AdverseDrugEffects(1)

Davis’s Drug Guide for Nurses,15th Edition

Detecting and Managing

Adverse Drug Events

Copyright © 2016 F.A. Davis Company


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



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



Types of Adverse Drug Events

 Adverse drug reactions

 Dose-related (toxic) reactions

 Drug-drug and drug-food interactions

 Hypersensitivity (allergic reactions)

 Idiosyncratic reactions



1. Adverse Drug Reactions



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



2. 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



Dose-Related (Toxic) Reactions ( cont’d)

Examples of medications that require careful monitoring or lab tests

 Digoxin, lithium

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Aminoglycosides

Anticonvulsant drugs

Anticoagulants

Nephrotoxic drugs

Anti-infectives: aminoglycosides, vancomycin, etc.



DoseRelated (Toxic) 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)



DoseRelated (Toxic) 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.



3. Drug-Drug Interactions

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



DrugDrug Interactions (cont’d)

 Pharmacokinetics

 Absorbing

 Distributing

 Metabolizing

 Excreting

“What the body does to the drug”



DrugDrug Interactions (cont’d)

 Pharmacodynamics

 The chemical and physiological changes that the drug causes

 Drug effect

“What the drug does to the body”



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.



Types of DrugDrug Interactions (cont’d)

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

Azithromycin taken with:

 Digoxin = elevated blood levels of digoxin

 Coumadin = risk of toxicity

Potential for serious adverse effects!



Types of Drug-Drug Interactions (c ont’d)

 Displacement: Two drugs compete for protein binding sites

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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!




 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 ketoconazole effectiveness.




 Cytochrome P450 (CYP450) enzymes and drug-drug interactions

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

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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.




 CYP450 Inhibitors & Inducers

 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!



Drug-Drug Interactions


 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.



3. Drug-Food Interactions

 Similar to drug-drug interactions

 Food can alter the absorption or metabolism of medications (see Appendix M).

 Diets can alter the bacterial flora of the intestine and may affect the metabolism of certain drugs.



DrugFood 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 ciprofloxacin and can potentiate or interfere with drug reactions.



DrugFood 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.



4.

Hypersensitivity (Allergic Reactions)

 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

A life-threatening medical emergency



Hypersensitivity (Allergic 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




 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





 Ask patient or family about allergies on admission; document prominently and obtain allergy bracelet.

 When anaphylaxis occurs, stop the drug and assess ABCs (airway, breathing, circulation).

 Notify physician, nurse practitioner, or physician assistant immediately.




Nursing responsibilities (cont’d)

 Stay with the patient.

 Maintain IV access.

 Ensure ready access to emergency resuscitative equipment.

 Monitor during initial administration of crosshypersensitive agen.t



5. Idiosyncratic Reactions

 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

 Unrelated to dose

 Unpredictable and sporadic

 May be caused by pharmacogenetic differences in drugmetabolizing enzymes

 Pharmacogenetic disease affects approximately 100 million people.

 80 types of the disease; all may produce drug-induced hemolysis



Idiosyncratic Reactions (cont’d)

Reactions may include

 Fever

 Blood dyscrasias

 Cardiovascular effects

 Change in mental status



Idiosyncratic Reactions (cont’d)

 Drugs prone to cause idiosyncratic reaction

 Aspirin

 Nitrofurantoin (treats UTIs)

 Primaquine (antimalarial drug)

 Probenecid (treats gout)

 Sulfonamides (anti-infective/sulfonamide)



Nurse’s Role in Recognizing and Managing an




Signs and Symptoms of an


 Change in

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Respiratory rate

Heart rate

Blood pressure

Mental status

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Occurrence of

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Seizure

Anaphylaxis

Diarrhea

Fever

 Rash



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



Reporting 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 1-800-332-0178 or mail to

FDA using the postage-paid form


AdverseDrugEffects(1)

Detecting and Managing

Adverse Drug Events

Adverse Drug Event

Types of Adverse Drug Events

1. Adverse Drug Reactions

2. Dose-Related (Toxic) Reactions

3. Drug-Drug Interactions

DrugDrug Interactions (cont’d)

DrugDrug Interactions (cont’d)

Types of Drug-Drug Interactions

Drug-Drug Interactions

3. Drug-Food Interactions

DrugFood Interactions (cont’d)

DrugFood Interactions (cont’d)

4.

5. Idiosyncratic Reactions

Idiosyncratic Reactions (cont’d)

Idiosyncratic Reactions (cont’d)

Reporting Adverse Events

Products

Support

AdverseDrugEffects(1)

Detecting and Managing

Adverse Drug Events

Adverse Drug Event

Types of Adverse Drug Events

1. Adverse Drug Reactions

2. Dose-Related (Toxic) Reactions

3. Drug-Drug Interactions

DrugDrug Interactions (cont’d)

DrugDrug Interactions (cont’d)

Types of Drug-Drug Interactions

Drug-Drug Interactions

3. Drug-Food Interactions

DrugFood Interactions (cont’d)

DrugFood Interactions (cont’d)

4.

5. Idiosyncratic Reactions

Idiosyncratic Reactions (cont’d)

Idiosyncratic Reactions (cont’d)

Reporting Adverse Events

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