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VALIDITY OF DIFFERENT
DRUG AND ALCOHOL
TESTING METHODS
IMHA Workshop & Seminar, Mumbai, 2006
DRUG AND ALCOHOL PREVENTION PROGRAMME –
TRAINING SEMINAR
Dr. M. Luisa Canals
PhD, Specialist in Occupational Health. Master in Drug addictions and AIDS.
Maritime Health MD, ISM, URV Tarragona Spain
Spanish Society of Maritime Medicine (SEMM) / International Maritime
Health Association (IMHA)
Background points of Drug
and Alcohol Testing:
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WHAT ? -- Especial characteristics of
seafarers work and vessels / Effects of drugs
and alcohol … DEFINITIONS
WHEN ? – Reasonable suspicious / Medical
Fitness Exams / Drug and alcohol test
collection in situ: at random … PREVENTION
HOW ? International recommendations for
screening, 1993. E.g. ships that transport
dangerous goods CERTIFICATE-VALIDITY
Questions related to Validity:
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Why to test?  What are dangerous drugs? 
What drugs to test? Where?
Should informed consent be required? 
Ethical considerations > How to keep
confidentiality? What are the implications of a
positive test?
Method of collection and transport to lab with
all the circumstances, chain off custody
procedures  How can we assure that the
urine belongs to the patient?
Validity: How? Limitations of clinical test
laboratory

WHAT & WHY ?
 "Dangerous drugs" – e.g. under the US
Department of Transportation rules - are:
marijuana, cocaine, opiates, phencyclidine (PCP),
and amphetamines.
 “Individual and Community Problem” - Alcohol &
drugs in the workplace have a close relation to:
1. Decrease of work concentration.
2. Increased prevalence of absenteeism and social
problems.
3. Increased number of injures and accidents.
4. Increased prevalence of associated diseases.
5. Increased risk of mortality and disasters…
Research:

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Detection of drugs / Detection
of the problem: E.g: Description
of addictive substances use
register though a computerised
data base of seafarers’ medical
records of fitness examinations to
embark in Spain (ISM. 93-98,
134.219 * )  73.2 %
Evidence based medicine,
studies, references,
international meetings.
Increased permanence
in days according to the
method: Blood, saliva,
urine, sweat, hair.
(*) Registro de un factor de riesgo a través del reconocimiento médico laboral
preceptivo para embarque en España: el uso de sustancias adictivas. Med Marit 1 (8): 407-416.
Spain: Seafarers’ fitness examinations
Areas that exceed the average of consumption per substances
Tobacco
Alcohol
Heroine
Cocaine
Cannabis
Sedatives
Others
Almería
Figura 1: Distribu ción del consumo de sustancias adictivas registrado en los reconocimientos médicos
prece ptivos para embarque según sustan cias que superan la media por provincias marítimas
% DE USO MEDIO POR
PROVINCIA MARÍTIMA
(Global 73 % *IC 95% 68,42 - 77,77)
Tabaco
Alcohol
Heroína
Cocaína
Cannabis
Sedantes
Otros
61 % *59,43 - 67,23 % (48 a 75 %)
56 % *45,24 - 62,26 % (15 a 86 %)
2 % * 1,3 - 2,52 % (0,02 a 5,5%)
1,4% * 0,51 - 2,6 % (0 a 12,1 %)
3 % * 1,7 - 4,8 % ( 0,35 a 19,1%)
0,4% * 0,02 - 0,69 % ( 0 a 4 %)
2,9% gran dispersión 0 a 51,2 %
Correlaciones politoxicomanías:
r=0,94
Cocaína
Cannabis
r = 0,71
1 + 1 + 2 ...
r=0,91
Heroína
Sedantes
Tabaco
Alcohol
r=0,77
Detection / Effects:
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Drug definition: legal
occupational and
medical aspects
Classification:
- NCS Depression (alcohol,
opiates, cannabis,
barbiturates)
- NCS Estimulation
(cocaine, anfetamines,
extasis)
- Alucinations (LSD)
- Volatils (solvents)
Drug abuse / Addition
(Consumption / substance)
 Withdrawal Syndrome
 Overdose
 Abuse (dependence,
tolerance, craving, DSM
IV-TR)
 Intoxication
PRE-ANALYTICAL VALIDITY
Points to take into account


1. Alcohol and Drugs Detection Programme
2. Medical Review Officer (MRO) USA exam & courses
“American Association of Medical Review Officers”, “American Society of Addiction
Medicine”, “American College of Occupational and Environmental Medicine”
accredited by the Medical Review Officer Certification Council; Europe ? Only
courses “European Workplace Drug Testing Society”.
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3. Specimen Collector.
4. Collection Site.
5. Collection Supplies.
6. Donor.
7. Custody and Control Form - Chain of Custody Form.
Screening:
Informed
Consent
in
Seafarers’
Fitness
Examination
in
Spain
Screening:
Informed Consent
Certificate
(Cruise Ships)
Sample collection
Chain of custody
(Tanker Certificate)
DETECTION
Indication (* urine, blood, sweat,
saliva, hair…)
 Validity of the test, technic drug testing
(cut-off level) / *#substances: alcohol
(hours), coca & opiates (2-3 days),
benzodiacepines (2 w), cannabis (2-30
days)
 Informed Consent & Confidenciality

Methods
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Urine: * high reliability
(inmunoassay, GC/MS), cheap, 5
DOT more used for screening,
minimum risk, legal backup.
Possibility on site test (acceptable
quality but legal risk).
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Blood: high liability,
expensive, many
drugs but not good
for cannabis.
Breath: used for
alcohol (alveolar air,
cheap, liability)
Inmunoassay, GC/MS
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Saliva: simple, on site,
liability, few legal
background
Sweat: 2-7 days,
acceptable, easy
Hair: long lasting, liability,
few laboratories, forensic
research
Drug Testing
State of the question:
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The Initial Test : an immunoassay test that has been approved
for commercial distribution as an in vitro diagnostic test by the
Food and Drug Administration (FDA). A number of different
immunoassay techniques are available to screen for the five
drug classes [e.g., radioimmunoassay (RIA), enzyme
immunoassay (EIA), kinetic interaction of microparticles in a
solution (KIMS), and fluorescence polarization immunoassay
(FPIA)].
The initial test is used to eliminate "negative" urine specimens
from further consideration and to identify the presumptively
positive specimens that require confirmation or further testing.
A negative specimen is any specimen that contains no drug or
whose apparent concentration of analyte is less than the cutoff
concentration for that drug or drug class.
Some laboratories may conduct a second initial test prior to
gas chromatography/mass spectrometry (GC/MS) confirmation
in an effort to enhance the specificity of the assay.
The following cutoff concentrations are used by certified laboratories to test
urine specimens collected by Federal agencies and by employers regulated by
the Department of Transportation:

Initial Test Cutoff Concentration: (nanograms/milliliter)
Marijuana metabolites 50, Cocaine metabolites 300, Opiate metabolites
2000, Phencyclidine25, Amphetamines1000
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Confirmatory Test Cutoff Concentration (nanograms/milliliter)
Marijuana metabolite (1) 15, Cocaine metabolite (2) 50, Opiates:
Morphine2000, Codeine2000, 6-Acetylmorphine (4) 10, Phencyclidine25,
Amphetamines:
Amphetamine500, Methamphetamine (3)500.
Footnotes:
(1) Delta-9-tetrahydrocannabinol-9-carboxylic acid
(2) Benzoylecgonine
(3) Specimen must also contain amphetamine at a concentration >= 200
nanograms/milliliter
(4) Test for 6-AM when morphine concentration exceeds 2000
nanograms/milliliter
The Validity Test
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Refers to testing to identify any attempt to tamper
with a specimen. This includes testing to identify
adulteration (e.g., putting a substance into a
specimen that is designed to mask or destroy the
drug or drug metabolite that the specimen may
contain or to adversely affect the assay reagent) or
substitution (e.g., diluting a urine specimen with a
liquid to effectively decrease the concentration of a
drug below the cutoff concentration, or replacing a
valid urine specimen with a Drug-Free specimen).
The Mandatory Guidelines for Federal Workplace
Drug Testing Programs published in the Federal
Register on June 9, 1994 (59 FR 29908) and the U.S.
Department of Transportation (DOT) regulations (49
CFR Part 40) applicable to DOT federally regulated
programs permit laboratories to conduct additional
tests to determine the validity of a urine specimen.
The laboratories certified under the National
Laboratory Certification Program (NLCP) have
reported that the number of adulterated, diluted, and
substituted urine specimens has been increasing. In
response, the U.S. Department of Health and Human
Services (HHS) and DOT began the process, using the
HHS Substance Abuse and Mental Health Services
Administration’s (SAMHSA) Drug Testing Advisory
Board (DTAB), to develop standards for the testing
and reporting of validity test results for urine
specimens tested in federally regulated programs.
(*) Urine specimens are defined in PD #35 as "dilute" if the creatinine
concentration is < 20 mg/dL and the specific gravity is < 1.003. An
analysis of that review resulted in selecting urine creatinine < 5 mg/dL
and urine specific gravity <1.001 or >1.020 as the criteria to define a
"substituted" specimen.
“Sample integrity failed”
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Samples with creatinine results less than or equal to 0.5 mmol/l (56
mg/l) or specific gravity results out of range are unsuitable for
testing.
Measurement of pH: Results within the range 4-9 are deemed to be
within a normal range. Results less than 3 or greater than 11 should
be considered to be adulterated. Samples falling outside this range
should be reported as eg “sample integrity failed”.
Nitrite test: If the nitrite concentration is determined: A nitrite level
equal to or above 500 μg/ml is conclusive proof of an adulterated
sample. The result should be reported as eg “sample integrity
failed”.
Testing for other adulterants: If other tests indicate that the sample
has been adulterated, or is otherwise unsuitable for analysis then it
should be reported as eg “sample integrity failed”
This remark is also reported when the sample does not fall under
the criteria of pH, creatinine or nitrite above, yet is still not suitable
for testing. This can be due to an unidentified interferant or poor
sample quality such as turbidity.
European Laboratory Guidelines
for Legally Defensible
Workplace Drug Testing (EWDTS)
Objectives The guidelines are designed to:
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1 Provide a minimum set of criteria for the providers of workplace
drug testing services within Europe.
2 Ensure that the processes undertaken are capable of legal scrutiny.
3 Provide safeguards to protect the specimen donors.
4 Define for laboratories common quality assurance and quality control
criteria that are capable of being accredited by an external body.
Scope  These guidelines consider the three key stages of the
workplace drug testing process.
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1 Obtaining the specimen from the donor (specimen collection).
2 Analysis of the sample for the presence of drugs (laboratory
analysis).
3 Review and interpretation of the analytical results
When a positive result:
Long-term frozen storage (-15°C or less) for any
necessary retest, storage for a minimum of 1 year.
Quality system (ISO 17025 must apply) which
encompasses all aspects of the testing process
including but not limited to:
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Sample receipt.
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Chain of custody.
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Security and reporting of results.
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Screen and confirmation testing.
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Certification of calibrators and controls.
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Validation of analytical procedures.
Interpretation results
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An analytical positive result may be due to medication
(prescribed or over-the-counter) or to dietary causes. An
essential part of the drug testing process is the final
review of positive analytical results.
The interpretation is best carried out by a qualified
medical practitioner (Medical Review Officer) who can
consult with the laboratory toxicologist, the donor, and
the donor's medical practitioner.
A toxicologist must be available to advise the customer
and/or Medical Review Officer regarding queries with
results. The toxicologist cannot issue a negative report
for a positive analytical result even if the test result is
likely to be due to the use of declared medication.
Some examples of prescription and over-the-counter drugs:
Analgesics
Aspirin w/codeine, Codeine, Darvocet, Darvon, Demerol, Dilaudid, Empirim Compound w/codeine, Levo-Dromoran,
Methadone, Percocer, Percodan, Soma Compound s/codeine, Talacet, Talwin, Tylenol w/codeine, and Vicodin.
Anti-Motion Sickness
Antivert, Dramamine, Marezine, Phenergan, Transdram-Scop
Tranquilizers & Sedatives
Ativan, Denadryl, Centrax, Compazine, Dalmane, Diazepam, Equani, Halcion, Haldol, Libritabs, Librium, Limbitrol,
Paxipam, Phenergan, Prolixin, Serax, Stelazine, Thorazine, Tranxene, Valium, Vlarelease, Xanax.
Antidepressants
Adapin, Amltriptyline, Asendin, Deprol, Desyrel, Elavil, Endep, Etrafon, Limbitrol, Lithium, Ludiomil, Marplan,
Nardil, Norpramin, Pamelor, Parnate, Petrofrane, Sinequan, Surmontil, Tofranil, Triavil, Vivactil.
Barbiturates
Alurate, Butisol, Dilantin, Mebaral, Nembutal, Pentobarital, Phenobarbiral, Secobarbital, Seconal, Sedapap, Tuinal.
Skeletal Muscle Relaxants
Flexeril, Parafon, Soma
Non-Prescription Cough & Cold Remedies, Antihistamines
Bendadryl, Bromfed, Chlortrimetron, Comtrex, Contac, Deconamine, Dimetapp, Dristan, Drixoral, Externdryl,
Fedahist, Kronofed, Naldecon, Nolamin, Novafed, Ornade, Phenergan, Rondec, Rynatan, Sinubid, Sinulin, Tavist-D.
Medical Review
(a) The Medical Review Officer (MRO) is a medical physician with
responsibility for interpreting laboratory results.
(b) A medical physician will have greater access to medical records than a
toxicologist and may therefore be in a better position to provide
interpretation of positive analytical results.
(c) The MRO must have specialist knowledge of and training in · Specimen
collection procedures.
· Analytical procedures.
· Chain of Custody.
· Alternative explanations for positive analytical results.
(d) The MRO can issue a negative report for a positive analytical result if
the test result is likely to be due to the use of declared medication, or a
valid alternative explanation has been found.
(e) The service provider may provide access to an independent medical
review service.
How to interpret a positive result
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For how long the sample is positive after drug
consumption? E.g. cocaine 250 mg (8-48 h)
Is the seafarer a drug addict or a casual consumer?
Repeat controls in intervals, it depens on the substance,
use hair E.g. Cannabis once a week (7-30 days, every
day (6-80 days)
In the time of urine collection, was the seafarer under
drug effects? Saliva-blood-breath are better correlated.
E.g. Heroine 10 mg IV (1-4 days), morfine IV (>72 h.),
metadone 38mg (8-56 h.)
Is it reliable? Yes about consumption not about addiction
and legal considerations. What way of administration?
Can it be by accident? Opiates & poop seeds, thé? &
cocaine. By contamination? Hair & cannabis oil, Because
of prescribed or self-administrated medicines? Cocaine
no, cannabis? Marinol®, look for metabolite in Opiates…
International Recomendations
Identify drug & alcohol problems
(Research ...).
 Policy of control: 1993 procedures
for ‘screening’ (tankers, urine
test…).
 Prevention campaigns:
information, education ...).
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Research in seafarers
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WJ Inzhong (1991) seafarers with HT 80 % smokers
& 85,3 % drinkers.
S. Balanza (1996) 72,3 % seafarers smokers, 88 %
drinkers (Cartagena - Spain).
M. Villanueva (1997, tesis) 51,1 % smokers & 50,3 %
drinkers (País Vasco - Spain).
Alcohol: F. Mestre (1997) 85 % smokers in coastal
fishing (Castellón-Spain) & J. Montoya (1991) 83 % in
injured ones (Almería-Spain). MJ. Loira (1987) in deep
sea fishing 54,5 % drink more at home that on board.
Alcohol