Introduction into Pharmacology

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Terms in this set (...)

Chemical name
Specifies the chemical structure
Generic name
Name assigned to each drug entity
Nonproprietary name
The official name under which licensed by FDA
Nonproprietary
Less expensive
Usually do not differ significantly in therapeutic response
Trade name
Name associated with company that markets the drug
Proprietary name
May be more than one brand name
Issues With Trade Names
One generic name can be associated with multiple trade names

Trade name refers to the entire product and not just a single drug entity
Generic and Trade Name Drug Ingredients
Must have same active ingredients and must be identical in strength and dosage form

Trade-name drugs patented for 12 years

FDA recommends and all states allow pharmacists to dispense generic equivalent of brand-name drug
Classification by Chemical Structure
Grouped based on chemistry
Classification Based on Mechanism of Action
Grouped based on how the drugs work
Classification Based on Legal Classification
Grouped based on legal classification

Nonprescription or over-the-counter (OTC) drugs
Prescription or legend drugs
Controlled substances or scheduled drugs
Suffix -ine, -one
common pain opioids
E.g. Morphine, oxycodone
Suffix -en, -ib, -ac
NSAIDS
E.g. Naproxen, ibuprofen, celecoxib (celebrex)
Suffix -cet
indicates a combo med
E.g. Percocet (oxycodone + acetaminophen)
-olol, -pril
cardiac
E.g. Atenolol, Monopril
-caine
anesthetics
E.g. Lidocine, Novocain
-or
cholesterol
E.g. Lipitor, Crestor, Zocor
Nonprescription drugs or OTC drugs
Do not require a prescription

Usually contain less drug than corresponding prescription
Characteristics of OTC drugs
Low frequency of adverse effects
No need for periodic monitoring requirements
Effective at appropriate OTC dose
Prescription (legend) drugs
Requires medical supervision for use
Characteristics of prescription drugs
Potential for adverse effects
Requirements for monitoring
Drug interactions
Can only be used for a short time period
Controlled substances or scheduled drugs
Potential for abuse

More restrictions on distribution, storage, and record keeping

Five schedules based on the potential for abuse and whether the drug has an accepted medical use
Schedule I
High abuse potential
No accepted medical use in the United States

Examples
Marijuana
LSD
Heroin
Schedule II
High abuse potential
Accepted medical use in the United States

Examples
Cocaine
Amphetamine
Morphine
Demerol
Oxycontin
Ritalin
Adderall
Schedule III
Lower abuse potential than Schedule II
Accepted medical use in the United States

Examples
Anabolic steroids
Tylenol #3 (Tylenol with codeine)
Lortab
Schedule V
Lowest abuse potential
Contain small amounts of drug
May be nonprescription in some states
Controlled substances
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 #
Schedule IV
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?
Immediate care

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
Team Pharmacy
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
Administering
Medication given to patient and consumed within 24 hours
Dispensing
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
Treating
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
Treatment Authorization
Must have written authorization from the team physician

Records of treatment must be kept
Athlete Authorization
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)
Expired medications
Remove from active medication supplies
Record expired medications
Give to outside agency for disposal
Who can dispense?
Only someone licensed by the state may dispense.

E.g.: Pharmacist, Physician, Physician's Assistant, Nurse Practitioner

One cannot delegate this authority to a non-licensed personnel.
Security
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
DEA requirements
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
Travel
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
Accessibility
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