Preventing Medication Tampering and Diversion

November 2021 - Vol.18 No. 11 - Page #48
Category: Diversion Prevention

Pharmacy Purchasing & Products recently held a webinar entitled:
Strategies to Prevent Medication Tampering and Diversion
presented by Kimberly New, JD, BSN, RN

The following questions were submitted by attendees.
The webinar slides and full presentation can be downloaded at pppmag.com/webinars.

Q: Besides standard manual audits for drug diversion, what other elements should be monitored?

A: With manual audits, facilities typically track the time a given drug was pulled, administered, and returned or wasted. Many newer analytics programs now monitor for additional elements, which add significant value to the resulting reports. It is helpful to monitor the usage of non-controlled drugs that are commonly pulled as part of a diversion scheme. For example, acetaminophen is commonly swapped out for oxycodone, and Zofran (ondansetron) is often diverted alongside opioids. By monitoring these drugs, unexplained usage patterns may reveal diversion.

Additionally, I recommend monitoring staff for certain specific behavior changes. Changes that may be concerning include suddenly picking up a lot of overtime, spending a lot of time in the bathroom, leaving the floor inexplicably during a shift, or patient complaints about poorly controlled pain. Usually, signs indicating overt impairment are not going to be the first thing you notice in a colleague who is diverting, which is why monitoring for these other behaviors is more effective.

Another element to monitor is the time at which diversion is occurring. Often, diversion occurs early in a shift or very late in a shift. This pattern may be due to the individual who is diverting needing to satiate their dependence at the beginning of the shift, and then again before they leave the facility. Therefore, monitoring the timing of drug pulls may reveal the pattern of a specific individual. Similarly, reviewing scheduling can elicit key patterns as spikes in substance usage often occur just prior to time off.

Q: What is a reasonable time to delay administering or wasting medication?

A: The outside parameter for pulling medications or holding waste should be 30 minutes. Certainly, when pulling a PRN opioid for a pain score of 8, the delay would never be longer than 30 minutes to administer. The ideal is for all administrations to occur in under 30 minutes.

If wasting delays are regularly exceeding the 30 minute window, there may be an issue with the overall workflow which would then require review. If a unit is struggling with waste, conduct waste rounds and analyze their approach to the wasting process with the following questions in mind:

  • Are the staffing levels sufficient?
  • Is the wasting process consistent?
  • Are there an adequate number of waste locations?
  • Are these locations conveniently located?

Q: What is the best way to test a controlled substance that may have been tampered with?

A: Definitively, utilizing an external lab for testing is the best practice if you are concerned a medication may have been tampered with. However, some facilities choose to conduct these tests in-house utilizing a handheld urine refractometer to save cost. This practice can be problematic if you cannot refract what you are testing for. Even when using a sophisticated refractometer, should the results come back as abnormal, the sample will still need to be sent to an external lab for testing.

My recommendation is to send concerning specimens to an external lab. To navigate this in advance of an issue, reach out to several external labs, and prepare a series of questions ahead of time, such as:

  • What is the turnaround time for testing?
  • What are the logistics for shipping specimens, and how is the chain of custody maintained?
  • How much will the process cost?

Q: What is the best way to ensure that leftover narcotic drugs are not replaced with water or saline?

A: Since it is generally not realistic to test all waste, the best option is to narrow the required timeframe for wasting to either wasting at the cabinet immediately after pulling or wasting immediately after administration. The goal is to lessen the time period for possible tampering.

An additional option is to introduce random testing of drug waste; however, this requires a very precise chain of custody in order to deliver actionable results. Under most circumstances in a clinical unit, the best option is to narrow the timeframes available for staff to detour perhaps to a bathroom to refill a syringe with water or saline.

Q: Are there drugs that are not listed as controlled substances that should be handled as such to better improve control?

A: Some facilities treat gabapentin as a controlled substance to improve accountability through monitoring. Since this drug is diverted on occasion, tracking any discrepancies is a good idea. Many facilities also treat propofol as a controlled substance and while it is not a federally designated controlled substance, some states do list it as a controlled substance.

It is important to note that if you treat any nonscheduled drugs as controlled substances, you should not include them in your DEA biennial inventory as a controlled substance. Be sure to remove gabapentin or propofol from the electronic printout.

Q: In both the OR and post-op ICU, documentation is often delayed and then the documentation does not match what was administered. Is there any way to mitigate this issue?

A: To address this issue, set an expectation for staff that the documentation must occur in real time, whenever possible. In my experience, the vast majority of administrations can be documented in real time. Situations wherein a delay is necessary, even during a procedure in the ICU, are quite rare. A delay may be expected during a rapid response, although it is unlikely that controlled substances are administered in that situation. All too often, documentation delays occur simply because they are permitted. Once staff is committed to documenting in real time, any time there is a discrepancy between what is documented and what was expected to be administered, that is likely the sign of a significant problem.

You should be able to count on the fact that your clinical staff is well trained and capable of documenting accurately, yet there is no question that people can have a bad day when things do not go as they had planned. Nevertheless, such occurrences should be the exception, not the rule. I recommend approaching this as a process issue: first, establish that there are rarely legitimate reasons for significant documentation delays, and second, set the expectation that everyone must follow the new process. Share with your staff that inaccurate documentation can be very expensive as the DEA can fine hospitals up to $10,000 or more for each discrepancy in the notes.

Q: What are effective strategies for monitoring anesthesiologist providers?

A: Monitoring anesthesiologists’ controlled substance use is a complicated task. There are a few advanced analytics programs that can provide better data and go beyond the basic “apples to apples” comparison that many programs have traditionally offered. One of the biggest difficulties with monitoring anesthesiologists is the inherent complexity of comparing drug usage case by case, as opioid use is going to be very different for someone supporting tonsillectomies and adenoidectomies versus someone assigned to complex heart surgery.

Despite this obstacle, there are several steps you can take. Educating anesthesia staff about behavioral red flags can assist in identifying those early warning signs of diversion. Additionally, reviewing a standard number of transactions for anesthesia each month can provide significant insights. Look at both what was pulled and what was administered, review whether those products align with the types of cases in question. While this process can be labor-intensive, it is intrinsically important to successfully identifying possible diversion events.

To monitor anesthesia practitioners, some facilities analyze anesthesia waste. This approach provides important data, but it can be difficult to implement properly. To ensure effectiveness, the specimen must be maintained under a very precise chain of custody and the testing must occur in the presence of a witness. I recently saw a case wherein a pharmacist was able to divert the anesthesia waste because they were solely responsible for both testing and disposal. Furthermore, it is important to remember that testing waste only works if there is waste. I have seen more than one case where an anesthesia provider avoided detection by ensuring that they never wasted their drug of choice.

Q: What policies should be in place to address controlled substance hand-offs between anesthesia providers?

A: The best practice when a staff member is going to be relieved is to waste any controlled substances rather than hand them off and have the relieving staff member then pull their own medications.

Unfortunately, there are many situations where this approach is simply not realistic. This best practice is challenged both by drug shortages and specialized opioid infusions, as just two examples. In those situations, the best approach is to document the handoff. While I discourage hand-offs, when they must occur, ensure that the documentation is as detailed and thorough as possible.

Q: Have hospitals successfully implemented waste-on-dispense?

A: Yes, many hospitals have had success in implementing waste-on-dispense. Most of the facilities I have worked with that have implemented waste-on-dispense have established it as standard practice, permitting only rare exceptions. However, implementing waste-on-dispense as a standard practice cannot be accomplished overnight. It is important to address the rollout thoughtfully, educate staff, monitor progress, and continually assess staff concerns during that process.

Q: For our palliative patients in the community setting, what is the best practice for destroying leftover medication to reduce the risk of diversion?

A: In that setting, I recommend that you provide a secure controlled substance waste receptacle in the patient’s home. It is important to avoid returning that medication to the pharmacy because that adds another touchpoint where diversion could occur. There are several waste receptacles on the market that denature the controlled substance and provide secure disposal. Keep in mind that if these are the patient’s own medications, the homecare staff is not responsible for the destruction process; rather the patient or their family member should be instructed in how to manage the disposal process.

Q: Do you recommend that hospitals or long-term care facilities contact the FDA OCI when tampering cases are discovered?

A: Absolutely. I understand that some facilities may be uncomfortable with contacting the FDA but having worked with the FDA’s Office of Criminal Investigations (OCI) in several cases, I have found them to be a great help.

In many instances, the FDA’s OCI will take custody of the tampered evidence and test it at their forensic lab. This action relieves the facility of the expense of testing and the hassle of managing potentially tampered medications.

To find the contact information for your local office, visit https://tinyurl.com/35c772m9. Additional information, including helpful brochures identifying diversion by tampering, is available on their website, https://tinyurl.com/2ycsr7rc


Kimberly New, JD, BSN, RN, is the founder of Diversion Specialists, LLC, a consulting service providing solutions for all aspects of institutional drug diversion. She is a specialist in controlled substance security and DEA regulatory compliance, working with health systems across the country to establish and expand drug diversion programs, with the overriding goal of improving patient safety. Kim is also the cofounder and executive director of the International Health Facility Diversion Association.

 

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