hour time-span, a vehicle will be leaving your building with controlled substances? Seems a bit unsafe for the staff providing the transportation.

• The DEA has stated that it will not accept any medications considered hazardous waste from a long-term care provider. Current take-back programs will not solve any MPCA hazardous waste disposal requirements, and manifests will not be provided.

• Nursing home rules and Class F home care rules require providers to destroy scheduled narcotics using forms provided by the Minnesota Board of Pharmacy. Given that DEA agents have been instructed to not sign for receipt of any medications at the drop-off sites, this creates a bit of a dilemma. Representatives from MDH felt it should be acceptable for a provider to use the Board of Pharmacy form, have two carefully selected licensed staff count and verify on the form the controlled substance pills that will be brought to the drop-off site, and provide the date and location of the drop off site (see if you can get the name of who is collecting the pills) on the form. Have both licensed persons sign that they saw the pills get turned in to the drop-off site. Send the form to the Board of Pharmacy each month and keep a copy on file for two years.

• The United States Environmental Protection Agency (EPA) also had some concerns regarding the DEA take-back process. View a letter on this from the EPA to the DEA.

Disposal or return/reuse of unused medications (scheduled, non-scheduled, hazardous, and non-hazardous) is a national issue involving numerous types of providers and governmental agencies. Everyone wants to “do the right thing,” but it is still unclear exactly what the “right thing” should be! The currently-promoted DEA take-back program is a great start to one potential resolution to part of the issue. It certainly is a great start to helping individuals rid their homes of unwanted medications. However, it clearly is not designed to resolve a number of issues providers must deal with or to properly coordinate potentially conflicting policies and regulations throughout the country.

Care Providers of Minnesota, along with the American Health Care Association and the National Centers for Assisted Living, will continue to monitor these issues and advocate for successful resolutions into the future. Stay tuned!

Doug Beardsley
952.851.2489
dbeardsl@careproviders.org