Disposal for Pharmacists
Medication Disposal for Pharmacists
The Drug Disposal Act of 2010 was passed to reduce harm from unwanted medications and to create accessible opportunities for simple, secure disposal from an ultimate user. The DEA defines an ultimate user as “a person who has lawfully obtained, and possesses, a controlled substance for their own use or for the use of a member of their household or for an animal owned by them or a member of their household.” The drug disposal act provides a framework for collection and disposal strategies while keeping a focus on the needs of patients and their families or friends. The Indian Health Service understands the benefit of safe disposal services, and has outlined various methods for pharmacy programs to consider below.
Facility Drug Disposal Policy
Facilities should consider implementing a drug disposal policy in accordance with the Drug Disposal Act of 2010 that considers best practice guidelines from the Environmental Protection Agency and Food and Drug Administration for proper disposal from the ultimate user. This medication disposal is referring to disposal of medications from the ultimate user and does not include waste from other health care operations such as medication administration, expired medications, and hazardous waste. Facility policy should be customized to local program processes. Key aspects of the policy may include: defining the purpose for a mechanism of disposal, defining the mechanism of disposal (i.e.: mail-back programs, take-back events), defining the management of the mechanism of disposal. The following is an example medication disposal policy:
Sample DEA Disposal Policy [DOC - 60 KB]
Registering as a DEA collector allows facilities to become legally authorized to accept controlled substances for the purpose of destruction by the ultimate user. Defined by the DEA, an ultimate user is “a person who has lawfully obtained, and who possesses, a controlled substance for his own use or for the use of a member of his household or for an animal owned by him or a member of his household”. Patients are able to dispose of unused and unwanted medications in a safe and private manner at locations they frequently visit. This can decrease the amount of obsolete medication in homes and may reduce unintentional patient harm from the non-medical use of prescription medications. This method creates a process that is simple and private, while providing patients open access to ongoing disposal services.
Manufacturers, distributors, reverse distributors, narcotic treatment programs, hospitals/clinics with on-site pharmacy, and retail pharmacies may modify their DEA registration to obtain authorization to become a collector. The collection mechanism needs to be identified before registration. Once registered, a site can obtain a secure receptacle to collect and store unwanted patient medications in a secure disposal cabinet. The types of medications accepted include prescription and OTC medications, ointments, creams, liquids, lotions, patches, and vitamins. Certain medications that are not accepted include: needles, inhalers, aerosol cans, hydrogen peroxide, thermometers, and illicit drugs.
Costs for this solution are minimal and include start-up costs for the collection receptacle at initial registration and pre-paid replacement liners for use when the receptacle is full. Pharmacy staff remove the receptacle liner when full and follow the provided instructions to prepare the liner for transport to a reclamation facility. The reclamation facility destroys the unwanted medications in a manner to render them non-retrievable. Incineration and chemical digestion are DEA approved methods to achieve the non-retrievable standard. Different from the reverse distributer where unwanted medications are collected, a reclamation facility destroys the medications making them non-usable. The DEA defines a reverse distributor as “a person who receives controlled substances acquired from another DEA registrant for the purpose of returning unwanted, unusable, or outdated controlled substances to the manufacturer or the manufacturer’s agent, or, where necessary, processing such substances or arranging for processing such substances for disposal”.To register as a collector:
- Review state law to determine whether collector registration is lawful in your area. If it is not, consider submitting a request to the State Board of Pharmacy to proceed at your federal facility as special accommodations are possible
- The DEA defines eligible collectors as any of the following:
- Reverse distributors
- Retail pharmacies
- Registered narcotic treatment programs
- Long term care facilities
- Hospitals/clinics with an on-site pharmacy - Collection receptacles must be placed in the immediate proximity of where controlled substances are stored where an employee is present. This ensures appropriate security of the area and is required for lawful registration. The DEA also prohibits collectors from placing receptacles in an area where emergency or urgent care are provided due to the chaotic nature of traffic flow near them
- When ready to register, visit the DEA CSA Collector Status Request/Update page.
- Complete the brief form to create a login/ Please note, you will need information from your registration certificate in order to login
- Proceed with the remaining steps as directed via the DEA website
Permanent collection receptacles are locked cabinets that can be placed inside a facility where a patient can deposit unwanted medications in a drop box at their convenience. They combine a stainless steel collection container with a removable prepaid ship-back inner liner. The cabinets are fastened to a permanent structure to prevent diversion and theft of collected substances. When the inner liner fills, authorized personnel can safely remove the liner from the collection receptacle, seal it and return it via common carrier. The liners are waterproof, tamper-evident, and tear resistant. The internal contents are not viewable from the outside when sealed. The liners have a prepaid return label which includes a unique identification number this is trackable. Upon removal the internal liner must be stored in a securely locked, substantially constructed or a securely locked room until transferred. The full liners may only be stored for three business days.
Once sealed, a common carrier transports the package to a reclamation facility. The inner liners are disposed of using the DEA preferred method of disposal, incineration, rendering the pharmaceuticals non-retrievable. The receptacles accepts controlled, non-controlled and over the counter medications. MedSafe, American Security Cabinets, MedReturn, and RxDrugDropBox are examples of permanent collector receptacles.
Diversion may occur during any part of the disposal process, quality controls need to be in place to prevent diversion. The disposal cabinet shall be securely fastened to permanent structure to prevent cabinet displacement. The cabinet has two different locks to access the content of the cabinet, the keys shall be placed in a secure location only accessible to authorized staff. Two employees shall be present every time the cabinet is opened. When the cabinet is full and the liner needs to be replaced two employees shall remove the contents and seal the liner immediately. Upon removal the inner liner may only be stored for three business days in a securely locked, substantially constructed cabinet or a securely locked room with controlled access until transferred to the common carrier.
These programs provide mailing envelopes for patient use. Unwanted medications are placed in prepaid envelopes and sent via designated mail carrier for disposal. Patients have privacy and can use them from the convenience of their own home, but may not be able to dispose of all substances. Costs are highly variable based on the number of envelopes used and patients may not understand which medications are eligible.
Takeaway Medication Recovery Systems
A takeaway medication recovery system is a mail back program. A facility may purchase prepaid envelopes and boxes to provide to their patients. They are also sold in pharmacies and can be provided by other entities for consumers to prepare and mail right from their homes. The envelopes are designed to be taper evident with unique serialization for tracking and destruction. For more information regarding Takeaway Medication Recovery System visit their website.
A take-back event is a scheduled day in cooperation with local law enforcement where community members are encouraged to bring their unwanted items to a specific drop-off location. Collectors are not authorized to conduct take-back events. Law enforcement may conduct take-back events at any time. Any person or community group, registrant or non-registrant, may partner with law enforcement to conduct take-back events. Medications are then disposed of in accordance with the Code of Federal Regulations Title 21 part 1317.05. Attention must be given to the types of items accepted, Scheduled I medications are not accepted. Law enforcement facilities may have permanent drop boxes, but restrict the type of items accepted for disposal. If you are interested in participating in a take-back event or searching for locations with ongoing services visit the links below. Be aware that take back events and locations offered by tribal law enforcement may not be listed, so it is important to check locally as well.
- National Prescription Drug Take Back Day,- U.S. DOJ Diversion Control Division website - the U.S. Department of Justice, Drug Enforcement Administration (DEA), Diversion Control Division
- Disposal of Controlled Substances - DEA Registrant Disposal, Disposal of Controlled Substances - the Federal Register
- Taking Stock of Medication Wastage Unused Medicines in U.S. Households - report
- Where and How to Dispose of Unused Medicines - U.S. Food and Drug Administration
- Collecting and Disposing of Unwanted Medicines - U.S. Environmental Protection Agency