Microsoft word - therapeutic use exemption for asthma
THERAPEUTIC USE EXEMPTION FOR ASTHMA Excerpts taken from WADA’s Medical Information to Support the Decisions of TUECs for Asthma, Version 5.0 January 2013
Since January 01, 2010, a TUE is no longer required for the use of salbutamol* and salmeterol taken by inhalation as they were removed from the Prohibited List. Additionally, as of January 01, 2013, inhaled formoterol up to a maximum dose of 54micrograms over 24 hours is no longer prohibited and therefore does not require a TUE. If an athlete legitimately requires dosage in excess of 54mcg/day then a TUE must be requested. Even though some beta-2 agonists have been removed from the Prohibited List, it is recognized that asthma is not always well diagnosed or treated and therefore it is highly recommended that all athletes who are considering taking any asthma medications seek a clear diagnosis from a respiratory specialist and undergo the appropriate tests. It is also important to note that all athletes on medications for asthma that are not prohibited should still write all the medications and substances taken on the Doping Control Form, once they have been selected to undergo testing. Substances usually prescribed for control of Asthma
a) Beta-2 agonists
i) All beta-2 agonists (e.g. terbutaline, procaterol) not mentioned as exceptions below are prohibited and require a TUE.
ii) Salbutamol* (eg ventolin) Inhaled salbutamol is no longer prohibited. However, the presence of salbutamol in the urine in excess of 1000 ng/mL is presumed not to be a therapeutic use of the substance and will be considered as an adverse analytical finding. The athlete would then need to document the details of his/her, medical condition and medication use. The athlete may then be required to prove, by a controlled pharmacokinetic study that the abnormal test result was the consequence of the use of a therapeutic dose (maximum 1600 micrograms over 24 hours) of inhaled salbutamol. (1 puff of ventolin is 100micrograms so maximum allowed without TUE is 16 puffs per day)
iii) Salmeterol (eg seretide) Inhaled salmeterol is no longer prohibited.
iv) Formoterol (eg symicort and advair) Inhaled formoterol to a maximum dose of 54 micrograms over 24 hours is no longer prohibited. The presence in urine of formoterol in excess of 40 ng/mL is presumed not to be a therapeutic use of the substance and will be considered as an Adverse Analytical Finding unless the Athlete proves, through a controlled pharmacokinetic study, that the
abnormal result was the consequence of the use of the no greater than 54 micrograms over 24 hours. If a dosage in excess of 54mcg/day is legitimately required by the athlete, then a TUE must be requested.
b) Glucocorticosteroids (eg prednisone) The systemic use (e.g. oral or intravenous administration) of GCS is prohibited and requires a TUE. When systemic GCS are used for the treatment of an exacerbation of asthma, a retroactive/emergency TUE should be submitted as soon as possible to the appropriate anti- doping organization. V. Route a) Only certain inhaled beta-2 agonists are permitted and only when used by inhalation at therapeutic dosages. b) The systemic use (oral, intravenous or rectal) of GCS is prohibited and requires a TUE. N.B: An athlete’s health should never be jeopardized by withholding medication in an emergency.
Special circumstances Where circumstances are deemed to be exceptional and treatment must be initiated before a TUE could be approved, retroactive/emergency TUEs are possible. Please see WADA’s International Standard for TUE attached. A Full and clear documentation of the medical incident is required and the TUE application process must be initiated at the first opportunity.
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