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
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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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MARYLOU V. ROBINSON, PHD, FNP-CTERI MOSER WOO, RN, PHD, CPNP-PC, FAANP
ABOUT THE AUTHORS
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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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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
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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
PHARMACOLOGYTHE 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)
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.
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21
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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.
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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
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.
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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
TIMERELATED CLASSIFICATION OF ADRS, 53
DOSERELATED 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
NONHISPANIC 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
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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
PGLYCOPROTEIN, 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.
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
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