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Drug Testing in the Workplace – Fit for Purpose
James Wruck, Business Unit Manager Toxicology   January 25, 2010
28 October 2011



        A1153                                                1
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
  A1153                                                          2
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
       A1153
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
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.




 A1153
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.




A1153
Where is drug screening performed?
• Laboratory           • Schools

• Workplace            • Hospital Emergency
                         Room
• Sporting arena

• Roadside

• Prisons

• Clinical treatment



 A1153
Types of Drug tests Carried out in
Workplace

• Pre-employment
• Random workplace
• Post incidence
• Just Cause




  A1153
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

 A1153
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

        A1153
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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Which Product?



A1153
Urine Drug Screen Tests




 A1153                    Not all products are available in all markets.
Oral Fluid Drug Screen Tests




 A1153
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


    A1153
Example of testing requirements
Oral Fluid




                      Urine




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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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Visual vs. Instrument
• How many lines do you see?
1

2

3

4

5

6

7

8

9

10

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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




A1153
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
      A1153
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
 A1153                              21
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


A1153
Smart. Connected. Empowering.
 A1153
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


A1153

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Drug Testing in the Workplace – Fit for Purpose

  • 1. Drug Testing in the Workplace – Fit for Purpose James Wruck, Business Unit Manager Toxicology January 25, 2010 28 October 2011 A1153 1
  • 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 A1153 2
  • 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 A1153
  • 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. A1153
  • 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. A1153
  • 7. Where is drug screening performed? • Laboratory • Schools • Workplace • Hospital Emergency Room • Sporting arena • Roadside • Prisons • Clinical treatment A1153
  • 8. Types of Drug tests Carried out in Workplace • Pre-employment • Random workplace • Post incidence • Just Cause A1153
  • 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 A1153
  • 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 A1153
  • 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 A1153
  • 13. Urine Drug Screen Tests A1153 Not all products are available in all markets.
  • 14. Oral Fluid Drug Screen Tests A1153
  • 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 A1153
  • 16. Example of testing requirements Oral Fluid Urine A1153
  • 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 A1153
  • 18. Visual vs. Instrument • How many lines do you see? 1 2 3 4 5 6 7 8 9 10 A1153
  • 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 A1153
  • 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 A1153
  • 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 A1153 21
  • 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 A1153
  • 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 A1153

Editor's Notes

  1. http://www.medterms.com/script/main/art.asp?articlekey=89631 viewed 20/10/2011