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Flashcards in Controlled Substances Deck (32)
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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