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Sterile Products

Key Terms

Adverse Drug Reaction (ADR)
Adverse Drug Reaction (ADR) An unexpected and undesirable effect caused by a drug. This is different from a known side effect.
Anaphylactic Shock Severe or fatal reaction by a patient to an agent for which the patient has become extremely sensitized. Symptoms include: hives, shortness of breath, swelling of limbs or tongue, fainting, etc.
Antagonistic Drug Effect When two or more drugs are administered together and causes opposite effects. (i.e. one drug can offset the effect of the other).
Antibacterial Agent A substance that kills bacteria or inhibits its growth.
Antibiotic A drug that is able to kill or inhibit the growth of bacteria or other microorganisms. The first antibiotics were produced by living organisms, such as fungi. Many modern antibiotics are now manufactured synthetically.
Antibody A substance produced by white blood cells in the body, which identifies and then inactivates a specific foreign substance, such as a virus or a bacteria, which has entered the body.
Antimetabolites Used to treat cancer by substituting in or blocking the use of essential nutrients and enzymes.
Aseptic Preparation Procedures designed to prevent contamination of drugs, packaging, equipment, or supplies by microorganisms during processing.
Bactericidal Agent Capable of killing a bacteria (i.e. penicillin). •
Bacteriostatic Agent Agent that stops or inhibits the growth of bacteria. (i.e. erythromycin). •
Bolus One single, relatively large quantity of a substance administered rapidly.
Batch Any specific quantity of a drug with a uniform specified quantity produced during a single manufacturing session.
Batch Preparation /Compounding … Compounding of multiple sterile-product units, in one process, by the same individual for future use. This does not include the preparation of multiple sterile-product units pursuant to a medication order for a specific patient.
Central Line An IV access into one of the major blood vessels.
Chemical Incompatibility … Occurs when two or more chemical substances react and cause a significant change of one or more of the substances.
Contamination Introduction of microorganisms or particles such as pathogens or pyrogens to an otherwise aseptic or sterile area/object.
Contraindication Condition or circumstance that mandates that a drug should not be given.
Cumulative Effect … When a drug accumulates in the body faster than the body can metabolize or eliminate it.
Diluents Fluid used to dissolve drugs in solid form. •
Disinfectant Agent that destroys or inhibits harmful microorganisms on inanimate objects.
Incompatible Two or more drugs mixed together that cause either a physical, chemical, or therapeutic change in the drug, and produce undesirable effects.
Infection The successful invasion of the body by pathogenic organisms, the reaction of the tissues to their presence, and to the toxins generated by them.
Infusion a drug administered for therapeutic purposes into the body via the vascular system.
Nosocomial Infection An infection acquired while the patient is in the hospital
Parenteral A sterile, injectable medication. (i.e. administered by SC, ID, IM, IV.)
Particulate Matter Extraneous undissolvedmobile substances, such as precipitate present in the parenteral products. •
Positive Air Pressure … Air pressure is greater inside of an enclosed area as compared to outside of enclosed area. This forces particulate matter to the outside of the enclosed area.
Process Validation Measured and documented evidence, providing a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes.
Prognosis The outcome that is expected for a particular disease, and whether there is chance for recovery.
Quality Assurance The set of activities used to assure that the process used in the preparation of sterile drug products, leads to products that meet predetermined standards of quality.
Quality Control The set of testing activities used to determine that the ingredients, components, and final sterile pharmaceuticals prepared, meet predetermined requirements with respect to identity, purity, non-pyrogenicity, and sterility.
Reconstitution Some drugs are in a powder form because they are too unstable to be mixed until ready for use. Mixing the powder with a liquid (diluent) is called reconstitution.
Side Effect Undesired effect of a drug seen when the therapeutic dose is used
Solute The substance that is dissolved in a solution.
Solvent The substance used to dissolve another substance. (solute)
Sterilization The complete destruction of microorganisms by heat or other method. (Free of microorganisms) •
Synergistic Drug Effect … Actions of two or more drugs administered together, whereby an effect produced is greater than if administered separately. (i.e. 1+1>2)
Subcutaneous (s.q. or s.c.) Under the skin, an injection administered under the skin.
Total Parenteral Nutrition (TPN) Long or short term intravenous feeding of high protein, high carbohydrate solutions to provide a patient’s total nutritional requirements.
Toxicity Condition resulting from exposure to a poison or a dangerous amount of a drug. (Amount exceeding the therapeutic level)
Unit Dose Packaging a single dosage, repackaged, from a bulk bottle labeled with brand name or generic name, strength of drug, manufacturer, facility’s lot number and expiration date of drug.
ac before meals
qhs at bedtime
prn as needed
pc after meals
qid four times a day
bid twice daily
qod every other day
q4h every 4 hours
q6h every 6 hours
q8h every 8 hours
q12h every 12 hours
stat at once, immediately
ut.dict. use as directed
amp ampule
EC- enteric coateds
DS double strength
gtts drops
inj injection
supp suppository
susp suspension
syr syringe
ung/oint ointment
SCHEDULE I Drugs with no accepted medical use, or other substances with a high potential for abuse. EXAMPLES: HEROIN MARIJUANA
SCHEDULE II Drugs with accepted medical uses and high potential for abuse, which may lead to severe psychological and / or physical dependence. EXAMPLES: COCAINE FENTANYL CODEINE MORPHINE
SCHEDULE III… Drugs with accepted medical uses and a moderate potential for abuse (less than Schedule I & II), which if abused may lead to moderate or low psychological dependence or high physical dependence. EXAMPLES: VICODIN TESTOSTERONE TYLENOL #2,3,4
SCHEDULE IV… SCHEDULE IV… Drugs with accepted medical uses and low potential for abuse relative to those in Schedule III, which is abused, may lead to limited physical dependence or psychological dependence relative to drugs in Schedule III.
SCHEDULE V… Drugs with accepted medical uses and low potential for abuse relative to those in Schedule IV, which if abused may lead to limited physical dependence or psychological dependence relative to drugs in Schedule IV. EXAMPLE: LOMOTIL
Filter Filter tubing required when dispensing
DNREF Do not refrigerate when dispensing
NS Only stable when mixed in Sodium Chloride Solutions
D5W Only stable when mixed in Dextrose Solutions
Glass Only stable when stored in glass bottles
PFL Protect from light when dispensing
Created by: chelo_baby8
 

 



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