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PROPERTIES AND UNITS IN THE CLINICAL LABORATORY SCIENCES

VI. PROPERTIES AND UNITS IN IOC PROHIBITED DRUGS

(IUPAC-IFCC Recommendations 1996)

Prepared by the IUPAC–IFCC/C-NPU & IFCC/C-LDA:

H. OLESEN, D. COWAN, I. BRUUNSHUUS, K. KLEMPEL, G. HILL

Hypertext version July 1996 by Inge Ibsen. Link Revision: 01-04-06.

The following text is based on the document published in  Eur J Clin Chem Clin Biochem 1997; 35: 805-31. Clin Chim Acta 1997; 268: S5-73.

Contents

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  • Preface
  • Foreword and scope
  • Definitions
  • Standardised request and report of clinical laboratory results
  • Elements of an entry
  • References
  • Index of Abbreviations
  • List of Properties and units in IOC prohibited Drugs
  • Members of IUPAC-IFCC/C-NPU and IFCC/C-LDA at the time of preparation
  • Addresses of authors
  • Preface

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    The present document is part of a series on properties and units in the clinical laboratory sciences initiated in 1987.

    The series will comprise: 
    I Syntax and semantic rules [Ref. 1
    II Kinds-of-property [Ref. 2
    III Elements and their code values 
    IV Properties and code values 
    V Properties and units in Thrombosis and Haemostasis 
    VI Properties and units in IOC prohibited Drugs (This document)
    VII Properties and units in Inborn Errors of Metabolism 
    VIII Properties and units in Microbiology 
    IX Properties and units in Trace Elements 
    X Properties and units in General Clinical Chemistry 
    XI Coding systems - Structure and Guidelines 
    XII Properties and units in Clinical Pharmacology and Toxicology 
    XIII Properties and units in Reproduction and Fertility
    XIV Properties and units in Tumor markers
    XVI Properties and units in Allergology

    The size and complexity of parts III and IV are such that they will be presented in electronic format. This is for ease of handling and to facilitate expression of concepts in different languages.
    The overall aim is access by electronic media (Internet) of: 'Compendium of terminology and nomenclature of properties in clinical laboratory sciences' [Ref. 3].
    'Glossary of terms in quantities and units in clinical chemistry' [Ref. 4].
    'Properties and units in the clinical laboratory sciences'. At the end, standard 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 prone to incur on translation between languages.

    Foreword and scope

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    Clinical Laboratory Sciences are characterised by the exacting nature of the work performed and the demand for a precise presentation of the outcome.
    In drugs of abuse the parent compound is usually named in a report although the metabolites are often the components determined by the laboratory. 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 laboratory medicine which is well understood by all concerned; but when the communication possibilities are wider, even transnational, risks of serious misunderstanding arise.
    The purpose is to apply the IFCC–IUPAC recommended syntax structures for request and report and to create a standard systematic terminology which can be used as the basis for encoding laboratory messages in the domain of drugs of abuse. This is to facilitate communication of messages about such properties through computing and telecommu- nication between databases, messages that contain sufficient information to allow translation from and to the required "local dialect" at each end.
    Only drugs of abuse as defined by the International Olympic Committee Medical Code are dealt with. This is because the delineation in other domains is variable depending on legal requirements, culture, guidelines, attitude, etc.
    Essential is, that the structure used in IOC defined drugs of abuse, can be applied also to the domain "drugs" in general as a paradigma.
    The number of entries is 326, but the list is not exhaustive in that "related substances" for practical reasons is incomplete.
    The standard systematic names recommended here are for the purpose of electronic transmission and are not intended for standardisation of the language used by clinicians or laboratory practitioners.

    Definitions

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    component
    definable part of a system [Ref. 1; Ref. 5]
    NOTE: In the domain of drugs of abuse, the name of the component usually refers to the parent compound
    EXAMPLE: Acebutolol

    difference scale
    set of values, each being the product of a number and a unit, arranged according to magnitude, and with arithmetic meaning such that equal differences in scale numbers correspond to equal differences in magnitude [Ref. 14]
    NOTE: The principle of equality of differences is not violated by changing the size of the unit or the zero point; consequently, both are chosen arbitrarily, but should be conventional
    EXAMPLE: Testosterone/Epitestosterone substance ratio increment

    drug
    any substance which when absorbed into a living organism may modify one or more of its functions [Ref. 12]
    NOTE: The term is generally accepted for a substance taken for a therapeutic purpose, but is also commonly used for abused substances

    drug of abuse
    drug used for non-therapeutic purpose

    kind-of-property
    attribute of phenomena, bodies or substances that may distinguished qualitatively [Ref. 1; Ref. 5]
    NOTE: In Ref. 5 the term property (in a general sense) is used as synonym for kind-of-property
    EXAMPLE: colour (value: green; blue; ..), transparency, length (value: long; short; 2 m; 5 m; ..), amount-of-substance (value: 2 mol; 5 mol; ..)
    NOTE: Kind-of-property includes the concept kind-of-quantity . All kinds-of-property may be related to nominal scale (ex. green; blue) or ordinal scales (ex. small; large), but kinds-of-quantity are generally related to difference scales (ex. 10 ░C (i.e. 10 ░C more than an arbitrary zero)) or ratio scales (length 2 m or 5 m)

    nominal scale
    set of values, each having a unique name (la nomen) or symbol listed in arbitrary order according to practical considerations [Ref. 14]
    EXAMPLE: list of names of drugs of abuse

    ordinal scale
    set of values, each symbolised by words or a combination of numbers and words indicating magnitude and used for ranking [Ref. 14]
    EXAMPLE: arbitrary concentration of anabolic steroids in urine
    ("negative" "non-negative" or 0 1)

    property
    set of data elements comprising information on system, component and kind-of-property and their adherent specifications
    NOTE: Information about identification, time and result is not considered
    EXAMPLE: substance concentration of caffeine in urine

    particular property
    property of a given object (phenomenon, body or substance) [Ref. 1; Ref. 5]
    NOTE 1: 'Particular property' includes the concept of particular quantity
    NOTE 2: The adjective 'particular' may be omitted, if no ambiguity is caused
    EXAMPLE: substance concentration of caffeine in urine of NN at time xx

    ratio scale
    set of values, each being the product of a number and a unit, arranged according to magnitude and having its zero corresponding to the natural zero value [Ref. 14]
    EXAMPLE: 0 0,1 0,2 - - - 31 32 Ámol/l

    system
    demarcated arrangement of a set of elements and a set of relationships between these elements [Ref. 1; Ref. 5]
    EXAMPLE: Urine

    Standardised request for and report of clinical laboratory results

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    The main parts of a request and a report are presented in Table 1.

    Table 1. Standard systematic description and some recommended sources of names and symbols 
    Elements Sources of recommended terms 
    Particular property 
    1 Identification and time 
      1.1 identification of patient 
      1.2 date and time(s) of sampling 
    2 Property 
      2.1 system Nomina Anatomica 
      2.2 component WHO, IUPAC, IFCC, IUBMB 
      2.3 kind-of-property ISO, IUPAC, IFCC 
    3 Result 
      3.1 equality, inequality or other operator 
      3.2 numerical value 
      3.3 prefix SI 
      3.4 unit SI, WHO, IUPAC, IFCC, IUBMB 
    4 Note(s) 

    Essential for a request (Table 1) is parts 1 and 2, that is information on patient identification, time or time interval for sampling, and information on the property requested.
    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 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 property comprise:

    System(specification)—Component(specification); kind-of-property(specification)

    EXAMPLE [NPU01008]

    Urine—Acetazolamide; arbitrary concentration(IOC 95 Confirm; 0 1)

    The elements of a result comprise: an operator (=; <; <=; >; >=; etc.), a value, a prefix and a coherent unit.

    EXAMPLE [NPU01432]

    = 60 Ámol/l (prefix (: 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 a measure of uncertainty [Ref. 13].
    The names of components are from the International Nonproprietary Names (INN) of WHO [Ref. 6] for pharmaceutical substances (English, French, Russian and Spanish). If not recorded in INN, preference is for CAS [Ref. 7], USAN [Ref. 8], BAN [Ref. 9], Martindale [Ref. 10], in that sequence.
    In addition to the systematic name of the property, an example and other useful information is given.
    For details, see IUPAC–IFCC Recommendations 1995 - Syntax and semantic rules [Ref. 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 or not detectable. If so, the result given to the requester is on the parent compound, 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".
    Entries relating to IOC screening procedures are given in two forms:
    In short form with the result of a screening for a set of compounds on a nomimal scale listing the names of parent compounds, or if none are detected, the outcome as "none". See NPU04763, NPU04764, NPU04765, NPU04767, NPU04768, NPU04833.
    In extended form with the list of compounds screened for with an ordinal scale. See NPU04559, NPU04560, NPU04561, NPU04562, NPU04572, NPU04832.
    The confirmatory outcome is in only one form comprising the standard systematic name for a property on a parent compound, the scale values "0" (negative) or "1" (non-negative) and if "1" a "deduced from" followed by systematic names of metabolites found.
    Furthermore it should assist in the collation of data in databases and knowledge bases and facilitate improvement of procedures f.ex. in delineating the metabolites that are the more reliable in confirmation tests.

    Elements of an entry

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    The terms recommended (elements 1-6) are given in bold, that is: the code value, the standard systematic name, and the unit.

    1. Name of system and parenthetic specification spelled out in full, and followed by a long dash (em dash)
    2. Alphanumeric chemical prefixes to component name
    3. Recommended name of component and parenthetic specification Shifted to the left for alphabetical sorting and searching, and followed by a semicolon
    4. Kind-of-property and parenthetic specification
    5. Unit
    6. Molar mass (M) for conversion from other units
    7. Presently recommended calibrator
    8. Previous calibrator(s)
    9. Other term(s)
    10. Authority: Code value for the international organisation recommending the name of the component or the combined elements of an entry
    11. Note with any further information
    12. [NPUXXXXX]. Code value, intended for interlaboratory transmission between databases
    13. Example in abbreviated form

    EXAMPLES

    a. Nominal scale 
    1 Urine— 
    3 Anabolic steroid; 
    4 taxon(IOC 95 Screen) 
    10 Authority: IOC; IFCC/C-LDA 
    11 Note: Report is on parent compounds, based on specific metabolites for each compound. These are reported with the outcome of the confirmation study.
    12 [NPU04763] 
    13 U—Anabolic steroid; taxon(IOC 95 Screen) = Metandienone, Nandrolone, Oxymetholone 

     

    b. Ordinal scale 
    1 Urine— 
    3 Anabolic steroid; 
    4 arbitrary concentration(list; IOC 95 Screen) 
    10 Authority: IOC; IFCC/C-LDA 
    12 [NPU04560] 
    13 [NPU04560]U—Anabolic steroid; arb.c.(list; IOC 95 Screen) 
    [NPU3811] U—Androstanolone; arb.c.(IOC 95 Screen; 0 1) = ? 
    [NPU1394] U—Bolasterone; arb.c.(IOC 95 Screen; 0 1) = ? 
    [NPU1397] U—Boldenone; arb.c.(IOC 95 Screen; 0 1) = ? 
    [NPU1623] U—Clostebol; arb.c.(IOC 95 Screen; 0 1) = ?
    [NPU4301] U—Danazol; arb.c.(IOC 95 Screen; 0 1) = ? 
    [NPU1849] U—Dehydrochloromethyl testosterone; arb.c.(IOC 95 Screen; 0 1) = ? 
    [NPU4325] U—Drostanolone; arb.c.(IOC 95 Screen; 0 1) = ? 
    [NPU2064] U—Fluoxymesterone; arb.c.(IOC 95 Screen; 0 1) = ? 
    [NPU4321] U—Formebolone; arb.c.(IOC 95 Screen; 0 1) = ? 
    [NPU4408] U—Mestanolone; arb.c.(IOC 95 Screen; 0 1) = ? 
    [NPU2706] U—Mesterolone; arb.c.(IOC 95 Screen; 0 1) = ? 
    [NPU2712] U—Metandienone; arb.c.(IOC 95 Screen; 0 1) = ? 
    [NPU2716] U—Metenolone; arb.c.(IOC 95 Screen; 0 1) = ? 
    [NPU4309] U—Methandriol; arb.c.(IOC 95 Screen; 0 1) = ? 
    [NPU2801] U—Methyltestosterone; arb.c.(IOC 95 Screen; 0 1) = ? 
    [NPU4305] U—Mibolerone; arb.c.(IOC 95 Screen; 0 1) = ? 
    [NPU2885] U—Nandrolone; arb.c.(IOC 95 Screen; 0 1) = ? 
    [NPU2918] U—Norethandrolone; arb.c.(IOC 95 Screen; 0 1) = ? 
    [NPU2972] U—Oxandrolone; arb.c.(IOC 95 Screen; 0 1) = ? 
    [NPU3015] U—Oxymesterone; arb.c.(IOC 95 Screen; 0 1) = ? 
    [NPU3018] U—Oxymetholone; arb.c.(IOC 95 Screen; 0 1) = ? 
    [NPU3469] U—Stanozolol; arb.c.(IOC 95 Screen; 0 1) = ? 
    [NPU4410] U—Trenbolone; arb.c.(IOC 95 Screen; 0 1) = ? 

     

    1 Urine— 
    3 Metandienone; 
    4 arbitrary concentration(IOC 95 Confirm; 0 1) 
    6 M = 300,42 g/mol 
    9 Other term(s): Methandrostenolone 
    10 Authority: IOC; IFCC/C-LDA; INN88; CAS72-63-9 
    12 [NPU02713] 
    13 U—Metandienone; arb.c.(IOC 95 Confirm; 0 1) = 1 
    deduced from
    6[[beta]]-Hydroxymetandienone
    3'-Hydroxystanozolol

     

    1 Urine— 
    3 Nandrolone; 
    4 arbitrary concentration(IOC 95 Confirm; 0 1) 
    6 M = 274,39 g/mol 
    10 Authority: IOC; IFCC/C-LDA; INN88; CAS434-22-0 
    12 [NPU02886] 
    13 U—Nandrolone; arb.c.(IOC 95 Confirm; 0 1) = 1 
    deduced from 
    19-Norandrosterone
    19-Noretiocholanolone

     

    1 Urine— 
    3 Oxymetholone; 
    4 arbitrary concentration(IOC 95 Confirm; 0 1) 
    6 M = 332,47 g/mol 
    10 Authority: IOC; IFCC/C-LDA; INN88; CAS434-07-1 
    12 [NPU03019] 
    13 U—Oxymetholone; arb.c.(IOC 95 Confirm; 0 1) = 1 
    deduced from
    17[[alpha]]-Methyl-5[[alpha]]-androstane-2-hydroxymethylene-3[[alpha]],4,17[[beta]]-triol
    17[[alpha]]-Methyl-5[[alpha]]-androstane-3[[alpha]],17[[beta]]-diol

     

    d. Difference scale 
    1 Urine— 
    3 Testosterone/Epitestosterone; 
    4 substance ratio increment(IOC 95; dates) 
    10 Authority: IOC; IFCC/C-LDA 
    12 [NPU04402] 
    13 U—Testosterone/Epitestosterone; subst. ratio incr.(IOC 95; 1995-03-21 – 1995-02-21) = 8,3 

     

    e. Ratio scale 
    1 Urine— 
    3 Ephedrine; 
    4 substance concentration(IOC 95 Screen; (< 30 >= 30) micromole/litre) 
    5 micromole/litre 
    6 M = 165,23 g/mol 
    10 Authority: IOC; IFCC/C-LDA; BAN; CAS299-42-3 
    11 Note: IOC decision limit 30 Ámol/l 
    12 [NPU01936] 
    13 U—Ephedrine; subst.c.(IOC 95 Screen; (< 30 >= 30) Ámol/l) = < 30 Ámol/l 

     

    1 Urine— 
    3 Caffeine; 
    4 substance concentration(IOC 95 Confirm) 
    5 micromole/litre 
    6 M = 194,19 g/mol 
    10 Authority: IOC; IFCC/C-LDA; BAN; CAS58-08-2 
    11 Note: IOC decision limit 60 Ámol/l 
    12 [NPU01433] 
    13 U—Caffeine; subst.c.(IOC 95 Confirm) = ? Ámol/l 

    References

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    1. Commission/Committee on Quantities and Units(in Clinical Chemistry) of the IUPAC–IFCC (International Union of Pure and Applied Chemistry–International Federation of Clinical Chemistry, 1995. 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 IUPAC–IFCC (International Union of Pure and Applied Chemistry– International Federation of Clinical Chemistry, 1996. Properties and units in the clinical laboratory sciences. II. Kinds-of-property. Prepared for publication by D Kenny, H Olesen. To be published.
    3. Commission/Committee on Quantities and Units (in Clinical Chemistry) of the IUPAC–IFCC (International Union of Pure and Applied Chemistry–International Federation of Clinical Chemistry), 1995. Compendium of terminology and nomenclature of properties in clinical laboratory sciences. Prepared for publication by J.C. Rigg, S.S. Brown, R. Dybkaer, H. Olesen. Oxford: Blackwell Science, 290 pages.
    4. Commission/Committee on Quantities and Units(in Clinical Chemistry) of the IUPAC–IFCC (International Union of Pure and Applied Chemistry – International Federation of Clinical Chemistry, 1995. Glossary of terms in quantities and units in clinical chemistry. Prepared for publication by HP Lehmann, X Fuentes-Arderiu, L Bertello. Biochim Clin 1995; 19: 471-502; Pure & Appl Chem 1996; 68: 957-1000.
    5. CEN/TC 251,1995. European Prestandard ENV 1614. Medical informatics. Structure for nomenclature, classification and coding of properties in clinical laboratory sciences.
    6. WHO (World Health Organization), 1988. International Nonproprietary Names (INN) for Pharmaceutical Substances. Cumulative list no. 7. Geneva: WHO.
    7. CAS (Chemical Abstracts Service) Registry Number.
    8. USAN (United States Adopted Name). 1961-1987 Cumulative List. List 147-289.
    9. BAN (British Approved Names) booklet, 1986, 1st, 2nd, 3rd, and 4th supplements.
    10. Reynolds EF (ed.), 1989. Martindale. The Extra Pharmacopoeia. 29th edition. London: The Pharmaceutical Press.
    11. IOC (International Olympic Committee), Medical Commission, Sub-commision Doping and Biochemistry of Sport, 1995. Definition of doping and list of doping classes and methods. Given Lausanne, 27th January 1995.
    12. Duffus JH. Glossary for chemists of terms used in toxicology. Pure and Appl Chem 1993; 65: 2003-2122.
    13. CEN/TC 251, 1996. European Prestandard, ENV xxxxxx. Medical informatics. Expression of the results of measurement in health sciences.
    14. DybkŠr R, J°rgensen K, 1989. Measurement, value and scale. Scand J Clin Lab Invest 1989; 49: Supp 194: 69-79.

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    Index of Abbreviations

    BAN British Approved Name 
    CAS Chemical Abstract Service 
    C-LDA Committee on Laboratory Assessment on Drugs of Abuse of the IFCC/SD 
    ID Identification 
    IFCC International Federation of Clinical Chemistry 
    INN International Nonproprietary Names of WHO 
    *INN Name to be approved 
    IOC International Olympic Committee 
    ISO International Organization for Standardization 
    IUBMB International Union of Biochemistry and Molecular Biology 
    IUPAC International Union of Pure and Applied Chemistry 
    SD Scientific Division of the IFCC 
    SI International System of Units 
    USAN United States Adopted Name 
    WHO World Health Organization 

    List of Properties and units in IOC prohibited Drugs

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    Note: An asterisk before INN88 signifies that an objection has been raised to the proposed name by a WHO Member State.


    Addresses of authors

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    David Cowan: Drug Control Centre, London University, King's College, London SW3 6LX, United Kingdom

    Gilbert Hill: Department of Clinical Chemistry, Hospital for Sick Children, 555 University Avenue, Toronto, Ontario M5G 1X8, Canada

    Henrik Olesen, Ivan Bruunshuus, Karina Klempel: Department of Clinical Pharmacology Q 7642, Copenhagen University Hospital (Rigshospitalet), 20 Tagensvej, DK-2200 Copenhagen, Denmark


    Members

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    Membership of C-LDA:
    Chairman: H. Catlin (USA). Members: D. Cowan (United Kingdom); R. de la Torre (Spain); M. Donike (Germany)+ ; D. Fraisse (France); H. Oftebro (Norway).
    +Deceased 1995-08

    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); PL Storring (United Kingdom; 1989-1995); P Soares de Araujo (Brazil; 1994-1997); Clem McDonald (USA; 1996-1997).