Hello all!
It's been a while since I posted. I've been very busy at work plus traveling a lot. Let's focus on something more simple and focused: controlled substance theft and loss.
If you are at your facility and you note quantities of controlled substances are not matching how do you handle this?
Don't freak out. Recount the medications! Human error is a major culprit in wrong counts.
If the quantities are still off compared to say your paper perpetual inventories your next step would be to check your math on the perpetual! Was an error noted in the counts? Again, human error is a major factor here ESPECIALLY if you do not use automated tools to maintain inventories. Even with automated tools human error may have occurred...basically an incorrect entry that was not caught as an example. Automation is only as good as the person entering the information. Garbage in = Garbage out. This is why it is imperative for you to maintain a close watch on the quantities within your facility. Regular inventories (ex. Monthly) can often catch problems before they get massive.
Ok you've counted everything and the numbers add up correctly....now you have to determine via investigation what happened to the missing product. Evaluating reports of previous runs is important. Evaluating cameras to see who has accessed the machines (if you use automation on the units and in the pharmacy) or the locked cabinets used for storage (if you do not use automation). With this in mind...if you do not have cameras watching be processes of handling controlled substances you may want to truly consider them as a tool to help in investigations.
Per 21 CFR 1301.76 Other security controls for practitioners, Within one (1) business day you must notify the DEA in writing if you have a theft or "significant" loss. I will discuss significance in just a bit. So the "in writing" requirement could take a couple forms: complete a note to send to the local DEA field office and fax to them OR scan the document and email it to them. If you do not know which the local field office prefers, contact them for clarification. Personally I would print this "sent" email and save in a drop folder to show that you accomplished the required task.
After the initial notification per 21 CFR 1301.76 a DEA Form 106 must follow (if after the investigation it is determined to be theft or significant loss). This can be completed electronically in the DEA website. Complete all sections of the form. Be as precise as possible with the facts that you know. I personally do not recommend that you put supposition or opinions on the 106 but it is your form to decide what is needed. Print a copy of the 106 and put a copy in the drop folder I mentioned earlier. The regulations are silent on when the 106 is due. In the past, DEA has given advise to complete and if the form cannot be sent in within 60 days that you should communicate with the local field office to inform them. BE ON THE LOOKOUT ---DEA did put forward for comments a change in regs to require the 106 to be sent in within 15 days. Many organizations such as ASHP have expressed concern with this time frame. As of today's date there is no word on this changing.
If your state requires communications (including with BOPs, local police, etc) complete that process and document.
So how do you determine if something has been stolen or that the quantity is significant? These are the $10,000 questions! To determine theft can be quite daunting especially if you do not have someone admitting to it, caught on camera, another employee catching the individual, etc. Of course this would create a need to question the possible people involved. Using tools such as RxAuditor to evaluate deviations from normal (ex. a nurse dispensing more opioids than other nurses, problematic waste buddy matters, etc.). DEA will expect that you have some system in place to truly monitor for questionable activities! This is all part of the idea of maintaining a "closed system" within your facility! Cameras! Cameras! CAMERAS! If you don't have them in the pharmacy controlled substance areas or med rooms again I highly recommend them!
So, after investigation you cannot prove any matter of theft. Maybe an item was inadvertently thrown away? It happens! Make sure that if a box is thrown away all the sleeves are removed from the box. If you don't you may have just lost 10 tablets! Well now you think ok this is not theft so I've got to determine if it is significant level of loss. You probably think...I'll just look at what the DEA says percentage wise how much is considered significant. Well there's a problem: the DEA does not exactly define what they envision as significant! They do have some thoughts that you should consider in 21 CFR 1301.76(b)
(1). The actual quantity of controlled substances lost in relation to the type of business;
(2) The specific controlled substances lost;
(3) Whether the loss of the controlled substances can be associated with access to those controlled substances by specific individuals, or whether the loss can be attributed to unique activities that may take place involving the controlled substances;
(4) A pattern of losses over a specific time period, whether the losses appear to be random, and the results of efforts taken to resolve the losses; and, if known,
(5) Whether the specific controlled substances are likely candidates for diversion;
(6) Local trends and other indicators of the diversion potential of the missing controlled substance.
So....using these thoughts....consider what you have in stock vs your previous orders. Is the loss a large quantity? Your facility should determine what quantity or percentage of quantity that is the limit. Follow that process at all times to maintain consistency. Always remember that the DEA loves consistency!
So...you've determined using your facility decided quantity or percentage of quantity that the loss does not constitute a consistent level of loss. Now what? Can you just forget that this occurred...chalk it up as a one off? NO!!!! I highly recommend documenting loss regardless of significance in some way that you can track and trace patterns. If you see (4) above patterns are part of significance evaluation. If one week you have 1 tablet of lorazepam missing, the next week 1 tablet of alprazolam missing, and the next week 1 tablet of diazepam missing you are starting to see a pattern! Remember patterns can be with drug classes as well. You should investigate. If it looks questionable you should do all the steps I noted above about reporting to the DEA, state, etc.
You MUST be able to monitor your controlled substances and communicate with the DEA when necessary. Always stay on top of these things. Consistency is key! Maybe consider having a procedure that discusses how to handle theft and loss to help maintain consistency?
Also---very importantly---you must instill the thought into everybodies mind at your facility they all have a hand on DEA readiness including for these matters! If the employee (including nursing staff!) see something they should say something!
Share the below with all people handling controlled substances!
21 CFR 1301.91 Employee responsibility to report drug diversion.
Reports of drug diversion by fellow employees is not only a necessary part of an overall employee security program but also serves the public interest at large. It is, therefore, the position of DEA that an employee who has knowledge of drug diversion from his employer by a fellow employee has an obligation to report such information to a responsible security official of the employer. The employer shall treat such information as confidential and shall take all reasonable steps to protect the confidentiality of the information and the identity of the employee furnishing information. A failure to report information of drug diversion will be considered in determining the feasibility of continuing to allow an employee to work in a drug security area. The employer shall inform all employees concerning this policy.
Oh P.S.!!! If your facility is robbed you MUST report the theft of the DEA just like any other theft/significant loss. Remember to also ensure compliance with DSCSA reporting if necessary! See my DSCSA post regarding this!
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