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These flashcards cover drug nomenclature, federal legislation and schedules, the stages of new drug development, and intravenous therapy equipment and complications.
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Biosimilar
A biologic product that is close in structure and function to an existing approved biologic product.
The United States Pharmacopeia (USP)/National Formulary (NF)
The official source for American drug standards.
Federal Food, Drug, and Cosmetics Act (1938)
A primary piece of US drug legislation enacted in 1938.
Contaled Substance Art (1970)
Defined 5 classifications/schedules of controlled substances.
Schedule 1 Controlled Substance
High abuse potential with no medical use; include examples like heroin and cocaine.
Schedule 2 Controlled Substance
High abuse potential with some medical use, such as pentobarbital.
Schedule 3 Controlled Substance
High abuse potential with some medical use, such as codeine.
Schedule 4 Controlled Substance
Low abuse potential with some medical use, such as diazepam.
Schedule 5 Controlled Substance
Low abuse potential where a prescription is not needed, such as Robitussin.
Preclinical research phase
The first stage of new drug development; involves research and development and commonly takes 18months.
Clinical Research and development
The second stage of drug development; can take up to 10years but commonly lasts 5years.
New Drug Application (NDA) Review
The third stage of drug development, which lasts an average of 17months.
Post-marketing Surveillance
The fourth stage of drug development used to see if the drug is effective and functioning as desired.
Drugs
Chemical substances that have an effect on living organisms.
Biologic Therapy
A new class of drugs consisting of large, complex proteins manufactured in a living system to treat disorders attacking the body's own organs, tissues, and cells.
Chemical Name
Significant to chemists to understand the make-up of a drug.
Generic Name
The official name listed by the FDA; not capitalized and used by formularies.
Brand or Trademark Name
The name registered by manufacturers, which is always capitalized.
Intracellular Compartment
The fluid compartment located inside cells.
Intravascular Compartment
The fluid compartment including blood vessels, arteries, and capillaries.
Interstitial Compartment
The fluid compartment located between cells.
Macrodrip
A drip chamber that delivers 10, 15, or 20drops/mL.
Microdrip
A drip chamber that delivers 60drops/mL.
Formula for drops/min
Hours of adminmL of Solution×60minsDrops (drip factor)=drops/min
Peripheral Access Devices
Devices for short-term use in peripheral veins of the hand or forearm.
Midline Catheters
Catheters inserted into intermediate-sized veins and advanced into larger vessels.
Central Access Device Sites
Typically established in the subclavian, jugular, or femoral veins.
Implantable Infusion Ports
Used for long-term therapy in central veins; accessed with a 90∘ Huber needle.
Tunneled central venous catheters
Surgically placed catheters where the proximal end exits on the chest.
IV Complications
Includes phlebitis, thrombophlebitis, infection, septicemia, infiltration, extravasation, air embolus, circulatory overload, pulmonary edema, pulmonary embolism, and speed shock.