NCAA Policies on Medications and Supplements FR3173 ACHA June 2 2017 Mary Wilfert MEd NCAA Sport Science Institute wwwNCAAorgssi Disclosure Statement The presenter has no actual or potential conflict of interest associated with this presentation ID: 932521
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Slide1
Are You Serving Student-Athletes? NCAA Policies on Medications and Supplements
FR3-173
ACHA June 2 2017
Mary
Wilfert
, MEd
NCAA Sport Science Institute
www.NCAA.org/ssi
Slide2Disclosure StatementThe presenter has no actual or potential conflict of interest associated with this presentation.This activity may contain discussion of unlabeled/unapproved use of drugs.
The content and views presented in this educational program are those of the faculty and do not necessarily represent those of YNHH or University of Connecticut School of Pharmacy.
Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.
Slide3Learning Objectives:After this session, attendees should be able to:
Identify
drug policies related to
NCAA student-athlete
eligibility.
Identify
guidelines and resources
to support
student-athlete health
and eligibility
.
Slide4NCAA Sport Science Institute:Mission: To promote and develop safety, excellence, and wellness in college student-athletes, and to foster life-long physical and mental development.
Slide5Charged by Executive Committee to oversee NCAA drug testingWorking in conjunction with the NCAA Sport Science Institute to provide guidance on drug use deterrence
NCAA Committee on
Competitive Safeguards and
Medical Aspects of Sports
Slide6Drug PoliciesTo deter cheatingTo protect health and safety
To maintain the integrity of the game
Testing is part of a comprehensive approach to drug deterrence:
Written policy
Education
Testing
Slide7Banned Drug ClassesStimulants Anabolic agentsAlcohol and Beta Blockers (banned for rifle only)Diuretics and other masking agents Street drugsPeptide hormones and analogues
Anti-estrogens
Beta 2 Agonists
Slide8What NCAA Tests For and Why?What we can in urine (no effective test available for hGH)Performance enhancing substancesSubstances with potential to harm health
To protect integrity of the game
To deter use
To give student-athletes another reason to say no.
Slide9NCAA Drug Test PenaltiesPEDs:
1
st
positive =out of competition for 365 days from date of test
Loss of season of competition
Second positive = loss of remaining eligibility
Street/illicit Drugs (marijuana, heroin):
1
st
positive = withholding from competition for half season
Second positive=out of competition for 365 and loss of season of competition
Appeal options
:
denied and the full penalty is upheld;
denied and the penalty is reduced by 50%;
granted and the positive test is overturned and no penalty is assessed, but student-athlete must test negative before competing.
Slide10Medical Exceptions for Banned Drug Use
Not for street/illicit drug class
Pre-approval required for anabolic agents (testosterone) and peptide hormones and analogues (EPO,
hGH
)
Stimulants, diuretics, anti-estrogens, beta-2 agonists and beta blockers request a medical exception review following a positive drug test
Documentation must be in place prior to test
Slide11No NCAA Medical Exception for“Medical Marijuana”Becauseregulation of “medical marijuana” is variable, with no FDA oversight; no uniform procedures for procuring a medical marijuana card; marijuana delivered through smoking is a crude delivery system that also delivers harmful substances;
there are other approved effective treatments for those medical conditions generally identified for medical marijuana, especially with the collegiate athlete population.
Slide12Marijuana Use(Within the Last 12 Months)
Slide13Marijuana Use by Division(Within the Last 12 Months)
Slide14Prescription Drug Use NCAA Study of 20K+
Year
With Prescription
Without Prescription
ADHD Medication
2009
4.5%
6.7%
2013
5.8%
8.8%
Pain Medication
2009
13.7%
5.1%
2013
18.0%
5.8%
Slide15Pain ManagementThe International Olympic Committee held a consensus conference on pain management in the elite athlete in November 2016.NCAA CMO was co-chair.One outcome is an expected Fall 2017 release of a consensus document that will influence pain management in sport.
Slide16GuidelinesNCAA Sports Medicine HandbookAthletics Health Care AdministratorSubstance Abuse Prevention Tool Kit
Slide17Quick Quiz:TRUE OR FALSE?NCAA bans drugs by class with all related substances banned. NCAA student-athletes may receive an exception to the banned drug policy for medical use of marijuana.The NCAA bans corticosteroids.NCAA student-athletes may receive an exception to the banned drug policy for use of stimulants.
NCAA bans growth hormone.
NCAA requires medical documentation be submitted prior to competition while being treated with testosterone.
Slide18Quick Quiz:TRUE OR FALSE?NCAA bans drugs by class with all related substances banned. TRUENCAA student-athletes may receive an exception to the banned drug policy for medical use of marijuana
.
FALSE
The NCAA bans corticosteroids
.
FALSE
NCAA
student-athletes may receive an exception to the banned drug policy for use of stimulants
.
TRUE
NCAA bans growth hormone. TRUENCAA requires medical documentation be submitted prior to competition while being treated with testosterone
.
TRUE
Slide19US Dietary Supplement Health and Education Act of 1994 (DSHEA):
Puts burden onto FDA to prove that a nutritional supplement is harmful before it can regulate its sale.
Slide20Dietary Supplements* . . . *
These statements have not been evaluated by the Food and Drug Administration.
This product is not intended to diagnose, treat, cure, or prevent any disease
.
Do not need to be proven effective
Do not need to be proven safe
Lack standards on potency and
PURITY
Slide21Herbs and Dietary Supplements FAIL Ingredient TestsConsumerLab.com tested over 4,500 products Nov 1999-July 2015 20% of the vitamins and minerals, 43% of herbals, 24% of nutritional powders and drinks, 21%of other failed their evaluation
most common problem was too little or no main ingredient.
other problems included
too much active ingredient;
the wrong ingredient;
potentially dangerous or illegal ingredients;
contamination with heavy metals;
"
spiking" with unexpected ingredients
;
poor disintegration (which affects absorption);
and misleading or incomplete product information.Bottom line – supplements are risky business!
Slide22Where do athletes get their supplement information?
Slide23What student-athletes tell us about supplement use . . . I can’t gain weight withoutI can’t meet nutrient needs withoutI want the extra edgeIt can’t be all bad – everyone is using
I
googled them and saw nothing banned
I only use legal OTC supplements
The store clerk approved them
Slide248 Things To Know About SupplementsSupplement products are not required to undergo safety or efficacy testing before they’re sold. There’s no regulatory definition for a “multivitamin.”
Vitamins and supplements are not the same thing, but vitamins are supplements.
Most dietary supplement ingredients, including vitamins, are not made in America.
It’s difficult to tell if a supplement is of good quality.
Dietary supplements can be spiked with prescription drugs.
More is not better. . .
We probably ingest supplements even if we don’t realize it.
Slide25Our Concerns About Dietary Supplement ProductsSupplement products can and often do contain banned substances (contaminated or spiked).
No one can currently guarantee the contents and the accuracy of the label on a supplement product.
The contents of a supplement product can change from one batch to the next.
Even when companies list their contents accurately –
“proprietary blends” and chemical names can mislead.
Slide26NCAA Bylaw 16.5.2.g Nutritional Supplements Restricts what nutritional supplements* NCAA institutions may provide to student-athletesFor the purpose of calorie and fluid replacement onlyFalls into carbohydrate and electrolyte replacements, and vitamins and mineralsProtein supplements are now permissible
No banned substances.
*
NCAA defines nutritional supplements as any product that is identified as a dietary supplement per DSHEA or that includes a dietary supplement ingredient.
Slide27NCAA “Impermissible” Nutritional Supplements NOTE: any product with any added dietary supplement ingredient that is not a vitamin or mineral, or now protein powder from whole protein source, renders the product impermissible to provide.
Slide28illegal vs. banned vs. Impermissible supplementsLegal/illegal= use is addressed by municipal, state or federal regulations/lawBanned/not banned= use is addressed by NCAA bylaws or policies
Impermissible/permissible= addresses what institutions may/not provide as a “benefit”
Slide29NCAA Position on Supplements- NCAA Sports Medicine HandbookAthletes ingest a sufficient amount of protein without supplements
Vitamins and minerals needs can be met via eating a variety of foods
Concerned about lack of regulation
Poor labeling
Impurities
Slide30to disseminate list of banned drugsto educate student-athletes about products that may contain themDI requires the designation of an individual (or individuals) as the athletics department resource for questions related to NCAA banned drugs and the use of nutritional supplements
Institutions are required under NCAA regulations
Slide31NCAA Drug Testing Consent Form Advisory:Before consuming any nutritional/dietary supplement product, review the product with your athletics department staff
!
Dietary supplements are not well regulated and may cause a positive drug test result.
Student-athletes have tested positive and lost their eligibility using dietary supplements.
Many dietary supplements are contaminated with banned drugs not listed on the label.
Any product containing a dietary supplement ingredient is
taken at your own risk
.
It is your responsibility to check with the appropriate athletics staff
before using any substance.
Slide32Common Dietary Supplements Not Banned, BUT . . . . Protein powdersAmino acidsCreatineHerbal OTC “ED” products“testosterone boosters”, eg.
tribulus
Vitamins and minerals
Slide33Risky Ingredients in Supplement Products Anabolic agentsOther hormonesStimulantsDiuretics and masking agents
Slide34SARMS, SERMS and Other PED’sNCAA Positive Drug TestsPositive tests for ostarine2014-15 -- 142015-16 -- 20
2016-17 – 18 so far
Positive tests for clomiphene and SERMS
2014-15 – 0
2015-16 – 9
2016-17 – 12 so far
Slide35Anabolic Steroid Control Act of 2004Prohormones are now Anabolic Steroids and classified as Schedule III Controlled SubstancesIllegal to possess without a prescription
Carved out an exception for DHEA—but still banned by NCAA
Slide36DHEADehydroepiandrosterone is a pro-hormone, produced by the adrenal gland and is found naturally in the body.
Advocates claim that DHEA supplements can improve mood, increase energy and libido, counteract the effects of stress, preserve muscle, strengthen the immune system, and prevent cancer and heart disease.
DHEA is an NCAA banned substance.
Slide37What happens when FDA adds a “new” steroid to the list of controlled substances?The Steroid Control Act requires the FDA give notice they are starting the process to add a steroid to the controlled substancesThe sports supplement industry uses that window to heavily market them until they are withdrawn.
Slide38Stimulants and Predisposing FactorsOverweightUnconditioned
Not acclimated
(Possibly unknown) health problems
Palpitations
Arrhythmias
Seizures
Susceptibility to heat illnesses and stroke
Slide39What do these athletes have in common? the toxicity of ephedra played a significant role in their deaths
Steve
Bechler
Korey
Stringer
Rashidi
Wheeler
Slide40Ephedrine(Ma Huang or Ephedra)CVissues & CNS stimulant
Irregular heart beat, increased heart rate, tremors, stroke and
death
The FDA received over 16,000 reported ephedrine-related health problems and
over 155 deaths
Slide41“Weight-loss supplement linked to at least 155 deaths” (FDA)The use of stimulants
--
eg:
caffeine
,
ephedrine
/
Ma Huang
,
amphetamine
,
methamphetamine– before, during or after exercise, especially when such use is accompanied by hot and/or humid environments is dangerous.
Slide42What about “Ephedra-free” versions?Many contain high levels of caffeine, plus guarana and other herbal stimulants.
Some contain
Synephrine
, aka bitter orange,
zhi
shi
.
Slide43DMAA-Methylhex Olympic Doping violationPopular ingredient in pre-workout products involved in doping violations leading up to London Games, banning athletes from the games.Syrian runner results removed from the Olympic record because of positive test for DMAA.
Industry is fighting with government over whether DMAA occurs naturally in geranium oil, an ingredient in spit tobacco and supplement products.
Slide44April 2013--FDA had received 60 reports of illnesses and death associated with supplements containing DMAADMAA is most commonly used in supplements promising weight loss, muscle building and performance enhancement; DMAA can elevate blood pressure and lead to cardiovascular problems, including heart attack, shortness of breath and tightening of the chest. DMAA may be particularly dangerous when used with caffeine.
Slide45Synephrine replaces ephedra and methylhexEphedra (aka Bitter orange,
Citrus
aurantium
) claims to increase energy expenditure, facilitate the breakdown of fat and increase glucose uptake by muscles, and widely used in weight management and sports nutrition supplements.
FDA ban on ephedra in 2004 increased use of
synephrine
as an ephedra substitute.
Reported surge as ingredient to replace controversial ingredient DMAA in the wake of the FDA’s recent crackdown on the stimulant.
Slide46May 2015--FDA Warns 14 Sports Supplement Companies Of Illegal DMBA17 products contained BMPEA, an unapproved and poorly-studied amphetamine relativeBMPEAdrug from the 1940sListed on ingredients labels as a new dietary ingredient No history or evidence for its safe use
Raises blood pressure
Slide47Shell Games – Companies revamp their product lines and their products’ labels without consumer warning:
No guarantee the formula has changed.
Old products are still on the shelves.
Consumer cannot rely on label and Website listing, as what is listed may not be what’s in the bottle.
Slide48The energy drink buzz is a False EnergySo called “energy” drinks
are essentially caffeine and stimulant delivery systems.
Caffeine content in energy drinks is not FDA controlled or well defined.
Too many energy drinks* can contribute to
gastric upset
, heart
palpitations
, sleep
disturbances,
sugar
crash,
fatigue and other
performance detractions
.
Slide49Sports drinks vs. “Energy” drinksSports DrinksRehydrate!
Contain an appropriate carbohydrate level for recovery
Help maintain electrolyte balance
Do not contain stimulants*
Energy Drinks
Are not recommended for rehydration!
May contain more concentrated sugar
Contain one or more sources of stimulants (caffeine,
guarana
)
May contain amino acids and herbals (unregulated
)
Slide50What about Multi-Vitamins?
Subject to the same lack of regulation
No guarantees
Added herbs and stimulants
These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease
.
Slide51Vitamins and Supplements . . . 10 things that may surprise youNot risk free—6300 serious adverse effects
reported to FDA in last 5 years, and expected to increase to over 8000 reports in next 3 years.
Some are
spiked
with Rx drugs found in
viagara
&
cialis
You can
overdos
e on V & M.No requirements for warning labels re: drug interactionsNot proven to cure disease.“Natural” does not mean safe
, (arsenic is natural. . . . so is testosterone), nor does it really mean natural. . . .
Slide52Quick Quiz:TRUE OR FALSE?Student-athletes can lose a year of competition if they ingest a banned ingredient in an OTC supplement. Legal dietary supplements are approved for NCAA student-athlete use.Creatine is banned for student-athlete use.Creatine is safe for student-athlete use.
DHEA is legal and banned.
Student-athletes need supplemental protein.
A thorough reading of a supplement product’s ingredients protects student-athlete eligibility.
Slide53Supplements --do they work?Supplement manufacturers resist product testing for effectiveness--- Product testing results in one of two outcomes:
The product will be proven ineffective, or
The product will be proven effective, and then taken off the supplement market and governed like a drug.
Slide54Before deciding to use a supplement, ask . . . Do I need this supplement?Do I know that this supplement is safe?Does this supplement interact with any drug or food I am consuming?Do I know that this supplement works?
Can I afford this supplement?
Do I know enough about this supplement?
Slide55What You Should Do . . . .Be aware that nutritional/dietary supplements are not well regulatedBe aware that nutritional/dietary supplements do not provide as good nutrition as foodCheck out every medicine and supplement with appropriate athletics department staff.
Slide56Formerly the Resource Exchange Center (REC)
To serve as a pivot point for services, resources, and information related to athlete health and wellness.
56
Slide57Formerly the Resource Exchange Center (REC)
Includes:
Dietary Supplement Inquiry
Prescription/OTC Database
Drug Program Information/ Banned Drug Lists/ Medical Exception processes
Sports Nutrition Handouts
Athlete Recipes
Substances of Abuse Resources & Information
57
Slide58Risk Level Rating System
58
Slide59Trends: Supplement Categories(NCAA Data: Jan 1, 2016 – April 24, 2017)
59
Slide60List of Safe Supplements
Slide61Play True!Eat Real FoodStay HydratedConditionRest and RecoverManage Stress Avoid Substance AbuseStay Well!
To promote the Health and Safety
of the more than 480,000
NCAA Student-Athletes!