ASSIGNMENTS, CHAPTER 1, INTRODUCTION TO DRUGS

Written Assignment
1. How does the term pharmacology differ from clinical pharmacology? Give examples of
how nurses utilize pharmacology in clinical practice.
Pharmacology, in its simplest term is defined as the study of biological effects of
chemicals (Karch, 2011). The term covers and digs the mechanism by which drugs cause
the biological effects, its chemical properties, physiological and behavioral effects,
biological transformations, and both therapeutic and non-therapeutic use (The University
of Texas Health Science Center, 2016).
Karch (2011) described Clinical Pharmacology, on the other hand, as a branch of
pharmacology that utilize the drug in treating, preventing, and diagnosing diseases. It
addresses two key concerns namely, the drugs effects on the body and the bodys
response to the drug.
Furthermore, The American Society for Pharmacology and Experimental
Therapeutics showed that both Pharmacology and clinical pharmacology deals with drugs
and how it affects the body, and the main difference is that Pharmacology is the general
term, a branch of science, while clinical pharmacology is a subdivision of pharmacology.
According to Karch (2011), the nurse is in a unique position in utilizing
pharmacology in clinical practice because nursing responsibilities include the following:
1. Administration of drugs
2. Assessing drug effects
3. Intervening to make the drug regimen more tolerable
4. Providing client education about the drug regimen
5. Monitoring the overall patient care plan
The responsibilities aforementioned are important aspects of nursing practice that
requires understanding and knowledge in the clinical setting. For instance, clients often
follow complicated drug regimen and may potentially receive toxic drugs. The side
effects may vary from client to client, ranging from mild to severe, and the nurse should
know which one will occur when a specific drug is administered, and the appropriate

interventions to take. The nurses knowledge about pharmacology is undeniably useful in

caring for patients (Karch, 2011)
2. Briefly describe the phases involved in each step of developing and approving a new
drug in the United States.
The U.S. Food and Drug Administration (FDA), is the agency that regulates the
development and sale of drugs. The thorough process begins when a chemical that might
have a therapeutic value is identified. A series of test is used to evaluate its actual
therapeutic and toxic effects. The entire drug development and approval process can take
5 to 6 years (Karch, 2011).
1. Preclinical Trials
Chemicals are tested on laboratory animals to determine whether they have the
presumed therapeutic effect in living tissue and to evaluate any adverse effects.
Chemicals are discarded if it lacks therapeutic activity when used with living animal,
it is too toxic to living animals to be worth the risk of developing into a drug, it is
highly teratogenic, and the safety margins are so small that the chemical would be
ineffective in the clinical setting.
2. Phase I Studies
Phase 1 study uses human volunteers to test the drug. Some chemicals show
therapeutic effects on animals but fail to manifest in humans. Chemicals are dropped
if they lack therapeutic effect in humans, they cause unacceptable adverse effects, and
they are highly teratogenic and too toxic.
3. Phase II Studies
Phase II study allows the drug to be tested to clients who have the disease that the
drug is designated. A drug may be removed from further testing if it shows less
effectiveness than anticipated, too toxic to clients, produces unacceptable adverse
effects, has low benefit-to-risk ratio, and if an existing drug is more effective and
available in the market.
4. Phase III Studies
Phase III study involves use of the drug in vast clinical market. Prescribers are
informed of all the known reactions to the drug and its safe use. Patients are observed
carefully and monitoring them for any adverse effects. Drug Company who are

developing the drug will collect the information and are shared with the FDA. A drug
may be remove if it produces unacceptable side effects and unexpected responses.
5. FDA Approval
Drugs that passed Phased III are further evaluated by the FDA. The FDA
committee relies on experts and give approval of the drug to be marketed. An
approved drug is given a brand name, generic name, and chemical name.
REFERENCE:
Karch, A. M. (2011). Chapter 1 - Introduction to Drugs. In Focus on Nursing Pharmacology (5th
ed.) (pp. 3 11). Philadelphia: Wolters Kluwer Health/Lippincott Williams & Wilkins.
The American Society for Pharmacology and Experimental Therapeutics (n.d.). About
Pharmacology. Retrieved January 14, 2017, from https://www.aspet.org/knowledge/what-ispharmacology/
The University of Texas Health Science Center at San Antonio (2016, December 21). What is
Pharmacology?. Retrieved January 14, 2017, from http://pharmacology.uthscsa.edu/whatis.asp