Lecture 11 - Controlled Substance Ordering and Inventory Flashcards by Corey Brend

What does the CSA say about employee screening in positions that involve controlled substances?

The registrant shall not employ…any person who has been convicted of a felony offense related 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

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What are some recommended questions for screening applicants for a position involving controlled substances?

-Have you been convicted of a felony?
-Any misdemeanor or are you presently formally charged with committing a criminal offense?
-Have you ever knowingly used any narcotics, amphetamines or barbiturates

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When may an employee apply for an employment waiver?

-If the registrant wants to employ an individual who does not qualify for employment
-DEA will not consider a waiver unless diversion is unlikely to occur

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How long must records and reports involving controlled substances be kept?

Two years from their origin start date

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How does the DEA penalize violations in recordkeeping?

-$10,000 fine for each unintentional violation
-More severe penalties or jail time for intentionally committed violations

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How must controlled records be stored?

-Complete and accurate record for each substance manufactured, imported, received, sold, delivered, exported, or otherwise disposed of by them
-C2 records must be kept separately from other records, while C3, C4, C5 records may be kept separately or with other records, so long as they are readily retrievable

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What are the two ways to store controlled and non-controlled prescriptions?

-Three-file system
-Two-file system

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What is the three-file system?

-File for C2 prescriptions
-File for C3, C4, C5 prescriptions
-File for non-controlled prescriptions

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What is the two-file system?

-File for C2 prescriptions
-File for C3, C4, C5 and non-controlled substance prescriptions

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What two criteria must a prescription meet to be readily retrievable

-Have a red “C”, no less than 1 inch high, stamped in the lower right corner of the prescriptions 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

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When will the DEA allow central recordkeeping?

-If the registrant notifies the DEA of its intent in writing 14 days in advance
-If allowed, all records must be transferred to central location within 2 business days

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What three things can not be stored centrally?

-Executed order forms (DEA form 222)
-Inventories
-Prescriptions

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How do you order C3, C4, and C5s?

-Can utilize standard invoice for record of receipt so long as it contains a date and must be able to easily identify controlled substances from non-controlled medications

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How do you order C2s and C1s?

-All distributions of C2s must be completed utilizing a DEA form 222 including purchases, transfers and sales
-The only other way to deliver a C2 is via a prescription

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Who is allowed to fill out DEA form 222?

-The signatory of the DEA registration may fill out order forms
-Agency may provide Power of Attorney to others so they can execute DEA form 222s

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How many people does one power of attorney cover?

One person, must fill one out for each individual

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When can POAs be revoked?

Any time, and must be available for inspections alongside other records

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How do POA agents sign?

Roberta registrant by Agnes Agent, attorney in fact

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How does someone order a DEA form 222?

By filling out a DEA form 222a

What must be on a DEA 222a?

-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

What must be present on a DEA 222?

-Supplier information
-Purchaser name
-Purchaser signature
-Date
-Number of packages
-Package size
-Drug name
-Last line completed

How must DEA form 222s be filled out?

-Typewriter
-Computer printer
-Pen
-Indelible pencil

What is a filled-out DEA 222 form called?

Executed DEA 222

What is a blank DEA 222 form called?

Unexecuted DEA 222

How many products can be ordered on one DEA 222 form?

No more than 20 products

What must be done once a DEA form 222 is completed?

A copy must be made because the original will be sent to the supplier

What must you do if an error occurs when filling out a DEA form 222?

Must be voided by writing VOID across the front and filed with all other executed forms

What information does the supplier add to the DEA form 222 when received?

-Supplier DEA number -NDC number for products sent -Number of bottles or containers sent -Date sent

What does the supplier do with the completed DEA form 222?

The supplier keeps the original DEA form 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

Is a supplier allowed to partial fill a 222 order?

Yes but they have 60 days to supply the balance of the order

What does it mean when a supplier endorses an order?

A supplier may send an order to another supplier within 60 days. Second supplier fills full order (all or nothing)

What should a supplier do if the find a 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

Can a supplier refuse to fill an order?

Yes, they must send the form back to the purchaser with a explanation as to why the order was not accepted

Can a supplier void part of an order?

Yes, 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 modifications completed by the supplier

What must a purchaser record when they receive an order?

-Date the order is received -Number of containers of each item received

What should the purchaser do if an executed DEA 222 is 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

What should you do if unexecuted DEA 222 forms are 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

What should you do with extra DEA 222 forms when you close your business?

Return order forms to DEA

How can someone get an electronic DEA 222 form?

-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

When must controlled substances be inventoried?

-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 previous non-controlled medication becomes a controlled substance. Only includes the newly controlled drug -Final inventory: conducted when a registrant goes out of business

What two ways can inventory be taken?

-At the opening of business on the inventory date -At the close of business on the inventory date

Which schedules must be inventoried as an exact count?

C1 and C2

Which schedules can be inventoried as an estimated count?

C3, C4, C5

Can you use a perpetual inventory for your official inventory?

No, you must handle the product

What should each CS record record?

-Drug name -Dosage form -Strength -Number of loose units -Full containers

What do you need to know how much of a product is stolen or missing?

-Most recent biennial inventory -Records and receipts for drugs received by the pharmacy -Records of drugs dispensed, distributed returned, lost, stolen, or destroyed -The number of controlled substances you have on hand