Drugs contraindicated in breastfeeding mnemonic

FOURTH EDITION

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vii

T

ORGANIZATION

The Foundation

PREFACE

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Pharmacotherapeutics With Single Drugs

Pharmacotherapeutics With Multiple Drugs

Special Drug Treatment Considerations

FEATURES

Unit I chapters

Unit II chapters

Unit III chapters

viii

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Unit IV chapters

SUMMARY ACKNOWLEDGMENTS

ix

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xi

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

ABOUT THE AUTHORS

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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

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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

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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

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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

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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

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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

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UNIT I

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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

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Advanced Practice Registered Nurses

ROLES AND RESPONSIBILITIES OF APRN PRESCRIBERS

ADVANCED KNOWLEDGE

4

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BENEFITS OF AN APRN AS PRESCRIBER

CLINICAL JUDGMENT IN PRESCRIBING

5

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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

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7

COLLABORATION WITH OTHER PROVIDERS

Physicians

Pharmacists

Other APRNs

Physician Assistants

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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

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9

Level of Education of Team Members

Reimbursement

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10

REFERENCES

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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

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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

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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.

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Drug Selectivity

Drug Responses in the Real World

Brand Versus Generic Drugs

14

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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.

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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.

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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

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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

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19

Site of Administration

Bioavailability

Peak Blood Levels

Parenteral Administration

Oral Administration

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Distribution

Properties That Affect Distribution

20

Time (hours)

Bl oo

d 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.

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21

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Metabolism

Phase I and Phase II Metabolism

22

Extracellular fluid ~1/3 of total bodyPl

as m

a

Extracellular fluid ~1/3 of total bodyPl

as m

a

Intracellular fluid ~2/3 of total body water

Extracellular fluid ~1/3 of total bodyPl

as m

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.

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Cytochrome P450

Metabolism and Half-Life

23

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

CYP3A CYP2C CYP1A CYP2E CYP2D

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Patterns of Metabolism

Drug Interactions

24

Metabolism

Dr ug

a ct

ivi ty

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.

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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.

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Tubular Reabsorption

Tubular Secretion

Renal Excretion of Drugs

Biliary Excretion

Other Sites of Excretion

26

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SUMMARY

REFERENCES

27

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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

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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.

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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

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DRUG FACTORS INFLUENCING DRUG SELECTION

Pharmacodynamic Factors

Pharmacokinetic Factors

Therapeutic Factors

Safety

Cost

32

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33

Patient Factors

Previous Adverse Drug Reactions

Health Beliefs

Current Drug Therapy

Patient Age

Pregnancy

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Provider Factors Ease of Prescribing or Monitoring

Formularies

INFLUENCES ON RATIONAL PRESCRIBING

Pharmaceutical Promotion When Prescribing Recommendations Change

34

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REFERENCES

35

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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

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U.S. Food and Drug Administration Regulatory Jurisdiction

The New Drug Approval Process

Preclinical Research

38

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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.

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Bioavailability Studies

Regulatory Review: New Drug Application

Accelerated Approval of a New Drug Application

Postapproval Research

Official Labeling

Off-Label Use

40

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Controlled Substance Laws Controlled Substance Prescribing Precautions

41

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42

Table 4–1 Controlled Drug Schedules

Schedule Controls Required Drug Examples

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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

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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

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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

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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.

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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

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Prescribing for Self, Family, or Friends

Sale of Pharmaceuticals and Supplements

NURSE PRACTITIONER ROLE OUTSIDE THE UNITED STATES

48

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REFERENCES

49

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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

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52

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

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TIME-RELATED CLASSIFICATION OF ADRS

53

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DOSE-RELATED ADRS

SEVERITY OF ADRS

54

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55

COMMON CAUSES OF ADRS

RISK FACTORS

Genetics

Age

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Gender

Drug Interactions

Medical Conditions

DETECTION AND ASSESSMENT OF ADRS

56

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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

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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

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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

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60

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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

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OVERVIEW OF NONADHERENCE Intentional Versus Nonintentional Nonadherence

ADVERSE DRUG REACTIONS

ASYMPTOMATIC CONDITIONS

62

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CHRONIC CONDITIONS

KNOWLEDGE DEFICIT AND PATIENT PERCEPTION

63

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

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Keys to Patient Education

Health and Cultural Beliefs

Medical Terminology Literacy

Written Handouts

64

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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

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COMPLEXITY OF DRUG REGIMEN AND POLYPHARMACY

Personalized Drug Schedules

Simplifying the Regimen

Sensory or Mobility Challenges

Cues as Reminders

66

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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

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Public and Private Assistance

COMMUNICATION DIFFICULTIES

Non–English Speakers and Interpreters

Speech and Hearing Issues

COMMUNICATION BETWEEN PROVIDERS

PATIENT’S RESPONSIBILITIES

68

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MEASURING ADHERENCE

Patient Reports

Clinical Outcomes

Pill Counts

Refill Records

Biological and Chemical Markers

Medication Adherence Scales

69

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!

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.

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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.

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REFERENCES

72

Table 6–2 Factors Influencing Adherence

General Health Status Medical History, Nutritional Assessment, and Comorbidities

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73

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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

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U.S. Demographic Groupings

Health Disparities in the United States

Cultural Influences on Care

76

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TRANSCULTURAL NURSING CARE THEORIES

STANDARDS OF CULTURAL COMPETENCY

77

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78

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ELIMINATING HEALTH DISPARITIES

ETHNOPHARMACOLOGY

79

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AFRICAN AMERICANS

Cultural Factors Demographics

Education and Employment

Family Relationships

Health-Care Utilization

80

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Health Status and Other Biological Variables

81

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Health Beliefs and Practices

82

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Racial Differences in Drug Pharmacokinetics and Response

83

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AMERICAN INDIAN/ALASKA NATIVE GROUPS

Cultural Factors Demographics

Education and Employment

84

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Family Relationships

Health-Care Utilization

Health Status and Other Biological Variables

85

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Health Beliefs and Practices

86

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Racial Differences in Drug Pharmacokinetics and Response

ASIAN AMERICANS

Cultural Factors Demographics

Education and Employment

Family Relationships

87

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Health-Care Utilization

Health Status and Other Biological Variables Health Beliefs and Practices

88

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Racial Differences in Drug Pharmacokinetics and Response

89

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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

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Health Beliefs and Practices

Racial Differences in Drug Pharmacokinetics and Response

HISPANIC AMERICANS

Cultural Factors Demographics

Education and Employment

92

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Family Relationships

Health-Care Utilization

Health Status and Other Biological Variations

93

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Health Beliefs and Practices

94

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Racial Differences in Drug Pharmacokinetics and Response NON-HISPANIC WHITES

95

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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

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REFERENCES

97

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98

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99

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100

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101

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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

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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

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HISTORY OF PHARMACOGENETICS

PHARMACOGENOMICS

GENETIC DIFFERENCES IN DRUG METABOLISM

Genetic Polymorphism

Phase I and Phase II Metabolism

105

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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.

No . 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

Dr ug

C on

c. 100

50

0 0 50

wt/wt

wt/m

m/m 100

Ef fe

ct (%

)

100

50

0 0

wt/m

24 h

Dr ug

C on

c. 100

50

0 0 50

wt/wt

wt/m

m/m 100

Ef fe

ct (%

)

99

100

50

0 0

m/m

24 h

Dr ug

C on

c. 100

50

0 0 50

wt/wt

Drug ConcentrationTime

wt/m

m/m 100

Ef fe

ct (%

)

Drug Metabolism Genotypes

Drug Receptor Genotypes

+ =

Therapeutic Effect (%)

Toxicity (%)

Genetic Polymorphism of Drug Exposure

Genetic Polymorphism

of Drug Sensitivity

Genetically Regulated Heterogeneity in Drug Effects

Efficacy Toxicity

A

75 1 35 1 10 1

B

85 <10 45 <10 10 <10

C

95 >80 50 >80 10 >80

Figure 8–1. Genetic polymorphisms and drug metabolism/receptors.

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107

Figure 8–3. Proportion of drugs metabolized by CYP450 isoenzymes.

CYP2D6 19%

CYP3A4 36%

CYP1A2 CYP2A6CYP2B6

CYP2E1

CYP2C9

CYP2C19

Table 8–2 Medications and Their Receptors

Gene Medications Drug Effect Linked to Polymorphism

Drug-Metabolizing Enzymes

Drug Targets

3827_Ch08_103-114 01/07/15 12:37 PM Page 107

CYP2C9

108

Table 8–3

Substrate Inhibitors Inducers

60

30

0 0 24 48 72

Pl as

m a

no rtr

ip ty

lin e

(n m

ol /L

)

Hours

0 Functional CYP2D6 genes 1 Functional CYP2D6 genes 2 Functional CYP2D6 genes 3 Functional CYP2D6 genes 13 Functional CYP2D6 genes

Figure 8–4. European population and the CYP2D6 substrate nortriptyline.

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109

Table 8–4 ( and )

Substrate Inhibitors Inducers

35

30

25

20

15

10

5

0

2 3.7

10

20

29

Pe rc

en ta

ge o

f i nd

ivi du

al s

Percentage Duplication of CYP2D6 Across Different Populations

Sweden Germany Spain Saudi Arabia Ethiopia

Figure 8–5. Percentage distribution of individ- uals across countries showing a duplication of an allele of CYP2D6. The figure explains the exaggerated metabolism of some drugs in the specified percentage of individuals belonging to certain ethnic backgrounds (generously as- suming ethnic homogeneity in some coun- tries) due to increased 2D6 activity.

3827_Ch08_103-114 01/07/15 12:37 PM Page 109

CYP3A4

110

Table 8–5

Substrate Inhibitors Inducers

12

10

8

6

4

2

0

Pe rc

en ta

ge o

f A lle

lic F

re qu

en cy

Percentage of Allelic Variation CYP2C9 Across Different Ethnicities

CYP2C9*2 CYP2C9 Allelic Mutations

CYP2C9*3

Caucasians Africans Asians

Figure 8–6. Percentage distribution of individuals across ethnicities exhibiting polymorphism in CYP2C9.

120

100

80

60

40

20

0

Pe rc

en ta

ge o

f A lle

lic F

re qu

en cy

Percentage of Allelic Variation VKORC1 Across Different Ethnicities

VKORC1 Allelic Variant (–1639) VKORC1

Caucasians Africans Asians

Figure 8–7. Percentage distribution of individuals across ethnicities showing variation in VKORC1.

3827_Ch08_103-114 01/07/15 12:37 PM Page 110

P-GLYCOPROTEIN

111

Parent Drug

CYP3A4

Metabolite

P-Glycoprotein

Intestinal WallSmall Intestine Enteric Blood Flow

Figure 8–8. Drug–metabolism interactions.

CLINICAL IMPLICATIONS OF PHARMACOGENOMICS

Adverse Drug Reactions

Warfarin

Pharmacogenetic Testing Prior to Prescribing

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112

Table 8–6 U.S. Food and Drug Administration Positions on Necessity of Pharmacogenetic Testing as Indicated on Drug Labeling

Pharmacogenetic Biomarker Drug

Test Required

Test Recommended

Information Only

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SUMMARY

REFERENCES

113

Table 8–7 FDA-Approved Diagnostic Test Commercially Available for Commonly Prescribed Pharmacologic Therapies

Genetic Test Drug Benefit of Genetic Test

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114

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115

Teri Moser Woo

NUTRIENTDRUG INTERACTIONS, 115 Influence of Diet on the Pharmacokinetics of Drugs

Drug-Induced Nutrient Depletion

Outcomes of Nutrient–Drug Interactions

NUTRITIONAL MANAGEMENT, 118

NUTRACEUTICALS, 119 Fiber

Vitamins and Minerals

Fatty Acids

Plant Sterols

Pre-, Pro-, and Symbiotics

E

NUTRIENT–DRUG INTERACTIONS

Influence of Diet on the Pharmacokinetics of Drugs Drug Absorption

CHAPTER 9

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Drug Metabolism

116

3827_Ch09_115-128 01/07/15 12:35 PM Page 116

Drug Excretion

Drug-Induced Nutrient Depletion

Outcomes of Nutrient–Drug Interactions Clinical Decision Making

117

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NUTRITIONAL MANAGEMENT

118

Table 9–1 Vitamin K Content in Common Foods

Food Serving Size Daily Value (%)

Foods High in Vitamin K (more than Eat No More Than 1 Serving per Day or equal to 200% DV)

Foods Moderately High in Vitamin K Eat No More Than 2 Servings per Day (60% to 199% DV)

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NUTRACEUTICALS

Fiber

119

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Vitamins and Minerals

Vitamin A

120

Table 9–2 Recommended Fiber Intake

Gender/Age Fiber (g/d)

Table 9–3 Recommended Reference Intakes of Vitamins and Minerals

Nutrient Age RDA Food Sources

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121

Table 9–3 Recommended Reference Intakes of Vitamins and Minerals—cont’d

Nutrient Age RDA Food Sources

Vitamin B1

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Vitamin B2

Vitamin B3

Vitamin B6

Vitamin B12

Vitamin C

122

3827_Ch09_115-128 01/07/15 12:35 PM Page 122

Vitamin D

Vitamin K

Folate

123

Table 9–4 Serum 25-Hydroxyvitamin D [25(OH)D] Concentrations and Health*

ng/mL** nmol/L** Health Status

3827_Ch09_115-128 01/07/15 12:35 PM Page 123

Calcium

Iron

Fatty Acids

124

BOX 9–1 MEDICATIONS INTERFERING WITH FOLATE UTILIZATION

Antiepileptic drugs (phenytoin, primidone) Metformin Sulfasalazine Triamterene Methotrexate Barbiturates Trimethoprim Pyrimethamine Isoniazid Oral contraceptives

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Plant Sterols

Pre-, Pro-, and Symbiotics

125

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REFERENCES

126

BOX 9–2 RESOURCES

American Dietetic Association http://www.eatright.org

Drugs.com Drug Interaction Checker http://www.drugs.com/drug_interactions.php

Food and Medication Interactions http://www.foodmedinteractions.com

Medscape Drug Interaction Checker www.medscape.com

National Institutes of Health Office of Dietary Supplements http://ods.od.nih.gov/Health_Information/Health_ Information.aspx

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127

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128

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129

CHAPTER 10

Fujio McPherson

Ayurvedic Herbs

Herbs for Common Disorders

HERBAL PREPARATIONS, 147

CONSIDERATIONS FOR THE APN PRESCRIBER, 147

SUGGESTED READING, 148 Western Herbs

Chinese Medicine

Ayurvedic Medicine

General Recommendations

P

OVERVIEW OF HERBAL MEDICINE, 130

DEFINITIONS, 130 Western Herbal Medicine

Traditional Chinese Medicine

Ayurvedic Medicine

HERBAL SAFETY, 133 Evidence Grading

Matrix for Evidence Grading

Challenges to Using an Evidence-Based Method

COMMON HERBS, 138 Western Herbs

Traditional Chinese Herbs

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OVERVIEW OF HERBAL MEDICINE

DEFINITIONS

130

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Western Herbal Medicine

Traditional Chinese Medicine

131

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Ayurvedic Medicine

132

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133

HERBAL SAFETY

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Evidence Grading

Natural Standard

Healthnotes

Rakel Evidence Versus Harm Scale

Cochrane Database of Systematic Reviews

German Commission E Monographs

134

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Matrix for Evidence Grading

135

Hypertension

CAM Therapy Natural Standard Healthnotes Rakel WHO Commission- E

Cochrane Summary:

Clinical Implications for Practice: Hypertension

Herb/Supplement Indications Contraindications Dose Rakel Harm Scale

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136

Hypertension Commentary

Hyperlipidemia

CAM Therapy Natural Standard Healthnotes Rakel WHO Commission- E

Cochrane Summary:

Clinical Implications for Practice: Hyperlipidemia

Herb/Supplement Indications Contraindications Dose Rakel Harm Scale

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Hyperlipidemia Commentary

Challenges to Using an Evidenced- Based Model

137

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COMMON HERBS

Western Herbs Mental Health Symptoms

138

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139

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140

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141

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Traditional Chinese Herbs

The Four Energies

142

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The Five Flavors

The Four Movements

Meridian Routes

Actions

Herbal Formulas

How to Take Chinese Herbs

Rules for Taking a Formula

143

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Insomnia

Heart–Spleen Deficiency

144

CLINICAL PEARL

TCM diagnosis Although this text does not cover TCM diagnosis or an explanation of the disorder mentioned (e.g., spleen de- ficiency, heart fire, etc.), the general purpose of includ- ing the differential diagnosis is to demonstrate how diverse TCM diagnosis is and how it applies to the choice of herbal medicine prescribed. Please refer to TCM textbooks to further understand TCM diagnosis.

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Ayurvedic Herbs

Additional Approach to Choosing

Digestive Disorders

Rejuvenative Disorders

145

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Herbs for Common Disorders

146

Table 10–1 Selective Herbal Agents Used for Common Conditions

Condition Treatment

Pain

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HERBAL PREPARATIONS

CONSIDERATIONS FOR THE APRN PRESCRIBER

147

BOX 10–1 WEB-BASED RESOURCES FOR HERBS AND ALTERNATIVE THERAPIES

• American Botanical Council, http://www .herbalgram.org

• American Herbalist Guild, http://www .americanherbalistsguild.com

• Biofeedback Certification Institute of America, http://www.bcia.org

• National Center for Complementary and Alternative Medicine, http://nccam.nih.gov

• Natural Standard: The Authority on Integrative Medicine, http://www.naturalstandard.com/

• Cochrane Database of Systematic Reviews, http:// www.cochran.org

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SUGGESTED READING

Western Herbs

Chinese Medicine

Ayurvedic Medicine

General Recommendations

REFERENCES

148

BOX 10–2 HERBAL RESOURCES

East West School of Herbology

P.O. Box 275 Ben Lomond, CA 95005 1-800-717-5010 herbcourse@planetherbs.com or www

.planetherbs.com Sponsor of planetary herbal formulas that supplies

Western, Eastern, and Ayurvedic herbs.