EXECUTIVE SUMMARY

ASCs are at risk of drug diversion, but can reduce the risk by following best practices.

  • If an ASC uses controlled substances, it must report all thefts and significant losses to the Drug Enforcement Agency.
  • ASC leaders should be aware of staff acting out of the ordinary and possibly stealing drugs.
  • Security cameras, monthly inventory-invoice reconciliation, and other strategies can help prevent diversions or catch them early on.

Amid a nationwide opioid epidemic, ASCs are not immune to problems related to misuse of controlled substances. Drug diversion should be a chief concern.

“Drug diversion is a huge problem, and with the national opioid epidemic, it’s gotten worse,” says Christopher M. Dembny, RPh, president of Dembny Pharmacy Consultants in Richardson, TX. The company works with 85 surgery centers, overseeing their medication inventory and regulatory compliance.

Even if an ASC has instituted effective checks and balances against theft of opioids and other drugs, it still must complete documentation, such as regular listings of every controlled substance purchased and used, for the Drug Enforcement Agency (DEA).

“Surgery centers and any DEA registrant that has controlled substances is required by the DEA to do a biannual registry,” Dembny says. “Every two years, you produce a document that shows how on this date you had each of these items, and there should be a set endpoint if they want to check your audit trail. That is required by law by the DEA, and a lot of people don’t realize that it’s a requirement.”

To meet this requirement, ASCs must retain the blue copy of each DEA form 222 to keep in their records.

“You put that with your invoice to show what you ordered and what you received,” Dembny says. “The overriding principle is to have a reproducible audit trail of everything that comes in and out of the facility. Keep all invoices. Keep blue copies of form 222, and keep records of where those drugs went.”

Failure to maintain these records could land ASCs in trouble, he adds.

“The DEA won’t haul you off to jail because you lost one bottle of morphine, but if someone is ordering morphine on the side and is taking it home, the DEA is going to have an issue with that,” Dembny says.

With the right systems in place, diversion is less likely. The difficult part is implementing systems to prevent diversions that one could not imagine occurring.

Dembny offers a good example of a creative diversion: “It’s the most embarrassing,” he says.

“I had a nurse taking care of the pharmacy in my ASC. Each week, she would order a bottle of Ambien tablets. When the order came in, she’d take the invoice, cut it in half, and cover up the line of the invoice that listed Ambien on it,” he explains.

“She sent it to accounts payable to be paid, and unless someone added up the totals, they’d never know there was a line missing,” Dembny says. “She got away with that for several months — until we caught her. And it’s one of those things where you say, ‘How could you let that happen?’”

The nurse was extremely clever about covering her tracks, he says. In addition to doctoring the invoice, she stole the monthly drug vendor’s summary of all the controlled substances that had been ordered. She was suspended prior to the discovery of her diversion due to other types of suspicious activity, according to Dembny. During her suspension, another nurse saw the Ambien order and asked someone why the ASC was ordering the drug when it was never used. That was how the ASC learned that the nurse had been diverting pills for several months.

“People will always steal drugs. It’s just a question of how long, and in this case, the nurse was very clever and got away with it for a while,” Dembny says.

Dembny learned from that experience that monthly summaries from wholesalers must be reconciled with the ASC’s inventory. If pharmacists do not see the summary, they should call the wholesaler to ask for it.

Before the Ambien diversion, Dembny was not adamant about reconciling the monthly reports. “It was a learning experience,” he says. “If you do [reconciliation], you don’t have wholesale diversion because problems show up immediately. So, every time we get controlled substances, I validate they were added to our stock, and at the end of the month, I take a monthly summary and validate that every item is on that list.”

Another good internal check on possible diversion is to direct one person to order the drugs and a different person to receive them, he says. ASC leaders should know that the drug diversion culprit often is the last person they might suspect. “They’re the ones who will help you with anything. They might be young, friendly, happy, pretty, and everybody’s friend,” Dembny cautions.

There are several ways that drug diversions can occur. Some are difficult to detect, and can put patients at risk. For example, a nurse could take a patient’s 10 mg of morphine and transfer half to another syringe, giving the patient only 5 mg of morphine.

“If a nurse pops off a top of morphine and puts saline back into it, she’s exposing your patients to potential diseases,” Dembny says.

This type of diversion is difficult to catch unless someone notices suspicious behavior, or sees that vial has been resealed, or if the ASC operates security cameras in all areas.

Another diversion could occur if an ASC employee opened a new account with an existing drug vendor, disposing of all documentation except for invoices sent to accounts payable. The only way this could be discovered or prevented is if accounts payable employees know how to question an unusual occurrence.

Small ASCs are most vulnerable to this type of diversion, and, occasionally, they are victims of embezzlement because of the same type of practice. Larger and chain ASCs typically put a series of loss prevention systems in place, Dembny notes. Although it’s very important to prevent drug diversion from a patient safety standpoint, it’s also important to maintain regulatory compliance, and ASCs must provide adequate resources to do so.

“You need to keep all Schedule II invoices together,” Dembny says. “Document every location where drugs went after you received them.”

For example, when drugs are administered to patients, documentation of this should be maintained separately from the patient chart, he advises.

“If you have expired medication, you send this to reverse management for destruction,” Dembny says.

Reverse management companies are licensed by the DEA to destroy expired substances.

“Track every single dosage unit that comes into and leaves a surgery center, whether it’s through administration to patients, destruction, or theft and loss,” Dembny says. “If someone steals 10 fentanyls, I report this to the DEA and keep a record of it because I have to account for every dosage unit, including those that are lost.”

Technically, organizations have to report all thefts and significant losses of controlled substances. A pill thrown out with the laundry might not be significant, but its loss could be documented. “I’m conservative on interpreting that,” Dembny says. “If I lose more than three vials, I say that’s significant. If it’s one vial a week for three weeks, then that’s a trend, and I’ll say, ‘What’s going on here?’”

When losses seem random, but begin to escalate, that’s a sign of diversion. As people steal drugs, they often become more careless, he notes. ASCs are required to institute adequate security on controlled substances, but this is not well defined.

“Some people say they have two locks, but the DEA doesn’t say anything about two locks,” Dembny says. “Adequate security, to me, is a substantial cabinet that is permanently affixed.” Security cameras also are very helpful. “A lot of places have a security camera overlooking the drug cabinet,” he adds. “And biometric IDs are very helpful.”

Thanks to a newly installed security camera, one ASC solved a mystery of a narcotics loss. “After installing the camera, they saw the night maintenance guy was breaking into the supervisor’s office, getting the key to the narcotic cabinet, helping himself to drugs, and then using alcohol wipes to wipe down the cabinet,” Dembny recalls. “He didn’t know the camera was installed on the ceiling.”

The employee was fired, and there were no more medication losses. “People will find a way to steal drugs. It’s our job to catch them,” Dembny adds.