Controlled substance ordering and inventory - lecture 11 Flashcards
Controlled Substance Security
The Controlled Substance Act (CSA) states “Registrants shall provide effective controls and procedures to guard against theft and diversion of controlled substances.”
he registrant puts safety measures in place, and the DEA determines whether they are appropriate. The DEA considers:
-Activities conducted
-Type and form of controlled substances handled
-Quantity of controlled substances handled
-Storage system of controlled substances
Employee Screening
The registrant shall not employ…any person who has been convicted of a felony offense relating to controlled substances or who, at any time, had an application for registration with the DEA denied, had a DEA registration revoked or has surrendered a DEA registration for cause.”
DEA Recommended Questions
The DEA assumes that employers will ask each of the following questions when screening applicants:
Within the past five years, have you been convicted of a felony, or within the past two years, of any misdemeanor or are you presently formally charged with committing a criminal offense?
In the past three years, have you ever knowingly used any narcotics, amphetamines or barbiturates, other than those prescribed to you by a physician? If the answer is yes, furnish details.
Answers do not disqualify applicants, but should be considered to assess potential for diversion
Records and Reports
The CSA requires all records and reports involving controlled substances to be kept for at least two years
from their origin date.
The DEA is serious about recordkeeping, with a $10,000 fine for each unintentional violation, and more severe penalties or jail time for intentionally committed violation.
Registrants must maintain “a complete and accurate record of each substance manufactured, imported, received, sold, delivered, exported, or otherwise disposed of by them.”
C-II records must be kept separately from other records, while C-III, C-IV, and C-V records may be kept separately or with other records, so long as they are readily retrievable
Prescription Storage
Three-file System (most common)
AND
Two file system
Three-file System (most common)
File for C-II prescriptions
File for C-III, C-IV, and C-V prescriptions
File for non-controlled prescriptions
Two File System
File for C-II prescriptions
File for C-III, C-IV, C-V, and non-controlled substance prescriptions*
*C-III, C-IV, and C-V prescriptions must be readily retrievable
Readily Retrievable
For a prescription to be “readily retrievable” it must meet one of the two criteria below:
Have a red “C,” no less than 1 inch high, stamped in the lower right corner of the prescription’s face
Must identify prescriptions by prescription number in a computer system, and be able to search by:
-Prescriber name,
-Patient name,
-Drug dispensed, and
Date filled
Central Recordkeeping
Records are expected to be held at the registered location as a default
Some registrants lack the space to appropriately store these records
The DEA allows central recordkeeping if the registrant notifies the DEA of its intent in writing 14 days in advance. This note must include:
1. The records to be kept centrally
2. The exact location of the records
3. The name, address, DEA registration number, and type of DEA registration of the registrant storing records centrally
4. Whether central records will be maintained manually or by computer
If allowed, all records must be transferred to central location within 2 business days
Central Recordkeeping Prohibitions
Three things cannot be stored centrally:
Executed order forms (DEA Form 222)
Inventories
Prescriptions
ALL the above items must be maintained at the registered location
Ordering C-III, C-IV, and C-Vs
Order the same way as non-controlled medications. Can utilize standard invoice for record of receipt so long as it contains:
-Date
-Must be able to easily identify controlled substances from non-controlled medications
Ordering C-IIs (and C-Is)
-All distributions of C-IIs must be completed utilizing a DEA Form 222
-Includes purchases, transfers, and sales
-The only other way to deliver C-IIs is via a prescription
Long-standing triplicate form was utilized for decades, but was retired October 31st, 2021
Single-sheet order form first introduced in 2019, only form available since October 2021
Power of Attorney
POAs allow pharmacists to operate efficiently, and prevent regular changes related to changing pharmacist positions
A separate POA must be filled out for each person individually
POAs may be revoked at any time, and must be available for inspections alongside other records (keep at registered locations)
POA agents should sign “Roberta Registrant by Agnes Agent, Attorney in Fact”
Ordering Order Forms
To order DEA Form 222s, the registrant must submit a DEA Form 222a. This is usually done upon registration and again as needed.
Requisitions must have the name, address, and registration number of the registrant, and the number of books desired.
Must be signed by the registrant or an authorized agent
DEA Form 222s are sent with order form numbers and contain the name, address, registration number, authorized activities, and schedules the registrant can handle. These cannot be altered.
If there are errors, registrants must send the forms back to the DEA, who will correct the information and issue new forms.
Current DEA Form 222
Supplier information
Purchaser name
Purchaser signature
Date
# of packages
Package size
Drug name
Last line completed
Supplier completes Part 3 & Part 4
Purchaser completes Part 5 upon receipt
Purchaser DEA 222 Form Important Points
Forms must be completed via typewriter, computer printer, pen, or indelible pencil
A filled-out form is an executed DEA 222, a blank form is an unexecuted DEA 222
NDCs may be filled in by purchasers, but if the NDC is not available the order may be delayed.
If you are ordering more than 20 products, you must complete multiple forms
Once completed, a copy of the form must be made because the original will be sent to the supplier
If an error occurs when filling out a DEA 222, it must be voided by writing “VOID” across the front and filed with all other executed forms
Supplier DEA Form 222 Order Fulfillment
Upon receiving the order, the supplier will verify it can be filled, and then add the following information:
Supplier DEA number
NDC number for product(s) sent
Number of bottles or containers sent
Date sent
The supplier keeps the original DEA 222 and forwards a copy of the form to the DEA by the end of the month, or reports information on the Automation of Reports and Consolidated Orders System (ARCOS)
Unique Situations: Supplier DEA Form 222
Voiding part of an order:
Voiding part of an order: if a supplier cannot fill a full order, they may draw a line through the voided items and print “canceled” on the number of items shipped. Purchasers can cancel drugs as well, with the same modification completed by the supplier.
Unique Situations: Supplier DEA Form 222
Partial filling an order
Partial filling an order: a supplier may partially fill an order, after which time they have 60 days to supply the balance of the order.
Unique Situations: Supplier DEA Form 222
Endorsing an order:
Endorsing an order: a supplier may send an order to another supplier within 60 days. Second supplier fills full order (all or nothing).
Unique Situations: Supplier DEA Form 222
Defective order:
Defective order: if a supplier finds an issue with a DEA 222, they must send the form back to the purchaser with a statement explaining the refusal to fill.
Unique Situations: Supplier DEA Form 222
Order refusal:
Order refusal: a supplier may refuse to accept an order. They must send the form back to the purchaser with a not that the order was not accepted.
Purchaser Order Receipt
When the purchaser receives the order, they must record:
-Date the order is received
-Number of containers of each item received
On their copy of the DEA 222. If maintained electronically, a scan of the completed DEA 222 should be linked to the receipt of products
Lost, Stolen, and Unused Order Forms
Executed DEA 222: typically lost in the mail.
If this occurs, the purchaser must execute a new DEA 222 identical to the first. Note accompanying this states the original form number, date of lost form, and a note that substances were not received.
Lost, Stolen, and Unused Order Forms
Unexecuted DEA 222: forms either lost or stolen.
Must report immediately to the DEA, with form numbers if known, or dates ordered if unknown. If found, report to DEA immediately. Stolen DEA forms do not usually yield successful drug diversion
Lost, Stolen, and Unused Order Forms
Unused DEA 222: termination of business
Return order forms to DEA
Electronic DEA Form 222
Registrants must apply for a digital certificate from the DEA, which authorizes a digital certificate as proof of identity.
The digital certificate gives access to the Controlled Substance Order System (CSOS)
CSOS orders may include drugs from any schedule and non-controlled drugs
Electronic 222s cannot be endorsed from one supplier to another
Controlled Substance Inventory
Every registrant must have “a complete and accurate record of all controlled substances on hand on the date the inventory is taken.”
This includes:
Drugs stored in other areas of an institution (e.g. emergency kits)
Drugs returned by a patient
In the waiting bins ready to be picked up by a patient
If the drug is in the registrant’s possession, it must be inventoried
Inventory Dates
Initial inventory: must be conducted on the day the registrant first engages in activities with controlled substances
Official inventory: must be conducted at least once every two years (biennially). Some states have stricter requirements, CSA states two years.
Rescheduling inventory: must be conducted when a previously non-controlled medication becomes a controlled substance. Only includes the newly controlled drug
Final inventory: conducted when a registrant goes out of business
Method of Inventory
MUST NOTE if which method is used in your inventory
At the opening of business on the inventory date - activities on this date must be included on the next upcoming inventory
At the close of business on the inventory date - activities completed on the inventory date are not included on the next upcoming inventory
Inventory Counting/Estimating
C-I and C-II substances must be inventoried as an EXACT count
C-III, C-IV, and C-V substances may be estimated, unless the bottle holds more than 1,000 product units. If more than 1,000 units within the stock bottle, an exact count must be conducted
You cannot utilize a perpetual inventory for your official inventory, you must handle the product (count, or when estimating, look at and feel the weight of the product)
Each CS record should record the drug name, dosage form, strength, number of loose units, and full containers
Inventory Calculations
Official inventories are maintained to assist the registrant and authorities in the event of a robbery or burglary. To know how much was stolen/missing, you need:
1.Most recent biennial inventory
2.Records and receipts for drugs received by the pharmacy
3.Records of drugs dispensed, distributed returned, lost, stolen, or destroyed
4.The number of controlled substances you have on hand
