CSH Flashcards

1
Q

Q

A

A

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2
Q

Safe Disposal of Unused Controlled Substance

A

Public may dispose of CS without identifying themselves

Does not constitute transfer between registrants

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3
Q

Consumers handling CS

A

It is illegal to store CS in any other container than what it was received

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4
Q

Listed wastes

A

P-Listed Wastes
Warfarin, Nicotine

U-Listed Wastes
Chloral Hydrate

Selenium Sulfide (dandruff)

Some chemotherapy drugs (but not most)

Others

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5
Q

Characteristic Wastes

A

Toxic
Mercury (thimerisol), arsenic, selenium

Ignitable (D001) >24% alcohol

Corrosive (acids and bases)

Reactive (no pharmaceuticals)

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6
Q

Resource Conservation and Recovery Act (RCRA)

A

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

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7
Q

EPA

A

The EPA is proposing new rules to improve management and disposal of hazardous waste
Hospitals

Healthcare facilities (NH)

Pharmacies

Physician’s offices

Others.

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8
Q

Disposal Sites

A

Pharmacies authorized to dispose of CS by the DEA

Authorized to collect from the Consumer

Temporarily storing

Transferring it to an authorized disposal site

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9
Q

DEA Drug Disposal

A

Disposal of Controlled Substances by Registrants

Prior:
Normal transfers had to be between 2 DEA registrants

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10
Q

DEA Form 41

A

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

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11
Q

Practitioner Inventory

A

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

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12
Q

Surrender or Disposal of Controlled Substances

A

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.

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13
Q

Collected Controlled Substances from Consumers

A

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

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14
Q

Collected Controlled Substances from Consumers From Collection Receptacles (Kiosks)

A

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.

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15
Q

Pharmacy Collector

A

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

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16
Q

Authorized Collector

A

Voluntary

Maintain collection receptacles inside their registered location

Long Term Care Facilities

Authorized hospitals/clinics with an on-site pharmacy

Retail pharmacies

17
Q

Authorization to Collect from Nonregistrants

A

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

18
Q

Hospital/ Clinic

A

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.

19
Q

Narcotic Treatment Program

A

A collection receptacle shall be located in a room:

that does not contain any other controlled substances and is securely locked with controlled access

20
Q

Long-term Care Facilities

A

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:

  1. One employee of collector and one supervisor-level employee of LTCF or
  2. 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.

21
Q

Destruction from All Collectors Transfer to a non-registered site

A

(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.

22
Q

Where Are These Collection Receptacles?

A

Most independents

All Chains

Hospitals

Sheriff Departments

Police Stations

College Campuses