about your responsibility, and serious about compli- ance, in the event of an audit. While the DEA regulations do not require SOPs, they are standard practice in the medical industry. You should de- velop SOPs relative to the handling of CSs—order- ing, receiving, storing, administering, dispensing, auditing, and disposing. These policies should form the foundation of your CS training for staff.


Controlled Substance Officer


A controlled substance officer (CSO) should to be appointed for every practice. This person is respon- sible for training new as well as current employees about CS policies and protocols, keeping Biennial inventories, maintaining accurate records of CS and Forms 222, etc. As a part of that training, staff members should be directed that if the DEA pays a visit, the agents should immediately and politely be taken to a conference room or other neutral site in the practice. All files they request should be brought to them by the CSO. Agents should not be allowed to roam loose in the practice. Because DEA agents are required to identify themselves when they arrive at a facility, there will be no mys- tery as to their identity.


Dispensing


Although in the language of the DEA regulations, dispensing equals administration, most veterinari- ans consider dispensing as providing a supply of medication to a client for their use in a patient. Sometimes treatment of certain conditions (e.g., sei- zures) requires the daily use of CSs. In order to dispense CSs, one must write a CS prescription. For practices that choose to dispense CSs to clients, this will require a written CS prescription, which in some states must be reported online within 24 hours. Although a practitioner might consider a workaround of writing an invoice that states that the CSs were actually administered in order to avoid the inconvenience of the required paperwork, this is a clear untruth and grounds for criminal enforcement.


Ways to Get the DEA’s Attention


● Submission of a Form 106 with the loss or theft of large amounts of CSs


● A disgruntled employee calls the DEA to re- port that you have inadequate compliance


● An individual is arrested with CS drugs in their possession that were improperly dis- pensed by your practice or diverted from the practice without a report of loss


● An employee of your practice diverts practice CS and overdoses, or is arrested selling these drugs


● A routine DEA visit reveals your practice is grossly out of compliance


THE BUSINESS OF PRACTICE: MANAGING PRACTICE CHALLENGES AND OPPORTUNITIES 5. Handling Loss or Theft


Consultants suggest that security cameras be placed on the primary location of CS storage in order to deter theft. Your policies should include frequent enough audits of your CS that you would recognize theft or loss swiftly. This should include regular monitoring of the perpetual inventory and frequent physical counts of CS stock. Upon discovering a discrepancy in the perpetual inventory, it is recom- mended that a note in red pen be inserted that documents the mismatch between expected calcu- lated stocks and actual physical counts, and the results of an investigation. If, after an investiga- tion, the CSO has not discovered the source of the error and corrected the perpetual inventory, a deter- mination must be made whether a Form 106 must be filed. You must file a Form 106 online for all thefts and


any “significant” losses within 24 hours of their dis- covery. Each practice needs to determine what is considered a “significant” loss. Consultants sug- gest that a “significant” loss be considered 5% of your inventory of a particular CS. Loss occurs when CS are damaged, or missing without explana- tion (e.g., fire or act of nature). Breakage of CSs does not constitute a “loss” of CSs. When there is breakage, damage, spillage, or some other form of destruction, any recoverable CSs must be disposed of according to DEA requirements. If the breakage or spillage is not recoverable, the registrant must document the circumstances of the breakage in the inventory records. Two individuals who witnessed the breakage must sign the inventory records indi- cating what they witnessed. Note well that all theft must be reported. If you experience a theft of CS, you may wish to consider the use of a consultant to help you get into compli- ance and weather any ensuing storm. If possible, any requests for services of a DEA consultant should originate from the practice’s attorney, so that there will be attorney/client privilege about the findings of the consultation and any deficiencies found.


6. What to Do If the DEA Arrives at Your Door


Because veterinary practices usually only dispense (administer) CSs, the number of files that must be maintained by law is reasonably small. All files should be maintained in a secure manner; access should be limited to those employees with a clear need. The files should be maintained by the CSO, preferably in the limited access room where the ac- tual drugs are to be stored, or in a locked file cabinet dedicated to CS records at the CSO’s desk. Handling the CS records in this fashion will en-


able you to confine the DEA personnel to a confer- ence room to which you can quickly transport individual controlled substance files as they are re- quested. This minimizes the possibility of the DEA rummaging through files which may contain infor- mation which you might prefer they not see. It also should go a long way toward instilling confidence by


AAEP PROCEEDINGS  Vol. 65  2019 105


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