Adverse drugeffects

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Adverse drugeffects

  1. 1. Detecting and Managing Adverse Drug Reactions
  2. 2. Adverse Drug Reaction <ul><li>Unexpected, undesired, excessive response t o a medication that results in </li></ul><ul><ul><li>Temporary or permanent serious harm or disability </li></ul></ul><ul><ul><li>Admission to a hospital </li></ul></ul><ul><ul><li>Transfer to a higher level of care </li></ul></ul><ul><ul><li>Prolonged stay </li></ul></ul><ul><ul><li>Death </li></ul></ul>
  3. 3. Incidence of Adverse Drug Events (ADEs) <ul><li>The FDA entered 441,367 reports of adverse drug events in 2008 </li></ul><ul><li>http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/ AdverseDrugEffects/ucm070434.htm </li></ul><ul><li>10.7% of hospital admissions in older adults are associated with adverse drug reactions </li></ul><ul><li>Kongkaew C, et al. Hospital admissions associated with adverse drug reactions: a systematic review of prospective observational studies. Ann Pharmacother 2008; 42:1017-25 . </li></ul>
  4. 4. Types of Adverse Drug Effects <ul><li>Dose-related (toxic) reactions </li></ul><ul><li>Drug-drug and drug-food interactions </li></ul><ul><li>Hypersensitivity (allergic reactions) </li></ul><ul><li>Idiosyncratic reaction </li></ul>
  5. 5. Dose-Related (Toxic) Reactions <ul><li>May be related to </li></ul><ul><ul><li>Renal or hepatic impairment </li></ul></ul><ul><ul><li>Extremes in age (neonates, elderly) </li></ul></ul><ul><ul><li>Drug-drug or drug-food interactions </li></ul></ul><ul><ul><li>Underlying illnesses </li></ul></ul><ul><ul><li>Inadequate assessment of blood levels </li></ul></ul>
  6. 6. Dose-Related Reactions <ul><li>Examples of medications that require careful monitoring or lab tests </li></ul><ul><ul><li>Digoxin, lithium </li></ul></ul><ul><ul><li>Aminoglycosides </li></ul></ul><ul><ul><li>Antiepileptic drugs </li></ul></ul><ul><ul><li>Anticoagulants </li></ul></ul><ul><ul><li>Nephrotoxic drugs </li></ul></ul>
  7. 7. Dose-Related Reactions (Cont’d) <ul><li>Medical Management </li></ul><ul><ul><li>Discontinue drug temporarily </li></ul></ul><ul><ul><li>Reduce dose or increase dosing interval </li></ul></ul><ul><ul><li>Provide antidote (e.g., Digibind for digoxin toxicity) </li></ul></ul><ul><ul><li>Get careful, well-timed drug-level monitoring </li></ul></ul><ul><ul><li>Review all medication </li></ul></ul><ul><ul><li>Consider dietary change (e.g., eliminate grapefruit or grapefruit juice) </li></ul></ul>
  8. 8. Dose-Related Reactions (Cont’d) <ul><li>Nursing Responsibilities </li></ul><ul><ul><li>Review all medications and patient history </li></ul></ul><ul><ul><li>Administer meds at the correct time </li></ul></ul><ul><ul><li>Obtain blood levels as ordered; coordinate administration with lab technician </li></ul></ul><ul><ul><li>Assess for signs and symptoms of toxicity </li></ul></ul><ul><ul><li>Provide education about drugs and diet </li></ul></ul><ul><ul><li>Report relevant lab values </li></ul></ul>
  9. 9. Hypersensitivity Reactions <ul><li>Can be allergic or nonallergic </li></ul><ul><li>Anaphylactic (allergic) reactions </li></ul><ul><ul><li>Occur minutes to hours after exposure and are manifested by </li></ul></ul><ul><ul><ul><li>Urticaria (hives), pruritis (itching) </li></ul></ul></ul><ul><ul><ul><li>Bronchospasm, wheezing </li></ul></ul></ul><ul><ul><ul><li>Vomiting, diarrhea </li></ul></ul></ul><ul><ul><ul><li>Circulatory collapse </li></ul></ul></ul><ul><li>A life-threatening medical emergency! </li></ul>
  10. 10. Hypersensitivity Reactions (Cont’d) <ul><li>Nonallergic hypersensitivity reactions occur within 2 days or up to 3 weeks and are manifested by </li></ul><ul><ul><ul><li>Hemolytic anemia, glomerulonephritis </li></ul></ul></ul><ul><ul><ul><li>Lymphadenopathy, thrombocytopenia, neutropenia </li></ul></ul></ul><ul><ul><ul><li>Arthralgia </li></ul></ul></ul>
  11. 11. Hypersensitivity Reactions (Cont’d) <ul><li>Nonallergic, hypersensitivity reactions include </li></ul><ul><ul><ul><li>Erythema multiforme </li></ul></ul></ul><ul><ul><ul><li>Stevens–Johnson syndrome </li></ul></ul></ul><ul><ul><ul><li>Toxic epidermal necrolysis </li></ul></ul></ul><ul><ul><ul><li>Contact dermatitis </li></ul></ul></ul><ul><li>Require prompt recognition and treatment because of high morbidity and mortality </li></ul>
  12. 12. Hypersensitivity Reactions (Cont’d) <ul><li>Nursing Responsibilities </li></ul><ul><li>Ask patient or family about allergies on admission; document prominently and obtain allergy bracelet </li></ul><ul><li>When anaphlaxis occurs stop the drug, assess ABCs (airway, breathing, circulation) </li></ul><ul><li>Notify physician, nurse practitioner, or physician assistant immediately </li></ul>
  13. 13. Hypersensitivity Reactions (Cont’d) <ul><li>Nursing Responsibilities (Cont’d) </li></ul><ul><li>Stay with the patient </li></ul><ul><li>Maintain IV access </li></ul><ul><li>Ensure ready access to emergency resuscitative equipment </li></ul><ul><li>Monitor during initial administration of cross-hypersensitive agent </li></ul>
  14. 14. Drug-Drug Interactions Pharmacokinetic and pharmacodynamic properties of one drug affect either the pharmacokinetics or pharmacodynamics of another drug .
  15. 15. Drug-Drug Interactions (Cont’d) <ul><li>Pharmacokinetics </li></ul><ul><ul><ul><li>Absorbing </li></ul></ul></ul><ul><ul><ul><li>Distributing </li></ul></ul></ul><ul><ul><ul><li>Metabolizing </li></ul></ul></ul><ul><ul><ul><li>Excreting </li></ul></ul></ul><ul><li>“ What the body does to the drug” </li></ul>
  16. 16. Drug-Drug Interactions (Cont’d) <ul><li>Pharmacodynamics </li></ul><ul><ul><ul><li>The chemical and physiologic changes that the drug causes </li></ul></ul></ul><ul><ul><ul><li>Drug effect </li></ul></ul></ul><ul><li>“ What the drug does to the body” </li></ul>
  17. 17. Types of Drug-Drug Interactions <ul><li>Potentiation: Drugs with similar actions cause an additive effect </li></ul><ul><ul><ul><li>Coumadin and aspirin taken together cause excessive bleeding </li></ul></ul></ul><ul><ul><ul><li>Sedatives and alcohol cause excessive sedation </li></ul></ul></ul>
  18. 18. Types of Drug-Drug Interactions (Cont’d) <ul><li>Interference: One drug accelerates or slows the metabolism or excretion of another drug </li></ul><ul><ul><li>Erythromycin taken with </li></ul></ul><ul><ul><li>Digoxin = elevated blood levels of digoxin </li></ul></ul><ul><ul><li>Coumadin = enhanced action of Coumadin </li></ul></ul><ul><ul><li>Potential for serious adverse effects! </li></ul></ul>
  19. 19. Types of Drug-Drug Interactions (Cont’d) <ul><li>Displacement: Two drugs compete for protein binding sites </li></ul><ul><ul><li>One drug “wins” (is bound to protein) </li></ul></ul><ul><ul><li>Displaced drug is active in greater quantities </li></ul></ul><ul><ul><li>Same effect as taking a higher dose of the displaced drug! </li></ul></ul><ul><li>A major cause of drug-drug interactions! </li></ul>
  20. 20. Types of Drug-Drug Interactions (Cont’d) <ul><li>Antagonism: One drug decreases the effectiveness of another drug because of divergent actions </li></ul><ul><ul><li>Oral ketoconazole (Nizoral) is absorbed in an acidic environment </li></ul></ul><ul><ul><li>H2-receptor antagonists or proton pump inhibitors decrease acidity in the stomach </li></ul></ul><ul><ul><li>Differing action decreases Nizoral effectiveness </li></ul></ul>
  21. 21. Types of Drug-Drug Interactions (Cont’d) <ul><li>CYP450 enzymes and drug-drug interactions </li></ul><ul><ul><li>CYP450 Inhibitors: Drug A inhibits CYP450 enzymes in the liver; slows metabolism of drug B, toxic levels of drug B accumulate </li></ul></ul><ul><ul><li>CYP450 Inducers: Drug A stimulates production of CYP450 enzymes; increases rate of metabolism of drug B, clears drug B out of the system faster </li></ul></ul><ul><li>A major source of drug-drug interactions! </li></ul>
  22. 22. Drug-Drug Interactions <ul><li>Nursing Responsibilities </li></ul><ul><li>Check your Drug Guide for interactions (e.g., check lopinavir/ritonavir in Davis’s Drug Guide for Nurses ) </li></ul><ul><li>Check labs for drug levels </li></ul><ul><li>Assess patient for increased or decreased drug effects or side effects </li></ul>
  23. 23. Drug-Food Interactions <ul><li>Similar to drug-drug interactions </li></ul><ul><li>Food can alter the absorption or metabolism of medications </li></ul><ul><li>Diets can alter the bacterial flora of the intestine and may affect the metabolism of certain drugs </li></ul>
  24. 24. Drug-Food Interactions (Cont’d) <ul><li>MAOs taken with tyramine -containing foods can cause hypertension and intracranial bleeding </li></ul><ul><li>Foods high in Vitamin K cause an antagonistic effect with oral anticoagulants </li></ul><ul><li>Dairy products cause decreased absorption of t etracycline and can potentiate or interfere with drug reactions </li></ul>
  25. 25. Drug-Food Interactions (Cont’d) <ul><li>Calcium channel blockers taken with grapefruit juice can increase effects of the drug </li></ul><ul><li>Iron taken with acidic foods can cause increased iron absorption </li></ul><ul><li>Herbs and supplements taken with any drug can potentiate or interfere with the action of the drug </li></ul>
  26. 26. Idiosyncratic Reactions <ul><li>Unrelated to dose </li></ul><ul><li>Unpredictable and sporadic </li></ul><ul><li>May be caused by pharmacogenetic differences in drug-metabolizing enzymes </li></ul>
  27. 27. Idiosyncratic Reactions (Cont’d) <ul><li>Reactions may include </li></ul><ul><ul><li>Fever </li></ul></ul><ul><ul><li>Blood dyscrasias </li></ul></ul><ul><ul><li>Cardiovascular effects </li></ul></ul><ul><ul><li>Change in mental status </li></ul></ul>
  28. 28. Nurse’s Role in Recognizing and Managing an Adverse Drug Event
  29. 29. Signs and Symptoms of an Adverse Drug Event <ul><li>Change in </li></ul><ul><ul><li>Respiratory rate </li></ul></ul><ul><ul><li>Heart rate </li></ul></ul><ul><ul><li>Blood pressure </li></ul></ul><ul><ul><li>Mental status </li></ul></ul><ul><li>Occurrence of </li></ul><ul><ul><li>Seizure </li></ul></ul><ul><ul><li>Anaphylaxis </li></ul></ul><ul><ul><li>Diarrhea </li></ul></ul><ul><ul><li>Fever </li></ul></ul><ul><ul><li>Rash </li></ul></ul>
  30. 30. Nurse’s Role in Managing an Adverse Drug Effect <ul><li>Stop drug infusion and monitor patient status for improvement </li></ul><ul><li>Determine that the drug ordered was the drug given and intended </li></ul><ul><li>Determine that the drug was given in the correct dosage by the correct route </li></ul><ul><li>Establish the chronology of events </li></ul><ul><ul><li>Time drug was taken </li></ul></ul><ul><ul><li>Onset of symptoms </li></ul></ul>
  31. 31. Reporting Adverse Events <ul><li>Report signs/symptoms and your suspicions to the prescriber immediately </li></ul><ul><li>Alert supervisor </li></ul><ul><li>Contact MedWatch at www.fda.gov/medwatch/ </li></ul><ul><ul><li>Complete voluntary form 3500 online </li></ul></ul><ul><ul><li>Call 1-800-FDA-1088 to report by telephone </li></ul></ul><ul><ul><li>Download form and fax to FDA at 1-800-FDA-0178 or mail to FDA using the postage-paid form </li></ul></ul>

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