James Wruck Business Unit Manager – Toxicology, ANZ (P37, Friday 28, Civic Room 1, 12.00)

1. Drug Testing in the Workplace – Fit for Purpose
James Wruck, Business Unit Manager Toxicology January 25, 2010
28 October 2011
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2. Alere Overview
• Global leader in near-patient diagnostics for Cardiology,
Infectious Disease, Women’s Health and Drugs of Abuse, with
expanding capabilities in Oncology.
• 2010 revenues > $USD2.1 Billion
• Employs over 13,000 staff worldwide
• Has a substantial presence in Asia Pacific region, with
manufacturing, R&D, Sales and marketing staff in all major
countries
• World’s largest manufacturer of Point of care Drugs of Abuse
tests
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3. Alere Toxicology Solutions
Smart products & services for DOA testing, roadside testing,
workplace testing & advanced laboratory services:
• Leader in POC DOA devices
• Blood, urine, oral fluid & hair testing
• >US $350 million revenue annually
• >190 million tests manufactured in 4 countries
• 7 toxicology labs with global reach in 3 countries
• Routine drug screening
• Hair testing
• Pain Management
Empowering decision makers to make timely decisions to
improve workplace safety, personal safety and clinical outcomes
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4. A Definition – Fit for Purpose
• Something that is fit for purpose is good enough to
do the job it was designed to do
• That is capable of meeting its Objectives or
Service Levels
A1153 Drug Testing in the Workplace – Fit for Purpose

5. What is a Drug Test?
An examination of biologic material (such as urine,
hair, saliva, or sweat) to detect the presence of
specific drugs and determine prior drug use.
Drug tests may be performed to detect illegal drug
use as well as the use of drugs and substances
not permitted in specific occupations or athletic
competitions.
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6. Note:
• Drug abuse isn't just about illicit drugs like
marijuana or cocaine.
• Legal medicines with legitimate uses can be
abused
• Commonly abused prescription drugs
• depressants, pain relievers, and stimulants and
• some non-prescription (over-the-counter) drugs.
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7. Where is drug screening performed?
• Laboratory • Schools
• Workplace • Hospital Emergency
Room
• Sporting arena
• Roadside
• Prisons
• Clinical treatment
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8. Types of Drug tests Carried out in
Workplace
• Pre-employment
• Random workplace
• Post incidence
• Just Cause
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9. What is the purpose of Drug Test in
the workplace?
• Corporate Governance • Retaining good
employees
• Safety of employees,
customers or public • Cleaning out drug users
• Genuine concern for • Scare / to Deter from
wellbeing use
• Meeting Legislative
requirements
• Ticking the boxes
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10. Drug Testing Specimens
• Blood
• Used for Therapeutic Drug Monitoring (TDM)
• Detection period: 0-2 days for most drugs
• Oral Fluid (Saliva)
• Lower levels of drugs
• Detection from hours to 1-2 days
• Used in roadside testing in AUS, EU
• Hair
• No detection for about 7-10 days
• Detects as long as the sample obtained (1/2”/month)
• Sweat
• Leave patch on for 2 days to 2 weeks
• Analyze sweat that is collected
• Lower levels, similar to blood and saliva
• Urine
• Drug concentrations are higher in urine than in blood – easier to detect
• Urine is aqueous = simpler testing matrix
• Large amount of data
• Detection periods typically 1-3 days
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11. Generalised Window of detection
Oral Fluid/
Blood Urine Hair
Time
(Hours – Days) (Days – Weeks) (Days – Months)
 Dose & Route
Please
 Frequency of dose
Remember
 Individual Metabolism
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12. Which Product?
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13. Urine Drug Screen Tests
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14. Oral Fluid Drug Screen Tests
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15. Comparison of Urine and Oral Fluid
Parameter Saliva Urine
Collection Non -Invasive Intrusion of privacy
Need special
facilities and checks
Principle Analyte Parent Drug Metabolites
Analyte Low Moderate to High
Concentration
Potential Problem Oral Contamination Possibility of
adulteration
Potential Advantage Almost impossible Long window of
to adulterate detection
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16. Example of testing requirements
Oral Fluid
Urine
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17. What drug testing product to use?
• Testing method should reflect desired objective
• Understand the features of each method
• Understand the value gained of one method over
the other, not just the cost of the testing product
• Accredited to standards
• Part of independent verification
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18. Visual vs. Instrument
• How many lines do you see?
1
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19. Test Reading Methods
Visual Instrument
No instrument cost Extra Cost for instrument
Decision on the person reading Assured results are correct
the test
No record or results Results can be stored and
checked at later date
Can test multiple people at one Need multiple devices to test
time multiple people
Person reading may be legally Takes away subjectivity
liable for incorrect results
Results may be bias towards an Removes bias as instrument
individual makes decision
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20. Internal or External Testers
Internal External
• May seem less expensive • More expensive per test but
• Need to be employed longer only test when needed
• Onsite - quick to respond • May take time to get to site for
• Experience only on past and in post incidence
current business • Wider experience – working
• May not be up to date on latest with other businesses
products and technology • Well trained and continue to be
• May be biased trained
• Working side by side with fellow • Experts in field of knowledge
employees • Have accreditations and quality
systems
• Independent
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21. Other factors
• Cost vs Value
• Technical ability of product
• False positive / False negative
• Portability
• Support from manufacturer
• Interpretation of results
• Time to carry out test
• Fit for purpose
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22. Selection for purpose is complex
• Outcomes of program • Quality of the product
being used
• Methods Available
• Cost of incorrect result
• Cost benefits of to business
program
• Instrument vs visual
• Internal vs external
testers • Oral vs Urine or Hair
• Time to carry out • Risk of not testing
testing
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23. Smart. Connected. Empowering.
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24. For Further Information
Technical Assistance
Alere
James Wruck,
Business Unit Manager Toxicology ANZPI
www.alere.com.au
www.alere.co.nz
Email: james.wruck@alere.com
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