PROPERTIES
AND UNITS IN THE CLINICAL LABORATORY SCIENCES
Technical report IFCC-IUPAC 1999)
Prepared
for publication by
Henrik
Olesen1, David Cowan2, Rafael de la Torre3 ,
Ivan Bruunshuus1, Morten Rohde1, Desmond Kenny4
1Office
of Laboratory Informatics, Copenhagen University Hospital (Rigshospitalet),
Copenhagen, Denmark
2Drug
Control Centre, London University, Kings College, London, United Kingdom
3IMIM, Dr. Aiguader
80, Barcelona, Spain
4Dept.
of Clinical Biochemistry, Our Ladys Hospital for Sick Children, Crumlin,
Dublin 12, Ireland
#§The
combined Memberships of the Committee and the Commission (C-NPU) during the
preparation of this report (1994 to 1996) were as follows:
Chairman:
1989-1995 H. Olesen (Denmark); 1996 - D Kenny (Ireland). Members: X. Fuentes-Arderiu
(Spain; 1991-1997); J.G. Hill (Canada; 1987-1997); D. Kenny (Ireland;
1994-1997); H. Olesen (Denmark; 1985-1995);
P.L. Storring (United Kingdom; 1989-1995); P. Soares de Araujo (Brazil; 1994-1997); R. Dybkęr (Denmark;
1996-1997); C. McDonald (USA; 1996-1997).
Please forward comments to:
H.
Olesen, Office of Laboratory Informatics 76-6-1, Copenhagen University Hospital
(Rigshospitalet), 9 Blegdamsvej, DK-2100 Copenhagen, Denmark. E-mail: holesen@rh.dk
The term designating a substance being an active
ingredient of a drug may be a generic name, a nonproprietary name, a registered
trade name, a fantasy name or other. This causes difficulties in the transmission
of requests and reports on properties for such substances in biological fluids
to and from the clinical laboratories, and in the collating of this information
from different sources.
The document
comprises a list of properties of drugs in biological fluids for use in electronic
transmission systems. Systematic names are presented together with a code value
for each.
Preface
The present document is part twelve (XII) of a series
on properties and units in the clinical laboratory sciences initiated in 1987.
The series
will comprise:
I
Syntax and semantic rules [1]
II
Kinds-of-property [2]
III
Elements (of properties) and their code
values
IV
Properties and their code values
V
Properties and units in Thrombosis and
Haemostasis
VI
Properties and units in IOC prohibited
Drugs
VII
Properties and units in Inborn Errors of
Metabolism
VIII
Properties and units in Clinical
Bacteriology
IX
Properties and units in Trace Elements
X
Properties and units in General Clinical
Chemistry
XI
Coding systems - structure and guidelines
[3]
XII
Properties and units in Clinical
Pharmacology and Toxicology
(this report)
XIII
Properties and units in Reproduction and
Fertility
XVI
Properties
and units in Clinical Allergology
The size and complexity of parts III and IV are such
that their lists will be presented in electronic format. This is for ease of
handling and to facilitate expression of concepts in different languages.
At the end,
systematic names, elaborated according to international standards and recommendations
should be available in the different domains of clinical laboratory sciences.
The core of the series is code value strings representing concepts, that in
combination delineate and define each property regardless of linguistic
expression, thus avoiding errors during translation between languages.
Foreword and Scope
Clinical Laboratory Sciences are characterised by the
exacting nature of the work performed and the demand for an accurate
presentation of the outcome.
Further the domain is transnational, international or
"global".
The
adherent informatics system therefore needs to identify the findings accurately
and to present them with the degree of detail required. At the same time it has
to facilitate the transfer over linguistic and cultural barriers without
distortion or loss of clarity, in order to promote clear, unambiguous,
meaningful and fully informative communication in different terminologies.
The degree
to which a message (such as a laboratory report) needs to be expressed in a
formal, systematic language depends on the geographical, linguistic, social or
professional distance between the communicating parties. The greater the
distance, the greater the risk of misunderstanding.
Within one
laboratory, local jargon terms may be used which are usually well understood
between colleagues, but which would not be sufficiently widely known for
communication with the outside world. Likewise, a laboratory and its local
community of users, such as hospital or community physicians, may use a
"local dialect" of the language of clinical laboratory sciences which
is well understood by all concerned; but when the communication possibilities
are wider, even transnational, risks of serious misunderstanding arise.
The purpose
of this document is to apply the IFCCIUPAC recommended syntax structures for
request and report and to create a systematic terminology which can be used as
the basis for encoding laboratory messages in the domain of drugs. The
systamatic names recommended here are primarily for the purpose of unambiguous
data exchange. Their use in routine language by clinician or laboratory
practitioners is optional but encouraged.
Definitions
component: definable
part of a system [ENV 1614; 4]
EXAMPLE: Dextropropoxyphene as part of a plasma sample
discrimination value: value of a quantity established from purpose related
considerations
NOTE 1 - The term cut-off value is used as a synonym.
detection limit: result of a measurement by a given measurement
procedure for which the probability of an analytically false negative result is
b, given the probability a
of an analytically false positive result [5]
drug: substance which when absorbed into a living organism
may modify one or more of its functions [6]
NOTE - The term
is generally accepted for a substance taken for a therapeutic purpose, but is
also commonly used for abused substances
kind-of-property: attribute of phenomena, bodies or substances that
may distinguished qualitatively [after ENV 1614; 4]
NOTE 1 - In ENV 1614 the term property (in a general
sense) is used as synonym for kind-of-property.
NOTE 2 - A kind-of-property may be related
to nominal scale (ex. green; blue), ordinal scale (ex. small; large),
difference scale (ex. 10 °C (i.e. 10 °C more than an arbitrary zero)) or ratio scale (length
2 m or 5 m); the last two types of kind-of-property are also called
kind-of-quantity.
nominal scale: scale with a set of
possible values for a given kind-of-property that are each a word or symbol
without any relation to magnitude [5]
EXAMPLE:
Names of analgesic drugs.
NOTE
- The values may be listed in any arbitrary order according to practical
considerations and convention.
ordinal scale: scale with an
ordered set of possible values for a given kind-of-property that are each a
word or symbol used for ranking according to magnitude, but where differences
or ratios between values have no arithmetic meaning [5]
EXAMPLE:
arbitrary concentration of cannabinoid in urine (not detected; detected or
0 1).
difference scale:
scale with an ordered set of possible values of a given kind of measurable
quantity that are each a product of numerical value and unit of measurement
such that a given difference between values corresponds to the same difference
between magnitudes of the measurable quantities along the scale [5]
EXAMPLE:
(substance concentration increment) -32
µmol/l
property: set of data elements comprising information on
system, component and kind-of-property and their adherent specifications.
NOTE 1 - There is presently no officially approved definition
of this concept. The present definition is for use in this document only.
NOTE 2 - Information about identification of system,
time and result is not considered.
EXAMPLE: substance concentration of fentanyl in blood
plasma.
ratio scale: scale of
measurement with an ordered set of values for a given kind of measurable
quantity that are each a product of numerical value and unit of measurement
such that a given ratio between values corresponds to the same ratio between
magnitudes of the measurable quantities along the scale [5]
EXAMPLE:
0 0,1 0,2 - -
- 31 32 µmol/l.
system: demarcated arrangement of a set of elements and a
set of relationships between these elements [ENV 1614; 4].
EXAMPLE: a portion of urine, a portion of blood.
Systematic Request and
Report of Clinical Laboratory Results
By convention, properties and results of examinations
are represented by the equation:
Equation 1
Property =
Result
Tab. 1. Systematic request and report |
|
1 |
Identification and
time |
1.1 |
object or patient
identification |
1.2 |
date and time(s) of sampling |
|
|
2 |
Property |
2.1 |
System |
2.2 |
Component |
2.3 |
kind-of-property |
|
|
3 |
Result |
3.1 |
Equality, inequality or other operator |
3.2 |
value (for quantities on a difference or ratio
scale, a numerical value multiplied by a unit) |
|
|
4 |
Notes |
·
The laboratory report on a particular property
comprises the three parts 1, 2 and 3.
·
To each element in part 2 may be
added a specification as a parenthetic suffix for clarification, identification
and to avoid ambiguity.
·
Note(s) (part 4) relating to, for
example, diagnosis, medication, haemolysis or hardware breakdown are not
included, except when needed for the interpretation of results such as
pretreatment of patient or subject.
·
Thus the elements of a term for a
type of property comprise: System(specification)Component(specification);
kind-of-property(specification)
·
This is as recommended by IFCC
and IUPAC (3) and by the European standard ENV 1614:1995 [4]
·
EXAMPLE [NPU02164]
PlasmaGentamicin; substance concentration
·
The elements of a result
comprise: an operator (= < £ > ³ etc.), a numerical value and a unit, usually in
symbolic form. This is as recommended by the European standard ENV 12435:1996
[7]
·
EXAMPLE [NPU02164]
= 6 µmol/l
(prefix µ: micro = 10-6)
·
Nominal and ordinal scale values
carry no unit. In difference and ratio scales the unit must never be omitted in
reporting results, except for the unit 1.
·
It is further recommended that
the result includes or refers to a value for a measure of uncertainty [7].
·
The names of components are from
the International Nonproprietary Names (INN) of WHO [8] for pharmaceutical
substances (English, French, Russian and Spanish). If not recorded in INN,
preference is for CAS trivial names [9], USAN [10], BAN [11], Martindale [12],
in that sequence.
·
In addition to the systematic
name of the property, an example and other useful information are given.
For details, see IUPACIFCC
(Recommendations 1995). Syntax and semantic rules [1].
Most drugs are metabolised by the organism. Therefore
the analytical findings pertain to the drug administered and to its
metabolites. Often the non-modified drug is hardly detectable. If so, the
result given to the requester is on the parent compound in the form of a result
deduced from the presence of specific metabolites. Information on metabolites
found is part of the report and is given after a deduced from.
The terms
recommended are given in bold, that is: the systematic term for the type of
property, the unit and the code value.
Name of system and
parenthetic specification spelled out in full, and
followed by a long dash (em
dash).
Alphanumeric chemical
prefixes to component name.
Recommended name of component and parenthetic specification.
Shifted
to the left for alphabetical sorting and searching, and followed by a
semicolon.
Kind-of-property
and parenthetic specification.
Unit.
Other term(s)
Authority: Code
value for the international organization recommending the name of the component
or the combined elements of an entry
Note(s) with any further information
[NPUXXXXX]
Coding scheme
identifier and code value, intended for interlaboratory
transmission between
databases
Example in abbreviated form.
The term arbitrary in princible cannot be related to a volume. In clinical chemistry however a less well defined inhouse or a regional calibrator is often referred to and is expressed in arbitrary unit per litre in order to enable comparison of patient data over time and regionally. In each of these instances further information should be given in the parenthesis procedure. This could be information on the calibrator used, f.ex. BCR/CRM148/149R or it could refer to the inlaboratory document procedure xx. which is available on request.
In the examples given, a question mark, ?, has been used to represent the value of a result for properties including quantities.
EXAMPLES
a. Nominal scale
1. Urine
3. Analgesic drug;
4. taxon(procedure)
9. [NPU04479]
10. UAnalgesic drug; taxon(Firm
xxx) = Buprenorphine; Dextropropoxyphene
1. Urine
3. Narcotic drug;
4. taxon(procedure)
9.
[NPU08930]
10.
UNarcotic drug; taxon(Firm xxx) =
Cocaine
deduced
from
Benzoylecgonine
(CAS519-09-5)
Ecgonine
(CAS481-37-8)
b. Ordinal
scale
In the actual reporting the possible
scale values should be listed in the parenthesis after the kind-of-property.
1. Urine
3. Analgesic drug;
4. arbitrary
concentration(list; procedure)
9. [NPU04845]
10. UAnalgesic drug; arb.c.(list; 0 1)
[NPU04934]
UAlphaprodine; arb.c.(0 1) = 0
[NPU04401]
UAnileridine; arb.c.(0 1) = 0
[NPU04584]
UBuprenorphine; arb.c.(0 1) = 1
[NPU01710]
UCodeine; arb.c.(0 1) = 0
[NPU04916]
UDextromoramide; arb.c.(0 1) = 0
[NPU01866]
UDextropropoxyphene; arb.c.(0 1) = 1
[NPU04450] UDiamorphine; arb.c.(0
1) = 0
[NPU04454] UDipipanone; arb.c.(0 1) = 0
[NPU04463] UEthoheptazine; arb.c.(0 1) =
0
[NPU04464] UEthylmorphine; arb.c.(0 1) =
0
[NPU02032] UFentanyl; arb.c.(0 1) = 0
[NPU02408]
UHydrocodone; arb.c.(0 1) = 0
[NPU02523]
UKetobemidone; arb.c.(0 1) = 0
[NPU04497]
ULevorphanol; arb.c.(0 1) = 0
[NPU02722] UMethadone; arb.c.(0 1)
= 0
[NPU02846] UMorphine(non-complexed);
arb.c.(0 1) = 0
[NPU04536]
UNalbuphine; arb.c.(0 1) = 0
[NPU04591] UOxycodone; arb.c.(0 1)
= 0
[NPU04596] UParacetamol; arb.c.(0 1) = 0
[NPU03035] UPentazocine; arb.c.(0 1) = 0
[NPU03049] UPethidine; arb.c.(0 1) = 0
[NPU04599] UPhenazocine; arb.c.(0 1) = 0
[NPU03384]
USalicylate; arb.c.(0 1) = 0
[NPU04549]
UTramadol; arb.c.(0 1) = 0
[NPU04647]
UTrimeperidine; arb.c.(0 1) = 0
1. Urine
3. Cocaine;
4. arbitrary
concentration(procedure)
7.
Authority: BAN
9.
[NPU01706]
10. UCocaine;
arb.c.(0 1) = 1
deduced from
Benzoylecgonine (CAS519-09-5)
Ecgonine (CAS481-37-8)
c. Ratio
scale
1.
Plasma
3. Fentanyl;
4. substance
concentration
5. nanomole/litre
9.
[NPU08918]
10. PFentanyl; subst.c. = ? nmol/l
References
1. Commission/Committee on Quantities and Units (in Clinical Chemistry) of the IUPACIFCC (International Union of Pure and Applied Chemistry International Federation of Clinical Chemistry). Properties and units in the clinical laboratory sciences. I. Syntax and semantic rules. Prepared for publication by H Olesen. Pure & Appl Chem 1995; 67: 1563-74; Eur J Clin Chem Clin Biochem 1995; 33: 627-36; Clin Chim Acta 1996; 245: S5-S21.
2.
Commission/Committee on
Quantities and Units (in Clinical Chemistry) of the IUPACIFCC (International
Union of Pure and Applied Chemistry International Federation of Clinical
Chemistry). Properties and units in the clinical laboratory sciences. II.
Kinds-of-property. Prepared for publication by D Kenny, H Olesen. Eur J Clin Chem Clin Biochem, 1997; 35:
317-44.
3.
IUPACIFCC (International Union
of Pure and Applied Chemistry International Federation of Clinical Chemistry),
Commission-Committee on Nomenclature, Properties and Units.
Properties and units in the clinical laboratory sciences. XI. Coding systems -
structure and guidelines. (Technical report 1997). Prepared for publication by
H Olesen, D Kenny, R Dybkęr, I Ibsen, I Bruunshuus, X Fuentes-Arderiu, G Hill,
P Soares de Araujo, C McDonald. Pure and Appl Chem 1997; 35: 317-44.
4. CEN/TC 251,1995. European Prestandard ENV 1614. Medical informatics. Structure for nomenclature, classification and coding of properties in clinical laboratory sciences.
5. Dybkaer R. Vocabulary for use in measurement procedures and description of reference materials in laboratory medicine. Eur J Clin Chem Clin Biochem 1997; 35(2): 141-73.
6. Duffus JH. Glossary for chemists of terms used in toxicology. Pure and Appl Chem 1993; 65: 2003-2122.
7. CEN/TC 251, 1996. European Prestandard, ENV 12435. Medical informatics. Expression of the results of measurement in health sciences.
8. WHO (World Health Organization). International Nonproprietary Names (INN) for Pharmaceutical Substances. Geneva: WHO.
9. CAS (Chemical Abstracts Service) Registry Number.
10. USAN (United States Adopted Name). 1961-1987 Cumulative List. List 147-289.
11. BAN (British Approved Names) booklet, 1986, 1st, 2nd, 3rd, and 4th supplements.
12.
Reynolds EF (ed.), 1996. Martindale. The Extra Pharmacopoeia. 31st edition.
London: The Pharmaceutical Press.
BAN
British
Approved Name
CAS
Chemical
Abstracts Service
IFCC
International
Federation of Clinical Chemistry and Laboratory Medicine
INN
International Nonproprietary Names of WHO
(approved)
*INN
for
name to be approved
ISO
International Organization for
Standardization
IUPAC
International
Union of Pure and Applied Chemistry
USAN
United
States Adopted Name
WHO
World
Health Organization