To assist with controlled substance compliance the following forms and guides have been compiled. These forms focus mainly on controlled substance inventories, particularly perpetual inventories and maintaining legal compliance with Virginia CS inventory requirements.
Failure to maintain accurate and complete perpetual inventories is a commonly cited deficiency on Virginia pharmacy inspections that is 100% avoidable provided a complete investigation occurs for each discrepancy noted. Importantly, the following best practice guidelines should be observed:
- All discrepancies (both overages and shortages) should be investigated. A commonly missed discrepancy is overages; while better than having a shortage, overages are still a discrepancy and must be reconciled
- Any discrepancies should have a thorough explanation of the steps taken to resolve the discrepancy. Noting “dispensing error” and moving on is not an acceptable explanation. Instead, the notes should be considered a legal document (because in the case of a BOP or DEA investigation, they are) and should be clear, concise, and provide a step-by-step root cause analysis of the discrepancy. An acceptable note would be “Discrepancy noted and determined to be related to a dispensing error on RX #12345. Confirmed dispensing error by reviewing pharmacy camera footage and confirmed with patient on mm/dd/yyyy she had x remaining tablets, when she should only have x tablets. The error was reported to the patient’s prescribing physician and noted in the perpetual logbook. As we have determined the exact source of the error and cause for the discrepancy, no actual loss has occurred and the discrepancy has been reconciled”.
- Inventories are required per 18VAC110-20-240 to be completed monthly within a 7 day window. This means if you have completed an inventory on January 10th, you must complete the February inventory between the 3rd and the 17th.
- Any true losses must be reported to the Board and the DEA within 1 business day; as a rule of thumb it is good practice to report any loss that cannot be explained, even if it is not significant. If a significant loss is determined to have happened, you are required to follow-up with a DEA 106 form; otherwise you would notify the appropriate agency(ies) that no significant loss occurred after investigation.
With regards to ID requirements, VA BoP guidance is clear that if the person is known to the pharmacist or his agent, no ID is required for when a CII is dispensed. If a patient or the patient’s agent is unknown to the pharmacist or his agent, then an ID is required and those records must be retained for 1 month. Again, a best practice is to simply require an ID for all CII medications, as it is virtually impossible to know every single patient and/or their agents, and an easily cited deficiency would be to look at dispensing records for new patients presenting from a local ER, as these patients (being new) would almost always be unknown.
Perpetual Log Setup
Based on practice experience and feedback, I recommend setting up your perpetual log in the following manner (especially if you have multiple pharmacists that may fill in). You’ll need:
- Heavy-duty, 3″ binder (do not get the cheap binder, get a high-quality commercial-grade binder)
- Plastic 5-tab dividers (Avery makes these, the rounded tabs are preferred with insertable labels, not the write-on tabs). You’ll need enough for each unique product (e.g., one tab each for Adderall, Adderall XR, HC/APAP, oxycodone/APAP, Focalin, Focalin XR, dexmethylphenidate, dexmethylphenidate ER).
- Plastic 8-tab dividers (again, Avery makes these, the squared tabs are fine as long as you can insert and remove the labels), enough for each unique strength of each product (e.g., one divider for HC/APAP 5/325, HC/APAP 7.5/325, HC/APAP 10/325, HC/APAP 7.5/325/15ml, etc.)
Setup the notebook using the larger, rounded tabs to denote your unique products by product name. If you have both brand and generic Adderall, you would have a separate tab for each. Organize those tabs alphabetically. Behind each product tab, insert 8-tab dividers for each strength you have for that product.
Once completed, a standardized log makes recording easier, as finding the product is simply a matter of locating the large product tab for the dispensed product and then the strength behind that tab.
Some caveats:
- Don’t combine products if they are not AB-rated, same dosage form, or same ingredients. E.g., you would separate Adderall and Adderall XR as they cannot be substituted. Conversely, though, because it is still immediate release and the same combination of ingredients, HC/APAP 7.5/325/15ml solution would be with the HC/APAP product tab.
- No longer have a product? Wait until the biennial inventory to remove it. Consider the annual inventory your “cleanup” time, because this inventory should reconcile all movement of CII medications, even if you have 0 on-hand.
- Need to add a product? Add and remove tabs as needed; for those of us with OCD, the removable tab labels mean we can move those dividers around easier to keep the book neat.
Additional Resources
VA BoP Inspection and Monetary Penalty Guide
VA CII Identity Requirements (Guidance Document)
VA Inventory Requirements (Guidance Document)
Links to VA Laws and Regulations governing the practice of pharmacy
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