Article Archive
January/February 2016

Medication Disposal Challenges in LTC
By Mark D. Coggins, PharmD, CGP, FASCP
Today's Geriatric Medicine
Vol. 9 No. 1 P. 8

The disposal of unused and expired medications creates a significant issue in long term care facilities (LTCFs), with patients reported to receive, on average, eight scheduled (routine) medications and an additional three PRN (as needed) medications.1 The number of medications that go unused by the nearly 1.4 million skilled nursing patients in the United States alone results in about 1.5 million pounds of medication waste each year.2

The improper disposal of these medications led in part to the detection of these pharmaceuticals in waterways and eventually in the water supply. A 2002 US Geological Survey Study confirmed that pharmaceutical compounds were detected in 80% of the 139 streams sampled.3 The Environmental Protection Agency (EPA) released a 2008 study on unused pharmaceuticals in the health care industry that discussed the management and disposal of unused pharmaceuticals and the presence of pharmaceuticals in the water supply. The EPA report noted that these medications enter the water supply through direct excretion or improper disposal by patients themselves and improper disposal by health care facilities that have improperly flushed pharmaceuticals, placed medications in "red bag" regulated medical waste, or just thrown them into the trash.2

Reasons for Unused Medications
A survey by the American Society of Consultant Pharmacists (ASCP) estimates that, on average, 17% of medications dispensed in LTCFs go unused. The ASCP notes that the significant amount of pharmaceutical waste in LTCFs is due to prescribed medications, both controlled and noncontrolled, going unused for a variety of reasons, including the following:1

• a resident's medical condition has been resolved before the medication is completely consumed;

• a resident has an adverse effect from the medication and must discontinue therapy;

• a resident is transferred to a hospital and it is unclear whether he or she will return to the facility;

• the medication is ineffective and the physician modifies the resident's medication;

• a resident fails to adhere to the therapy prescribed;

• a resident dies, leaving behind a supply of medications; or

• medications are not completely used before their expiration date is reached.

Consequences of Inappropriate Medication Disposal
Inappropriate medication disposal practices in LTCFs can lead to a number of negative consequences including the following:

• increased potential for accidental poisoning;

• unintended overdoses;

• prescription drug diversion;

• possible environmental contamination;

• disruption to facility operations due to extended external investigations;

• negative public relations within the community;

• regulatory citations, penalties, and fines; and

• potentially costly cleanup efforts.

The Centers for Medicare & Medicaid Services (CMS) requires LTCFs to have policies and procedures for the storage and disposal of medications with a method of disposition that is consistent with applicable state and federal requirements, local ordinances, and standards of practice.

However, medication disposal in LTCFs is complex and often confusing due to the competing objectives from multiple regulatory agencies that have taken steps to address pharmaceutical waste. Despite good intentions, the recommendations or regulations from these agencies have typically been uncoordinated and are often in conflict with one another, thereby increasing the potential for noncompliance.

The FDA website page "Disposal of Unused Medicines: What You Should Know," provides guidance to consumers and LTCFs in certain cases on the disposal of medications through take-back programs or Drug Enforcement Administration (DEA)-authorized collectors.4

Flushing of Certain Medicines
The FDA provides a list of medicines recommended for disposal by flushing, noting that there is a small number of medicines that may be especially harmful and, in some cases, fatal with just one dose if they are used by someone other than the person for whom the medicine was prescribed. To prevent accidental ingestion of these potentially dangerous medicines by children or pets, it is recommended that these medicines be disposed of quickly through a medicine take-back program or by transferring them to a DEA-authorized collector. If these disposal options are not readily available, it is recommended that these medicines be flushed down the sink or toilet as soon as they are no longer needed.4

In particular, the FDA recommends that used fentanyl patches be disposed of by folding together the adhesive side of the patch and then flushing it down the toilet to reduce the risk of accidental exposure, ingestion, or overdose, particularly by children. Fentanyl patches, marketed under the brand name Duragesic, are a focus of the FDA's Safe Use Initiative, an ongoing effort to educate consumers and health care professionals and reduce preventable medication harm.5 In a November 2012 memo, CMS also provided additional guidance to nursing home surveyors around fentanyl patch disposal.6

It should be noted that the recommendation to flush medications or dispose of them down the drain is prohibited in some states or local municipalities. It is recommended to consult local wastewater treatment plants to determine what pharmaceutical wastes are appropriate to dispose of via the sewer system in health care facilities. In general, this practice should be avoided if at all possible in LTCFs.7

White House Office of National Drug Control Policy
The White House Office of National Drug Control Policy, with input from the FDA, provides guidelines on drug disposal. The guidelines include the following:4

• Do not flush prescription drugs down the toilet or drain unless the label or accompanying patient information specifically instructs you to do so.

• If a drug take-back or collection program is not available, use the following disposal method:

1. Take prescription drugs out of their original containers.

2. Mix drugs with an undesirable substance, such as cat litter or used coffee grounds.

3. Put this mixture into a disposable container with a lid, such as an empty margarine tub, or a sealable bag.

4. Conceal or remove any personal information from Rx containers.

5. Place the sealed container with the mixture and the empty drug containers in the trash.

Occupational Safety and Health Administration
The Occupational Safety and Health Administration (OSHA) may play a role in disposal, especially when sharps containers are involved (eg, Duragesic patches placed in sharps containers). The ASCP indicates that OSHA has advised that medications should not be put into sharps containers. OSHA also maintains a "hazardous drug" list, which dictates certain disposal methods and also requires Material Safety Data Sheets. State government agencies may maintain their own list of hazardous pharmaceuticals.

Alternative Chemical Medication Disposal Solutions
Medication disposal systems such as carbon adsorbents are becoming available as a way for consumers to directly inactivate medications and reduce harm to the environment. These proprietary systems (eg, Rx Destroyer) allow the disposal of unwanted nonhazardous medications, including liquids, tablets, capsules, and transdermal patches, by placing products in a disposal pouch or other container and discarding directly in the trash. The use of deactivating and binding agents is intended to render the medication unusable and prevent both drug diversion and contamination of the environment.

On October 9, 2014, the Secure and Responsible Drug Disposal Act of 2010 went into effect. The law authorizes the DEA to implement regulations establishing mail-back programs, take-back events, and the use of secured on-site disposal receptacles for the safe disposal of controlled substances with the intent to prevent serious injury/death as a result of unauthorized use of controlled substances, and to prevent the accumulation of unwanted controlled substances. The disposal options outlined in the final rule are voluntary. LTCFs may continue to use current disposal practices such as mail-back programs, take-back events, and flushing, provided they are legal within existing state and federal regulations. LTCFs and LTC provider pharmacies that opt to utilize these options must do so within the parameters of the rule.

Key Points of the Disposal Act
• LTCFs may dispose of pharmaceutical controlled substances on behalf of a person who resides in or has resided at the facility.

• LTCFs may dispose of pharmaceutical controlled substances by depositing them into an authorized collection receptacle.

• In LTCFs, an authorized retail pharmacy or hospital/clinic with an on-site pharmacy may install, manage, and maintain a collection receptacle.

• Controlled substances and noncontrolled substances may be placed into receptacles.

• Controlled substances disposed of by transferring into a collection receptacle should occur immediately, or not longer than three business days after discontinuation.

• Discontinuation of use includes a permanent discontinuation as directed by the prescriber, as a result of the resident's transfer from the LTCF, or upon death of the resident.

• One supervisor-level employee of the LTCF (eg, charge nurse) designated by the authorized collector may assist in changing the collection receptacle inner liner, provided it is done under the supervision of one employee of the authorized collector.

• Upon removal, sealed inner liners may be stored at the LTCF for up to three business days in a securely locked, substantially constructed cabinet or a secured room with controlled access.

• Controlled substances transferred from ultimate users to authorized collectors via either collection receptacles or mail-back programs must be securely stored or transferred until rendered nonretrievable.8

The EPA oversees the implementation of the Resource Conservation and Recovery Act (RCRA), which controls the management and disposal of solid and hazardous wastes. In 2008, the EPA proposed adding pharmaceuticals to the Universal Waste Program but declined to finalize that proposal. Following several comment periods, the EPA revised the proposed regulation with the most recent proposed rule published in the Federal Register. The comment period was recently extended until December 24, 2015.9

The EPA proposal's revised regulations are intended to improve the management and disposal of hazardous waste pharmaceuticals and to address specific issues health care facilities face related to the management of unused/expired pharmaceuticals.

All health care facilities are subject to the EPA rule as proposed. The term "health care facility" is broadly defined and includes LTCFs. The EPA defines these LTCFs as licensed entities "that provide assistance with activities of daily living, including managing and administering pharmaceuticals to one or more individuals at the facility."9

Per EPA definition, LTCFs include but are not limited to assisted living facilities, hospices, nursing homes, skilled nursing facilities, and the assisted living and skilled nursing care portions of continuing care retirement communities (CCRCs). Note that group homes, independent living communities, and independent living portions of CCRCs are not included.9

Hazardous Waste Pharmaceuticals
LTCFs must be able to segregate their hazardous waste pharmaceuticals based on the pharmaceutical hazardous waste classification including P-Listed or acute waste, which are acutely hazardous to drinking water and the environment and include nicotine and warfarin/Coumadin; U-Listed or nonacute waste, which typically includes chemotherapeutic agents but also other medications such as lindane; and characteristic hazardous waste, displaying one of four characteristic traits (ignitable, corrosive, reactive, or toxic).9

A complete list of P-Listed and U-Listed hazardous waste can be found at

Categories of Hazardous Waste Generators
Currently, health care facilities are divided into three categories: large-quantity generators, small-quantity generators, and conditionally exempt small-quantity generators (CESQGs), based on the quantity of hazardous waste generated per month. CESQGs are subject to fewer regulations, and may send hazardous waste to solid waste landfills rather than regulated hazardous waste treatment, storage, and disposal facilities.9

Loss of Household Waste Exemption
Currently, all hazardous waste, including hazardous waste pharmaceuticals, generated by patients in LTCFs is treated as exempted household waste. As proposed, the EPA expresses its intent to abolish this household waste exemption for many LTCFs.9

Flushing/Drain Disposal
The proposal would ban all health care facilities from flushing or drain disposal of hazardous waste pharmaceuticals. The EPA recommends against flush or drain disposal for nonhazardous waste pharmaceuticals, except where specifically directed by FDA guidance.9

Treatment of Hazardous Waste Pharmaceutical Residue
Empty containers that held hazardous waste pharmaceuticals can be treated as nonhazardous waste if it is RCRA empty. Currently, containers that once held acute hazardous waste must be triple rinsed to be RCRA empty, while the residue in containers that held nonacute hazardous waste must weigh less than 0.3% by weight of the container's capacity. To simplify this determination, the EPA proposes the following rules:

• Unit-dose containers including medication packets, pill cups, blister packs, bottles, and vials holding up to one liter of liquid or 1,000 pills will be considered RCRA empty if the pharmaceuticals have been fully dispensed.

• Syringes that held hazardous waste pharmaceuticals are also medical waste. Currently, these dual wastes must be managed to be in compliance with both RCRA and medical waste regulations. The EPA proposes to exclude syringes that contain residue of hazardous waste pharmaceuticals and instead, dispensed syringes can be disposed of as medical waste.

The EPA proposes to regulate other containers with residue of hazardous waste pharmaceuticals (eg, IV bags and tubing, inhalers, aerosols, and medicine tubes) as hazardous waste if the residues contain listed hazardous wastes or exhibit a hazardous waste characteristic. In determining whether a pharmaceutical is a characteristic hazardous waste, the dose form is considered; for example, if in alcohol, then the drug is likely ignitable under EPA procedures, and therefore hazardous.9

Additional Standards
Under the EPA's proposal, health care facilities that generate hazardous waste pharmaceuticals that do not qualify as CESQGs would be subject to the following rules:

• Health care facilities must inform employees who handle hazardous waste pharmaceuticals regarding the proper handling and disposal of these wastes. Training can be administered verbally or through written materials.

• Instead of assigning containers for hazardous waste pharmaceuticals' specific waste codes, the EPA proposes to eliminate this requirement and instead allow health care facilities to simply mark containers "hazardous waste pharmaceuticals."

• The EPA proposes allowing health care facilities to accumulate hazardous waste pharmaceuticals for up to one year before they must be shipped to a disposal facility.9

So, What Now?
Because of the complexity of medication disposal, increased scrutiny by regulatory agencies, and a rapidly changing environment, leadership at LTCFs are well advised to evaluate their current medication disposal processes. For the medication disposal program to be most effective and sustainable, a team approach is recommended. The consultant pharmacist can be a valuable resource in developing and evaluating all pharmaceutical services, including medication disposal. Contracting with a qualified medical waste disposal contractor is advisable. Operational procedures should be kept as simple as possible to help improve compliance. Increased education and training regarding unused pharmaceutical waste segregation and implementation best practice guidelines that are reinforced by training and self-audit programs is essential to any formalized waste stream management plan.

— Mark D. Coggins, PharmD, CGP, FASCP, is senior director of pharmacy services for skilled nursing centers operated by Diversicare in nine states, and is a director on the board of the American Society of Consultant Pharmacists. He was nationally recognized by the Commission for Certification in Geriatric Pharmacy with the 2010 Excellence in Geriatric Pharmacy Practice Award.

1. American Society of Consultant Pharmacists. Comments to Drug Enforcement Administration Re: DOCKET No. DEA-316. Published March 23, 2009.

2. Siler S, Duda S, Brown R, Gbemudu J, Weier S, Glaudemans J. Safe disposal of unused controlled substances: current challenges and opportunity for reform. Avalere Health.

3. Buxton HT, Kolpin DW. Pharmaceuticals, hormones, and other organic wastewater contaminants in U.S. streams. US Geological Survey. Updated August 4, 2015.

4. Disposal of unused medicines: what you should know. FDA website.
SafeDisposal ofMedicines/ucm186187.htm
. Updated November 3, 2015.

5. Fentanyl patch can be deadly to children. FDA website. Updated September 4, 2015.

6. Centers for Medicare & Medicaid Services. Nursing homes — clarification of guidance related to medication errors and pharmacy services. Published November 2, 2012.

7. Hospitals for a Healthy Environment. Managing pharmaceutical waste: a 10-step blueprint for health care facilities in the United States. Updated August 2008.

8. Disposal act: long-term care facility fact sheet. Drug Enforcement Administration Office of Diversion Control website.

9. Management standards for hazardous waste pharmaceuticals: a proposed rule by the Environmental Protection Agency on September 25, 2015. Federal Register website. Published September 25, 2015.