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Pharmacology Exam 1Chemicals that are introduced into the body to bring about some sort of change - correct
answer-drugs
The study of the biological effects of chemicals - correct answer-pharmacology
The branch of pharmacology that deals with drugs; chemicals that are used in medicine for
the treatment, prevention, and diagnosis of disease in humans - correct
answer-Pharmacotherapeutics (Clinical Pharmacology)
Natural sources of meds - correct answer-plants, animal products, inorganic compounds
Genetic engineering to alter chemicals or bacteria that are therapeutic - correct
answer-synthetic sources of meds
The goal of drug therapy is to provide maximium ________ with minimum ___________ -
correct answer-benefit, harm
Nursing process - correct answer-Assessment
Diagnosis
Planning
Implementation
Evaluation
Derived from the Belmont Report, the World Medical Association Declaration of Helsinki Set
WHAT THREE ethical principles for medical research that involves human subjects-Integral
to issues of informed consent and risk-benefit ratio? - correct answer-Respect for persons,
Beneficence, Justice (informed consent is also important)
Treat patients as independent persons making decisions in their own best interest - correct
answer-respect for persons
Considering respect for persons, Patients with diminished decision-making capacity are
entitled to... - correct answer-protection
Patients should be aware of alternatives, when available, as well as the consequences from
taking the alternatives. _______________should be honored whenever possible considering
respect for persons - correct answer-Patient's choice
Nurse's responsibility to be aware when a patient is unable to make a decision in their own
best interest. _____________ is the right to self determination and is a key component of
respect for persons - correct answer-Autonomy
The duty to protect research subjects from harm-Assessing potential risks and possible
benefits and ensuring the benefits are greater than the risk - correct answer-Beneficence
,Requirement of the Department of Health and Human Services (DHHS) is that institutional
review boards (IRB's) determine that ________ to subjects be reasonable in relation to the
anticipated benefits, if any, for subjects - correct answer-risks (beneficence)
-Most complex problem faced by the researcher-All potential consequences of a clinical
study must be analyzed and balanced against the inherent risks and the anticipated benefits-
physical, psychological, and social - correct answer-Risk-Benefit Ratio (beneficence)
Selection of subjects is fair, and Research subjects reflect all social classes and racial and
ethnic groups - correct answer-Justice
The Tuskegee Study of Untreated Syphilis in the Negro Male, also known as the Tuskegee
Syphilis Study or Tuskegee Syphilis Experiment was an infamous, unethical, and malicious
clinical study conducted between 1932 and 1972 by the U.S. Public Health Service. What
main core ethical principlal does it not follow? - correct answer-justice
-Two most relevant aspects of the Code are the right to be informed and that participation is
voluntary, without coercion
-The nurse's responsibility if coercion is suspected is to report immediately - correct
answer-informed consent (Origin in the 1947 Nuremburg Code)
-Mutual sharing of information
-Respect for person
-Active involvement of the patient in their care
-Respects the patients right to self determination (autonomy)
Describes informed _______________ - correct answer-consent
Once a chemical that might have therapeutic value is identified, it must undergo a series of
scientific tests to evaluate its actual ________________&______________ effects - correct
answer-therapeutic and toxic (This process is tightly controlled by the U.S. Federal Drug
Administration (FDA))
For every 100,000 chemicals identified as being potential drugs, only ________ end up
being marketed. These drugs must go through several stages of development - correct
answer-5
Most reliable way to objectively assess drug therapies (↓bias) in new drug development -
correct answer-RCTs (randomized control trials, essentially step one)
Testing drugs under development to see how they compare with standard drugs used for the
same disorder or how it compares with no treatment at all describes the use of... - correct
answer-controls
In RTCs, some subjects are given the new drug, and some are given either the _________
or a ____________ (which are referred to as the controls). These help us identify if the new
treatment is more or less effective than standard treatment. - correct answer-standard
treatment, placebo
, What parts of RTC prevent bias? - correct answer-randomization (subjects randomly
assigned to groups) and blindness
when subjects do not know what group they are in - correct answer-single blind
when subjects do not know what group they are in and neither does the researcher - correct
answer-double blind
Preclinical trials of new drug development - correct answer-lab animal testing (to see if drugs
have a presumed effect in living tissue and Evaluate any adverse effects)
At the end of preclinical trials some chemicals are discarded for:
›Lack of therapeutic activity when used on living tissue
›Chemical is too toxic to living animals
›Chemical is highly ___________________________
›Safety margins are so small-not useful in the clinical setting - correct answer-teratogenic
(causing harm to the fetus)
There are 4 Stages of New Drug Development (Phases of Pharmaceutical) Research in
Human clinical experimentation. Which describes the following:
›Small group (20 - 80) of healthy volunteers
›Tightly controlled
›Focus is on safety - correct answer-1
There are 4 Stages of New Drug Development (Phases of Pharmaceutical) Research in
Human clinical experimentation. Which describes the following:
›Drugs are tested in patients who have the disease (100 - 300) that the drug is designed to
treat
›Focus is on effectiveness - correct answer-2
There are 4 Stages of New Drug Development (Phases of Pharmaceutical) Research in
Human clinical experimentation. Which describes the following:
›Large groups 3,000 or more
›Focus remains on safety and efficacy
›If the FDA agrees trial results are positive, approves drug or device - correct answer-3
There are 4 Stages of New Drug Development (Phases of Pharmaceutical) Research in
Human clinical experimentation. Which describes the following:
›Drug has been approved for marketing by FDA
›Continued surveillance once it is released
›Collect information related to drugs' effects in various populations to assess any side effects
associated with long-term use - correct answer-4 (Post Marketing Surveillance)
The Best Pharmaceuticals for Children Act (BPCA) of 2002 and the Pediatric Research
Equity Act (PREA) of 2003 encourage pharmaceutical companies to do what? - correct
answer-study their drugs in children
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