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Waste Drug Diversion Testing with VeriLinkRx

Waste Drug Diversion Testing is incumbent on hospitals handing left over narcotics from the OR and other areas. Hospitals handle large volumes of narcotics, and as a result are vulnerable to drug diversion. Drug diversion by hospital workers is one of the major threats for patient safety, and is one of the largest liability risks for hospitals. Drug diversion can be thwarted through strong security protocols and active monitoring systems.

By nature, drug diversion is a clandestine activity and the lack of control points in many hospitals leave drug diversion undiscovered and unreported. The major factors impacting the incidence of drug misuse by healthcare professionals are broken links in the chain of custody near narcotic waste return control points. The gap that the VeriLinkRx narrows in on is the testing of narcotic waste. Specifically, the VeriLinkRx tests what’s in the vial, rather than banking on a witness to assume what’s in the vial. A witness or inventory controller can only assume that there is narcotic in the vial, but cannot authenticate if it is narcotic, water or saline.

While the DEA does not provide specific protocols for testing waste, §482.25(a)(3) states that current and accurate records must be kept for the receipt and disposition of all scheduled drugs. Hospitals must be capable of quickly identifying loss or diversion of controlled substances and determining the extent of the diversion. It states that a hospital must have must have policies and procedures in place to minimize scheduled drug diversion.
It is reported that over 15 % of healthcare professionals struggle with drug dependence at some point in their career. Addicted healthcare workers will go to great measures to secure narcotics such as Fentanyl and identify exactly where the weak links are in a given facility.

There are three major areas of hospital liability. In the first instance, when a narcotic is diverted prior to patient contact the patient is not receiving the recommended dosage and is experiencing unnecessary pain and anxiety.
Secondly, in severe documented cases, infected hospital workers have exposed patients with diseases from contaminated needles and syringes.
Over six major outbreaks have occurred in hospitals over the last ten years. Two outbreaks involved tampering with opioids administered via patient-controlled analgesia pumps and resulted in gram-negative bacteremia in 34 patients. The remaining four outbreaks involved tampering with syringes or vials containing fentanyl; hepatitis C virus was transmitted to 84 patients. In each of these outbreaks the implicated healthcare professional was infected with Hepatitis C and served as the source; nearly 30,000 patients were potentially exposed to blood borne pathogens and targeted for notification advising testing.

Not engaging in waste drug diversion testing puts workers at risk

And the third risk is that healthcare workers working under the influence of narcotics are a danger to the healthcare facility. If a healthcare worker harms a patient both the healthcare worker and the employer are liable.
From an exposure and financial perspective, health care corporations have faced civil lawsuits and regulatory fines in the hundreds of millions, not counting the negative publicity and risk of losing Medicare and Medicaid. Addiction is expensive with Health Insurance costs exceeding over $ 72.5 billion just for opioid use. (Coalition Against Insurance Fraud).
The question becomes “How can a hospital test the hundreds to thousands of leftover narcotic waste each day, and suspected tampered containers”? Outsourced laboratory methods are too slow and expensive to test the high volumes of returned narcotics administered daily. A simple, rapid, and inexpensive in-house solution is essential. In-house narcotic test methods are considered as presumptive tests, similar to field chemical test kits, and mobile analyzers routinely used by law enforcement. These mobile tests can be submitted as evidence in court cases, but are typically implemented in plea bargain negotiations. These presumptive tests are used to identify and delineate diversion issues in the hospital.
Presumptive testing of narcotics returned to the hospital pharmacy with the VeriLinkRx immediately alerts staff to tampered or sub-therapeutic dosage levels. The VeriLinkRx rapidly tests Dilaudid, Fentanyl, Morphine, Versed and other liquid injectables with results as fast as 10s.

The VeriLinkRx validates what’s in the vial, and tests drug waste for concentrations.

The VeriLinkRx contains a library of drug references, and any new drug can be added as a reference standard. A simple pass/fail or red light/green light is provided on the display after each test. If the sample fails, the VeriLinkRx provides dilution (concentration) values.
To detect dilutions of Fentanyl in water the VeriLinkRx needs to meet the verifiable ±0.000005 reproducibility and have a high stable temperature control system to stabilize the temperature to 20°C ±0.01°C. Other technologies like wet chemical tests and handheld refractometers have been used to test narcotic waste. However, technologies like handheld refractomers are performance limited because of their design and are not sensitive enough to detect concentration levels less than 1 mg per ml, including Waste Drug Diversion Testing.

Rudolph’s operating system, graphical user interface, encrypted database, and optical system were designed based upon strict pharmaceutical compliance criteria, and these features are enabled in the VeriLinkRx. Prior to implementing the VeriLinkRx a hospital pharmacy must have procedures in place to collect narcotic waste. Some hospitals simply collect suspect samples, while others implement routine or random waste collection. Secured waste containers are typically implemented. Testing with the VeriLinkRx takes only seconds per sample allowing the operator to test large quantities of drug waste returns quickly.

A Waste Drug Diversion Testing Program can be implemented.

The VeriLinkRx system is easily integrated by adding an audit or spot check routine. It is not necessary to test every sample. Normally, a protocol is established to check the returns from rotations in operating wards. Inspection of the data metrics obtained from the VeriLinkRx will display patterns of narcotic diversion, requiring investigation as further action.

If there are other sources of evidence (e.g. video, witness testimony etc.) this is added to the case file. In some cases, outside certified testing may be requested, the VeriLink Rx is a non-destructive test and the same sample can sent to certified testing. Rudolph has a partnership with a certified laboratory for potency and chain of custody testing. Hospital management might also require department wide or individual urine tests based on failed VeriLinkRx measurements.

Diversion Testing is a major benefit to the VeriLink.

The major benefit is that it can test for dilution of Fentanyl, and many other narcotics with concentrations below 1 mg per mL. Sampling is a major feature and benefit of the VeriLink. The VeriLinkRx allows for high volume and non-destructive testing at low cost with no consumables or monthly lease payments. The measurement time is less than 10 s on most narcotics and very little sample is required. Less than 200 microliters of sample can be tested, and this is assisted with Rudolph’s “Smart Sampling” feature. The flat “sapphire” prism is resistant to scratching and provides easy cleaning, and the sample can be easily re‐extracted if necessary.

The entire sampling process and graphical user interface is easy to use by pharmacists’ s and technicians’.
The VeriLinkRx fits seamlessly into workflows by adding a simple and rapid narcotic testing procedure. The encrypted database tracks the number of tests each day, the operator of the test, and provider tested. These data metrics can be used at monthly diversion meetings in order to delineate problem areas.

In summary, presumptive testing with the VeriLinkRx is inexpensive, and allows for high volumes of tests each day. There are no consumables, no monthly fees, no costly training, and no need for specialized operators. A breakdown of these cost saving include minimization of lab testing costs, which are prohibitive when testing large volumes of narcotics. Certified potency testing can cost upward of $200 per test or more. Outside lab testing also involves shipping costs, documentation, and time. Other technologies require continued leasing, a charge of cost per test, and/or do not have the sensitivity to detect small dilutions.

• A one time cost of VeriLinkRx includes the system, a two year warranty, and Rudolph’s 20 year guarantee to service the instrument. The instrument can be directly purchased or leased with a $1.00 buyout.
• Optional items included warranties out to three or more years, installation/training, certified laboratory testing, and preventive maintenance agreements.
• For continuing costs, each test can be broken down into $0.00 per test plus the cost of labor. USP sterile water is used as certified standard to zero the system.
• Those who are diverting narcotics from your hospital know that the point of waste is the weak link in your chain of custody program and will exploit this. If you are not testing waste now it is a vulnerability you must address.
• For additional information on adding VeriLinkRx Drug Diversion Testing to your current Chain or Custody Program contact Rudolph Research Analytical

info@rudolphresearch.com
www.rudolphresearch.com
973-584-1558