The No Fear DEA Audit

Transcription

1 U.S. Drug Enforcement Administration Albuquerque District Office The No Fear DEA Audit Is there such a thing?!? Hopefully you will think so after this presentation! Shirley J. Scott Diversion Investigator Drug Enforcement Administration NMPhA Mid-Winter Meeting Hotel Albuquerque January 24, 2016 But first The information provided in this presentation is STRICTLY for GENERAL INFORMATIONAL PURPOSES ONLY. The presentation does not in any way constitute legal advice and is not legally binding in any capacity. Any use or copying of this presentation is strictly prohibited without the written permission of the presenter. Where to find the regulations Inspection process Mini-audit Common issues Controlled substance regulations Title 21 Code of Federal Regulations (CFR) Part (electronic code of federal regulations) Let s find an inventory requirement 21 CFR

2 CFR (the federal regulations) also found at 2

3 One other resource Pharmacist s Manual 3

4 Process Overview & Mini-Audit It s your lucky day. We have arrived unannounced prior to the opening of your pharmacy 4

5 WHAT!? DEA is here!?! Arrive unannounced Introduce ourselves Present our credentials Tell you the purpose of the visit Present you with a Notice of Inspection (or Administrative Inspection Warrant) Provide you with a list of requested documents Pharmacy Employees Licenses Records Security 5

6 The list varies and the following is NOT all-inclusive but in general Pharmacy Company structure Home office address Pharmacy type Days/hours of operation Number of employees Part time Full time Individuals with access to controlled substances Pharmacy Suppliers (controlled substances) Alarm company Alarm system Type of devices Location of devices (floor diagram) Alarm system identifier of the device Testing Reverse Distributor Pharmacy... SOPs re controlled substances Ordering Receiving Theft/loss Destruction Transfers Diversion Background checks Due diligence ETC. Licenses Pharmacy DEA registration NMBOP licenses City business license NM tax & revenue license Employees Practice licenses Records Biennial inventory Annual inventory (NMBOP) Receipts Invoices DEA Forms 222 CSOS records Transfers Etc. Distributions Dispensing Transfers Theft/loss Destruction Etc. Recommendation Make a DEA Binder Keep it updated 6

7 Employee gathering documents Ask you some questions For example, How long have you been the pharmacist at the location? When did you conduct your most recent complete, physical inventory? (to determine audit period) 5/1/2015, COB 1/24/2016, BOB Conduct inventory (with you) Review requested documents Ins Actual date received Outs Physically left the registered location AUDIT PERIOD ONLY 250 tablets of 2mg alprazolam Ins (receipts): 5/17/2015, Qty 200, 2mg alprazolam tablets Outs (distributions): 5/1/2015, Qty 75, 2mg alprazolam tablets 5/21/2015, Qty 50, 2mg alprazolam tablets Beginning Inventory (which you provided to us) Remember COB or BOB! Audit Formula Ending Inventory (which you conducted with us) Remember COB or BOB! + + Receipts Distributions = What you are accountable for = What you accounted for 7

8 Audit Chart Complete audit calculations (which you provided to us) Remember COB or BOB! Audit Formula (which you conducted with us) Remember COB or BOB! Consider Making an Microsoft Excel spreadsheet (with formula) = What you are accountable for 300 = What you accounted for 300 What if I don t balance? Review & Investigate Poor recordkeeping? Employee pilferage? WHY do you not balance? Common Issues Complete & accurate records Inventory counts ALL Controlled Substances Onsite 8

9 Filled prescriptions not picked up yet? Pending destruction? Pending manufacturer returns? Pending pharmacy transfers? Comparing an apple to an orange does not work Do Not Remember count only what has not been removed from the computer inventory use the inventory that the computer says you have Apple to Apple BOB BOB 9

10 Power of Attorney (POA) BOB = Beginning of Business (BOB) COB = Close of Business (COB) BOB or COB is REQUIRED Current Revocations Review 21 CFR Controlled Substance Ordering System (CSOS) No NOT see saw CSOS Date received Quantity CSOS Controlled Substance Ordering System (CSOS) CSOS 10

11 DEA Registration Validation Verify DEA registrations & Authorized schedules DEA Registration Validation Conduct alarm test with you (diagram/ list) Motion Detector Camera C1 MD3 THIS IS IMPORTANT And lastly The Closing Reality Perceived 11

12 You survived! Contact Information Duty Investigator Shirley J. Scott Diversion Investigator Albuquerque District Office Drug Enforcement Administration Questions? 12