Transcript Drug Testing Advisory Board (DTAB) Initiatives 2013

Drug Testing Advisory Board (DTAB) Initiatives in 2013
Presented by:
Dr. Donna R. Smith
Regulatory Affairs Officer, EDPM, Inc.
[email protected]
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Written recommendation to the SAMHSA
administrator on including lab-based oral
fluid testing for drugs of abuse in the
Mandatory Guidelines
Written recommendation to the SAMHSA
administrator on including additional
Schedule II drugs (e.g. synthetic
opiate/opioids) in the Mandatory Guidelines
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SAMSHA Administrator acceptance of DTAB
recommendations—Jan 26, 2012
Div. of Workplace Programs tasked with preparing
notice of proposed revisions to the DHHS Guidelines
◦ Documents prepared, however remain in SAMHSA/DHHS
clearance process
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Comment periods and review and evaluation of all
comments
◦ Expected to take at least 6 months after publication of the
proposed DHHS Guideline changes
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Revised Guidelines—2014 ??
Implementation dates—2015 ??
◦ DOT must go through its own rulemaking process in order to
adopt/modify/implement DHS changes in the DOT-regulated
testing programs
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Continued review of research projects and data on oral
fluid testing and expanded opiates testing
Working groups convened to advise DWP on electronic
CCF and MRO standards of practice
 Teleconference meetings with RTI and DWP staff
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Federal CCF renewal/extension and approval for eCCF
 July 15, 2013, FR Notice, SAMHSA requested public comment on its proposal
that the OMB approve use of a new Federal CCF and eCCF technology in federal
workplace drug testing programs, with a proposed implementation date of
September 1, 2013.
 OMB continues to evaluate the privacy and security issues surrounding eCCF
information collections. It has not approved the use of an eCCF
 While they complete their review, OMB has authorized extending the use of the
current 5-part carbonless manifold CCF, and it remains the only approved Federal
CCF.
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Evaluation of the scientific supportability of
the hair specimen for Federal Workplace Drug
Testing
◦ Began in July 2013; expected to continue for
approximately one year.
◦ Review historical and current perspectives of hair
testing for drugs of abuse
◦ Perform exhaustive literature search
◦ Identify unanswered questions about hair testing
and conduct additional literature review, request for
information, research studies, coordination on legal
and public policy issues
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SAMHSA’s Division of Workplace Programs has prepared
proposed revisions to the Mandatory Guidelines for
Federal Workplace Drug Testing Programs
The proposed revisions would create separate Guidelines
for each approved specimen/matrix:
◦ Mandatory Guidelines for Federal Workplace Drug Testing
Programs using Oral Fluid Specimens
◦ Mandatory Guidelines for Federal Workplace Drug Testing
Programs using Urine Specimens
◦ If hair testing is recommended and approved for use in Federal
Workplace Drug Testing Programs, a third Mandatory Guidelines
would be created.
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The Guidelines are parallel in their organization
The Mandatory Guidelines apply to Federal agencies in
the Executive branch under the authority of Executive
Order 12564
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Key components of proposed Mandatory
Guidelines– Urine Specimens
◦ Addition of synthetic opioids to existing HHS drug panel
◦ Further synchronization with DOT Part 40
◦ Provisions to allow additional screening and
confirmatory technologies
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The proposed oral fluid Guidelines and the
changes to the Urine Guidelines are “coupled” in
the approval, submission and release process.
Thus, no significant movement on getting
expanded opiates testing in place for federal
drug testing programs
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Review the historical and current perspective
of hair as a drug testing matrix
Perform an exhaustive hair specimen
literature search
Identify specific questions associated with
hair testing issues that require in-depth
discussion and further study
Deliberation on the scientific supportability
based on the above
Make recommendations to SAMHSA
administrator
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Key components of scientific review
Specimen characterization
Specimen collection
Preparation of specimen for testing
Stability—decomposition of compounds in hair
Target analytes
Cut-off concentrations
Initial/screening methods
Confirmation methods
Proficiency testing
Impact of hair color/pigmentation; external
contamination and other exposures; hair dyes,
processors, etc.
◦ Appropriate use of hair testing in Federal programs
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Drug(s)
Hair
Urine
% Difference
Overall
12.6%
7.6%
66%
AMP
5.9%
2.1%
179%
METHAMP
5.9%
1.8%
222%
COCAINE
4.8%
0.65%
635%
THC
3.4%
3.4%
0
OPIATES
0.23%
0.52%
-56%
PCP
0.049%
0.048%
1%
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Positive prevalence rates for “paired” hair and
urine specimens
“concordance” between hair and urine test
results—same donor; same collection date
Data based on 193K paired collections Jan 20042009 tested at QDI laboratories
◦ Pre-employment 73%, random 12%, other 15%
◦ 5-drug panel (THC, COC, AMP, OPI, PCP)
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Positive rates higher in hair than urine for most
drugs
Both specimens detect some positives that the
other does not
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DOT officially supported DTAB recommendations
for oral fluid testing and expansion of DHHS drug
testing panel to include synthetic opioids
DOT will have to prepare and publish revisions to
49 CFR Part 40 to incorporate any changes made
to the Mandatory Guidelines
◦ Process will be subject to the usual rulemaking
procedures of proposed and final rule issuances
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The motor carrier industry continues to press
DOT for allowing the use of hair testing in DOTmandated testing, especially for pre-employment
testing