Drugs of abuse testing

NORMAN B. COFFMAN, PhD

JOHN FERNANDES, DO

Modern medical technology it is recognized that a group of drugs may pro-

has made available a complex array of test- duce similar syndromes in a patient, that the
ing methods for drugs of abuse. The gath- disposition of treatment will be essentially the
ering of the best information from these same for all patients having those symptoms,
methods demands that the clinician be fa- and that exact identification of the pharma-
miliar with the different testing protocols. cologic substance as a specific chemical entity
In this, the third article in a monthly se- has little or no impact on therapy. This is the
ries, the authors discuss the more common case with most patients requiring treatment
and useful tests and describe their use for for drug abuse or overdose.
optimal results. The second approach is designed to be
(Key words: Drug testing, abused- highly specific. When society intrudes into the
drug testing, spot tests, immunologically life of an individual for the purpose of alter-
mediated tests, chromatography, spec- ing his or her behavior or lifestyle, or for the
trometry, forensics) purpose of taking punitive action against that
individual, then it is only proper that the data
Drugs of abuse testing may be helpful in used in justifying that action be of the high-
identifying the cause of a wide range of symp- est, unimpeachable character-that is, that it
toms and in making a diagnosis. The wide- have very high specificity. Confirmatory tech-
spread availability and use of drugs in con- niques using gas chromatography/spectrome-
temporary American society impinges on all try meet such high standards for definitive iden-
aspects of our daily lives. The pervasiveness tification.
of the effects of abused drugs on the symptoms
manifested by any particular patient demands Types of tests
that in all evaluations the physician always Commonly encountered drug-testing proce-
bear in mind the possibility of drug abuse. Ta- dures belong to one of a rather small number
ble 1 summarizes commonly abused drugs, of test types (Table 2). Spot tests, immunolo-
their effects on patients, and the window of gically mediated tests, chromatography tests,
time during which they can be detected. and chromatography/spectrometry coupled
There exist, in general, two distinct ap- tests are the methods most frequently used.
proaches to identification of drugs in biologi-
Spot tests
cal specimens. The first approach is one with
a high degree of sensitivity. In this approach, Spot tests usually test for a particular class
of drugs. These tests are usually wet chemical
From the Department of Pathology and Laboratory Medi- methods that require little technical manipu-
cine, Philadelphia College of Osteopathic Medicine, Phila- lation. At the same time, their proper per-
delphia, Pa. formance and interpretation often demand
Reprint requests to John Fernandes, DO, Chairman,
Department of Pathology and Laboratory Medicine, 4150 that the analyst be highly experienced. False-
City Ave, Philadelphia, PA 19131-1696. positive test results are frequently encountered

Clinical practice/laboratory medicine • Coffman and Fernandes JAOA • Vol 91 • No 4 • April 1991 • 385
 Table 1
Drugs of Abuse and Their Effects

Detection period
Substance and form How used Possible dangers in urine*

Alcohol Taken orally Liver disease 24 hours or less

Liquid Respiratory failure
Depression
Anxiety
Coma
Psychologic/physical
dependence

Amphetamines Taken orally, High blood pressure 2-4 days or more

Capsules or tablets injected, Loss of appetite
or inhaled Stroke
Fever
Heart failure
Psychoses

Barbiturates Taken orally Respiratory failure 1-21 days or more

Capsules or tablets Depression
Anxiety
Convulsions
Insomnia
Coma
Psychoses
Psychologic/physical
dependence
Death

Benzodiazepines Taken orally Respiratory failure 3 days or more

(tranquilizers) Depression
Capsules or tablets Anxiety
Convulsions
Insomnia
Coma
Psychologic/physical
dependence
Death

Cannabinoids Eaten or Damage to short-term 5-36 days or more

(marijuana and smoked memory and lungs
hashish) Psychoses
Dried herbs with seeds Psychologic dependence
and stems Birth defects

*Figures are estimates on ly. The amount taken, frequency of use, and individual's age, weight, health, and body chemistry all
affect the period of time a drug remains evident in a urine specimen.
Source: Adapted by permission from Drug Abuse: It Affects Us All. Abbott Park , Ill, Abbott Laboratories.

(because these tests are designed for high sen- The clinician must be aware of the limits
sitivity), but false-negative test results are usu- of detection for any test that is used. The cur-
ally not a problem so long as the drug level rently widely used spot tests detect toxic lev-
is high enough. (In fact, a spot screening test els of drugs, and may detect even lower levels.
should have no false-negative results. ) Examples of the spot tests are the FPN (ferric-

386 • JAOA • Vol 91 • No 4 • April 1991 Clinica l practice/laboratory medicine • Coffman and Fernandes
 Table 1 (continued)
Drugs of Abuse and Their Effects

Detection period
Substance and form How used Possible dangers in urine*

Cocaine (coke and crack) Inhale, injected, Damage to nasal passages 2-4 days or more
Liquid or power or smoked Weight loss
High blood pressure
Heart attacks
Convulsions
Strokes
Psychologic/physical
dependence

Lysergic acid diethylamide Taken orally, High blood pressure 2 days or more
(LSD) or in eyedrops Loss of appetite
Capsules, gelatin, liquid, Sleeplessness
or tablets Tremors
Anxiety
Flashbacks
Psychologic disorders

Opiates (heroin and Taken orally, Nausea 2-5 days or more

morphine) injected, inhaled, Vomiting
Crystals, liquid, powder, or smoked Loss of appetite
or tablets Respiratory failure
Convulsions
Coma
Psychologic/physical
addiction
Death

Phencyclidine (PCP) Taken orally, injected, Dulled coordination 3-8 days or more
Capsules, liquid, or smoked and senses
powder, or tablets Depression
Anxiety
Violent behavior
Convulsions
High blood pressure
Heart failure
Stroke
Coma
Death

Synthetic narcotics Taken orally, Nausea 2-5 days or more

(China white and injected, Vomiting
fentanyl) or inhaled Respiratory failure
Capsules, liquid or Convulsions
powder Coma
Infections from
needles
Psychologic/physical
dependence
Death

*Figures are estimates only. The amount taken , frequency of use, and individual's age, weight, health, and body chemistry all
affect the period of time a drug remains evident in a urine specimen.
Source: Adapted by permission from Drug Abuse: It Affects Us All. Abbott Park, Ill, Abbott Laboratories.

Clinical practice/labora tory medicine • Coffman a nd Fernandes JAOA · Vol 91 • No 4 • April 1991 • 387
 Table 2
Common Thsts for Drugs

'JYpe of test Uses Advantages Disadvantages

Spot tests Screening Simple, easy to use Need experience to

(eg, ferric-perchloric- Little instrumentation run correctly
nitric [FPN], mercurous required Usually low
nitrate, acid Rapid specificity
dichromate) ~ ~

Immunologic Screening Readily available Specificity may be

eg, ELISA, FPIA, Therapeutic drug instrumentation that low
RIA*) monitoring can be operated by Assays available for
qualified personnel limited number of
with minimal training drugs
Easy to use
Rapid turnaround time
usually detects a
class of drugs

Thin-layer Screening Detects wide range of Data interpretation

chromatography compounds required highly
Low instrumentation skilled and
cost experienced
Fairly rapid personnel
Easy to use

Chromatography (other) Screening or Detects a wide range Expensive to acquire

(eg, gas-liquid therapeutic of compounds and operate
chromatography drug monitoring Can do complex Requires highly
[GL]; high-pressure Confirmation of separations skilled operators
liquid chromatography drugs found by
[HPLC]) another method

Coupled methods Confirmation of Very specific (forensic) Very expensive

(eg, gas-liquid positive results to acquire
chromatography tentatively identi- and operate
with mass fied by another Requires highly
spectrometry method trained and
[GC/MS]) skilled operators

*ELISA, enzyme-linked immunosorbent assay; FPIA, fluorescence polarization immunoassay; RIA, radioimmunoassay.

perchloric-nitric) test for phenothiazines, the Immunologically mediated tests

mercurous nitrate test for barbiturates, and At present, immunologically mediated tests
the acid dichromate test for volatiles such as are the most commonly used methods for
ethanol and aldehydes. abused-drug (and therapeutic drug) testing.
Spot tests are simple, but care must be This wide usage results, in large measure,
taken to assure that reagents are fresh and from the commercial availability of several
that both positive and negative control speci- instruments designed specifically for the per-
mens are included with each analytic run. Spot formance of immunologically mediated drug
tests are most useful in emergency situations, tests. Some more widely used methods include
when rapid diagnostic information is required. Syva's EMIT system (Syva Company, Palo
Not infrequently, these tests are useful for ''bed- Alto , Calif) and Abbott Diagnostics' TDx and
side" testing. ADx instruments (Abbott Laboratories, Diag-
( continued on page 395)

388 • JAOA • Vol 91 • No 4 • April 1991 Clinical practice/laboratory medicine • Coffman and Fernandes
 Patients taking
antihistamines may have
impaired performance
without feeling drowsy1.2

HUMAN PERFORMANCE
DEMANDS AN
ANTIHISTAMINE
PROVEN TO
FREE PATIENTS
FROM IMPAIRED
PERFORMANCE 2 23
-

Impairment-free relief
from the first dose through the season
SE&DA NE®
rterfenadineJ 60 mg tablets bid
for seasonal allergic rhinitis

Starts fast and lasts

>lease see brief summary of prescribing information on back page
DEMANDS AN
ANTIHISTAMINE
PROVEN
TO HAVE
NO EFFECTS ON
COGNITIVE
EFFICIENCY AND
ATTENTION SPAN
GREATER THAN
PLACEBO

Impairment-free relief
from the first dose through the season
SIE&DANIE®
(terfenadineJ 60 mg tablets bid
for seasonal allergic rhinitis

Starts fast and lasts

© 1991. Marion Merrell Dow Inc.
 DEMANDS AN
ANTIHISTAMINE
PROVEN
TO HAVE
NO EFFECTS ON
REACTION TIME
AND MOTOR
COORDINATION
GREATER THAN
PLACEBO

Lack of performance impairment must

be proven through extensive objective
testing-distinct from subjectively
reported drowsiness~4 .2 5 More than
60 objective tests of cognitive. motor;
and integrated performance-
documented in over 20 published
studies-show that Seldane has no
effects on human performance greater
than placebo.2-22

Impairment-free relief
from the first dose through the season
SIE&DAitiiE ~
rterfenadineJ 60 mg tablets bid
for seasonal allergic rhinitis
Please see brief summary of
prescribing information on next page. Starts fast and lasts 079850
FREES PATIENTS
FROM
PERFORMANCE
IMPAIRMENT
CAUSED BY Seldane®
(terfenadine)60mgTablets

CLASSICAL
BRIEF SUMMARY In controlled clinical studies using the recommended doseof60 mg b.i .d.•

s.---·--s.--
CAUTION: Federal law prohibits dispensing without prescriplion. the incidence of reported adverse effects in patients receiving Setdane was
DESCRIPTION similar to that reported in patients receiving placebo. (See Table below.)
Seldane (terfenadine) is available as tablets for oral administration. Each ADVERSE EVENlS REPORTED IN CUNICAL TRIALS
t~btet contains 60 mg terfenadine. Tablets also contain. as inactive in9re·

ANTIHISTAMINES,
d1ents: corn starch, gelatin , lactose, magnesium stearate, and sod1um
bicarbonate.
INDICATIONS AND USAGE
Seldane is indicated lor the relief of symptoms associated with seasonal
.......
E""
-S11101os" Coolnl
M=lt1 N=IIS N=625-
jAIICIIolciiSIM,..-
1=2W N=Wll
allergicrhinitissuchassneezing, rhinorrhea,pruritus,andlacrimation .
CONTRAINDICATION$ Central Nenous System

WHILE IT
Seldane is contraindicated in patients with a known hypersensitivity to llrowsmess 9.0 8.1 18.1 8.5 8.2
terfenadine or any of its ingredients. He>daclle 6.3 7.4 3.8 15.8 11.2
PRECAUTIONS
General: Terfenadine under~s extensive metabolism in the liver; Patients
with impaired hepatic function (alcoholic cirrhosis. hepatitis). or on
Fatigue
llzziness
Nervousness
...
2.9
0.9
0.9
1.1
0.2
5.8
1.0
0.6
4.5
1.5
1.7
3.0
11
1.0
ketocooazole or troleandomycin therapy, or havino conditions leadang to or We"'""' 0.9 0.6 0.2 0.6 0.5

PROVIDES FAST,
Appetite Increase 0.6 0.0 0.0 0.5 0.0
gro~o~r;~~a~i~engan7:~~~~Ur~~J~=: ~~~r~=:~ride:: Gastrointestinal System
The effect of terfenadine in palients who are receiving agents which alter Gastrointeslillil
the OT interval is not known. These events have also occurred In patients Distress(Abdominal
onmacrolideantibiotics,includingerythromycin,butcausalityisunclear. distress. Nausea,
!he events may be related to altered metabolism of the drug , to electrolyte

STRONG RELIEF
\tnri~ng , Change in
•[Link]. 5.4
Bowel habits) 4.6 3.0 2.7 7.6
Information tor patients: Patients taki~Q Seldane should receive the follow- E)o,E>;Noso,andllvoa1
ing information and instructions. AntihiStamines are prescribed to reduce 2.3 1.8 3.5 4.8 3.1
llrt-
~~~~~~~n~~g:~~!rt~~i~~~Ja~~~~~dra~. ~j~:~~:~r~~~~~~~~~~nsC:d ?~ Co<J9h
S...Throal
0.9
0.5
0.2
0.3
0.5
0.5
2.5
3.2
1.7
1.6
pregnancy or lactation only if the potential benefit justifies the potential risk
to fetus Of baby. Patients should be instructed to take Seldane only as needed Epistaxis 0.0 0.8 0.2 0.7 0.4
and not to exceed the prescribed dose. Patients should also be instructed Skin
to store this medication in a tightly closed container in a cool . dry place. E""""[[Link]
;rwaylromheatordirectsunlight,and'htayfromchildren. andurticaria)oritl::OOg 1.0 1.7 1.4 1.6 2.0
Drug Interactions: Preliminary evidence exists that concurrent ketocona-

• Effects on patient
zole or macrolide administralion significantly alters the metabolism of "Duration of treatment in " CONTROLLED STUDIES" was usually 7-14
terfenadine. Concurrent use of Seldane with ketoconazole or troleandomy- DAYS.
cin is not recommended. Concurrent use of other macrolides should be
.::g~~~~Q~f6~~'G$~n~~~~~~~~~!~f!1~P~~~~~~~~~fo~:~.':::
performance no greater approachedwithcaulion.
Carcinogenesis. mutagenesis. impairment of fertility: Oral doses of ter-
fenadine, corresponding to 63 times the recommended human daily dose,
mine (189 patients), Clemastine (146 patients)
Rare reports of severe cardiovascular adverse effects have been received

than placebo [Link]

tumorigenicity. Microbial and micronucleus test assays with terfenaclil'le tiM
reveatednoevidenceofmutagenesis.
which include arrhythmias (>Rrnriculartachyarrhythmia,torsades de pointes,
ventricular fibrillation). hypotension, palpitations, and syncope. In controlled
clinical trials in otherwise normal patients with rhinitis. at doses ol60 mg
b.i.d. small increases in arc interval were observed. Changes of this
Reproduction and fertility studies in rats showed no [Link] male ocfemale

• Lets patients stay alert fertility at oral doses of up to 21 times the human daily dose. 14. 63 times
~~~A":r::er,~~~=~:~~~~~=~e:~ct:~~=~
implantation losses were observed , which were judged to be secondary to
~=~.~~ !~~;e~r~:J.r~~~ig~i~~s)fa~~~ ~-'!_~i~:~~~ii~~:see
-4~
in Ole of 10% (range to +30%) (mean increase of -46 msec) was
observedwithoutclinical signsorsymptoms.
In addition to the more frequent side effects reported in clinical trials (See

• Strong through-the-
maternal toxicity.
Table), adverse effects have been reported at a lower incidence in clinical
Pregnancy Category C: There was no evidence of animal teratogenicity. trials and/or spontaneously during marketing of Seldane that warrantlist •
Reproduction studies have been performed in rats at doses 63 times and ing as possibly associated with drug administration. These include: alope-

season relief
t25timesthehumandailydoseandhaverevealeddecreasedpupwt:ight cia (hair Joss or thinning), anaphylaxis, angioedema, bronchospasm,
~~~ :r~il~~:~en ~~~~~d~2e~~~d~~st!e~~~:gl~g~i~~ confusion , depression. galactorrhea, Insomnia. menstrual disorders (InClud-
ing dysmenorrhea), musculoskeletal symptoms, nightmares. paresthesia ,
pregnant women . Seldane should be used during pregnancy only if the photosensitivity, seirures, sinus tachycardia, sweating , tremor. urinary
potential benefit justifies the potential risk to the fetus.

• Convenient 24-hour relief

frequency, and visual disturbance.
Nonteratogeniceffects: Seldane is not recommended for nursing women . In clinical trials, several instances of mild, or in one case. moderate trans-
~:e~~ ~~e~a~;:~2d;~i~;~~~~~;!~gS!1fya~~~~~hs~~~~~~P~~;~~~~ aminase elevations were seen in patients receiving Seldane. Mild elevations

at recommended dosage :~:~~~n~=:: ~Pa~=~:'~?-~~W~u;~s~~~::~a;~

during lactation.
wt:realsoseeninplacebotreatedpatients. Marketingexperiencesinclude
isolated reports of jaundice. cholestatic hepatitis, and hepatitis. In most cases
availabtelnformationisincomplete.
OVERDOSAGE
Pedatric use: Safety and effectiveness of Seldane in children below the age
• Proven worldwide with
Information concerning possible overdosage and its treatment appears in
of 12yearshavenotbeenestabtished. Full Prescribing Information.
ADVERSE REACTIONS DOSAGE AND ADMINISTRATION

more than 100 million Experience from clinical studies, including both controlled and uncontrolled
studies involving more than 2,-400 patients who received Seldane, provides
information on adverse experience incidence for periods of a few days up
~~~~~~i~J~m~ff~:,W~~~f~~~Y~;:,ulls and children 12 years and older.
MARION MERRELL DOW INC.

patient-months of use
to six months. The usual dose in these studies was 60 mg twice daily, but Prescription Products Division
in a small number of patients, the dose was as low as 20 mg twice a day, Kansas City, MO 6411-4
or as high as 600 mg daily.

References: 1. Seidel WF. Cohen S. Bliwise NG. et al. Ann Allergy. 1987;S9(Jif.S8-62. 2. Clarke CH, Nicholso1
AN. Br J Clin Pharmacol1978;6,31·35. 3. Swire FMM, Marsden CA. Barber C. et al. Psychopharmacology.
Impairment-free relief 1989;98425429. 4. Nicholson AN, Stone BM. Eur J Clin Pharmacol1983;25563-566. 5. Nicholson AN. Ston
BM. Br J Clin Pharmacol1982;13,199·202. 6. Nicholson AN, Smith PA. Spencer MB. Br J Clin Pharmacal
from the first dose through the season 1982;14,683-690. 7. Reinberg A. Levi F, Guillet P. et al. Eur J Clin Pharmaco11978;14,245-252. 8. Moser L.
HOther KJ. Koch-Weser J. et al. Eur J Clin Pharmacol1978;14:417423. 9. Goetz [Link] JM, Murnane
JE. et al. J Allergy Clin lmmuno11989;84,316·322. 10. Weiner M. Arzneim-Forsch/Drug Res. 1982;320~1193
SE&DAitiE ~ 1195. 11. Meador KJ. Loring DW. Thompson EE. et al. J Allergy Clin lmmuno11989;84,322-325. 12. Aso T.
Sakai [Link] Pharmacal Ther.1988;19!4f.681-688 13. Luscombe DK, Nicholls P~ Parish PA Pharmather<
peutica. 1983;B70-375. 14. Gaillard AWK. Gruisen A. de Jong R. Eur J Clin Pharmaco11988;35249-253.
rterfenadineJ 60 mg tablets bid 15. Moskowitz H. Burns M. Cutis 1988;42,14·18. 16. Cohen AF. Hamilton MJ, Peck AW. Eur J Clin Pharmacal
1987;32279-288. 17. Roehrs TA. Tietz El. Zorick FJ. et al. Sleep. 1984;7!2).137-141. 18. Fink M, Irwin P. Pharm<
for seasonal allergic rhinitis kopsychiat 1979;1B5-44. 19. Betts T. Markman D. Debenham S. et al. BrMedJ 1984;288281·282.

Starts fast and lasts

20. O'Hanlon JF. Cutis 1988;42,10-13. 21. Kulshrestha VK. Gupta PP. Turner P. et al. Br J Clin Pharmacal
1978;625·29. 22. Nicholson AN, Stone BM. Eur J Clin Pharmacol1986;3Q27·32. 23. Data on file, Marion
Merrell Dow Inc.. Kansas City, MO 64114. 24. Broadbent DE. Br J C/in Pharmacol1984;1855-9S.
25. Hindmarch I. Br J Clin Pharmacal 1980;10,189-209.
SELXD546 Printed in USA 11185,10798) 1V90
nostic Division, Irving, Tex). These analytic absorbing phase through which a fluid flows.
systems have been found to produce reliable An extract of the specimen is placed at one
data with minimal technologist's time. '.fum- location within the absorbing phase. As the
around times are much shorter than with ear- fluid moves along, it carries the drugs with
lier methods. it, but at varying rates, depending on the
The instrumentation is such that within- drugs' individual polarities, sizes, charges, and
facility testing is feasible . In fact, the routine other variables. Thus, the various drugs are
measurement of drug levels in clinical labora- separated from one another within the flow-
tories became a reality with the introduction ing fluid phase.
of these instruments. Even though immunolo- Thin-layer chromatography (TLC) is a use-
gic methods are available for a limited num- ful technique for emergency drug screening.
ber of classes of abused drugs, they are still It can detect a wide range of drugs, and usu-
very useful in emergency screening. Their use- ally at toxicologically useful levels. This tech-
fulness derives from the fact that only a few nique may miss the presence of some impor-
drugs (often fewer than ten) actually account tant drugs, especially at therapeutic levels. As
for nearly all the drugs of abuse encountered usual, one must be cognizant of the detection
in a given locality. limits of the particular system used. The TLC
Immunologic tests use antibodies as re- technique uses minimum instrumentation and
agents. When a drug (hapten) is combined affords a realistic turnaround time of a couple
with a protein, the complex can elicit antibody of hours. However, TLC does demand highly
production. The antibodies react with free drug trained and skilled personnel; continual prac-
found in serum, urine, or other biological fluid. tice is necessary for proper identification and
Choosing an antibody with the proper speci- interpretation of the data.
ficity allows the development of an analytic Gas liquid chromatography (GLC) and high-
test system that is specific for a particular drug pressure/performance liquid chromatography
or drug class. Monoclonal antibodies can be (HPLC) are useful for both drug screening and
made and used which will react with a mo- for the quantitation of drugs . The HPLC
lecular site unique to a class of drugs or even method has been helpful for some difficult thera-
completely unique to a particular drug or drug peutic drug analyses. The GLC determination
metabolite; polyclonal or mixed monoclonal an- of volatile substances in blood (for example,
tibodies usually react with a whole class of alcohols) is the most widely used method for
drugs. In developing a test system, it is neces- volatiles. A drawback to both the GLC and the
sary to conjugate the antibodies with a label HPLC techniques is that both require expen-
that can be used to measure either the anti- sive instrumentation and skilled operators.
body coupled with drug, or conversely, to meas- Both methods also require relatively long in-
ure that fraction not so coupled. Labels com- strument time per analysis. Therefore, except
monly used are radionuclides such as iodine for the analysis of volatiles, they are not usu-
125 and tritium, enzymes of which horserad- ally found in laboratories doing routine
ish peroxidase and alkaline phosphatase are studies.
examples, or fluorescent molecules such as fluo-
rescein. These immunologically linked tests Chromatography/spectrometry
have been most useful both in the screening Only coupled methods have the requisite speci-
of urine for classes of abused drugs and in the ficity for forensic work. Usually, gas liquid chro-
measurement of therapeutic drug levels. matography is coupled with mass spectrome-
try (GC/MS) . For a few specialized analyses,
Chromatography infrared spectrometry is also coupled to the gas
Chromatographic methods are useful for simul- chromatography (GC/IR/MS). The gas chroma-
taneous screening for a wide array of drugs- tograph separates the drugs from one another.
especially when overdose is suspected. All chro- Then the mass spectrometer "disassembles"
matographic methods use a stationary drug- the drug molecules under controlled conditions

Clinical practice/laboratory medicine • Coffman and Fernandes JAOA • Vol 91 • No 4 • Aprill991 • 395
and measures the weights and numbers of the documentation process is called establishing
resultant pieces. This method is analogous to a "chain of custody."
identifying a vehicle by taking it apart and The analytic process itself must comply ex-
then counting and weighing the various parts. actly with written procedures, that is, the stan-
One could then discern cars from trucks based dard operating procedure (SOP). The labora-
on the numbers and weights of just the tires, tory must analyze specimens the way it says
spark plugs, and lights. Infrared spectroscopy it does. If "creative" variations were to occur,
can distinguish drugs that are optical isomers then the validity of the whole analytic process
of one another. The specificity of these cou- could be subject to questioning. The usual pro-
pled methods measures up to the "beyond a tocol will specify that initial screening be done
reasonable doubt" standard of criminal judi- by an immunologic process and that specimens
cial proceedings. found positive by the screening procedure be
confirmed by GC/MS, the sequence in compli-
Forensic considerations ance with US federal government specifica-
A laboratory engaged in abused-drug testing tions ofthe National Institute on Drug Abuse.
for other than diagnostic purposes should be These specifications are often referred to as
prepared to present and defend their testing the NIDA Guidelines (Federal Register April
results in court. Such a defense demands that 11, 1988;53).
certain protocols be rigorously followed in the Finally, someone with extensive training
collection of specimens, in the analytic proce- and experience in drug analyses must review
dures, and in the review of instrumental data and certify instrumental data. Only then can
prior to the release of a report. the results be certified as accurate. In addi-
Collection and storage of the specimen must tion, the medical interpretation of the data
be completely documented with respect to the should be done by a physician (medical review
exact identity of the donor, the location of the officer, MRO) who is familiar with the medi-
specimen at all times, and the person(s) who cal interpretation of analytic data as it per-
handled or had access to the specimen. This tains to abused-drug testing.

396 • JAOA • Vol 91 • No 4 • April 1991 Clinical practice/laboratory medicine • Coffman and Fernandes