International Standard for TUE: What These Changes Mean to You

Like anyone, athletes may have illnesses or conditions that require them to take particular medications. In some cases, these medications may fall under the Prohibited List. If so, a Therapeutic Use Exemption (TUE) may give the athlete authorization to take the needed medication while participating in sport.

Coming with the International Standards of Therapeutic Use Exemptions (ISTUE) revisions in 2009, there will be key differences of which athletes need to be aware. Below, we have provided a summary of these changes and also listed helpful TUE resources. It will also be necessary to check with the appropriate International Federation (IF) as to how they are handling the changes, especially in cases where the IF is responsible for granting the TUE.

First, how does an athlete know whether a medication is safe to take…

Drug Reference Resources: When considering taking a pharmaceutical medication, athletes need to know whether the product is prohibited or permitted. USADA provides four helpful ways to determine if a substance is permitted or not:

  1. Drug Reference Online (DRO): www.usada.org/DRO is a valuable resource with a comprehensive search function, by name of medication – whether by brand name or generic -- to determine its status.
  2. Drug Reference Line (DRL): Allowing athletes to call in and receive expert advice on the status of a medication, this toll-free number (800-233-0393) is operated Monday-Friday 9AM-4PM Mountain Standard Time.
  3. Guide to Prohibited Substances and Prohibited Methods of Doping: A comprehensive booklet providing a detailed summary of the WADA annual Prohibited List.
  4. Wallet Card: A portable, condensed version of the Guide, for easy reference on-the-go.

Abbreviated TUE

The Abbreviated TUE will no longer be a part of the TUE process. All uses of prohibited medications and substances will require a TUE for medications.

There is a grace period, however: Athletes with a current Abbreviated TUE will have until their Abbreviated TUE expires or December 31, 2009 (whichever occurs first) to re-apply for a TUE. Those athletes who currently have an Abbreviated TUE will receive a letter in the near future elaborating on the necessary steps during this transition period. As mentioned above, it is necessary to consult with the appropriate IF for their specific rules governing Abbreviated TUE transitions.

This applies specifically to two types of substances: beta-2 agonists and glucocorticosteroids.

  1. Beta-2 Agonists
    The use of inhaled formoterol, salbutamol, salmeterol and terbutaline will require advance declaration on the USADA website, a TUE, and documentation on the “Declaration of Use” section of the Doping Control Official Record at the time of testing. Obtaining a TUE for a beta-2 agonist will require more documentation than previously was needed for an Abbreviated TUE:
    1. a medical file pertaining to the diagnosis and need to use the beta-2 agonists;
    2. a comprehensive report of the clinical examination with specific focus on the respiratory system;
    3.  a report of spirometry, known as a Pulmonary Function Test (PFT), with the measure of the Force Expiratory Volume in 1 second (FEV1)
    4. if airway obstruction is present, evidence of the spirometry being repeated after inhalation of a short-acting beta-2 agonist to demonstrate reversibility of bronchoconstriction;
    5. in the absence of reversible airway obstruction, a bronchial provocation test is required to establish the presence of airway hyperresponsiveness; and
    6. exact name, specialty, address (including telephone, email and fax) of examining physician.

    A Few Things To Note Regarding Beta-2 Agonists:

    • USADA will accept a PFT from as much as 4 years prior to the date of the application.
    • It is important to remember that even with a current TUE on file, the presence of Salbutamol over 1,000 ng/mL may constitute an Adverse Analytical Finding.
  2. Glucocorticosteroids

    3. Glucocorticosteroids are commonly used to treat inflammation, asthma, and skin rashes. Depending on how the corticosteroid is used will determine if a TUE is required.
    1. Systemic Administration - Corticosteroids used by oral, intravenous, inter-muscular or rectal require the submission of a TUE..
    2. Non-Systemic or Inhalation Administration - Corticosteroids used by intraarticular, periarticular, peritendinous, epidural, intradermal injections and inhalation will require notation on the “Declaration of Use” section of the Doping Control Official Record when tested, as well as on USADA’s website.
    3. Topical Administration - Corticosteroids used as eye drops, nose drops, ear drops or iontophoresis are permitted and do not require the submission of a TUE.

Some Things Haven’t Changed

Where to Send a TUE: As before, USADA is trying to make the TUE process as easy as possible. Depending on the sport, in some instances USADA can authorize the TUE, and in other instances the athlete’s IF has to authorize the TUE. Nevertheless, we suggest that all US athletes (regardless of sport) submit their TUEs to USADA - we will forward them on to the appropriate organization for approval, if need be. With this, should there be a question or a delay in a response from an IF, we can easily follow-up and answer any questions an athlete may have.

ATTENTION ATHLETES - if are entered to compete at any event on this list, you are required to be approved by the IAAF to use prohibited substances that require a Therapeutic Use Exemption under the WADA Code. TUE applications must still be submitted to USADA (719-785-2029), but must include the name of the international competition that applies to the application.

If you have questions – please contact USATF’s Melissa Beasley at 317-713-4650 or USADA’s Becky Renck at 719-785-2045.

Granting of A TUE: A TUE may be granted to an athlete if it meets the following conditions:

  1. The athlete would experience a significant impairment to health if the use of the Prohibited Substance or Prohibited Method were to be withheld;
  2. The therapeutic use of the Prohibited Substance or Prohibited Method would not provide an enhancement to performance other than what might be anticipated by a return to a state of normal health;
  3. There are no reasonable, therapeutic alternatives to the use of the otherwise Prohibited Substance or Prohibited Method; and
  4. The need for the Prohibited Substance or Prohibited Method is not a consequence to the prior non-therapeutic use of another prohibited substance or method.

Once a TUE is granted or denied, a letter and/or a certificate is issued to the athlete with a copy sent to the athlete’s National Governing Body, IF and WADA as appropriate. The decision of the TUE is recorded by USADA. If a TUE request is denied, an athlete has the right to appeal the decision.

TUEs and Sport: It is important to remember that anti-doping rules only govern conditions under which sport is played. The approval or denial of a TUE only pertains to the use of the medication in sport. USADA does not provide medical advice on the direction of an athlete’s care. Any decision to stop or start a treatment should be made in consultation with the athlete’s physician.

For any questions regarding the International Standard for TUEs, please contact USADA’s TUE Department, at 719-785-2045 or via email at tue@usada.org.

Please note that this message only highlights some of the changes in the International Standard for TUE and is not intended to be a detailed summary of the changes.