DRUG LABELSDRUG LABELS

OR “READ THE FINE OR “READ THE FINE PRINT PLEASE!”PRINT PLEASE!”

DRUG LABELS

Drug labels tell how the drug is supplied. There are 15 different pieces of information

supplied on each label. We will look at each of these items

individually.

BRAND & GENERIC NAMES

Brand, trade, or proprietary name is the manufacturer’s name for the drug.• Prominent on label

• Often followed by Generic name,

established, or nonproprietary name• Often in

parentheses

• Required by law that it is on label

DOSAGE STRENGTH The weight or amount of drug in a specific unit of

measurement. Some drugs

come in more than one strength.

FORM Identifies structure and composition of the drug Some come in powder and need to be reconstituted.

SUPPLY DOSAGE Refers to dosage strength and form Read as “X measured units per some quantity”.

• Tablets are by tablet

• Liquids are by given milliliters

TOTAL VOLUME Full quantity contained in a

package or bottle.

• Tablets: total number of tablets in bottle

• Liquid: total fluid volume

ADMINISTRATION ROUTE

Site of body or method of drug delivery into patient.

EX: oral, sublingual, injectable, otic, rectal, etc.

DIRECTIONS FOR MIXING OR RECONSTITUTION

When drugs are dispensed in powder form and must have a liquid substance added to administer.

LABEL ALERTS

Manufacturers may print warnings on packaging or special alerts may be added by pharmacy on AUXILLARY LABELSAUXILLARY LABELS.

EX: “Protect from light” Note warning on label to right.

NAME OF MANUFACTURER

Name of manufacturer of drug is on label.

EXPIRATION DATE The date by which the drug should be used,

discarded, or returned to pharmacy.

LOT OR CONTROL NUMBERS

Federal law requires all medication packages be identified with a lot or control number.

If drug is recalled the lot number quickly identities particular group of drugs that need to be removed from shelves.

NATIONAL DRUG CODE (NDC)

Federal law also requires each prescription drug have a unique number that identifies it (like your SS#).

This number must appear on every manufacturer’s label and is printed with “NDC” followed by 3 groups of numbers.

These 3 numbers identify the product, manufacturer, and packaging.

CONTROLLED SUBSTANCE SCHEDULE

Controlled Substance Act - passed May 1971 Purpose to improve administration and regulation of

production, distribution, & dispensing of controlled substances

Drugs considered controlled substances are classified according to their potential for use and abuse

Those with highest potential for abuse are Schedule I and lowest are Schedule IV.

BAR CODE SYMBOLS

Bar code symbols are used in retail sales Also document drug dosing for recordkeeping and stock

reorder Can automate medication documentation at patient bedside.

UNITED STATES PHARMACOPEIA (USP) & NATIONAL FORMULARY (NF)

Codes found on many manufacturer labels. USP and NF are 2 official national lists of approved drugs. There are specific guidelines about when to include these

initials. Placed AFTER generic drug name Be careful not to mistake these letters for initials that

indicate other characteristics of drug (like SR for sustained release).

UNIT OR SINGLE-DOSE LABELS

Most oral medications administered in hospitals are available in unit doses – i.e. a single capsule or tablet packaged separately (blister pack).

In this form, the total volume of the package is often omitted because the volume is one tablet or capsule.

Dosage strength is understood as “per one”.

COMBINATION DRUGS

Some medications are a combination of 2 or more drugs in one form.

Usually prescribed by number of tablets instead of dosage strength.

So…..

Let’s Practice!