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Adherence to Drug-Dispensation and Drug-Administration Laws and Guidelines in Collegiate Athletic Training Rooms 252
Volume 38 Number 3 September 2003
Journal of Athletic Training
2003;38(3):252258
by the National Athletic Trainers Association, Inc
www.journalofathletictraining.org
Adherence to Drug-Dispensation and
Drug-Administration Laws and Guidelines
in Collegiate Athletic Training Rooms
Leamor Kahanov; David Furst; Sam Johnson; Jeff Roberts
San Jose State University, San Jose, CA
Leamor Kahanov, EdD, ATC, contributed to conception and design; acquisition and analysis and interpretation of the data; and
drafting, critical revision, and nal approval of the article. David Furst, PhD, contributed to drafting, critical revision, and nal
approval of the article. Sam Johnson, MS, ATC, contributed to conception and design and critical revision and nal approval of
the article. Jeff Roberts, MS, ATC, contributed to analysis and interpretation of the data and critical revision and nal approval
of the article.
Address correspondence to Leamor Kahanov, EdD, ATC, San Jose State University, Human Performance Department, One
Washington Square, San Jose, CA 95192. Address e-mail to leamor@hup.sjsu.edu.
Objective: To assess adherence in collegiate athletic training
rooms to federal drug laws and to describe current practices.
Design and Setting: We created a survey of drug-law ad-
herence using federal drug laws and administration guidelines
and mailed it to randomly selected certied athletic trainers
(ATCs) in United States college and university athletic training
rooms. Means, standard deviations, and cross-tabulations were
calculated to assess demographic information. A nonparametric
test (Kruskal-Wallis) was calculated to compare adherence-
score means.
Results: Adherence scores were collected from 168 college
and university ATCs. The data suggest that ATCs in most ath-
letic training rooms are still not complying with federal drug
laws. Drug-dispensation and -administration adherence scores
ranged from 5 to 20 (20% to 80% adherence) of 25 points. On
average, 49.3% of ATCs in athletic training rooms had marginal
adherence to federal regulations (12.34 adherence score). The
difference between adherence scores and National Collegiate
Athletic Association athletic divisions (Division I, II, III, and III/
National Association of Intercollegiate Athletics;
P
.002) was
signicant. In most athletic training rooms, ATCs (55.9%) and
students (13.3%) dispensed prescription drugs. In addition,
ATCs in most athletic training rooms (53.8%) administered any
amount of over-the-counter medication as necessary, and
many did not record the transaction (46.2%).
Discussion: Nine years after the National Collegiate Athletic
Association drug-distribution study in university athletic pro-
grams, similar problem areas persist, including unqualied per-
sonnel dispensing medications, inappropriately packaged and
labeled medications, and a lack of record keeping.
Conclusions: Athletic trainers should work in conjunction
with members of the sports medicine team to review federal
and state laws and revise institutional drug policies and pro-
cedures to comply with regulations in order to provide the best
health care to student athletes in a legal and safe manner.
Key Words: medication administration, Food and Drug Ad-
ministration, medication dispensation, National Collegiate Ath-
letic Association, National Association of Intercollegiate Athlet-
ics, Pharmacy Act
T
he administration and distribution of over-the-counter
(OTC) and prescription drugs in the athletic training
room is a multifaceted process governed by federal and
state laws and regulations (Tables 1 and 2).
153
Administration
and distribution of drugs in the athletic training room must ad-
here to laws and regulations in order to avoid legal penalties
and, more importantly, to maintain appropriate and safe medical
agents for athletes.
1
Therefore, individuals who are responsible
for pharmaceutical care must be knowledgeable in the legal and
regulatory issues related to drug distribution.
153
Certied athletic trainers (ATCs) who practice in collegiate
settings are in a unique position regarding drug dispensation,
administration, and record keeping. The collegiate athletic
training room environment is often self-contained, with little
or no relationship to a health center or outside medical facility.
Thus, drugs are often stored, dispensed, and administered on
site. A combination of state and federal laws and regulations
mandate how and under what conditions medications should
be distributed.
153
State denitions differ in provisions for dispensing and ad-
ministering medication; therefore, ATCs in each athletic train-
ing room need a working knowledge of current state regula-
tions (see Table 2).
453
Specic laws for athletic training
rooms are lacking; therefore, the administration and distribu-
tion of medication in athletic training rooms should follow
federal
13
and state laws
453
in addition to published, peer-
reviewed guidelines for the ATC.
461
Drug distribution entails the selection, acquisition, control,
storage, delivery, packaging, labeling, dispensing, and adminis-
tration of medications.
5456
Federal laws to ensure drug safety
for patients began in 1938 with the Federal Food, Drug, and
Cosmetic Act,
1
with subsequent laws to ensure safe drug quality,
purity strength, labeling, and packaging (see Table 1).
13,5561
In
addition, federal regulations specify proper storage conditions,
labeling, and record-keeping standards. Such regulations are spe-
cically designed to ensure that medication is potent, that patients
(athletes) know what the medication is and how to take it, and
that drug usage is appropriately monitored.
13,5561 Journal of Athletic Training
253
Table 1. Federal Regulations Governing Pharmaceutical Care
Regulation
Purpose
Federal Food, Drug, and Cos-
metic Act (FDCA) of 1938*
Regulates the quantity, strength,
bioequivalence, and labeling of
prescription and nonprescrip-
tion drugs
Durham-Humphrey Amendment
of 1951
Separates prescription from non-
prescription drugs
Federal Anti-Tampering Act of
1983
Created 7-point label require-
ments and tamper-resistant
packaging on all nonprescrip-
tion medications
Omnibus Reconciliation Act of
1990 (OBRA)§
Mandates drug review, patient
medication records, and verbal
patient education as part of
dispensing of prescription
medications
*21 U.S.C. §201(1938).
21 U.S.C. §331(1951).
Pub L No. 98127, 18 U.S.C. §1365(1983).
§Pub L No. 101508, 5 U.S.C. §13214(1990).
Past research regarding drug distribution has been limited.
However, a 2-year study conducted by the National Collegiate
Athletic Association (NCAA)
59
identied a myriad of drug-
distribution problems that could lead to serious legal rami-
cations and compromise athlete health. Examples of problems
included (1) unqualied personnel dispensing medications, (2)
athletes receiving prescription and nonprescription medica-
tions with inappropriate package labeling according to federal
guidelines, (3) a lack of security and control, and (4) a lack
of required federal record keeping.
59
Safety risks and failure of appropriate drug-law adherence
to the athletes were apparent in 1993; however, the impact of
Laster-Bradleys study
62
on current athletic training room prac-
tices is unknown. Thus our purpose was to revisit drug dis-
pensation in collegiate athletic training rooms 9 years after the
initial NCAA investigation
59
to assess athletic training room
adherence to federal laws and regulations and describe current
practices regarding drug dispensation.
METHODS
The Athletic Training Room Drug Distribution Survey was
mailed to 300 ATCs employed in the collegiate setting. One
hundred surveys were each sent to NCAA Division I, Division
II, and Division III universities. Two Division III schools held
dual membership with the National Association of Intercolle-
giate Athletics (NAIA) and were placed in a separate Division
III/NAIA category. Thirty surveys were returned for insuf-
cient addresses; therefore, 270 surveys were considered
mailed. Certied athletic trainers were identied through the
National Athletic Trainers Association (NATA) membership
listing. The San Jose State University Institutional Review
Board approved the study.
Survey Instrument
The Athletic Training Room Drug Distribution Survey was
created for use in this study based on federal laws
13
(see
Table 1) and the 20022003 NCAA Sports Medicine Hand-
book
63
regarding the administration and dispensation of pre-
scription and OTC