Week 1 - Clinical Judgment and Safety Flashcards
List three most important properties of drugs. Which is the most important?
Effectiveness, safety, selectivity.
Effectiveness most important.
What does selectivity mean?
Produces only desired responses for which it is given.
List three types of drug names. Which is the best for communicating between health professionals?
Chemical, generic, trade
Generic name is the best.
What factor primarily determines the drug concentration at the receptor?
Administration.
Pharmacokinetics determines what?
How much of a drug reaches the sites of action
List four processes of pharmacokinetics.
Absorption, distribution, metabolism, excretion`
How does changing the route from intravenous to oral influence dosage?
Oral dosages are usually higher than intravenous dosages, because there is a barrier to absorption.
Pharmacodynamics refers to what action?
The nature and intensity of response at its site of action.
Name the six rights of safe medication administration.
Right patient, right drug, right dose, right route, right time, right documentation
Explain the difference between a contraindication and precaution.
A contraindication prevents the drug use under all but the most severe circumstances. A precaution increases the likelihood of an adverse reaction, but not a life–threatening one.
The Federal Food, Drug, and Cosmetic Act of 1938 resulted in what mandate?
Testing for toxicity
The Harris-Kefauver Amendment of 1962 mandated what two requirements?
Proof of effectiveness and rigorous testing procedures.
The Controlled Substances Act of 1970 identified drugs with a potential for what? What was developed?
Potential for abuse.
Developed Schedules I – V
Schedule I includes what types of drugs? Schedule II?
Schedule I- Drugs with no acceptable medical use and high abuse potential.
Schedule II- Drugs with therapeutic use, but high abuse potential.
THE FDA Amendments Act (FDAAA) of 2007 allowed the FDA oversight over what?
Safety oversight over drugs that had been approved. Specifically gave the FDA the authority to require postmarketing safety studies, labeling changes to include new safety information, and restricting the distribution of drugs with safety concerns.
What does “off-label” mean?
Taking a drug approved by the FDA for as different reason. The FDA did not approve it for this alternative use.
The Randomized Controlled Trial (RCT) requires what three features in drug testing?
Controls, randomization, blinding
Preclinical testing of a drug is done on whom?
Animals
List the four phases of clinical testing and identify the sample and goal. Which is post-marketing?
Phase I – healthy volunteers, evaluation of drug metabolism, pharmacokinetics, and biologic effects
Phase II & III– patients, therapeutic use and dosage, safety and effectiveness
Phase IV – patients, postmarketing surveillance of a large population
What is the best human resource for drug information?
Pharmacists.
Define an adverse drug reaction.
Any noxious, unintended, and undesired effect that occurs at NORMAL drug doses.
List 4 risk factors for adverse drug reactions.
Elderly, very young, severe illness, multiple drug use
Define side effect.
A nearly unavoidable secondary drug effect produced at therapeutic doses.
Define toxicity.
An adverse drug reaction caused by excessive dosing.
Define allergic reaction.
An immune response triggered by a previous sensitizing administration.
Define idiosyncratic effect.
An uncommon response resulting from a genetic predisposition.
Define iatrogenic disease.
A disease produced by a healthcare provider or by a drug.
Define physical dependence.
A state in which the body has adapted to prolonged drug exposure and will result in an abstinence syndrome if the drug is abruptly discontinued.
Define carcinogenic effect.
The ability to cause cancer.
