A Growing Problem for Healthcare Organizations
The opioid crisis and drug addiction are not just among criminals. The issue is growing among all segments of the population including healthcare workers. This is a multi-faceted problem. There are patient safety issues, fraud and abuse issues, and regulatory compliance issues just to name a few. Healthcare facilities are expected to have controls in place to help ensure drug diversion is not occurring and to identify and resolve instances when it does occur. Failing to have such controls in place can result in enforcement actions.
There have been recent enforcement actions for failing to have such controls.
- In September of 2015, Massachusetts General Hospital (MGH) paid a $2,300,000 settlement with the Department of Justice (DOJ) for failing to have appropriate controls in place to comply with the Controlled Substances Act. MGH reported the theft of over 16,000 pills.
- In July 2014, Dignity Health (Dignity) settled a similar case with DOJ for $1,550,000. Dignity identified the theft of over 20,000 pills.
- In 2016, the Georgia Pharmacy Board fined the Emory University Hospital-Midtown $200,000 and placed its pharmacy license on a three-year probation. According to the consent order from the Georgia Board of Pharmacy, the hospital reported an estimated loss of over one million doses of controlled substances.
Possible Points of Diversion
Anyone who has access to controlled substances has the potential to become a diverter. There are multiple points in the cycle of procuring, preparing and dispensing, prescribing, administering, and disposing of a controlled substance can result in diversion.
Organizations will have defined individuals who can order controlled substances. Like with any good accounting structure, there should be a separation of duties between who can order, receive, and pay for controlled substances. The same person should not be performing all three functions. The organization should be engaging in process of monitoring the amounts of a controlled substance purchased against the amount dispensed. These statistics should be compared not only over time, but by user and ideally as close to real time as possible.
If the organization gets an alert that a certain user has just increased the ordering pattern for certain medications, an inquiry can be initiated to determine why. It could be the result of a legitimate need i.e. the opening of a new pain management clinic triggers the anticipation of an increased in the legitimate prescribing of controlled substances. However, this changing pattern could also be in indicator of compromised credentials or the user beginning to engage in diversion.
The organization should also be monitoring the instances where there are reports of a product container being compromised. This can be an indication that someone has tampered with and possible removed some of the product.
Preparation and Dispensing
Individuals responsible for preparing and dispensing medications have the potential to become diverters. This process can be corrupted in multiple ways. A controlled substance can be replaced with a similar looking product during the prepacking process. If the controlled substance comes in the form of a premixed infusion a diverter may remove some of the infusion substance from the total volume. A multi-dose container may be intentionally overfilled so that the additional volume can be diverted. The individual preparing a syringe with the controlled substance may substitute the syringe with the medication with one filled with another solution, often normal saline.
Again, there are several methods in the prescribing process that can result in diversion. Something as simple as someone misappropriating a prescription pad and forging the prescription to obtain the controlled substance. Physician and others with the ability to prescribe controlled substances are not immune from addiction. Therefore, they may be writing prescriptions for themselves. Another possible point is when the order for the controlled substance is done through a verbal order that is never verified by the prescriber. Finally, while less common within healthcare organizations, the patient alters the prescription by increasing the quantity, dosage or both.
Many modern healthcare organizations have installed automated distribution devices (ADDs) for medications, including controlled substances. This makes it more convenient to get the medications needed for patient care but also creates another point of potential of diversion. Looking at the use of ADDs can help identify possible diversion activity. Assessing if there is a withdraw of medication for a discharged or transferred patient might be a trigger for further inquiry. Evidence that a medication was documented as given but there is not documentation of the actual administration of the medication to the patient. Multiple instances where the wasting of excess medication was not appropriately witnessed. Improper counts are identified in the ADD, i.e. the device is opened, and drug A is identified as being removed when it is actually drug B, the controlled substance that is removed.
Waste and Removal
The proper wasting of excess medication generally requires a witness. This control is one measure to help avoid diversion. However, if the disposal container is not properly secured then there is potential for someone to remove the wasted medication from the container. There is also the potential a diverter can substitute the medication that is supposed to be wasted with another substance like normal saline. Another method for diversion is when an expired medication is improperly removed from the inventory.
Because diversion can happen at one or more points in the cycle of controlled substances entering and leaving the facility healthcare organizations must have a controlled substance diversion prevention program (CSDPP). A CSDPP must be as multi-faceted as the problem is. Organizations must assure controls are in place at each step of the process. There have and continue to be traditional controls but with the increasing availability of electronic information, data analytics and machine learning has become a more common tool in combatting drug diversion.
Traditional controls may include:
- Separation of duties
- Unique usernames and passwords to key systems in procurement, pharmacy, clinical areas, etc.
- Inventory control systems
- Requiring a witness for wasting
- Surveillance of areas where diversion would be at high risk such as pharmacy, surgery, anesthesia, pharmacy and the emergency department
- Security and limited access rights to areas where controlled substances are stored
A downside of some of the traditional controls is that a diversion issue can go unnoticed if, as is commonly the case, someone is intentionally attempting to bypass the controls. Drug diversion may only be identified when the culprit trips up, a coworker reports unusual activity, or an audit reveals the control was bypassed. This is why data analytics and machine learning may provide a more robust method for identifying possible diversion.
Data Analytics and Machine Learning
With the increased instances of activities being done in an automated fashion, there is more opportunity for real-time or near real-time data analytics that can alert the organization to a potential problem. Combine this with the ever-improving tools for machine learning that allows for detection of aberrant patterns and the ways in which organizations can detect and deter drug diversion will be vastly improved. When looking at the various points where a controlled substance could be diverted it is not difficult to see where data analytics could provide data regarding aberrations.
In the procurement process, the system could be set up to flag items such as an increased in the ordering pattern by some predefined standard deviation at both the user level and the overall system level. This could alert the appropriate parties to make inquiry as soon as the aberration is noted to determine if it is legitimate. Data analytics comparing data across multiple systems could allow for a comparison the amount of medication ordered to the amount dispensed. Collating the data across these systems will allow significant disparities to be identified and investigated.
Combining and analyzing data from multiple systems can also help detect potential patterns faster. If the controlled substances dispensed by shift is compared to the patient pain scores it could indicate a nurse who is diverting drugs for his own use. Comparing the records of when individuals are scheduled to work to the dates and times when they are accessing the ADD could flag those instances when the access is during off hours. Similarly, evaluating the medications marked as dispensed for patients against the status of that patient could alert to instances where the medication is identified for a patient listed as discharged or transferred.
Likewise, comparing the time the medication is listed as dispensed from the ADD to the time it is administered could identify instance were the diverter is self-administering a portion of the medication prior to giving the remaining dosage to the patient. Comparing the level of absenteeism for an employee to other signs of possible diversion previously discussed could be another alert to the possibility of an issue since increased absenteeism is one sign of a possible addiction issue.
Drug diversion continues to be a significant issue for healthcare organizations. The continuing and increasing opioid epidemic will only serve to assure the issue is not going away. Having controls in place through a CSDPP is essential for any organization. Using some of the newer technologies for data analytics and machine learning will help entities identify the problem faster which will allow for faster investigations and resolutions