Medication Return, Donation and Disposal
PDF Version of BQA 06-022
(PDF 47 KB)
Date: November 3, 2006 -- OQA Memo 06-022
Homes NH 12
From: Otis Woods, Director, Office of Quality Assurance
Medication Return, Donation, and Disposal
This memo provides guidance on situations where removal of
medication from a Nursing Home facility is required. This memo also waives
a portion of section HFS 132.65(6)(c) (see http://www.legis.state.wi.us/rsb/code/dhs/dhs132.pdf)
, Wis. Admin. Code, related to medication destruction.
Many situations in nursing homes may require medications to be removed
from the premises, e.g., medication order changes, expired medications,
adulterated or contaminated medications, resident discharge, resident
death, etc. The amount of medications, the options for removing these
medications, and environmental concerns have increased, and have led
nursing homes to ask how medications should be removed. Some nursing homes
have asked about outside sources picking up medications for removal and
how that should be handled. Although not comprehensive, this memo provides
some information and options relating to removal of medications from
Rule and Waiver
Section HFS 132.65(6)(c) (see http://www.legis.state.wi.us/rsb/code/dhs/dhs132.pdf),
Wis. Admin. Code, is the current State nursing home rule relating to
medication destruction and removal.
HFS 132.65(6)(c) Destruction of medications. 1. 'Time
limit.' Unless otherwise ordered by a physician, a resident's medication
not returned to the pharmacy for credit shall be destroyed within 72 hours
of a physician's order discontinuing its use, the resident's discharge,
the resident's death or passage of its expiration date. No resident's
medication may be held in the facility for more than 30 days unless an
order is written every 30 days to hold the medication.
2. 'Procedure.' Records shall be kept of all medication returned for
credit. Any medication not returned for credit shall be destroyed in the
facility and a record of the destruction shall be witnessed, signed and
dated by 2 or more personnel licensed or registered in the health field.
Pursuant to this memo, for nursing homes that contract
with companies to remove medications for the purpose of credit, donation,
or destruction; the requirement at HFS 132.65(6)(c)1 (see http://www.legis.state.wi.us/rsb/code/dhs/dhs132.pdf)
to destroy medications within 72 hours is being waived, subject to the
following specific conditions. The nursing home must assure that
medications that will be removed by the contracted company are:
Physically separated from medications being
used in the facility;
Locked with access limited; and
In an area with a system to reconcile, audit or
monitor them to prevent
Medications requiring removal fall into three categories: 1)
Medications that can potentially be used or returned; 2) Medications that
cannot be used or returned; and 3) Controlled substances.
Medications That Can Be Used or Returned
Physician Order: Physician orders are used to hold resident medications
that are temporarily stopped, and may potentially be restarted for the
same resident. This practice can eliminate some medication destruction or
returns. Facilities can hold these medications in facility storage as
indicated at HFS 132.65(6)(c)2 (see http://www.legis.state.wi.us/rsb/code/dhs/dhs132.pdf).
Return to pharmacy: Wisconsin pharmacy regulations under
section Phar 7.04, (see http://www.legis.state.wi.us/rsb/code/phar/phar007.pdf)
, Wis. Admin. Code, allow medications to be returned from a nursing home
to a pharmacy for use by other residents under certain circumstances (see
attachment section A for a summary of Phar 7.04). This return practice can
eliminate some medication waste.
Return to Pharmacy Exceptions/Issues:
Controlled substances, per Federal Drug Enforcement
Administration (DEA) regulations, in general cannot be returned to a
pharmacy to be used for other residents. See controlled
substance discussion below.
Many private insurance companies (and now Medicare
Part D) do not have a mechanism for pharmacies to credit the
insurance plan for medications that have been returned and will be
used for other residents. Therefore, these medications need to
be removed from the facility through another mechanism.
(Medicaid continues to have a mechanism to accept returns and
Cancer/Chronic Disease Drug Repository: Newly promulgated
Wisconsin Administrative Code, Chapter HFS 148, created a mechanism for
usable medications to be donated to participating pharmacies. These
medications may be used by individuals who do not have the means to pay
for medications. Information on the repository, including participating
providers, can be accessed at: http://www.dhs.wisconsin.gov/bqaconsumer/cancerdrugreposy.htm.
In general, a nursing home that has medications in a tamper-evident,
unit dose package, e.g. blister or bubble pack, can contact one of the
participating pharmacies to determine if it will accept the medication. If
a participating pharmacy will accept the medication, the nursing home can
fill out a donation form and send the medication to that pharmacy.
Use of a Reverse Distributor: Although rare, a nursing home and a
pharmacy may have the ability for some medications to be returned through
a reverse distributor. This will involve medications that were not
dispensed to a specific resident and typically involve contingency supply
and emergency kit medications. Nursing homes will typically send the
medications back to the pharmacy, and the pharmacy will then work with the
Medications That Cannot Be Used or Returned
This includes expired medications, adulterated or contaminated
medications, and medications that cannot be accepted for return or donated
for future use.
Medication waste generally falls into one of three regulatory
categories: hazardous waste, infectious waste (commonly called
biohazardous waste), and solid waste. All waste generators, including
nursing homes, are responsible for separating their wastes into the
correct regulatory categories and ensuring that the wastes are disposed of
Destroying medications by placing them in the sink
or toilet and flushing them into the waste water is highly discouraged,
because waste water treatment plants do not remove medications. Drug
components can harm plants and animals that live downstream. Furthermore,
it may be illegal to flush certain hazardous medications.
Mixing non-infectious waste with infectious waste is prohibited in
Wisconsin. Accordingly, medications, empty medication bottles, or empty
insulin or vaccine vials should not be disposed of in sharps containers or
biohazard waste bags. It is no longer true that most infectious waste is
incinerated; typically these wastes are disinfected and put in a landfill
Use of a Waste Hauler for Medication Waste
Hazardous waste is subject to both state and federal regulations (see
attachment section B). Hazardous waste involves items that are listed by
name in the regulations or exhibit characteristics of hazardous waste.
Common hazardous waste medications include epinephrine, Coumadin, vaccines
preserved with thimerosal, and even certain shampoos and vitamin/minerals.
An estimated 5-15 percent of medication waste may be hazardous. A
reputable hazardous waste hauler can help you separate these wastes.
State-owned facilities must use the state hazardous waste contractor for
disposing of their hazardous waste. Facilities owned by local governments
may also use the state contractor.
Infectious waste is regulated by the Wisconsin Department of Natural
Resources (see attachment section C). This category includes sharps such
as syringes and intravenous delivery devices that can cut or puncture the
skin. If the needle can be detached from an IV delivery device in
accordance with worker safety regulations, only the needle needs to be
managed as infectious waste. In most cases, syringes are empty after use.
However, when medication is left in a syringe or IV bag with a needle
attached, you must determine if the medication is hazardous waste or not.
In some cases you might have to manage a waste as both infectious waste
and hazardous waste.
Medications that are not infectious or hazardous are considered general
solid waste and may be handled like other garbage. The solid waste hauler
may have specific containers and procedures for dealing with medications.
Controlled substances can only be in the possession of Drug Enforcement
Administration (DEA) Registrants, law enforcement, consumers (nursing home
residents) who have a prescription for the controlled substance, or the
nursing home where the residents are residing. Physicians, pharmacies, and
hospitals are usually DEA registrants. Most nursing homes are not DEA
Federal law currently prohibits controlled substances from being
returned from a non-DEA registrant to a DEA registrant, such as a
pharmacy. Accordingly, nursing homes that are not DEA registrants need to
follow the destruction requirements in section HFS 132.65(6)(c)2 for all
unused controlled substances.
If there are any questions related to medication removal, please
contact Doug Englebert at 608-266-5388.
Section A Pharmacy Returns
Regulatory Practice: Phar 7.04 Summary
Medications from a nursing home can be returned to a pharmacy if:
1) Medications are in the original container;
2) The pharmacist determines that the medications are not adulterated or
misbranded (not contaminated or mislabeled); or
3) In the judgment of the pharmacist there is a safety concern, e.g.,
medication was dispensed in error (medication error), medication is
expired, or medication is defective.
Section B Hazardous Waste
Hazardous Waste contacts and rules can be accessed at http://dnr.wi.gov/org/aw/wm/hazard/.
A publication regarding disposal of vaccines includes information about
how to use the state contractor to dispose of hazardous wastes.
General information about hazardous waste in healthcare facilities, based
on the federal regulations, is offered by Hospitals for a Healthy
Environment (H2E), an environmental resource highly recommended for all
H2E's information about pharmaceutical disposal is at:
Some other hazardous waste websites that may be helpful include:
Section C Infectious Waste and trace chemotherapy waste
Infectious Waste information can be accessed at:
Infectious waste regulations are mostly found in chapter NR 526 http://www.legis.state.wi.us/rsb/code/nr/nr526.pdf
, Wis. Adm. Code.
One publication that includes basic information is entitled "For
Generators of Small Amounts." Larger facilities should review
"Medical Waste Reduction and the Annual Report."
Trace chemotherapy waste is regulated under s. NR 526.055, Wis. Adm.
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