Pharma companies must submit extensive data to the FDA demonstrating the safety and effectiveness of new drugs before receiving approval for
... [Show More] sale.
True
Average review time for a new drug
18 months
Sales Team
Pg 7
The "engine of innovation," focused on discovering or inventing promising new product.
Research & Development
This includes supply chain, manufacturing, trade, and distribution functions of the business.
Manufacturing & Operations
In 2012, FDA regulators approved 39 new drugs for use in the U.S.
True
3,070 new meds are in development for cancer.
True
Define Off-label
Usage of a medication for purposes other than the specific ones appearing on the label
Toxicity
The extent, quality, or degree to which a substance is poisonous or harmful to the body
Institutional review Board (IRB)
A committee of physicians, staticians, community advocated, and others which ensure that a clinical trial is ethical and that the rights of the study participants are protected. All clinical trials must be approved by an IRB before they begin.
Placebo
Inactive pill, liquid, or powder that has no treatment value aka sugar pill
Edema
Swelling
Asymptomatic
Without signs or symptoms
Clinical Pharmacology
The study of the effects and movement of drugs in the human body
Anatomy
The study of basic structures of the body
Physiology
The study of how those body structures function
Basic clinical pharmacology involves 3 main concepts
Pharmacodynamics, Pharmacokinetics, drug distribution and elimination.
Pharmacodynamics
Study of the biochemical and physiological effects of drugs and their mechanisms of action i.e. the study of what a drug does to the body. It describes the therapeutic effects of drugs (pain relief, blood pressure reduction, their side effects and their sites of action.
Pharmacokinetics
Study of how a drug is processed by the body, with emphasis on the time required for absorption, duration of action, distribution, and method of excretion. The study of how the body affects drugs.
Drug distribution & elimination
Drug delivery systems, route of administration , modes of excretion.
Plasma
The liquid portion of the blood that carries proteins and other substances
Organs
Specialized cells and tissues grouped together to perform specific body function for a common purpose. (Kidney, heart, intestines, and skin)
Nucleus
Brain of the cell that regulates all activities.
Proteins
A nutrient made up of of chains of amino acids
Fats
A nutrient stored in special body tissues as a great source of reserve energy
Carbohydrates
A nutrient that is the body's immediate source of energy. It's broken down to glucose and used for immediate metabolic reactions.
Vitamins
A nutrient substance necessary for growth, development, and normal regulation of metabolic processes. Must be taken from outside the body.
Minerals
A nutrient necessary for bodily purposes such as the balance of body fluid
Water is NOT a nutrient
True
Body's Major Systems
Cardiovascular, Respiratory, nervous, musculoskeletal, reproductive, immune
Absorption
How the drug passes from its side of administration into the bloodstream
Distribution
How the drug is dispersed among the organs after absorption into the blood
Metabolism
How the active part of a drug is metabolized into a more water-soluble compound that can be readily excreted by the kidneys
Excretion
How the drug is eliminated from the body. Usually drugs are eliminated via urine. They can also be excreted through the lungs, skin, or breast milk.
It takes about 10 years for a drug to hit the market
True
Routes of drug administration
Pg 26-29
Seven rights of drug administration
pg 30
Bioavailability
how quickly and how much of a drug reaches its intended target site of action
Bioequivalent
when they contain the same active ingredients and proceed virtually the same blood levels over time.
Therapeutic equivalence
Production of the same medicinal effect
Drug elimination and Excretion
pg 34
Drug Forms
Pg 35-38
Patent last 20 years
True
Inactive ingredients
Added to provide bulk, strength, aid dissolving, color, taste, etc. IAs do not affect the body
Pharmaceutical Ingredients
Pg 54
BID
twice a day
Cmax
Peak plasma concentration on a measuring curve
Half-life
Period of time it takes for a specific amount of drug in the body to be reduced, through the excretion or elimination process, to exactly one-half that original amount
PRN
As needed
QD
Once a day
QID
Four times a day
Protein binding
the ability of certain drugs to bind to plasma protein.
TID
three times a day
Titration
the process of adjusting drug doses to achieve the max positive therapeutic effects while minimizing adverse or side affects
Tmax
Time of peak plasma concentration on a measuring curve
STAT
Immediately
Primary wholesale distributors
Buy most of their drugs directly from manufacturers. Legally considered authorized distributors within the meaning of the PDMA because they usually have ongoing relationships with manufacturers
Secondary wholesale distributors
Buy from a primary and other secondary wholesalers as well as manufacturers but are not considered authorized distributors of the manufacturers within the meaning of the PDMA
Distribution Terminology
Pg 60-61
Average wholesale price (AWP)
Published wholesale price of list price suggested by the manufacturer.
Chain drug store
Company that owns and operates four or more pharmacies
Drop shipment
Drug manufacturer directly delivers the drugs to a dispenser, but order and payments are made through a wholesaler
Group purchasing organization (GPO)
An entity consisting of two or more hospitals or other healthcare entities that is formed to offer its members access to purchasing contracts for health supplies
Upcharge
Percentage fee that is paid by the dispenser to the wholesaler for the cost of distribution
Package Insert Info
Pg 63
Drug Patents
Pg 65
Terms pg 67
Orange Book ratings
A
AA
AN
AO
AP
AT
B
Hatch-Waxman Act
aka Drug Price Competition and Patent Term Restoration Act of 1984. Considered the most significant drug-related legislation affecting pharma and healthcare. H-W made it easier to bring generics to the marker by requiring FDA to only look at bioavailability studies in order to approve. Also gave protection to the research based manu's by providing a 30 months automatic cooling off period
It is important not to change the order of a sample closet
True
Manufacturers and distributors are required to have systems to monitor and audit the distribution of their drug samples
True
Meticulous records must be kept of sample inventories and reps are required to account for their samples periodically.
True
Representatives are required to store samples in a secure area where people cannot access them without permission and where they will not be subjected to extremes of temperature, moisture, and contamination
True [Show Less]