Controls Flashcards
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
what are CI drug examples
MDMA
marijuana
heroin
mescaline
etorphine (not HCl)
GHB
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)
what are CIII drug examples
fiorcet
fiornial
anabolic steroids
suboxone, temgesic
ketaset, ketalar (ketamine)
tylenol 3
Soma
Xyrem
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
what are CV drug examples
vimpat
lomotil, logen
lyrica
robitussin AC
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
which DEA registration types do not have coincident activities
narcotic treatment program
reverse distributing
exporting
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
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
how often do DEA registrations need to be renewed
annually
every 3 years for form 224
what are the exemptions to DEA registration
pharmacies in institutions
contract carrier
patient
how do you store controls in a pharmacy
disperse CII-V throughout the stock
CI required to be in a safe
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
what information is required to record for dispensed controls
name and address of patient
date dispensed
quantity
dispenser initials
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
NO
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
