Module 4: Adverse Drug Reactions and Medication Errors

Question 1

Idiosyncratic drug effect

Answer 1

An uncommon drug response resulting from a genetic
predisposition

Succinylcholine-induced paralysis refers to the pharmacological action of succinylcholine (also known as suxamethonium), which is a depolarizing neuromuscular blocker used to induce muscle relaxation and short-term paralysis. It is commonly used in emergency settings and during the induction phase of general anesthesia to facilitate endotracheal intubation and to provide muscle relaxation during surgical procedures.

Question 2

Paradoxical effect

Answer 2

The opposite of the intended drug response
 For example, when using benzodiazepines for
sedation to treat insomnia, excitement may occur
instead (especially in children and older adults

Question 3

Iatrogenic disease

Answer 3

Iatrogenic: Literally, “a disease produced by a
physician”; also used to refer to a disease produced
by drugs (eg, drugs for antipsychotic disorders can
cause Parkinson-like symptoms)

 Sometimes also called drug-induced disease
 Essentially identical to naturally occurring patholog

Question 4

Physical drug dependence

Answer 4

 Develops during long-term use of certain drugs
(opioids, alcohol, barbiturates, and amphetamines)
 A state in which the body has adapted to drug
exposure in such a way that an abstinence syndrome
will result if drug use is discontinued
 Important to warn patients against abrupt
discontinuation of any medication without first
consulting a knowledgeable health professional

Question 5

Carcinogenic effect

Answer 5

Only a few therapeutic agents are carcinogenic
 Several drugs used to treat cancer are among those
with the greatest carcinogenic potential
 Evaluating drugs is difficult; it may take decades for
evidence of carcinogenesis to appear after exposure
 An example of this is diethylstilbestrol (DES)

Question 6

Teratogenic effect

Answer 6

Drug-induced birth defect

Question 7

Organ-Specific Toxicity

Answer 7

Many drugs are toxic to specific organs
-Common examples include:
 Kidneys: Amphotericin B (antifungal)
 Heart: Doxorubicin (anticancer)
 Lungs: Amiodarone (antidysrhythmic)
 Inner ear: Aminoglycoside (antibiotic)
 Hepatotoxic drugs
 QT interval drugs

Question 8

Hepatotoxic Drugs

Answer 8

 Leading cause of liver failure in the United States
 More than 50 drugs are known to be hepatotoxic
 As some drugs undergo metabolism, they are converted to toxic products that can injure liver cells
 Combining hepatotoxic drugs may increase the risk for liver damage (eg, acetaminophen and alcohol)
 Monitor aspartate aminotransferase (AST) and alanine
aminotransferase (ALT) for liver injury
 Watch for signs of liver injury; educate patients about
jaundice, dark urine, light-colored stools, nausea, vomiting, malaise, abdominal discomfort, and loss of appetite

Question 9

QT Interval Drugs:
More Than 100 Are Known

Answer 9

QT interval: Measure of the time required for the
ventricles to repolarize after each contraction

 QT drugs: Drugs that prolong the QT interval on
electrocardiography (ECG)
 Creates serious risk of life-threatening dysrhythmias
 Examples: Torsades de pointes, ventricular fibrillation
-Minimizing the risk:
 Most patients are at higher risk, including women, older adults, and patients with bradycardia, congestive heart failure (CHF), congenital QT prolongation, low potassium, and low magnesium
 Do not use two QT drugs concurrently

Question 10

Important sites of toxicity

Answer 10

• Liver: Signs of jaundice; monitor liver function tests
• Kidney: Routine urinalysis and serum creatinine level
  (periodic creatinine clearance testing)
• Bone marrow: Periodic blood cell counts

Question 11

Boxed Warnings

Answer 11

Also known as black box warnings

 Strongest safety warning a drug can carry and
still remain on the market
 Purpose of this warning is to alert prescribers to:
 Potentially severe side effects (eg, life-threatening
dysrhythmias, suicidality, major fetal harm)
 Ways to prevent or reduce harm (eg, avoiding a
teratogenic drug during pregnancy

Question 12

Risk Evaluation and Mitigation
Strategies (REMS)

Answer 12

REMS: A plan to minimize drug-induced harm

 For example, the REMS for isotretinoin is called
iPLEDGE
 Isotretinoin can cause serious birth defects
 iPLEDGE was designed to ensure that those who are
pregnant or who may become pregnant will not have
access to the drug

Question 13

Medication Errors

Answer 13

 Major cause of morbidity and mortality
 Documented in two landmark reports from the
Institute of Medicine:
-To Err Is Human, 1999
 Preventing Medication Errors, 2006
 It is estimated that medication errors:
 Injure 1.5 million people per year
 Kill 7000 people per year

Question 14

Medication Errors Reporting (MER) Program

Answer 14

Reporting is confidential
 Reporting can be done by phone, fax, or Internet
 Program encourages all healthcare providers—including pharmacists, nurses, physicians, and students—to report errors
 https://www.ismp.org/orderforms/reporterrortoismp.asp
 All information is forwarded to the U.S. Food and Drug
Administration (FDA), the Institute for Safe Medication
Practices (ISMP), and the product manufacturer