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Davis’s Drug
Guide for Nurses,15th Edition
Detecting and Managing
Adverse Drug Events
Copyright © 2016 F.A. Davis Company
Davis’s Drug
Guide for Nurses,15th Edition
Incidence of Adverse Drug Events (ADEs)

The FDA entered 715,331 reports of adverse
drug events in 2013.
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/
AdverseDrugEffects/ucm070434.htm

1 in 6 hospital admissions of older adults is
associated with adverse drug reactions.
RICHARD W. PRETORIUS, MD, MPH; GORDANA GATARIC, MD; STEVEN K. SWEDLUND, MD; and
JOHN R. MILLER, RPh,(2013). Reducing the Risk of Adverse Drug Events in Older Adults. Am Fam
Physician, Mar 1;87(5):331-336
Copyright © 2016 F.A. Davis Company
Davis’s Drug
Guide for Nurses,15th Edition
Adverse Drug Event
Unexpected, undesired, excessive response to
a medication that results in
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Temporary or permanent serious harm or disability
Admission to a hospital
Transfer to a higher level of care
Prolonged hospital stay
Congenital anomaly
Death
Copyright © 2016 F.A. Davis Company
Davis’s Drug
Guide for Nurses,15th Edition
Types of Adverse Drug Events
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Adverse drug reactions
Dose-related (toxic) reactions
Drug-drug and drug-food interactions
Hypersensitivity (allergic reactions)
Idiosyncratic reactions
Copyright © 2016 F.A. Davis Company
Davis’s Drug
Guide for Nurses,15th Edition
1. Adverse Drug Reactions
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Caused by processes within the patient’s body
Drug reaction that is unexpected and
undesired
May or may not be caused by medication
errors
May cause an increase in hospital stays
May or may not be preventable
Copyright © 2016 F.A. Davis Company
Davis’s Drug
Guide for Nurses,15th Edition
2. Dose-Related (Toxic) Reactions
May be related to
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Renal or hepatic impairment
Extremes in age (neonates, elderly)
Drug-drug or drug-food interactions
Underlying illnesses
Inadequate assessment of blood levels
Copyright © 2016 F.A. Davis Company
Davis’s Drug
Guide for Nurses,15th Edition
Dose-Related (Toxic) Reactions (cont’d)
Examples of medications that require careful
monitoring or lab tests
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Digoxin, lithium
Aminoglycosides
Anticonvulsant drugs
Anticoagulants
Nephrotoxic drugs
Anti-infectives: aminoglycosides, vancomycin, etc.
Copyright © 2016 F.A. Davis Company
Davis’s Drug
Guide for Nurses,15th Edition
Dose-Related (Toxic) Reactions (cont’d)
Medical management
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Discontinue drug temporarily
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Reduce dose or increase dosing interval
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Provide antidote (e.g., Digibind for digoxin toxicity)
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Get careful, well-timed drug-level monitoring
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Review all medication
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Consider dietary change (e.g., eliminate grapefruit or
grapefruit juice)
Copyright © 2016 F.A. Davis Company
Davis’s Drug
Guide for Nurses,15th Edition
Dose-Related (Toxic) Reactions (cont’d)
Nursing responsibilities
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Review all medications and patient history.
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Administer meds at the correct time.
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Obtain blood levels as ordered; coordinate
administration with lab technician.
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Assess for signs and symptoms of toxicity.
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Provide education about drugs and diet.
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Report relevant lab values.
Copyright © 2016 F.A. Davis Company
Davis’s Drug
Guide for Nurses,15th Edition
3. Drug-Drug Interactions
Pharmacokinetic and pharmacodynamic
properties of one drug affect either the
pharmacokinetics or pharmacodynamics of
another drug.
Copyright © 2016 F.A. Davis Company
Davis’s Drug
Guide for Nurses,15th Edition
Drug-Drug Interactions (cont’d)

Pharmacokinetics
 Absorbing
 Distributing
 Metabolizing
 Excreting
“What the body does to the drug”
Copyright © 2016 F.A. Davis Company
Davis’s Drug
Guide for Nurses,15th Edition
Drug-Drug Interactions (cont’d)

Pharmacodynamics
 The
chemical and physiological changes
that the drug causes
 Drug
effect
“What the drug does to the body”
Copyright © 2016 F.A. Davis Company
Davis’s Drug
Guide for Nurses,15th Edition
Types of Drug-Drug Interactions
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Potentiation: Drugs with similar actions cause
an additive effect.
 Coumadin
and aspirin taken together
cause excessive bleeding.
 Sedatives
sedation.
Copyright © 2016 F.A. Davis Company
and alcohol cause excessive
Davis’s Drug
Guide for Nurses,15th Edition
Types of Drug-Drug Interactions (cont’d)
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Interference: One drug accelerates or slows the
metabolism or excretion of another drug
Azithromycin taken with:
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Digoxin = elevated blood levels of digoxin
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Coumadin = risk of toxicity
Potential for serious adverse effects!
Copyright © 2016 F.A. Davis Company
Davis’s Drug
Guide for Nurses,15th Edition
Types of Drug-Drug Interactions (cont’d)
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Displacement: Two drugs compete for protein
binding sites
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One drug “wins” (is bound to protein)
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Displaced drug is active in greater quantities
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Same effect as taking a higher dose of the
displaced drug
A major cause of drug-drug interactions!
Copyright © 2016 F.A. Davis Company
Davis’s Drug
Guide for Nurses,15th Edition
Types of Drug-Drug Interactions (cont’d)
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Antagonism: One drug decreases the
effectiveness of another drug because of
divergent actions
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Oral ketoconazole (Nizoral) is absorbed in an
acidic environment.
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H2-receptor antagonists or proton pump
inhibitors decrease acidity in the stomach.
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Differing action decreases ketoconazole
effectiveness.
Copyright © 2016 F.A. Davis Company
Davis’s Drug
Guide for Nurses,15th Edition
Types of Drug-Drug Interactions (cont’d)
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Cytochrome P450 (CYP450) enzymes and
drug-drug interactions
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Enzymes that play an important role in drug metabolism
(mainly hepatic metabolism)
Targets mainly lipid-soluble drugs—the majority of
medications
Common drugs metabolized by the CYP450 enzyme
system include acetaminophen, ibuprofen, phenytoin,
omeprazole, propranolol, diltiazem, tricyclic
antidepressants, and many more.
Copyright © 2016 F.A. Davis Company
Davis’s Drug
Guide for Nurses,15th Edition
Types of Drug-Drug Interactions (cont’d)
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CYP450 Inhibitors & Inducers
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CYP450 inhibitors: Drug A inhibits CYP450 enzymes in
the liver; slows metabolism of drug B; toxic levels of drug
B accumulate
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CYP450 inducers: Drug A stimulates production of
CYP450 enzymes; increases rate of metabolism of drug
B; clears drug B out of the system faster
A major source of drug-drug interactions!
Copyright © 2016 F.A. Davis Company
Davis’s Drug
Guide for Nurses,15th Edition
Drug-Drug Interactions
Nursing responsibilities
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Check your Drug Guide for interactions (e.g.,
check lopinavir/ritonavir in Davis’s Drug Guide
for Nurses).
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Check labs for drug levels.
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Assess patient for increased or decreased drug
effects or side effects.
Copyright © 2016 F.A. Davis Company
Davis’s Drug
Guide for Nurses,15th Edition
3. Drug-Food Interactions
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Similar to drug-drug interactions
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Food can alter the absorption or metabolism of
medications (see Appendix M).
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Diets can alter the bacterial flora of the intestine
and may affect the metabolism of certain drugs.
Copyright © 2016 F.A. Davis Company
Davis’s Drug
Guide for Nurses,15th Edition
Drug-Food Interactions (cont’d)
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MAOs taken with tyramine-containing foods can
cause hypertension and intracranial bleeding.
Foods high in vitamin K cause an antagonistic effect
with oral anticoagulants.
Dairy products cause decreased absorption of
ciprofloxacin and can potentiate or interfere with
drug reactions.
Copyright © 2016 F.A. Davis Company
Davis’s Drug
Guide for Nurses,15th Edition
Drug-Food Interactions (cont’d)
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Calcium channel blockers taken with grapefruit
juice can increase effects of the drug.
Iron taken with acidic foods can cause increased
iron absorption.
Herbs and supplements taken with any drug can
potentiate or interfere with the action of the drug.
Copyright © 2016 F.A. Davis Company
Davis’s Drug
Guide for Nurses,15th Edition
4. Hypersensitivity (Allergic Reactions)
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Can be allergic or nonallergic
Anaphylactic (allergic) reactions
 Occur minutes to hours after exposure and are
manifested by
Urticaria (hives), pruritus (itching)
 Bronchospasm, wheezing
 Vomiting, diarrhea
 Tachycardia, circulatory collapse
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A life-threatening medical emergency
Copyright © 2016 F.A. Davis Company
Davis’s Drug
Guide for Nurses,15th Edition
Hypersensitivity (Allergic Reactions) (cont’d)
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Nonallergic hypersensitivity reactions occur
within 2 days or up to 3 weeks and are
manifested by
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Hemolytic anemia, glomerulonephritis
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Lymphadenopathy, thrombocytopenia, neutropenia
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Arthralgia
Copyright © 2016 F.A. Davis Company
Davis’s Drug
Guide for Nurses,15th Edition
Hypersensitivity (Allergic Reactions) (cont’d)
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Nonallergic, hypersensitivity reactions include
Erythema multiforme
 Stevens-Johnson syndrome
 Toxic epidermal necrolysis
 Contact dermatitis
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Require prompt recognition and treatment
because of high morbidity and mortality
Copyright © 2016 F.A. Davis Company
Davis’s Drug
Guide for Nurses,15th Edition
Hypersensitivity (Allergic Reactions) (cont’d)
Nursing responsibilities
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Ask patient or family about allergies on admission;
document prominently and obtain allergy bracelet.
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When anaphylaxis occurs, stop the drug and
assess ABCs (airway, breathing, circulation).
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Notify physician, nurse practitioner, or
physician assistant immediately.
Copyright © 2016 F.A. Davis Company
Davis’s Drug
Guide for Nurses,15th Edition
Hypersensitivity (Allergic Reactions) (cont’d)
Nursing responsibilities (cont’d)
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Stay with the patient.
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Maintain IV access.
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Ensure ready access to emergency resuscitative
equipment.
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Monitor during initial administration of crosshypersensitive agen.t
Copyright © 2016 F.A. Davis Company
Davis’s Drug
Guide for Nurses,15th Edition
5. Idiosyncratic Reactions
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Major targets are skin, liver, and bone marrow
Faculties of Pharmacy and Medicine, University of Toronto, Toronto, Canada (2013). Idiosyncratic Adverse Drug
Reactions: Current Concepts. Pharmacol Rev, Apr; 65(2):779–808
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Unrelated to dose
Unpredictable and sporadic
May be caused by pharmacogenetic differences in drugmetabolizing enzymes
 Pharmacogenetic disease affects approximately 100
million people.
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80 types of the disease; all may produce drug-induced
hemolysis
Copyright © 2016 F.A. Davis Company
Davis’s Drug
Guide for Nurses,15th Edition
Idiosyncratic Reactions (cont’d)
Reactions may include
 Fever
 Blood dyscrasias
 Cardiovascular effects
 Change in mental status
Copyright © 2016 F.A. Davis Company
Davis’s Drug
Guide for Nurses,15th Edition
Idiosyncratic Reactions (cont’d)
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Drugs prone to cause idiosyncratic reaction
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Aspirin
Nitrofurantoin (treats UTIs)
Primaquine (antimalarial drug)
Probenecid (treats gout)
Sulfonamides (anti-infective/sulfonamide)
Copyright © 2016 F.A. Davis Company
Davis’s Drug
Guide for Nurses,15th Edition
Nurse’s Role in Recognizing
and Managing an
Adverse Drug Event
Copyright © 2016 F.A. Davis Company
Davis’s Drug
Guide for Nurses,15th Edition
Signs and Symptoms of an
Adverse Drug Event
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Change in
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Respiratory rate
Heart rate
Blood pressure
Mental status
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Occurrence of
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Copyright © 2016 F.A. Davis Company
Seizure
Anaphylaxis
Diarrhea
Fever
Rash
Davis’s Drug
Guide for Nurses,15th Edition
Nurse’s Role in Managing an
Adverse Drug Effect
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Stop drug infusion and monitor patient status for
improvement.
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Determine that the drug ordered was the drug given
and intended.
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Determine that the drug was given in the correct
dosage by the correct route.
Establish the chronology of events
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Time drug was taken
Onset of symptoms
Copyright © 2016 F.A. Davis Company
Davis’s Drug
Guide for Nurses,15th Edition
Reporting Adverse Events
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Report signs/symptoms and your suspicions to the
prescriber immediately.
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Alert supervisor.
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Contact MedWatch at www.fda.gov/medwatch/
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Complete voluntary Form 3500 online
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Call 1-800-FDA-1088 to report by telephone
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Download form and fax to FDA at 1-800-332-0178 or mail to
FDA using the postage-paid form
Copyright © 2016 F.A. Davis Company