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July 1, 2016

Anti-doping: 2012 Guide for Prescribers

The World Anti-Doping Code, published by the World Anti-Doping Agency (WADA), harmonises anti-doping regulations across all sports and in all countries. This Code includes a list of substances and methods which are prohibited in sport. Some of these substances are contained in medicinal products marketed in Ireland. However, in recognition of the fact that some prohibited substances may be necessary for legitimate medical treatment, the code permits athletes and their physicians to apply for a Therapeutic Use Exemption (TUE).

Irish Sports Council Therapeutic Use Exemption (TUE) Policy

If a medication is prohibited and requires a TUE, athletes should first seek to use an alternative permitted medication.  If there is no permitted alternative athletes should adhere to the Irish Sports Council TUE Policy which states that athletes on the Irish Sports Council Registered Testing Pool must apply for a TUE before using the substance (a Pre-Test TUE); athletes not on the Registered Testing Pool may take the substance, and if required, apply for a Post-Test TUE, but should ensure that a medical file* for use of the medication is in place.  Athletes who compete at an International Level or who are on their International Federation Registered Testing Pool should check and comply with the TUE requirements of their International Federation.

All TUE applications MUST be accompanied by a medical file* reflecting current best medical practice to include:

1) A complete medical history

2) Copies of all relevant examinations and clinical notes (for example, if a clinic visit is referenced in a letter or summary, a copy of the clinical notes taken during the visit must be included)

3) Copies of laboratory results/reports, and imaging studies

4) Exact name, speciality, address (including telephone, e-mail, fax) of examining physician

For asthma TUE applications, the medical file should also specifically include:

5) A comprehensive report of the clinical examination with specific focus on the respiratory system

6) A report of spirometry with the measure of the Forced Expiratory Volume in 1 second (FEV1)

7) If airway obstruction is present, the spirometry will be repeated after inhalation of a short acting beta-2 agonist to demonstrate the reversibility of bronchoconstriction

8 ) In the absence of reversible airway obstruction, a bronchial provocation test is required to establish the presence of airway hyperresponsiveness

Abbreviated TUEs which existed under a previous system are no longer valid.

Athletes should be advised to declare the use of all medications and supplements taken in the 14 days prior to the drug test on the doping control form (regardless if they have completed and submitted a TUE).

Full details, TUE Application Form and guidelines on the TUE Policy are available at www.irishsportscouncil.ie/tue.

Summary of the WADA 2012 Prohibited List

Substances and Methods Prohibited In and Out of Competition

S0 Non-Approved Substances: The prohibited list includes any pharmacological substance with no current approval by any governmental regulatory health authority for human therapeutic use (e.g. drugs under pre-clinical or clinical development or discontinued, designer drugs, veterinary medicines).

Prohibited Substances

S1 Anabolic Agents are prohibited. Examples include danazol, testosterone, stanozolol, tibolone and selective androgen receptor modulators (SARMs).

S2 Peptide Hormones, Growth Factors and Related Substances: The following substances, including other substances with similar chemical structure or similar biological effect(s) and their releasing factors are prohibited:

  • Erythropoiesis-Stimulating Agents (e.g. erythropoietin (EPO), darbepoietin, CERA, peginesatide)
  • Chorionic Gonadotrophin and Luteinizing Hormone are prohibited in men-only.
  • Insulins
  • Corticotrophins
  • Growth Hormone, and certain growth factors, e.g. Insulin-like Growth Factor-1 (IGF-1), Mechano Growth Factor (MGF), Platelet-Derived Growth Factor (PDGF), Vascular-Endothelial Growth Factor (VEGF), etc.

S3 All Beta-2 Agonists are prohibited except:

  • inhaled formoterol (up to a maximum dose of 36 micrograms over 24 hours)
  • inhaled salbutamol (up to a maximum dose of 1600 micrograms over 24 hours)
  • inhaled salmeterol in accordance with the manufacturers’ recommended therapeutic regime.

To use any other inhaled beta-2 agonist, including terbutaline, formoterol (at inhaled doses >36µg over 24 hours) and salbutamol (at doses >1600µg over 24 hours, such as by nebuliser), an athlete must adhere to the TUE Policy paying particular attention to the requirements of a medical file* (for TUE applications in relation to asthma medications, see coloured box at beginning).

The presence in urine of salbutamol in excess of 1000ng/ml or formoterol in excess of 30ng/ml is presumed not to be an intended 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 therapeutic inhaled dose up to the maximum indicated above.

Note: A Turbohaler device labelled as containing 6µg of formoterol results in the inhalation of 4.5µg of formoterol.

S4 Hormones and Metabolic Modulators such as aromatase inhibitors (e.g. letrozole, exemestane, formestane), selective oestrogen receptor modulators (SERMS, e.g. tamoxifen, raloxifene, toremifene), other anti-oestrogenic substances (e.g. clomiphene, fulvestrant) and myostatin modifying agents are prohibited.

S5 Diuretics and other Masking Agents: Diuretics (including substances with a similar chemical or biological effect), desmopressin, plasma expanders (e.g. oral and IV glycerol, IV administration of albumin, dextran, hydroxyethyl starch and mannitol, etc.) and probenecid are prohibited. Drosperinone, topical dorzolamine and brinzolamide are permitted.

Glycerol is prohibited as a plasma expander which requires the ingestion of quantities far beyond that which are commonly found in foodstuffs and toiletries.

The use In- and Out-of-Competition, as applicable, of any quantity of a substance subject to threshold limits (i.e. formoterol, salbutamol, morphine, cathine, ephedrine, methylephedrine and pseudoephedrine) in conjunction with a diuretic or other masking agent requires the deliverance of a specific TUE for that substance in addition to the one granted for the diuretic or other masking agent.

Prohibited Methods

M1 Enhancement of oxygen transfer through blood-doping or the use of products that enhance the uptake, transport or delivery of oxygen e.g. modified haemoglobins. Supplemental oxygen is not prohibited.

M2 Tampering or attempting to tamper to alter the integrity and validity of a sample such as urine substitution and/or adulteration (e.g. use of proteases) is prohibited.

IV infusions and/or injections of more than 50ml per 6 hour period are prohibited and require a TUE except for those legitimately received in the course of hospital admissions or clinical investigations.  Emergency infusions will require a retroactive TUE.

Sequential withdrawal, manipulation and reinfusion of whole blood into the circulatory system is prohibited.

M3 Gene doping.

Substances and Methods Prohibited In-Competition

Prohibited Substances

S6 Stimulants including their related substances and both their optical isomers are prohibited.  Examples include modafinil, amphetamine and pseudoephedrine.

Since 1 January 2010 pseudoephedrine is prohibited in-competition at urinary concentrations >150µg/ml.  Pseudoephedrine is found in many over the counter medicines available in pharmacies including many multi-ingredient products used as cough and cold remedies, hayfever and decongestant treatments.

Athletes should stop taking any pseudoephedrine containing products at least 24 hours before competition. For therapeutic applications during the in-competition period, athletes should consider the use of alternative permitted medications after prior consultation with their doctor or pharmacist, or apply for a TUE for the use of pseudoephedrine for therapeutic purpose(s).

Local administration (e.g. nasal, ophthalmologic) of adrenaline or co-administration with local anaesthetic agents is not prohibited.

Buproprion, caffeine, nicotine, phenylephrine and phenylpropanolamine are not prohibited and are instead monitored in-competition by WADA in order to detect patterns of misuse in sport as part of its 2012 Monitoring Programme.

S7 Narcotics: Prohibited narcotics include buprenorphine, dextromoramide, hydromorphone, morphine, methadone, oxycodone, pethidine, fentanyl and its derivatives. Codeine, dextromethorphan, dihydro-codeine, diphenoxylate, pholcodine and tramadol are permitted.

Hydrocodone, the morphine/codeine ratio and tramadol are monitored in-competition only by WADA in order to detect patterns of misuse in sport as part of its Monitoring Programme.

S8 Cannabinoids (natural and synthetic) are prohibited.

S9 Glucocorticosteroids are prohibited and require a TUE when used orally, rectally, or by intravenous or by intramuscular injection. Glucocorticosteroids administered by all other routes do not require a TUE.

Glucocorticosteroids are monitored out-of-competition only by WADA in order to detect patterns of misuse in sport as part of its Monitoring Programme.

Substances Prohibited in Specific Sports

P1 Alcohol: Prohibited in-competition in certain sports including automobile (FIA) and motorcycling (FIM).

P2 Beta-Blockers: Prohibited in-competition in certain sports such as automobile (FIA), golf (IGF) and darts (WDF).  Prohibited both in- and out- of competition in Archery (FITA) and Shooting (ISSF, IPC).

WADA have undertaken to update the Prohibited List regularly.

This summary is deliberately concise and is intended to be used as a guide only. For an authoritative reference source consult the complete World Anti-Doping Code, The 2012 Prohibited List and the International Standard for TUE (ISTUE) which are available from the Irish Sports Council or www.wada-ama.org.  All information correct at time of going to press.

Only those products with a marketing authorisation or CE mark can be classified. Products should only be used in accordance with their marketing authorisation.

Compiled by Eirpharm.com on behalf of the Irish Sports Council for MIMS Ireland.

More information is available from the Irish Sports Council (telephone: (01) 8608818; fax: (01) 8608860; website: www.irishsportscouncil.ie/Anti-Doping), www.eirpharm.com and National Governing Bodies of Sport.