Controls Flashcards by ashley wellington

what are the 8 factors that decide scheduling or removal of scheduling

1 - potential for abuse
2 - scientific evidence
3 - state of knowledge
4 - history of abuse
5 - significance of abuse
6 - risk to public health
7 - psychic dependence
8 - immediate precursor to controlled drug

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what are CI drug examples

MDMA
marijuana
heroin
mescaline
etorphine (not HCl)
GHB

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what are CII drug examples

ADHD stimulants
cocaine
codeine
MS Contin, Roxanol, Oramorph, RMS, MSIR (morphine)
fentanyl
Dolophine (methadone)
phenobarbital (non-suppository)
Desoxyn (methamphetamine)
percocet
Norco
Vyvanse
OxyContin
Endocet
Etorphine HCl
Thianil (thiafentinil)

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what are CIII drug examples

fiorcet
fiornial
anabolic steroids
suboxone, temgesic
ketaset, ketalar (ketamine)
tylenol 3
Soma
Xyrem

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what are CIV drug examples

BZD
luminal, bellergal-S (phenobarbital)
lonamin, fastin, adipex, obe-nix, zantril
ultram
urbadan, urbanyl
ambian, ivadal, stilnoct, stilnox
halcion
librium, libritabs, limbitrol, SK-lygen

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what are CV drug examples

vimpat
lomotil, logen
lyrica
robitussin AC

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what are the 10 types of DEA registrations

1 - manufacturing
2 - distributing
3 - reverse distributing
4 - research CI
5 - research CII-V
6 - dispensing or instructing
7 - narcotic treatment program
8 - importer
9 - exporter
10 - chemical analysis

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which DEA registration types do not have coincident activities

narcotic treatment program
reverse distributing
exporting

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what are the coincident activities for the types of DEA registrations

manufacture - dispense and chemical analysis
distribute - reverse distribute
dispense or instruct - research, compound
research - manufacture, import, distribute, chemical analysis
import - distribute
chemical analysis - manufacture, import, distribute, research, export

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what forms need to be filled out for registration from the DEA

form 224 - dispense or instruct
form 225 - manufacture, distribute, research, import, export
form 363 - narcotic treatment program
form 510 - chemical analysis

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how often do DEA registrations need to be renewed

annually
every 3 years for form 224

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what are the exemptions to DEA registration

pharmacies in institutions
contract carrier
patient

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how do you store controls in a pharmacy

disperse CII-V throughout the stock
CI required to be in a safe

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how do you store controls in a practitioner’s office

MUST be in a locked cabinet
thiafentanil, carfentanil, etorphine HCl, diprenorphine MUST be in a safe or steel cabinet

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what information is required to record for dispensed controls

name and address of patient
date dispensed
quantity
dispenser initials

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central recordkeeping requirements

notify board in writing
can start 14 days after DEA receives notification and MUST transfer to location within 2 days

what records CANNOT be stored centrally

completed DEA 222
inventories
prescriptions

how do we physically order CII

1 - DEA 222
2 - person who signed registration OR POA has to do order
3 - drug, strength, pack size, quantity
4 - send original and keep copy

can a manufacturer partial fill or endorse physical CII orders

YES - has 60 days to complete order or can endorse and has to be done within 60 days

how to electronically order CII

MUST apply for digital certificate from DEA to use CSOS

can a manufacturer partial fill or endorse electronic CII orders

how are physical CII orders filled

copy is sent to DEA by the end of the month or reported to ARCOS

how are electronic CII orders filled

copy is sent to DEA within 2 business days

how often should inventory be taken

biennial inventory

what are red flags for prescribers writing controls

1 - prescriber writes a lot 2 - writes large quantities 3 - patient fills to frequently 4 - writes for antagonistic drugs 5 - patient has rx for other names 6 - multiple patient with same rx 7 - not regulars 8 - rx looks too good 9 - quantities differ from guidelines 10 - not acceptable abbreviations in sig 11 - photocopied 12 - directions written in full 13 - different color ink

rx requirement for controls

date name and address of patient drug name, strength, dosage form quantity directions name, address, DEA of prescriber signature

what can pharmacists change on prescriptions

patient's address dosage form, strength, quantity, directions

what can pharmacists NOT change on prescriptions

patient's name drug prescriber need new rx for CII can take oral for other controls

partial filling for CII

ONLY OPIOIDS remaining is filled no later than 30 days or 72 hours if emergency (60 days for LTCF)

emergency rx for CII

can take oral prescriber MUST write covering rx within 7 days with "authorize for emergency dispensing"

rx label requirements for controls - does not apply if <7 day supply for CII or <34 days in institution

date filled pharmacy name, address, number serial number patient name prescriber name directions cautionary statements drug name "this is an opioid" "federal law prohibits transfer"

when can CII be faxed

narcotic INJ for immediate use narcotic for LTCF any for hospice

transfer information requirements - receiving pharmacy

date of original original refills date of first fill valid refills remaining pharmacy name, address, DEA, rx number name of pharmacist

methadone clinic requirements for prescriber

CANNOT prescribe but can administer for a max of 3 days

can a pharmacist deliver controls to a practitioner's office

YES - if delivering based on prescription for an individual for them to administer within 14 days

how to destroy controls

fill out form 41 on site - two employees deliver to reverse distributor send back to distributor request DEA

how are physical CII orders filled

copy is sent to DEA by the end of the month or reported to ARCOS

what should you do for loss of theft of controls

submit form 106 within 15 days report within 1 day of discovery