Using New Technology to Validate Returned Narcotics in the OR

THE NARCOTIC CONTROL PROCESS IN THE OPERATING ROOM HAS ALWAYS been one of the most challenging areas for the pharmacy department to manage. Large amounts of potent agents must be readily available for the anesthesiologists and CRNAs to administer to their patients throughout the course of any given day. In order to prevent diversion of these highly abused substances, it is the pharmacy’s responsibility to ensure that reconciliation occurs to account for medications that are circulated throughout the operating room areas.

Pharmacies currently use refractometry, trend analysis, and quantitative laboratory testing to validate returned narcotics and identify diversion. There are disadvantages or practical limitations for each of these methodologies when attempting to quickly and accurately identify narcotic diversion.

Refractometry relies on differences in the density of drugs in solution to refract or bend light in order to give a refractive index that can be used to validate the identity of a known substance in solution. While refractometry allows some capability to validate the identity of a substance, it will not distinguish some commonly used substances from others in the operating room environment. For example, refractometry does not allow a user to differentiate between fentanyl 50 mcg/ml and sterile water. In addition, common OR drugs such as preservative-free morphine 0.5 mg/ml, midazolam 1 mg/ml, and hydromorphone 0.2-0.4 mg/ml in normal saline all have the same refractive index, making it impossible to tell one from the others.

Trend analysis relies on deviations in usage patterns to key in to possible diversionary activities. Spikes in narcotic usage of a particular drug or by a particular practitioner can be indicators of diversion or can be a cause for further investigation. Trend analysis can be a very subjective, time-consuming methodology for identifying diversion.

Quantitative laboratory testing is the most definitive testing available to determine the chemical makeup of a particular substance in solution. In these tests, a gas chromatograph or some other lab instrument is used to determine the exact identities and quantities of medications in solution. These tests can be time-consuming, and results are often not returned for weeks. The cost of these laboratory tests ($250 to $350) can make them impractical for day-to-day sample testing.

At the University of Utah Hospitals and Clinics, a university-based teaching hospital in Salt Lake City, Utah, our pharmacy department sought to improve our capabilities to further discourage and prevent drug diversion. This, in turn, would improve compliance with JCAHO and state board of pharmacy recommendations for having good procedures in place to validate narcotic returns and prevent diversion. The solution needed to be practical, efficient, and cost-effective enough to allow for daily use in the OR pharmacy satellite, and needed to provide a greater degree of specificity than could be attained using refractometry.

The pharmacy department decided to investigate ultra-violet spectral medication validation and began working with the ValiMed System by CDEX. The ValiMed device uses ultra-violet light waves to identify medications in liquid or solid form. When the ValiMed light source energizes a given medication, it produces a uniformly consistent pattern of fluorescent energy called a spectral fingerprint, which is stored in a library of fingerprints for future validation. Each medication reveals its own distinct and easily readable signature. By comparing the fingerprints of a tested medication against the signature for that medication in the library, the ValiMed technology will indicate a match, presuming there is one. The pharmacy deployed a ValiMed unit to the operating room satellite pharmacy to validate returned narcotic waste and to test samples in cases of suspected package tampering.

The ValiMed drug detection device is a self-contained, 9 by 10 by 21-inch unit that resides on a countertop, and requires only standard electrical power to function. The device uses a touch screen and Windows XP to provide a simple software user interface that facilitates the testing process.

To perform a validation test with the ValiMed device, the user simply starts the machine, places a sample of the medication to be validated into the unit and uses the touch screen interface to activate the device. The device can validate the identity of most medications against samples in the library in less than 30 seconds.

The ValiMed device provides us with the ability to test all of our returns and offers reliable, on-the-spot data, resulting in significant control and safety benefits. The pharmacy plans to expand its use of the ValiMed device to other surgical areas within the university health system. In addition, we are looking at ways to utilize the device’s capabilities to validate chemotherapy preparations compounded in the university’s Huntsman Cancer Hospital pharmacy and to perform QA concentration testing of bulk items manufactured in the central pharmacy.

James A. Jorgenson is the director of pharmacy services at the University of Utah Health Sciences Center. He completed his BS in pharmacy and MS in hospital pharmacy from the University of Minnesota. Jorgensen completed a residency in hospital pharmacy administration at United and Children’s Hospital in St. Paul, Minnesota. He also serves as associate dean for clinical affairs at the University of Utah College of Pharmacy, where he is responsible for experiential teaching site development.