PharmChem , Inc.

1. PharmChem, Inc. PharmChek® Drugs of Abuse Sweat Patch Kerri Wagner Drugs of Abuse Sweat Patch Training Consultant Phone: 605.695.8898 kerri_wagner@pharmchem.com 10-2011

2. PharmChek® Drugs of Abuse Sweat Patch 10-2011

3. What You Will Learn today • Drug testing as part of the 24/7 Program • Cost benefits of the Sweat Patch vs. urinalysis • Sweat Patch technology • Applying the Sweat Patch • Removing the Sweat Patch • Review • Sweat Patch Certification 10-2011

4. The 24/7 Program South Dakota’s Model • Originally designed for repeat DUI offenders • Drug testing added to address substitution • Sets the standard of zero tolerance • Intensive monitoring enforced by 24/7 officials • Violations lead to immediate incarceration • Consequences are: • Swift • Certain • Meaningful 10-2011

5. “The Patch” and The 24/7 Program • Goals of the 24/7 Program: • Reduce recidivism • Improve community safety • Change behavior • Hold offenders accountable • Testing-Treatment-Sanctions • Alternative to incarceration • Remain in the community • Maintain employment and housing • Saves tax dollars 10-2011

6. Why Drug Test? 10-2011

7. Why Drug Test? • Reduce recidivism • Recidivism: The act of a person repeating an undesirable behavior after they have experienced negative consequences of that behavior, or have been treated or trained to extinguish that behavior. • Improve community safety • Change behavior • Hold offenders accountable 10-2011

8. Substance Abuse Among Offenders • Substance abuse is the leading cause of recidivism • Currently ½ of all drug offenders on probation/parole will return to prison (48%) • 1/3 of all arrests involve possession/use of drugs • Not including property crimes to support habit. 10-2011

9. Substance Abuse, cont. • A revolving door • We can’t stop all drug abuse • We can start in our own back yard! • Develop strategies to combat drug use and break the cycle 10-2011

10. “The Patch” • PharmChek® is a TOOL that can be used at every stage of the criminal justice process as a comprehensive strategy to combat drug use • Pre-trial, bond, sentencing • Supervision (Probation & Parole) • Placement (Juvenile offenders & CPS) • Treatment 10-2011

11. What is PharmChek® ? • Release Liner • Absorption Pad • Unique Number • Polyurethane Film 10-2011

12. FDA Clearance, October 4, 1990 • Cocaine, opiates (1990) • Methamphetamine (1995) • Marijuana and phencyclidine (1996) 10-2011

13. How The Sweat Patch Works • Two means by which the body produces sweat. • Insensible perspiration • The passive uncontrolled loss of moisture from the skin • Sensible perspiration • The active controlled loss from specific glands in the skin 10-2011

14. Understanding Sweat Patch Results • Results cannot be used to: • Reflect the dose of drugs taken • Time-stamp exact date/time of usage Detection periods in sweat differ from urine. 10-2011

15. Understanding Sweat Patch Results • A positive result indicates drug use occurred during the time the patch was worn or 24-48 hours before patch application. Why? 10-2011

16. Wear-Time • Sweat patches can be worn for up to 7-14 days. • Patches must be worn for a minimum of 24 hours. • Use of the Overlay may enhance wear time beyond 7-10 days. 10-2011

17. Testing Methods & Cutoff levels 10-2011

18. 7 day Period- 3 Urinalysis Tests 10-2011

19. 14 day Period- 4 Urinalysis Tests 10-2011

20. Cost-Benefit Analysis Cost/Day: $2.27 Cost/Day: $2.65 Cost/Day: $4.54 Total Cost $31.80 Includes all supplies & confirmation Wear Time – 7 Days Cost $31.80 Includes all supplies & confirmation Wear Time – 14 Days Cost $31.80 Includes all supplies & confirmation Wear Time – 12 Days 10-2011

21. Advantages • Increased Window of Detection • Visual Deterrent to Drug Use • Detects Parent Drug and Metabolites • Variable Removal Date • Quick Application and Removal • No Urine Collections • No Sample Substitutions or dilutions • Gender Indifferent 10-2011

22. Clinical Reference Laboratory (CRL)PharmChem’s sole laboratory (SAMHSA certified) Lenexa, KS • Once specimen is received by the lab • Bar codes are scanned to match • Information keyed in • Screening starts (Open controls/Blind testing) • Negatives released and reported (24 hours) • Presumptive positives are analyzed using LC/MS/MS to confirm presence of metabolite and parent drug • Confirmation within 72 hours by Fax or Web 10-2011

23. PharmChek® Drugs of Abuse Sweat Patch PharmChek® Sweat Patch Application 10-2011

24. Application Review • Have offender flex arm. Why? • The patch should not be placed on skin that has scratches, lesions, or excessive hair. Why? • The patch can be placed over a tattoo if no other areas are available. • Choose the lightest part of the tattoo to apply the patch. Why? 10-2011

25. Overlay Overlay • Same Polyurethane material • Who Needs it? • Offenders unable to wear patch for at least 7 days. • Exercise heavily • Perform strenuous labor • Live in hot, humid climates • Sweat can’t evaporate fast enough and may cause the adhesive to loosen. • Construction allows excess sweat to evaporate and keep the patch adhered to the skin. 10-2011

26. Overlay Application 1)Remove the backing from half of the Overlay 2) Remove the outer cover of the Overlay 3)Press firmly against the skin for good adhesion. . 10-2011

27. Instructions For Offenders • Offender must contact you immediately if patch appears to be coming loose. • Removing the patch is a failure on the program. • Offender may perform normal activities such as work, bathing, showering and exercising, etc. • Tanning beds • Offender should gently pat the patch area after these activities. 10-2011

28. PharmChek® Drugs of Abuse Sweat Patch PharmChek® Sweat Patch REMOVAL 10-2011

29. Pharmchek® Drugs of Abuse Sweat patch Contamination & Testing Criteria 10-2011

30. Avoiding Sweat Patch Contamination • Must wear gloves • Must use single-use tweezers • Use the enclosed specimen & transport bags • Do not place anything other than the absorption pad in the specimen bag. 10-2011

31. Contamination 10-2011

32. Contamination 10-2011

33. Contamination 10-2011

34. Contamination 10-2011

35. Contamination 10-2011

36. Testing Criteria • Offender signs or initials “Donor Completes” • The majority of the absorption pad must be submitted for laboratory analysis. • 2nd ply of the chain-of-custody form must be in transport bag. • Barcode must be affixed to the specimen bag and must match chain-of-custody barcode • Trained observer must sign “Observer’s Certification” both at application and at removal. 10-2011

37. Sweat Patch Results Upheld In Court • Between January 1998 and July 2009 • The Sweat Patch has been upheld in Federal and State Courts 50 times • A 2006 appeal in Federal Court was upheld the TheHonorable Judge Sandra Day O’Connor 10-2011

38. Pharmchek® Drugs of Abuse Sweat patch REVIEW 10-2011

39. Review • Which Portion of the patch do you send to the lab for analysis? • After cleaning with alcohol, how long should the area dry before applying the patch? • If the adhesive seal around the pad is no longer attached, is the patch compromised? • What drugs does the patch test for? • Why should the offender flex the skin before application? 10-2011

40. Review • Why do you have to wear rubber gloves and use tweezers when applying or removing the patch? • Which ply of the Chain of Custody Form is sent to the lab? • Why doesn’t the offender just remove the entire patch by himself? • Why is it important to aggressively clean the area where the patch will be placed? 10-2011

41. Review • If you fail to attach the barcode on the specimen bag, what will happen? • If you don’t sign the certification on the chain of custody form, what will happen? • Who is a candidate for the overlay? • Why should the patch be placed on the lightest area of a tattoo? 10-2011

42. Questions? 10-2011

43. PharmChek® Sales North Dakota Leslie Folsom 512.516.9933 leslie_folsom@pharmchem.com 10-2011