schedule changes:
when scheduling change occurs, a pharmacy must complete an inventory of the drug on the ___ the change become effective
date
dronabinol oral solution ( syndros) is classified as class ____ where as dronabinol capsule ( Marinol) is classified as scheduled ____
II
III
codeine single entity products are classififed as class ___ where as combination tablets/capsules that contain codeine are classified ____. Combination cough syrups with codeine are classified as class ____
II
III
V
Barbituate schedules refer to page 6
6
NMT: For a drug to be classified as schedule 3, opioid quantity should not have more than___
1.8 g of codeine per 100 mL or 90 mg per dosage unit ( when combined with an equal or greater quantity of an isoquinoline alkaloid of opium)
1.8 g of codeine per 100 mL or 90 mg ( when combined with one or more active non-narcotic ingredient)
1.8 g of dihydrocodeine per 100 mL or 90 mg per dosage unit
schedule IV: A drug is classified as class IV if NMT than
1 mg difenoxin and not less than 25 mcg of atropine per dosage unit
schedule V if NMT
200 mg of codeine per 100 mL or 100 g
100 mg of dihydrocodeine per 100 mL or 100 g
2.5 mg of diphenoxylate and not elss than 25 mcg of atropine per dosage unit
what are two natural compounds found in marijuana
THC and CBD
Federally, are pharmacies allowed to sell marijuana?
Pharmacies are not permitted to sell amrijuana or drug paraphernalia ( eg rolling papers)
calculation example on page 115
refer
Examples of schedule V medications are
these are codeine/promethazine, codeine/guaifenesin, codeine/promethazine/phenyephrine
Brivacetam
Cheratussin AC
Robutissun A-C
Virtussin A/C
Schedule IV drugs are
Benzodiazepines
Hypnotics
Weight loss drugs
Others: armodafinil etc refer to page 113
brand names and generics review skipped repeat
brand names and generic review skipped repeat
Controlled substances Section II
Section II
What are healthcare provider practices that can prescribe administer, or dispense controlled substances without registering with the DEA
Federal bureau of prisons
indian health service
US Armed forces ( Air Force, Army, Coast guard, Navy, Marine corps, Space force)
US Public health service
Ordering of controlled drugs for schedules 3-5 through CSOS, receipts of must be readily available in the pharmacy and should contain what?
name of each controlled substance
drug formulation
number of dosage units
numbe rof packages ordered and delivered
When ordering first control schedule I and II, the PIC must first register with the DEA form ____
222
CSOS can be used to oder I-V while dea 222 is limited to I-II. Note Schedule I have no medical use but may be ordered for investigational purposes
complete the following
DEA method of submission is ___ where as CSOS is ____
Limit of items in DEA form 222 ___ itms on triplate form, ___ on single sheet, ___ CSOS
Form 222 turn around time___, CSOS turn around time
DEA form 222 signature is ___ CSOS is
Can order be endorsed for Form 222? For CSOS?
Form 222 when does supplier report transaction to DEA?For CSOS?
Paper, electronic
10,20,no limit
2-5 days, 1-2 days
handwritten, digital
yes, no
by end of month, within 2 days
Triplate form ( copy 1,2,3) and no longer accepted after octoer 2021, we only use single sheet forms
each entity invloved in the transfer of schedule II must retain a copy for form 222
page 124
page 124
triplicate form 222 for scheduled II drug transactions
Pharmacy orders drug from a supplier copy 1(brown) goes to ___ copy 2 ( green) goes to ___ copy 3 ( blue) goes to___
Supplier, DEA, Pharmacy
triplicate form 222 for scheduled II drug transactions
Pharmacy returns unused drugs back to a supplier, copy 1 goes to ___ copy 2___ copy 3___
pharmacy
DEA
Supplier
triplicate form 222 for scheduled II drug transactions
Pharmacy sends unused drugs back to reverse distributor for disposal, copy 1 goes to __ copy 2__ copy 3___
pharmacy ( cause they are the supplier)
DEA
reverse distributor
triplicate form 222 for scheduled II drug transactions
Pharmacy sells or lends drugs to another pharmacy copy 1__ copy2__ copy 3___
supplying pharmacy
DEA
Receiving pharmacy
triplicate form 222 for scheduled II drug transactions
Pharmacy sells or lends drugs to a physician for administration or dispensing
copy 1___ copy 2____ copy 3____
pharmacy
DEA
Physician
The supplier must report the transaction to DEA within ___ business days from the date the order was filled
2
Lost or stolen DEA form 222
If a completed form 222 is lost or stolen,the pharmacy must provide a statement to the distributor with the new form 222. The pharmacy must provide a statement to the distributor with the new form 222 containing the following information:
serial number of original form
the date of the initial order
a statement that the controlled substances were not received
Distribution of controlled substances between dea registrants. An invoice or csos is used to transfer schedule III-IV drugs and must contain
drug name, dosage form, strenght, quantity
dtae of controlled substance transfer
recipient name address and dea number
If a pharmacy goes out of business All records of transfer should be kept for at least ____ years
2
initial and final inventory should bedone before the dispensing day has started or end of the day
Pharmacy can sell controlled substances to other pharmacies or prescribers registered with DEA to dispense controlled substances. The total quantity sold cannot exceed ____ % of the total quantity dispensed each year by the selling pharmacy
5%
cancelled or voiding controlled substances orders
the purchaser can cancel the order and notifying the supplier in writing
purchase must draw line and write _____ where as supplier must indicate _____ on form 222
cancell
cancellation
a supplier can void part or all of an order by notifying the purchaser.. Supplier must draw a line through the cancelled items on form 222 and print___ in the space for the number of items shipped
void
Loss or theft of controlled substances
Report theft within ___ business day of discovery. Submit form __ to DEA. If theft is determined not occurred the form doesn't need to be submitted
1
106
DEA Form ___ is used to document the destruction of controlled substances
41
even for breakage damage, spillage
if breakage or spillage is not recoverable, registrant must document the incident of inventory record, two witnesses to the breakage or spillage must sign the record
GA LAW: All controlled substances which are outdated
or expired must be disposed of in a manner
that generates a DEA
Form 41 (Drug Destruction Form), a copy of which must be
retained by the pharmacy. Such controlled substances can be
disposed of by one of the
following:
(a) Representatives of the Georgia Drugs and Narcotics Agency
(GDNA);
(b) Agents of the U.S. Drug Enforcement Administration
(DEA); or
(c) A reverse distributor holding a current permit
issued by the Georgia State Board of
Pharmacy (Board).
DEA Controlled substances inventory requirements
The registrant needs a record showing ___ inventory if there are no controlled substances at the time of opening. After initial inventory, a complete inventory of current stock on hand is taken minimally on a __ basisi
zero
biennial ( every two years)
how are records of inenvenotry of schedule II drugs kept?
separate from all other controlled substances
for sealed, unopened containers of all controlled substances an ____ count is needed
exact, there is no need to open a sealed container to perform a count
for opened containers fill the following
all scheduled I and II require ____ count
scheduled III , IV, V containers holding < 1000 dosage unit can be exact or estimated?
scheduled III , IV, V containers holding > 1000 can be exact or estimated?
exact
estimated
exact
record keeping of controlled substances
All scheduled II drug records must be kept separate from all other records. What about scheduled III, IV and V?
iii, iv, v must either be kept separately from all other records or stored in a way that the information is readily retrivable
Paper prescription record keeping: according to fedral law pharmacies have two options for filing paper
Option 1( three separate files): explain these
Option 2 ( two separate files) : explain these
option 1: 2S
345 S
Non controlled S
option 2:
2S
345 with red C at least 1 inch high + Non together but
letter c is waived if pharmacy has an electronic prescription recordkeeping system
federal law requires keeping records for ___ years
2
notify the DEA and borad of pharmacy in each state which intends to conduct business ___ days before dispensing through the inetrnet
30
Part III
PART III