Adverse drugeffects

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  • 1. Detecting and Managing Adverse Drug Reactions
  • 2. Adverse Drug Reaction
    • Unexpected, undesired, excessive response t o a medication that results in
      • Temporary or permanent serious harm or disability
      • Admission to a hospital
      • Transfer to a higher level of care
      • Prolonged stay
      • Death
  • 3. Incidence of Adverse Drug Events (ADEs)
    • The FDA entered 441,367 reports of adverse drug events in 2008
    • 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 .
  • 4. Types of Adverse Drug Effects
    • Dose-related (toxic) reactions
    • Drug-drug and drug-food interactions
    • Hypersensitivity (allergic reactions)
    • Idiosyncratic reaction
  • 5. Dose-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
  • 6. Dose-Related Reactions
    • Examples of medications that require careful monitoring or lab tests
      • Digoxin, lithium
      • Aminoglycosides
      • Antiepileptic drugs
      • Anticoagulants
      • Nephrotoxic drugs
  • 7. Dose-Related Reactions (Cont’d)
    • Medical 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)
  • 8. Dose-Related Reactions (Cont’d)
    • Nursing 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
  • 9. Hypersensitivity Reactions
    • Can be allergic or nonallergic
    • Anaphylactic (allergic) reactions
      • Occur minutes to hours after exposure and are manifested by
        • Urticaria (hives), pruritis (itching)
        • Bronchospasm, wheezing
        • Vomiting, diarrhea
        • Circulatory collapse
    • A life-threatening medical emergency!
  • 10. Hypersensitivity Reactions (Cont’d)
    • Nonallergic hypersensitivity reactions occur within 2 days or up to 3 weeks and are manifested by
        • Hemolytic anemia, glomerulonephritis
        • Lymphadenopathy, thrombocytopenia, neutropenia
        • Arthralgia
  • 11. Hypersensitivity Reactions (Cont’d)
    • Nonallergic, hypersensitivity reactions include
        • Erythema multiforme
        • Stevens–Johnson syndrome
        • Toxic epidermal necrolysis
        • Contact dermatitis
    • Require prompt recognition and treatment because of high morbidity and mortality
  • 12. Hypersensitivity Reactions (Cont’d)
    • Nursing Responsibilities
    • Ask patient or family about allergies on admission; document prominently and obtain allergy bracelet
    • When anaphlaxis occurs stop the drug, assess ABCs (airway, breathing, circulation)
    • Notify physician, nurse practitioner, or physician assistant immediately
  • 13. Hypersensitivity Reactions (Cont’d)
    • Nursing Responsibilities (Cont’d)
    • Stay with the patient
    • Maintain IV access
    • Ensure ready access to emergency resuscitative equipment
    • Monitor during initial administration of cross-hypersensitive agent
  • 14. Drug-Drug Interactions Pharmacokinetic and pharmacodynamic properties of one drug affect either the pharmacokinetics or pharmacodynamics of another drug .
  • 15. Drug-Drug Interactions (Cont’d)
    • Pharmacokinetics
        • Absorbing
        • Distributing
        • Metabolizing
        • Excreting
    • “ What the body does to the drug”
  • 16. Drug-Drug Interactions (Cont’d)
    • Pharmacodynamics
        • The chemical and physiologic changes that the drug causes
        • Drug effect
    • “ What the drug does to the body”
  • 17. Types 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
  • 18. 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!
  • 19. 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!
  • 20. 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
  • 21. 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!
  • 22. Drug-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
  • 23. Drug-Food Interactions
    • Similar to drug-drug interactions
    • Food can alter the absorption or metabolism of medications
    • Diets can alter the bacterial flora of the intestine and may affect the metabolism of certain drugs
  • 24. Drug-Food Interactions (Cont’d)
    • 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 t etracycline and can potentiate or interfere with drug reactions
  • 25. Drug-Food Interactions (Cont’d)
    • 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
  • 26. Idiosyncratic Reactions
    • Unrelated to dose
    • Unpredictable and sporadic
    • May be caused by pharmacogenetic differences in drug-metabolizing enzymes
  • 27. Idiosyncratic Reactions (Cont’d)
    • Reactions may include
      • Fever
      • Blood dyscrasias
      • Cardiovascular effects
      • Change in mental status
  • 28. Nurse’s Role in Recognizing and Managing an Adverse Drug Event
  • 29. Signs and Symptoms of an Adverse Drug Event
    • Change in
      • Respiratory rate
      • Heart rate
      • Blood pressure
      • Mental status
    • Occurrence of
      • Seizure
      • Anaphylaxis
      • Diarrhea
      • Fever
      • Rash
  • 30. Nurse’s Role in Managing an 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
  • 31. Reporting Adverse Events
    • Report signs/symptoms and your suspicions to the prescriber immediately
    • Alert supervisor
    • Contact MedWatch at
      • 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