Controlled Substances Flashcards
1
Q
DEA
A
- Established in 1973 to serve as primary agency to enforce federal drug laws
- Prevent diversion and abuse of controlled substances
- Ensuring adequate/uninterrupted supply to meet country’s legitimate needs
2
Q
CIII Registration Requirements
A
- State controlled substances license and registered with the DEA to dispense controlled substances
- Done through DEA 224, renewed every 3 years
3
Q
Transfer of Business
A
- Submitted at least 14 days in advance
- Complete inventory must be taken on day of transfer and records of copy and original needs to be keot
- Use DEA 222 form to transfer CII
- Records don’t need to be sent unless requested
4
Q
Change of Business Address
A
- Modification of registration
- Proper state license, if state changed
- Maintain new certificate with old one until expiration
5
Q
Registration Termination
A
- Return certificate and unused DEA 222s
- Controlled substance records need to be kept for at least 2 years
- Dispose of unwanted controlled substances in accordance with DEA regulations
6
Q
Deny/Revoking Registrations
A
- DEA can deny or revoke registration
- Can be a state recommendation, experience/conviction of applicant, lack of law compliance, of conduct that threatens public health/safety
7
Q
Transferring Controlled Substances
A
- Can transfer to pharmacy of original supplier/manufacturer
- Can hire outside firm for transfer but pharmacy is responsible
- Records kept for 2 years
- Receiver needs to use 222 for CII (all others document drug, dose, strength, quantity, and date)
8
Q
Disposal of Controls
A
- DEA registered reverse distributor
- Local DEA office for current list
- DEA 222 form to record destruction for CII
- All others record distribution with name, dosage form, strength, quantity, and date transferred
- DEA 41 is submitted by reverse distributor to DEA when drug is destroyed
9
Q
Security Requirements
A
- Provide effective controls and procedures to guard against theft and diversion
- Don’t employ those with convicted felony offenses related to controlled substances
- Need waiver from DEA to employ an individual with this record
- Notify DEA within one business day of discovery about theft or loss in writing
- Use DEA 106 form
- If not theft/loss found, don’t need to submit 106 form but report why it wasn’t filed
10
Q
Theft/Significant Loss
A
- Registrant needs to identify significant loss
- Quantity in relation to business
- Specific controlled substance
- Pattern of loss over time
- Control substance likely for diversion
- Local trends of diversion potential
- Report to NM BoP within 5 days of discovery
11
Q
In-Transit from Pharmacy
A
- Pharmacy responsible, not carrier
- Purchaser completes 106
12
Q
Breakage/Spillage
A
- Dispose accordingly
- DEA form 41
13
Q
Robbery
A
- Potential federal investigation
- Penalty on conviction is up to $25,000 fine or 20 years in prison, goes up if used a weapon or someone dies
14
Q
Record Keeping
A
- Complete and accurate records
- Maintain at least 2 years
- Separate CII from III-V
- Must be readily retrievable
- Can be filed electronically or in paper form
- Choose a system that complies with federal and state laws
15
Q
DEA 222
A
- Used to order CI and CII
- Number/size of packages, name of drug, signed by authorized person document date and packages receives and file
- Lost/stolen forms should be reported to DEA immediately, give serial numbers of each form or approximate date of issue
16
Q
Schedule III-V Ordering
A
- Keep receipt with product information
- Record date of receipt
- Confirm accurate order
- Readily retrievable
17
Q
Prescription Requirements
A
- Dated/signed
- Patients’ name, address
- Physician name, address, DEA number (only if allowed in jurisdiction and registered with/working for institution registered with DEA)
- Drug name
- Strength
- Dosage form
- Quantity
- SIG
- Number of refills, if any
18
Q
Prescriptions must be…
A
- Used for legitimate purpose in usual course
- Exercise professional judgement when determining legitimacy of prescription
- Can be electronic if meets software requirements
- Pharmacist must verify practitioner and their DEA number
19
Q
CII Rx
A
- Must be written or manually signed and meets all electronic prescription requirements
- No federal limit regarding quantities
- Amount dispensed must be consistent with legitimate use/usual course
- Refills prohibited
- Can write 90-day refills on separate Rxs
- Must comply with laws
- Must ensure it is for medical use
- Must indicate earliest fill date
20
Q
Faxable CIIs
A
- Long-term care
- Hospice
- Compound for direct administration
21
Q
CIII-V Rx Requirements
A
- Can call, fax, or electronic
- Refill up to 5 times in 6 months
- Must include dispensing pharmacy initials, date it was refilled, and amount refilled when refilled
22
Q
Transferring CIII-V
A
- Can transfer between pharmacies once
- If part of the same system, can transfer between pharmacies as long as Rx is valid
- Prescription Monitoring Program
23
Q
Central Fill Pharmacy
A
- One pharmacy gets Rx and second fills/delivers medication
- Both must keep records
- Rxs for controls from CII-V may be transmitted electronically to central fill Rx through fax
24
Q
Businesses not Requiring Registration (NM)
A
- Warehouse storage areas
- Soliciting agent offices where no samples are controls
- Physicians office where there are no controls administered or dispensed
25
Q
Registration Terminated when…
A
- Registrant dies
- Business is discontinued
- License is revoked or suspended
- No longer has DEA registration for any reason
- Changes his/her name or address
- Notify BoP within 30 days
26
Q
Inventory Records
A
- Done on May 1st for initial inventory by registrant
- Don’t vary more than 4 days and notify BoP
- New PIC should inventory all controlled within 72 hours
- Upon transfer of ownership of pharmacy a inventory should be done
- Records should be readily retrievable
27
Q
CI/CII Order Forms
A
- Records on copy 3 of order form
- Mark number of commercial or bulk containers furnished of each item
- Date on which containers were received
28
Q
Rx/Dispensing Records
A
- Keep CII separate
- CII-V w/o electronic records should have dispensing pharmacist name and date on Rx
- Keep CIII-V separate as well
29
Q
NM CIII-V Limitations
A
- New opiate called over the phone shall not exceed 10 day supply
- Verbal refill authorizations are exempt from requirement
- Employees shall verify identity of patient or their representative before a new script for a controlled substance (II-IV) is delivered
30
Q
Voluntary Consent to Inspection
A
- Board inspector will ask for voluntary consent
- Constitutional right to ask for an inspection warrant
- If waived, will ontain a signed consent waiver statement from registrant
31
Q
PMP
A
- Mandatory electronic reporting to PMP
- For all II-V controls so the board can monitor them
- Must report within 1 business day of filling Rx
32
Q
Buprenorphine
A
- Must receive 24 hours of training to be eligible to prescribe
- Includes NPs and PAs
- Allows 30 patients/year
- Verify provider, DEA should start with X
