Schaum's Outline of Pharmacology

By Jim Keogh

Tough Test Questions? Missed Lectures? Not Enough Time?

Fortunately for you, there's Schaum's.

More than 40 million students have trusted Schaum's to help them succeed in the classroom and on exams. Schaum's is the key to faster learning and higher grades in every subject. Each Outline presents all the essential course information in an easy-to-follow, topic-by-topic format. You also get hundreds of examples, solved problems, and practice exercises to test your skills.

This Schaum's Outline gives you

• More than 570 fully solved problems
• Complete review of all course fundamentals

Fully compatible with your classroom text, Schaum's highlights all the important facts you need to know. Use Schaum's to shorten your study time--and get your best test scores!

Topics include: What is Pharmacology?; Medication Actions and Interactions; Pharmacology and the Nursing Process; Substance Abuse; Principles of Medication Administration; Route of Administration; Dose Calculations; Herbal Therapy; Vitamins and Minerals; Fluid and Electrolyte Therapy; Nutritional Support Therapies; Inflammation and Anti-Inflammatory Medication; Infection and Antimicrobials; Respiratory Diseases and Medication; The Neurologic System and Medication; Narcotic Agonists; Immunologic Agents; The Gastrointestinal System; Cardia Circulatory Medications; Skin Disorders; Endocrine Medications; and Eye and Ear Disorders

Schaum's Outlines--Problem Solved.

• Language: English
• Publisher: McGraw-Hill Education
• Release date: Mar 12, 2010
• ISBN: 9780071623636

Book preview

SCHAUM’S outlines

Pharmacology

SCHAUM’S outlines

Pharmacology

JAMES KEOGH, R.N.

Instructor, New York University

Schaum’s Outline Series

Copyright © 2010 by The McGraw-Hill Companies, Inc. All rights reserved. Except as permitted under the United States Copyright Act of 1976, no part of this publication may be reproduced or distributed in any form or by any means, or stored in a database or retrieval system, without the prior written permission of the publisher.

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This book is dedicated to Anne, Sandy, Joanne, Amber-Leigh Christine,

Shawn and Eric, without whose help and support

this book couldn’t have been written.

Contents

CHAPTER 1. What Is Pharmacology?

1.1 Definition

1.2 The Roots of Pharmacology

1.3 The Sources of Pharmaceuticals

1.4 Herbals

1.5 The United States Pharmacopeia National Formulary

1.6 The 1938 Food, Drug, and Cosmetic Act

1.7 The 1952 Durham-Humphrey Amendment to the Food, Drug, and Cosmetic Act

1.8 The 1962 Kefauver-Harris Amendment to the Food, Drug, and Cosmetic Act

1.9 The 1970 Comprehensive Drug Abuse Prevention and Control Act

1.10 Medication Names

1.11 Medication Effects

1.12 Medication Safety

1.13 The Human Trial

1.14 Pregnancy Categories

CHAPTER 2. Medication Actions and Interactions

2.1 Medication Actions

2.2 Multiple Medication Actions

2.3 Strength of Medication Action

2.4 Medication Activity

2.5 The Pharmaceutic Phase

2.6 Pharmacokinetics

2.7 Medication Absorption

2.8 Absorption Rate

2.9 Bioavailability

2.10 Medication Concentration

2.11 Distribution

2.12 Medication Accumulation

2.13 Elimination

2.14 The First Pass Effect

2.15 Pharmacodynamics

2.16 Medication Time Response

2.17 Receptor Theory

2.18 Agonist and Antagonist

2.19 Categories of Medication Action

2.20 Therapeutic Index and Therapeutic Range

2.21 Peak and Trough Levels

2.22 Side Effects

2.23 Allergic Reactions

CHAPTER 3. Pharmacology and the Nursing Process

3.1 The Nursing Process

3.2 Assessment Related to Drugs

3.3 Patient Information

3.4 Nursing Diagnosis

3.5 Planning

3.6 Teaching the Patient about Medication

3.7 Prompt for Feedback

3.8 Medication Plan

3.9 Impact of Cultural Influences in Medication Administration

3.10 Culture-Based Communication

3.11 Genetic Considerations

3.12 Maternity

3.13 Pediatrics

3.14 Elderly Patients

3.15 Assessing Elderly People

CHAPTER 4. Substance Abuse

4.1 Medication Misuse and Abuse

4.2 Behavioral Patterns of Addiction

4.3 Substance Abuse and Healthcare Professionals

4.4 Detecting Substance Abuse

4.5 Delayed Detection with Healthcare Professionals

4.6 Testing for Substance Abuse

4.7 Why Substances Are Abused

4.8 Characteristics of Frequently Abused Medications

4.9 Dependence versus Tolerance

4.10 Pathophysiologic Changes

4.11 Commonly Abused Substances

4.12 Assessment for Substance Abuse

CHAPTER 5. Principles of Medication Administration

5.1 The Process of Medication Administration

5.2 Assessment Required for Specific Medications

5.3 Administering Medication

5.4 Preparing the Medication

5.5 Administering the Medication

5.6 Useful Tips When Administering Medication

5.7 Avoiding Medication Errors

5.8 Proper Disposal of Medication

5.9 Administering Medication at Home

5.10 Controlling Narcotics

CHAPTER 6. Route of Administration

6.1 Medication and Routes

6.2 Oral Route

6.3 Sublingual and Buccal Medication Routes

6.4 Transdermal Route

6.5 Topical Route

6.6 Instillation Route

6.7 Inhalation Route

6.8 Nasogastric and Gastrostomy Tubes Route

6.9 Suppositories Route

6.10 Parenteral Route

6.11 Intradermal Parenteral Route

6.12 Subcutaneous Parenteral Route

6.13 Intramuscular Parenteral Route

6.14 Z-Track Injection Technique

6.15 Minimize Pain Parenteral Route

6.16 Intravenous Parenteral Route

CHAPTER 7. Dose Calculations

7.1 Medication Measurements

7.2 Converting Metric Units

7.3 Converting Metric Units to Apothecaries’ System Units

7.4 Calculating the Desired Dose

7.5 The Formula Method

7.6 Ratio-Proportion

7.7 Calculating the IV Flow Rate

7.8 Pediatric Dose Calculation Formula

7.9 Heparin Dose Calculation Formula

7.10 Dopamine Dose Calculation Formula

CHAPTER 8. Herbal Therapy

8.1 Understanding Herbal Therapy

8.2 Lack of Uniform Information

8.3 Herbal Therapies and Patients

8.4 Forms of Herbal Therapies

8.5 Hazards of Herbal Therapeutics

8.6 Herbal Therapy and the Nursing Process

8.7 Avoiding Common Herbal Therapy Errors

8.8 Common Herbal Therapies

CHAPTER 9. Vitamins and Minerals

9.1 Vitamins

9.2 A Well-Balanced Diet

9.3 Recommended Dietary Allowance

9.4 Fat-Soluble Vitamins

9.5 Water-Soluble Vitamins

9.6 Vitamins and Assessment

9.7 Vitamins and Vitamin Supplements

9.8 Vitamins and Teaching

9.9 Minerals

CHAPTER 10. Fluid and Electrolyte Therapy

10.1 Body Fluids

10.2 Electrolytes

10.3 Fluid Movement

10.4 Fluid Concentration

10.5 Intravenous Fluids

10.6 Classification of Intravenous Solutions

10.7 Blood and Blood Products

10.8 Fluid Replacement

10.9 Replacing Fluid

10.10 Risk of Replacing Fluid

10.11 Potassium

10.12 Hyperkalemia

10.13 Responding to Hyperkalemia

10.14 Hypokalemia

10.15 Responding to Hypokalemia

10.16 Sodium

10.17 Hypernatremia

10.18 Responding to Hypernatremia

10.19 Hyponatremia

10.20 Responding to Hyponatremia

10.21 Calcium

10.22 Hypercalcemia

10.23 Responding to Hypercalcemia

10.24 Hypocalcemia

10.25 Responding to Hypocalcemia

10.26 Magnesium

10.27 Hypermagnesemia

10.28 Responding to Hypermagnesemia

10.29 Hypomagnesemia

10.30 Responding to Hypomagnesemia

10.31 Phosphorus

10.32 Hyperphosphatemia

10.33 Responding to Hyperphosphatemia

10.34 Hypophosphatemia

10.35 Responding to Hypophosphatemia

CHAPTER 11. Nutritional Support Therapies

11.1 Nutrition

11.2 Malnutrition

11.3 Nutritional Support Therapy

11.4 Enteral Nutrition Support Therapy

11.5 Group of Enteral Feeding Preparations

11.6 Enteral Feeding Preparations

11.7 Ways to Administer Enteral Feeding Preparations

11.8 Complications of Enteral Feeding

11.9 Calculating Enteral Feedings

11.10 Administering Enteral Feeding Preparations

11.11 Parenteral Nutrition Support Therapy

11.12 Risk of Parenteral Nutrition Support Therapy

11.13 Administering Parenteral Nutrition Support Therapy

CHAPTER 12. Inflammation and Anti-Inflammatory Medication

12.1 The Inflammation Process

12.2 Signs of Inflammation

12.3 Phases of Inflammation

12.4 Anti-Inflammatory Medication

12.5 Categories of Anti-inflammatory Medication

12.6 Corticosteroids

12.7 Nonsteroidal Anti-inflammatory Drugs

12.8 Arthritis Medication

12.9 Gout Medication

CHAPTER 13. Infection and Antimicrobials

13.1 Microorganisms

13.2 Natural Defense

13.3 Medication for Symptoms

13.4 Antimicrobials

13.5 How Antimicrobials Work

13.6 Side Effects of Antimicrobials

13.7 Super Infections

13.8 Preventing Antibiotic-Resistant Bacteria

13.9 Administering Antimicrobial Medication

13.10 Patient Information for Antimicrobial Medication

13.11 Penicillin

13.12 Classification of Penicillin

13.13 Precautions When Administering Penicillin

13.14 Penicillin and Drug–Drug Interactions

13.15 Penicillin and Patient Education

13.16 Cephalosporin

13.17 Before Administering Cephalosporin

13.18 Generations of Cephalosporins

13.19 Cephalosporin and Drug–Drug Interactions

13.20 Cephalosporin and Patient Education

13.21 Macrolide Antibiotics

13.22 Administering Macrolide Antibiotics

13.23 Macrolides and Drug–Drug Interactions

13.24 Macrolides and Patient Education

13.25 Lincomycins

13.26 Administering Lincomycin Antibiotics

13.27 Lincomycins and Drug–Drug Interactions

13.28 Lincomycins and Patient Education

13.29 Vancomycin

13.30 Administering Vancomycin Antibiotics

13.31 Vancomycin and Drug–Drug Interactions

13.32 Vancomycins and Patient Education

13.33 Aminoglycosides

13.34 Administering Aminoglycosides

13.35 Aminoglycosides and Drug–Drug Interactions

13.36 Aminoglycosides and Patient Education

13.37 Tetracyclines

13.38 Administering Tetracyclines

13.39 Tetraclyclines and Drug–Drug Interactions

13.40 Tetracyclines and Patient Education

13.41 Chloramphenicol (Chloromycetin)

13.42 Chloramphenicol and Drug–Drug Interactions

13.43 Chloramphenicol and Patient Education

13.44 Fluoroquinolones

13.45 Administering Fluoroquinolones

13.46 Fluoroquinolones and Drug–Drug Interactions

13.47 Fluoroquinolones and Patient Education

13.48 Miscellaneous Antibiotics

13.49 Sulfonamides

13.50 Administering Sulfonamides

13.51 Sulfonamides and Drug–Drug Interactions

13.52 Sulfonamides and Patient Education

CHAPTER 14. Respiratory Diseases and Medication

14.1 Respiration

14.2 Compliance

14.3 Controlling Respiration

14.4 The Tracheobronchial Tube

14.5 Respiratory Tract Disorders

14.6 Acute Rhinitis (The Common Cold)

14.7 Home Remedies for Acute Rhinitis

14.8 Medications for Acute Rhinitis

14.9 Sinusitis

14.10 Acute Pharyngitis (Sore Throat)

14.11 Acute Tonsillitis

14.12 Acute Laryngitis

14.13 Lower Respiratory Disorders

14.14 Pneumonia

14.15 Tuberculosis

14.16 Chronic Bronchitis

14.17 Bronchiectasis

14.18 Emphysema

14.19 Acute Asthma

14.20 Medications to Treat Chronic Obstructive Pulmonary Disease

CHAPTER 15. The Neurologic System and Medication

15.1 The Nervous System

15.2 Neurologic Pathways

15.3 Central Nervous System Stimulants

15.4 Migraine Headaches

15.5 Treatment for Migraine Headaches

15.6 Central Nervous System Depressants

15.7 Sedative-Hypnotics

15.8 Barbiturates

15.9 Anesthetic Agents

15.10 Administering General Anesthetic Agents

15.11 Four Stages of Anesthesia

15.12 Topical Anesthetic Agents

15.13 Local Anesthesia

15.14 Spinal Anesthesia

15.15 Autonomic Nervous System and Adrenergic Blockers

15.16 The Fight or Flight Response

15.17 Adrenergics and Adrenergic Blockers

15.18 Alpha-Adrenergic Blockers

15.19 Beta-Adrenergic Blockers

15.20 Cholinergics

15.21 Anticholinergics

15.22 Antiparkinsonism-Anticholinergic Medication

15.23 Skeletal Muscle Relaxants

15.24 Parkinsonism Medication

15.25 Myasthenia Gravis

15.26 Multiple Sclerosis

15.27 Alzheimer’s Disease

15.28 Muscle Spasms

15.29 Epilepsy

15.30 Antipsychotics

15.31 Phenothiazines

15.32 Anxiolytics

15.33 Antidepressants

CHAPTER 16. Narcotic Agonists

16.1 Pain

16.2 The Gate Control Theory

16.3 Defining Pain

16.4 Assessing Pain

16.5 Pain Management Treatment Plans

16.6 Nonpharmacologic Management of Pain

16.7 Pharmacologic Management of Pain

16.8 Narcotic Analgesics

16.9 Narcotic Agonist-Antagonists

16.10 Narcotic Antagonists

CHAPTER 17. Immunologic Agents

17.1 The Immune System

17.2 Human Immunodeficiency Virus and the Immune System

17.3 Human Immunodeficiency Virus Therapies

17.4 Human Immunodeficiency Virus Medication

17.5 Human Immunodeficiency Virus Therapy and Pregnancy

17.6 Postexposure Prophylaxis

17.7 Types of Immunity

17.8 Vaccines

17.9 Administering Vaccinations

17.10 Patient Education

17.11 Immunosuppressant Medication

CHAPTER 18. The Gastrointestinal System

18.1 The Gastrointestinal System

18.2 The Esophagus

18.3 The Stomach

18.4 The Intestines

18.5 Vomiting and Nausea

18.6 Causes of Vomiting

18.7 Nonpharmacological Treatment of Vomiting

18.8 Pharmacological Treatment of Vomiting

18.9 Prescription Antiemetics

18.10 Emetics

18.11 Antidiarrhea Medications

18.12 Constipation

18.13 Peptic Ulcers

CHAPTER 19. Cardiac Circulatory Medications

19.1 The Cardiovascular System

19.2 The Heart

19.3 Coronary Arteries

19.4 Blood Pressure

19.5 Circulation

19.6 Blood

19.7 Cardiac Medications

19.8 Glycosides

19.9 Antianginals

19.10 Antidysrhythmics

19.11 Heart Failure Medication

19.12 Hypertension

19.13 Blood Pressure and Kidneys

19.14 Antihypertensives

19.15 Combining Antihypertensive Drugs

19.16 Angiotensin Antagonists, ACE Inhibitors, and Angiotensin II

19.17 Diuretics

19.18 Types of Diuretics

19.19 Thiazide Diuretics

19.20 Loop or High-Ceiling Diuretics

19.21 Osmotic Diuretics

19.22 Carbonic Anhydrase Inhibitors

19.23 Potassium-Sparing Diuretics

19.24 Circulatory Medication

19.25 Anticoagulants and Antiplatelets

19.26 Thrombolytics

19.27 Antilipemics

19.28 Peripheral Vascular Disease

CHAPTER 20. Skin Disorders

20.1 The Skin

20.2 Skin Disorders

20.3 Acne Vulgaris

20.4 Psoriasis

20.5 Warts

20.6 Dermatitis

20.7 Alopecia

20.8 Burns

20.9 Abrasions and Lacerations

CHAPTER 21. Endocrine Medications

21.1 The Endocrine System

21.2 Hormones

21.3 The Pituitary Gland: Growth Hormone

21.4 The Pituitary Gland: Antidiuretic Hormone and Oxytocin

21.5 The Adrenal Gland

21.6 The Thyroid Gland

21.7 Hypothyroidism

21.8 Hyperthyroidism

21.9 The Parathyroid Glands

21.10 The Pancreas

21.11 Insulin

21.12 Oral Antidiabetics

21.13 Medication That Increases Glucose

CHAPTER 22. Eye and Ear Disorders

22.1 Eye Disorders

22.2 Eye Medication

22.3 Eye Medication: Patient Education

22.4 Ear Disorders

22.5 Ear Medication: Patient Education

Index

SCHAUM’S outlines

Pharmacology

CHAPTER 1

What Is Pharmacology?

1.1 Definition

Pharmacology, derived from two Greek words: Pharmakon (the Greek word for drugs) and logos (the Greek word for science). It is the study of the effects of chemicals on living tissues. It focuses particularly on how chemicals help to:

•   Prevent diseases

•   Correct physiology of living tissues

•   Cure or minimize diseases

Chemicals that have medicinal properties are referred to as pharmaceuticals. Pharmacology explores the safe and effective use of pharmaceuticals.

1.2 The Roots of Pharmacology

Ancient civilizations discovered that extracts from plants, animals, and minerals had medicinal effects on tissue. These discoveries became the foundation of empirical pharmacology. It was not until the late 1800s that developments in the sciences of physiology, organic chemistry, and biochemistry provided the scientific approach that is used in today’s pharmacology.

Two separate disciplines developed. These are pharmacy and pharmacology. Pharmacy focuses on preparation and dispensing medication. Pharmacology is a blend of disciplines that collectively enable scientists to develop new medications that combat diseases. The branches of pharmacology are:

•   Behavioral pharmacology: The study of how medication interacts with human behavior

•   Biochemical pharmacology: The study of how medication interacts with the chemistry of the body

•   Cardiovascular pharmacology: The study of how medication interacts with the cardiovascular system

•   Chemotherapy: The study of how medication inhibits growth or kills selected cells

•   Clinical pharmacology: The study of how medication affects the disease process and how medications interact with other medications

•   Immunopharmacology: The study of how medication interacts with the body’s immune response

•   Molecular pharmacology: The study of how medication and hormones interact with cells

•   Neuropharmacology: The study of how medication interacts with the neurologic system

•   Pharmacokinetics: The study of how medications are absorbed, distributed, and eliminated from the body

1.3 The Sources of Pharmaceuticals

Pharmaceuticals are derived from one of four sources:

•   Plants: Chemicals that provide medicinal properties are extracted from plants; for example, leaves from the foxglove plant are used to produce digitalis, which is used to treat congestive heart failure and cardiac arrhythmias.

•   Animals: Animal byproducts, particularly hormones, are used to supplement human hormones. For example, estrogen can be recovered from the urine of a mare and insulin from the pancreas of pigs.

•   Minerals: Trace elements of inorganic crystals are used to supplement minerals in humans. For example, iron is used to combat fatigue. Minerals are obtained from animals and plants.

•   Synthetic Derivatives: Scientists are able to develop new medications, such as sulfonamides, by synthesizing (rearranging) chemical derivatives, resulting in new compounds.

1.4 Herbals

Herbals are nonwoody plants whose extracts are used for dietary supplements, but not for medication. Herbals are described according to their effects on tissue, such as increasing blood flow to the heart. Herbals are not usually described as cures for specific diseases. The Food and Drug Administration does not test or regulate herbals. Therefore there are no purity and strength standards for herbals, which make the effect of an herb unreliable. Herbals are sold over the counter. No prescription is required.

Unwanted side effects and undesirable interactions can occur when herbals are taken with prescription medication. For example, Coumadin, which is an anticoagulant, interacts with ginkgo, an herb that inhibits platelets, resulting in increased bleeding and stroke.

1.5 The United States Pharmacopeia National Formulary

The purity and strength of a medication influence the accuracy and reliability of the dose that is administered to the patient. Purity is the dilution or mixture of the medication with other materials that give the medication form so it can be given to the patient. The strength of a medication is its concentration or weight. The dose is the amount of the medication taken at one time and dosage is the amount taken over a period of time.

The United States Pharmacopeia National Formulary is a book that contains strength and purity standards for the manufacturing and control of medication. A medication that is listed in the United States Pharmacopeia National Formulary has the letters U.S.P. following its official name.

1.6 The 1938 Food, Drug, and Cosmetic Act

In the late 1930s, a pharmaceutical manufacturer distributed a sulfa medication to treat pediatric patients. The medication contained a highly toxic chemical similar to antifreeze that resulted in the death of hundreds of children. In response, the United States Congress passed the 1938 Food, Drug, and Cosmetic Act, which imposed strict regulations on the manufacturing of food, medication, and cosmetics. The 1938 Food, Drug, and Cosmetic Act requires that:

•   Medication be proved safe before being sold

•   The tolerance levels of medication be determined to assure patients are not poisoned

•   Medication manufacturing facilities must pass government inspection

•   Cosmetic and therapeutic devices be regulated

1.7 The 1952 Durham-Humphrey Amendment to the Food, Drug, and Cosmetic Act

Anyone could distribute medication so long as the medication was proved safe. This changed in 1952, when Congress determined that some medications were not safe unless the medication was directly supervised by a medical practitioner. These medications are those that are given by injection; depress the nervous system (hypnotics); dull the senses, relieve pain, and induce sleep (narcotics); are habit forming; and are still under investigation.

Congress passed the 1952 Durham-Humphrey Amendment to the 1938 Food, Drug, and Cosmetic Act that divided medications into two categories:

•   Legend Medication: These are medications that must be prescribed and directly supervised by a medical practitioner and are known as a controlled substance. These include opioids, hypnotics, and potentially habit-forming or harmful medication. The medication label must read: Caution: Federal law prohibits dispensing without a prescription.

•   Over-the-Counter Medication: These are medications that do not need direct supervision by a medical practitioner. No prescription is required to purchase these medications.

1.8 The 1962 Kefauver-Harris Amendment to the Food, Drug, and Cosmetic Act

Manufacturers only had to prove that their medication is nontoxic to sell their medication. With the 1962 Kefauver-Harris Amendment to the 1938 Food, Drug, and Cosmetic Act, manufacturers also had to prove the effectiveness of the medication before it could be administered to patients. In addition, the 1962 Kefauver-Harris Amendment authorized the Food and Drug Administration, who oversees the pharmaceutical industry, to evaluate testing methods used by pharmaceutical manufacturers. This act also required the use of standard labeling on medication containers, specifically requiring that the label display contraindications for using the medication and possible adverse reactions that the medication might cause.

1.9 The 1970 Comprehensive Drug Abuse Prevention and Control Act

In an effort to contain widespread abuse of legend (prescription) medication, Congress passed the 1970 Comprehensive Drug Abuse Prevention and Control Act. This act categorized legend medication into five schedules based on the medication’s potential for abuse. In addition, this act limited the number of refills for legend medication and required that practitioners use specially designated prescription pads when prescribing the medication.

These schedules are:

•   Schedule I: Highest risk for abuse. May be available for investigational use only. Includes LSD, heroin, marijuana, and mescaline.

•   Schedule II: High risk for abuse. Can lead to physical and psychological dependence. Can be used for medicinal purpose. Includes opioids, barbiturates, and stimulants.

•   Schedule III: Moderate risk for abuse. Typically these medications are combined with other medication. Can be used for medicinal purpose. Includes opioids and barbiturates.

•   Schedule IV: Low risk for abuse. Can lead to psychological dependency. Can be used for medicinal purpose. Includes chlordiazepoxide (Librium), benzodiazepines, and propoxyphene (Darvon).

•   Schedule V: Least risk for abuse. Small amount combined with other medication. Can be used for medicinal purposes. Includes opioids.

1.10 Medication Names

Medication is given three names. These are:

•   Chemical Name: Identifies the medication’s chemical elements and compounds and used by scientists who work at the chemical level of the medication. For example, N-acetyl-p-aminophenol.

•   Generic Name: The universally accepted name for the medication; appears on the medication label and in medication books such as the Physicians’ Desk Reference (PDR); for example, acetaminophen.

•   Brand Name: The trade name that manufacturers use to use market the medication. A medication can have multiple brand names; for example, Tylenol.

1.11 Medication Effects

Medication effects on tissue are classified as desirable and undesirable. A desirable effect occurs when the medication improves the patient’s health. An undesirable effect occurs when the medication interferes with the patient’s normal physiology. A medication can have both a desirable and an undesirable effect. The healthcare provider determines whether the desirable effects outweigh the undesirable effects before administering the medication to the patient. Additional medication may be given to reduce the undesirable effects of another medication.

A desirable effect is called the medication’s therapeutic effect and is the reason for the healthcare provider to administer the medication. An undesirable effect is called either a side effect or an adverse side effect, depending on the consequence the undesirable effect has on the patient. A side effect is an undesirable effect that is relatively not harmful to the patient, such as drowsiness caused by an antihistamine. An adverse side effect is an undesirable consequence that is harmful to the patient, such as when healthy cells are destroyed along with cancerous cells during chemotherapy.

1.12 Medication Safety

The Food and Drug Administration requires that medication undergo rigorous testing before approving the medication. Testing includes the following animal studies to determine the medication’s therapeutic index. A therapeutic index is a ratio between the median lethal dose and the median effective dose and indicates the safe dose to administer to the patient to achieve the therapeutic effect. These tests also provide scientists with information on how the medication is absorbed, distributed, metabolized, and excreted.

•   Acute Toxicity Study: This is the initial test that determines the dose that is lethal to 50% of tested laboratory animals. The study reports symptoms experienced by the animals and the time symptoms appeared.

•   Subchronic Toxicity Study: Two animal species are administered daily doses of the medication for 90 days. Animal test subjects are given physical examinations and laboratory tests during the 90 days to determine the medication’s effect on organs.

•   Chronic Toxicity Study: Two animal species are administered three dose levels—nontoxic, therapeutic, and toxic. The medication is usually administered over the life span of the test animal or the duration that the medication is intended to be given to humans. Animals are given physical exams and laboratory tests to determine the effect of the medication on organs and its potential carcinogenicity.

1.13 The Human Trial

Medications are tested in humans after animal studies are successfully completed. Testing in humans is called a human trial. There are four phases of a human trial, each of which requires approval from the Food and Drug Administration.

•   Phase I: Initial Pharmacological Evaluation. Determines the safe dosage level for humans. The medication is given to volunteers at gradual doses. The first sign of toxicity is noted. Dosage levels below the toxic dose level are considered safe.

•   Phase II: Limited Controlled Evaluation. Determines the therapeutic range for humans. Volunteers who have the disease or disorder are given the medication at gradual doses and are examined to determine the dose that provides the therapeutic effect.

•   Phase III: Extended Clinical Evaluation. Determines the effects of the medication on a large group of patients who have the disease or disorder. If the medication proves effective, then the pharmaceutical manufacturer submits a New Drug Application (NDA) to the Food and Drug Administration for approval to market the medication.

•   Phase IV: Post Marketing Surveillance Trial. Determines ongoing safety of the medication after the medication is being prescribed by healthcare providers.

1.14 Pregnancy Categories

Medications are tested to determine the medication’s effect on a fetus. Based on these test results, medications are categorized according to their safety for being administered to patients during pregnancy. The pregnancy categories are:

•   Category A: Adequate and well-controlled studies indicate no risk to the fetus in the first trimester of pregnancy or later.

•   Category B: Animal reproduction studies indicate no risk to the fetus; however, there are no well-controlled studies in pregnant women.

•   Category C: Animal reproduction studies have reported adverse effects on