RXPREP Chapter 7: controlled substances part 2 Flashcards
What DEA form?
registration form for retail pharmacies, hospitals/clinics, teaching insitutions, practitioners or mid-level practitioners
224
What DEA form?
registration form for drug manufacturers, distributors (supplier/wholesaler) and researchers
225
What DEA form?
registration form for narcotic (opioid) treatment clinics
363
what dea form?
registration form for bulk chemical manufacturers and distributors
510
what dea form?
ordering form for schedule I and II drugs
222
reporting form for theft or significant loss of controlled substances
106
record of controlled substances destroyed dea form
41
individual persons must register with who for authorization to prescribed controlled substances
DEA
the exception: medical residents in a healthcare facility who can prescribed controlled substances for patients within the institituion by using the facility’s DEA number
facilities participating in the manufacture, distribution, research, prescribing, and dispensing of controlled substances must also register with the DEA
true
healthcare providers practicing at these facilities can prescribe, administer, or dispense controlled substances WITHOUT registering with the DEA
federal bureau of Prisons
IHS
us armed forces (air force, army, coast guard, navy, marine corps, space force)
US public health service
schedule III-V drugs can be obtained from a supplier/wholesaler by using a PURCHASE ORDER or through where?
the controlled substance ordering system (CSOS)
this is electronic!!!!
the receipts from the CSOS should contain what
name of each controlled substance in the order
drug formulation
number of dosage units in each container
number of packages ordered and delivered
before ordering schedule I or II drugs, the PIC must first register with who with what form?
the DEA using the form 224
CSOS can be used to order schedlue I-V drugs, while DEA form 222 is limited to obtaining schedlue I and II drugs.
Limit of items per order using the dea form 222 vs CSOS?
10 items (triplicate form); 20 items (single-sheet form)
no limit for CSOS
what is the typical turnaround time for dea form 222 vs CSOS?
222: 2-5 business days
CSOS: 1-2 business days
Type of signature used for form 222 vs CSOS?
handwritten for 222
digital signature for CSOS
can the orer be endorsed to another supplier for 222 or CSOS?
for form 222 only not CSOS
if a supplier cannot fill all or part of the order, then the order can be endorsed to another supplier for filling. only the initial supplier can endorse the order to another supplier
when must the supplier report the transaction to the DEA using the form 222 vs CSOS?
222: by the end of the month during which the order was filled
CSOS: within 2 business days of filling the orer
ONLY the PIC/registrant authorized to order schedule I and II drugs, uless the registrant grants…
a power of attorney to another individual – this allos them to place orders in their absence
the following provisions apply to the use of a POA:
it can be granted to licensed or unlicensed pharmacy personnel?
the registrant can grant how many POAs?
The registrant may terminate a POA at any time by executing a notice of:
licensed OR unlicensed
multiple
revocation
the following provisions apply to the use of a POA:
the new POA is only needed if a different person signs the _____ application
the POA should be filed where with the executed DEA form 222 and must be readily retrievable
renewal
AT THE PHARMACY – it is not submitted to the DEA
a copy of form 222 will accompany the drug duirng what movements?
distribution, purchase, or transfer
When is a schedule II drug not documented for its drug movement?
dispensed to a patient/or administered
when a central fill pharmacy associated with a retail chain is filling schedule II drugs for one of the chains retail stores
DEA Form 222 is available as both a single sheet form and a triplicate form with three carbon copies (copy 1, copy 2, copy 3). true or false
true
the single replaced the triplicate
what items are preprinted on form 222
serial number, in a consecutive number series
pharmacy name and address
pharmacy DEA number
drug schedules that the pharmacy is permitted to order
if the supplier is unable to provide the entire quanitity, provide partial shipment and. supply the balance within __ days or endorse the other to another supplier
60
Pharmacy orders drugs from a supplier- who keeps copy 1(brown), copy 2(green), copy 3(blue)?
1- supplier
2- DEA
3- pharmacy
pharmacy returns unused drugs back to a supplier- who keeps what forms
1-pharmacy
2-DEA
3-supplier
pharmacy sends unused drugs back to reverse distributor for disposal
1-pharmacy
2-DEA
3- reverse distributor
pharmacy sells or lends drugs to another pharmacy
1-supplying pharmacy
2-DEA
3-receiving pharmacy
pharmacy sells or lends drugs to a physician for administration or dispensing
1-pharmacy
2-DEA
3-physician
each person authorized to place orders for schedule I and II drugs must obtain what to sign orders
personal digital certificates, it cannot be shared
what are advantages of CSOS?
reduced ordering errors dec paperwork reduced administrative costs faster drug delivery easy to use
Who reports the transaction to the DEA within TWO business days from the date of the order was filled?
the supplier
the supplier also verifies the certificate with the DEA before supplying to hparmacy
if a completed form 222 is lost or stolen, the purchaser must resubmit the order with a new form 222 and submit it to the supplier. the pharmacy must do what to the distributor
provide a statement with new form containing the following info:
- serial number of the original form
- date of initial order
- statement that the controlled substances were not received
all records of the inventory, form 222, and invoice of trainer should be kept for __ yeasr
2
T/F?
a pharmacy can cell controlled substances to other pharmacies or prescribers without registering as a distributor, provided both parties are registered with the DEA to dispense control substances. the total quantity sold cannot exceed 20% of the total quantity dispensed each year by the selling pharmacy
false, no more than 5%
a pharmacy must report a significant loss or theft of controlled substances to the local DEA office in writing within ___ business day of discovery
1
after initially notifying the DEA, the pharmacy must conduct an investigation and submit form ___ to the DEA with the findings
106
this form also used to report in transit losses of control substances
who is responsible for reporting in transit loss to the DEA?
supplier
who must issue the form 222 or the electronic equivalent when transferring schedule II drugs for disposal?
the reverse distributor (they keep copy 3, pharmacy keeps copy 1 and send 2 to DEA)
The reverse distributor will submit form ___ to the DEA once the CS have been destroyed
41
if a controlled substance has damage, breakage or spillage, this isn’t considered a loss; form __ must be filled out to document the disposal
41
is drug wastage in a hospital reported to the DEA using form 41?
no but it is recorded in a logbook or electronic system
if a pharmacy has no controlled substance at the time of opening, there needs to be a record showing..
zero inventory
after the initial inventory, a complete inventory of the current stock on hand is taken minimally on a biennial bases
true
every 2 years
schedule II drug inventory records must be kept separate from all other controlled substances
the record must include: date, at the beginning or close of day, names of CS, dosage form and strength, quantity or volume in each container and number of commercial containers – don’t need to send to DEA
for opened containers of CS
all schedule I and II containers require what type of count
schedule III, IV, V containers holding <1000 dosage units what type of count
schedule III, IV, V containers holding >1000 dosage units require what type of count:
exact
estimated
exact
what are records that must be kept by a pharmacy in regards to record keeping of controlled substances
completed and blank dec form 222 or CSOS
POA forms
receipts/invoices for schedule III, IV, V
initial and biennial inventory records
records of transfers
records of distribution
records of dispening
reports of theft or significant loss (106)
drugs surrendered for disposal (41)
DEA registration certificate
logbook for pseuoephedrine
what records must be kept on site?
original prescriptions
executed copies of form 222
inventory records
what records can be stored at a central location?
shipping and financial records
unless the DEA denies the request to keep records off site, the registrant can begin storing the records at a central location ___ days after the DEA receives the request. upon request, the pharmacy must provide the DEA with the central records within __ Hours
14 days
48 hours
if pharmacies keep their schedule III, IV, and V records with all other drugs, how must they keep the record?
stamping a red C that is at least ONE INCH high in the LOWER RIGHT HAND CORNER
if a prescription is received electronically, the record must be kept….
electronically
federally, keep these for 2 eeyars
what act was signed into law to prevent illegal sales of CS via the internet
the Ryan Haight Online Pharmacy Consumer Protection Act (2008)
for a pharmacy to sell CS online, it must notify who before 30 days before dispensing through the internet
DEA and boards of pharmacy they intend to sell to (states)
