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Page 1: Adverse drugeffects

Copyright © 2011 F.A. Davis Company

Davis’s Drug Guide for Nurses, 12th EditionDavis’s Drug Guide for Nurses, 12th Edition

DetectingDetecting and Managing and Managing Adverse Drug ReactionsAdverse Drug Reactions

Page 2: Adverse drugeffects

Copyright © 2011 F.A. Davis Company

Davis’s Drug Guide for Nurses, 12th EditionDavis’s Drug Guide for Nurses, 12th Edition

Adverse Drug ReactionAdverse Drug Reaction

Unexpected, undesired, excessive response to o a medication that results ina medication that results in

Temporary or permanent serious harm or disability Admission to a hospital Transfer to a higher level of care Prolonged stay DeathDeath

Page 3: Adverse drugeffects

Copyright © 2011 F.A. Davis Company

Davis’s Drug Guide for Nurses, 12th EditionDavis’s Drug Guide for Nurses, 12th Edition

Incidence of Adverse Drug Events (ADEs)Incidence of Adverse Drug Events (ADEs) The FDA entered 441,367 reports of adverse

drug events in 2008http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/

AdverseDrugEffects/ucm070434.htm

10.7% of hospital admissions in older adults are associated with adverse drug reactions

Kongkaew C, et al. Hospital admissions associated with adverse drug reactions: a

systematic review of prospective observational studies. Ann Pharmacother 2008; 42:1017-

25 .

Page 4: Adverse drugeffects

Copyright © 2011 F.A. Davis Company

Davis’s Drug Guide for Nurses, 12th EditionDavis’s Drug Guide for Nurses, 12th Edition

Types of Adverse Drug EffectsTypes of Adverse Drug Effects

Dose-related (toxic) reactions Drug-drug and drug-food interactions Hypersensitivity (allergic reactions) Idiosyncratic reaction

Page 5: Adverse drugeffects

Copyright © 2011 F.A. Davis Company

Davis’s Drug Guide for Nurses, 12th EditionDavis’s Drug Guide for Nurses, 12th Edition

Dose-Related (Toxic) ReactionsDose-Related (Toxic) Reactions

May be related to Renal or hepatic impairment Extremes in age (neonates, elderly) Drug-drug or drug-food interactions Underlying illnesses Inadequate assessment of blood levels

Page 6: Adverse drugeffects

Copyright © 2011 F.A. Davis Company

Davis’s Drug Guide for Nurses, 12th EditionDavis’s Drug Guide for Nurses, 12th Edition

Dose-Related ReactionsDose-Related Reactions

Examples of medications that require careful monitoring or lab tests Digoxin, lithium Aminoglycosides Antiepileptic drugs Anticoagulants Nephrotoxic drugs

Page 7: Adverse drugeffects

Copyright © 2011 F.A. Davis Company

Davis’s Drug Guide for Nurses, 12th EditionDavis’s Drug Guide for Nurses, 12th Edition

Dose-Related Reactions (Cont’d)Dose-Related Reactions (Cont’d)

Medical ManagementMedical Management Discontinue drug temporarily Reduce dose or increase dosing interval Provide antidote (e.g., Digibind for digoxin toxicity) Get careful, well-timed drug-level monitoring Review all medication

Consider dietary change (e.g., eliminate grapefruit or grapefruit juice)

Page 8: Adverse drugeffects

Copyright © 2011 F.A. Davis Company

Davis’s Drug Guide for Nurses, 12th EditionDavis’s Drug Guide for Nurses, 12th Edition

Dose-Related Reactions (Cont’d)Dose-Related Reactions (Cont’d)

Nursing ResponsibilitiesNursing Responsibilities Review all medications and patient history Administer meds at the correct time

Obtain blood levels as ordered; coordinate administration with lab technician

Assess for signs and symptoms of toxicity Provide education about drugs and diet Report relevant lab values

Page 9: Adverse drugeffects

Copyright © 2011 F.A. Davis Company

Davis’s Drug Guide for Nurses, 12th EditionDavis’s Drug Guide for Nurses, 12th Edition

Hypersensitivity ReactionsHypersensitivity Reactions

Can be allergic or nonallergic Can be allergic or nonallergic Anaphylactic (allergic) reactions Anaphylactic (allergic) reactions

Occur minutes to hours after exposure and are Occur minutes to hours after exposure and are manifested bymanifested by Urticaria (hives), pruritis (itching)Urticaria (hives), pruritis (itching) Bronchospasm, wheezingBronchospasm, wheezing Vomiting, diarrheaVomiting, diarrhea Circulatory collapseCirculatory collapse

A life-threatening medical emergency!A life-threatening medical emergency!

Page 10: Adverse drugeffects

Copyright © 2011 F.A. Davis Company

Davis’s Drug Guide for Nurses, 12th EditionDavis’s Drug Guide for Nurses, 12th Edition

Hypersensitivity Reactions (Cont’d)Hypersensitivity Reactions (Cont’d)

Nonallergic hypersensitivity reactions occurNonallergic hypersensitivity reactions occur within 2 days or up to 3 weeks and are within 2 days or up to 3 weeks and are manifested bymanifested by

Hemolytic anemia, glomerulonephritisHemolytic anemia, glomerulonephritis Lymphadenopathy, thrombocytopenia, neutropeniaLymphadenopathy, thrombocytopenia, neutropenia ArthralgiaArthralgia

Page 11: Adverse drugeffects

Copyright © 2011 F.A. Davis Company

Davis’s Drug Guide for Nurses, 12th EditionDavis’s Drug Guide for Nurses, 12th Edition

Hypersensitivity Reactions (Cont’d)Hypersensitivity Reactions (Cont’d) Nonallergic, hypersensitivity reactionsNonallergic, hypersensitivity reactions include

Erythema multiformeErythema multiforme Stevens–Johnson syndromeStevens–Johnson syndrome Toxic epidermal necrolysisToxic epidermal necrolysis Contact dermatitis

Require prompt recognition and treatment because of high morbidity and mortality

Page 12: Adverse drugeffects

Copyright © 2011 F.A. Davis Company

Davis’s Drug Guide for Nurses, 12th EditionDavis’s Drug Guide for Nurses, 12th Edition

Hypersensitivity Reactions (Cont’d)Hypersensitivity Reactions (Cont’d)

Nursing ResponsibilitiesNursing Responsibilities Ask patient or family about allergies on admission; Ask patient or family about allergies on admission;

document prominently and obtain allergy braceletdocument prominently and obtain allergy bracelet

When anaphlaxis occursWhen anaphlaxis occurs stop the drug, assess stop the drug, assess

ABCsABCs (airway, breathing, circulation) (airway, breathing, circulation)

Notify physician, nurse practitioner, or Notify physician, nurse practitioner, or

physician assistant immediatelyphysician assistant immediately

Page 13: Adverse drugeffects

Copyright © 2011 F.A. Davis Company

Davis’s Drug Guide for Nurses, 12th EditionDavis’s Drug Guide for Nurses, 12th Edition

Hypersensitivity Reactions (Cont’d)Hypersensitivity Reactions (Cont’d)

Nursing ResponsibilitiesNursing Responsibilities (Cont’d)(Cont’d)

Stay with the patientStay with the patient

Maintain IV accessMaintain IV access

Ensure ready access to emergency resuscitative emergency resuscitative

equipmentequipment

Monitor during initial administration of cross-

hypersensitive agent

Page 14: Adverse drugeffects

Copyright © 2011 F.A. Davis Company

Davis’s Drug Guide for Nurses, 12th EditionDavis’s Drug Guide for Nurses, 12th Edition

Drug-Drug InteractionsDrug-Drug Interactions

Pharmacokinetic and pharmacodynamic properties of one drug affect either the pharmacokinetics or pharmacodynamics of another drug.

Page 15: Adverse drugeffects

Copyright © 2011 F.A. Davis Company

Davis’s Drug Guide for Nurses, 12th EditionDavis’s Drug Guide for Nurses, 12th Edition

Drug-Drug Interactions (Cont’d)Drug-Drug Interactions (Cont’d) Pharmacokinetics

Absorbing Distributing Metabolizing Excreting

“What the body does to the drug”

Page 16: Adverse drugeffects

Copyright © 2011 F.A. Davis Company

Davis’s Drug Guide for Nurses, 12th EditionDavis’s Drug Guide for Nurses, 12th Edition

Drug-Drug Interactions (Cont’d)Drug-Drug Interactions (Cont’d) Pharmacodynamics

The chemical and physiologic changes that the drug causes

Drug effect

“What the drug does to the body”

Page 17: Adverse drugeffects

Copyright © 2011 F.A. Davis Company

Davis’s Drug Guide for Nurses, 12th EditionDavis’s Drug Guide for Nurses, 12th Edition

Types of Drug-Drug InteractionsTypes of Drug-Drug Interactions

Potentiation: Drugs with similar actions cause an additive effect

Coumadin and aspirin taken together cause excessive bleeding

Sedatives and alcohol cause excessive sedation

Page 18: Adverse drugeffects

Copyright © 2011 F.A. Davis Company

Davis’s Drug Guide for Nurses, 12th EditionDavis’s Drug Guide for Nurses, 12th Edition

Types of Drug-Drug Interactions (Cont’d)Types of Drug-Drug Interactions (Cont’d)

Interference: One drug accelerates or slows the metabolism or excretion of another drug

Erythromycin taken with

Digoxin = elevated blood levels of digoxin

Coumadin = enhanced action of Coumadin

Potential for serious adverse effects!

Page 19: Adverse drugeffects

Copyright © 2011 F.A. Davis Company

Davis’s Drug Guide for Nurses, 12th EditionDavis’s Drug Guide for Nurses, 12th Edition

Types of Drug-Drug Interactions (Cont’d)Types of Drug-Drug Interactions (Cont’d)

Displacement: Two drugs compete for protein binding sites

One drug “wins” (is bound to protein)

Displaced drug is active in greater quantities

Same effect as taking a higher dose of the displaced drug!

A major cause of drug-drug interactions!

Page 20: Adverse drugeffects

Copyright © 2011 F.A. Davis Company

Davis’s Drug Guide for Nurses, 12th EditionDavis’s Drug Guide for Nurses, 12th Edition

Types of Drug-Drug Interactions (Cont’d)Types of Drug-Drug Interactions (Cont’d)

Antagonism: One drug decreases the effectiveness of another drug because of divergent actions Oral ketoconazole (Nizoral) is absorbed in an

acidic environment H2-receptor antagonists or proton pump

inhibitors decrease acidity in the stomach Differing action decreases Nizoral effectiveness

Page 21: Adverse drugeffects

Copyright © 2011 F.A. Davis Company

Davis’s Drug Guide for Nurses, 12th EditionDavis’s Drug Guide for Nurses, 12th Edition

Types of Drug-Drug Interactions (Cont’d)Types of Drug-Drug Interactions (Cont’d)

CYP450 enzymes and drug-drug interactions

CYP450 Inhibitors: Drug A inhibits CYP450 enzymes in the liver; slows metabolism of drug B, toxic levels of drug B accumulate

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!

Page 22: Adverse drugeffects

Copyright © 2011 F.A. Davis Company

Davis’s Drug Guide for Nurses, 12th EditionDavis’s Drug Guide for Nurses, 12th Edition

Drug-Drug InteractionsDrug-Drug Interactions

Nursing Responsibilities

Check your Drug Guide for interactions (e.g., check lopinavir/ritonavir in Davis’s Drug Guide for Nurses)

Check labs for drug levels

Assess patient for increased or decreased drug effects or side effects

Page 23: Adverse drugeffects

Copyright © 2011 F.A. Davis Company

Davis’s Drug Guide for Nurses, 12th EditionDavis’s Drug Guide for Nurses, 12th Edition

Drug-Food InteractionsDrug-Food Interactions

Similar to drug-drug interactions

Food can alter the absorption or metabolismalter the absorption or metabolism of

medications Diets can alter the bacterial floraalter the bacterial flora of the intestine

and may affect the metabolism of certain drugs

Page 24: Adverse drugeffects

Copyright © 2011 F.A. Davis Company

Davis’s Drug Guide for Nurses, 12th EditionDavis’s Drug Guide for Nurses, 12th Edition

Drug-Food Interactions (Cont’d)Drug-Food Interactions (Cont’d)

MAOsMAOs taken with tyraminetyramine-containing foods can cause hypertension and intracranial bleeding

Foods high in Vitamin KVitamin K cause an antagonistic effect with oral anticoagulantsoral anticoagulants

Dairy productsDairy products cause decreased absorption of tetracyclineetracycline and can potentiate or interfere with drug reactions

Page 25: Adverse drugeffects

Copyright © 2011 F.A. Davis Company

Davis’s Drug Guide for Nurses, 12th EditionDavis’s Drug Guide for Nurses, 12th Edition

Drug-Food Interactions (Cont’d)Drug-Food Interactions (Cont’d) Calcium channel blockersCalcium channel blockers taken with grapefruit grapefruit

juice juice can increase effects of the drug Iron Iron taken with acidic acidic foods foods can cause increased

iron absorption Herbs and supplements Herbs and supplements taken with any drug any drug can

potentiate or interfere with the action of the drug

Page 26: Adverse drugeffects

Copyright © 2011 F.A. Davis Company

Davis’s Drug Guide for Nurses, 12th EditionDavis’s Drug Guide for Nurses, 12th Edition

Idiosyncratic Reactions Idiosyncratic Reactions

Unrelated to dose Unpredictable and sporadic May be caused by pharmacogenetic differences in

drug-metabolizing enzymes

Page 27: Adverse drugeffects

Copyright © 2011 F.A. Davis Company

Davis’s Drug Guide for Nurses, 12th EditionDavis’s Drug Guide for Nurses, 12th Edition

Idiosyncratic Reactions (Cont’d)Idiosyncratic Reactions (Cont’d)

Reactions may include Fever Blood dyscrasias Cardiovascular effects Change in mental status

Page 28: Adverse drugeffects

Copyright © 2011 F.A. Davis Company

Davis’s Drug Guide for Nurses, 12th EditionDavis’s Drug Guide for Nurses, 12th Edition

Nurse’s Role in RecognizingNurse’s Role in Recognizingand Managing an and Managing an

Adverse Drug EventAdverse Drug Event

Page 29: Adverse drugeffects

Copyright © 2011 F.A. Davis Company

Davis’s Drug Guide for Nurses, 12th EditionDavis’s Drug Guide for Nurses, 12th Edition

Signs and Symptoms of an Signs and Symptoms of an Adverse Drug EventAdverse Drug Event

Change inChange in Respiratory rate Heart rate Blood pressure Mental status

Occurrence ofOccurrence of Seizure Anaphylaxis Diarrhea Fever Rash

Page 30: Adverse drugeffects

Copyright © 2011 F.A. Davis Company

Davis’s Drug Guide for Nurses, 12th EditionDavis’s Drug Guide for Nurses, 12th Edition

Nurse’s Role in Managing an Nurse’s Role in Managing an Adverse Drug Effect Adverse Drug Effect

Stop drug infusion and monitor patient status for improvement

Determine that the drug ordered was the drug given and intended

Determine that the drug was given in the correct dosage by the correct route

Establish the chronology of events Time drug was taken Onset of symptoms

Page 31: Adverse drugeffects

Copyright © 2011 F.A. Davis Company

Davis’s Drug Guide for Nurses, 12th EditionDavis’s Drug Guide for Nurses, 12th Edition

Reporting Adverse EventsReporting Adverse Events Report signs/symptoms and your suspicions to the

prescriber immediately Alert supervisor Contact MedWatch at www.fda.gov/medwatch/

Complete voluntary form 3500 online Call 1-800-FDA-1088 to report by telephone

Download form and fax to FDA at 1-800-FDA-0178 or mail to FDA using the postage-paid form


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