CSH Flashcards
Q
A
Safe Disposal of Unused Controlled Substance
Public may dispose of CS without identifying themselves
Does not constitute transfer between registrants
Consumers handling CS
It is illegal to store CS in any other container than what it was received
Listed wastes
P-Listed Wastes
Warfarin, Nicotine
U-Listed Wastes
Chloral Hydrate
Selenium Sulfide (dandruff)
Some chemotherapy drugs (but not most)
Others
Characteristic Wastes
Toxic
Mercury (thimerisol), arsenic, selenium
Ignitable (D001) >24% alcohol
Corrosive (acids and bases)
Reactive (no pharmaceuticals)
Resource Conservation and Recovery Act (RCRA)
Some pharmaceuticals are regulated as hazardous waste under this law.
Some issues: Healthcare workers are not familiar with the RCRA
Healthcare facilities have thousands of medications some of which many could be considered hazardous
EPA
The EPA is proposing new rules to improve management and disposal of hazardous waste
Hospitals
Healthcare facilities (NH)
Pharmacies
Physician’s offices
Others.
Disposal Sites
Pharmacies authorized to dispose of CS by the DEA
Authorized to collect from the Consumer
Temporarily storing
Transferring it to an authorized disposal site
DEA Drug Disposal
Disposal of Controlled Substances by Registrants
Prior:
Normal transfers had to be between 2 DEA registrants
DEA Form 41
Can be filled online
Use this form to record the destruction of all controlled substances:
From your regular inventory
Collected in the receptacles from the ultimate users
Both sets of drugs must be listed separate and kept separate
Practitioner Inventory
This is your regular dispensing inventory (Not the medications in the consumer drug disposal kiosk)
Promptly destroy all controlled substances via an on-site method of destruction
Must ask permission DEA and BNE
Promptly deliver the medications to a reverse distributor’s registered location by a common or contract carrier
Or pick up by reverse distributor
Return to the registered person from whom it was obtained, the registered manufacturer of the substance, or another registrant authorized by the manufacturer to accept returns or recalls on the manufacturer’s behalf
Either via a common carrier
Picked up by authorized registrant
Request assistance from the DEA
Surrender or Disposal of Controlled Substances
Controlled substances that are undesired, deteriorated, obsolete, or for any reason no longer needed
Full containers to manufacturer or distributor
Surrender to person approved by the BNE to take controlled substances
Destroy the controlled substances in in presences of a with
Licensed practitioner
Nurse Pharmacist
Provided that:
Request permission from BNE at least 2 weeks in advance in writing
Inventory to be destroyed
Specific method of destruction
Date/time/location of destruction
Identity of the two people
Reason for the destruction
DOH BNE: Determine whether or not to grant approval
Record of compliance:
License holder
Employees
Persons witnessing
DOH BNE approval:
Type, nature of drugs to be destroyed & potential for diversion
License pattern and frequency of requests
If no approval then:
Surrender to BNE
Inventory
Reason
Date of surrender
Surrender no later than 5 days of estimated surrender date
Specific requirements to pack
Surrender to the DEA
Specific requirements by DEA
Recordkeeping requirements: Date of return or destruction Name form quantity of CS Name/address/registry # To the manufacturer/distributor Name/license # person performing the destruction
Manufacturer/distributor must keep same records All parties must keep records for?
Single-unit doses or partial doses remaining after the administration of a portion Liquid Solid May be destroyed on the premises by a pharmacist or nurse provided that: Notation on administration record sheet Destruction witnessed by
Surrender/Disposal of C.S. record keeping:
All records for surrender must include Date of return or destruction name,form,quantity of CS name,address, DEA # of you. name,address, DEA # to whom returned name and license #’s of who is performing and witnessing destruction.
Collected Controlled Substances from Consumers
Mail back programs
Offered for sale or for free
Package
Non-descript
Water and spill proof
Tamper-evident
Tear resistant
Sealable
Preaddressed
Collector or law enforcement
Postage paid
Unique ID number
No information on patient or disposer
Accept only those CS contained within the packages
Package shall not be opened, xrayed, analyzed or otherwise penetrated.
Notify DEA within 3 business days of receiving package that the collector did not agree.
Securely store package according to specific DEA requirements until destruction is authorized.
Only law enforcement
Collected Controlled Substances from Consumers From Collection Receptacles (Kiosks)
Pharmacy
Dispose of sealed inner liners and their contents by utilizing any method as per practitioner inventory previously.
Destroy on site with permission
Deliver to reverse distributor
Deliver to manufacturer
Or deliver sealed inner liners and content to distributors registered location by common carrier or distributor pick up.
Pharmacy Collector
Must have your DEA registration modified
No fee
“Authorized Collector”
Note: Authorized collectors may NOT perform take-back programs
Only law enforcement
May partner with law enforcement
Not allowed to co-mingle the ultimate user’s controlled substances with your existing inventory
NOTE: you may NOT dispose of your regular controlled substance inventory in a collection receptacle, mail back package or through a take back event.
You may not require identification of any ultimate user.
You may not take back illicit drugs
Schedule I
Receptacle must be placed in area where employee must watch at all times: can be seen from pharmacy counter.
Must be securely placed and maintained
May take back CII-CV
May also take back non-controls
May not be counted, sorted, inventoried or otherwise individually handled.
Must be securely locked, substantially constructed container.
Securely fastened to a permanent structure: Floor
Outer container shall include a small opening that allows contents to be added to an inner liner
But not removal from
Inner liner:
Be waterproof, tamper-evident and tear resistant
Shall be removable and sealable immediately upon removal without emptying or touching the contents
The contents of the inner liner shall not be viewable from the outside when sealed
The size of the inner liner shall be clearly marked on the outside
Must bear a permanent, unique identification number that enables the liner to be traced
Access to the inner liner shall be restricted to employees of the collector
Must be sealed by 2 employees of authorized collector upon removal from the permanent outer container
May not be reopened, x-rayed, analyzed or penetrated
Must have sign that clearly states CII-CV and non-controls
Other items not accepted
Authorized Collector
Voluntary
Maintain collection receptacles inside their registered location
Long Term Care Facilities
Authorized hospitals/clinics with an on-site pharmacy
Retail pharmacies
Authorization to Collect from Nonregistrants
Approval from DEA and BNE
May take from:
Ultimate user in lawful possession of a controlled substance
Any person lawfully entitled to dispose of a decedent’s property
If decedent died in possession
From LTC facility on behalf of ultimate user who resides or resided in the LTC facility in lawful possession
Hospital/ Clinic
Receptacle must be placed where an employee can be vigilant
Although allowed in emergency department area
May not be located in the proximity of any area where emergency or urgent care is provided.
Narcotic Treatment Program
A collection receptacle shall be located in a room:
that does not contain any other controlled substances and is securely locked with controlled access
Long-term Care Facilities
Collection receptacles at LTCF
Authorized community pharmacies
Hospitals/clinics with an on-site pharmacy
May manage, install, maintain the receptacle
Supervise the removal, sealing, transfer, storage of inner liners
Located in an area that does not contain any other controlled substances and is securely locked with controlled access.
Must be regularly monitored by long-term care facility employees
May dispose of a current or former resident’s pharmaceutical controlled substances only
Into the receptacle
When disposing into the receptacle it must be done STAT but no longer than 3 business days after the discontinuation of use by the ultimate user.
D/C med, transfer patient, patient death
LTCF Inner Liners
The installation, removal, transfer and storage of the inner liners shall be performed by:
- One employee of collector and one supervisor-level employee of LTCF or
- Two employees of the collector
Once removed, the sealed inner liners may be stored at the LTCF for up to 3 business days in a securely locked, substantially constructed cabinet or a securely locked room with controlled access until the transfer is made.
Destruction from All Collectors Transfer to a non-registered site
(1) Transportation shall be directly to the destruction location (the substances shall be constantly moving towards their final destruction location and unnecessary or unrelated stops and stops of an extended duration shall not occur);
(2) Two employees of the transporting registrant shall accompany the controlled substances to the destruction location;
(3) Two employees of the transporting registrant shall load and unload or observe the loading and unloading of the controlled substances;
(4) Two employees of the registrant shall handle or observe the handling of any controlled substance until the substance is rendered non-retrievable;
(5) Two employees of the registrant shall personally witness the destruction of the controlled substance until it is rendered non-retrievable.
Where Are These Collection Receptacles?
Most independents
All Chains
Hospitals
Sheriff Departments
Police Stations
College Campuses
