Pharmacology for Undergraduate

Nursing Students with a Basic

Pathophysiological Connection
2019
 OER: Module 1: Introduction
to Pharmacology and its Basic
Concepts
Objectives for Module One

 Identify the definition of terms related to pharmacology

 Identifythe history of pharmacology and its application
to the present.
 Identify the stages of new drug development
 Identifythe role of the FDA and its impact on drug
regulations
 Identify the new June 2015 FDA pregnancy regulations
 Identify the current drug schedules and give examples 
Definition of Terms and Brief History
 Pharmacology is the study of drugs. This name is from the Greek language
pharmakon (drugs) and logos (study).
 Brief History: Experimenting with herbals, clinical practitioners work from the
Chinese, Indian, and Peruvian cultures. In 1785 experimentation began with
the purple foxglove plant which brought forth many years later, the drug
digoxin (discussed in Module 11. Nineteenth century brought about
introduction of more current pharmacology when chemists started working
with morphine and cocaine even experimenting on themselves.
 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1885127/
 Still
towards the end of the 19th century, John Jacob Abel founded the first
pharmacology department at the University of Michigan! Go Blue!
 http://id.loc.gov/authorities/names/n82108754
 Some of our drugs still come from plants/trees but more are prepared using
recombinant DNA technology. If you want to read more about this you can
access this article: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5178364/
More Terms to Know

 Pharmacogenomics: study of how a person’s genes affect their response to

drugs. Currently there are pharmacies which synchronize medication
according to a person’s DNA but this is very expensive and the person must
assume the cost.
 Ifyou want to read more about this please go to:
https://ghr.nlm.nih.gov/primer/genomicresearch/pharmacogenomics
 Pharmacodynamics: the study of a drug’s response at the cell’s receptor
site and the mechanism of action. Some drugs do not affect cell receptors
such as antacids which increase the gastric pH for several hours and
antiseptics such as alcohol wipes. These are simple chemical reactions. We
will learn the terms in a little more detail in Module 3.
 Kipta, M. (2011).  Pharmacology 101 (1st ed.). Open Educational Resources.
More Terms to Know Continued
 Pharmacokinetics is the study of how drugs move throughout the
body.
 How is the drug absorbed? This depends on the route such as the
oral route where drugs are affected by the acidity of the stomach and
the processing by the liver.
 Another aspect of pharmacokinetics is how drugs are distributed.
This depends on the blood flow of the tissues.
 Then we will discuss how the drug is metabolized usually through the
liver.
 Finally how is the drug excreted which is usually through the kidneys.
 https://www.cancer.gov/publications/dictionaries/cancer-terms/def/ph
armacokinetics
 We will learn the terms in a little more detail in Module 3.
Stages of How a New Drug is Developed

 StepOne is Discovery and Development: Research for a new drug

begins in the laboratory.
 StepTwo is Preclinical Research: drugs undergo animal and
laboratory testing to answer safety questions (see pic).
 StepThree is Clinical Research: drugs are tested on specific groups
of people (those with a health issue) to see if they respond.
 StepFour is Food & Drug Administration (FDA) Review: all the
previous steps are reviewed prior to approval or denial
 Step Five is FDA Post-Market Safety Monitoring: The drug is released
to the public and the FDA reviews any calls or concerns.
 Read by copying/pasting this link: https://www.fda.gov/drugs/
guidancecomplianceregulatoryinformation
/surveillance/ucm090385.htm
FDA’s Role in Medication Safety
Management
 Assess the drug’s benefits versus the risk to the patient. They do this by
putting warning labels on drugs or “black box” warnings in online
software such as Micromedex.
 Developed tools such as package inserts to decrease the risks and
educate the person or caregiver about the drug.
 Evaluate the effectiveness of the warnings and package inserts.
 Make adjustments based on results from the Post-marketing Safety
Monitoring and might remove a drug from the market.
 Here is a link to the last 40 years of the history of the FDA and its Risk
Management There is only 1 page to read and please copy/paste this
link.
https://www.fda.gov/drugs/risk-evaluation-and-mitigation-strategies-rems/
fdas-role-managing-medication-risks
FDA’s Old/New Ruling on Labeling Drugs
for Pregnancy and Lactation

 The old ruling labeled all drugs developed before

2015 as Category A, B, C, D, and X:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5083
079/
 What does this mean for male/female patients in
their reproductive years or those lactating females?
 Individualizedcounseling between the healthcare
provider and the patient about the risks versus the
benefits based on research.
 Lookat Table 2 in the above link to see the
comparison of changes.
Controlled Substance Schedules from
the Drug Enforcement Agency
 Asof 2018 here is the link to the current drugs for Schedule I through Schedule
V: https://www.deadiversion.usdoj.gov/21cfr/cfr/2108cfrt.htm
 Schedule I drug has no current medical use in the United States such as
peyote, heroin, marihuana, and 3,4-methylenedioxymethamphetamine which is
Ecstasy.
 Schedule II drug has a high potential for abuse which could lead to
physical/psychosocial abuse such as hydromorphone, oxycodone, and fentanyl
 Schedule III drug has less potential for abuse then Schedule I or II physically but
can still cause a risk for high psychological abuse such as Tylenol with Codeine.
 ScheduleIV drug has a lower potential for abuse than Schedule III such as
lorazepam.
 ScheduleV drug has an even lower potential for abuse then Schedule IV such
as cough syrups like Robitussin with Codeine.
Learning Outcomes You Should Be
Able to:
 Define/explain
the terms listed in Module I such as
pharmacodynamics.
 Briefly describe the history of pharmacology
 Identify the FDA’s Stages of New Drug Development
 Identify
and briefly describe the FDA’s Role in Medication Risk
Management including the last 40 years of their history
 Identify the FDA’s Pregnancy and Lactation Rule
 Identify
and give an example of the DEA’s Controlled
Substance Schedules I through Schedule V