Reading 10 Flashcards
Covers CSA security, records and reports, controlled substance ordering rules, and inventories.
What factors might the DEA take into account when evaluating pharmacies’ safety measures?
- type of activity conducted
- type and form of controlled substances handled
- quantity of controlled substances handled
- type of vault/safe/secure enclosure used to store the controlled substances
True or false: pharmacies must store all controlled substances in the same area.
false; “for CII-V, pharmacies and institutional practitioners can disperse such substances throughout the stock of non-controlled substances in such a manner as to obstruct the theft or diversion of the controlled substances”
Is a locked safe required for controlled substance storage?
no
What is the requirement for C-I drug storage?
“stored in a securely locked, substantially constructed cabinet”
Where must controlled substances be stored if they are kept in a practitioner’s office or clinic?
locked cabinet
How must practitioners store thiafentanil, carfentanil, etorphine, and/or diprenorphine?
“in a safe or steel cabinet equivalent to a US Government Class V security container”
Who CAN’T be hired when working with controlled substances?
- convicted of a felony related to controls, OR
- has had an application for registration with the DEA denied, registration revoked, or has surrendered their DEA registration for cause
True or false: someone arrested for a felony cannot work in a pharmacy dispensing controlled substances.
false; arrested is different than convicted
What can be done if an employer wants to hire someone who meets the criteria for denial?
they can request a waiver from the DEA
What must be included on a DEA employment waiver?
- detailed description of the individual’s previous violations with supporting documents
- extent of the individual’s potential access to controlled substances
- registrant’s proposed safeguards to prevent by individual
Can an employee request a DEA waiver?
no
What questions may an employer ask to assess a hiree’s potential risk for controlled substance diversion?
- if they have been convicted of a felony/misdemeanor, or charged with committing a criminal offense
- if they have ever knowingly used controlled substances not prescribed to them
How long should controlled substance records be kept by all registrants?
at least 2 years from the record or inventory date
What must registrants record for their recordkeeping purposes?
“a complete and accurate record of each substance manufactured, imported, received, sold, delivered, exported, or otherwise disposed of by them” in addition to records of destruction
True or false: DEA registrants must maintain a perpetual inventory.
false
What information must be maintained by pharmacies and other dispensers about their controlled substances?
- name and address of the person to whom it was dispensed
- date of dispensing
- number of units/volume dispensed
- written/typewritten name or initials of the individual who dispensed/administered the substance
What are the basic rule around storing controlled substance records?
C-II stuff must be kept separate from all other records; III-V can be kept separately from the non-controls, or in a way that the information is readily retrievable
What is the three file system?
include C-IIs in one file, III-V in the second file, and non-controls in the third file
What is the two-file system?
C-IIs in one file and all others in another
What are the two ways in which a prescription can be considered “readily available”?
- have a red “C” no less than 1 inch high, stamped in the lower right corner on the prescription’s face
- pharmacy’s computer system can identify prescriptions by their number and retrieve them in the system by prescriber name, patient name, drug dispensed, and date filled
Does the DEA allow central recordkeeping?
yes (if the registrant notifies the DEA in writing)
What must be included in a registrant’s notification to the DEA that they will be storing records in a centralized location?
- nature of the records
- exact location
- registrant name
- registrant DEA number
- registrant type
- whether central records will be manual or computer-readable
In general, a registrant can start maintaining centralized records ____ days after the DEA received notification unless they receive denial from the DEA
14
If allowed to store records centrally, records must be transferred to the central location within _____ business days.
2
What three items CANNOT be stored centrally?
- executed order forms (i.e., completed DEA 222)
- inventories
- prescriptions
What schedules can be ordered on a regular invoice, the same as non-controls?
III-V
What is the official order form for C-Is and -IIs?
DEA Form 222
True or false: ALL distributions of C-IIs must be done on a 222 Form.
mostly true; the only way to deliver these drugs without a 222 is with a prescription
Today, the 222 Form is a ________.
single-sheet form
Who must order and execute 222s?
the individual who signed the most recent registration paperwork; if they are unavailable, can use a POA
True or false: there can only be one POA for an institution’s 222 Forms.
false; can have multiple but they must fill out separate POAs
Give an example of how a 222 signed by a POA should look.
Roberta Registrant by Frieda Farmacist, Attorney in Fact.
Who may obtain copies of 222s?
registrants registered to handle C-IIs
What must be submitted to receive initial 222 order forms?
DEA Form 222a (often done as part of the registration process)
What pre-printed information should a 222 already have?
- registrant name
- registrant address
- registration number
- authorized activities
- schedules the registrant may handle
What implements may be used to fill out a 222?
- typewriter
- computer printer
- pen
- indelible pencil (dye in the lead)
What is considered an “item” on a 222 form?
“one or more commercial containers of the same substance in the same finished form and in the same quantity.”
True or false: purchasers must include the NDC number of the drug they’re requesting.
false (but is usually completed by the supplier noting the exact product sent with the order)
How does one prevent the fraudulent addition of items to a 222 after it has been finished?
they indicate the last line completed on the form in the space provided at the bottom
How many lines are on a 222 Form?
20
How many suppliers can be listed on a DEA 222?
1
What MUST be done after a 222 form has been signed and completed?
copy or scan it; the original will be sent to the supplier
How do you void an original 222 with an error on it?
write “VOID” across the front
True or false: purchasers don’t need to keep voided forms since they aren’t being executed.
false
What will a supplier do with the completed DEA 222 Form?
they keep it and forward a copy to the DEA by the end of the month, or report it through ARCOS
If the supplier cannot fill the entire order when received due to stock or another issue, the supplier may partially fill the order and supply the balance within ___ days of the date on the order form.
60
Endorsing an order is an _______ process.
all-or-nothing; either the original supplier endorses the entire order, or they keep it
Endorsing an order must be done within the 60-day time frame, and the new supplier must complete the order within ____ days of the original order date.
60
What must a supplier do if they encounter an issue with the order form?
send it back to the purchaser with a statement explaining why the form can’t be filled
If a supplier must void or cancel part of the order received, they must notify the purchaser in writing and then ______________________________.
draw a line through the voided items and print “canceled” in the space provided for the number of items shipped on the original DEA 222.
How can a purchaser cancel all or part of their 222 order?
by notifying the supplier in writing (mail, fax, email)
What must the purchaser record when a 222 order is received?
the date(s) received and the number of containers of each item received from the supplier (on the 222 copy, or electronically linking the receipt to the 222)
What are considered to be “unfilled order forms”?
222s that are lost in the mail or lost by the supplier before being filled
What happens if a 222 is lost in the mail or by a supplier prior to fulfillment?
the purchaser must execute a new, identical 222 Form and send it to the supplier again, with a statement containing the order number from the original form the date of the lost form, and a note that the substances ordered were not received
What should a supplier do if a lost form ever shows up?
send the forms back to the purchaser, so that they may add it to the original copy
What must happen if an unused 222 Form is lost or stolen?
purchaser must immediately notify the DEA, and (if known) provide the form number; if not known, must provide the approximate date the forms were ordered
True or false: registrants are automatically allowed to order manually and electronically.
false; must apply for a digital certificate from the DEA
What is the secure ordering system for transmitting an electronic 222 called?
Controlled Substance Order System (CSOS)
Unlike paper 222s, electronic orders _____________________________.
may include substances from any schedule and non-controlled drugs
Can endorsements happen for virtual 222s?
no; but still can partially fill the order and have 60 days to complete it
For accepted digital 222 orders, suppliers must keep the original and linked records for two years and forward a copy of the electronic order to the DEA within ___ business days of completing the electronic order.
2
What would make a controlled substance considered to be “on hand” for an inventory?
If they are in possession of or under the control of the registrant, including:
- substances returned by a customer
- substances ordered by a customer but not yet invoiced
- substances stored in a warehouse on behalf of a registrant
- substances in possession of employees of the registrant and intended for distribution as complimentary samples
Registrants have to inventory all controlled substances on hand at least once every ___ years after the initial inventory.
2
True or false: the time of day that an inventory is taken is irrelevant.
false; must note open or close of business on the inventory with the date
True or false: you must give an EXACT count of C-I and -II substances on hand.
true
When can we estimate CIII-Vs for inventory?
if the bottle holds 1000 product units or less
True or false: when completing the inventory, you must handle all controlled substances and can’t use a printout or system-based perpetual inventory to determine your numbers.
true; you are required to pour out and count all products requiring an exact count and must at least hold a bottle, feel the weight, shake it, or look inside when estimating
What should be included in each controlled substance’s record?
- drug name
- dosage form
- strength
- number of loose units
- number of full containers
How do you calculate the amount of controlled substances stolen after a robbery?
quantity from last inventory + drugs purchased since - drugs dispensed/distributed/returned/lost/stolen/destroyed
then, subtract the above number from the quantity on hand
