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Opioids & pHDrug Testing Advisory Board Meeting
March 20-21, 2018
Marquita G. Brogdon
Mandatory GuidelinesThe Department of Health and Human Services (HHS)
published the following Notice in the January 23, 2017 Federal Register:
Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine (UrMG)
Effective October 1, 2017
The Revised Mandatory Guidelines
Expanded the drug testing profile to include new drug analytes: oxycodone, oxymorphone, hydrocodone, and hydromorphone
Removed MDEA from the drug testing profile, added MDA as an initial test analyte,
Raised the lower pH cutoff from 3 to 4 for identifying specimens as adulterated, and
Revised MRO requalification requirements
Implementation – October 1, 2017• Revised pH cutoff for federal agency specimens & DOT-
regulated specimens
• Discontinued testing federal agency specimens for MDEA
• Continued testing DOT-regulated specimens for MDEA
• Delayed testing of federal agency specimens for the added opioids until the effective date specified by the federal agency.
• Delayed testing of DOT-regulated industry specimens for the added opioids until further notice from DOT
Implementation……….• Some federal agencies were not prepared to add additional analytes to their drug testing programs by October 1, 2017
SAMHSA instructed agencies to notify their service providers of the date they will begin testing their workplace specimens for these drugs
• DOT implemented testing for semi-synthetic opioids January 1, 2018
• DOT removed MDEA from its drug testing panel January 1, 2018
Non-Negative Results (2014-2017)
-
2,000
4,000
6,000
8,000
10,000
12,000
14,000
Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec
Num
ber
of S
peci
men
s
Reporting Month
2014
2015
2016
2017
Non-Negative Results (2014-2017)
-
2,000
4,000
6,000
8,000
10,000
12,000
14,000
Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec
Num
ber
of S
peci
men
s
Reporting Month
2014
2015
2016
2017
Semi-Synthetic Opioids
Positivity Rate by Drug Class (Oct. '17 - Feb. '18)
0.000%
0.100%
0.200%
0.300%
0.400%
0.500%
0.600%
0.700%
0.800%
0.900%
0.572%
0.517%
% P
osit
ive
Drug Class*Feb ‘18 – Missing data from 2 small HHS-certified labs
Semi-synthetic Opioids
Positive as % of total tested
Period HYC/HYM OXYC/OXYM
Oct-17 0.54% 0.49%
Nov-17 0.41% 0.49%
Dec-17 0.64% 0.72%
Jan-18 0.65% 0.47%
Feb-18 0.62% 0.43%
Opioid Positivity Rate by Month
0.00%0.10%0.20%0.30%0.40%0.50%0.60%0.70%0.80%
Oct-17 Nov-17 Dec-17 Jan-18 Feb-18%
Pos
itiv
eHYC/HYM OXYC/OXYM
*Feb ‘18 – Missing data from 2 small HHS-certified labs
Adulteration
Invalid…. to…. Adulterated• Raised pH cutoff from 3.0 to 4.0 for specimens reported Invalid due to pH
• pH <4.0 is now Adulterated
What was impact to the number of specimens reported Adulterated?
Change in Number of Specimens Reported Adulterated due to pH
• 25.5% average % increase
• Invalid Adulterated
• For donors….
“If the donor is unable to providea legitimate explanation, the MROreports a refusal to test”1
1UrMG Section 13.5(e)(2)
PeriodTotal
AdulteratedAD due to
pHpH ≥3 and
<4
AD (pre-Oct. 1, 2017 UrMG)
Aug-17 92 91 37
Sep-17 122 120 24
Oct-17 106 102 20 82
Nov-17 119 118 22 96
Dec-17 187 187 22 165
Jan-18 66 65 19 46
Feb-18 45 45 19 26
*Feb ‘18 – Missing data from 2 small HHS-certified labs
0.000%
0.005%
0.010%
0.015%
0.020%
0.025%
0.030%
0.035%
0.040%
Jan-
16
Feb
-16
Mar
-16
Apr
-16
May
-16
Jun-
16
Jul-1
6
Aug
-16
Sep-
16
Oct
-16
Nov
-16
Dec
-16
Jan-
17
Feb
-17
Mar
-17
Apr
-17
May
-17
Jun-
17
Jul-1
7
Aug
-17
Sep-
17
Oct
-17
Nov
-17
Dec
-17
Jan-
18
Feb
-18
% o
f Tot
al T
este
d
% Total Tested Low pH (pH <3.0 or <4.0) % Total Tested High pH (pH >11.0)% Total Tested Low pH (pre-Oct.1, 2017)
% of Total Tested Adulterated Low/High pH
*Feb ‘18 – Missing data from 2 small HHS-certified labs
Summary
•ReflectionsRevised UrMG Effective October 1, 2017Added opioids, raised pH cutoff, removed MDEA and revised MRO requalification requirements
• ImpactspH: Detecting more donors trying to subvert the drug testOpioids: To be determined……