adams ch01 lecture

PHARMACOLOGY FOR NURSESPHARMACOLOGY FOR NURSESA Pathophysiological ApproachA Pathophysiological Approach

FOURTH EDITIONFOURTH EDITION

Copyright © 2014, © 2011, © 2008 by Pearson Education, Inc.All Rights Reserved

CHAPTER

Introduction to Pharmacology

1

Pharmacology for Nursing: A Pathophysiology Approach, Fourth EditionMichael Patrick Adams | Leland N. Holland | Carol Urban

History of PharmacologyHistory of Pharmacology

• Records exist in every culture dating to antiquity.

• Records describe use of plants (herbs) to relieve symptoms.

• Dark Ages show few records; still using herbs.


Pharmacologia seu Manuductio ad Pharmacologia seu Manuductio ad Materiam MedicamMateriam Medicam

• Written by Samuel Dale in 1693• First recorded reference to

pharmacology


Modern Pharmacology Began in Modern Pharmacology Began in Early 1800sEarly 1800s

• Chemists isolated pharmacological substances from natural substances.

• Effects on animals were studied.• Early researchers used themselves as

test subjects.


Pharmacology Recognized as Pharmacology Recognized as Distinct DisciplineDistinct Discipline

• First department of pharmacology established at Estonia in 1847


John Jacob Abel John Jacob Abel

• Father of American pharmacology• Founded first pharmacology

department in United States at University of Michigan in 1890


20th Century to Present20th Century to Present

• Drugs synthesized in laboratory• Drugs tested for relatively short time• Increased understanding of how drugs

produce their effects• Focus is on improvements in quality of

life.


PharmacologyPharmacology

• Simply defined, from the Greek, as the study of medicine

• Pharmacology is an expansive subject encompassing:– How drugs are administered– Where drugs travel in the body– Responses that drugs produce


Interrelated Subject AreasInterrelated Subject Areas

• Anatomy and physiology• Chemistry• Microbiology• Pathophysiology


Pharmacology Is Challenging and Pharmacology Is Challenging and Always ChangingAlways Changing

• 10,000 drugs currently available• Each drug has its own characteristics:

– Therapeutic applications– Interactions– Side effects– Mechanisms of action


Pharmacology Is Challenging and Pharmacology Is Challenging and Always ChangingAlways Changing

• Many drugs prescribed for more than one disease

• Drugs elicit different responses depending on individual factors:– Age– Sex– Body mass– Health status– Genetics


Nursing and PharmocologyNursing and Pharmocology

• Knowledge of pharmacology is essential to the nursing profession.

• Nurses are health care providers most often directly involved in patient care.– Applies to nurses in all settings, from

hospital to home care• Study of pharmacology is a long,

challenging, and continual process.


Therapeutics and Pharmacology Therapeutics and Pharmacology Are Closely Connected Are Closely Connected

• Therapeutics is concerned with– Prevention of disease– Treatment of suffering

• Pharmacotherapy is the application of drugs for – Disease prevention– Treatment of suffering


Traditional Drugs Are Chemical Traditional Drugs Are Chemical AgentsAgents

• Synthesized in a laboratory• Produce biological responses in the

body– If desirable response—therapeutic– If undesirable response—adverse

• After a drug is administered, it is called a medication.


BiologicsBiologics

• Biologics are agents naturally produced in animal cells, by microorganisms, or by the body itself.


Examples of BiologicsExamples of Biologics

• Hormones• Monoclonal antibodies• Natural blood products and components• Interferon• Vaccines


Complementary and Alternative Complementary and Alternative TherapiesTherapies

• Natural plant extracts, herbs, vitamins, minerals, dietary supplements

• Acupuncture, hypnosis, biofeedback, massage


Prescription Drugs and Over the Prescription Drugs and Over the Counter (OTC) DrugsCounter (OTC) Drugs

• Prescription drugs require that the recipient obtain a written order from a person with the legal authority to write such a prescription.


Advantages and Disadvantages Advantages and Disadvantages of Prescription Drugsof Prescription Drugs

• Advantages– Health care provider examines the

patient and orders the proper drug. Amount and frequency of drug is

controlled. Instructions on use and side effects of

drug are discussed.


Advantages and Disadvantages Advantages and Disadvantages of Prescription Drugsof Prescription Drugs

• Disadvantages– Require a prescription to obtain– Need for health care provider

appointment


Advantages and DisadvantagesAdvantages and Disadvantagesof OTC Drugsof OTC Drugs

• Advantages– No health care provider appointment

required– Often less expensive than prescription

drugs


Advantages and DisadvantagesAdvantages and Disadvantagesof OTC Drugsof OTC Drugs

• Disadvantages– Patient may choose wrong drug.– Patient may not know reactions or

interactions.– Ineffective treatment may result in

progression of disease.


Prior to 19th CenturyPrior to 19th Century

• Few standards or guidelines to protect the public– Some drugs contained hazardous levels

of Dangerous substances Addictive substances


Early Drug ReferencesEarly Drug References

• The first standard commonly used by pharmacists was the formulary, or list of drugs and drug recipes.

• A pharmacopeia is a medical reference summarizing standards of drug purity, strength, and directions for synthesis.


United States Pharmacopeia (USP)United States Pharmacopeia (USP), , 18201820

• First comprehensive publication of drug standards

• Summarized standards of drug:– Purity– Strength– Directions for synthesis


American Pharmaceutical American Pharmaceutical Organization (APhA)Organization (APhA)

• National professional society of pharmacists, established 1852

• Maintained the national compendia of drug standards, the National Formulary (NF)

• National Formulary competed with other compendia, U.S. Pharmacopeia (USP).


USP and NF Merged in 1975USP and NF Merged in 1975

• Formed United States Pharmacopeia–National Formulary (USP-NF)

• Official monographs and interim announcements published regularly

• Full bound version printed every five years


United States Develops and Enforces United States Develops and Enforces Tougher Drug Laws, 1900sTougher Drug Laws, 1900s

• Biologics Control Act, 1902– Standardized serum and blood-related

products• Pure Food and Drug Act, 1906

– Government controls labeling of medicines.

• Sherley Amendment, 1912– Prohibited drugs labeled with false

therapeutic claims


United States Develops and Enforces United States Develops and Enforces Tougher Drug Laws, 1900sTougher Drug Laws, 1900s

• Food, Drug, and Cosmetic Act (1938) and amendments– Thorough testing of drug – Proof of safety and efficacy of drug

• Dietary Supplement Health and Education Act, 1994– Controls misleading industry claims


Figure 1.1 Medication with the USP label (left)Source: Practice Label “for educational purposes only.”

continued on next slide


Figure 1.1 (continued) Medication without USP label (right)Source: Practice Label “for educational purposes only.”


Food and Drug Administration Food and Drug Administration (FDA)(FDA)

• Officially established in 1988 • Agency of U.S. Department of Health

and Human Services in 1988


Figure 1.2 A historical time line of regulatory acts, standards, and organizations

continued on next slide


Figure 1.2 (continued) A historical time line of regulatory acts, standards, and organizations


Center for Drug Evaluation and Center for Drug Evaluation and ResearchResearch

• Branch of FDA• Determines safety and efficacy of drugs• Pharmaceutical laboratories must solicit

approval from FDA before marketing a drug.


Center for Biologics Evaluation and Center for Biologics Evaluation and Research (CBER)Research (CBER)

• Branch of FDA• Regulates use of biologics (serums,

vaccines, and blood products)• 1986 Childhood Vaccine Act result of

CBER work


Center for Food Safety andCenter for Food Safety andApplied Nutrition (CFSAN)Applied Nutrition (CFSAN)

• Branch of FDA• Oversees herbal and dietary products


Center for Food Safety andCenter for Food Safety andApplied Nutrition (CFSAN)Applied Nutrition (CFSAN)

• Enforces 1994 Dietary and Supplemental Health and Education Act– Regulation not as close as Food, Drug,

and Cosmetic Act– Herbal and dietary supplements can be

marketed without prior approval from FDA.


Four Stages of Approval for Four Stages of Approval for Therapeutic and Biologic DrugsTherapeutic and Biologic Drugs• Four stages:

– Preclinical investigation– Clinical investigation– Review of new drug application (NDA)– Postmarketing surveillance

• Amount of time for approval varies.


Figure 1.3 A new drug development time line with the four phases of drug approval


Preclinical InvestigationPreclinical Investigation

• Involves laboratory research • Tests done on cells and animals• Determines drug-dose range• Examines adverse effects• Results considered inconclusive


FDA Critical Path InitiativeFDA Critical Path Initiative

• In 1997, FDA restated its concern that a number of innovative and critical medical products had decreased since the 1990s.– Critical Path Initiative was initiated to

modernize the sciences to enhance the use of bioinformation to improve the “safety, effectiveness, and manufacturability of candidate medical products.”


Clinical Investigation Clinical Investigation

• Takes place in three different stages termed clinical phase trials

• Longest part of approval process • Evaluates human benefits • Tests on healthy humans first, then on

those with the target ailment


Review of New Drug Application Review of New Drug Application (NDA)(NDA)

• If results of clinical investigation are positive, even if precautions are noted, a New Drug Application is the next step.

• NDA is the third step of the drug approval process.

• Average review time 17–24 months • Drug approved: process continues • Drug rejected: process suspended


Investigational New Drug Investigational New Drug Application (IND)Application (IND)

• May be submitted for Phase I clinical trials when it is determined there are significant therapeutic benefits, and the product is reasonably safe for initial use in humans


Postmarketing SurveillancePostmarketing Surveillance

• New drug placed on market • Surveyed for harmful effects in larger

population– Diabetes drug troglitazone (Rezulin) is

an example of a drug that did not exhibit harmful effects until the year after release.


Postmarketing SurveillancePostmarketing Surveillance

• FDA holds annual public meetings.– Will withdraw a drug if serious problem

found


The Lengthy FDA The Lengthy FDA Drug-Approval ProcessDrug-Approval Process

• NDAs can be massively long and FDA review can take several years.

• Pharmaceutical manufacturer expenses for creating and marketing a new drug can be in the millions of dollars.

• Core FDA goal is to make sure drugs are safe for the public.


The Lengthy FDA The Lengthy FDA Drug-Approval ProcessDrug-Approval Process

• In 1990s, delays in process determined– Outdated guidelines– Insufficient staff– Poor communication


Prescription Drug Prescription Drug User Fee Act, 1992User Fee Act, 1992

• Established on five-year trial basis• Drug and biologic manufacturers

provide drug-user fee.• FDA hired more employees.• FDA restructured its organization.


Results SuccessfulResults Successful

• Doubled the number of drugs approved• Some review times cut by half


FDA Modernization Act, 1997FDA Modernization Act, 1997

• Reauthorized Prescription Drug User Fee Act

• FDA Amendments Act expanded the reforms in 2007.


Research ShowsResearch Shows

• Researchers recently completed a review of all adverse drug events reported to the FDA since 2006.– Clinicians found 10 potentially fatal

drugs.• Nurses should constantly review the

literature for drugs that have been recalled or reported dangerous.


Nurses and the Drug Approval Nurses and the Drug Approval ProcessProcess

• Nurses participate most in the drug approval process during the postmarketing surveillance period of Phase IV.

• All nurses administering medications monitor for therapeutic effects and adverse reactions from the drugs.

• Responsible for reporting adverse reactions