Figure 2–6. Steroid hormones diffuse through the cell membrane to interact with steroid receptors in the cytoplasm. The hormone– receptor pair relocates to the nucleus, where it can interact with DNA to effect RNA transcription and the synthesis of proteins.

FOURTH EDITION

3827_FM_i-xviii 03/07/15 10:25 AM Page i

 

 

3827_FM_i-xviii 03/07/15 10:26 AM Page v

 

 

vii

T

ORGANIZATION

The Foundation

PREFACE

3827_FM_i-xviii 03/07/15 10:26 AM Page vii

 

 

Pharmacotherapeutics With Single Drugs

Pharmacotherapeutics With Multiple Drugs

Special Drug Treatment Considerations

FEATURES

Unit I chapters

Unit II chapters

Unit III chapters

viii

3827_FM_i-xviii 03/07/15 10:26 AM Page viii

 

 

Unit IV chapters

SUMMARY ACKNOWLEDGMENTS

ix

3827_FM_i-xviii 03/07/15 10:26 AM Page ix

 

 

3827_FM_i-xviii 03/07/15 10:26 AM Page x

 

 

xi

MARYLOU V. ROBINSON, PHD, FNP-CTERI MOSER WOO, RN, PHD, CPNP-PC, FAANP

ABOUT THE AUTHORS

3827_FM_i-xviii 03/07/15 10:26 AM Page xi

 

 

3827_FM_i-xviii 03/07/15 10:26 AM Page xii

 

 

xiii

Lorena C. Guerrero, PhD, MN, ARNP, FNP-BC

Anne Hedger, DNP, ACNP-CS, ANP-CS, CPNP-AC, ENP-BC, CCRN

Leila N. Jones, MSN, BA, RN

Jennifer Jordan, RPh, PharmD, BCPS

Tracy Klein, PhD, FNP, ARNP, FAANP, FRE, FAAN

Ashim Malhotra, BPharm, PhD

Theresa Mallick-Searle, MS, RN-BC, ANP-BC

Erin Anderson, MSN, CPNP

Cally Bartley, MSN, FNP-C

Jane M. Carrington, PhD, RN

Diana L. Dewell, ARNP, ANP

Gina Dobbs, MSN, CRNP

Krista Estes, DNP, FNP-C

Teral Gerlt, MS, RN, WHCNP-E

Theresa Granger, PhD, ARNP, FNP

CONTRIBUTORS

3827_FM_i-xviii 03/07/15 10:26 AM Page xiii

 

 

Fujio McPherson, RN, DAOM, MSN, FNP, LAC

Benjamin J. Miller, PhD, MN, ARNP, FNP, ACNP

Anne E. Morgan, PharmD

Joan Nelson, DNP, RN

Patricia Nodine PhD, CNM

Kristen Lambert Osborn, MSN, CPNP–AC/PC

James L. Raper, DSN, CRNP, JD, FAANP, FAAN

Peter J. Rice, PharmD, PhD, BCPS

Laura Rosenthal, DNP, ACNP

Ruth Schaffler, PhD, FNP

Tracy Scott, DNP, FNP

Kathy Shaw, DNP, RN, CDE

R. Brigg Turner, PharmD, BCPS

Connie Valdez, PharmD, MSEd, BCPS

Mary Weber, PhD, PMHNP-BC, FAANP

xiv

3827_FM_i-xviii 03/07/15 10:26 AM Page xiv

 

 

xv

Joan Parker Frizzell, PhD, CRNP, ANP-BC

Tammy Gilliam, DNP, APRN-BC, FNP

Cathy R. Kessenich, DSN, ARNP, FAANP

Pamela King, PhD, APRN, FNP, PNP

Angela I. Kulesza, DNP, NP-C

Christine Nelson-Tuttle, DNS, RN, PNP-BC

David G. O’Dell, DNP, ARPN, FNP-BC

JoAnne Pearce, MS, PhDc, RN, APRN

Marianne Adam, PhD, RN, CRNP

Nancy Beckham, PhD, FNP-C

Christopher W. Blackwell, PhD, ARNP, ANP-BC, AGACNP-BC, CNE

Sharon Chalmers, PhD, CNE, APRN-BC

Patsy E. Crihfield, DNP, APRN, FNP-BC, PMHNP-BC, PMHS

Linda Dayer-Berenson, PhD, MSN, CRNP, CNE, FAANP

Carolynn A. DeSandre, PhD, CNM, FNP-BC

Abimbola Farinde, PharmD, MS

REVIEWERS

3827_FM_i-xviii 03/07/15 10:26 AM Page xv

 

 

Julie Ponto, PhD, RN, ACNS-BC, AOCNS

Susan Quisenberry, DNP, APRN, CNP, FNP-C

Sandra Restaino, DNP, NP-C, FAANP, CSC

Maria Rosen, PhD, RN, PNP-BC

Kathleen R. Sheikh, MSN, FNP-BC

Jennifer Sipe, RN, MSN, APRN-BC

Angela Thompson, PhD, PharmD

Diane Yorke, MSN, MBA, PhD, RN, CPNP

xvi

3827_FM_i-xviii 03/07/15 10:26 AM Page xvi

 

 

xvii

Chapter 16 Drugs Affecting the Cardiovascular and Renal Systems 295 Marylou V. Robinson, PhD, FNP-C

Chapter 17 Drugs Affecting the Respiratory System 361 Teri Moser Woo, PhD, CPNP

Chapter 18 Drugs Affecting the Hematopoietic System 415 Teri Moser Woo, PhD, CPNP and Kristen Lambert Osborne MSN, CPNP AC/PC

Chapter 19 Drugs Affecting the Immune System 447 Teri Moser Woo, PhD, CPNP

Chapter 20 Drugs Affecting the Gastrointestinal System 497 Teri Moser Woo, PhD, CPNP

Chapter 21 Drugs Affecting the Endocrine System 541 Marylou Robinson, PhD, FNP and Kathy Shaw, DNP, RN, CDE

Chapter 22 Drugs Affecting the Reproductive System 615 Diana L. Dewel, ARNP, ANP

Chapter 23 Drugs Affecting the Integumentary System 647 Cally Bartley, MSN, FNP-C

Chapter 24 Drugs Used in Treating Infectious Diseases 691 Jennifer Jordan, RPh, PharmD, BCPS; R. Brigg Turner, PharmD, BCPS; and Teri Moser Woo, PhD, CPNP

Chapter 25 Drugs Used in Treating Inflammatory Processes 801 Teri Moser Woo, PhD, CPNP

Chapter 26 Drugs Used in Treating Eye and Ear Disorders 837 Teri Moser Woo, PhD, CPNP

UNIT III. PHARMACOTHERAPEUTICS WITH MULTIPLE DRUGS 863

Chapter 27 Anemia 865 Teri Moser Woo, PhD, CPNP and Kristen Osborn MSN, CPNP AC/PC

Chapter 28 Chronic Stable Angina and Low-Risk Unstable Angina 881 Laura D. Rosenthal, DNP, ACNP

Chapter 29 Anxiety and Depression 897 Mary Weber, PhD, PMHNP-BC, FAANP and Krista Estes, DNP, FNP-C

UNIT I. THE FOUNDATION 1 Chapter 1 The Role of the Nurse Practitioner

as Prescriber 3 Teri Moser Woo, PhD, CPNP and Marylou V. Robinson, PhD, FNP-C

Chapter 2 Review of Basic Principles of Pharmacology 11 Peter J. Rice, PharmD, PhD, BCPS

Chapter 3 Rational Drug Selection 29 Teri Moser Woo, PhD, CPNP

Chapter 4 Legal and Professional Issues in Prescribing 37 Tracy Klein, PhD, FNP

Chapter 5 Adverse Drug Reactions 51 Connie A. Valdez, PharmD, MSEd, BCPS; Anne E. Morgan, PharmD; and Peter J. Rice, PharmD, PhD, BCPS

Chapter 6 Factors That Foster Positive Outcomes 61 Marylou V. Robinson, PhD, FNP-C and Teri Moser Woo, PhD, CPNP

Chapter 7 Cultural and Ethnic Influences in Pharmacotherapeutics 75 Lorena C. Guerrero, PhD, MS, ARNP, FNP-BC and Leila M. Jones, RN, MSN

Chapter 8 An Introduction to Pharmacogenomics 103 Ashim Malhotra, BPharm, PhD

Chapter 9 Nutrition and Neutraceuticals 115 Teri Moser Woo, PhD, CPNP

Chapter 10 Herbal Therapy and Nutritional Supplements 129 Fujio McPherson, RN, DAOM, MSN, FNP, LAC

Chapter 11 Information Technology and Pharmacotherapeutics 151 Jane M. Carrington, PhD, RN

Chapter 12 Pharmacoeconomics 159 Teri Moser Woo, PhD, CPNP

Chapter 13 Over-the-Counter Medications 165 Teri Moser Woo, PhD, CPNP

UNIT II. PHARMACOTHERAPEUTICS WITH SINGLE DRUGS 171

Chapter 14 Drugs Affecting the Autonomic Nervous System 173 Tracy Scott, DNP, FNP

Chapter 15 Drugs Affecting the Central Nervous System 225 Teri Moser Woo, PhD, CPNP

CONTENTS

3827_FM_i-xviii 03/07/15 10:26 AM Page xvii

 

 

Chapter 30 Asthma and Chronic Obstructive Pulmonary Disease 913 Benjamin J. Miller, PhD, MN, ARNP, FNP, ACNP

Chapter 31 Contraception 943 Teri Gerlt, MS, RN, WCHNP

Chapter 32 Dermatological Conditions 957 Teri Moser Woo, PhD, CPNP

Chapter 33 Diabetes Mellitus 991 Kathy Shaw, DNP, RN, CDE and Marylou Robinson, PhD, FNP-C

Chapter 34 Gastroesophageal Reflux and Peptic Ulcer Disease 1021 Teri Moser Woo, PhD, CPNP

Chapter 35 Headaches 1035 Theresa Mallick-Searle, MS, RN-BC, ANP-BC

Chapter 36 Heart Failure 1063 Laura Rosenthal, DNP, ACNP

Chapter 37 Human Immunodeficiency Virus Disease and Acquired Immunodeficiency Syndrome 1081 James Raper, DSN, CRNP, JD, FAANP, FAAN and Gina Dobbs, MS, CRNP

Chapter 38 Hormone Replacement Therapy and Osteoporosis 1103 Marylou V. Robinson, PhD, FNP-C

Chapter 39 Hyperlipidemia 1129 Marylou V. Robinson, PhD, FNP-C

Chapter 40 Hypertension 1155 Marylou V. Robinson, PhD, FNP-C

Chapter 41 Hyperthyroidism and Hypothyroidism 1179 Marylou V. Robinson, PhD, FNP

Chapter 42 Pneumonia 1195 Anne Hedger, DNP, ACNP-CS, ANP-CS, CPNP-AC, ENP-BC, CCRN

Chapter 43 Smoking Cessation 1205 Benjamin J. Miller, PhD, MN, ARNP, FNP, ACNP

Chapter 44 Sexually Transmitted Diseases and Vaginitis 1217 Theresa Granger, PhD, ARNP, FNP

Chapter 45 Tuberculosis 1237 Teri Moser Woo, PhD, CPNP

Chapter 46 Upper Respiratory Infections, Otitis Media, and Otitis Externa 1253 Teri Moser Woo, PhD, CPNP

Chapter 47 Urinary Tract Infections 1267 Erin Anderson, MSN, CPNP

UNIT IV. SPECIAL DRUG TREATMENT CONSIDERATIONS 1281

Chapter 48 Women as Patients 1283 Priscilla M. Nodine, PhD, CNM

Chapter 49 Men as Patients 1303 James Raper, DNS, CRNP, JD, FAANP, FAAN

Chapter 50 Pediatric Patients 1321 Teri Moser Woo, PhD, CPNP

Chapter 51 Geriatric Patients 1337 Joan M. Nelson, DNP, RN

Chapter 52 Pain Management: Acute and Chronic Pain 1351 Ruth L. Schaffler, PhD, FNP

INDEX 1373

xviii

3827_FM_i-xviii 03/07/15 10:26 AM Page xviii

 

 

UNIT I

3827_Ch01_001-010 01/07/15 12:33 PM Page 1

 

 

3827_Ch01_001-010 01/07/15 12:33 PM Page 2

 

 

3

CHAPTER 1

Teri Moser Woo • Marylou Robinson

Other APRNs

Physician Assistants

Nurses Not in Advanced Practice Roles

CANADIAN NURSE PRACTITIONER PRACTICE, 8

CURRENT ISSUES AND TRENDS IN HEALTH CARE AND THEIR EFFECT ON PRESCRIPTIVE AUTHORITY, 8 Autonomy and Prescriptive Authority

Interdisciplinary Teams

Level of Education of Team Members

Reimbursement

N ROLES OF REGISTERED NURSES IN MEDICATION MANAGEMENT

Registered Nurses

ROLES OF REGISTERED NURSES IN MEDICATION MANAGEMENT, 3 Registered Nurses

Advanced Practice Registered Nurses

ROLES AND RESPONSIBILITIES OF APRN PRESCRIBERS, 4

ADVANCED KNOWLEDGE, 4

BENEFITS OF AN APRN AS PRESCRIBER, 5

CLINICAL JUDGMENT IN PRESCRIBING, 5

COLLABORATION WITH OTHER PROVIDERS, 7 Physicians

Pharmacists

3827_Ch01_001-010 01/07/15 12:33 PM Page 3

 

 

Advanced Practice Registered Nurses

ROLES AND RESPONSIBILITIES OF APRN PRESCRIBERS

ADVANCED KNOWLEDGE

4

3827_Ch01_001-010 01/07/15 12:33 PM Page 4

 

 

BENEFITS OF AN APRN AS PRESCRIBER

CLINICAL JUDGMENT IN PRESCRIBING

5

3827_Ch01_001-010 01/07/15 12:33 PM Page 5

 

 

Is There a Clear Indication for Drug Therapy?

What Drugs Are Effective in Treating This Disorder?

What Is the Goal of Therapy With This Drug?

Under What Conditions Is It Determined That a Drug Is Not Meeting the Goal and a Different Therapy or Drug Should Be Tried?

Are There Unnecessary Duplications With Other Drugs That the Patient Is Already Taking?

Would an Over-the-Counter Drug Be Just as Useful as a Prescription Drug?

What About Cost?

Where Is the Information to Answer These Questions?

6

3827_Ch01_001-010 01/07/15 12:33 PM Page 6

 

 

7

COLLABORATION WITH OTHER PROVIDERS

Physicians

Pharmacists

Other APRNs

Physician Assistants

3827_Ch01_001-010 01/07/15 12:33 PM Page 7

 

 

8

Nurses Not in Advanced Practice Roles

CANADIAN NURSE PRACTITIONER PRACTICE

CURRENT ISSUES AND TRENDS IN HEALTH CARE AND THEIR EFFECT ON PRESCRIPTIVE AUTHORITY

Autonomy and Prescriptive Authority

Interdisciplinary Teams

3827_Ch01_001-010 01/07/15 12:33 PM Page 8

 

 

9

Level of Education of Team Members

Reimbursement

3827_Ch01_001-010 01/07/15 12:33 PM Page 9

 

 

10

REFERENCES

3827_Ch01_001-010 01/07/15 12:33 PM Page 10

 

 

11

CHAPTER 2

Peter J. Rice

Intracellular Receptors Regulating Gene Expression

Enzymes

Drug Action at Receptors

Disease States and Receptors

Non-receptor Mechanisms

PHARMACOKINETICS, 18 Absorption

Distribution

Metabolism

Drug Interactions

Excretion

SUMMARY, 27

PHARMACOLOGY—THE STUDY OF DRUGS

HOW NEW DRUGS ARE DEVELOPED

PHARMACOLOGYTHE STUDY OF DRUGS, 11

HOW NEW DRUGS ARE DEVELOPED, 11

DRUG RESPONSES, 12 Dose–Response Curves

Types of Drug Responses

Expressing Drug Responses

Drug Selectivity

Drug Responses in the Real World

Brand Versus Generic Drugs

RECEPTORS, 15 Ion Channel Receptors

Receptors Coupled to G Proteins

Transmembrane Receptors

3827_Ch02_011-028 01/07/15 12:33 PM Page 11

 

 

DRUG RESPONSES

Dose–Response Curves

Types of Drug Responses

12

BOX 2–1 IDEAL DRUG PROPERTIES

• Convenient route of administration, probably taken by mouth

• Established dosage • Immediate onset of action • Produces a single desired biological action • Produces no unwanted effects • Convenient duration of action • Dosage unaffected by loss of kidney or liver function

or by disease state • Improves quality of life • Prolongs patient survival

3827_Ch02_011-028 01/07/15 12:33 PM Page 12

 

 

Expressing Drug Responses

13

BOX 2–2 EXAMPLES OF GRADED RESPONSES TO DRUGS

• Blood pressure • Heart rate • Diuresis • Bronchodilation • FEV1 • Pain (scale 1–10) • Coma score

BOX 2–3 EXAMPLES OF QUANTAL RESPONSES TO DRUGS

• Convulsions • Pregnancy • Rash • Sleep • Death

Potency differences

Drug concentration (Molar)

R es

po ns

e pe

rc en

ta ge

o f m

ax im

um

100

75

50

25

0 10-9 10-8 10-7 10-6 10-5

Figure 2–1. Concentration–effect curves for three drugs that differ in potency (i.e., the dose or concentration required to produce an effect). The drug concentration on the x-axis is expressed in molar units, representing the number of molecules in each liter of solution. The graded response is expressed as a percentage of maximum effect.

3827_Ch02_011-028 01/07/15 12:33 PM Page 13

 

 

Drug Selectivity

Drug Responses in the Real World

Brand Versus Generic Drugs

14

3827_Ch02_011-028 01/07/15 12:33 PM Page 14

 

 

15

RECEPTORS Ion Channel Receptors

“Real world” drug responses

Drug concentration (µg/mL)

R es

po ns

e pe

rc en

ta ge

o f m

ax im

um 100

75

50

25

0 0.1 1 10 100 1000

Desired effect

Placebo effect

Toxicity

Ineffective

Figure 2–2. Theoretical representation of how drugs produce effects in clinical practice. Drug concentration (x-axis) increases from left to right. Some patients will respond at low dosages, either because of the placebo effect or sensitivity to the drug. As drug concentrations increase, greater numbers of patients will respond favorably but some will also respond adversely. At some dosage or concentration, the presence of toxic effects precludes the use of higher doses in patients.

3827_Ch02_011-028 01/07/15 12:33 PM Page 15

 

 

Receptors Coupled to G Proteins

16

ACh

Na+

K+

ACh

Figure 2–3. The nicotinic acetylcholine (ACh) receptor comprises five subunits that come together to form an ion channel receptor. When ACh binds to two sites on the receptor, the ion channel opens to let sodium (Na+) and potassium (K+) cross the cell membrane to initiate a response.

Drug

G protein Effector protein

Figure 2–4. G-protein–coupled receptors are proteins that cross the cell membrane 7 times, creating a pocket in which drugs can interact. Bound drugs may stimulate the receptor to release a G protein that can interact with various effector proteins to produce physiological responses.

3827_Ch02_011-028 01/07/15 12:33 PM Page 16

 

 

Transmembrane Receptors

Intracellular Receptors Regulating Gene Expression

17

Drug

-p -pp-

-p -pp-

Figure 2–5. The insulin receptor is prototypical of tyrosine kinase re- ceptors. These receptors are brought together by extracellular drug binding (insulin in the case of the insulin receptor), which activates the intracellular enzyme tyrosine kinase. Tyrosine kinase receptors activate one another by adding a phosphorus (P) to select sites on cellular proteins, which in turn activates a physiological response.

Steroid hormone

RNA

DNA

Protein

Receptor

Figure 2–6. Steroid hormones diffuse through the cell membrane to interact with steroid receptors in the cytoplasm. The hormone– receptor pair relocates to the nucleus, where it can interact with DNA to effect RNA transcription and the synthesis of proteins.

Binding

“Transition state” Products

Enzyme

Substrate

Active site

Enzyme Enzyme

Figure 2–7. Enzymes bind to substrates and speed up biochemical reactions. Enzymes can serve as receptors to the substrate, which binds at the active site, or to drugs that control enzyme activity through binding at a different site.

Enzymes

Drug Action at Receptors

3827_Ch02_011-028 01/07/15 12:33 PM Page 17

 

 

Non-receptor Mechanisms

PHARMACOKINETICS

Absorption

Disease States and Receptors

18

BOX 2–4 EFFECTS OF ROUTE OF ADMINISTRATION

• Compliance • Bioavailability • Onset of action • Duration of action

3827_Ch02_011-028 01/07/15 12:33 PM Page 18

 

 

19

Site of Administration

Bioavailability

Peak Blood Levels

Parenteral Administration

Oral Administration

3827_Ch02_011-028 01/07/15 12:33 PM Page 19

 

 

Distribution

Properties That Affect Distribution

20

Time (hours)

B lo

od le

ve l (

ar bi

tra ry

) 100

80

60

40

20

0 0 63 129 15 18 21 24

20 min 60 min 120 min

Figure 2–8. Blood levels for the same dose absorbed with peak-times of 20 minutes, 60 minutes, or 120 minutes. Rapid absorption results in faster effect, but blood levels are higher with a greater likelihood of toxicity.

3827_Ch02_011-028 01/07/15 12:33 PM Page 20

 

 

21

3827_Ch02_011-028 01/07/15 12:33 PM Page 21

 

 

Metabolism

Phase I and Phase II Metabolism

22

Extracellular fluid ~1/3 of total body

P la

sm a

Extracellular fluid ~1/3 of total body

P la

sm a

Intracellular fluid ~2/3 of total body water

Extracellular fluid ~1/3 of total body

P la

sm a

Intracellular fluid ~2/3 of total body water

Intracellular fluid ~2/3 of total body water

A B

Concentration = amount/volume

C

Phenobarbital

Phase 1 Phase 2 O

O

O NH

NH

p-hydroxy-phenobarbital O

OHO

O NH

NH

p-OH-phenobarbital glucuronide

O

OOO

O

HO

OH OHHO

O NH

NH

Figure 2–10. Metabolism of phenobarbital. Phase I metabolism adds an –OH to the molecule. A water-soluble glucuronide molecule is linked to this site during phase II metabolism.

Figure 2–9. Drug concentration in the plasma following administra- tion depends on the volume of dis- tribution. If a drug is confined to plasma (A), then plasma concentra- tion will be higher compared with distribution into extracellular fluid (B) or intracellular fluid (C). Dilution in increasing volumes is shown by shading of the areas containing a drug.

3827_Ch02_011-028 01/07/15 12:33 PM Page 22

 

 

Cytochrome P450

Metabolism and Half-Life

23

BOX 2–5 DRUG-METABOLIZING ENZYMES (LISTED IN ORDER OF IMPORTANCE)

CYP3A CYP2C CYP1A CYP2E CYP2D

3827_Ch02_011-028 01/07/15 12:33 PM Page 23

 

 

Patterns of Metabolism

Drug Interactions

24

Metabolism

D ru

g ac

tiv ity

Active drug

Prodrug

Active metabolite

Inactive metabolite

Phase 1 metabolism

Phase 2 metabolism

Active metabolite

(greater solubility)

Inactive metabolite

(greater solubility)

Figure 2–11. Typical effect of metabolism (solid arrows) on drug activity. Prodrugs are metabolized to active drugs that can undergo phase I and phase II metabolism, with metabolites varying in activity, compared with the parent drug, and in solubility, which increases the likelihood of renal elimination. Sometimes metabolism produces unusual effects (dashed arrows), such as drug metabolites that retain drug activity or accumulate in the body.

3827_Ch02_011-028 01/07/15 12:33 PM Page 24

 

 

Excretion

Renal Excretion

25

Glomerulus

Proximal tube Distal tube

Loop of Henle

Reabsorption Secretion Collecting

duct

Urine Figure 2–12. Diagram of the nephron, the functional unit of the kidney. Blood vessels flowing into the glomerulus provide blood, which is filtered into the lumen, the inner opening of the nephron. As fluid passes along the nephron, transporters can either reabsorb drugs (dark arrow) back into the blood or secrete (light arrow) drugs from blood into the lumen.

3827_Ch02_011-028 01/07/15 12:33 PM Page 25

 

 

Tubular Reabsorption

Tubular Secretion

Renal Excretion of Drugs

Biliary Excretion

Other Sites of Excretion

26

3827_Ch02_011-028 01/07/15 12:33 PM Page 26

 

 

SUMMARY

REFERENCES

27

3827_Ch02_011-028 01/07/15 12:33 PM Page 27

 

 

3827_Ch02_011-028 01/07/15 12:33 PM Page 28

 

 

29

CHAPTER 3

Teri Moser Woo

Therapeutic Factors

Safety

Cost

Patient Factors

Provider Factors

INFLUENCES ON RATIONAL PRESCRIBING, 34 Pharmaceutical Promotion

When Prescribing Recommendations Change

THE PROCESS OF RATIONAL DRUG PRESCRIBING, 29 Define the Patient’s Problem

Specify the Therapeutic Objective

Choose the Treatment

Start the Treatment

Educate the Patient

Monitor Effectiveness

DRUG FACTORS INFLUENCING DRUG SELECTION, 32 Pharmacodynamic Factors

Pharmacokinetic Factors

T

THE PROCESS OF RATIONAL DRUG PRESCRIBING

Define the Patient’s Problem

3827_Ch03_029-036 01/07/15 12:32 PM Page 29

 

 

Specify the Therapeutic Objective

Choose the Treatment

Start the Treatment

30

BOX 3–1 WORLD HEALTH ORGANIZATION’S SIX-STEP MODEL OF RATIONAL PRESCRIBING

Step Description

Step 1 Define the patient’s problem. Step 2 Specify the therapeutic objective. Step 3 Choose the treatment. Step 4 Start the treatment. Step 5 Educate the patient. Step 6 Monitor effectiveness.

Source: de Vries, T. P., Henning, R. H., Hogerzeil, H. V., & Fresle, D. A. (1994). Guide to good prescribing. WHO/DAP/94.11. Geneva, Switzerland: World Health Organization.

Diagnosis Treatment

Treatment script

Analytic Slow, conscious, systematic, evidence-based, novice

Non-analytic Fast, unconscious, heuristic, experience-based, expert

Figure 3–1. Hypothetical model of therapeutic reasoning. Bissessur et al, 2009.

BOX 3–2 THE ‘I Can PresCribE A Drug’ MNEMONIC

Indication Contraindications Precautions Cost/Compliance Efficacy Adverse effects Dose/Duration/Direction

Source: Iglar, K., Kennie, N., & Bajcar, J. (2007). I Can PresCribE a Drug: Mnemonic-based teaching of rational prescribing. Family Medicine, 39(4), 236–240.

3827_Ch03_029-036 01/07/15 12:32 PM Page 30

 

 

Educate the Patient

Monitor Effectiveness

31

CLINICAL PEARL

Drugs don’t work in patients who don’t take them. —C. Everett Koop, MD

Table 3–1 Example of the Use of the ‘I Can PresCribE a Drug’ Mnemonic

3827_Ch03_029-036 01/07/15 12:32 PM Page 31

 

 

DRUG FACTORS INFLUENCING DRUG SELECTION

Pharmacodynamic Factors

Pharmacokinetic Factors

Therapeutic Factors

Safety

Cost

32

3827_Ch03_029-036 01/07/15 12:32 PM Page 32

 

 

33

Patient Factors

Previous Adverse Drug Reactions

Health Beliefs

Current Drug Therapy

Patient Age

Pregnancy

3827_Ch03_029-036 01/07/15 12:32 PM Page 33

 

 

Provider Factors Ease of Prescribing or Monitoring

Formularies

INFLUENCES ON RATIONAL PRESCRIBING

Pharmaceutical Promotion When Prescribing Recommendations Change

34

3827_Ch03_029-036 01/07/15 12:32 PM Page 34

 

 

REFERENCES

35

3827_Ch03_029-036 01/07/15 12:32 PM Page 35

 

 

3827_Ch03_029-036 01/07/15 12:32 PM Page 36

 

 

37

CHAPTER 4

Tracy Klein

Systemic Solutions to Problems of Controlled Substance Prescribing

STATE LAW, 45 Jurisdiction

Writing and Transmitting the Prescription

ETHICAL ASPECTS OF PRESCRIBING, 47 Informed Consent

Prescribing for Self, Family, or Friends

Sale of Pharmaceuticals and Supplements

NURSE PRACTITIONER ROLE OUTSIDE THE UNITED STATES, 48

FEDERAL DRUG LAW, 37 History

U.S. Food and Drug Administration Regulatory Jurisdiction

The New Drug Approval Process

Official Labeling

Controlled Substance Laws

Controlled Substance Prescribing Precautions

CONTROLLED SUBSTANCE MISUSE: PRESCRIBER EDUCATION, 43 Behavioral Red Flags

Pressure to Prescribe

Enabling

When You Suspect a Patient Is Misusing Medications

FEDERAL DRUG LAW

History

3827_Ch04_037-050 01/07/15 12:30 PM Page 37

 

 

U.S. Food and Drug Administration Regulatory Jurisdiction

The New Drug Approval Process

Preclinical Research

38

3827_Ch04_037-050 01/07/15 12:30 PM Page 38

 

 

Clinical Studies

39

Adverse reaction reporting

Preclinical Investigation (Stage 1)

Range: 1–3 years

Average: 18 months

Range: 2–10 years

Average: 5 years

Range: 2 months to 10 years

Average: 24 months

Initial Synthesis

Animal Testing

Inspections

Surveys/ sampling/ testing

Clinical Investigation (Stage 2)

Clinical Phase I Trials

Short Term

Long Term

Clinical Phase III Trials

Clinical Phase II Trials

NDA Review (Stage 3)

Postmarketing studies (Stage 4)

30-day safety review NDA submitted NDA approved

Industry time FDA time Figure 4–1. New drug development timeline.

3827_Ch04_037-050 01/07/15 12:31 PM Page 39

 

 

Bioavailability Studies

Regulatory Review: New Drug Application

Accelerated Approval of a New Drug Application

Postapproval Research

Official Labeling

Off-Label Use

40

3827_Ch04_037-050 01/07/15 12:31 PM Page 40

 

 

Controlled Substance Laws Controlled Substance Prescribing Precautions

41

3827_Ch04_037-050 01/07/15 12:31 PM Page 41

 

 

42

Table 4–1 Controlled Drug Schedules

Schedule Controls Required Drug Examples

3827_Ch04_037-050 01/07/15 12:31 PM Page 42

 

 

CONTROLLED SUBSTANCE MISUSE: PRESCRIBER EDUCATION

Behavioral Red Flags

43

BOX 4–1 WEB RESOURCES FOR LEGAL AND ETHICAL ISSUES IN PRESCRIBING

National Cancer Institute Clinical Trials: http://www .cancer.gov/clinicaltrials

National Institute of Health Clinical Trials: http:// clinicaltrials.gov/ct2/home

FDA MedWatch: http://www.fda.gov/Safety/MedWatch/ default.htm

U.S. Drug Enforcement Administration: http://www .dea.gov

National Provider Identifier Number application: https://nppes.cms.hhs.gov/NPPES/Welcome.do

National Council of State Boards of Nursing: www .ncsbn.org

Institute for Safe Medication Practices: www.ismp.org Opioid Assessment, Medication Agreement and Man-

agement Tools: http://www.painedu.org/tools .asp?Tool=11

Table 4–2 Behaviors More and Less Predictive of Addiction

Probably More Predictive Probably Less Predictive

3827_Ch04_037-050 01/07/15 12:31 PM Page 43

 

 

Pressure to Prescribe

Enabling

When You Suspect a Patient Is Misusing Medications Communication Barriers

Communication Skills

Systemic Solutions to Problems of Controlled Substance Prescribing

44

3827_Ch04_037-050 01/07/15 12:31 PM Page 44

 

 

Prescription Drug Monitoring Programs

STATE LAW

Jurisdiction

45

PRESCRIBING TIPS

A few prescribing tips can help the practitioner reduce environmental facilitation of prescription misuse. First, collect and document a complete history and examina- tion before prescribing controlled substances. Do not rely on patient-supplied history, x-rays, or medical records to confirm your assessment—obtain this information di- rectly from the primary source. Passik and Weinreb (2000) advise use of the four “A’s” to guide initial and on- going assessment of medication efficacy: (1) analgesia measurement by use of pain scales or other assessment tools, (2) activities of daily living (ADLs) as measured by levels of physical and psychological functioning, (3) ad- verse effects, and (4) abuse issues.

Prescribe limited quantities without refills on a first visit, allowing additional time for patient assessment and confirmatory documentation. Educate medical and as- sistive staff in reinforcement of consistent clinic policies and procedures related to scheduling, forms, urine drug screening, records review and release, and refills. It is not uncommon for patients who do misuse substances to quickly identify the “weak link” among the treatment team and focus their energies on this person or process. Standardize expectations regarding after-hours calls, use of multiple providers, and weekend or early refills and post them where they are readily available.

Patients covered by insurance plans, including Med- icaid and Medicare, can be limited to one pharmacy or one prescriber through their payment plan. Case man- agers can often be utilized to help review and manage medication use and advocate for access to additional options for pain management and control. Other tips in- clude prescribing generic, longer-acting formulations of drugs that have less street value and writing out the quantity prescribed rather than using only numerals, which can be altered.

Medication Agreements

3827_Ch04_037-050 01/07/15 12:31 PM Page 45

 

 

Writing and Transmitting the Prescription The Prescription Format

46

Health and Wellness Clinic 5000 N. Willamette Blvd.

Portland, Oregon 503-555-1111

Anita Lee Wynne PhD, FNP-C Teri Woo, CPNP

Jane Doe DOB: 4/18/01

Amoxicillin 250 mg per 5 mL Disp: 300 mL. Give pediatric dosing spoon. Sig: 15 mL po bid X 10 days for otitis media. No refills Teri Woo, CPNP

Wt. 48 lb

Date:

Figure 4–2. Sample prescription.

3827_Ch04_037-050 01/07/15 12:31 PM Page 46

 

 

What May Be Prescribed

State-Specific Elements

Electronic Prescribing and Secure Prescribing

ETHICAL ASPECTS OF PRESCRIBING

Informed Consent

47

Figure 4–3. Sample prescription for controlled substance.

Date:

Health and Wellness Clinic 5000 N. Willamette Blvd.

Portland, Oregon 503-555-1111

Anita Lee Wynne PhD, FNP-C Teri Woo, CPNP

John Doe DOB: 6/5/51

Oxycodone 5 mg Disp: 30 (thirty) Sig: 1 tablet q4–6h pm back pain.

Do not drive or use hazardous machinery until response is known. May produce drowsiness. Do not exceed 6 tablets per day.

No refills Anita Lee Wynne, FNP-C DEA # on file in pharmacy

3827_Ch04_037-050 01/07/15 12:31 PM Page 47

 

 

Prescribing for Self, Family, or Friends

Sale of Pharmaceuticals and Supplements

NURSE PRACTITIONER ROLE OUTSIDE THE UNITED STATES

48

3827_Ch04_037-050 01/07/15 12:31 PM Page 48

 

 

REFERENCES

49

3827_Ch04_037-050 01/07/15 12:31 PM Page 49

 

 

3827_Ch04_037-050 01/07/15 12:31 PM Page 50

 

 

51

CHAPTER 5

Connie A. Valdez • Anne E. Morgan • Peter J. Rice

Gender

Drug Interactions

Medical Conditions

DETECTION AND ASSESSMENT OF ADRS, 56 Responding to ADRs and Warnings

Narranjo ADR Probability Scale

ADR REPORTING, 57

SUMMARY, 59

A

MECHANISTIC CLASSIFICATION OF ADRS

MECHANISTIC CLASSIFICATION OF ADRS, 51

TIMERELATED CLASSIFICATION OF ADRS, 53

DOSERELATED ADRS, 54

SEVERITY OF ADRS, 54

COMMON CAUSES OF ADRS, 55

RISK FACTORS, 55 Genetics

Age

3827_Ch05_051-060 01/07/15 12:30 PM Page 51

 

 

52

Table 5–1 Pharmacological Adverse Drug Reactions Table 5–2 Immune-Mediated Adverse Drug Reactions

3827_Ch05_051-060 01/07/15 12:30 PM Page 52

 

 

TIME-RELATED CLASSIFICATION OF ADRS

53

3827_Ch05_051-060 01/07/15 12:30 PM Page 53

 

 

DOSE-RELATED ADRS

SEVERITY OF ADRS

54

3827_Ch05_051-060 01/07/15 12:30 PM Page 54

 

 

55

COMMON CAUSES OF ADRS

RISK FACTORS

Genetics

Age

3827_Ch05_051-060 01/07/15 12:30 PM Page 55

 

 

Gender

Drug Interactions

Medical Conditions

DETECTION AND ASSESSMENT OF ADRS

56

3827_Ch05_051-060 01/07/15 12:30 PM Page 56

 

 

Responding to ADRs and Warnings Naranjo ADR Probability Scale

ADR REPORTING

57

Table 5–3 Naranjo Adverse Drug Reaction Scoring

Naranjo Adverse Drug Reaction Scoring Yes No Not Known Score

3827_Ch05_051-060 01/07/15 12:30 PM Page 57

 

 

Figure 5–1. The FDA MedWatch form provides a mechanism for health professionals to report ADRs. Source: U.S. Food and Drug Administration, www.fda.gov/Safety/MedWatch

58

3827_Ch05_051-060 01/07/15 12:30 PM Page 58

 

 

SUMMARY

REFERENCES

59

BOX 5–1 COMMON DRUGS WITH REMS

• Isotretinoin • Extended-release and long-acting opioid analgesics • Rosiglitazone • Testosterone • Verenicline • Metoclopramide • Mifepristone • Buprenorphine and naloxone • Naltrexone

3827_Ch05_051-060 01/07/15 12:30 PM Page 59

 

 

60

3827_Ch05_051-060 01/07/15 12:30 PM Page 60

 

 

61

CHAPTER 6

Marylou V. Robinson • Teri Moser Woo

FINANCIAL IMPACTS, 67 Cost Versus Complications

Out-of-Pocket Versus Insurance

Family Versus Self

Generic Versus “New and Improved” Brand Name

Public and Private Assistance

COMMUNICATION DIFFICULTIES, 68 Non–English Speakers and Interpreters

Speech and Hearing Issues

COMMUNICATION BETWEEN PROVIDERS, 68

PATIENT’S RESPONSIBILITIES, 68

MEASURING ADHERENCE, 69 Patient Reports

Clinical Outcomes

Pill Counts

Refill Records

Biological and Chemical Markers

Medication Adherence Scales

PREDICTORS OF ADHERENCE, 70

SUMMARY, 70

OVERVIEW OF NONADHERENCE, 62 Intentional Versus Nonintentional Nonadherence

ADVERSE DRUG REACTIONS, 62

ASYMPTOMATIC CONDITIONS, 62

CHRONIC CONDITIONS, 63

KNOWLEDGE DEFICIT AND PATIENT PERCEPTION, 63 Keys to Patient Education

Health and Cultural Beliefs

Medical Terminology Literacy

Written Handouts

COGNITIVE IMPAIRMENT AND PSYCHIATRIC ILLNESS, 65 Longer-Acting Drugs

Use of Reinforcements

CAREGIVER’S ROLES, 65 The Pediatric Patient

Caregiver’s Quality of Life

Behavioral Therapy

COMPLEXITY OF DRUG REGIMEN AND POLYPHARMACY, 66 Personalized Drug Schedules

Simplifying the Regimen

T

3827_Ch06_061-074 01/07/15 12:38 PM Page 61

 

 

OVERVIEW OF NONADHERENCE Intentional Versus Nonintentional Nonadherence

ADVERSE DRUG REACTIONS

ASYMPTOMATIC CONDITIONS

62

3827_Ch06_061-074 01/07/15 12:38 PM Page 62

 

 

CHRONIC CONDITIONS

KNOWLEDGE DEFICIT AND PATIENT PERCEPTION

63

Table 6–1 Factors Contributing to Medication Adherence With Chronic Illness

3827_Ch06_061-074 01/07/15 12:38 PM Page 63

 

 

Keys to Patient Education

Health and Cultural Beliefs

Medical Terminology Literacy

Written Handouts

64

3827_Ch06_061-074 01/07/15 12:38 PM Page 64

 

 

COGNITIVE IMPAIRMENT AND PSYCHIATRIC ILLNESS

Longer-Acting Drugs

Use of Reinforcements

CAREGIVER’S ROLES

The Pediatric Patient

Caregiver’s Quality of Life

Behavioral Therapy

65

3827_Ch06_061-074 01/07/15 12:38 PM Page 65

 

 

COMPLEXITY OF DRUG REGIMEN AND POLYPHARMACY

Personalized Drug Schedules

Simplifying the Regimen

Sensory or Mobility Challenges

Cues as Reminders

66

3827_Ch06_061-074 01/07/15 12:38 PM Page 66

 

 

Scheduling Visits for Medication Follow-Up

FINANCIAL IMPACTS

Cost Versus Complications

Out-of-Pocket Versus Insurance

Family Versus Self

Generic Versus “New and Improved” Brand Name

67

3827_Ch06_061-074 01/07/15 12:38 PM Page 67

 

 

Public and Private Assistance

COMMUNICATION DIFFICULTIES

Non–English Speakers and Interpreters

Speech and Hearing Issues

COMMUNICATION BETWEEN PROVIDERS

PATIENT’S RESPONSIBILITIES

68

3827_Ch06_061-074 01/07/15 12:38 PM Page 68

 

 

MEASURING ADHERENCE

Patient Reports

Clinical Outcomes

Pill Counts

Refill Records

Biological and Chemical Markers

Medication Adherence Scales

69

3827_Ch06_061-074 01/07/15 12:38 PM Page 69

 

 

!

PREDICTORS OF ADHERENCE

SUMMARY

70

BOX 6–1 MORISKY SIMPLIFIED SELF-REPORT MEASURE OF ADHERENCE

Scoring: 0 = High Adherence; 1–2 Medium Adherence; 3–4 Low Adherence

1. Do you ever forget to take your medicine? 2. Are you careless at times about taking your

medicine? 3. When you feel better do you sometimes stop

taking your medicine? 4. Sometimes if you feel worse when you take your

medication, do you stop taking it?

Adapted from Jani, A. A., Stewart, A., Nolen, R. D., & Tavel, L. (2002). Medication adherence and patient education. Florida AIDS Education & Training Center. In HIV/AIDS primary care guide (p 87). Gainesville, FL: University of Florida Press.

3827_Ch06_061-074 01/07/15 12:38 PM Page 70

 

 

71

Patient

Five spheres of influence and multiple factors that impact adherence and self-management. M. Robinson, 2015.

Personal Influences Psychological well-being

Self-efficacy Health beliefs

Spiritual beliefs Prior success Willingness

Ability to trust

Health System Influences Access to care

Availability of specialty care Self-management support

Continuity of care providers Continuity of insurance plan coverage

Wait times Insurance coverage for medications

Pharmacy access Automatic renewals

Personalize messaging concerning adherence

Biomedical Influences Timing of diagnosis Duration of impact

Degree of physical impact Comorbidities Polypharmacy

Functional impact Anticipated trajectory of impact

Frequency of dosing Drug-to-drug interactions

Socioeconomic Influences Occupational support

Occupational demands Financial stability Educational level

Impact of costs on prior lifestyle Impact of costs on other family members

Cost of medications Transportation access

Cultural barriers and considerations Religious barriers and considerations

Rural locations Living arrangements

Housing stability Legal status

Formal dependency status

Interpersonal Influences General external social support

Familial support Familiarity with others

with similar circumstances Changes in above factors

after diagnosis Language barriers

Patient provider relationship Patient provider stability

Figure 6–1. Five spheres of influence and multiple factors that impact adherence and self-management. Robinson, M. (2015). Derived from Wheeler, K. J., Roberts, M. E., & Neiheisel, M. B. (2014). Medication adherence part two: Predictors of nonadherence and adherence. Journal of the American Association of Nurse Practitioners,26(4), 225–232.

3827_Ch06_061-074 01/07/15 12:38 PM Page 71

 

 

REFERENCES

72

Table 6–2 Factors Influencing Adherence

General Health Status Medical History, Nutritional Assessment, and Comorbidities

3827_Ch06_061-074 01/07/15 12:38 PM Page 72

 

 

73

3827_Ch06_061-074 01/07/15 12:38 PM Page 73

 

 

3827_Ch06_061-074 01/07/15 12:39 PM Page 74

 

 

75

CHAPTER 7

Lorena C. Guerrero • Leila M. Jones

ASIAN AMERICANS, 87 Cultural Factors

Racial Differences in Drug Pharmacokinetics and Response

NATIVE HAWAIIAN/PACIFIC ISLANDERS, 90 Cultural Factors

Racial Differences in Drug Pharmacokinetics and Response

HISPANIC AMERICANS, 92 Cultural Factors

Racial Differences in Drug Pharmacokinetics and Response

NONHISPANIC WHITES, 95

SUMMARY, 96

U.S. DEMOGRAPHICS, 75 U.S. Demographic Groupings

Health Disparities in the United States

Cultural Influences on Care

TRANSCULTURAL NURSING CARE THEORIES, 77

STANDARDS OF CULTURAL COMPETENCY, 77

ELIMINATING HEALTH DISPARITIES, 79

ETHNOPHARMACOLOGY, 79

AFRICAN AMERICANS, 80 Cultural Factors

Racial Differences in Drug Pharmacokinetics and Response

AMERICAN INDIAN/ALASKA NATIVE GROUPS, 84 Cultural Factors

Racial Differences in Drug Pharmacokinetics and Response

T U.S. DEMOGRAPHICS

3827_Ch07_075-102 01/07/15 12:38 PM Page 75

 

 

U.S. Demographic Groupings

Health Disparities in the United States

Cultural Influences on Care

76

3827_Ch07_075-102 01/07/15 12:38 PM Page 76

 

 

TRANSCULTURAL NURSING CARE THEORIES

STANDARDS OF CULTURAL COMPETENCY

77

3827_Ch07_075-102 01/07/15 12:38 PM Page 77

 

 

78

3827_Ch07_075-102 01/07/15 12:38 PM Page 78

 

 

ELIMINATING HEALTH DISPARITIES

ETHNOPHARMACOLOGY

79

3827_Ch07_075-102 01/07/15 12:38 PM Page 79

 

 

AFRICAN AMERICANS

Cultural Factors Demographics

Education and Employment

Family Relationships

Health-Care Utilization

80

3827_Ch07_075-102 01/07/15 12:38 PM Page 80

 

 

Health Status and Other Biological Variables

81

3827_Ch07_075-102 01/07/15 12:38 PM Page 81

 

 

Health Beliefs and Practices

82

3827_Ch07_075-102 01/07/15 12:38 PM Page 82

 

 

Racial Differences in Drug Pharmacokinetics and Response

83

3827_Ch07_075-102 01/07/15 12:38 PM Page 83

 

 

AMERICAN INDIAN/ALASKA NATIVE GROUPS

Cultural Factors Demographics

Education and Employment

84

3827_Ch07_075-102 01/07/15 12:38 PM Page 84

 

 

Family Relationships

Health-Care Utilization

Health Status and Other Biological Variables

85

3827_Ch07_075-102 01/07/15 12:38 PM Page 85

 

 

Health Beliefs and Practices

86

3827_Ch07_075-102 01/07/15 12:38 PM Page 86

 

 

Racial Differences in Drug Pharmacokinetics and Response

ASIAN AMERICANS

Cultural Factors Demographics

Education and Employment

Family Relationships

87

3827_Ch07_075-102 01/07/15 12:38 PM Page 87

 

 

Health-Care Utilization

Health Status and Other Biological Variables Health Beliefs and Practices

88

3827_Ch07_075-102 01/07/15 12:38 PM Page 88

 

 

Racial Differences in Drug Pharmacokinetics and Response

89

3827_Ch07_075-102 01/07/15 12:38 PM Page 89

 

 

NATIVE HAWAIIAN AND PACIFIC ISLANDERS

Cultural Factors Demographics

Education and Employment

90

3827_Ch07_075-102 01/07/15 12:38 PM Page 90

 

 

Family Relationships

Health-Care Utilization

Health Status and Other Biological Variations

91

3827_Ch07_075-102 01/07/15 12:38 PM Page 91

 

 

Health Beliefs and Practices

Racial Differences in Drug Pharmacokinetics and Response

HISPANIC AMERICANS

Cultural Factors Demographics

Education and Employment

92

3827_Ch07_075-102 01/07/15 12:38 PM Page 92

 

 

Family Relationships

Health-Care Utilization

Health Status and Other Biological Variations

93

3827_Ch07_075-102 01/07/15 12:38 PM Page 93

 

 

Health Beliefs and Practices

94

3827_Ch07_075-102 01/07/15 12:38 PM Page 94

 

 

Racial Differences in Drug Pharmacokinetics and Response NON-HISPANIC WHITES

95

3827_Ch07_075-102 01/07/15 12:38 PM Page 95

 

 

SUMMARY

96

BOX 7–1 RESOURCES FOR CULTURALLY COMPETENT CARE

Center for Cross-Cultural Research

WESTERN WASHINGTON UNIVERSITY

Housed within an integral part of the Department of Psychology at Western Washington University, the Center for Cross- Cultural Research was started in response to the Euro-American bias in psychological theory, research, and practical applica- tions. The mission of the Center for Cross-Cultural Research is to promote culture-related research, offer courses on culture, promote exchange between cultural scientists, and disseminate the results of culture research. http://www.wwu.edu/culture/

Cross Cultural Health Care Program

The mission of the Cross Cultural Health Care Program is to serve as a bridge between communities and health-care institu- tions to ensure full access to quality health care that is culturally and linguistically appropriate. http://www.xculture.org

Diversity Rx

Diversity Rx promotes language and cultural competence to improve the quality of health care for minority, immigrant, and ethnically diverse communities. http://www.diversityrx.org

National Center for Cultural Competence

The mission of the National Center for Cultural Competence (NCCC) is to increase the capacity of health and mental health programs to design, implement, and evaluate culturally and linguistically competent service delivery systems to address growing diversity, persistent disparities, and to promote health and mental health equity. http://nccc.georgetown.edu/

PharmGKB

The PharmGKB is managed by Stanford University and is a pharmacogenomics knowledge resource that encompasses clini- cal information including dosing guidelines and drug labels, potentially clinically actionable gene-drug associations and genotype-phenotype relationships. PharmGKB collects, curates and disseminates knowledge about the impact of human ge- netic variation on drug responses.

Transcultural Nursing Society

The mission of the Transcultural Nursing Society (TCNS) is to enhance the quality of culturally congruent, competent, and equitable care that results in improved health and well-being for people worldwide. The TCNS seeks to provide nurses and other health-care professionals with the knowledge base necessary to ensure cultural competence in practice, education, research, and administration. www.tcns.org

3827_Ch07_075-102 01/07/15 12:38 PM Page 96

 

 

REFERENCES

97

3827_Ch07_075-102 01/07/15 12:38 PM Page 97

 

 

98

3827_Ch07_075-102 01/07/15 12:38 PM Page 98

 

 

99

3827_Ch07_075-102 01/07/15 12:38 PM Page 99

 

 

100

3827_Ch07_075-102 01/07/15 12:38 PM Page 100

 

 

101

3827_Ch07_075-102 01/07/15 12:38 PM Page 101

 

 

3827_Ch07_075-102 01/07/15 12:38 PM Page 102

 

 

103

CHAPTER 8

Ashim Malhotra

PGLYCOPROTEIN, 111

CLINICAL IMPLICATIONS OF PHARMACOGENOMICS, 111 Adverse Drug Reactions

Warfarin

Pharmacogenetic Testing Prior to Prescribing

SUMMARY, 113

A

GENETICS REVISITED, 104

HISTORY OF PHARMACOGENETICS, 105

PHARMACOGENOMICS, 105

GENETIC DIFFERENCES OF DRUG METABOLISM, 105 Genetic Polymorphism

Phase I and Phase II Metabolism

Specific CYP450 Enzymes

3827_Ch08_103-114 01/07/15 12:37 PM Page 103

 

 

GENETICS REVISITED

104

BOX 8–1 DEFINITIONS

Genetic polymorphism: multiple differences of a DNA sequence found in at least 1% of the population

Genetics: the study of heredity and its variations Genomics: the study of the complete set of genetic in-

formation present in a cell, an organism, or species Pharmacogenetics: the study of the influence of hered-

itary factors on the response of individual organisms to drugs (Venes, 2005); the study of variations of DNA and RNA characteristics as related to drug response (U.S. Food and Drug Administration, 2010b)

Pharmacogenomics: the study of the effects of genetic differences among people and the impact that these differences have on the uptake, effectiveness, toxic- ity, and metabolism of drugs

SNP: single-nucleotide polymorphism

Source: Venes, D. (2005). Taber’s cyclopedic medical dictionary (21st ed.). Philadelphia: FA Davis; U.S. Food and Drug Adminis- tration. (2010b). Table of valid genomic biomarkers in the context of approved drug labels. Retrieved from http://www .fda.gov/RegulatoryInformation/Guidances/ucm129286.htm

3827_Ch08_103-114 01/07/15 12:37 PM Page 104

 

 

HISTORY OF PHARMACOGENETICS

PHARMACOGENOMICS

GENETIC DIFFERENCES IN DRUG METABOLISM

Genetic Polymorphism

Phase I and Phase II Metabolism

105

3827_Ch08_103-114 01/07/15 12:37 PM Page 105

 

 

106

Figure 8–2. Pharmacogenomics of acetylation in isoniazid. Plasma isoniazid concentrations in 267 patients measured 6 hours post- dose. The bimodal distribution shows the effect of an NAT-2 genetic polymorphism.

N o.

s ub

je ct

s

0

24

12

0 4 8 12

Fast rate of acetylation

Slow rate of acetylation

Plasma isoniazid (mcg/mL)

Table 8–1 Clinical Implications of Genetic Polymorphisms

Metabolizer Effect on Clinical Phenotype Drug Metabolism Implications

Specific CYP450 Enzymes CYP2D6

30

65

100

50

0 0

wt/wt

24 h

D ru

g C

on c. 100

50

0 0 50

wt/wt

wt/m

m/m 100

E ffe

ct (%

)

100

50

0 0

wt/m

24 h

D ru

g C

on c. 100

50

0 0 50

wt/wt

wt/m

m/m 100

E ffe

ct (%

)

99

100

50

0 0

m/m

24 h

D ru

g C

on c. 100

50

0 0 50

wt/wt

Drug ConcentrationTime

wt/m

m/m 100

E ffe

ct (%

)

Drug Metabolism Genotypes

Drug Receptor Genotypes

+ =

Therapeutic Effect (%)

Toxicity (%)

Genetic Polymorphism of Drug Exposure

Genetic Polymorphism

Need a simillar or different assignment help?"Our Prices Start at $11.99. As Our First Client, Use Coupon Code GET10 to claim 10% Discount This Month!!":

Get started WhatsApp