WHAT’S NEW FOR MRO

WHAT’S NEW FOR THE MRO

• Presented at MARCOEM

• Karl Auerbach MD, MS, MBA, FACOEM

• Staff Physician, OEHC of Eastern NY

• Kauerbach@emblemhealth.com

• Certified MRO

• October 7, 2018

• Rutgers University

• New Brunswick, NJ

TODAY’S OBJECTIVES

1. Explain recent developments in making job

related decisions that involve drug and alcohol

testing.

2. Discuss frequent questions that come up about

ongoing issues for medical review officers

MRO

Medical

Review Officer

OPERATING AGENCIES

• Federal Aviation Admin- 14 CFR Part 120 • Random drug testing 2018 25%

• Random alcohol testing 2018 10%

• Follow 49 CFR part 40

• Federal Motor Carrier Safety Admin- 49 CFR part 382• Random drug testing 2018 25%

• Random alcohol testing 2018 10%

• Follow 49 CFR part 40

• Federal Railroad Admin 49 CFR Part 219• Random drug testing 2018 25% covered service

• 50% maintenance of way

• Random alcohol testing 2018 10% covered service

• 25% maintenance of way

• Follow 49 CFR part 40

OPERATING AGENCIES

• Federal Transit Admin 49CFR Part 655

• Random drug testing 2018 25%

• Random alcohol testing 2018 10%

• Follow 49 CFR part 40

• Pipeline & Hazardous Materials Safety Admin

• 49 CFR part 199

• Random drug testing 2018 50%

• Random alcohol testing 2018 n/a

• Follow 49 CFR part 40 for drug testing

OPERATING AGENCIES

• US Coast Guard (now part of Homeland Security)

• 46 CFR Part 16; 46 CFR part

• Random rate drug testing for 2018 25%

• Random rate alcohol testing 2018 n/a

• Follows 49 CFR part 40 for drug testing

OTHER PROGRAMS

• Nuclear Regulatory Agency 10CFR Part 26

• Random rate drug and alcohol 50%

• At a minimum, licensees and otherentities shall test for marijuana metabolite, cocaine

metabolite, opiates (codeine, morphine, 6-

acetylmorphine), amphetamines (amphetamine,

methamphetamine), phencyclidine, adulterants, and

alcohol.

• But can test for any schedule I-V

• Can adjust cut offs including to level of detection

• Collection and MRO generally follow part 40

• Embedded in a fitness for duty program

OTHER PROGRAMS

• Federal executive branch employees 73 FR 71858

• at present fairly close to part 40

• Military

• Non-regulated

MRO 29 CFR PART 40.123

• Acting as an independent and impartial “gatekeeper” and advocate for the accuracy and integrity of the drug testing process.

•

• (b) Providing a quality assurance review of the drug testing process for the specimens under your purview. This includes, but is not limited to:

•

• (1) Ensuring the review of the CCF on all specimen collections for the purposes of determining whether there is a problem that may cause a test to be cancelled (see §§40.199–40.203 ). As an MRO, you are not required to review laboratory internal chain of custody documentation. No one is permitted to cancel a test because you have not reviewed this documentation;

•

• (2) Providing feedback to employers, collection sites and laboratories regarding performance issues where necessary; and

•

• (3) Reporting to and consulting with the ODAPC or a relevant DOT agency when you wish DOT assistance in resolving any program issue. As an employer or service agent, you are prohibited from limiting or attempting to limit the MRO's access to DOT for this purpose and from retaliating in any way against an MRO for discussing drug testing issues with DOT.

•

MRO 29 CFR PART 40.123

• (c) You must determine whether there is a legitimate medical explanation for confirmed positive, adulterated, substituted, and invalid drug tests results from the laboratory.

•

• (d) While you provide medical review of employees' test results, this part does not deem that you have established a doctor-patient relationship with the employees whose tests you review.

•

• (e) You must act to investigate and correct problems where possible and notify appropriate parties (e.g., HHS, DOT, employers, service agents) where assistance is needed, (e.g., cancelled or problematic tests, incorrect results).

•

• (f) You must ensure the timely flow of test results and other information to employers.

•

• (g) You must protect the confidentiality of the drug testing information.

•

• (h) You must perform all your functions in compliance with this part and other DOT agency regulations.

DRUG TEST POLICIES (EMPLOYERS)

• If sub-categories of drugs tested under the 5-panel are listed –for example, if a policy lists "Opiates (codeine, heroin, & morphine)" and/or “Amphetamines (amphetamine, methamphetamine, MDMA, MDA, MDEA), then “Opiates“ needs to change to “Opioids (codeine, heroin, morphine, oxycodone, oxymorphone, hydrocodone, hydromorphone)” and “MDEA” will need to be removed from the list under Amphetamines. If however, employers would like to delete the sub-categories of drugs, doing so will also be acceptable.

• Likewise, if cut-off levels are listed in current policies, employers must update those cut-off levels. Again, employers may simply delete the cut-off levels completely and be in compliance if the DOT policy refers to adhering to “... Part 40.”

• While these DOT Agencies and USCG suggest that employers provide written notice to employees about their updated DOT policies, doing so is an employer's prerogative.

COLLECTION FORM

• Revision of Federal Drug Testing Custody and Control

Form on August 8, 2017

• DOT agency to be listed

• MDEA (methylenedioxyethylamphetamine) removed

• Oxycodone, Oxymorphone, Hydrocodone,

Hydromorphone are added

• Old form could be used until June 30, 2018

• After that, if old form used then need memorandum to

record filed same day you become aware of old form

having been used

• IF NOT CORRECTED THEN THE TEST MUST BE CANCELLED

COLLECTORS

• The shy bladder process has been modified so that

the collector will discard any specimen provided

during the collection event when the employee

does not provide a sufficient specimen by the end

of the three hour wait period.

5 PANEL

• After January 1, 2018

• Still “5 panel”

• Marijuana, Cocaine, Amphetamines, Opioids,

Phencyclidine

• Opioids continues to include Codeine, Morphine

and 6-AM but added semi-synthetic opioids initial

and conformation testing for:

• Hydrocodone

• Hydromorphone

• Oxycodone

• Oxymorphone

5 PANEL

• After January 1, 2018

• Amphetamine

• Testing for:

• Methamphetamine

• MDMA (3,4-Methylenedioxymethamphetamine) (Ecstasy)

• MDA (newly added initial testing) (3,4-Methylene dioxy

amphetamine (MDA))

• MDEA removed (methylenedioxyethylamphetamine )

5 PANEL

• Effective January 1, 2018

• MROs will continue to report to employers the

specific drugs / drug metabolite they verify as

positive; and MROs will add hydrocodone,

hydromorphone, oxycodone, and oxymorphone

verified positives, as appropriate.

5 DAY RULE

• Covered in 29 CFR 40.135

• Prior to November 13,2017

• (e) You must also advise the employee that, after informing any third party about any medication the employee is using pursuant to a legally valid prescription under the Controlled Substances Act, you will allow 5 days for the employee to have the prescribing physician contact you to determine if the medication can be changed to one that does not make the employee medically unqualified or does not pose a significant safety risk. If, as an MRO, you receive such information from the prescribing physician, you must transmit this information to any third party to whom you previously provided information about the safety risks of the employee's other medication.

5 DAY RULE

• 29 CFR 40.135

• As of November 13, 2017

• (e) You must also advise the employee that, before informing any

third party about any medication the employee is using pursuant to a

legally valid prescription consistent with the Controlled Substances

Act, you will allow 5 business days from the date you report the

verified negative result for the employee to have the prescribing

physician contact you to determine if the medication can be

changed to one that does not make the employee medically

unqualified or does not pose a significant safety risk. If, in your

reasonable medical judgment, a medical qualification issue or a

significant safety risk remains after you communicate with the

employee’s prescribing physician or after 5 business days, whichever

is shorter, you must follow §40.327. If, as the MRO, you receive

information that eliminates the medical qualification issue or

significant safety risk, you must transmit this information to any third

party to whom you previously provided information under §40.327.

5 DAY RULE

• Q&A (1/18)

• During the verification interview, the MRO may learn about a legally prescribed medication that would likely make the employee medically unqualified or would likely pose a significant safety risk. Section 40.135(e) requires the MRO to tell the employee to have his/her prescribing physician contact the MRO to discuss the MRO’s concern about the medication. If the prescribing physician does not speak with the MRO within 5 business days of the MRO informing the employee to have his/her prescribing physician contact the MRO, the MRO will report the information about the legally prescribed medication to the appropriate third party. Can the MRO report that information to a third party before 5 business days have elapsed?

5 DAY RULE

• Q&A (1/18) (Answer)

• Yes, there could be instances where the MRO would not have to wait the 5 business days to report the information, for example: • The prescribing physician speaks with the MRO before 5 business days

have elapsed and the significant safety risk remains unresolved.

• The employee expressly declines to have his/her prescribing physician speak with the MRO.

• If, during the verification interview, the MRO learns of a medical condition or diagnosis that is likely to result in the employee’s being medically unqualified under a DOT agency regulation (e.g., FAA, FMCSA, USCG), the MRO must report that information under the procedures in § 40.327. The 5-day pause provision in § 40.135(e) is inapplicable.

5 DAY RULE

• The rule regarding communication with the

prescribing doctor and having to wait 5 days

applies to MRO activity- not the medical

examination

• Form MCSA-5895 is for use with medical

examinations, not for MRO use.

• Not clear if MCSA can be used for MRO work

MARIJUANA

• (f) You must not accept an assertion of

consumption or other use of a hemp or other non-

prescription marijuana-related product as a basis

for verifying a marijuana test negative. You also

must not accept such an explanation related to

consumption of coca teas as a basis for verifying a

cocaine test result as negative. Consuming or using

such a product is not a legitimate medical

explanation.

MARIJUANA

• For federal tests:

• This applies to medical marijuana

• This applies to recreational marijuana

• This applies to hemp products

• This applies to CBD oil

• For non federal tests:

• Know your state rules

• Let your medical judgement be your guide

• But best to stay consistent

MRO MUST NOTS

• (g) You must not accept an assertion that there is a legitimate medical explanation for the presence of PCP, 6-AM, MDMA, MDA, or MDEA in a specimen.

• (h) You must not accept, as a legitimate medical explanation for an adulterated specimen, an assertion that soap, bleach, or glutaraldehyde entered a specimen through physiological means. There are no physiological means through which these substances can enter a specimen.

• (i) You must not accept, as a legitimate medical explanation for a substituted specimen, an assertion that an employee can produce urine with no detectable creatinine. There are no physiological means through which a person can produce a urine specimen having this characteristic.

OTHER SPECIMENS

• Saliva- as screen test for alcohol under DOT

• Hair-has been under discussion for years• Congress authorized hair and required HHS to develop

regulations and guidelines by Dec 16, 2015

• Reality check- its October 2018 and HHS still developing guidelines and no proposal has been issued

• Hair increasingly used in non federal

• Concerns about proper preparation-washing- especially cocaine

• Oral Fluid• Proposed and “final” guidelines 2015

• Was expected to be released with changes in urine drug testing but did not happen and expected date unknown

PROS AND CONS OF HAIR AND ORAL FLUIDS

• PROS• Less invasive

• Directly observed

• Multiple sampling; drug use history

• Easier shipment and storage

• More resistant to adulteration and substitution

• CONS• Variation in detection windows

• Science less clear especially dose vs concentration

• Sensitivity still concern though better

• Proficiency testing for collector

• Contamination issues

DETECTION PERIOD

• Blood- minutes to days

• Breath- minutes to unclear

• Oral fluids- minutes to unclear

• Urine- hours to days

• Sweat-weeks

• Hair-days to months

• Nails-days to month

CONCERN ABOUT DIFFERENT SPECIMENS

• If different people subject to different type of test

with different windows of detection, are they being

treated equally

• If two type of specimens used on a single “test”

they may not show the same due to different

windows of detection

• Evolving understanding of contaminants especially

hair

• How to collect a sweat sample which may need to

stay attached for a time

STATE LAWS

• New Jersey• First offense possession conditional release but if sentenced could be

mandatory minimum including life• Drugged driving forbids operating motor vehicle if detectable level• Medical Marijuana allowed• Hemp not addressed• Recreational –failed when last introduced in 2017

• New York• First offense possession treated like traffic violation but higher levels

can have mandatory minimum sentence including life• Drugged driving forbids operating motor vehicle if detectable level• Medical Marijuana allowed• Hemp for research allowed• Recreational under review

STATE LAWS

• Pennsylvania• First offense possession conditional release and some localities entirely

decimalized

• Drugged driving forbids operating motor vehicle if detectable level

• Medical Marijuana allowed

• Hemp if registered can grow for industrial and research

• Recreational –bill recently introduced

• Delaware • First offense possession conditional release and/or decimalized

• Drugged driving forbids operating motor vehicle if detectable level

• Medical Marijuana allowed

• Hemp -an active hemp industry

• Recreational –bill recently failed

STATE LAWS

• Maryland• Largely decriminalized, first offense treated like minor traffic violation

• But higher level offenses have mandatory minimal sentencing

• Drugged driving forbids operating motor vehicle if detectable level

• Medical Marijuana allowed

• Hemp -an active hemp industry

• Recreational –“big push”

• District of Columbia• First offense typically probation

• Drugged driving forbids operating motor vehicle if detectable level

• Medical Marijuana allowed

• Hemp -not discussed

• Recreational –decimalized for personal use so effectively allowed

CONTROVERSIES

• The big issue regarding drug testing relates to medical marijuana• How to deal with non federal tests

• Medical marijuana

• Recreational marijuana

• Medical or recreational for travelers

• The main points to consider are• Federally still not allowed

• Locally some prohibitions re testing in states such as Iowa

• Generally employers can still prohibit and test

• Difference between use and impairment

• Timing of use vs. finding on drug test

CONTROVERSIES

Source of next slide

Blood levels do not predict behavioral or

physiological effects of Δ9-tetrahydrocannabinol in

rhesus monkeys with different patterns of exposure.

Ginsburg,Hruba,Zaki,Javors and McMahon

Drug Alcohol Depend. 2014 June 1;139:1-8

Dose 3.2 mg/kg

CONTROVERSIES

CONTROVERSIES

• Marijuana in blood after single “dose”

CONTROVERSIES

• Colorado

• Considered to be under influence of marijuana

where THC is identified in a driver's blood in quantities

of 5ng/ml or higher,

CONTROVERSIESFROM: HUMAN CANNABINOID PHARMACOKINETICS, HUESTIS,

CHEM BIODIVERS. 2007 AUG;4(8): 1770-1801.SINGLE MARIJUANA CIGARETTE 3.55% THC

URINE

CONTROVERSIESDETECTION ON DRUG TEST

FROM DRUGS.COM

Usage Estimate of marijuana

detection time

* Occasionally, some chronic users with a high tolerance may

eliminate THC as fast as a one-time user.

One time only 4-8 days

2-4 times per week 23-35 days

5-6 times per week 33-48 days

Daily usage 49-70 days after last use*

2-4 times per month 11-18 days

NOT IN FEDERAL TEST

• Many other opioids- fentanyl is the current problem

• Synthetic marijuana- K2, spice

• Any number of designer drugs

• Benzodiazepines and other tranquilizers

• Gabapentin and Lyrica

• Hundreds of other prescription drugs that have

either psychoactive of sedating effects

• Many over the counter drugs

IT’S NOT A PERFECT PROGRAM

• Not every drug user will test positive

• Drugs not tested

• Tested drug below cut off

• Timing of test since use

• Dilution

• Adulterant that isn’t detected

• Substitution that isn’t detected

• Intermittent use

• Use of medication in way that cannot be

determined as not valid

KEEPING UP TO DATE

• Collectors, alcohol testing technicians, MROs, and

Substance Abuse Professionals will be required to

subscribe to ODAPC's list-serve at https://www.transportation.gov/odapc/ListServe_Notices

MRO LIST

• List serve/web

• About 600 people involved

• Questions, answers, comments

• Please avoid rants

• Post to MRO-List@GoogleGroups.com

QUESTION 1

Which of the following is true regarding a prescribed medication about which a MRO learns and feels would likely make the employee medically unqualified or would likely pose a significant safety risk?Choose all that applya. The MRO is required to wait 5 days before making a report to the third party such as employer.b. If the employee expressly declines to have his/her prescribing physician speak with the MRO then the MRO does not have to wait 5 days to make a report to a third party.c. The CMV Driver Medication Form, MCSA-5895, must be used to communicate with the treating physician when an MRO encounters a medication with likely safety risk.d. A & B are truee. A & C are truef. B & C are trueg. All are trueh. None are true

QUESTION 1- ANSWER

b is true

a is not true as stated. Typically an MRO would have

to wait 5 days but if the driver expressly declines the

contact or if there is a medical reason or if the

contact is made before 5 days are some examples

c is not true. The form 5895 is for the medical

examiner, not the MRO, to optionally use to obtain

medication information

QUESTION 2

Which of the following (may choose more than 1) is true when the lab reports a positive marijuana on a Federally regulated test and the MRO report

a. If the driver has a valid medical marijuana card then for a Federally regulated test the MRO must consider the test to be a “negative” testb. If the driver has a valid medical marijuana card then for a Federally regulated test the MRO must consider the test to be “positive”c. If the driver has no medical marijuana card but indicates they live in or have recently visited a state where recreational marijuana is legal then the MRO must consider the test to be “positive” for a Federally regulated test.d. A & B are truee. A & C are truef. B & C are trueg.All are trueh. None are true

QUESTION 2-ANSWER

Answer

f is the correct answer

a is not true because in the Federal system marijuana is a prohibited substance without regard to having a medical marijuana card.

b is true because in the Federal system, marijuana is a prohibited substance without regard to having a medical marijuana card.

c is true because recreational marijuana is a prohibited substance in the Federal system without regard to its legality in a given state situation.

QUESTION 3

Is the US Coast Guard a DOT agency with respect to

the DOT Drug and Alcohol Testing regulations in 49

CFR Part 40?

a. Yes for drug testing and no for alcohol testing

b. Yes for alcohol testing and no for drug testing

c. Yes for both drug and alcohol testing

d. No for both drug and alcohol testing

QUESTION 3-ANSWER

Answer

a. With respect to part 40, the USCG incorporates

part 40 in drug testing but not in alcohol testing. Thus

it is a DOT agency with respect to part 40 only for

drug testing

THANK YOU

•Questions?