What’s Ahead for Federal Drug Testing Programs

Drug Testing Advisory Board (DTAB) Initiatives in 2013

Presented by:Dr. Donna R. Smith

Regulatory Affairs Officer, EDPM, Inc.dsmith@edpm.com

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

July 13 2011—DTAB Recommendations

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 Comment periods and review and evaluation of all

comments◦ Expected to take at least 6 months after publication of the

proposed DHHS Guideline changes 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

Progress on July 2011 DTAB Recommendations

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 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.

SAMHSA & DTAB Initiatives in 2013

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

SAMHSA & DTAB Initiatives in 2013

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.

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

Proposed Revisions to the Mandatory Guidelines for Federal Workplace Drug Testing Programs

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 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

Expansion of drug panel in Urine Testing

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

DTAB Evaluation Process for Hair Testing

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

Hair Testing

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%

Positive Prevalence in Hair and Urine

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 2004-2009 tested at QDI laboratories◦ Pre-employment 73%, random 12%, other 15%◦ 5-drug panel (THC, COC, AMP, OPI, PCP)

Positive rates higher in hair than urine for most drugs

Both specimens detect some positives that the other does not

Comparing Hair & Urine Testing

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 The motor carrier industry continues to press

DOT for allowing the use of hair testing in DOT-mandated testing, especially for pre-employment testing

DOT Impact