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Pharamacology
The study of drugs and their action on living organisms
Digitalis
An extract from the foxglove plant that acts as a potent heart medication
Mipomersen (brand name Kynamero)
A chemically engineered drug designed to target specific cell components in people with high cholesterol
What are the three different names drugs may have?
Chemical name, generic name, and trade name
What is a drug's chemical name?
A scientific term that describes the molecular structure of a drug
What is a drug's generic name?
The name given to a drug that can be made or marketed by any company
Who gives a drug their official generic name?
The US Food and Drug Administration (FDA)
Which of the three names a drug may have is found in the National Formulary or the US Pharmacopeia?
Generic name
What is a drug's trade name?
The name selected by a specific company producing the drug for marketing purposes
True or false: A drug can be classified into only one kind of drug class
False
What are the three different things drugs may be classified by?
Their chemical type, their active ingredient, the way they're used to treat a particular condition
What are the three categories a drug may be assigned by the FDA once approved for use?
Prescription, nonprescription, controlled substance
What are prescription drugs also called?
Legend drugs
Which category of drugs is the largest?
Prescription drugs
Who are prescription drugs prescribed by?
A licensed health care provider
What does a prescription contain?
The drug, the dosage, the method and times of administration, and the electronic signature of the health care provider prescribing the drug
When are nonprescription drugs designations made by the FDA?
When the drug is safe (taken as directed) and obtainable without a prescription
What are nonprescription drugs frequently called?
Over-the-counter (OTC) drugs
What are some examples of places a nonprescription drug may be purchased?
A drugstore, a local supermarket, a large warehouse retailer
What is the most carefully monitored class of drugs?
Controlled substances
Which class of drugs have a high potential for abuse and may cause physical or psychological dependency?
Controlled substances
Physical dependency
The habitual use of a drug in which negative physical withdrawal symptoms result from abrupt discontinuation
Psychological dependency
A compulsion or craving to use a substance to obtain a pleasurable experience
What did the Controlled Substances Act of 1970 establish?
A classification system for drugs with abuse potential
What does the Controlled Substances Act of 1970 regulate?
The manufacture, distribution, and dispensing of the drugs classified as having abuse potential
What are the five groups the Controlled Substances Act of 1970 divided drugs into called?
Schedule I, Schedule II, Schedule III, Schedule IV, and Schedule V
What is a drug's assigned schedule based on?
The substance's potential for abuse and physical and psychological dependence
Who monitors the prescription practices of the primary health care provider for controlled substances?
The Drug Enforcement Administration (DEA)
Fill in the blank: Limited quantities of certain schedule BLANK drugs may be purchased without a prescription.
V
Who records the purchase of nonprescription schedule V drugs?
The dispensing pharmacist
Fill in the blank: In hospitals or other agencies that dispense controlled substances, the scheduled drugs are counted every BLANK hours to account for each injectable, tablet, or other form of the drug
8-12
How long does the process of drug development typically take?
7-12 years
Who has the responsibility for approving new drugs and monitoring drugs currently in use for adverse or toxic reactions?
The Food and Drug Administration (FDA)
What are the names of the two phases the development of a new drug is divided into?
The pre-FDA phase and the FDA phase
What happens during the first part of the pre-FDA phase?
A manufacturer conducts in vitro testing using animal and human cells to discover new drug compounds
What is in vitro testing?
Testing in an artificial environment, such as a test tube
What happens during the second part of the pre-FDA phase?
Studies on live animals
What happens during the third part of the pre-FDA phase?
The manufacturer makes application to the FDA for Investigational New Drug (IND) status
What begins during the FDA phase?
Clinical testing
What is clinical testing?
Testing conducted on humans
What does phase 1 of clinical testing involve?
20-100 individuals who are healthy volunteers
What is phase 1 of clinical testing designed to observe?
What the drug substance does to healthy tissue
What must happen to allow clinical testing to progress to phase 2?
Successful phase 1 studies
Who is given the drug in phase 2 of clinical testing?
People who have the disease or condition for which the drug is thought to be effective
What must happen to allow clinical testing to progress to phase 3?
The results of phase 2 are positive for helping to reduce or eliminate the problem and show that adverse reactions are not too great
Who is the drug given to in phase 3 of clinical testing?
Large numbers of clients in medical research centers
What is the main purpose of phase 3 of clinical testing?
To discover more information about adverse reactions
What is studied in all three phases of clinical testing?
Pharmacologic and biologic effects
What is submitted after the completion of phases 1, 2, and 3 of clinical testing (assuming the drug was found to be safe and effective)?
A New Drug Application (NDA)
After the NDA is submitted, what does a manufacturer do?
They submit all data collected concerning the drug during the clinical trials
Who reviews a NDA and makes a recommendation to the FDA?
A panel of experts, including pharmacologists, chemists, physicians, and other professionals
After FDA approval, what does the company making the drug give the new drug?
A brand name
What does the provision of a new brand name after FDA approval allow a company to do?
Sell the specific drug using this name for a limited time
Who is the brand name reserved for?
The company that first produced the specific drug substance
After FDA approval of a drug, what is done to ensure safety?
Continued surveillance
When does postmarketing surveillance occur?
After the manufacturer places the drug on the market
Where are health care providers supposed to report adverse effects of a drug to the FDA?
MedWatch or the Institute for Safe Medication Practices Medication Errors Reporting System
Why was the Orphan Drug Act of 1983 passed?
To encourage the development and marketing of products used to treat rare diseases
What does the Orphan Drug Act of 1983 define a rare disease as?
A condition affecting fewer than 200,000 individuals in the United States or a condition affecting more than 200,000 persons in the United States but for which the cost of producing and marketing a drug to treat the condition would not be recovered by sales of the drug
What are examples of rare disorders?
Gaucher disease, amyloidosis, and phenylketonuria
What are some incentives the Orphan Drug Act of 1983 provides for?
Research grants, protocol assistance by the FDA, and special tax credits
If an orphan drug is approved, how many years does a manufacturer have of exclusive marketing rights?
7 years
What are some examples of orphan drugs?
Velcade for multiple myeloma, Cerezyme (enzyme replacement therapy for Gaucher disease), and Valstar for the treatment of bladder cancer
Why is accelerated approval of drugs offered by the FDA?
As a means to make promising products for life-threatening diseases available on the market
When is accelerated approval of drugs given?
After preliminary evidence has been gathered and before formal demonstration of client benefit
What is accelerated approval considered?
A "provisional approval"
What are examples of diseases that qualified as posing a significant health threat, such that finding new drugs qualified for the accelerated program?
Acquired immunodeficiency syndrome (AIDS) and COVID-19
What is the The Risk Evaluation and Mitigation Strategies (REMS) program designed to do?
Monitor drugs that have higher risk to the client compared with benefit
Who may prescribe drugs with REMS restrictions?
HCP-trained, enrolled, and certified providers
What are the three phases oral drugs go through?
The pharmaceutic phase, pharmacokinetic phase, and the pharmacodynamic phase
Which phase do liquid and parenteral drugs bypass?
The pharmaceutic phase
What are parenteral drugs given by?
Injection or infusion
What must drugs be to be absorbed by the body?
A soluble liquid
What happens during the pharmaceutic phase?
The drug is dissolved
Where do tablets and capsules go through the pharmaceutical phase?
The gastrointestinal (GI) tract
Which drugs do not disintegrate until they reach the alkaline environment of the small intestine?
Tablets that have an enteric coating and time-release capsules
What does pharmacokinetics refer to?
The transportation activity of drugs in the body after administration
What does the transportation activity of drugs in the body after administration include?
Absorption, distribution, metabolism, and excretion
What are some examples of the subphases absorption, distribution, metabolism, and excretion can be broken down into?
Transport, first-pass effect, and half-life
Absorption
The process by which a drug is made available for use in the body
What does the process of absorption involve?
Moving the drug from the site of administration into the body fluids
When does absorption occur?
After the solid form of the drug dissolves or after the administration of an oral liquid or parenteral drug
During absorption, the drugs particles in the GI tract are moved into where?
The body fluids
Active transport
Cellular energy is used to move the drug from an area of low concentration to one of high concentration
Passive transport
No cellular energy is used as the drug moves from an area of high concentration to an area of low concentration (small molecules diffuse across the cell membrane)
Pinocytosis
Cells engulf the drug particle (the cell forms a vesicle to transport the drug across the cell membrane and into the cell)
What are some examples of factors that influence the rate of absorption?
The route of administration, the solubility of the drug, and specific conditions of the body's tissues
When does the most rapid route of drug administration occur?
When the drug is given by the intravenous (IV) route
Bioavailability
When 100% of the drug given is available to the cells of the body
When does absorption occur more slowly?
When the drug is administered orally, intramuscularly, or subcutaneously
Why does absorption occur more slowly when the drug is administered orally, intramuscularly, or subcutaneously?
The complex membranes of the GI mucosal layers, muscle, and skin delay drug passage
What is an example of a condition in the body that inhibits absorption of a drug given in the affected site?
Lipodystrophy
When can conditions in the body that inhibit absorption of a drug given in the affected site occur?
When clients have to administer drugs repeatedly into the skin tissue, such as insulin administration for diabetes
True or false: The first-pass effect is a factor affecting absorption.
True
What happens after a drug is absorbed by the small intestine?
It passes first into the liver before being released to circulate within the rest of the body
True or false: The liver metabolizes a small of the drug before releasing it into the body
False
First-pass effect
The drug is released into the circulation from the liver and the remaining amount of active (or available) drug may not be enough to produce a therapeutic effect, and the client will need a higher dosage
Where is a drug transported and distributed after systemic circulation?
Various body tissues or target sites
What are three factors that affect the distribution of an absorbed drug in the body?
Blood flow, solubility, protein binding
Name three areas of the body in which drugs are distributed quickly due to a large blood supply.
Heart, liver, kidneys
Note 
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