The glossary on Rx-wiki is an ongoing project to provide definitions to various terms used throughout the site and in the field of pharmacy. The terms have been placed in alphabetical order to aid in finding them.

__NOTOCNUM__

0-9

A

B

behind the counter (BTC) - These are medications that do not require a prescription, but can only be obtained at the pharmacy counter. Examples of this include:

• products containing pseudoephedrine,
• emergency birth control,
• insulins, and
• some states allow cough syrups with small amounts of codeine.

brand name - This is the manufacturers trademark designation. Each brand name is owned by the company and begins with a capital letter, and it is protected by a trademark. Drugs often have several brand names. The terms trade name and proprietary name may also be used interchangeably with brand name.

C

classification - This is how a medication is grouped and is typically defined according to its use in treating a particular disease or disorder. A potential source of confusion is that many medications could be grouped multiple ways. An example of this is aspirin, which can be classified as an analgesic, antipyretic, and anti-inflammatory agent.

contraindication - A contraindication is a condition or factor that serves as a reason to withhold a certain medical treatment.

controlled substances - Controlled substances are medications with restrictions due to abuse potential. There are 5 schedules of controlled substances with various prescribing guidelines based on abuse potential counter balanced by potential medicinal benefit as determined by the Drug Enforcement Administration and individual state legislative branches.

D

dietary supplements - A dietary supplement is intended to supply nutrients, (vitamins, minerals/electrolytes, and amino acids) that are missing or not consumed in sufficient quantity in a person's diet. This category may also include herbal supplements.

dosage form - A dosage form is the physical form of a dose of medication, such as capsule, patch, or injection. The route of administration is dependent on the dosage form of a given drug. As an example, persistent vomiting may make it difficult to use an oral dosage form; therefore, an antiemetic in suppository form may be desirable.

E

excipient - An excipient is anything in a medication other than its active ingredient. Common categories for excipients include antiadherents, binders, coatings, disintegrants, fillers, flavors and colors, glidants, lubricants, preservatives, sweeteners, and printing inks.

F

G

generic name - This is the official non-proprietary name assigned by the manufacturer with the approval of the USAN (United States Adopted Name) Council. The Federal Food and Drug Administration (FDA) requires that each drug has a generic name, even if currently it is only available as a brand name product. A generic name may also be referred to as the non-proprietary name.

H

I

indication - This is the primary condition(s) treated by a particular drug. This may include both FDA approved uses as well as off-label (generally based on scientific studies but lacking FDA approval) medication uses.

interactions - Medications have the potential to interact with other medications, dietary supplements, and constituents of various foods. Medications may also interact with various diseases.

J

K

L

legend drug - Legend drugs are medications that require a prescription prior to dispensing. These medications may or may not be considered abusable, but consultation with a medical professional that has prescribing authority is necessary due to the complex health conditions that these medications may be able to treat or ameliorate. Often, you will see the phrase "Rx only" used to denote legend drugs.

M

N

National Drug Code (NDC) - Each medication is assigned a unique 10-digit, 3-segment number. This number, known as the National Drug Code (NDC), identifies the labeler or vendor, product, and trade package size.

• The first 4 or 5 digits indicate the manufacturer
• The second 3 or 4 indicate the medication, strength, and dosage form
• The third set of numbers always has 2 digits and indicates the package size

O

off-label uses - Off-label use is the use of a medication in a manner different from that approved by the FDA including:

• for an unapproved indication,
• in an unapproved age group,
• unapproved dosage, or
• unapproved form of administration.

over the counter (OTC) - Over the counter medications are drugs that do not require the use of a prescription for a patient to obtain it. These medications are generally considered sufficiently safe for a patient to acquire and self medicate with by following the instructions included on the vial.

P

pharmacology - The term pharmacology is derived from two Greek words "pharmakon" and "logos". Pharmakon can mean sacrament, remedy, poison, talisman, cosmetic, perfume or intoxicant, but in this case, it can be broadly defined as drug. Logos can be translated as a principle of order and knowledge. By combining the terms you can see that pharmacology is concerned with the knowledge of drugs.

pregnancy category - The pregnancy category of a pharmaceutical agent is an assessment of the risk of fetal injury due to the pharmaceutical, if it is used as directed by the mother during pregnancy. It does not include any risks conferred by pharmaceutical agents or their metabolites that are present in breast milk. The United States FDA has the following definitions for the pregnancy categories:

• Pregnancy Category A - Adequate and well-controlled studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters).
• Pregnancy Category B - Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women OR Animal studies which have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.
• Pregnancy Category C - Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
• Pregnancy Category D - There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
• Pregnancy Category X - Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

Q

R

S

side effect - A side effect is an effect, whether therapeutic or adverse, that is secondary to the one intended. The term is predominantly employed to describe adverse effects, but it can also apply to beneficial consequences of the use of a drug. A side effect of diphenhydramine (an antihistamine) is drowsiness, which would be an adverse effect is someone needed to be alert, but could be beneficial if they required help going to sleep.

T

therapeutic equivalents - Drug products are considered to be therapeutic equivalents only if they are available in the same dosage strength, dosage form, achieve the same blood levels, and if they can be expected to have the same clinical effect and safety profile when compared to the original innovator drug. To ensure that a specific generic product is considered to be a therapeutic equivalent, it is recommended that you refer to the Orange Book, a publication from the Food and Drug Administration (FDA). If the products being compared in the Orange Book are considered therapeutic equivalents, it will be given a Therapeutic Equivalence (TE) Code that begins with an "A". If the products are not considered therapeutic equivalents, they will be given a TE Code that begins with a "B". Sometimes these will be referred to as "A" ratings and "B" ratings. These ratings are typically two letters long and will sometimes include a number as well. Usually, a tablet or capsule that is therapeutically equivalent to the innovator drug will have a TE Code 'AB' (with the first letter establishing whether or not the drugs are therapeutically equivalent, and the second letter establishing dosage form category). If a number is included after the two letter code that must also match to be considered therapeutically equivalent.

U

V

vaccines - A vaccine is a biological preparation that improves immunity to a particular disease. A vaccine typically contains an agent that resembles a disease-causing microorganism, and is often made from weakened or killed forms of the microbe, its toxins or one of its surface proteins.

W

X

Y

Z