Understanding Infectious Disease Risks Associated with Drug Diversion & How to Prevent Events
If there are controlled substances at your facility, diversion is happening. What can be done to prevent future events?
In the United States, drug abuse has become a serious issue, reaching epidemic proportions. In fact, it’s estimated that overdose is one of the leading causes of death in Americans who are under 50 years of age. As the number of drug abusers continues to increase, demand for prescription drugs also goes up, resulting in drug diversion.
Drug diversion, or tampering, is an issue in and of itself, but it arguably becomes even more serious when it happens in health care facilities. In these settings, drugs run the risk of being diverted at any point during the supply chain by staff who have easy access to controlled substances on a daily basis. As the opioid epidemic rages on, addiction to these prescription narcotics has become a major driver of drug diversion.
When health care staff choose to divert drugs for their own personal use, they put patients at increased risk of health care-associated infections, such as hepatitis C and other blood-borne infections, bacterial infections, and others. Drug diversion can also result in substandard care delivered by an impaired provider and the withholding of needed pain medications.
In a session at the SHEA Spring 2018 Conference in Portland Oregon, Kimberly New, a specialist in controlled substance security and Drug Enforcement Administration (DEA) regulatory compliance, shared with conference attendees how to investigate the infectious risks after a narcotic diversion event has occurred at their facilities as well as programs that can be put in place to prevent future events.
The first thing that she pointed out is that, terrifyingly enough, most facilities are not even aware that they have a diversion problem. “It doesn’t matter what kind of facility you are,” New stressed. “If you have controlled substances, you will have diversion.” Therefore, increased efforts need to be channeled into detection, response, and prevention.
Facilities need to assess their organizational awareness and find out how many cases have occurred at the facility and how they have been identified in the past. She reminded attendees that behavioral indicators are often late indicators. With the use of an automated dispensing cabinet, providers can discover diversion within a matter of weeks, and so, ideally, diversion should be detected long before behavioral indicators.
There are several reasons why facilities may not be detecting diversion, the biggest of which is lack of surveillance. Although some kind of auditing is typically in place, most facilities are just doing the bare minimum to meet requirements, according to New. “The reality is, you need to have ongoing auditing going on within your facility,” she said. “Look at those drug transactions that are occurring. Look at the analytics report so you can focus your auditing.”
In addition to lack of surveillance, sometimes surveillance can be ineffective. Everyone needs to be on the same page and aware of what needs to be done. “Just checking that box [that surveillance occured] is not enough,” she said.
Arguably, one of the biggest reasons that diversion is not detected in the first place is lack of awareness among staff and leadership.
“If people don’t believe that diversion is happening at a facility, they are not going to buy into the program,” New said. “They’re not going to believe that they will see things that are indicative of diversion, and they will not report them, and they will not pursue them. It’s really important to have education [in place].”
Why do we need to start the dialogue about drug diversion?
Health care professionals are not invulnerable to the opioid epidemic; because personnel has ready drug access, individuals can self-medicate that much easier. “We can look at this as part of what we are doing to combat the opioid epidemic,” said New. Furthermore, “it’s vital to your mission to prevent harm." When diversion happens, patients, associates, and the community get harmed.
Although drug diversion programs may not be profitable, they will mitigate potential risk. “You may have massive financial fines. The DEA will fine you $12,000 per discrepancy, and if you looked at an average facility, they usually have a lot of discrepancies.” Diversion can result in damage to an organization’s reputation as well. “People look at diversion as a sign that a facility is somehow not doing something they should be doing,” she said. “The reality is it’s happening at all facilities and the hit can you can take when you have one of these massive outbreaks is very substantial.”
According to New, the following are some key steps that can be taken to protect patients and staff from diversion:
- Develop a formal program devoted to diversion, prevention, detection, and response; it should include an oversight committee, a response team, and an operations manager or diversion specialist.
- Increase transparency and develop a culture of accountability.
- Demonstrate that diversion is happening and present some of the risks it presents.
- Ensure ongoing surveillance occurs and that it’s uniformly executed.
- Make certain that resources are appropriately allocated.
According to New, it’s important to gain an understanding of the risks seen across the country when it comes to diverters. First, for the most part, individuals are diverting an opioid or a few opioids of choice and more often than not, they are diverting for personal use, not for sale. Furthermore, over 75% to 80% of diverters that are caught have started with injectables, she said; they escalate over time, they engage in risky behavior, and “anything is game,” she said. “If you are desperate, you’re going to go for every possible source you can find, even if you’re tampering, that’s not going to prevent you from going to waste containers. You’re looking for absolutely everything you can get your hands on.”
It’s also important to know the areas of highest risk for diversion in health facilities: emergency medical services (EMS) or air transport service areas are at the top of the list; procedural areas such as the operating room, Cath Lab, IR, labor and delivery, post-anesthesia care unit (PACU), and special procedures along with the intensive care unit and the emergency room are all areas of risk. Outpatient settings also make the list, according to New.
Injectables present an increased risk; these include drips, carpujects, and vials. Tampering is extremely common. “You’ve heard about the cases with the outbreaks. I can’t tell you how common this is,” she stressed. “We find tampering every week at a facility; this is not something that’s just every now and then, and that’s why you need to be aware, because when we see these cases, many times the folks that are involved, the people who are at the table looking at the case, really aren’t thinking about it in terms of blood-borne pathogen transmission, bacterial infection, or any of those types of things.” In fact, from 1983 to 2013 alone, the US Centers for Disease Control and Prevention (CDC) highlighted 9 infectious disease outbreaks associated with drug diversion.
There are many telltale signs that indicate when a medication has been tampered with. New shared several examples from past investigations which included broken tamper seals, using tamper-evident sleeves to hold caps in place after they had been moved, using super glue to place caps back on, leaving levels very low in the vials, and more.
Here’s how it works, according to New. “Used syringes and vials are filled with other fluids, reassembled, sometimes so artfully that pharmacists can’t even identify what’s been tampered with,” she said. “All you have to do is go in and say you’re going to take medication for a patient.” The individual would then put his name, the medicine they intend to take, and then a secure pocket opens allowing them access to a little bin containing about 20 vials. All they need to do “is take the bad ones and swap them out with the good ones,” she explained. “If they’re smart, they’ll actually cancel the transaction, so it looks like they didn’t even take anything, and that way, it doesn’t appear on any kind of statistical comparison report.” Any time they access the drug supply, they can do this.
New provided the room with advice on what should be done immediately if tampering is suspected. The first is to preserve any evidence; ensure to take a photo of the tampered medicine. Other steps include working to maintain the chain of custody, inspect all medication in the drawer, and remember to notify pharmacy, the diversion specialist, and security.
A few ways to prevent tampering include:
- Withdrawal from PCA and drip lines (use lockboxes, portless tubing, secure keys, and monitor any key transactions).
- Return unused medication to a separate return bin, not stock, for inspection.
- Keep controlled substances secure (use tamper evident caps on infusions).
- Use serialized locks during transport and on kits.
- Confirm integrity by checking inventories, counts, and administration.
- Educate the staff.
“Look for signs of tampering and educate people so that they can use that opportunity,” she stressed. “It only takes a second to just confirm that it looks intact. Your efforts could save a life.”
Feature Picture Source: US Department of Agriculture / flickr / Creative Commons.