Best Practices To Prevent and Detect Wrongful Conduct Rule Diversion
s the former attorney for the Board of Pharmacy, I have seen first-hand how devastating the diversion of controlled drugs can be to a pharmacist. That’s why I am focusing this series of Compliance Corner articles on the best practices to prevent and detect diversion. In the last installment, I discussed tips for improving the physical and site security measures at your pharmacy. In this edition, I’ll concentrate on policies and procedures you will need for ordering, receiving and tracking controlled substances. First, the ordering and receiving procedures used in your pharmacy are a crucial area that is often overlooked. Most of the serious instances of diversion that I’ve seen are where the same employee ordered the controlled drugs and received the order. That type of policy makes it very easy for your employees to divert drugs before you even knew that they had come in the door.
Have a robust inventory control system in place. It can be difficult to find the time to run reports and reconcile invoices but it really is the best way to detect diversion in progress. Recommended policies: • • •
Restricting the authorization to order and receive controlled drugs to only the most trusted employees. Under no circumstances should the same employee order and receive controlled drugs. If you use a website-based ordering method, make sure that each authorized employee has an individual log in/ password. If you allow the entire pharmacy staff to use one log in, you will not be able to trace unusual ordering patterns. Conduct an initial check-in to confirm quantities against the invoice upon receipt of the controlled drug order. Where possible, make sure that pharmacists are doing the initial check-in. A different employee than the one conducting the initial check-in should confirm the quantities and put away the controlled drug order. Both employees should sign the invoice to confirm the check in process was followed.
Second, you should have a robust inventory control system in place. It can be difficult to find the time to run reports and reconcile invoices but it really is the best way to detect diversion in progress.
Recommended policies: • •
Consider perpetual inventories for all CII, CIII and other drugs with a high street value. On a monthly basis, the PIC should reconcile the invoices received with the controlled drug orders with printouts from your wholesaler of controlled drugs shipped to the pharmacy. Ensure that employees are following the “check in” policy and that no invoices are missing. On a monthly basis, the PIC should run a “shrink report” on at least the top 5 drugs diverted. You can do this manually, use your own software or download an Excel spreadsheet shrink report from the Board of Pharmacy at http://pharmacyboard.arkansas.gov/faqs/Documents/ ShrinkReportToolbackup2.xls. Conduct annual inventory for all controlled drugs. The permit holder, if different than the PIC, should ensure that the PIC trains the employees on the controlled drug policies and that all of the diversion prevention and protection measures in place are mandatory. The permit holder and PIC should have a plan and policy in place for how suspected diversion will be reported and investigated.
In the next installment of this series, we will discuss employee management and how to protect yourself from diversion by properly hiring and training your employees. § _____________________________________________________
About the author: Erika Gee represents clients in government relations, regulatory and compliance matters at Wright, Lindsey & Jennings LLP. She previously served as general counsel to the Arkansas State Board of Pharmacy for 6-1/2 years and as Chief of Staff and Chief Deputy Attorney General for Attorney General Dustin McDaniel. She uses her experience as general counsel for state agencies and licensing boards to assist clients to resolve regulatory and disciplinary disputes with state government.
THE ARKANSAS PHARMACIST
ARRX - The Arkansas Pharmacist Summer 2015