Negligence
Any act of omission or commission which is not in accord with what an ordinary, reasonable, prudent person would do given the same circumstances.
Malpractice
- Any professional misconduct, unreasonable lack of skill or fidelity in professional duties.
Pharmacology
- Study of drugs. Includes sources, properties and interactions with the body
Pharmacodynamics
- Mechanisms by which drugs cause their effects on the body
Toxicology
- Study of substances harmful to the body and how to reduce those harmful effects
Food Drug and Cosmetic Act (1938)
Established the process for approval of a new drug. Its focus was on safety.
Harrison Narcotic Act (1914)
Set minor limitations on importation, distribution and sale of narcotics.
Durham-Humphrey Amendment (1952)
- Established those drugs and types of drugs that could be sold only by a physician or with a prescription from a physician. Somewhat directly in response to the introduction of antibiotics.
Kefauver-Harris Amendment (1963)
- First time any proof of efficacy of drugs was required.
Controlled Substance Act (1971)
- Restricted use, sale and prescription of narcotics and other dangerous drugs. Schedules of drug groups based on potential for abuse.
Negligence is a situation where
a therapist or other health professional does something that causes injury to a patient.
The actions in the circumstance would be compared to
a person with the same amount of training and experience. An important qualification is that the actions be done under the same circumstances.
Battery
- is both a tort and a crime...it is an intentional unpermitted act causing harmful or offensive contact with the person of another
Pharmacokinetics
- the action of drugs in the body over a period of time
Assault
- an unlawful physical attack upon another, an attempt or offer to do violence to another
Tort
- a wrongful act, not including a breach of contract or trust
Libel
- defamation by written or printed words
Slander
- the action or crime of making a false spoken statement damaging to a persons reputation
Advantages of FDA Process
Makes sure drugs are safe, effective and protects public
Disdvantages of FDA Process
Takes a lot of time and makes drugs very expensive
State which of the drug names is considered official
The generic name is considered the official name.
For which of these are the characteristics does the government of the United States of America regulate drugs that are sold to the public?
safety and effectiveness
In which phase of required testing do a small group of persons receive a drug to determine how it is absorbed and eliminated by the body?
Phase I
Which of these federal agencies is responsible for determining which drugs are available for sale in the United States of America?
Food and Drug Administration
Official source of information about drugs established by federal law in the United States of America?
United States Pharmacopia
What is this an example of???
not taking pulse of patient receiving a medication
error of omission?
medical negligence is an example of a legal ________
tort
Sending an e-mail that defames another person is an example of _________
libel
Pharmacokinetics
is defined as all effects the body has on drugs
In which decade was the first law to regulate drugs enacted in the United States of America?
1900
What is the central, critical role of all we do as respiratory therapists?
Deliver oxygen to the tissues
What is the primary purpose of all the drug laws?
protection of public
phase requires testing of a new drug must the manufacturer test the drug in large numbers of persons who have the problem the drug is to treat?
Phase III
Most commonly administered bronchodilator
albuterol
An orphan drug is a drug that
is useful to a small number of persons.
Which drug was introduced on the market that created a situation that caused the government to require that some drugs not be sold without a prescription from a physician?
penicillin
In which decade was the Controlled Substance Act enacted into law?
1970
WHich of these if the first phase of testing of a proposed new drug?
animals with charachteristics similar to humans
Telling something untrue about a nurse is an example of _______
slander
Who determines which drugs are listed in the Physician's Desk Reference?
Drug manufacturers
If a respiratory therapy student is named as a person who contributed to negligence in a suit, to whom would the actions of the student be compared.
respiratory therapy student with the same experience
Which of these is defined as a reason that a treatment should not be performed?
contraindication
Which of these means the study of substances harmful to the body and how those harmful effects may be reduced?
toxicology
Which of these form of malpractice WOULD NOT be handled in the legal system?
ethical breaches
After a new drug is approved by the FDA, the manufacturer must comply with a detailed reporting process to assure there are no unexpected effects. For what length of time must this be done?
six months
Which of these provided funding for the treatment of persons with addictions to drugs?
controlled substance act
List the four classes or types of names a new drug may be assigned.
code, chemical, generic, brand
List the five Rights about which a respiratory therapist must be concerned whenever administering a medication to a patient.
drug, dose, patient, time, route
List the four elements a person must prove for a person to be found to be negligent.
duty to perform
injury
not normal
proximate cause
List six things a respiratory therapist must know about any drug they administer to a patient to safely administer that drug.
TIME DID----T time--I ingredients--M Mode of action--E Excretion--I Drug Interactions--D Differing Responses
A respiratory therapist observes a patient has a significant increase in heart rate while receiving a bronchodilator by aerosol. List three things the therapist should do in response this change in heart rate.
stop treatment
monitor patient
document what occurred
What type of resistor is needed to provide Positive End Expiratory Pressure to a patient.
threshold
In which century was the first law regulating drugs passed in the United States of America?
1900
The main focus or purpose of this first drug law in the United States of America was to regulate
the safety of drugs.
Which of these types of drug names is usually assigned to the drug in the early development and testing phase of drug approval?
code
Printing untrue information about an employee in a company newsletter is an example of _______
slander
Which group of drugs, approved in the 1940's led to an amendment to require a prescription from a physician for a person to obtain those drugs?
antibiotics
In all areas of the world other the United States of America, the drug we call albuterol is called
salbutamol
Which of the following is designated legally as the official name of a drug?
generic
Which of the following is legally designated as the official source of drug information?
United States Pharmacopoeia - National Formulary
Which of these governmental agencies is responsible for the regulation of drugs in the United States of America?
FDA
According to the study by DiMasi cited in your text, what is the calculated cost to develop and conduct the pre- and post-market testing to bring a new drug to market in the USA?
$900 million
How many phases of clinical trials in humans are required during the investigation to obtain approval of a new drug?
3
For what purpose other than treatment of cystic fibrosis might 7% hypertonic saline be used by a respiratory therapist?
sputum induction
Which of these is the primary purpose of the governmental process for testing and approving new drugs.
assure drugs are safe
List six pieces of information a respiratory therapist must know about any drug they administer to a patient.
ingredients
side effects
toxicity
excretion
routes
unusual reactions
What was the primary change to the Food, Drug and Cosmetic Act that occurred with the implementation of the Kefauver Harris amendment?
Require manufacturer to show the drug had the effects claimed.
What modification did the Durham Humphrey amendment make to the Food, Drug and Cosmetic Act?
Drugs sold by prescription only.
Phase 3
The drug is investigated in a large multicenter studies to establish safety and efficacy.
Phase 2
The drug is next investigated as a treatment in a small number of individuals with the disease the drug is intended to treat.
Phase 1
The drug is investigated in a small group of healthy volunteers to establish its activity. This investigation is the basis for the pharmacokinetic description of the drug.
1 inch equals _______ cm
2.54 cm equals ________ inch
1 cc equals ______ ml of H2O at 4 degrees celcius
_______ cc equals 1 ml of H20 at 4 degrees celcius
1 pint equals_______ ml
______ pint equals 473 ml
1 fluid ounce equals _______ ml
_____ fluid ounce equals 29.57 ml
1 kg equals ______ pounds
_________ kg equals 2.2 pounds
1 ounce equals ______ g
________ ounce equals 28.3 g
1 tsp ~ ____ ml
_____ tsp ~ 5 ml