Lower abuse potential than Schedule II Accepted medical use in the United States
Examples Anabolic steroids Tylenol #3 (Tylenol with codeine) Lortab
Lowest abuse potential Contain small amounts of drug May be nonprescription in some states
Federal offense to possess without a prescription
Federal offense to provide to anyone other than the individual prescribed.
Requires accurate record keeping regarding inventory, use, and disposal of drugs.
Labeling Requirements OTC medications
Name of product Expiration date and lot # Net content of package Directions for safe, effective use Name of any habit forming drug contained Cautions and warnings Name and address of manufacturer Name of active ingredients
Labeling requirements in general
Nonprescription drugs (OTCs) should NOT be repackaged without meeting labeling criteria.
All drugs dispensed from AT room must be properly labeled.
Legally liable if drugs removed from original package and dispensed.
Labeling requirements Prescription meds
Patient name and address Date issued Prescriber name # refills Expiration date Dosage instructions Name of medication, potency, and quantity Pharmacy name, address, and reference #
Lower abuse potential than Schedule III Accepted medical use
Examples Tramadol - added to list in 2014 Valium Xanax
Who currently prescribes meds?
Physicians, Doctors of Osteopathy, Physician Assistants, Ophthalmologists, Podiatrists, Veterinarians, Dentists, and Nurse Practitioners.
Why keep meds in ATR?
Availability during off-hours and travel
Compliance with taking meds
Cost savings to athletic dept.
Importance of good medication management policies
Compliance with laws regarding record keeping, drug labeling, packaging, dispensing, administration, storage, security, licensure, etc
Health and safety of the patients
Pharmacy in the A.T. Clinic
State and federal laws that govern controlled substances
AT should be aware of laws that pertain to them
All controlled substances found in ATR must have complete and accurate written inventory
Team physician is ultimately responsible for dispensing controlled substances
State versus Federal Regulation
Generally closely aligned
If conflicting, follow the stricter of the 2 codes
It is illegal for an athletic trainer to dispense medication
There is some variability in state laws regarding administration of nonprescription medication in a single dose pack
Head Team Physician
A licensed physician must take responsibility for medications stored at an athletic training facility
Drug Enforcement Agency (DEA) registration
Physician Separate registration for all locations Additional state registration may be required Licensure requirements apply for all sites where medications are stored, administered or dispensed
Ideally one pharmacy should service the entire athletic organization
Pharmacy licensure State license DEA license FDA license if repackaging
Athletic Training Clinic
Should maintain copies of team pharmacy licenses
Waste disposal company must be licensed to destroy prescription medications
Medication given to patient and consumed within 24 hours
Medication intended to be consumed by the patient over a period of time that exceeds 24 hours
Therapeutic dose pack
Must meet state and federal laws in regards to labeling
Medication applied or injected within the athletic training facility
Classification of Medications Compounded pharmaceuticals
Prepared from raw components in the team pharmacy Considered prescription drugs
Must have written authorization from the team physician
Records of treatment must be kept
Athlete should sign authorization granting permission to specific staff to forward prescription orders, pick up medications, store medications, etc.
Unsecured Medication Authorization
Medications should be locked and secured when stored
Physician should document in writing discretionary decision to keep emergency medications unsecured (ie, EpiPen)
Remove from active medication supplies Record expired medications Give to outside agency for disposal
One cannot delegate this authority to a non-licensed personnel.
Medications should be in a locked and secured cabinet or container
Classification of Medications Samples
Designed to be "administered" doses Must follow guidelines for dispensing or administering
Store controlled substances securely and separately from other prescription drugs
Biannual inventory of controlled substances
Nonlicensed personnel need to notify DEA licensed professional about controlled substances convictions
Separate registration for all locations
Separate records for acquisition and disposition of controlled drugs
Storage and refrigerated medications
Follow storage requirements specified for drug Controlled substances separate from other prescription drugs Secured and locked location
Medications must be locked and secure at all times
Drugs are the responsibility of the team physician
International travel not specifically addressed in laws
Guidelines for Storing & Dispensing Meds
Keep an inventory Have a policy with guidelines for storing and dispensing Keep in a locked cabinet Maintain in original container Store away from direct light, heat, damp or extreme cold Know what your patient is already taking (supplements, OTC meds, birth control pills, etc)
Role of the ATC
OTC drugs are considered safe and effective only at the recommended dosage on the label
As an ATC, you can be held liable if you recommend that an patient use a higher dose than is recommended by the manufacturer.
Safety Patient must be instructed on specifics of medications:
When to take it
How to take it
What the medication should be taken with
College and Professional Athletes
Most are of legal age and are allowed to use whatever nonprescription drugs they choose
ATC must still use reasonable care and be prudent about types of medication provided
In all cases, actions should be performed under the supervision of a physician
In formal athletic training facilities
Rx meds are to be secured by a licensed physician according to State, Federal and DEA regulations for dispensing
Advise the patient to do the following when traveling
Do not store in luggage; carry it with him/her Make sure there is a sufficient supply Make sure there is a source of meds while traveling Take copies of prescriptions Keep the medication in it's original container If traveling internationally, know the restrictions
Storage Environmental Control
OTC and prescription meds should be stored in a locked metal cabinet that is environmentally controlled (dry temperature between 59 - 86° F) and secured by tamper-proof locks.
Controlled substances must be stored separately from other meds within the locked cabinet, as must sample packs
Storage area should be inaccessible to patients and other unauthorized individuals (coaches). Access (keys) limited to the facility's authorized personnel. (ATC, MD, DO, PA, etc)
High school setting
Be very cautious!
Regulations may vary between states.
Informed parental / guardian consent must be obtained before administering an OTC drug to a minor