opioids & adulteration - samhsa

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……