TUE guidelines on IV infusions and injections...TUE guidelines on IV infusions and injections TUEC...

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TUE guidelines on IV infusions and injections TUEC Symposium Oct 23-24. 2014, Paris Ola Ronsen, MD PhD Member of TUE Expert Group

Transcript of TUE guidelines on IV infusions and injections...TUE guidelines on IV infusions and injections TUEC...

Page 1: TUE guidelines on IV infusions and injections...TUE guidelines on IV infusions and injections TUEC Symposium Oct 23-24. 2014, Paris ... Name of presentation/ 2 . Intravenous (IV) infusions

TUE guidelines on IV infusions and injections

TUEC Symposium Oct 23-24. 2014, Paris

Ola Ronsen, MD PhD Member of TUE Expert Group

Page 2: TUE guidelines on IV infusions and injections...TUE guidelines on IV infusions and injections TUEC Symposium Oct 23-24. 2014, Paris ... Name of presentation/ 2 . Intravenous (IV) infusions

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Page 3: TUE guidelines on IV infusions and injections...TUE guidelines on IV infusions and injections TUEC Symposium Oct 23-24. 2014, Paris ... Name of presentation/ 2 . Intravenous (IV) infusions

Intravenous (IV) infusions have been included on the WADA List of

Prohibited Substances and Methods since 2005 and are prohibited both

in- and out-of-competition.

“Intravenous infusions and/or injections

of more than 50 mL per 6 hour period

are prohibited.”

Intravenous (IV) infusions and WADA Prohibited List

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Page 4: TUE guidelines on IV infusions and injections...TUE guidelines on IV infusions and injections TUEC Symposium Oct 23-24. 2014, Paris ... Name of presentation/ 2 . Intravenous (IV) infusions

Method Prohibited Substance Prohibited

Method Permitted Substance Prohibited

Method Permitted Substance Permitted

Method Prohibited Substance Permitted

Method and Substance 2 x 2 table

Page 5: TUE guidelines on IV infusions and injections...TUE guidelines on IV infusions and injections TUEC Symposium Oct 23-24. 2014, Paris ... Name of presentation/ 2 . Intravenous (IV) infusions

M Proh: IV infusion of >50ml/6h S Proh: Dextran

M Perm: Infusion of < 50ml/6h S Proh: Insulin

M Perm: Infusion of < 50ml/6h S Perm : Liquid iron supplement

M Proh: IV infusion of >50ml/6h S Perm: Glucose/saline

Method and Substance 2 x 2 table with examples

Page 6: TUE guidelines on IV infusions and injections...TUE guidelines on IV infusions and injections TUEC Symposium Oct 23-24. 2014, Paris ... Name of presentation/ 2 . Intravenous (IV) infusions

M Proh: IV infusion of >50ml/6h S Proh: Dextran

M Perm: Infusion of < 50ml/6h S Proh: Insulin

M perm: Infusion of < 50ml/6h S Perm : Liquid iron supplement

M Proh: IV infusion of >50ml/6h S Perm: Glucose/saline

TUE requirement

Need TUE Need TUE

Need TUE No TUE

Page 7: TUE guidelines on IV infusions and injections...TUE guidelines on IV infusions and injections TUEC Symposium Oct 23-24. 2014, Paris ... Name of presentation/ 2 . Intravenous (IV) infusions

“Intravenous infusions and/or injections of more than 50 mL per 6 hour period

are prohibited except for those legitimately received in the course of hospital

admissions, surgical procedures or clinical investigations.”

Circumstances that may change the need for a TUE

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Hospital admission Surgical procedures Clinical investigations

Page 8: TUE guidelines on IV infusions and injections...TUE guidelines on IV infusions and injections TUEC Symposium Oct 23-24. 2014, Paris ... Name of presentation/ 2 . Intravenous (IV) infusions

M Proh: IV infusion of >50ml/6h S Proh: Dextran

M Perm: Infusion of < 50ml/6h S Proh: Insulin

M perm: Infusion of < 50ml/6h S Perm : Liquid iron supplement

M Proh: IV infusion of >50ml/6h S Perm: Glucose/saline

During hospital admission, surgical procedure or clinical investigation:

Need TUE Need TUE

No TUE No TUE

Page 9: TUE guidelines on IV infusions and injections...TUE guidelines on IV infusions and injections TUEC Symposium Oct 23-24. 2014, Paris ... Name of presentation/ 2 . Intravenous (IV) infusions

When an IV infusion of more than 50 ml/6h is given without hospital admission, no surgical procedure or clinical investigation the following criteria should be fulfilled: 1. A clear, well-justified diagnosis.

2. Evidence that no permitted alternative treatment exists.

3. Evidence that 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.

Medical best practice recommendations

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Page 10: TUE guidelines on IV infusions and injections...TUE guidelines on IV infusions and injections TUEC Symposium Oct 23-24. 2014, Paris ... Name of presentation/ 2 . Intravenous (IV) infusions

At all times the health and well-being of the patient must remain the priority

during medical investigations and treatments.

In Emergencies: Always a place for a retroactive TUE

TUECs should apply sound clinical judgment to their interpretation of the

International Standard, but mindful of the inappropriate use of IV infusion in

non-emergency situations where scientifically documented alternatives exist.

Guideline for the NADO TUEC

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Page 11: TUE guidelines on IV infusions and injections...TUE guidelines on IV infusions and injections TUEC Symposium Oct 23-24. 2014, Paris ... Name of presentation/ 2 . Intravenous (IV) infusions

1. Method and substance matrix 2. TUE requirements for IV’s 3. Circumstances that changes need for TUE 4. Best practice recommendations for TUE’s Questions on the WADA guidelines for IV’s ?

Summing up

Page 12: TUE guidelines on IV infusions and injections...TUE guidelines on IV infusions and injections TUEC Symposium Oct 23-24. 2014, Paris ... Name of presentation/ 2 . Intravenous (IV) infusions

QUESTIONS or COMMENTS ?