Drug Diversion: Revealing the Truth through Science
Aaron K. Thompson, Forensic & Technology Leader
Drug diversion is the illegal practice of transferring regulated pharmaceutical agents from legal sources for illicit use. Instances of drug diversion within the workplace pose a significant risk of civil liability to the employer. Not only can harm befall the drug-diverter, but contaminated drug products also pose a significant threat to patients including risk of infection, allergic response to substituted components within the drug product, and death. It is of the utmost importance for organizations to have operating procedures and surveillance programs in place which minimize the risk of drug diversion.
ARL Bio Pharma has extensive experience working with clients who face potential litigation from acts of drug diversion. In one instance, we received ten Hydromorphone syringes from a hospital. The organization wanted to know whether the syringes had been adulterated with another drug-containing product. Our analytical approach was multi-faceted. We tested the Hydromorphone potency within the syringes using traditional High Performance Liquid Chromatography (HPLC) and determined that most of the syringes contained < 5% of the expected label concentration. We further tested the samples using mass spectrometry and detected no additional compounds beyond Hydromorphone. Finally, we performed Ion Chromatography (IC) and determined that the sample concentrations were in align with that of 0.9% sodium chloride, suggesting the samples had been adulterated in normal saline.
In another high-profile case, we tested samples of Tobramycin Sulfate and Invanz (Ertapenem) that were purposefully compounded sub-potent by a pharmacist. The pharmacist had already confessed to the crime. Due to the lack of chromophore on Tobramycin, conventional HPLC-UV was not an option, Evaporative Light Scattering Detection (ELSD) was utilized as a detector. Tobramycin was only detected in one of the six submitted samples. No Ertapenem was detected in the Invanz sample.
ARL Bio Pharma is well equipped with a host of analytical instrumentation designed to test even the most complex of samples. ARL can test most commercial drug products for potency, microbiological activity, and determine the presence of “unexpected” components within samples using mass spectrometry. We issue Chain of Custody documentation to ensure the sample location and history are documented while in our presence. This is important for subsequent legal proceedings. Photographs of the sample(s) are taken, and a report generated. Our company has years of expert witness testimony in our portfolio and we are here to reveal forensic truth through sound, scientific practices. If you are in the midst of a drug diversion situation, ARL is available to talk to you about your specific situation and test your samples accordingly.