You are at your desk when you get the call from the pharmacy, maybe from where a med unit sits, or most terrifyingly, from the floor, and you’re told a patient didn’t get pain relief or has had a reaction to a drug which may or may not been the one prescribed. Your stomach drops and you reach for the extra-large tub of acid relievers that every compliance manager keeps on their desk. In that first moment, it is really easy to get caught up in the initial and critical question of “who did this?” But any time a drug diversion occurs, a series of questions, in addition to “who did it” need to be answered in order to take corrective action and to meet the various regulatory reporting requirements that relate to the diversion of drugs in a healthcare setting.

You can’t turn on a television, open a newspaper or pop up a blog post without hearing about the issues of opioid abuse. Whether prescription or illegally obtained, opioids are a fast-growing problem with a nearly 400% increase in prescription opioids purchased by hospitals and other healthcare providers between 1999 and 2010. In Iowa, Schedule II prescriptions increased more than 100% between 2011 and 2016. Reports to the Iowa Board of Medicine of opioid abuse, misuse, and failure to prescribe properly have also increased with; 4 of the 11 Iowa Board of Medicine cases decided on February 21, 2018, relating to pain, pain management and the prescription of opioids. Criminal prosecution, including for prescribers, has also increased nationally.

In dealing with any drug diversion issue it is critical that you ask the appropriate questions, create an investigative document showing what you have done to investigate and address the situation, and develop a plan of corrective action. For large scale problems, the plan of action may need to be revisited on a periodic basis to show ongoing assessment and correction.

Key Questions and Issues

Who - The big question that immediately pops to mind when a drug diversion issue occurs is almost always who. Who could have taken the drugs and who had access? There are a variety of ways to assess access: checking staffing logs, running full audits on various automated pharmacy systems, interviewing those who would have handled, managed or otherwise worked with the drugs, checking wastage logs, and similar records.

During the investigation process, it is likely that you will narrow it down to one or two people that you suspect may have taken the drugs. Don’t discount just asking them, “What happened to the drugs?” Employees will sometimes reveal process failures and even theft. 

Further, in asking this question, you have given the employee the opportunity to be honest with you and to tell his/her side of the story. If a termination is inevitable, the employee cannot later say, “No one ever let me tell my side.”

Testing Employees - Many employers ask me about drug testing employees when a loss of drugs has occurred. Iowa Code 730.5 governs employee drug testing. A facility cannot drug test unless there is a pre-existing, well-established, and publicized policy for drug testing which fully complies with the law

Testing of this type would come under the reasonable suspicion prong of 730.5 and require that you have articulated, prior to drug testing, clear and reasonable grounds for believing that this person may have been under the influence of drugs. However, drug diversion may or may not fit within this reasonable suspicion prong. Simply stealing drugs isn’t always an indication that the employee is using those drugs. They could have been diverted for sale, they could have been lost, or it could be for a family member. A drug test may or may not reveal the presence of drugs. Additionally, it can be difficult to adequately provide context for reasonable suspicion when there are no “observable phenomena” that the employee is under the influence, such as slurred speech or dilated pupils. 

Employers with union contracts or public employers face even greater hurdles in testing based on the NLRA and other statues. Finally, there is negative bias in many court cases about broad-based drug testing and the statute itself can be extremely difficult to manage.

Surveillance - Can we install surveillance? Sure. However, it is strongly recommended that you post in a highly visible area that surveillance occurs for the “safety of our patients and staff” or similar language. You are not required to tell employees or others where or when surveillance will occur, although common areas are certainly the pharmacy and med carts. However, don’t capture images in locker rooms, bathrooms, or patient treatment areas where there is a strong expectation of privacy and statutory limitations. 

If you would choose to capture audio as well as video, all employees should be made aware of the audio capture and sign off on a specific consent. Audio is a much more difficult argument in terms of balancing your rights for surveillance versus employee, patient, and family member’s basic rights to privacy. People are used to having their images captured. There are some estimates that your image might be captured between 1,500 and 6,000 times a day depending on a where you live. People are a little less likely to be comfortable when you start capturing their conversations.

If you do surveillance you will also need a plan for how long it is kept, where it is stored, and how it will be preserved if there is litigation.

Why - The next question to ask is, “Why did this issue occur?” This is critical as the answer will drive reporting and resolution of the problem as well as the appropriate type of corrective action. If the reason that drugs were missing is that you have deficient or sloppy procedures, it may not be a true diversion but simply a loss or inventory control failure. This would require updated systems, training, and higher accountability. It may also require a change in managers if the manager is not focused on meeting the DEA standards for handling these items. 

If the issue is one where providers are engaged in providing drugs to family and friends, prescribing to a nurse in the hallway or similar items, that is also likely to involve training. Note it may also require reporting to the Iowa Board of Medicine, Board of Nursing, or the Pharmaceutical Board if inappropriate prescribing has occurred this would be a violation of the Rules of Ethics. The rules prohibit providers from prescribing in the hallway, in passing, or by text, even if the person indicates he or she has “forgotten” his/her medication at home and can the doc just write a short script?

Own Use - If the person has obtained medication, diverted or misused a prescription for the purposes of his/her own use or the use of another person or for sale that falls within criminal intent and is reportable as a crime.

Next week, I’ll cover what to consider if the drugs were stolen or adulterated.