By Lynne Peeples, originally published in Pharmacy Technology Report.
Raman spectroscopy, a technology long used by the pharmaceutical industry and academic laboratories, is emerging as a potential tool to detect and deter the diversion of controlled substances, according to a new study.
The anti-diversion tool uses laser technology to analyze the chemical fingerprint of a medication. Within seconds, the system can ascertain a drug’s identity and concentration through a clear syringe, vial or tube, without the need to touch and potentially contaminate or break down molecules in a sample.
John J. Lewin III, PharmD, MBA, the division director of Critical Care and Surgery Pharmacy at Johns Hopkins Hospital in Baltimore, and his colleagues are beta testing the system, WasteWitness, developed by PharmID. The team now collects waste material left over from operating room procedures; then by simply injecting samples through an analyzer and clicking a touch screen to denote the expected drug and its concentration, the Raman spectroscopy device reports a “pass” or a “fail.”
For example, if 2 mL of hydromorphone solution were drawn but only 1 mL was used during a procedure, the remaining 1 mL can be analyzed to confirm it is, in fact, hydromorphone and of the original concentration. Results are then saved to help in reporting and identifying trends over time.
“[Raman spectroscopy] is an effective screening tool and a powerful addition to a comprehensive controlled substance diversion prevention program,” Dr. Lewin said. “If you identify a case where it fails, then you can look into it further and factor that information into further investigation of the discrepancy.”
Diversion of controlled substances can result in tragic consequences for patient safety, including suboptimal therapy due to dilution, errors made by impaired health care workers, and risk for contamination and infection. Dr. Lewin highlighted a case from 2012, in which a hepatitis C–infected radiology technician diverted drugs and subsequently infected at least 32 people (Clin Infect Dis 2018;67:845-853). One person died.
The problem also puts employees—their lives and their careers—at risk.
An estimated one in 10 health care providers struggle with addiction, according to the U.S. Substance Abuse and Mental Health Services Administration. Likewise, health systems run the risk for legal liability, damaging their reputation, and the potential harm to patient care.
PharmID has a cloud-based, customizable library of at least 13 narcotic drugs and works with each client individually to create a package and set a price that fits their needs. The company anticipates that further fine-tuning will make the device more affordable, the library increasingly comprehensive and the measurements more precise for the clinical setting. The company also plans to integrate its system with Pyxis and Omnicell automated dispensing cabinets.
“Down the line, if we see the cost come down and the library of drugs that can be analyzed continue to expand, leveraging the huge cloud-based databases, then you can envision a time where you might have these things on every automated dispensing cabinet,” Dr. Lewin said.
He added that he anticipates the tool will help create a closed-loop between the pharmacy inventory system and the receipt of controlled substances. A computer could calculate what drug was drawn and administered to a patient, and that information would then be electronically reconciled with the proper waste returned.
“And this could be done in a way that will be easy for providers,” he said, noting that the current standard is for a provider to find another health professional to witness the disposal of the wasted drug. If a provider has diverted the remaining drug, and replaced or diluted it with water, that may not be detectable with the naked eye.
Christopher Fortier, PharmD, FASHP, the chief pharmacy officer at Massachusetts General Hospital in Boston, who was not involved in the presentation, said organizations “must have multiple strategies and solutions to proactively review and identify diversion.” Raman spectroscopy, he said, is one “great example.”
Drs. Lewin and Fortier reported no relevant financial relationships. The study was presented at the 2018 ASHP Midyear Clinical Meeting, in Anaheim, Calif