Medicines and Sport - Anti-doping: A Guide for Prescribers 2010

This summary is based on the World AntiDoping Agency Prohibited List 2010, which will be superseded by newer versions of the List
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 2010 Prohibited List and the International Standard for Therapeutic Use Exemptions which are available from the Irish Sports Council or www.wada-ama.org. All information correct at time of going to press..

Abbreviations
TUE Therapeutic Use Exemption
ISTUE International Standard for Therapeutic Use Exemptions

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).

• TUE forms (and guidelines) are available on www.irishsportscouncil.ie/Anti-Doping.
• Abbreviated TUEs which existed under a previous system are no longer valid.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 at the time of a drug test on the doping control form (regardless if they have completed and submitted a TUE).
• Not all athletes are bound by the TUE regulations - For details of which athletes need to submit TUE applications, check out www.irishsportscouncil.ie/Anti-Doping.

Summary of the WADA 2010 Prohibited List

• Substances and Methods Prohibited In and Out of Competition

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)
• Chorionic Gonadotrophin and Luteinizing Hormone are prohibited in men-only.
• Insulins. Insulin-dependent diabetics are required to apply for a TUE to cover their insulin use.
• Corticotrophins, Growth Hormone and certain growth factors e.g. Insulin-like Growth Factor-1 (IGF-1), Mechano Growth Factors (MGFs), Platelet-Derived Growth Factor (PDGF), etc,
• Platelet-derived preparations (e.g. Platelet Rich Plasma, "blood spinning") are prohibited when administered by intramuscular route; other routes of administration must be declared at the time of testing.

S3 All Beta-2-agonists are prohibited. As an exception inhaled salmeterol and salbutamol (up to a maximum dose of 1600 micrograms over 24 hours) but must be declared at the time of testing. To use any other inhaled beta-2-agonist, including formoterol, terbutaline or salbutamol (at doses >1600mcg over 24 hours) an athlete must have a medical file* in place and may require a TUE .

The presence of salbutamol in urine in excess of 1000 ng/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 a therapeutic dose (maximum 1600 micrograms over 24 hours) of inhaled salbutamol.

S4 Hormones Antagonists and Modulators e.g. aromatase inhibitors (e.g. letrozole, exemestane, formestane), selective estrogen receptor modulators (SERMS, e.g. tamoxifen, raloxifene, toremifene), other anti-estrogenic 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), probenecid, plasma expanders ((e.g.oral and intravenous glycerol, intravenous administration of hydroxyethyl starch etc.) are prohibited. Drosperinone and topical dorzolamine and brinzolamide are permitted.

A Medical approval obtained as part of a TUE is not valid if an athlete s urine contains a diuretic in association with threshold or sub-threshold levels of another prohibited substance.

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 catheterisation or urine substitution. and/or adulteration (e.g. use of proteases) is prohibited.

Intravenous infusions 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.

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, sibutramine, amphetamine, and pseudoephedrine (urinary concentrations> 150microgramme/ml). Topical imidazoles and adrenaline associated with local anaesthetic agents or by local administration (e.g. nasal or ophthalmologic) are not prohibited.

Buproprion, caffeine, 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 2010 Monitoring Program.

From 1 January 2010 Pseudoephedrine is prohibited in-competition at urinary concentrations >150 microgram/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).

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. The codeine/morphine ratio is monitored by WADA in order to detect patterns of misuse in sport as part of its Monitoring Program.

S8 Cannabinoids are prohibited.

S9 Glucocorticosteroids are prohibited and require a TUE when used orally, rectally, or by intravenous or by intramuscular injection.

Glucocorticosteroids administered by non-systemic (e.g. intraarticular, periarticular, perintendinous, epidural, intradermal) routes are permitted but must be declared at the time of testing.. Topical glucocorticosteroid preparations used for dermatological (including iontophoresis), auricular, nasal, ophthalmic, buccal, gingival and perinal disorders, are permitted.

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 gymnastics (FIG). 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 2010 Prohibited List and the International Standard for Therapeutic Use Exemptions 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 Product Authorisations (PA number) can be classified. Products should only be used in accordance with their PA. To clarify the status of a medical device containing a medicinal substance contact the Irish Sports Council.

From 1 January 2010 Pseudoephedrine is prohibited in-competition at urinary concentrations >150 microgram/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).

Medical File: *All TUE applications for asthma medications must be accompanied with a Medical File meeting the minimum requirements as defined by WADA (refer to www.irishsportscouncil.ie/Anti-Doping) and must reflect current best medical practice to include:
1) A complete medical history in relation to asthma
2) A comprehensive report of the clinical examination with specific focus on the respiratory system
3) A report of spirometry with the measure of the Forced Expiratory Volume in 1 second (FEV1)
4) 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
5) In the absence of reversible airway obstruction, a bronchial provocation test is required to establish the presence of airway hyperresponsiveness
6) Exact name, speciality, address (including telephone, e-mail, fax) of examining physician.

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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.