TPN, COMPOUNDING AND DRUG DIVERSION SYSTEM. Close the broken link in your narcotics chain of custody program Validate Fentanyl with VeriLinkRx TECHNICAL BULLETIN 944 Do you know what is in your syringe? • Diversion is a problem, because 15% of healthcare professionals struggle with drug dependence at some point in their career contributing to the drug diversion problem. • Testing narcotics returned to the hospital pharmacy with the VeriLinkRx® alerts staff to tampered or sub-therapeutic dosage levels. • The VeriLinkRx® can be used to test Morphine, Hydromor-phone, Fentanyl, and other narcotics e.g. hundreds of injectable solutions have been tested and added to the system library. • Standard existing chain of custody control measures like biomet-ric scanning, audit trails, passwords, and witness documentation are not sufficient to ensure that narcotics are returned to the hospital pharmacy untampered and undiluted. • An analytical method, like Rudolph’s VeriLinkRx® , is a reliable and cost effective solution to verify that the actual narcotic is wasted. • Outsourced laboratory testing is too slow and expensive to test returned narcotics that are administered daily. The VeriLinkRx® is easily integrated into your hospital pharmacy workflow. • Testing returned Narcotics with VeriLinkRx® takes just seconds. • Hospital pharmacists can integrate the VeriLinkRx® into their work flow by adding an audit or spot check routine. • Audits can be done for individual staff, shifts or departments: returning narcotics can be routinely or randomly tested and deviations noted. • Inspection of historical VeriLinkRx® data can show patterns requiring investigation or further action. • Further action can include: 1.) Investigation of suspect samples. 2.) Third party testing. 3.) Urine testing for individual staff, shifts, or departments. Rudolph Research Analytical 55 Newburgh Road, Hackettstown, NJ 07840 USA • Phone: 973-584-1558 • Fax: 973-584-5440 • E-mail: info@rudolphresearch.com • Internet: www.rudolphresearch.com Do you know what is in your syringe? Why $200 - $1,000 hand held refractometers don’t work? Handheld refractometers are performance limited because their inexpensive components drift and fluctuate with temperature and sample conditions. Handheld refractometers work fine to differentiate between a 10° and 11° Brix food product, but they do not have the refractive index accuracy and temperature control stability to distinguish the Refractive Index difference between substances such as Fentanyl and water. The VeriLinkRx® was developed by Rudolph using technology predicated on rigorous pharmaceutical standards such as USP<831>. To meet the verifiable ± 0.000005 reproducibility the VeriLinkRx® has a highly stable measurement and temperature control system. For temperature control, the VeriLinkRx® stabilizes the sample droplet to 20°C ± 0.01°C prior to measurement. The operating system and graphical user interface are designed using strict pharmaceutical compliance criteria. Although Rudolph is relatively new to hospital pharmacies, it has a 60 year history supplying instruments for pharmaceutical quality control. VeriLinkRx® Closes the Broken Link The VeriLinkRx® is easily integrated into your hospital in your Narcotics Chain of Custody Program pharmacy workflow. VeriLinkRx® is fast, easy, traceable, and accurate. • A high volume, low cost method to combat drug diversion. • Measurement time required – 10 seconds. • Sample volume – 200 microliters. • Measurement information is stored in a searchable and exportable database along with verification result, patient ID, medical staff, time and date. • VeriLinkRx® is easy to use with minimal training. • Create a baseline drug reference library for each drug in your facility. • VeriLinkRx® detects when Fentanyl has been diluted. VeriLinkRx® makes your chain of custody program better. • VeriLinkRx® verifies that dispensed and returned narcotics are the same. • Integrates into your current work flow easily. • Expands your current drug diversion program to include actual returned sample testing. • Is an inexpensive, in-house analytical test to identify possible diversion issues. • Action is only required when tested samples fail. • There are no consumables, monthly fees, costly training, or specialized operators. • VeriLinkRx® saves money by reducing third party testing. Rudolph Research Analytical 55 Newburgh Road, Hackettstown, NJ 07840 USA • Phone: 973-584-1558 • Fax: 973-584-5440 • E-mail: info@rudolphresearch.com • Internet: www.rudolphresearch.com VeriLinkRx® tests proprietary formulations for Compounding and TPN. Concentration Fentanyl Saline ug/ml 60 The VeriLinkRx® tests the quality of formulations and verifies the ingre 50 dients are mixed properly. For example, the VeriLinkRx can validate if a dextrose o 40 r insulin con- centration is mixed too high or low. The VeriLinkRx can also be us µg/mL ed fo 30 r special drug formulations in Children Hospitals such as Fentanyl to verify it is mixed p 20 roperly in low dosages. An example for the Fentanyl calibrations is shown below, and t 10 he system comes pre-calibrated for special formulations such as Fentanyl, and Hydromor 0 phone. More calibrations can be added to the system. -10 1.3328 1.333 1.3332 1.3334 1.3336 1.3338 1.334 1.3342 1.3344 1.3346 1.3348 Refractive Index Concentration Fentanyl Saline ug/ml Fentanyl Concentration ug/ml water 60 60 50 50 40 40 µg/mL 30 µg/mL 30 20 10 20 0 10 -10 0 1.3328 1.333 1.3332 1.3334 1.3336 1.3338 1.334 1.3342 1.3344 1.3346 1.3348 1.332988 1.33299 1.332992 1.332994 1.332996 1.332998 1.333 1.333002 1.333004 1.333006 Refractive Index Refractive Index The R Fentanyl Concentration ug/ml water 60 udolph VeriLinkRx® is a valuable addition to any hospital pharmacy 50 looking to stay a step ahead of drug diversion and exposure to drug 40 µg/mL diversion related risks. 30 20 10 VeriLinkRx® Specifications 0 Refractometer Specifications J457 (All models) 1.332988 1.33299 1.332992 1.332994 1.332996 1.332998 1.333 1.333002 1.333004 1.333006 Response time: User configurable, generally less than Measurement scales: Refractive Index (nD), Brix (% Sucrose), Refractive Index 30 seconds and up to 100 custom programmed scales Calibration: Using water or NIST traceable fluids. Measurement range: Refractive Index 1.32 – 1.45 Factory default calibration can always Brix 0 – 100 be reset. Accuracy: Refractive Index ±0.00002 Prism: Artificial sapphire Brix 0.015 Acid resistance: Hastelloy™ measurement surface (optional) Reproducibility: Refractive Index ±0.000005 Data storage/ Brix 0.015 internal memory: 32 GB Non-removable Compact Flash Resolution: Refractive Index 0.000001, Brix 0.01 Display: Adjustable 10.4 inch diagonal, 800-600 Temperature pixels, color, Flat Panel Monitor with control range: All samples are brought to 20.00°C Resistant Touch Screen Interface, 400 nits before measurement brightness, gasketted for spill protection Temperature control User interface: Touchscreen reproducibility: ±0.01°C Communication Ambient interface: 3 USB, RS232 and Cat5 Network temperature limit: 5°C to 40°C (Ethernet) Temperature Operating correction range: 4°C to 95°C (for sucrose solutions) dimensions/weight: L: 17 1/4” W: 12” H: 13” / 23 lbs. L: 43.5cm W: 30.5cm H: 33cm / 10.4 kg Sample temperature limit: -20°C to 250°C Power requirements: 100 - 240 volts, 50 Hz - 60 Hz Optical wavelength: 589.3nm (NaD line) Rudolph Research Analytical 55 Newburgh Road, Hackettstown, NJ 07840 USA • Phone: 973-584-1558 • Fax: 973-584-5440 • E-mail: info@rudolphresearch.com • Internet: www.rudolphresearch.com RRA-AD00309 9/2019