PHARMACOLOGY DISCUSSION QUESTIONS.
Written Assignments for Chapters 1-59
2022 Update
Chapter 1
Introduction to Drugs
Written Assignment
How does the term pharmacology differ from the term clinical pharmacology? Give
examples of how nurses utilize pharmacology in clinical practice.
Pharmacology is the branch of medicine and biology concerned with the uses, effects and modes
of action of drugs. It is, more to the point, the study of interactions between living Organisms
and chemicals that affect normal or abnormal biochemical function. Pharmacology deals with the
research, discovery and characterization of chemicals that show biological effects normal and
abnormal biochemical function. Substances that show medicinal properties are referred to as
pharmaceuticals. Aspects of pharmacology include; clinical pharmacology, neuropharmacology,
psychopharmacology, cardiovascular pharmacology, pharmacogenetics, pharmacoepidemiology,
toxicology etc.
Clinical Pharmacology is the science of drugs and their clinical application. It is based upon the
basic science of pharmacology. It bridges the gap between medical practice and laboratory
science. However, clinical pharmacology is not specific to medicine as pharmacists have to train
,to become clinical pharmacologists. The branches of clinical pharmacology include;
pharmacodynamics, pharmacokinetics, rational prescribing etc.
Give example of how nurses utilize pharmacology in clinical settings.
Nurses utilizes pharmacology mostly in clinical practice to promote the safety of prescriptions,
maximize the drug effects and minimize the side effects. Nurses Intervene so that the drugs are
well tolerated, Teaching the clients about the drug, and The nurse ensure that there are no
medication errors
Briefly describe the phases of involved in each step of developing and approving a new
drug in the United States.
The process of drug approval is controlled in most countries by a governmental regulatory
agency. In the U.S., the Food and Drug Administration (FDA) governs this process. The FDA
requires the following sequence of events before approving a drug.
1. Preclinical Testing: A pharmaceutical company conducts certain studies before the future drug
is ever given to a human being. Laboratory and animal studies must be done to demonstrate the
biological activity of the drug against the targeted disease. The drug must also be evaluated for
safety. These tests take on the average 3 1/2 years.
2. Investigational New Drug Application (IND): The pharmaceutical company files an IND with
the FDA to begin testing the drug in people. The IND becomes effective if the FDA does not
disapprove it within 30 days. The IND must include the following information: the results of
previous experiments; how, where and by whom the new studies will be conducted; the chemical
structure of the compound; how it is thought to work in the body; any toxic effects found in the
,animal studies; and how the compound is manufactured. The IND must also be reviewed and
approved by the Institutional Review Board where the studies will be conducted.
3. Phase I Clinical Trials: Phase I studies are usually the first tests of a drug under development
in healthy volunteers. These studies involve about 20 to 80 volunteers. The tests determine a
drug's safety profile, including the safe dosage range, plus how the drug is absorbed, distributed,
metabolized and excreted, and the duration of its action. Phase I trials take on the average 1 year.
4.Phase II Clinical Trials: These are slightly larger studies that are done in patients with the
disease for which the drug is intended. This phase is usually designed to identify what are the
minimum and maximum dosages. The trials generally involve 100 to 300 volunteer patients and
are controlled in design. They are done to assess the drug's effectiveness. Phase II typically takes
about 2 years.
5. Phase III Clinical Trials: These are the definitive, large randomized trials that are submitted to
the FDA in order to obtain approval of a drug. This phase examines the effectiveness as well as
the safety (adverse events) of the new drug. Phase III trials usually involve 1,000 to 3,000
patients in clinics and hospitals. Patients are usually asked a list of possible side effects, often
derived from what was observed in phase II studies. Patients are also free to report any other side
effects that occur while they are on the new drug or the placebo (the "sugar pill" that is given to a
percentage of patients in a trial study). Phase III takes on the average 3 years.
6. New Drug Application (NDA): Following the Phase III Clinical Trials, the drug manufacturer
analyzes all the data from the studies and files an NDA with the FDA (provided the data appear
to demonstrate the safety and effectiveness of the drug). The NDA contains all of the data
gathered to date about the drug. (An NDA typically consists of at least 100,000 pages.) The
average NDA review time for new drugs approved in 1992 was close to 30 months (2 1/2 years).
, 7. Phase IV Studies: Phase IV is any organized collection of data from patients who are taking a
drug that has already received approval from the FDA. In Phase IV studies, patients may check
boxes on a list (as in phase III studies) or they may just report other symptoms. Phase IV studies
are commonly called "post-marketing studies."
Nurses have utilized pharmacology in clinical practices in various instances i.e. drugs
administration, intervention to make drugs regimen tolerable, drug therapy etc.
GROUP ASSIGNMENT
Just because a drug is sold over the counter does not mean it’s harmless. Laxatives, for example,
are said to be among the most misused out of the counter medication, and I don’t mean by people
who abuse them in an effort to lose weight. Over-the-counter sleeping pills that contain
antihistamines can lose their effectiveness over time, which can result in people taking more than
the recommended dose. They should not be used for more than two weeks. Even if taken as
directed, they can result in daytime sleepiness, dizziness and a thickening of bronchial secretions.
Some people with chronic heartburn take antacids that counter the effects of stomach acid. But
these can also cause diarrhea or constipation and block the absorption of certain prescription
medications. Better choices now available over the counter are H2 blockers (like Pepcid
and Zantac) and proton-pump inhibitors (like Nexium, Prilosec and Prevacid) that stop the
production of stomach acid. But these drugs may also pose dangers when taken long term,
including bone fractures and magnesium deficiencies that can lead to seizures.
When Nsaids, or nonsteroidal anti-inflammatory drugs, like aspirin, ibuprofen and naproxen are
taken too long, they can likewise pose dangers, including bleeding ulcers, kidney or liver damage
and an increased risk of a heart attack or stroke. And so on.
Written Assignments for Chapters 1-59
2022 Update
Chapter 1
Introduction to Drugs
Written Assignment
How does the term pharmacology differ from the term clinical pharmacology? Give
examples of how nurses utilize pharmacology in clinical practice.
Pharmacology is the branch of medicine and biology concerned with the uses, effects and modes
of action of drugs. It is, more to the point, the study of interactions between living Organisms
and chemicals that affect normal or abnormal biochemical function. Pharmacology deals with the
research, discovery and characterization of chemicals that show biological effects normal and
abnormal biochemical function. Substances that show medicinal properties are referred to as
pharmaceuticals. Aspects of pharmacology include; clinical pharmacology, neuropharmacology,
psychopharmacology, cardiovascular pharmacology, pharmacogenetics, pharmacoepidemiology,
toxicology etc.
Clinical Pharmacology is the science of drugs and their clinical application. It is based upon the
basic science of pharmacology. It bridges the gap between medical practice and laboratory
science. However, clinical pharmacology is not specific to medicine as pharmacists have to train
,to become clinical pharmacologists. The branches of clinical pharmacology include;
pharmacodynamics, pharmacokinetics, rational prescribing etc.
Give example of how nurses utilize pharmacology in clinical settings.
Nurses utilizes pharmacology mostly in clinical practice to promote the safety of prescriptions,
maximize the drug effects and minimize the side effects. Nurses Intervene so that the drugs are
well tolerated, Teaching the clients about the drug, and The nurse ensure that there are no
medication errors
Briefly describe the phases of involved in each step of developing and approving a new
drug in the United States.
The process of drug approval is controlled in most countries by a governmental regulatory
agency. In the U.S., the Food and Drug Administration (FDA) governs this process. The FDA
requires the following sequence of events before approving a drug.
1. Preclinical Testing: A pharmaceutical company conducts certain studies before the future drug
is ever given to a human being. Laboratory and animal studies must be done to demonstrate the
biological activity of the drug against the targeted disease. The drug must also be evaluated for
safety. These tests take on the average 3 1/2 years.
2. Investigational New Drug Application (IND): The pharmaceutical company files an IND with
the FDA to begin testing the drug in people. The IND becomes effective if the FDA does not
disapprove it within 30 days. The IND must include the following information: the results of
previous experiments; how, where and by whom the new studies will be conducted; the chemical
structure of the compound; how it is thought to work in the body; any toxic effects found in the
,animal studies; and how the compound is manufactured. The IND must also be reviewed and
approved by the Institutional Review Board where the studies will be conducted.
3. Phase I Clinical Trials: Phase I studies are usually the first tests of a drug under development
in healthy volunteers. These studies involve about 20 to 80 volunteers. The tests determine a
drug's safety profile, including the safe dosage range, plus how the drug is absorbed, distributed,
metabolized and excreted, and the duration of its action. Phase I trials take on the average 1 year.
4.Phase II Clinical Trials: These are slightly larger studies that are done in patients with the
disease for which the drug is intended. This phase is usually designed to identify what are the
minimum and maximum dosages. The trials generally involve 100 to 300 volunteer patients and
are controlled in design. They are done to assess the drug's effectiveness. Phase II typically takes
about 2 years.
5. Phase III Clinical Trials: These are the definitive, large randomized trials that are submitted to
the FDA in order to obtain approval of a drug. This phase examines the effectiveness as well as
the safety (adverse events) of the new drug. Phase III trials usually involve 1,000 to 3,000
patients in clinics and hospitals. Patients are usually asked a list of possible side effects, often
derived from what was observed in phase II studies. Patients are also free to report any other side
effects that occur while they are on the new drug or the placebo (the "sugar pill" that is given to a
percentage of patients in a trial study). Phase III takes on the average 3 years.
6. New Drug Application (NDA): Following the Phase III Clinical Trials, the drug manufacturer
analyzes all the data from the studies and files an NDA with the FDA (provided the data appear
to demonstrate the safety and effectiveness of the drug). The NDA contains all of the data
gathered to date about the drug. (An NDA typically consists of at least 100,000 pages.) The
average NDA review time for new drugs approved in 1992 was close to 30 months (2 1/2 years).
, 7. Phase IV Studies: Phase IV is any organized collection of data from patients who are taking a
drug that has already received approval from the FDA. In Phase IV studies, patients may check
boxes on a list (as in phase III studies) or they may just report other symptoms. Phase IV studies
are commonly called "post-marketing studies."
Nurses have utilized pharmacology in clinical practices in various instances i.e. drugs
administration, intervention to make drugs regimen tolerable, drug therapy etc.
GROUP ASSIGNMENT
Just because a drug is sold over the counter does not mean it’s harmless. Laxatives, for example,
are said to be among the most misused out of the counter medication, and I don’t mean by people
who abuse them in an effort to lose weight. Over-the-counter sleeping pills that contain
antihistamines can lose their effectiveness over time, which can result in people taking more than
the recommended dose. They should not be used for more than two weeks. Even if taken as
directed, they can result in daytime sleepiness, dizziness and a thickening of bronchial secretions.
Some people with chronic heartburn take antacids that counter the effects of stomach acid. But
these can also cause diarrhea or constipation and block the absorption of certain prescription
medications. Better choices now available over the counter are H2 blockers (like Pepcid
and Zantac) and proton-pump inhibitors (like Nexium, Prilosec and Prevacid) that stop the
production of stomach acid. But these drugs may also pose dangers when taken long term,
including bone fractures and magnesium deficiencies that can lead to seizures.
When Nsaids, or nonsteroidal anti-inflammatory drugs, like aspirin, ibuprofen and naproxen are
taken too long, they can likewise pose dangers, including bleeding ulcers, kidney or liver damage
and an increased risk of a heart attack or stroke. And so on.
