as of may 20, 2015 presented by david green, ph.d., dabcc (cc&tc), facb for alere toxicology...
TRANSCRIPT
As of May 20, 2015
Presented by David Green, Ph.D., DABCC (CC&TC), FACB for Alere Toxicology Service, Inc.
Drug Testing Updates
2
Overview of Drug Testing Process
3
Collection
Accessioning
Screening
Result?
Confirmation Review
Reporting
Data Entry
Drug Testing Process
NegativeNon-Negative
4
Screening
• Highly automated• Uses antibodies to detect a drug
class• Specificity varies• Adequate sensitivity• Used to eliminate negative
specimens
5
Confirmation
• Very Specific• Very Sensitive• Little Automation• Usually designed to detect
single chemical compounds
6
New vs. Residual Use Case Study - THC
• Positive test results separated by one month or more normally indicate new use. The exception is long-term, chronic use.
• All results should be normalized to the measurement of ngTHC/mgCreatinine
• A ratio of 1.5 or greater between sequential positive test results separated by a week or more indicates new use.
• This has a degree of certainty of 95% or greater.
• The longer the period between testing, the higher the degree of certainty.
Formula
ng Drug
mg Creatinine
X 100
7
THCA ng/mL Creatinine mg/dL ngTHCA/mgCreatinine0
100
200
300
400
500
600
389
152
255
188
55
341
118
24.4
483
Day 1 Day 8 Day 14
New vs. Residual Use Case Study - THC
8
Federally Regulated Drug Testing
9
Federally Regulated Testing Panels
Drug Screen (ng/mL)
Confirm (ng/mL)
Amphetamines (AMPHS)
1000 500
Cocaine metabolite (BE)
300 150
Opiates (OPA)
2000 2000
Phencyclidine (PCP)
25 25
Marijuana metabolite (THC)
50 15
Prior to September 30, 2010 Effective October 1, 2010
Drug Screen (ng/mL)
Confirm (ng/mL)
Extended Amphetamines (AMPHEX)*
500 250
Cocaine metabolite (BE)
150 100
Opiates (OPA)
2000 2000
6AM 10.0 10.0
Phencyclidine (PCP)
25 25
Marijuana metabolite (THC)
50 15
*includes MDMA, MDA, & MDEA
10
Regulated Updates on the Horizon
• Oral Fluid Testing• Expanded Opiate test panels to
include Synthetic Opiates• New proposal published May 15,
2015 Comments due 60 days.
11
Opiate Testing
12
• HHS only allows for Morphine & Codeine confirmation.• Screen vs. Confirmation (2009 data)
• 346,990 regulated specimens tested• 3,141 regulated specimens screening positive for an opiate• 430 regulated specimens confirmed positive for an opiate
Federally Regulated Opiate Testing
Codeine Only Morphine Only Codeine & Morphine
Codeine, Morphine, &
6-AM
Morphine & 6-AM
0
50
100
150
200
250
124
236
50
218
Number of Confirmed Opiate Positive Specimens
13
43%
13%
15%
15%
15%
Hydrocodone Oxycodone HydromorphoneOxymorphone Codeine/Morphine
Construction Industry Breakdown of Opiate Positives
14
Metabolism of Opiates
Heroin
6-AM
Morphine
Codeine
Hydrocodone
Hydromorphon
e
Dihydrocodein
e
Oxycodone
Oxymorphone
15
Considerations When Using Expanded Opiate Testing
• Increased positives detected by the Laboratory
• Hydrocodone• Oxycodone
• Most likely covered by legal prescription
• What does the MRO do?• Overturn lab positive• Notify employer for safety
sensitive issues
16
Synthetic Marijuana / Designer Drugs
17
Synthetic Marijuana
• Psychoactive research chemicals sprayed on herbal mixtures
• Mimic the effect of THC, the active ingredient of cannabis
• Found to be 4 to 100 times stronger than marijuana
• Deceptively marketed as incense or herbal smoke products since early 2000s
• Available via the internet and in head shops and convenience stores
• Sold under names such as K2, K3 Legal, Spice, Syn, Haze, and Cloud Nine
• Smoked by wrapping it in joints, smoking it in pipes, or inhaling fumes via vaporizers
18
Synthetic Marijuana Effects
• Not regulated by FDA, “not approved for human consumption.”
• Immediate onset• Short effect time of 30 minutes• Similar impairment issues as
marijuana• Dangers
• Agitation → Psychosis • Rapid heart rate → Heart attack• Confusion• Dizziness • Nausea → Vomitting• Convulsions • Overdose
• John W. Huffman (who first synthesized these – “JWH”): “People who use it are idiots.”1
2009 20100
10002000300040005000600070008000
2,906
6,959
Year to year number of calls to poison centers about exposures to synthetic marijuana 2 • Annual increase of 140%• As of February 29, 2012 = 622,
46% increase over February 2011
1. http://www.msnbc.msn.com/id/354441582. Data from American Association of Poison Control Centers
19
• Potential active ingredients include:• JWH-05• JWH-018• JWH-019• JWH-073• JWH-049• JWH-081• JWH-175• JWH-199• JWH-200• JWH-250• JWH-398• Delta-9-THC• HU-210• CP-55940• CP-47497-C7• CP-47497-C8
• WIN-55212-2• WIN-55212-3• JWH-253/306• JWH-362/246• JWH-007/019• Nabilone• Analogues – V, VII, VIII, and XVI
Synthetic Marijuana’s Legality
• Chemists are constantly changing the formulations.
• The DEA has listed 5 highlighted substances as Schedule 1.
20
Designer Drugs
• Stimulant like amphetamine or hallucinogen like PCP
• Describes drugs which are created (or marketed if they had already existed) to get around existing drug laws
• Early 2000s, explosion in designer drugs being sold over the Internet
• “Research Chemicals” – selling the chemicals for "scientific research" rather than human consumption to avoid the intent clause of the U.S. drug laws
21
Designer Drugs
• Forms of use:• Snorted• Smoked• Taken orally
• Cost: $4 to $20 per pack• Can be purchased at:
• Corner stores• Truck stop• Head shops• Internet
• Some common names:• Black Rob • Blue Silk• Bolivian Bath • Cloud 9• Down2Earth • Energizing Aromatherapy• Hurricane Charlie • Ivory Wave• Kamikaze • Maddie • Ocean Burst • Purple Wave• Red Dove • Super Coke• Vanilla Sky • White Horse
Cathinone
22
23
Designer Drug Effects
• Not regulated by FDA, “not approved for human consumption. “
• Insomnia • Teeth grinding• Agitation → Psychosis • Paranoia → Suicide• Rapid heart rate → Heart attack• Nausea → Vomiting• Seizures• Kidney Failure• Death
2009 20100
1000
2000
3000
4000
5000
6000
7000
304
6,138
Year to year number of calls to poison centers about exposures to synthetic marijuana 2 • Annual increase of nearly 2,000%• As of February 29, 2012 = 229,
52% decrease over February 2011
1. Data from American Association of Poison Control Centers
24
• Includes:• Cathinones – 43 compounds created by modifying the molecular structure
• MDPV – “Bath Salts,” stimulant & euphoric effects for 3 to 8 hours• Mephedrone – “Plant Food,” stimulant & euphoric effects for 30 minutes to 3 hours• Methylone – “Room Odorizer”
• Piperazines – (BZP, TFMPP, mCPP)* stimulant & euphoric effects for 4 to 6 hours• Phenethylamine – “Bromo-DragonFLY,” hallucinatory effects for 12 to 24 hours
• The DEA listed 3 highlighted substances as Schedule 1 (October 2011)• “Except as authorized by law, this action makes possessing and selling these chemicals, or the products
that contain them, illegal in the United States … The temporary scheduling action will remain in effect for at least one year while the DEA and the United States Department of Health and Human Services (DHHS) further study whether these chemicals should be permanently controlled.”
• http://www.justice.gov/dea/pubs/pressrel/pr102111.html
• Other Federal Legislation includes• Federal House Bill HR1254• Federal Senate Bill S409
• State Legislation (as of 2/29/2012)• 22 States with current legislation• 12 States with proposed legislation• 3 States awaiting enactment of legislation
*DEA listed BZP and TFMPP as Schedule 1 on March 18, 2004.
Designer Drugs’ Legality
Thank you. Questions?
aleretoxicology.com
David Green, Ph.D., DABCC (CC&TC), FACB
800.433.3823 #68237
504.934.8237