Download DRUG TESTING AND THE ROLE OF THE MEDICAL REVIEW

Disclosure Information
84th Annual AsMA Scientific Meeting
DR NADIA BASTAKI
I have no financial relationships to disclose.
I will not discuss off-label use and/or investigational
use in my presentation
The Role of Medical Review
Officer (MRO)
Dr Nadia Bastaki
MD DipAVMed DipOCCMed /MRO
Chief Medical Officer
Etihad Airways Medical Center
Introduction
 Role and Function of an MRO
 Testing procedure
 Chain of custody collection procedure with POC
devices
 Errors false negative and positive
 Adulterants Dilutes
 Shared data
MRO Role
• Plays a major role in Drug and Alcohol testing
• Independent and Impartial Advocate
• Gatekeeper for the integrity and accuracy of the drug testing
process
• Quality assurance review
• Timely Flow
• Maintenance of Confidentiality
• To interpret the result
• To protect the donor
• To protect the employee
Training of the MRO
•
•
•
•
•
•
•
Must be a licensed physician
Qualification /Training
Certification examination
Good knowledge of Drug metabolism/Toxicology
CPD regular updates
Visiting the collection site seeing the process
Learning how to audit
MRO should be familiar and satisfied
•
•
•
•
•
•
•
Company policy
Drug Cut off levels
Procedure to ensure the chain of custody form
Learning about testing procedure /collection process
Discussing the results with toxicologist
Interpretation of result
Final reporting process
MRO Functions
• Review of all laboratory confirmed drug tests
 Positive
 Adulterated
 Substituted
 Invalid
 Dilute
MRO Functions cont.
•
•
•
•
•
Review CCF for validity
Interview employee/candidate
Determine if legitimate explanation for test result exists
Report the test as negative, positive, or cancelled.
If Test +, Rx legitimate: MRO negative
– If this presents a potential safety risk employer and/or
appropriate agency is notified.
Legislation effecting the MRO
•
•
•
•
•
•
•
•
Company policy
Responsibility to donor company and yourself
Record keeping and write, storage
Chain of custody documents
Access to health records
Access to medical records
Misuse of drug Act
Donor sample
Inform GCAA
for positive
Urine test
Drug and Alcohol collection Procedure
Drug Testing—Methods
•
•
•
•
•
•
Urine drug test
Alcohol breath test
Blood test
saliva test
Sweat test
Hair test
Pre Testing
•
•
•
•
•
•
•
Donor identification
Familiarise the donor with test
Donor preparation
Collection procedure site preparation
Declaration form
Date and time
Sign consent
Check the chain of custody form
• System of controls providing documentary evidence
• In place from specimen collection through to
reporting and beyond
• Tamper evident
• Record of each time the sample changed hands
Chain of custody Errors
Non fatal
• No id check on the donor
• Incomplete check for
temperature
• No time of collection
• No date of collection
Fatal
• No consent
• Missing or mismatched ccf
• Broken seal
• Insufficient sample for
challenge
• Sample broken or leaked
• No documents with sample
• Only one sample
Urine Testing
• Urine shows the presence of drug metabolites, or
the remains of drugs in the body.
• But urine tests can only detect drugs within a short
period of time from when they were taken.
• Urine tests are more effective for illicit and
prescription drugs than alcohol.
Expected Duration For A Positive Urine Drug
Screen
•
•
AMPHETAMINE
METHAMPHETAMINE
•
2 - 4 DAYS
•
•
BARBITURATES (SHORT ACTING)
•
•
•
•
•
•
•
•
•
BARBITURATES (LONG ACTING)
BENZODIAZEPINES
COCAINE
HEROIN/MORPHINE
MARIJUANA (CHRONIC USE)
MARIJUANA ( OCCASIONAL USE)
METHADONE
PCP (CHRONIC USE)
PCP (OCCASIONAL USE)
•
•
•
•
•
•
•
•
•
•
2 - 4 DAYS
2 - 4 DAYS
UP TO 30 DAYS
UP TO 30 DAYS
1 - 3 DAYS
1 - 3 DAYS
UP TO 30 DAYS
1 - 3 DAYS
2 - 4 DAYS
UP TO 30 DAYS
2 - 7 DAYS
17
Urine screening test
•
•
•
•
•
Screening by immunoassay:
High in sensitivity, low in specificity
Negative result quickly and cheaply
Positive result require conformation
Confirmation by chromoatography Mass
spectrometery
• Separation and detection technique
• Highly sensitive and highly specific
• Retention time quantity qualifiers
Drug Testing Process
Candidate or
Employee
Self Selects
Out
3. Confirmation Sample
Collected (employees)
ORALconfirm Kit
Chain of Custody Form
N0N-NEGATIVE
Sample Sent to Lab
NEGATIVE
4. GC / MS Laboratory
Confirmation
Candidate Hired, or
Employee Returns to
Work
24-48 hrs ARS, Results Posted to
Secure Internet Site for Employer
and/or MRO
2. On-Site Drug Screen
Result Reporting Form
On-Site Oral Fluid
Drug Free Workplace
Solution
NEGATIVE
NON-NEGATIVE
Employee Returns to
Work
5. MRO Review
MRO Reviews Lab Results and
contact Donor as required.
Candidate or
Employee
Self Selects
Out
1. Announcement
On-Site Drug Screen to be
NEGATIVE
MRO Posts Results to Secure
Internet Site for Employer Review
POSTIVE
Conducted
Employee Returns to
Work, or Candidate
Hired
Employer Action
per Corporate
Policy,
19
• Breath Testing
 Easy way and efficient way of testing .
 Under GCAA regulations 0.02 is high enough to
prevent someone from performing a safetysensitive task for 24 hours.
 UAE has zero tolerance for drinking and driving
 The use of evidential breath test is necessary to
stand in court of law
Interpretation of the result
Drug Screen Results
• Results can be reported as
 Negative; though they can be a true negative or a false
negative.
 Positive; though they can be a true positive,
 a true positive with a medically acceptable reason, or a
false positive.
for 4 of the 5 drugs tested(the exception is pcp)
there can be a legitimate medical reason
 indeterminate (adulterated or diluted)
22
Results
• True positive-check for:
 correct specimen
lab error?
 correct date
chain of custody form
 medical reason ??
urine collected just after a hospital discharge may
reflect hospital administered medications (opiates,
benzodiazepines)
Donor may not have documented all of their
medications
Recent outpatient medical/surgical procedure
23
Positive Results
Medical reason ??
• Amphetamine
– over the counter meds
» pseudoephedrine
» phenylpropanolamine
» dexedrine is an amphetamine
» vick’s inhaler contains l-methamphetamine
(drug of abuse is d- methamphetamine)
• Opiates
– under the care of a pain specialist
– recent surgery
24
Drug Screen Results
• FALSE POSITIVES
– Cross Reaction
– Patient taking another substance that is reported as a drug
of abuse
• chinese herb pills [cows head pills, miracle herb pills,
potentsex pills, black pearls(tung sheuh pills,chuifong
toukuwan) contain benzodiazepines]
• Chinese slimming pills and teas
25
POTENTIAL CROSS – REACTING DRUGS
CAUSING FALSE POSITIVE TESTS
DRUG GROUP FOUND
CANNABINOIDS
POTENTIAL CROSS REACTING
SUBSTANCE
NON STEROIDAL ANTI-INFLAMATORY
MEDICATIONS
EFAVIRENZ
OPIATES
POPPY SEEDS(SEE NEXT SLIDE)
CHLORPROMAZINE
RIFAMPIN
FLUOROQUINOLONES (EX.-CIPRO)
DEXTROMETHORPHAN(A SINGLE NORMAL
DOSE DOES NOT GIVE A POSITIVE OPIATE
RESULT (STORROW ET AL, 1995)
QUININE IN TONIC WATER
26
POTENTIAL CROSS – REACTING DRUGS
CAUSING FALSE POSITIVE TESTS
DRUG GROUP FOUND
AMPHETAMINE
POTENTIAL CROSS REACTING
SUBSTANCE
EPHEDRINE
(SEE IF INGESTING HERBAL DRUGS;
MA-HUANG (EPHEDRA sinica)
METHYLPHENIDATE
PHENYLPROPANOLAMINE AND OTHER
DECONGESTANTS AND COUGH
PREPARATIONS
BENZODIAZEPINE
CHINESE HERB PILLS [COWS HEAD PILLS,
MIRACLE HERB PILLS, POTENTSEX PILLS,
BLACK PEARLS(TUNG SHEUH
PILLS,CHUIFONG TOUKUWAN) CONTAIN
BENZODIAZEPINES
27
Passive exposure
• Social explanation for a positive drug screen
– passive inhalation is not usually a reason for positive
screen
– marijuana laced brownies can cause a positive test
– hemp seed oil ingestion can cause a positive test
• Cannabis
• Cocaine
• Crack
• Heroin
• methamphetamine
28
MARIJUANA – PASSIVE INHALATION IS NOT USUALLY A REASON
FOR A POSITIVE TEST
(MRO TEXT,2002)
# JOINTS EXPOSED
TO
AREA
EXPOSURE
TIME
TEST
RESULT
REF.
4
SMALL
ROOM
1 HR
<5 ng/ml
MULE ET AL
1988
6
SMALL
ROOM
3 HRS
< 7 ng/ml
LAW ET AL
1984
6
SMALL
CAR
½ HR
NEGATIVE
@ 20 ng/ml
MORLAND ET AL
1985
8
SMALL
ROOM
1 HR
NEGATIVE
@ 20 ng/ml
PEREZ-REYES ET
AL 1983
12
SMALL
CAR
½ HR
POSITIVE
(>20 ng/ml)
MORLAND ET AL
1985
4
SMALL
ROOM
1 HR X’S 3 DAYS
POSITIVE
(>20 ng/ml)
PEREZ-REYES ET
AL 1983
29
Breathalyzer procedure and decision tree
If the zero
No further action
Treat pass/ negative
Greater than zero
Record and repeat test
immediately
Repeat another pair of
reading 20 mins later
Record both pair
of values
Management tools to Asses the situation
•
•
•
•
•
If values increasing over 20 minutes getting drunk
If values stable over 20 minutes is drunk
If values decrease over 20 minutes sobering up
We should apply cut off levels
Any value above cutoff level consider positive /fail
Diluents and Adulterants
URINE PH (4-9) less 3
grater than 11 consider adulteration
URINE CRETANINE
Creatinine <5 mg/dl or SG out of
range
URINE TEMPRETURE
33
Cannot pass a sample
•
•
•
•
Minimum is 30mls per collection chain of custody
Minimum is 45 mls per collection poc
250mls each 20-30 up to 1L
Sample between 2-3 hours later
know the procedure if the donor still cannot pass
sample move to refusal
• Exclude shy bladder
D&A Testing at Etihad
Types of Testing ;
 Pre employment Drug test
 Random testing
 On suspicion test
 Post accident/ incident testing
• 20% of all flight crew to be tested for Random Testing GCAA
• Pre Employment Testing for all air crew (Drug Test only)
• Etihad has a zero tolerance policy across the company
D&A SCREENING REPORT 2012
(0.19%)
(20%)
D&A SCREENING REPORT 2013
(0.18%)
(0.25%)
(100%)
Questions ???
Dr Nadia Bastaki
CMO Etihad
Nbastaki @etihad.ae