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VALIDITY OF DIFFERENT VALIDITY OF DIFFERENT DRUG AND ALCOHOL TESTING DRUG AND ALCOHOL TESTING METHODS METHODS IMHA Workshop & Seminar, Mumbai, IMHA Workshop & Seminar, Mumbai, 2006 2006 DRUG AND ALCOHOL PREVENTION PROGRAMME – DRUG AND ALCOHOL PREVENTION PROGRAMME – TRAINING SEMINAR TRAINING SEMINAR Dr. M. Luisa Canals Dr. M. Luisa Canals PhD, Specialist in Occupational Health. Master in Drug PhD, Specialist in Occupational Health. Master in Drug addictions and AIDS. Maritime Health MD, ISM, URV addictions and AIDS. Maritime Health MD, ISM, URV Tarragona Tarragona Spain Spain Spanish Society of Maritime Medicine (SEMM) / Spanish Society of Maritime Medicine (SEMM) / International Maritime Health Association (IMHA) International Maritime Health Association (IMHA)

VALIDITY OF DIFFERENT DRUG AND ALCOHOL TESTING METHODS IMHA Workshop & Seminar, Mumbai, 2006 DRUG AND ALCOHOL PREVENTION PROGRAMME – TRAINING SEMINAR VALIDITY

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Page 1: VALIDITY OF DIFFERENT DRUG AND ALCOHOL TESTING METHODS IMHA Workshop & Seminar, Mumbai, 2006 DRUG AND ALCOHOL PREVENTION PROGRAMME – TRAINING SEMINAR VALIDITY

VALIDITY OF DIFFERENT VALIDITY OF DIFFERENT DRUG AND ALCOHOL DRUG AND ALCOHOL TESTING METHODSTESTING METHODS

IMHA Workshop & Seminar, IMHA Workshop & Seminar, Mumbai, Mumbai, 20062006

DRUG AND ALCOHOL PREVENTION PROGRAMME DRUG AND ALCOHOL PREVENTION PROGRAMME –TRAINING SEMINAR–TRAINING SEMINAR

VALIDITY OF DIFFERENT VALIDITY OF DIFFERENT DRUG AND ALCOHOL DRUG AND ALCOHOL TESTING METHODSTESTING METHODS

IMHA Workshop & Seminar, IMHA Workshop & Seminar, Mumbai, Mumbai, 20062006

DRUG AND ALCOHOL PREVENTION PROGRAMME DRUG AND ALCOHOL PREVENTION PROGRAMME –TRAINING SEMINAR–TRAINING SEMINAR

Dr. M. Luisa CanalsDr. M. Luisa CanalsPhD, Specialist in Occupational Health. Master in Drug addictions PhD, Specialist in Occupational Health. Master in Drug addictions and AIDS. Maritime Health MD, ISM, URV Tarragonaand AIDS. Maritime Health MD, ISM, URV Tarragona SpainSpainSpanish Society of Maritime Medicine (SEMM) / International Spanish Society of Maritime Medicine (SEMM) / International Maritime Health Association (IMHA)Maritime Health Association (IMHA)

Page 2: VALIDITY OF DIFFERENT DRUG AND ALCOHOL TESTING METHODS IMHA Workshop & Seminar, Mumbai, 2006 DRUG AND ALCOHOL PREVENTION PROGRAMME – TRAINING SEMINAR VALIDITY

Background points of Background points of Drug and Alcohol Drug and Alcohol

Testing:Testing: WHAT ? -- WHAT ? -- Especial characteristics of Especial characteristics of

seafarers work and vessels / Effects of seafarers work and vessels / Effects of drugs and alcohol … drugs and alcohol … DEFINITIONSDEFINITIONS

WHEN ? – WHEN ? – Reasonable suspicious / Medical Reasonable suspicious / Medical Fitness Exams / Drug and alcohol test Fitness Exams / Drug and alcohol test collection in situ: at random … collection in situ: at random … PREVENTIONPREVENTION

HOW ? HOW ? International recommendations for International recommendations for screening, 1993. E.g. ships that transport screening, 1993. E.g. ships that transport dangerous goods dangerous goods CERTIFICATE-VALIDITYCERTIFICATE-VALIDITY

Page 3: VALIDITY OF DIFFERENT DRUG AND ALCOHOL TESTING METHODS IMHA Workshop & Seminar, Mumbai, 2006 DRUG AND ALCOHOL PREVENTION PROGRAMME – TRAINING SEMINAR VALIDITY

Questions related to Questions related to Validity:Validity:

Why Why to test? to test? What are dangerous drugs? What are dangerous drugs? What drugs to test? Where? What drugs to test? Where?

Should informed consent be required? Should informed consent be required? Ethical considerationsEthical considerations > How to keep > How to keep confidentiality? What are the implications confidentiality? What are the implications of a positive test? of a positive test?

Method of collection and transport to lab Method of collection and transport to lab with all the circumstances, with all the circumstances, chain off custody chain off custody proceduresprocedures How can we assure that the How can we assure that the urine belongs to the patient?urine belongs to the patient?

Validity: How? Validity: How? Limitations of clinical test Limitations of clinical test laboratorylaboratory

Page 4: VALIDITY OF DIFFERENT DRUG AND ALCOHOL TESTING METHODS IMHA Workshop & Seminar, Mumbai, 2006 DRUG AND ALCOHOL PREVENTION PROGRAMME – TRAINING SEMINAR VALIDITY

WHAT & WHY ?WHAT & WHY ?

"Dangerous drugs" – e.g. under the US "Dangerous drugs" – e.g. under the US Department of Transportation rules - are: Department of Transportation rules - are: marijuana, cocaine, opiates, phencyclidine marijuana, cocaine, opiates, phencyclidine (PCP), and amphetamines(PCP), and amphetamines..

“ “Individual and Community ProblemIndividual and Community Problem” - Alcohol ” - Alcohol & drugs in the workplace have a close relation & drugs in the workplace have a close relation to:to:1. Decrease of work concentration.1. Decrease of work concentration.

2. Increased prevalence of absenteeism and social 2. Increased prevalence of absenteeism and social problems.problems.

3. Increased number of injures and accidents.3. Increased number of injures and accidents.

4. Increased prevalence of associated diseases.4. Increased prevalence of associated diseases.

5. Increased risk of mortality and disasters…5. Increased risk of mortality and disasters…

Page 5: VALIDITY OF DIFFERENT DRUG AND ALCOHOL TESTING METHODS IMHA Workshop & Seminar, Mumbai, 2006 DRUG AND ALCOHOL PREVENTION PROGRAMME – TRAINING SEMINAR VALIDITY

Research:Research:Research:Research: DetectionDetection of drugs / Detection of drugs / Detection

of the problem: of the problem: E.g: Description E.g: Description of addictive substances use of addictive substances use register though a computerised register though a computerised data base of seafarers’ medical data base of seafarers’ medical records of fitness examinations to records of fitness examinations to embark in Spain (ISM. 93-98, embark in Spain (ISM. 93-98, 134.219 * ) 134.219 * ) 73.2 % 73.2 %

EvidenceEvidence based medicine, based medicine, studies, references, studies, references, international meetings. international meetings.

(*) Registro de un factor de riesgo a través del reconocimiento médico laboralpreceptivo para embarque en España: el uso de sustancias adictivas. Med Marit 1 (8): 407-416.

Increased permanencein days according to themethod: Blood, saliva,urine, sweat, hair.

Page 6: VALIDITY OF DIFFERENT DRUG AND ALCOHOL TESTING METHODS IMHA Workshop & Seminar, Mumbai, 2006 DRUG AND ALCOHOL PREVENTION PROGRAMME – TRAINING SEMINAR VALIDITY

TobaccoAlcoholHeroineCocaineCannabisSedativesOthers

Almería

Figura 1: Distribución del consumo de sustancias adictivas registrado en los reconocimientos médicosprece ptivos para embarque según sustancias que superan la media por provincias marítimas

Spain: Seafarers’ fitness examinationsSpain: Seafarers’ fitness examinationsAreas that exceed the average of consumption per Areas that exceed the average of consumption per substancessubstances

Page 7: VALIDITY OF DIFFERENT DRUG AND ALCOHOL TESTING METHODS IMHA Workshop & Seminar, Mumbai, 2006 DRUG AND ALCOHOL PREVENTION PROGRAMME – TRAINING SEMINAR VALIDITY

% DE USO MEDIO POR% DE USO MEDIO PORPROVINCIA MARÍTIMAPROVINCIA MARÍTIMA(Global 73 % *IC 95% 68,42 - 77,77)(Global 73 % *IC 95% 68,42 - 77,77)

Tabaco 61 % *59,43 - 67,23 % (48 a 75 %)Alcohol 56 % *45,24 - 62,26 % (15 a 86 %)Heroína 2 % * 1,3 - 2,52 % (0,02 a 5,5%)Cocaína 1,4% * 0,51 - 2,6 % (0 a 12,1 %)Cannabis 3 % * 1,7 - 4,8 % ( 0,35 a 19,1%)Sedantes 0,4% * 0,02 - 0,69 % ( 0 a 4 %)Otros 2,9% gran dispersión 0 a 51,2 %

Tabaco 61 % *59,43 - 67,23 % (48 a 75 %)Alcohol 56 % *45,24 - 62,26 % (15 a 86 %)Heroína 2 % * 1,3 - 2,52 % (0,02 a 5,5%)Cocaína 1,4% * 0,51 - 2,6 % (0 a 12,1 %)Cannabis 3 % * 1,7 - 4,8 % ( 0,35 a 19,1%)Sedantes 0,4% * 0,02 - 0,69 % ( 0 a 4 %)Otros 2,9% gran dispersión 0 a 51,2 %

Tabaco 61 % *59,43 - 67,23 % (48 a 75 %)Alcohol 56 % *45,24 - 62,26 % (15 a 86 %)Heroína 2 % * 1,3 - 2,52 % (0,02 a 5,5%)Cocaína 1,4% * 0,51 - 2,6 % (0 a 12,1 %)Cannabis 3 % * 1,7 - 4,8 % ( 0,35 a 19,1%)Sedantes 0,4% * 0,02 - 0,69 % ( 0 a 4 %)Otros 2,9% gran dispersión 0 a 51,2 %

Page 8: VALIDITY OF DIFFERENT DRUG AND ALCOHOL TESTING METHODS IMHA Workshop & Seminar, Mumbai, 2006 DRUG AND ALCOHOL PREVENTION PROGRAMME – TRAINING SEMINAR VALIDITY

Correlaciones politoxicomanías:Correlaciones politoxicomanías:

Cocaína CannabisCocaína Cannabis

Heroína SedantesHeroína Sedantes

Tabaco AlcoholTabaco Alcohol

r = 0,71r = 0,71 r=0,91r=0,91

r=0,94r=0,94

r=0,77r=0,77

1 + 1 + 2 ...1 + 1 + 2 ...

Page 9: VALIDITY OF DIFFERENT DRUG AND ALCOHOL TESTING METHODS IMHA Workshop & Seminar, Mumbai, 2006 DRUG AND ALCOHOL PREVENTION PROGRAMME – TRAINING SEMINAR VALIDITY

Detection / Effects:Detection / Effects: Drug definition: Drug definition:

legal occupational legal occupational and medical aspectsand medical aspects

Classification:Classification:- NCS - NCS DepressionDepression

(alcohol, opiates, (alcohol, opiates, cannabis, cannabis, barbiturates)barbiturates)

- NCS - NCS EstimulationEstimulation (cocaine, (cocaine, anfetamines, extasis)anfetamines, extasis)

- - AlucinationsAlucinations (LSD) (LSD)

- - VolatilsVolatils (solvents) (solvents)

Drug abuse / AdditionDrug abuse / Addition

(Consumption / substance)(Consumption / substance) Withdrawal SyndromeWithdrawal Syndrome OverdoseOverdose Abuse Abuse (dependence, tolerance, (dependence, tolerance,

craving, DSM IV-TR)craving, DSM IV-TR) IntoxicationIntoxication

Page 10: VALIDITY OF DIFFERENT DRUG AND ALCOHOL TESTING METHODS IMHA Workshop & Seminar, Mumbai, 2006 DRUG AND ALCOHOL PREVENTION PROGRAMME – TRAINING SEMINAR VALIDITY

PRE-ANALYTICAL VALIDITYPRE-ANALYTICAL VALIDITYPoints to take into accountPoints 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”.

3. Specimen Collector. 4. Collection Site. 5. Collection Supplies. 6. Donor. 7. Custody and Control Form - Chain of Custody Form.

Page 11: VALIDITY OF DIFFERENT DRUG AND ALCOHOL TESTING METHODS IMHA Workshop & Seminar, Mumbai, 2006 DRUG AND ALCOHOL PREVENTION PROGRAMME – TRAINING SEMINAR VALIDITY

Screening: Screening: InformedInformedConsentConsent

ininSeafarers’Seafarers’

FitnessFitnessExaminatioExaminatio

nninin

SpainSpain

Page 12: VALIDITY OF DIFFERENT DRUG AND ALCOHOL TESTING METHODS IMHA Workshop & Seminar, Mumbai, 2006 DRUG AND ALCOHOL PREVENTION PROGRAMME – TRAINING SEMINAR VALIDITY

Screening: Screening: Informed ConsentInformed Consent

CertificateCertificate(Cruise Ships)(Cruise Ships)

Page 13: VALIDITY OF DIFFERENT DRUG AND ALCOHOL TESTING METHODS IMHA Workshop & Seminar, Mumbai, 2006 DRUG AND ALCOHOL PREVENTION PROGRAMME – TRAINING SEMINAR VALIDITY

Sample collectionSample collectionChain of custodyChain of custody

(Tanker (Tanker Certificate)Certificate)

Page 14: VALIDITY OF DIFFERENT DRUG AND ALCOHOL TESTING METHODS IMHA Workshop & Seminar, Mumbai, 2006 DRUG AND ALCOHOL PREVENTION PROGRAMME – TRAINING SEMINAR VALIDITY

DETECTIONDETECTION

Indication (* urine, blood, sweat, saliva, Indication (* urine, blood, sweat, saliva, hair…) hair…)

Validity of the testValidity of the test, technic drug testing , technic drug testing (cut-off level) / *#substances: alcohol (cut-off level) / *#substances: alcohol (hours), coca & opiates (2-3 days), (hours), coca & opiates (2-3 days), benzodiacepines (2 w), cannabis (2-30 benzodiacepines (2 w), cannabis (2-30 days)days)

Informed Consent & ConfidencialityInformed Consent & Confidenciality

Page 15: VALIDITY OF DIFFERENT DRUG AND ALCOHOL TESTING METHODS IMHA Workshop & Seminar, Mumbai, 2006 DRUG AND ALCOHOL PREVENTION PROGRAMME – TRAINING SEMINAR VALIDITY

MethodsMethods Urine:Urine: * high reliability * high reliability

(inmunoassay, (inmunoassay, GC/MS), cheap, cheap, 5 DOT more used for 5 DOT more used for screening, minimum risk, screening, minimum risk, legal backup. legal backup.

Possibility on site test Possibility on site test (acceptable quality but legal (acceptable quality but legal risk). risk).

Page 16: VALIDITY OF DIFFERENT DRUG AND ALCOHOL TESTING METHODS IMHA Workshop & Seminar, Mumbai, 2006 DRUG AND ALCOHOL PREVENTION PROGRAMME – TRAINING SEMINAR VALIDITY

BloodBlood: high : high liability, expensive, liability, expensive, many drugs but many drugs but not good for not good for cannabis.cannabis.

Breath:Breath: used for used for alcohol (alveolar alcohol (alveolar air, cheap, liability)air, cheap, liability)

Page 17: VALIDITY OF DIFFERENT DRUG AND ALCOHOL TESTING METHODS IMHA Workshop & Seminar, Mumbai, 2006 DRUG AND ALCOHOL PREVENTION PROGRAMME – TRAINING SEMINAR VALIDITY

Inmunoassay, Inmunoassay, GC/MS

Saliva:Saliva: simple, on site, simple, on site, liability, few legal liability, few legal backgroundbackground

Sweat:Sweat: 2-7 days, 2-7 days, acceptable, easyacceptable, easy

Hair: long lasting, Hair: long lasting, liability, few laboratories, liability, few laboratories, forensic researchforensic research

Page 18: VALIDITY OF DIFFERENT DRUG AND ALCOHOL TESTING METHODS IMHA Workshop & Seminar, Mumbai, 2006 DRUG AND ALCOHOL PREVENTION PROGRAMME – TRAINING SEMINAR VALIDITY

Drug TestingDrug TestingState of the question:State of the question:

Drug TestingDrug TestingState of the question:State of the question:

The Initial Test : an immunoassay testThe Initial Test : an immunoassay test that has been that has been approved for commercial distribution as an in vitro approved for commercial distribution as an in vitro diagnostic test by the Food and Drug Administration diagnostic test by the Food and Drug Administration (FDA). A number of different immunoassay techniques (FDA). A number of different immunoassay techniques are available to screen for the five drug classes [e.g., are available to screen for the five drug classes [e.g., radioimmunoassay (RIA), enzyme immunoassay (EIA), radioimmunoassay (RIA), enzyme immunoassay (EIA), kinetic interaction of microparticles in a solution (KIMS), kinetic interaction of microparticles in a solution (KIMS), and fluorescence polarization immunoassay (FPIA)]. and fluorescence polarization immunoassay (FPIA)].

The initial test is used The initial test is used to eliminate "negative" urine to eliminate "negative" urine specimensspecimens from further consideration and to identify the from further consideration and to identify the presumptively positive specimens that require presumptively positive specimens that require confirmation or further testing. A negative specimen is confirmation or further testing. A negative specimen is any specimen that contains no drug or whose apparent any specimen that contains no drug or whose apparent concentration of analyte is less than the cutoff concentration of analyte is less than the cutoff concentration for that drug or drug class. concentration for that drug or drug class.

Some laboratories may conduct a second initial test prior Some laboratories may conduct a second initial test prior to to gas chromatography/mass spectrometry (GC/MS) gas chromatography/mass spectrometry (GC/MS) confirmationconfirmation in an effort to enhance the specificity of the in an effort to enhance the specificity of the assay. assay.

Page 19: VALIDITY OF DIFFERENT DRUG AND ALCOHOL TESTING METHODS IMHA Workshop & Seminar, Mumbai, 2006 DRUG AND ALCOHOL PREVENTION PROGRAMME – TRAINING SEMINAR VALIDITY

The following cutoff concentrations are used by certified The following cutoff concentrations are used by certified laboratories to test urine specimens collected by Federal agencies laboratories to test urine specimens collected by Federal agencies and by employers regulated by the Department of Transportationand by employers regulated by the Department of Transportation::

Initial Test Cutoff Concentration: Initial Test Cutoff Concentration: (nanograms/milliliter)Marijuana metabolites 50, Cocaine metabolites 300, Opiate Marijuana metabolites 50, Cocaine metabolites 300, Opiate

metabolites 2000, Phencyclidine25, Amphetamines1000metabolites 2000, Phencyclidine25, Amphetamines1000

Confirmatory Test Cutoff Concentration Confirmatory Test Cutoff Concentration (nanograms/milliliter)(nanograms/milliliter)Marijuana metabolite (1) 15, Cocaine metabolite (2) 50, Opiates: Marijuana metabolite (1) 15, Cocaine metabolite (2) 50, Opiates:

Morphine2000, Codeine2000, 6-Acetylmorphine (4) 10, Morphine2000, Codeine2000, 6-Acetylmorphine (4) 10, Phencyclidine25, Amphetamines:     Amphetamine500, Phencyclidine25, Amphetamines:     Amphetamine500, Methamphetamine (3)500.Methamphetamine (3)500.

Footnotes:Footnotes:          (1) Delta-9-tetrahydrocannabinol-9-carboxylic acid(1) Delta-9-tetrahydrocannabinol-9-carboxylic acid

(2) Benzoylecgonine(2) Benzoylecgonine(3) Specimen must also contain amphetamine at a concentration (3) Specimen must also contain amphetamine at a concentration >= 200 nanograms/milliliter>= 200 nanograms/milliliter(4) Test for 6-AM when morphine concentration exceeds 2000 (4) Test for 6-AM when morphine concentration exceeds 2000 nanograms/milliliternanograms/milliliter

Page 20: VALIDITY OF DIFFERENT DRUG AND ALCOHOL TESTING METHODS IMHA Workshop & Seminar, Mumbai, 2006 DRUG AND ALCOHOL PREVENTION PROGRAMME – TRAINING SEMINAR VALIDITY

The Validity Test The Validity Test Refers to testing to identify any attempt to Refers to testing to identify any attempt to

tamper with a specimen. This includes testing tamper with a specimen. This includes testing to to identify adulterationidentify adulteration (e.g., putting a substance (e.g., putting a substance into a specimen that is designed to mask or into a specimen that is designed to mask or destroy the drug or drug metabolite that the destroy the drug or drug metabolite that the specimen may contain or to adversely affect the specimen may contain or to adversely affect the assay reagent) or assay reagent) or substitutionsubstitution (e.g., diluting a (e.g., diluting a urine specimen with a liquid to effectively urine specimen with a liquid to effectively decrease the concentration of a drug below the decrease the concentration of a drug below the cutoff concentration, or replacing a valid urine cutoff concentration, or replacing a valid urine specimen with a Drug-Free specimen).specimen with a Drug-Free specimen).

The The Mandatory Guidelines for Federal Workplace Mandatory Guidelines for Federal Workplace Drug Testing ProgramsDrug Testing Programs published in the Federal published in the Federal Register on June 9, 1994 (59 FR 29908) and the Register on June 9, 1994 (59 FR 29908) and the U.S. Department of Transportation (DOT) U.S. Department of Transportation (DOT) regulations (49 CFR Part 40) applicable to DOT regulations (49 CFR Part 40) applicable to DOT federally regulated programs permit laboratories federally regulated programs permit laboratories to conduct to conduct additional tests to determine the additional tests to determine the validity of a urine specimenvalidity of a urine specimen..

Page 21: VALIDITY OF DIFFERENT DRUG AND ALCOHOL TESTING METHODS IMHA Workshop & Seminar, Mumbai, 2006 DRUG AND ALCOHOL PREVENTION PROGRAMME – TRAINING SEMINAR VALIDITY

The The laboratories certified under the National laboratories certified under the National Laboratory Certification Program (NLCP)Laboratory Certification Program (NLCP) have have reported that the number of reported that the number of adulterated, adulterated, diluted, and substituted urine specimensdiluted, and substituted urine specimens has has been increasing. In response, the U.S. been increasing. In response, the U.S. Department of Health and Human Services Department of Health and Human Services (HHS) and DOT began the process, using the (HHS) and DOT began the process, using the HHS Substance Abuse and Mental Health HHS Substance Abuse and Mental Health Services Administration’s (SAMHSA) Drug Services Administration’s (SAMHSA) Drug Testing Advisory Board (DTAB), to develop Testing Advisory Board (DTAB), to develop standards for the testing and reporting of standards for the testing and reporting of validity test results for urine specimensvalidity test results for urine specimens tested tested in federally regulated programs.in federally regulated programs.

(*) Urine specimens are defined in PD #35 as "dilute" if the Urine specimens are defined in PD #35 as "dilute" if the creatininecreatinine concentration is < 20 mg/dL and the concentration is < 20 mg/dL and the specific gravity specific gravity is < 1.003. An analysis of that review resulted in selecting urine is < 1.003. An analysis of that review resulted in selecting urine creatinine < 5 mg/dL and urine specific gravity <1.001 or creatinine < 5 mg/dL and urine specific gravity <1.001 or >1.020 as the criteria to define a "substituted" specimen.>1.020 as the criteria to define a "substituted" specimen.

Page 22: VALIDITY OF DIFFERENT DRUG AND ALCOHOL TESTING METHODS IMHA Workshop & Seminar, Mumbai, 2006 DRUG AND ALCOHOL PREVENTION PROGRAMME – TRAINING SEMINAR VALIDITY

“Sample integrity failed” 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.

Page 23: VALIDITY OF DIFFERENT DRUG AND ALCOHOL TESTING METHODS IMHA Workshop & Seminar, Mumbai, 2006 DRUG AND ALCOHOL PREVENTION PROGRAMME – TRAINING SEMINAR VALIDITY

European Laboratory Guidelines for Legally

DefensibleWorkplace Drug Testing

(EWDTS)Objectives The guidelines are designed to: 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. 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

Page 24: VALIDITY OF DIFFERENT DRUG AND ALCOHOL TESTING METHODS IMHA Workshop & Seminar, Mumbai, 2006 DRUG AND ALCOHOL PREVENTION PROGRAMME – TRAINING SEMINAR VALIDITY

When a positive result:When a positive result: When a positive result: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: Sample receipt. Chain of custody. Security and reporting of results. Screen and confirmation testing. Certification of calibrators and controls. Validation of analytical procedures.

Page 25: VALIDITY OF DIFFERENT DRUG AND ALCOHOL TESTING METHODS IMHA Workshop & Seminar, Mumbai, 2006 DRUG AND ALCOHOL PREVENTION PROGRAMME – TRAINING SEMINAR VALIDITY

Interpretation resultsInterpretation results 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.

Page 26: VALIDITY OF DIFFERENT DRUG AND ALCOHOL TESTING METHODS IMHA Workshop & Seminar, Mumbai, 2006 DRUG AND ALCOHOL PREVENTION PROGRAMME – TRAINING SEMINAR VALIDITY

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.

Page 27: VALIDITY OF DIFFERENT DRUG AND ALCOHOL TESTING METHODS IMHA Workshop & Seminar, Mumbai, 2006 DRUG AND ALCOHOL PREVENTION PROGRAMME – TRAINING SEMINAR VALIDITY

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.

Page 28: VALIDITY OF DIFFERENT DRUG AND ALCOHOL TESTING METHODS IMHA Workshop & Seminar, Mumbai, 2006 DRUG AND ALCOHOL PREVENTION PROGRAMME – TRAINING SEMINAR VALIDITY

How to interpret a positive How to interpret a positive resultresult

For For how long the sample is positivehow long the sample is positive after drug after drug consumption? E.g. cocaine 250 mg (8-48 h)consumption? E.g. cocaine 250 mg (8-48 h)

Is the seafarer a Is the seafarer a drug addict or a casual consumerdrug addict or a casual consumer? ? Repeat controls in intervals, it depens on the Repeat controls in intervals, it depens on the substance, use hair E.g. Cannabis once a week (7-30 substance, use hair E.g. Cannabis once a week (7-30 days, every day (6-80 days)days, every day (6-80 days)

In the time of urine collection, was the seafarer In the time of urine collection, was the seafarer under under drug effectsdrug effects? Saliva-blood-breath are better ? Saliva-blood-breath are better correlated. E.g. Heroine 10 mg IV (1-4 days), morfine correlated. E.g. Heroine 10 mg IV (1-4 days), morfine IV (>72 h.), metadone 38mg (8-56 h.) IV (>72 h.), metadone 38mg (8-56 h.)

Is it Is it reliablereliable? Yes about consumption not about ? Yes about consumption not about addiction and legal considerations. What way of addiction and legal considerations. What way of administration? Can it be by accident? Opiates & administration? Can it be by accident? Opiates & poop seeds, thé? & cocaine. By contamination? Hair & poop seeds, thé? & cocaine. By contamination? Hair & cannabis oil, Because of prescribed or self-cannabis oil, Because of prescribed or self-administrated medicines? Cocaine no, cannabis? administrated medicines? Cocaine no, cannabis? Marinol®, look for metabolite in Opiates…Marinol®, look for metabolite in Opiates…

Page 29: VALIDITY OF DIFFERENT DRUG AND ALCOHOL TESTING METHODS IMHA Workshop & Seminar, Mumbai, 2006 DRUG AND ALCOHOL PREVENTION PROGRAMME – TRAINING SEMINAR VALIDITY

International International RecomendationsRecomendations

International International RecomendationsRecomendations

Identify Identify drug & alcohol drug & alcohol problems (Research ...).problems (Research ...).

Policy of control:Policy of control: 1993 1993 procedures for ‘screening’ procedures for ‘screening’ (tankers, urine test…).(tankers, urine test…).

Prevention campaignsPrevention campaigns: : information, education ...).information, education ...).

Page 30: VALIDITY OF DIFFERENT DRUG AND ALCOHOL TESTING METHODS IMHA Workshop & Seminar, Mumbai, 2006 DRUG AND ALCOHOL PREVENTION PROGRAMME – TRAINING SEMINAR VALIDITY

Research in seafarersResearch in seafarersResearch in seafarersResearch in seafarers

WJ Inzhong (1991) seafarers with HT 80 % WJ Inzhong (1991) seafarers with HT 80 % smokers & 85,3 % drinkers.smokers & 85,3 % drinkers.

S. Balanza (1996) 72,3 % seafarers smokers, 88 S. Balanza (1996) 72,3 % seafarers smokers, 88 % drinkers (Cartagena - Spain).% drinkers (Cartagena - Spain).

M. Villanueva (1997, tesis) 51,1 % smokers & M. Villanueva (1997, tesis) 51,1 % smokers & 50,3 % drinkers (País Vasco - Spain).50,3 % drinkers (País Vasco - Spain).

Alcohol: F. Mestre (1997) 85 % smokers in Alcohol: F. Mestre (1997) 85 % smokers in coastal fishing (Castellón-Spain) & J. Montoya coastal fishing (Castellón-Spain) & J. Montoya (1991) 83 % in injured ones (Almería-Spain). MJ. (1991) 83 % in injured ones (Almería-Spain). MJ. Loira (1987) in deep sea fishing 54,5 % drink Loira (1987) in deep sea fishing 54,5 % drink more at home that on board.more at home that on board.

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AlcoholAlcohol

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