Controlled Substances

Question 1

DEA

Answer 1

• 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

Question 2

CIII Registration Requirements

Answer 2

• State controlled substances license and registered with the DEA to dispense controlled substances
• Done through DEA 224, renewed every 3 years

Question 3

Transfer of Business

Answer 3

• 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

Question 4

Change of Business Address

Answer 4

• Modification of registration
• Proper state license, if state changed
• Maintain new certificate with old one until expiration

Question 5

Registration Termination

Answer 5

• 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

Question 6

Deny/Revoking Registrations

Answer 6

• 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

Question 7

Transferring Controlled Substances

Answer 7

• 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)

Question 8

Disposal of Controls

Answer 8

• 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

Question 9

Security Requirements

Answer 9

• 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

Question 10

Theft/Significant Loss

Answer 10

• 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

Question 11

In-Transit from Pharmacy

Answer 11

• Pharmacy responsible, not carrier

- Purchaser completes 106

Question 12

Breakage/Spillage

Answer 12

• Dispose accordingly

- DEA form 41

Question 13

Robbery

Answer 13

• 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

Question 14

Record Keeping

Answer 14

• 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

Question 15

DEA 222

Answer 15

• 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

Question 16

Schedule III-V Ordering

Answer 16

• Keep receipt with product information
• Record date of receipt
• Confirm accurate order
• Readily retrievable

Question 17

Prescription Requirements

Answer 17

• 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

Question 18

Prescriptions must be…

Answer 18

• 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

Question 19

CII Rx

Answer 19

• 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

Question 20

Faxable CIIs

Answer 20

• Long-term care
• Hospice
• Compound for direct administration

Question 21

CIII-V Rx Requirements

Answer 21

• 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

Question 22

Transferring CIII-V

Answer 22

• Can transfer between pharmacies once
• If part of the same system, can transfer between pharmacies as long as Rx is valid
• Prescription Monitoring Program

Question 23

Central Fill Pharmacy

Answer 23

• 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

Question 24

Businesses not Requiring Registration (NM)

Answer 24

• Warehouse storage areas
• Soliciting agent offices where no samples are controls
• Physicians office where there are no controls administered or dispensed

Question 25

Registration Terminated when…

Answer 25

• 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

Question 26

Inventory Records

Answer 26

• 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

Question 27

CI/CII Order Forms

Answer 27

• Records on copy 3 of order form
• Mark number of commercial or bulk containers furnished of each item
• Date on which containers were received

Question 28

Rx/Dispensing Records

Answer 28

• Keep CII separate
• CII-V w/o electronic records should have dispensing pharmacist name and date on Rx
• Keep CIII-V separate as well

Question 29

NM CIII-V Limitations

Answer 29

• 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

Question 30

Voluntary Consent to Inspection

Answer 30

• 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

Question 31

PMP

Answer 31

• 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

Question 32

Buprenorphine

Answer 32

• 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