Checklist template

Controlled substance diversion prevention for pharmacies

A ready-to-use checklist with 100 items in 6 sections, covering Counts and variances, Access, Ordering patterns, Dispensing reviews, Cameras, Reporting. Use it as-is in Bindy, or adapt it to your own standards in minutes.

  • 6 Sections
  • 100 Items
  • 82 Yes / No checks
  • 6 Scored ratings
  • 112 Points

Use this template How audits work

1. Counts and variances 17 items

  1. High-risk drugs (opioids, stimulants, benzodiazepines) blind-counted by the auditor during the visit Number
  2. Auditor counts that did not match the perpetual inventory Number
  3. The same employee does not both count a controlled substance and post the adjustment for it Yes / No 1 pt
  4. Cycle counts of controlled substances carry the initials of two employees Yes / No 1 pt
  5. The employee counting enters the count without seeing the system on-hand quantity Yes / No 1 pt
  6. Variance explanations on file name the cause that was found, not only "miscount" or "recounted" Yes / No 1 pt
  7. Variance explanations are signed by the pharmacist in charge rather than by the employee who counted Yes / No 1 pt
  8. Each on-hand adjustment to a controlled substance in the last 30 days was approved by a second pharmacist or the pharmacy supervisor Yes / No 1 pt
  9. The adjustment report for the last 30 days shows no repeated small adjustments on the same drug Yes / No 1 pt
  10. No single employee accounts for most of the controlled substance adjustments in the last 90 days Yes / No 1 pt
  11. Open stock bottles sampled from the cabinet contain only the labeled drug and strength, checked by tablet markings Yes / No 1 pt
  12. Manufacturer seals are intact on the unopened bottles sampled from the cabinet Yes / No 1 pt
  13. Open bottles of liquid controlled substances sampled show no sign of dilution or topping up (color, level against the record) Yes / No 1 pt
  14. An unannounced count by the pharmacy supervisor or loss prevention is on record in the last 12 months Yes / No 1 pt
  15. Date of the last full controlled substance count Date
  16. Variances still unresolved on the day of the visit Number
  17. Accuracy of controlled substance counts Rating
    • No variance found by the auditor or on record 5 pts
    • Small variances, all explained in writing 3 pts
    • Unexplained variances 1 pt

2. Access 18 items

  1. The cabinet is relocked after each retrieval rather than left open through the shift, on the fills observed Yes / No 1 pt
  2. Spare keys to the controlled substance cabinet are sealed in a signed envelope or held outside the pharmacy, as company policy requires Yes / No 1 pt
  3. The technicians asked do not know any pharmacist's cabinet code or alarm code Yes / No 1 pt
  4. Each employee signs in to the dispensing system under their own credentials Yes / No 1 pt
  5. No shared or generic login is active in the dispensing system Yes / No 1 pt
  6. System access was removed for every pharmacy employee who left in the last 90 days Yes / No 1 pt
  7. The pharmacist in charge keeps a current list of technicians allowed to handle controlled substances Yes / No 1 pt
  8. Personal bags and coats are stored in lockers outside the dispensary Yes / No 1 pt
  9. Front store employees, cleaners and vendors are escorted while inside the dispensary Yes / No 1 pt
  10. Time records sampled show no technician working in the dispensary before the pharmacist arrived or after the pharmacist left Yes / No 1 pt
  11. The pharmacy has its own alarm zone, armed while the front store remains open Yes / No 1 pt
  12. The alarm report for the pharmacy zone shows no entry outside scheduled hours in the last 30 days Yes / No 1 pt
  13. Dispensary trash is collected in clear bags Yes / No 1 pt
  14. Empty controlled substance stock bottles are checked by a pharmacist before they are discarded Yes / No 1 pt
  15. Filled controlled substance prescriptions waiting for pickup are stored out of reach of the pickup counter Yes / No 1 pt
  16. Wholesaler totes containing controlled substances are opened by a pharmacist Yes / No 1 pt
  17. Totes containing controlled substances are not left unopened overnight outside the locked cabinet Yes / No 1 pt
  18. Physical and system access to controlled substances Rating
    • Limited to authorized staff and locked 5 pts
    • Limited but found unlocked or unattended 3 pts
    • Open to unauthorized staff 1 pt

3. Ordering patterns 16 items

  1. Order quantities for controlled substances follow the system suggestion, or the manual increase carries a recorded reason Yes / No 1 pt
  2. The pharmacist who places an order is not the only person who checks it in Yes / No 1 pt
  3. Purchases of the store's 10 highest-volume controlled substances were compared with quantities dispensed for the last 3 months Yes / No 1 pt
  4. The purchase-to-dispensing comparison is signed by the pharmacist in charge Yes / No 1 pt
  5. No controlled substance was bought from a secondary wholesaler without the approval required by company policy Yes / No 1 pt
  6. Purchases of oxycodone and hydrocodone products show no unexplained increase against the same months of last year Yes / No 1 pt
  7. Each wholesaler threshold or suspicious-order inquiry in the last 6 months was answered in writing Yes / No 1 pt
  8. Every controlled substance order of the last 30 days has its invoice on file; none is without a receiving record Yes / No 1 pt
  9. Wholesaler credits for controlled substances in the last 90 days are matched to stock that was actually sent back Yes / No 1 pt
  10. Five invoices traced by the auditor to the perpetual inventory showed matching quantities Yes / No 1 pt
  11. Unused paper order forms for controlled substances are accounted for by serial number, with none missing Yes / No 1 pt
  12. Each off-cycle or emergency controlled substance order in the last 30 days has a recorded reason Yes / No 1 pt
  13. Transfers of controlled substances to another store carry the receiving pharmacist's signature Yes / No 1 pt
  14. No controlled substance was ordered in the last 90 days for which the store has no dispensing history Yes / No 1 pt
  15. Controlled substance orders placed in the last 30 days Number
  16. Match between controlled substance purchases and dispensing Rating
    • Purchases track dispensing closely 5 pts
    • Small differences without explanation 3 pts
    • Purchases well above dispensing 1 pt

4. Dispensing reviews 17 items

  1. The pharmacist in charge reviews the report of controlled substance prescriptions deleted or reversed after filling Yes / No 1 pt
  2. Each reversed controlled substance prescription of the last 30 days shows the product added back to inventory Yes / No 1 pt
  3. Add-backs to inventory after a reversal carry a pharmacist's initials Yes / No 1 pt
  4. Controlled substance prescriptions sampled by the auditor from the last 30 days Number
  5. Sampled prescriptions with a missing or incomplete record Number
  6. Each sampled prescription has its hard copy or electronic order on file Yes / No 1 pt
  7. The quantity dispensed on each sampled prescription equals the quantity prescribed or a documented partial fill Yes / No 1 pt
  8. A pickup signature or identification record exists for each sampled prescription Yes / No 1 pt
  9. Prescriptions for employees and their household members are filled and verified by a different employee Yes / No 1 pt
  10. The report of controlled substance prescriptions dispensed to employees is reviewed at the frequency set by company policy Yes / No 1 pt
  11. Prescriptions entered and verified under the same login appear on an exception report that is reviewed Yes / No 1 pt
  12. Early-refill overrides on controlled substances in the last 30 days are not concentrated on one employee's login Yes / No 1 pt
  13. Controlled substance prescriptions marked as picked up outside the pharmacy's opening hours are listed and explained Yes / No 1 pt
  14. Breakage and waste entries for controlled substances in the last 90 days are not concentrated on one employee or one drug Yes / No 1 pt
  15. Balances owing on controlled substance partial fills that were never collected were canceled in the system, with no pickup recorded Yes / No 1 pt
  16. Controlled substance prescriptions with no insurance claim are reviewed for unusual volume by prescriber Yes / No 1 pt
  17. Result of the dispensing sample Rating
    • Every prescription fully supported 5 pts
    • Minor record gaps 3 pts
    • Unsupported prescriptions or quantities that do not match 1 pt

5. Cameras 16 items

  1. A camera covers the controlled substance safe or cabinet Yes / No 1 pt
  2. A camera covers each filling station where tablets are counted Yes / No 1 pt
  3. A camera covers the spot where wholesaler totes are opened Yes / No 1 pt
  4. A camera covers the pharmacy pickup register Yes / No 1 pt
  5. A camera covers the pharmacy gate or door Yes / No 1 pt
  6. No camera view in the dispensary is blocked by shelving, signs or stock bottles Yes / No 1 pt
  7. The live image is clear enough to identify the person standing at the cabinet Yes / No 1 pt
  8. Days of recorded pharmacy video available on the recorder Number
  9. Video retention meets the number of days set by company policy Yes / No 1 pt
  10. The date and time shown on the recorder match the actual date and time Yes / No 1 pt
  11. The recorder is kept in a locked room or cabinet outside the dispensary Yes / No 1 pt
  12. Pharmacy employees cannot delete or export recorded video Yes / No 1 pt
  13. Each camera outage in the last 90 days was reported on the day it was found Yes / No 1 pt
  14. Video was reviewed for the most recent unexplained variance Yes / No 1 pt
  15. Random reviews of pharmacy video by loss prevention are logged Yes / No 1 pt
  16. Camera coverage of controlled substance handling Rating
    • Every handling point covered and recording 5 pts
    • One point not covered 3 pts
    • Several points not covered or recorder not working 1 pt

6. Reporting 16 items

  1. A written procedure for reporting suspected diversion is available in the pharmacy Yes / No 1 pt
  2. Two pharmacy employees asked could name the person or line to which suspected diversion is reported Yes / No 1 pt
  3. The confidential reporting line number is posted in the pharmacy staff area Yes / No 1 pt
  4. Controlled substance losses or thefts reported in the last 12 months Number
  5. Date of the most recent loss report Date
  6. Each significant loss or theft in the last 12 months was reported to the regulator as required by local regulation Yes / No 1 pt
  7. Copies of the loss reports filed are kept in the pharmacy Yes / No 1 pt
  8. Each loss report on file is closed with the outcome of its investigation Yes / No 1 pt
  9. Loss prevention was told of each unexplained variance within the time set by company policy Yes / No 1 pt
  10. The pharmacy supervisor initials the store's variance log at each visit Yes / No 1 pt
  11. Every employee with controlled substance access signed the diversion policy in the last 12 months Yes / No 1 pt
  12. Training covers behavioral warning signs such as unscheduled visits to the pharmacy and offers to count alone Yes / No 1 pt
  13. Corrective actions from the previous diversion review have been completed Yes / No 1 pt
  14. Name of the pharmacist in charge Short text
  15. Overall control of diversion risk Rating
    • Counts match, access restricted and exception reports reviewed 5 pts
    • Controls in place with gaps in reviews or records 3 pts
    • Unexplained variances or access open to unauthorized staff 1 pt
  16. Corrective actions required Comments

About this template

This checklist is part of the Bindy template library. Yes / No checks score 1 point when met; ratings score the points shown for each option. The overall score is the percentage of points earned, with N/A answers excluded. In Bindy you can add photos, assign corrective actions, require sign-off and compare results across sites.

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