ATHLETES & PRESCRIBING PHYSICIANS PLEASE READ

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1 ATHLETES & PRESCRIBING PHYSICIANS PLEASE READ Intravenous (IV) injections and infusions are administered to athletes under various circumstances and to treat numerous conditions. The goal of these guidelines is to clarify the situations where an athlete might require a Therapeutic Use Exemption (TUE) for an IV and what documentation should be provided if a TUE is indicated. For treatment in response to an emergency, please consider the athlete s health first all the decisions about your medical care are between the athlete and their physician. During a medical emergency, athletes are not required to notify USADA prior to receiving treatment. PLEASE DO NOT WAIT FOR AN APPROVAL BEFORE RECEIVING EMERGENCY TREATMENT Step 1: Determine if the substance(s) administered in the IV infusion or injection is(are) prohibited. The status of substances/medications can be found at GlobalDRO.com. Once you are aware of the status for each substance in the IV, proceed to the next step. Step 2: Determine if the type of IV infusion or injection received or intended is prohibited. Intravenous infusions and intravenous injections of any substance containing more than 100 milliliters in less than a 12-hour period are prohibited, unless it is administered legitimately during the course of hospital treatments, surgical procedures, or clinical diagnostic investigations. o IV infusions provided outside of a hospital including, but not limited to, on-site event medical services, ambulatory treatment, outpatient clinics, doctors or medical offices, home visits, mobile IV clinics, boutique IV clinics, etc., ALL require a TUE. If it is a prohibited substance that is administered intravenously or via injection, a TUE is necessary for this substance regardless of whether the infusion or injection is less than 100mL. Infusions or injections are permitted if the infused/injected substance is not on the Prohibited List AND the total volume of fluid administered does not exceed 100 ml per 12-hour period.

2 STEP 1 Find out the status of your substance at GlobalDRO.com STEP 2 Status of the Substance Administered Volume of the IV Injection and/or Infusion Include the volume of the substance/ medication AND the saline/iv bag. LESS than 100mL in a 12-hour period MORE than 100mL in a 12-hour period NO TUE NEEDED If given during a hospital treatment, surgical procedure, or clinical diagnostic investigation: NO TUE NEEDED If given by any other non-hospital location*: TUE REQUIRED TUE REQUIRED TUE REQUIRED * TUEs are still required for infusions provided through on-site event medical services, ambulatory treatment, outpatient clinics, IV or wellness boutiques, doctors or medical offices, home visits, and all other non-hospital locations. Step 3: Finally, determine what information is required for your TUE Application. The majority of TUE Applications for IV Infusions received by USADA fall into one of four categories: 1. General IVs (heat stroke, dehydration, etc.) 2. IV Iron Infusions (iron deficiency, anemia, blood loss, etc.) 3. IV Infusions for Gastrointestinal Disease (ulcerative colitis, Crohn s disease, IBS, etc.) 4. Emergency/Surgery/Procedural IVs On the following pages, you will find information and guidelines on preparing TUE Application packets for each of the four categories. If your condition does not fall into one of the specified categories, please check to see if your condition has its own TUE Application Guidelines Document. If you have any further questions or concerns, please contact the USADA TUE Department at tue@usada.org or

3 CATEGORY 1 GENERAL IV ADMINISTRATION This category comprises IVs administered for acute medical conditions including, but not limited to, dehydration, heat stroke, bacterial infections, viral infections, etc. Typically, the substances administered for these conditions are not prohibited, but the volume administered is more than 100mL which violates the IV Rule and dictates the need for a TUE. CATEGORY 1 - TUE APPLICATION CHECKLIST Complete and legible TUE Application form Copies of all relevant examinations and clinical notes related to the medical condition Copies of all laboratory results/reports related to the medical condition, if applicable A statement from the physician explaining why an IV infusion is needed o Please explain why permitted alternative treatments such as small volume injections, or oral fluid in the case of dehydration, were not effective or not appropriate/indicated for treatment KEY NOTE: Please specify the TOTAL VOLUME of liquid administered via the IV infusion and/or injection (amount of substance AND amount of saline). If possible, please include the amount of time required to administer the IV infusion and/or injection. CATEGORY 2 IV IRON INFUSIONS This category comprises IVs administered to treat medical conditions including, but not limited to, iron deficiency, iron deficiency anemia, blood loss, etc. Typically, the substances administered for these conditions are not prohibited, but the volume administered is more than 100mL which violates the IV Rule and dictates the need for a TUE. CATEGORY 2 - TUE APPLICATION CHECKLIST Complete and legible TUE Application form Copies of all relevant examinations and clinical notes related to the medical condition

4 Copies of all laboratory results/reports related to the medical condition o The athlete s blood results should be able to demonstrate a consistent iron deficiency (i.e., multiple lab results should be provided) o Iron absorption test results, if applicable A statement from the physician explaining why oral iron supplementation or a small volume (less than 100mL) IV iron push was not effective or appropriate. o It is highly unlikely that an IV Iron TUE Application will be approved if the athlete has not undergone a trial of oral iron supplementation. KEY NOTE: Please specify the TOTAL VOLUME of liquid administered via the IV infusion and/or injection (amount of substance AND amount of saline). If possible, please include the amount of time required to administer the IV infusion and/or injection. CATEGORY 3 IV INFUSIONS for CHRONIC GASTROINTESTINAL DISEASE **PLEASE ALSO REVIEW THE GUIDELINES DOCUMENT FOR IRRITABLE BOWEL SYNDROME** This category comprises IVs administered to treat medical conditions including, but not limited to, ulcerative colitis, Crohn s disease, IBS, etc. Occasionally, the substances administered for these conditions are prohibited in-competition only (i.e. glucocorticoids). If the athlete intends to compete shortly after receiving an IV infusion or the volume of the IV administered is more than 100mL, the method violates the IV Rule and dictates the need for a TUE. CATEGORY 3 - TUE APPLICATION CHECKLIST Complete and legible TUE Application form Copies of all relevant examinations and clinical notes related to the medical condition Copies of all laboratory results/reports related to the medical condition o Endoscopy or colonoscopy results, if applicable A statement from the physician explaining why the medication must be delivered via an IV infusion, and cannot be delivered any other way.

5 o Please explain why permitted alternative treatments were not effective or not appropriate/indicated for treatment KEY NOTE: Please specify the TOTAL VOLUME of liquid administered via the IV infusion and/or injection (amount of substance AND amount of saline) KEY NOTE: If the athlete requires multiple IV infusions and/or injections over a period of time, please specify the intended treatment regimen (e.g. one IV infusion every 3 months), and location of treatment (e.g. at home administered by a visiting nurse, in an outpatient clinic) CATEGORY 4 EMERGENCY, SURGICAL or PROCEDURAL IV ADMINISTRATION This category comprises IVs administered during emergencies, surgical procedures (planned or emergency), and clinical diagnostic/investigative procedures. The IV Rule states that IV infusions or injections administered during hospital treatment (i.e. emergency room admission), surgical procedures, or clinical diagnostic investigations are not prohibited, if the substances administered are not prohibited, regardless of the volume. Occasionally, the substances administered during these procedures contain prohibited substances (i.e. glucocorticoids or narcotics), which violates the IV Rule and dictates the need for a TUE. CATEGORY 4 - TUE APPLICATION CHECKLIST Complete and legible TUE Application form Copies of all relevant examinations and clinical notes related to the medical condition o Please include the surgical report including the substances utilized for general anesthesia Copies of all laboratory results/reports related to the medical condition, if applicable A statement from the physician explaining why the intravenous infusion is needed o Please explain why permitted alternative treatments were not effective or not appropriate/indicated for treatment KEY NOTE: Please specify the TOTAL VOLUME of liquid administered via the IV infusion and/or injection (amount of substance AND amount of saline). If possible, please include the amount of time required to administer the IV infusion and/or injection.

6 1. Introduction Intravenous Infusions and/or Injections Intravenous (IV) infusions have been included on the WADA List of Prohibited Substances and Methods under section M2. Prohibited Methods; Chemical and Physical Manipulation since An IV infusion or injection is the supply of fluid and/or prescribed medication by drip or push directly into a vein. Intravenous infusions are prohibited both in-competition and out-of-competition if the volume delivered exceeds 100 ml within a 12-hour period. The wording in the 2018 Prohibited List states that the following is prohibited: Intravenous infusions and/or injections of more than a total of 100 ml per 12-hour period except for those legitimately received in the course of hospital treatments, surgical procedures or clinical diagnostic investigations 1. The wording in the Prohibited List for IV infusions is unique in that the method is not prohibited under the three exceptions stated above. However, a TUE may be necessary for a Prohibited Substance delivered by intravenous infusion even if the infusion itself is delivered in the setting of one of the three exceptions. IV infusions are included on the Prohibited List mainly because some athletes could use this Prohibited Method to: a) enhance their performance by increasing plasma volume levels; b) mask the use of a Prohibited Substance; c) distort the values of their Athlete Biological Passport. Infusions or injections of 100 ml or less within a 12-hour period are permitted unless the infused/injected substance is on the Prohibited List. Infusions or injections of more than 100 ml within a 12-hour period are prohibited unless the infused/injected substance is administered during a hospital treatment, surgical procedure or clinical diagnostic investigation. Therefore, athletes should always apply for a TUE, if they are administered an intravenous treatment (more than 100 ml/12hrs), in any of the following situations: 1) a medical practitioner s office, suite, home, tent or vehicle; 2) IV clinics or any clinic/treatment room or centre outside of a hospital facility unless a clinical diagnostic investigation or surgical procedure has been performed; 3) event organizers medical facility, tent, first aid station, or start-finish line facility. Please consult the Tables in the Appendix for more details on the principles and examples of when IV infusion/injections of certain substances are permitted or prohibited. January This Guideline is reviewed annually to determine whether revisions to the Prohibited List or new medical practices or standards warrant revisions to the document. If no changes are deemed warranted in the course of this annual review, the existing version remains in force.

7 If a non-prohibited substance is infused or injected without being part of a hospital treatment, surgical procedure or clinical diagnostic investigation, a TUE must be submitted for this Prohibited Method if more than 100 ml of fluid in a 12-hour period is infused or injected. If a Prohibited Substance is administered via IV infusion or injection, a TUE application must be submitted for the Prohibited Substance regardless of whether the infusion is less than 100 ml or the setting/circumstances under which it is administered. In situations of medical emergency or clinical time constraints, a retroactive TUE application pursuant to Article of the International Standard for Therapeutic Use Exemptions is acceptable Diagnosis A. Medical history A summary of the athlete s history and the findings of a physical examination should confirm the diagnosis and establish the need for an IV infusion. A precise description of the clinical situation and specific medical indication for the IV infusion must be given in the TUE application. Note that if an IV infusion or injection of a non-prohibited substance is part of a hospital treatment, surgical procedure or clinical diagnostic investigation, there is no requirement for a TUE. The athlete is nevertheless advised to obtain and keep a copy of the medical records from the intervention or procedure. B. Diagnostic criteria A clearly defined diagnosis should be established in accordance with the International Classification of Diseases standards of the World Health Organization (ICD-10). C. Relevant medical information A detailed description of the substance to be infused, the rate of infusion and any other relevant clinical information from the treating physician should be included. It must be demonstrated why an alternative permitted therapy, for example oral rehydration in case of dehydration, is not a valid option. Any existing co-morbidities that would influence the decision for granting a TUE should also be included. 3. Medical best practice treatment Legitimate medical indications for IV infusions are well documented and are most commonly associated with either medical emergencies or in-patient hospital treatment. January

8 When an IV infusion is administered to an athlete, the following criteria should be fulfilled: 1. a clearly defined diagnosis; 2. supportive evidence that no permitted alternative treatment can be used; 3. the treatment has been ordered by a physician and administered by qualified medical personnel in an appropriate medical setting; 4. adequate medical records of the treatment. The use of IV infusions in sport is commonly linked with rehydration after exhaustive effort, and this situation is arguably the major cause of debate. It must be understood that the use of IV fluid replacement following exercise and/or acute weight reduction to correct mild to moderate dehydration is not clinically indicated nor substantiated by the medical literature. There is a well-established body of scientific evidence to confirm that oral rehydration is the preferred therapeutic choice, potentially even more effective than IV infusion A. Name of Prohibited Method IV infusion or injection of >100 ml within a 12-hour period unless legitimately received in the course of hospital treatments, surgical procedures or clinical investigations. B. Recommended Duration Depending on diagnosis and on the particular clinical situation, but if the infusion is a single intervention, the TUE should be valid for a relatively short duration. 4. Other non-prohibited alternative treatments Oral rehydration or oral delivery of medication. 5. Consequences to health if treatment is withheld These will be dependent on the clinical situation. However, in case of a medical emergency, a possible consequence of withholding treatment could result in serious harm to health or even death. Therefore, the health and well-being of the athlete must always remain the priority. Consequently, when an IV infusion is considered by medical personnel as a potential treatment option, an athlete s medical needs should be assessed as would those of any other patient. 6. Treatment monitoring Continuous evaluation by treating physician or someone acting on his/her behalf until the desired treatment effect has been achieved. January

9 7. TUE validity and recommended review process The duration of the TUE is usually for a short time period surrounding the initial medical intervention. Longer usage of an IV infusion would typically occur in a hospital setting and would therefore not require a TUE. 8. Any appropriate cautionary matters It is the responsibility of the treating physician to evaluate the clinical indication for an IV infusion or injection. However, it is the responsibility of the athlete to inform the treating physician that intravenous infusions are prohibited in non-emergency situations. It is also the responsibility of the athlete to initiate and complete a subsequent TUE application, if and when needed. It must be emphasized that at all times, the health and well-being of the athlete must remain the priority during medical investigations and treatments. TUECs should apply sound clinical judgment to their interpretation of the ISTUE, but be mindful of the inappropriate use of IV infusion in non-emergency situations where alternative permitted and evidence-based alternatives exist. 9. References 1. World Anti-Doping Agency, WADA Prohibited List 2018, 2. World Anti-Doping Agency, International Standard for Therapeutic Use Exemptions, 3. Arbitral Award, CAS 2002/A/ Arbitral Award, CAS 2006/A/1102 & Canadian Academy of Sports Medicine: A brief overview about intravenous hydration in athletics. Casa DJ, Maresh CM, Armstrong LE et al. Intravenous versus oral rehydration during a brief period: responses to subsequent exercise in the heat. Med. Sci. Sports Exerc Jan; 32(1): Webster S, Rutt R, Weltmann, A. Physiological effects of a weight loss regimen practiced by college wrestler. Med. Sci. Sports Exerc Apr; 22(2): Naghii, MR. The Significance of Water in Sport and Weight Control. Nutr. Health. 2000; 14(2), January

10 8. Sawka, MN. Physiological consequences of hypohydration: exercise performance and thermoregulation. Med. Sci. Sports Exerc Jun; 24(6): Maresh CM, Herrera-Soto JA, Armstrong LE, et al. Perceptual responses in the heat after intravenous versus oral rehydration. Med. Sci. Sports Exerc Jun; 33(6): Castellani JW, Maresh CM, Armstrong LE, et al. Endocrine responses during exercise-heat stress: effects of prior isotonic and hypotonic intravenous rehydration. Eur. J. Appl. Physiol. Occup. Physiol Feb; 77(3): Kraemer WJ, Fry AC, Rubin MR, Triplett-McBride T, et al. Physiology and performance responses to tournament wrestling. Med. Sci. Sports Exerc Aug; 33(8): Mudambo SM, Reynolds N. Body fluid shifts in soldiers after a jogging/walking exercise in the heat. Centr. Afr. J. Med Sept-Oct; 47(9-10): Landers DM, Arent SM, Lutz RS. Affect and cognitive performance in high school wrestlers undergoing rapid weight loss. J. Sport Exerc. Psychol Dec; 23(4): Riebe D, Maresh CM, Armstrong LE, Kenefick RW, et al. Effects of oral and intravenous rehydration on ratings of perceived exertion and thirst. Med. Sci. Sports Exerc Jan; 29(1): Noakes TD, Walsh RM, Hawley JA, Dennis SC. Impaired high-intensity cycling performance time at low levels of dehydration. Int. J. Sports Med Oct; 15(7): Rogers IR, Hook G, Stuempfle KJ, et al. An Intervention Study of Oral Versus Intravenous Hypertonic Saline Administration in Ultramarathon Runners with Exercise-Associated Hyponatremia: A Preliminary Randomized Trial. Clin. J. Sport Med May; 21(3); Casa DJ, Ganio MS, Lopez RM et al. Intravenous versus oral Rehydration: Physiological, Performance, and Legal Considerations. Curr. Sports Med. Rep. 2008: 7 (4); S Vandenbos F, et al. Relevance and complications of intravenous infusion at the emergency unit at Nice University Hospital. J. Infect Apr; 46(3): 173-6, ASOIF Medical Consultative Group: Minutes of the meeting 7 th May January

11 APPENDIX Below are three tables, which illustrate the possible four combinations of a Method and a Substance that may be either Permitted or Prohibited during the administration of an IV infusion. TABLE 1 In principle, four possibilities exist when both the substance and the method may be either Permitted or Prohibited Method and Substances 2 x 2 table Method Prohibited Substance Prohibited Method Permitted Substance Prohibited Method Prohibited Substance Permitted Method Permitted Substance Permitted TABLE 2 Requirements for a TUE when the infusion is NOT given during a hospital treatment, surgical procedure or clinical diagnostic investigation. (Prohibited substance/permitted Substance names are used as examples). Prohibited Method: IV infusion of >100 ml within a 12-hour period Prohibited Substance: Insulin Need TUE for substance Need TUE for method Permitted Method: Infusion of 100 ml within a 12-hour period Prohibited Substance: Insulin Need TUE for substance Prohibited Method: IV infusion of >100 ml within a 12-hour period Permitted substance: Glucose/saline Need TUE for method** Permitted Method: Infusion of 100 ml within a 12-hour period Permitted Substance: Liquid iron supplement NO TUE January

12 ** Note that, even though the substance may not be prohibited, a TUE for an infusion >100 ml may necessitate clinical justification for the use of the substance. TABLE 3 Requirements for a TUE when infusion is given during a hospital treatment, surgical procedure or clinical diagnostic investigation. Prohibited Method: IV infusion of >100 ml/12 h Prohibited Substance: Insulin Need TUE for substance Permitted Method: Infusion of 100 ml/12 h Prohibited substance: Insulin Need TUE for substance Prohibited Method: IV infusion of >100 ml/6 h Permitted substance: Glucose/saline NO TUE Permitted Method: Infusion of 100 ml/6 h Permitted Substance: Liquid iron supplement NO TUE January