Drug Testing: What the Pharmacist Should Know

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Drug Testing What the Pharmacist Should Know
by Paul L. Doering, M.S. Professor of Pharmacy
Practice College of Pharmacy University of Florida
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DisclaimerI do not have
(nor does any immediate family member have) a
vested interest in or affiliation with any
corporate organization offering financial support
or grant monies for this continuing education
activity, or any activity within the last 12
months. I do not have any affiliation with an
organization whose philosophy could potentially
bias this presentation.Tax, tag and title not
included.
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DisclaimerI do not have
(nor does any immediate family member have) a
vested interest in or affiliation with any
corporate organization offering financial support
or grant monies for this continuing education
activity, or any activity within the last 12
months. I do not have any affiliation with an
organization whose philosophy could potentially
bias this presentation.
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THREE DRUG EXPERTS FROM THE 1960s
James Marshall Hendrix Born-11/27/42 Died-9/18/70
Paul Louis Doering Born-2/25/49 Not Dead Yet
Janis Lyn Joplin Born-1/19/43 Died-10/4/70
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The Special Operations Unit is comprised of
highly trained, dedicated personnel who welcomed
our students for their field exercises. Students
were encouraged to ask questions on virtually any
subject.
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Better Living thru Chemistry
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Reasons for Drug Testing

• To determine social benefits eligibility(eg, food
  stamps)
• Compliance for addicts in treatment
• Determine cause of death

• Pre-employment
• Reasonable cause
• Random testing
• Periodic testing
• Rehabilitation testing (ex-convicts or felons on
  probation

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Concerns Regarding Drug Testing

• Violation of personal privacy
• Test accuracy
• Impairment
• Outcome of test
• Denial of employment
• Termination of job
• Discharge from military service
• Jail sentence
• Loss of parole/probation privileges

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Quality Assurance

• Activities necessary to ensure the correct result
• Monitors the quality and effectiveness of each
  step in the testing process
• Detects potential errors
• Continuous process

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Privacy Issues

• Drug tests results and records must be maintained
  under strict confidentiality by all persons
  involved.

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Biologic Specimens Used in Drug Testing

• Saliva
• Sweat
• Other Tissues

• Urine
• Blood
• Hair

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Alternative Specimens - Postmortem

• Vitreous Humor
• Cerebrospinal Fluid
• Hair
• Nails
• Bone
• Maggots

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Alternative Specimens - Workplace

• Hair
• Oral Fluid (Saliva)
• Sweat

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SAMHSA and CAPRegulated Analytes (NIDA-5)

• Amphetamines
• Cocaine Metabolite
• Opiates
• Cannabinoids
• Phencyclidine

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Other Assays

• Alcohol
• Barbiturates
• Benzodiazepines
• Lysergic acid diethylamide (LSD)
• Methadone
• Methaqualone
• Propoxyphene

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Forensic Specimen Collection

• Ensures the specimen is from the correct
  individual
• Ensures the specimen has not been tampered with
  in any manner
• Ensures the specimen has not been adulterated

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Forensic Specimen Collection

• Direct observation
• Indirect observation (most common)
• restrict access to water and soap
• bluing agents
• measure temperature of urine

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Forensic Specimen Collection

• Tamper-resistant tape
• Bottle labels
• Unique identification number
• Donor/collector initials
• Date
• Initiation of chain-of-custody

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Chain-of-Custody

• External COC
• donor --------- gt collector
• collector --------- gt courier
• courier --------- gt laboratory
• Internal COC

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Transportation

• Postal Service
• Commercial Overnight Courier
• Laboratory Courier

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Two Levels of Testing

• Screening by Immunoassay
• Confirmation by Gas Chromatography-Mass
  Spectrometry (GC/MS)

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Screening Methods

• Commercial Immunoassay
• radioimmunoassay (RIA)
• enzyme multiplied immunoassay technique (EMIT)
• fluorescence polarization immunoassay (FPIA)
• cloned enzyme donor immunoassay (CEDIA)
• kinetic interaction of microparticles in solution
  (KIMS)

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Gas Chromatography/Mass Spectroscopy(GC/MS)
A Virtual Fingerprint of the Drug in Question
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Gas Chromatography-Mass Spectrometry

• Considered the definitive method used to
  determine the presence or absence of an analyte
  in a urine specimen.

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Drug Testing

• Cutoffs or Thresholds
• Zero Tolerance

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Example Marijuana Test
Suppose cutoff is 50 ng/ml If screen is zero
then testing stops there and is reported as
negative If client screens positive at 51
ng/ml, the test goes forward to confirmation If
client screens at 49 ng/ml, the testing stops
there and is reported as negative
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Laboratory Interpretation

• Negative screen ----------gt NEGATIVE
• Positive screen and
• negative confirmation ---gt NEGATIVE

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Laboratory Interpretation

• Positive screen and --------gt POSITIVE
• positive confirmation
• Results sent to the Medical Review Officer for
  final review

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SAMHSA Cutoffs
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UAA Cutoffs
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Zero Tolerance
Screening Cutoffs for Cannabinoids
20 ng/ml
100 ng/ml
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Drug Testing

• Most drugs eliminated within 2-3 days of use
• THC is an exception - varies from several days to
  weeks
• Detection times vary with method of detection,
  dose, route of administration, frequency of use,
  and individual factors

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Persistence of Positive Urine Drug Assays

• Drug Detection Times
• Amphetamines up to 24 hours
• Barbiturates 5-10 days
• Benzodiazepines 5-7 days
• Cannabinoids 1-3 days greater with chronic use
• Cocaine 1-3 days
• Opiates 1-3 days
• Phencyclidine up to 3 days

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Drug Detection inAlternative Specimens
HAIR NAILS
BLOOD
SALIVA
URINE
SWEAT
Minutes Hours Days Weeks Months Years
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Laboratory Interpretation and Medical Review

• Negative result
• analyte not present
• analyte present below cut-off concentration
• Interference
• Positive result
• manner of ingestion unknown
• amount of drug ingested unknown
• time of ingestion unknown

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Positive Result - Legal Sources
Amphetamines Rx, OTC - Vicks inhaler Barbiturate
s Rx, OTC - Primatene Benzodiazepines Rx Cannabin
oids Marinol Cocaine ENT surgery Opiates popp
y seeds, codeine Phencyclidine none
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Unconventional Routes of Drug Exposure - Oral
Ingestion

• Food stuffs
• Cannabinoids
• Opiates in poppy seeds
• Cocaine in beverages
• Oral cocaine
• Cocaine concealment
• Cocaine and morphine from breastfeeding

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Opiates in Urine -Source Differentiation

• Morphine concentration
• Codeine concentration
• Codeine-to-morphine concentration ratio
• 6-Acetylmorphine

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• Excuses
• Passive exposure...
• Innocent ingestion - in my food or
  beverage...
• Physical contact (sexual)

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Cannabinoids in Urine -Passive Inhalation

• Unrealistic exposure may result in
  cannabinoid-positive test results
• Concentrations greater than 10 ng/mL represent
  active marijuana use
• Utilize immunoassay cutoff of 50 ng/mL to
  eliminate allegations that cannabinoid-positive
  test results are due to passive exposure

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Amphetamine AssayCross-Reactive Analytes

• Amphetamine/Methamphetamine Isomers
• Benzphetamine
• Ephedrine and Pseudoephedrine
• MDA and MDMA
• Phenmetrazine
• Phentermine
• Phenylpropanolamine
• Propylhexedrine

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Cocaine AssayCross-Reactive Analytes

• Benzoylecgonine
• Cocaine
• Cocaethylene
• Ecgonine methyl ester
• Ecgonine

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Opiate AssayCross-Reactive Analytes

• 6-Acetylmorphine
• Codeine
• Dihydrocodeine
• Hydrocodone
• Hydromorphone

• Morphine
• Morphine-glucuronide
• Oxycodone
• Oxymorphone

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Testing at Point of Collection

• Specimens - Urine, Oral Fluid
• POCT
• non-instrumented
• instrumented
• POCT Requirements
• FDA cleared
• HHS conforming products list
• Manufacturer certified
• POCT Certification Program Approved by HHS

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An Example of Rapid Drug Testing

• FDA approved
• Laboratory accurate
• No clinical personnel required
• Results in 3-5 minutes
• Simple - one step process
• Built in timer
• On site
• No need to expose specimen
• Low cost

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"The only NO STEP drug test product."
www.drugcheck.com

• Amphetamines
• Barbiturate
• Benzodiazepine
• Cocaine
• Marijuana
• Methamphetamines
• Opiates
• Phencyclidine

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Adulterants

• Alter pH or ionic strength of the specimen
• Inhibit antibody binding
• Interfere with method of detection
• Dilute the specimen

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• Specimen Integrity
• Adulteration
• Dilution
• Substitution

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Commonly Used Adulterants and Substitutes

• Apple juice
• Ammonia
• Bleach
• Detergent
• Drano
• Golden Seal
• Lime-A-Way
• MJ Super Clean 13
• Mountain Dew

• Peroxide
• Saline
• Salt
• Soap
• Sodium hydroxide
• UrinAid
• Vanish
• Vinegar
• Visine

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• Integrity Testing
• Temperature
• pH
• Creatinine
• Specific gravity
• Smell
• Appearance
• Other analytical tests

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• Beating the Drug Test!

• THC Free
• Clear Choice
• Purafyzit
• Amber 13

• Urine Luck
• Whizzies
• Klear
• Stealth

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• Beating the Drug Test!
• THC MaxOut
• Just take all 100 precleanse tablets over the
  course of a day (10-12 hours). While taking the
  precleanse tablets consume as a much liquid (ie
  water, coffee, oj, grapefruit or any fruit
  juice,) as possible, but at least 14 ounces per
  hour. You can eat at anytime during the
  precleanse pills. Three (3) hours after taking
  all 100 precleanse tablets you will drink 1/2 of
  the concentrate mixed with 8 oz. of water or
  fruit juice just before bedtime. Consume no
  additional liquids or eat till the following
  morning. Repeat the entire process the following
  day.

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Beating the Drug Test!
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• Common Mistakes
• Incorrectly estimating drug elimination
• Too confident
• Over educated
• Too trusting

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Summary

• A properly designed and excecuted drug testing
  program is a reliable and effective way to detect
  drug use in those who should not be using drugs