Chapter 7.3: Ordering, Inventory, Theft & Destruction

what is the 2 year rule?

• all records involving control substances - including invoices, rx hard copies, inventory logs, and DEA forms - must be kept readily available for inspection for a minimum of 2 years

what is used to order C-II substances (paper version)?

• DEA form 222

  • used to have triplicate carbon copies colored brown, green, and blue; used to only have 10 order lines

  • now uses a single form and creates a copy (photocopy) for pharmacy’s own records before sending the original copy to supplier; now can order up to 20 lines of items

who is authorized to sign the DEA inv order form?

• DEA registrant, typically the pharmacy owner or pharmacist in charge

  • can legally auth. someone to sign for these forms by granting Power of Attorney

• in reality, often by pharm techs

  • tech is permitted to order C-II if registrant is granted POA, otherwise it’s illegal

what is another way to order C-IIs (electronic version)?

• the Controlled Substance Ordering System (CSOS)

  • electronic equiv. of DEA form 222

• CSOS has no limit compared to paper form → pharmacy can order entire C-II inv in 1 transmission

• reduces handwriting errors and speeds up chain process

how do pharmacies order C-III to C-V drugs?

• less restrictive and doesn’t req a specific form

• ordered from wholesaler in the same manner as non-control “legend” drugs, typically through auto inventory system

what is the audit trail process for C-IIIs to C-Vs?

• official record of transaction is the supplier’s invoice/packing slip

• hard copy invoices containing the controls must be stamped with red “C” in lower right hand corner

• in electronic record-keeping system, it can separate, filter, and retrieve control substance records from non-controls (no need for red stamp)

how do pharmacies receive C-II substance shipments?

• totes should be opened and verified by pharmacists/ POA people

• compare physical bottles against original copy of DEA form 222 (or elec. CSOS record) used to order them

• after verification, pharmacist documents date received and # of containers received on order form

how do pharmacies receive C-III to C-V substance shipments?

• tech compares items to wholesaler’s invoice/packing slip to check for correct drug, strength, and quantity

• after verification, invoice is signed and dated by receiving employee

• can be stored in a locked cabinet / put throughout pharmacy shelves → harder for robbers to steal

when do pharmacies take inventory of their medications?

• on the first day the pharmacy opens (initial inventory)

  • record 0 if no control substances

• federal law requires inventory to be taken every 2 years (biennial inventory)

  • not required to submit to DEA

  • records must be kept on-site and easy to get for inspection

  • if drug is newly scheduled by DEA (non-ctrl → ctrl), inv must be taken on effective date of rescheduling

what are the counting rules?

C-II: exact count required

C-III - C-V: estimated count is permitted for open bottles w/ 1 exception

• if open bottle has more than 1,000 dosage units (ex: xanax 500 ct or 1,000ct), pharmacy must perform exact count

• can estimate half-full 100ct of tylenol #3 but must exactly count 1,000ct of tramadol

what is spillage?

• if someone accidentally drops a bottle of percocet and crushes 3 tablets on the floor

  • documented internally / via destruction form (Form 41)

what happens if there was theft?

• action plan: 1-day rule

  • federal law requires that registrant notify local DEA field division, local police, and state board of pharmacy within 1 business day of discovery

  • after, complete DEA form 106 (official report of incident)

how do pharmacies discard control substances?

• through reverse distribution

  • 3rd party service that is licensed by DEA to receive, inventory, and destroy unwanted drugs

  • when a pharmacy has expired control substances, they “sell”/transfer them to reverse distributors

• C-II: reverse distribution issues DEA form 222

• C-III to C-V: transfer is documented via invoice/packing slip

what is the certificate of destruction?

• drugs are incincerated/chemically neutralized at reverse distributions

• last step is DEA form 41 → official “Registrants Inventory of Drugs Surrendered”

  • reverse distributors complete and submit this

what are some labeling requirements and who’re in charge of it?

• FDA and DEA mandate this to prevent pts from sharing medicine w/ friends and family

• federal law requires this on specific control substances: federal law prohibits transfer of this drug to any person other than the pt whom it was prescribed

  • this warning is for C-II, III, and IV substances

  • C-Vs are not legally required to carry this warning statement

what is the Secure and Responsible Drug Disposal Act of 2010 for?

• it expanded options for drug disposal

how do pharmacies become “authorized collectors”?

• by registering w/ the DEA and installing drop boxes

• there is a no touch protocol to prevent diversion and protect staff from liability (staff cannot touch any contents of the collection bin); pts must but medicine into the slot themselves

how can pharmacy techs remove the inner liner of disposal drop boxes?

• the inner liner must be removed and sealed immediately by 2 employees

• cannot be stored at pharmacy, it must be shipped to reverse distributor

what is the name of the program monitors dispensing? how does it work?

• Prescription Drug Monitoring Program (PDMP) monitors dispensing at a state level

  • tracks every ctrl substance dispensed in the state

• before dispensing C-II and often C-III and C-IV, pharms. and techs are expected to query PDMP to check pt history

  • detect doctor shopping (pt visits multiple doctors to get multiple rxs for same ctrol substance)

  • if PDMP sees that pt just got a 30 day supply of percocet from a diff pharmacy last week, the new rx is flagged as over util/potential abuse and dispensing is stopped