Verilink RX

  • VerilinkRx was developed by Rudolph predicated on rigorous pharmaceutical standards such as USP<831> (model J457).
  • To meet the verifiable ±0.000006 reproducibility the VerilinkRx has a high stable temperature control system to stabilize the temperature to 20°C ±0.1°C.
  • The operating system, graphical user interface and audit trail are designed using strict pharmaceutical compliance criteria.
  • Rudolph is a new name to Health System Pharmacies, but it has a 60 year history supplying instruments for pharmaceutical quality control.


Will a Handheld Refractometer Work for Drug Diversion?

  • Handheld refractometers are performance limited because of their design.
  • Refractive index is very temperature sensitive, and these systems lack the temperature control and electronics of a high performance lab refractometer.
  • Handheld refractometers do not have the database necessary to support the audit trail in a laboratory environment.
  • They do not have the sensitivity to distinguish between low concentration substances (ca. 1 mg/mL, 50 µg/mL) such as Fentanyl and water.


Effects from Drug Diversion

  • Pain and anxiety among patients that did not received drugs prescribed.
  • Transmission of infections.
  • Substance –abused healthcare workers are not in the capacity to provide suitable healthcare to patients.
  • If healthcare worker harms patient both the healthcare worker and the employer are liable.
  • Health Insurance costs exceed over $ 72.5 billion just for opioid use. (Coalition Against Insurance Fraud).

*Centers for Disease Control and Prevention. http://www.cdc.gov/injectionsafety/drugdiversion/

Outbreaks from Drug Diversion

*Centers for Disease Control and Prevention. http://www.cdc.gov/injectionsafety/drugdiversion/

Know what’s in the vial

  • Over 15 % of healthcare professionals struggle with drug dependence at some point in their career.
  • Standard existing chain of custody control measures are not sufficient to ensure that narcotics are returned to the hospital pharmacy untampered and undiluted.
  • Outsourced laboratory methods are too slow and expensive to test returned narcotics that are administered daily.

VeriLinkRx as a Solution

  • Testing narcotics returned to the hospital pharmacy with the VeriLinkRx alerts staff to tampered or sub-therapeutic dosage levels.
  • The VeriLinkRx tests Morphine, Hydromorphone, Fentanyl, and other narcotics.
  • Any narcotic can be added to the VeriLinkRx library.
  • An analytical method, like Rudolph’s VeriLinkRx is a reliable and cost effective solution to verify that the actual narcotic is returned to the hospital pharmacy

VeriLinkRx Locations

  • Near in-house hospital pharmacy.
  • Near surgical areas, where there tends to be high volume solution based pain medication.
  • Regions where compounding takes place
  • Regions where waste can be collected.

VeriLinkRx Workflow Database

** Pass/Fail is dictated by the difference between Measured RI in Reference Library and Test Sample result.  Results are passed to a searchable Excel spreadsheet.

VeriLinkRx Sampling

  • High volume testing and low cost (no consumables).
  • Measurement time required (10 s) on most narcotics.
  • Sample Volume – 200 microliters.  Includes Rudolph’s “Smart Sampling” feature.
  • Flat “sapphire” prism resistant to scratching and provides easy cleaning, or sample can be re-extracted.
  • Easy to use by pharmacist and technicians.
  • Detects when Fentanyl and other narcotics have been diluted or substituted. 

How Often Must I  Test ?

ASHP Guidelines, https://www.ashp.org/news/2017/03/10/19/22/ashp-publishes-controlled-substances-diversion-prevention-guidelines

Ultimately, each organization is responsible for developing a CSDPP that complies with applicable federal and state laws and regulations but also one that applies technology and diligent surveillance to routinely review process compliance and effectiveness, strengthen controls, and seek to proactively prevent diversion.

For defined high-risk areas (e.g., surgical, anesthesia, procedural, high volume) and/or specific high-risk CS medications (e.g., fentanyl), waste is witnessed and reconciled with an authorized HCW. Approved methods for wasting CS are defined in policies and procedures and comply with universal precautions and organization waste disposal requirements.

In most cases the VeriLinkRx is located in near or in the OR, or in the main Internal hospital pharmacy.  Some hospitals are testing 100 samples/day in cases where pharmacy is collecting 100 % of OR waste and they have a dedicated technician for collecting and testing.   In other cases, hospital pharmacies are testing less than 10 samples /week with random testing in the OR.

VeriLinkRx Benefits

  • The VeriLinRx verifies that dispensed and returned narcotics are the same.
  • Integrates easily into your current workflow.
  • Expands drug diversion program to include actual returned waste testing.
  • Inexpensive, in-house analytical test to identify diversion issues.
  • Action is only required when samples fail.
  • No consumables, monthly fees, costly training, or specialized operators.
  • Saves costs by reducing 3rd party testing.

Cost Assessment Details

  • Routine lab testing is cost and time prohibitive
  • Certified Potency Testing >$150/test
  • Certified Identity and Quantitative Testing with chain of custody reporting>$2500/test
  • Costs of shipping samples, documentation etc.
  • Other Technologies require continued leasing, costs/test, or do not have the sensitivity.
  • VeriLinkRx Costs
  • Cost of System
  • System, two year warranty, 20 year service guarantee
  • Optional Costs
  • Extended warranty to three years
  • Installation Training
  • 5 potency tests with ARL labs in two years
  • Preventive Maintenance
  • Continuing Costs
  • Test Cost = $0.00 + Labor for 10 to 60s
  • Sterile water used as standard

VeriLinkRx For TPN

  • Total parenteral nutrition (TPN) is a complex multi-ingredient solution.
  • Can include up to 37 compounds. 
  • There is a relationship between refractive index and the concentration of dextrose and amino acids.
  • Optional package for testing the quality of TPN solutions.
  • Validates if the dextrose concentrations are too high or low.

VeriLinkRx References (partial)