Drug Distribution and Inventory Management
Control is the subject
Distribution and inventory questions test the trail of custody: who may order, store, dispense, transfer, return, or destroy a product, and what documentation proves it happened. The clinical question is usually secondary to the paperwork.
Concepts you must own
- Formulary management: pharmacy and therapeutics committee function, formulary versus nonformulary requests, therapeutic interchange, and restriction programs.
- Controlled substances: schedules I–V, registration, and the DEA forms - 224/224a for registration and renewal, 222 (or CSOS) for schedule II ordering, 106 for theft or loss, and 41 for destruction or surrender. Biennial inventory and secure storage apply.
- Supply chain law: DSCSA serialization and verification, authorized trading partners, transaction documentation, and Prescription Drug Marketing Act limits on samples and resale.
- Recalls: Class I (reasonable probability of serious harm or death), Class II (temporary or reversible harm), Class III (unlikely harm); know notification and retrieval steps.
- Operations: par levels, ABC analysis, perpetual inventory, automated dispensing cabinets, unit-dose versus floor stock, reverse distributors, beyond-use dates versus manufacturer expiration dates, and temperature excursion handling.
Traps
The favorite trap is confusing a beyond-use date with an expiration date; a BUD assigned after manipulation is always shorter. Another is applying schedule II ordering or inventory rules to schedules III–V. Recall class definitions are also tested against nonrecall events such as warning letters.
Worked example
A schedule II product is needed urgently: place the order on DEA Form 222 or via CSOS, receive only the quantity ordered, and verify the invoice against the receipt before the drug enters stock. Form 222 is never used for a schedule III drug, and any theft or significant loss of a controlled substance is reported on Form 106.