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DetectingDetecting and Managing and Managing Adverse Drug ReactionsAdverse Drug Reactions
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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
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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 .
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Types of Adverse Drug EffectsTypes of Adverse Drug Effects
Dose-related (toxic) reactions Drug-drug and drug-food interactions Hypersensitivity (allergic reactions) Idiosyncratic reaction
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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
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Dose-Related ReactionsDose-Related Reactions
Examples of medications that require careful monitoring or lab tests Digoxin, lithium Aminoglycosides Antiepileptic drugs Anticoagulants Nephrotoxic drugs
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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)
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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
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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!
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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
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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
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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
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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
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Drug-Drug InteractionsDrug-Drug Interactions
Pharmacokinetic and pharmacodynamic properties of one drug affect either the pharmacokinetics or pharmacodynamics of another drug.
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Drug-Drug Interactions (Cont’d)Drug-Drug Interactions (Cont’d) Pharmacokinetics
Absorbing Distributing Metabolizing Excreting
“What the body does to the drug”
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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”
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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
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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!
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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!
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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
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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!
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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
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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
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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
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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
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Idiosyncratic Reactions Idiosyncratic Reactions
Unrelated to dose Unpredictable and sporadic May be caused by pharmacogenetic differences in
drug-metabolizing enzymes
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Idiosyncratic Reactions (Cont’d)Idiosyncratic Reactions (Cont’d)
Reactions may include Fever Blood dyscrasias Cardiovascular effects Change in mental status
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Nurse’s Role in RecognizingNurse’s Role in Recognizingand Managing an and Managing an
Adverse Drug EventAdverse Drug Event
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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
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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
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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