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Therapeutic use exemptions of substances and methods prohibited in sport: myths and realities. 

Recently, considerable attention has been paid to using by medical indications of substances and methods prohibited in sport. Some sources provide contradictory information; others have a great number of inaccuracies and errors. All this hampers making appropriate and realistic conclusions about this procedure. Let us look into it more closely.

Asthma.

In relatively recent past, two procedures of obtaining therapeutic use exemptions (TUE) for the substances and methods prohibited in sport, were in place – the standard TUE and the abbreviated TUE. The abbreviated TUE procedure was applied for substances which are used in medicine, including for treatment of bronchial asthma. However, later the abbreviated TUE procedure was replaced with a notification of use, that is, it was not required to obtain TUEs – it was sufficient to only notify about their use by medical indications. Currently, the notification has been cancelled, and for using some substances from the prohibited list by medical indications (under the condition of observing the maximum allowed dosage), it is not necessary to take any action. This relates to inhalation use of salbutamol, salmeterol and formoterol, and also to inhalations of glucocorticosteroids and their respective combinations. All the other substances of “S3. Beta-2-agonists” class, and also the other modes of using the above mentioned substances require TUE.

Interestingly, some anti-doping organizations can be flexible to some extent in relation to bronchial asthma by granting so-called “dormant” TUE. What does it mean? If bouts of bronchial asthma emerge, doctors can recommend using the substances requiring TUE application. In this case, it is possible to submit a so-called retroactive application for TUE, that is after treatment has already been conducted. However, anti-doping organizations can grant regular TUE under the condition that after each bout of asthma, the athlete will notify the anti-doping organization about it and will provide medical records confirming the bout. It is necessary for the sake of an athlete, so that he/she could possess medications and use them when needed, without concerns about his/her career, since possession of the substance prohibited in sport, constitutes an anti-doping rules violation.

Attention deficit hyperactivity disorder (ADHD).

Methylphenidate which is prescribed by doctors from other countries for this disease, is not registered as a medication in Russia. However, there are some cases when foreign athletes who play in Russian teams, were granted TUE for this substance.

It is worth noting that TUE applications are reviewed for meeting some criteria, in particular, if there is a reasonable alternative therapy to the use of the prohibited substance.

Glucocorticosteroids (GCS)

They are among the most widespread substances, which athletes use by medical indications. And this is related, among other things, to high injury rate.

For the substances of this class, non-absolute ban is applied – they are prohibited only in oral, rectal, intramuscular and intravenous application. Intra-articular injections, ointments, inhalations and other modes of GCS application are not prohibited.

Meldonium, phenotropil and what else?

On the 2016 Prohibited List, meldonium was included. For many, to say the least, it came as a surprise. However, as early as in early 2015, this substance was included in the monitoring program. The monitoring program is a publicly accessible document published simultaneously with the Prohibited List.

 

 

The Prohibited List is usually updated once per year. But there were cases when it was updated more often. In particular, there were two updates in 2014, the second update banned xenon and argon.

One more drug which is produced in Russia, has been included in the monitoring program for 2018 - bemitil).

Speaking of the Prohibited List, the criteria for including a substance on the list, should be noted. There are 3 criteria, and any 2 of them must be simultaneously met 2:

- improving performance in sport

- posing a danger to athlete’s health

- contradicting the spirit of sport.

Many substances meet these criteria.

Also, a substance becomes prohibited in sport if it can disguise the use of other prohibited substances (for example, diuretics).

According to the World Anti-Doping Code, the WADA decision on including a particular substance or method on the Prohibited List is final and cannot be disputed.

Procedure of obtaining therapeutic use exemption

The procedure is extremely simple – it is necessary to fill in the TUE application form and enclose to it the medical records covering the state of the athlete during the application submission, and also the need for using the prohibited substance. As the matter is reviewed without the participation of the athlete, the medical records should contain maximum details.

TUE Committee (TUEC) of an anti-doping organization is directly involved in reviewing the applications for TUE, TUEC members are doctors with experience of working in sport. Also, TUEC can engage independent experts.

In decision making, TUEC must evaluate the application for meeting the following criteria:

а) whether the prohibited substance or method are required for treating acute or chronic disease, and failure to use them will significantly deteriorate the athlete’s health.

б) whether the use of the prohibited substance or method can highly unlikely result in additional improvement of performance in sport, besides anticipated improvement of the athlete’s health.

в) whether there is no reasonable alternative therapy to the use of the prohibited substance or method.

The criteria are quite vague and can cover a broad range of conditions. However, the World Anti-Doping Agency has issued several guidelines, which assist TUEC in reviewing applications for TUE with maximum precision.