Transcript File - DB Labs, LLC

DB Laboratory Services
The Present and Future of
“TRUE PAIN MANAGEMENT COMPLIANCE TESTING”
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Medical Director
Dr. Daniel J Magiera II, PhD, Laboratory Director
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Complexities of Pain Management
An
effective pain management
plan requires state of the art
ACCURATE monitoring to assure
your patient’s compliance to the
prescribed treatment program.
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Complexities of Pain Management

DB Labs offers the most comprehensive testing program available
today. With our expert staff we are able to provide the most advanced
analytic process available in the marketplace today.

Our testing panels can be customized to your practice to assure that
your patients are following the regimen you prescribed. We can assist
your practice by accurate low level detection of virtually any
prescription or illicit drug.

Reducing the risk of a patient’s misuse or abuse of medication.

Assuring that the patient is taking their prescribed medication.

Determining what, if any controlled substances a patient is taking to avoid any
potential drug interactions.

Advancing the treatment of chronic pain by providing detailed information and
insight on patient’s pain medication use. Our testing methodologies provide
accurate and insightful information to aid you in evaluating the effectiveness of
your treatment plan.

Molecular Genetic testing is also available to detect abnormalities affecting drug
metabolism.
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Complexities of Pain Management
 One
of the biggest challenges in High
Risk Pain patients is obtaining true
drug testing results
 Patients
have become very savvy and know how to
submit their own samples with “compliant” urine from
another donor to promulgate
 Pill
scraping to show only the drugs prescribed
 Taking
a few medications just before the visit and
selling the rest for additional income
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Solutions for Unraveling the
Complexities

Saliva testing ensures that no sample substitution
or scraping is taking place

Steady State Plasma Levels can detect if a
patient is truly taking the medication daily as
prescribed and not just enough to test positive
when it’s time for their refills

Hair Testing on initial patient visits to see further
back in their history and ensure true patient
results…not substitutes
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Technology and Process
Most routine urine drug testing simply determines
the absence or presence of a certain class of
drugs
 To develop the best treatment plans and identify
potential pain medication abuse or misuse, you
need to know more

 Our
advanced analytical technology delivers results and
detection levels that exceed the most demanding urine
drug testing standards by NIDA and SAMSHA
 State of the art processes’ identify and quantify the
specific drug or metabolite present for a broad range
of medications and illicit substances
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Confirmation Testing

Liquid chromatography-Tandem Mass Spectrometry
(LC/MS/MS) confirm and quantify positive screening tests,
which provides a graphic representation of the prescription
medication or illicit drugs detected

DB’s methodologies give you the highest possible sensitivities
to detect these drugs and their metabolites at the very
lowest levels. By quantifying the amount of drug present, we
can specify the amount of prescribed medications , nonprescribed medications, or illicit substances detected. This
information helps you determine whether your patient is
likely to be taking his or her medication in a manner that is
consistent with the prescribed regimen.
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National Statistics

Definition of pain--According to the International Association for the Study of
Pain, chronic pain generally refers to pain that “persists beyond normal tissue
healing time, which is assumed to be three months”1

One in four Americans suffers from chronic pain.2

Chronic Non-Cancer Pain (CNCP) is a leading cause of disability3.4

For many patients, opioids are an integral part of a comprehensive pain
management plan to help relieve pain, restore function, and restore quality
of life.5

Through urine drug testing, one national study found that 75% of pain patients
may not be taking their medications as prescribed. The study also found the
following about the monitored patients:

39% did not have the prescribed opioid present

29% had non-prescribed opioid medications present

27% had a higher than expected amount of the prescribed medication present
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15% had a lower than expected amount of the prescribed medications present
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11% had illicit drugs detected in their
urine6
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The statistics on the prevalence of chronic
pain and the pervasive inappropriate use of
pain medication make an overwhelming
case for pain medication monitoring.
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Integrated Monitoring Panels



Point-of-Care Testing (POCT) devices are screening tools
only. A positive result may be a false positive and should
never be considered the final answer per the FDA,
SAMSHA, and NIDA
High detection cut-offs of a POCT can also miss low levels
of potentially dangerous drugs
DB Laboratory Services Integrated Monitoring Panels backup the immediacy of the in-office POCT with reliability
and confidence.
These panels go beyond confirmation to provide
accurate information on a wide range of drugs.
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DB Labs Equipment Advantages

Agilent® LC QQQ’s have the ability to produce results 30x
more sensitive than competitive systems due to
proprietary higher pressures allowing double the peak
area measurement and total area calculation

Noise to signal ratio is approximately 1000x greater than
the “Big Three” because of higher operating pressures

Higher throughput due to sensitivity and specificity
15-20 min run times per patient at our competitive labs
2-6 min per patient with DB Labs configurations

Special probe washing and column flushing between
samples eliminates the possibility of contamination and
crossover
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Benzodiazepine Metabolites
Diazepam
(Valium)
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Opiate Metabolites
Oxycodone
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Isobars- The need for Adequate
Chromatographic Separation
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Quality

Specimens are barcoded from collection thru final
instrument run
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Automated extraction/pipetting to increase
reproducibility and decrease human error. Quality
increases by more than 30%
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Quality control in each run
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Beginning and end standard
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3 additional points added per 96 well plate to eliminate erroneous
reporting
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Proprietary internal standards to be injected into each patients
sample giving 100% confidence in the results
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Online Services

DB Laboratory Services’ Web Based Services allow you to
submit lab requisitions, manage patient selection for
monitoring and access a wide array of informative reports
24 hours a day, 7 days a week.

HL7 interfacing, fax, and direct printing of reports in
office are options as well

Certain environments allow for a DB Laboratory Services
employee to be onsite to assist in collection, shipping,
and reporting activities (varies by state)
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Statistics

The 2007 National Survey on Drug Use and Health reports a steady
increase in the number of Americans abusing prescription pain
relievers.7

Rising rates of prescription drug abuse and emergency room
admissions related to prescription drug abuse, as well as an increase
in the theft and illegal resale of prescription drugs, indicate that drug
diversion is a growing problem nationwide.8 The main source of drug
diversion is unlikely the prescriber as was once assumed, but rather
theft from family, friends, and workers in the home or from sharing
and selling medications though often with good intentions.9

The statistics underscore the importance of making urine monitoring
integral to chronic pain care
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References
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1. International Association for the Study of Chronic Pain. http://www.iasp-pain.org/ . Accessed October 23,
2015
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2. American Pain Foundation. Pain Facts: Overview of American Pain Surveys. Available at:
http://www.painfoundation.org/learn/library/qa. Updated January 2007. Accessed October 23, 20015.
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3. Centers for Disease Control and Prevention: Prevalence of disabilities and associated health conditions
among adults; United States, 1999. MMWR 50:120-125, 2001
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4. Stewart WF, Ricci JA, Chee E, Morganstein D, Lipton R: Lost productive time and cost due to common
pain conditions in the workforce. JAMA 290:2443-2454,2003
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5. Fine, PG. Opioid Therapy as a Component of Chronic Pain Management: Pain Experts Weight In on Key
Principles to Optimize Treatment. Topics in Pain Management. May 2008;23(10):1-8.
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6. Couto JE, Goldfarb NI, Leider HL, Romney MC, Sharma S. High Rates of Inappropriate Drug Use in the
Chronic Pain Population. Popul Health Manag. 2009;12(4):185-190.
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7. Office of Applied Studies. Results from the 2007 National Survey on Drug Use and Health: National
Findings. Rockville, MD: substance Abuse and Mental Health Administration;2008.
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8. Substance Abuse and Mental Health Services Administration, Office of Applied studies. Drug Abuse
Warning Network, 2005: National Estimates of Drug Related Emergency Department Visits. DAWN Series D29, DHSS Publication No. (SMA) 07-4256, Rockville, MD2007. Available at
http://dawninfo.samsha.gov/files/DAWN-ED-2005-Web.pdf.
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9. Substance Abuse and Mental Health Services Administration, (2008). Results from the 2007 National
Survey on Drug Use and Health: National Findings (Office of Applied Studies, NSDUH Series H-34).
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Sample
Reporting
Format
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