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Microsoft word - 091030 tr wada 2010 prohibited list member unions.doc

September 19, 2009
2010 Prohibited List
Summary of Major Modifications


INTRODUCTORY PARAGRAPH

 The introductory sentence on the use of drugs limited to medically justified  The reference to Specified Substances has been amended in accordance with
SUBSTANCES AND METHODS PROHIBITED AT ALL TIMES (IN- AND OUT-OF-
COMPETITION)

S1: Anabolic Agents
 The International Nonproprietary Name (INN) for methyltrienolone has been  Comment S1.1b, including revisions, is addressed in another WADA document S2. Peptide Hormones, Growth Factors and Related Substances  In order to better define the substances within this category, the title has been revised to “Peptide Hormones, Growth Factors and Related Substances”.  To reflect the growing number of new erythropoeisis-stimulating substances available, methoxy polyethylene glycol-epoetin beta (CERA) has been added as  The issue of growth factors enhancing certain functions was addressed in more detail. Additional examples of growth factors affecting muscle, tendon or ligament protein synthesis/degradation, vascularisation, energy utilization, regenerative capacity or fibre type switching [e.g. Platelet-derived Growth Factor (PDGF), Fibroblast Growth Factors (FGFs), Vascular-Endothelial Growth Factor (VEGF), Hepatocyte Growth Factor (HGF)] were included.  The status of Platelet-derived preparations (e.g. Platelet Rich Plasma, “blood  Comment S2 is addressed in another WADA document (Technical Document  The use of salbutamol and salmeterol by inhalation no longer requires a TUE but  It is specified that the maximum dose for the controlled pharmacokinetic study cannot exceed the maximum therapeutic dose for inhaled salbutamol (1600 µg/day).  Two examples of aromatase inhibitors, androstene-3,6,17 trione (6-oxo) and androsta-1,4,6-triene-3,17-dione (androstatrienedione) have been added in view of their wide availability as components of nutritional supplements.  The status of glycerol (oral and intravenous) as a plasma expander was clarified  The non-prohibited status of pamabrom was clarified because it is a weak diuretic largely available as a combined over-the-counter medication for pre-menstrual/menstrual symptoms.
PROHIBITED METHODS

M1. Enhancement of Oxygen Transfer
 Supplemental oxygen is no longer prohibited.  Proteases have been added as an example of sample adulteration.  The status of intravenous infusions has been reviewed and now reads: “Intravenous infusions are prohibited except for those legitimately received in the course of hospital admissions or clinical investigations.”  For clarification purposes the gene doping definition was reworded and split into
SUBSTANCES AND METHODS PROHIBITED IN-COMPETITION

S6. Stimulants
 Three stimulants, namely benfluorex, prenylamine, both known to metabolize to non-specified stimulants (amphetamine or norfenfluramine) as well as methylhexaneamine, a non-therapeutic substance, were added to the closed list of non-specified stimulants.  Until 2003, the stimulant pseudoephedrine had been prohibited in sports with a threshold of 25 μg/mL. Pseudoephedrine has been included in the Monitoring Program since 2004. Results from the Monitoring Program over the past 5 years have shown a sustained increase in urinary concentrations of pseudoephedrine. In addition, there is clear evidence of abuse in some sports and some regions which show clusters of samples with high pseudoephedrine concentrations many times in excess of concentrations normally found. Furthermore, the available literature demonstrates scientific proof of its performance enhancing effects at certain doses. Therefore, the List Committee has reintroduced pseudoephedrine as a specified stimulant in the 2010 Prohibited List at a urinary threshold of 150 µg/mL based on the results from controlled excretion studies as well as the literature. Given the wide availability of pseudoephedrine-containing medicines, WADA recommends that the reintroduction of pseudoephedrine is supported by active information/education campaign by all stakeholders.  Although pseudoephedrine is now prohibited, it will remain in the Monitoring Program for urinary concentrations below 150 µg/mL.  It is clarified that synthetic cannabinoids are covered by this section.

SUBSTANCES PROHIBITED IN PARTICULAR SPORTS


P1. Alcohol and P2. Beta-blockers
 As the responsibility for testing in the sports of Boules and Archery has been transferred from the International Paralympic Committee (IPC) to the World Bowling Federation and the International Archery Federation (FITA), respectively, references to the IPC have been deleted. THE 2010 MONITORING PROGRAM*

The following substances are placed on the 2010 Monitoring Program:
1. Stimulants: In-Competition Only: Bupropion, caffeine,
phenylephrine, phenylpropanolamine, pipradrol, pseudoephedrine (< 150 micrograms per milliliter), synephrine. 2. Narcotics:
In-Competition Only: Morphine/codeine ratio.

* The World Anti-Doping Code (Article 4.5) states: “WADA, in consultation
with Signatories and governments, shall establish a monitoring program

regarding substances which are not on the Prohibited List, but which WADA wishes to monitor in order to detect patterns of misuse in sport.” 2010 Prohibited List
What major changes does the 2010 List of Prohibited Substances and Methods
include compared to the 2009 List?

 The List reflects the latest scientific advances.  Several of the changes to be implemented in 2010 will allow anti-doping organizations to manage a number of substances and methods in a significantly more administrative- and cost-effective way. In particular: Salbutamol
Following several years of practice and consideration of all relevant information from stakeholders and others, WADA’s List Committee recommended a change for the status of the beta-2 agonist salbutamol – a substance listed as a specified substance in the 2009 List. Over the past few years, almost all cases where salbutamol has been detected were covered by Therapeutic Use Exemptions (TUEs). In the 2010 List, therapeutic use of inhaled salbutamol will not be prohibited and will therefore no longer require a TUE. For monitoring purposes, athletes using inhaled salbutamol will be required to declare their use on the Doping Control Form when they are tested. Salbutamol will still be prohibited for urinary concentrations above 1,000 nanograms per millilitre. In such cases, there will be a presumption that the substance was not taken by inhalation and the athlete will have the burden to demonstrate through a controlled pharmacokinetic study that the level found in his urine was the result of therapeutic inhaled use. Anabolic Steroids
The detailed technical comments on the management of analytical results related to anabolic agents have now been moved to the revised WADA Technical Document on Minimum Required Performance Levels for Detection of Prohibited Substances. No further collections or analyses will be required in cases where the testosterone to epitestosterone (T/E) ratio is greater than 4 and an isotope ratio mass spectrometry (IRMS) test or any other reliable analytical method has not revealed evidence of exogenous administration of a prohibited substance. What other noteworthy changes does the 2010 List include?
Pseudoephedrine
 Pseudoephedrine will be reintroduced to the List.  Until 2003, pseudoephedrine was prohibited in sport. It has been included in WADA’s Monitoring Program annually from 2004 on. (The Monitoring Program includes substances that are not prohibited in sport but are monitored by anti-doping laboratories in order to detect patterns of misuse.)  Results of the Monitoring Program over the past five years have shown a sustained increase in samples containing pseudoephedrine. The Program indicated clear abuse of this substance with high concentrations in a number of sports and regions. In addition, available literature shows scientific evidence of the performance-enhancing effects of pseudoephedrine beyond certain doses.  Based on the results of the Monitoring Program, as well as scientific literature and results of controlled excretion studies conducted by WADA, pseudoephedrine will be prohibited above 150 micrograms per millilitre. Oxygen
 The 2010 List clarifies that supplemental oxygen (hyperoxia) is not prohibited. Platelet-Derived Preparations
 The status of platelet-derived preparations (e.g. Platelet Rich Plasma, “blood spinning”) has been clarified. These preparations will be prohibited when administered by intramuscular route. Other routes of administration will require a declaration of use in compliance with the International Standard for TUEs. What is the status of sildenafil (Viagra)?
 Sildenafil (Viagra) is not on the List.  WADA is aware of studies presented in relation to the potential of sildenafil to restore pulmonary capacities at very high altitudes. WADA is funding a number of research projects on the effects of sildenafil at various altitudes. These projects are ongoing. Additional information in regards to the reintroduction of pseudoephedrine
to the 2010 Prohibited List
The WADA List Committee has reintroduced pseudoephedrine (PSE) to the 2010 Prohibited List as a specified stimulant prohibited In-Competition at a urinary threshold of 150µg/mL. This decision was based on the results of controlled excretion studies as well as scientific literature [1-5]. Given the wide availability of PSE-containing medicines, WADA recommends that the reintroduction of PSE be supported by an active information/education campaign by all stakeholders. In this regard, WADA recommends that the following information be communicated, as soon as possible, to Athletes and their support personnel:  The established threshold levels may be reached (rarely, but possibly) by some individuals within 6-20 hours of intake of some long-lasting therapeutic formulations.  Advise athletes to stop taking PSE pills at least 24 hours before competition.
For therapeutic applications during the In-Competition period, consider the use of alternative permitted medications upon previous consultation with a physician, or apply for a Therapeutic Use Exemption (TUE) for the use of PSE for therapeutic purpose(s).  The threshold level has been established based on the intake of therapeutic doses of PSE, defined as a maximum daily dose of 240mg PSE taken either as: i) four (4) daily administrations (one every 4-6 hours) of a 60mg pill (or 2 x 30mg pills), or ii) two (2) daily administrations (one every 12 hours) of a 120mg pill iii) one (1) daily administration of a 240mg pill (extended release).    In line with this dosing regimen, the intake, for example, of a single daily dose of 3 x 60mg pills constitutes a supratherapeutic administration that may lead to an Adverse References 1- Gill N.D. et al (1999). Br J Clin Pharmacol 50, 205-213. 2- Chester N. et al. (2003). Br J Clin Pharmacol 57 :1, 62-67 3- Hodges K. et al. (2006). Med & Science Sports & Exercise, 329-333 4- Strano-Rossi S et al. (2209). Ther Drug Monit 31: 520-526. 5- Deventer K. Et al. (2009). Drug Test Analysis 1, 209-213.

Source: http://www2.rugby.com.au/Portals/18/Files/Administration/Policies/Anti-Doping/WADA_explanatory_documentation_regarding_2010_Prohibited_List.pdf

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