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Questions and Answers
What is a characteristic of Type A adverse drug reactions?
What is a characteristic of Type A adverse drug reactions?
Which class of adverse drug effects is characterized by unusual patient responses that are not dose-related?
Which class of adverse drug effects is characterized by unusual patient responses that are not dose-related?
What term is used to describe the study responsible for monitoring adverse drug reactions?
What term is used to describe the study responsible for monitoring adverse drug reactions?
Which type of adverse drug reaction is specifically associated with end-of-treatment responses?
Which type of adverse drug reaction is specifically associated with end-of-treatment responses?
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Which of the following is NOT one of the six groups of adverse drug reactions?
Which of the following is NOT one of the six groups of adverse drug reactions?
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What are delayed adverse effects primarily associated with after starting medication?
What are delayed adverse effects primarily associated with after starting medication?
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Which of the following is NOT a symptom of end-of-treatment effects after sudden withdrawal of narcotics?
Which of the following is NOT a symptom of end-of-treatment effects after sudden withdrawal of narcotics?
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What serious effect did Thalidomide cause for infants when taken during pregnancy?
What serious effect did Thalidomide cause for infants when taken during pregnancy?
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Which class of antibiotics is known for its potential to cause irreversible ototoxicity?
Which class of antibiotics is known for its potential to cause irreversible ototoxicity?
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What is a common withdrawal manifestation linked to prolonged use of narcotics?
What is a common withdrawal manifestation linked to prolonged use of narcotics?
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What is classified as an adverse drug effect type F?
What is classified as an adverse drug effect type F?
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Which grade of adverse drug reaction requires intensive medical treatment?
Which grade of adverse drug reaction requires intensive medical treatment?
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Which of the following is an example of a secondary effect of a medication?
Which of the following is an example of a secondary effect of a medication?
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In which category of adverse drug effects would tolerance fit?
In which category of adverse drug effects would tolerance fit?
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What characterizes a toxic effect of a drug?
What characterizes a toxic effect of a drug?
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Which adverse drug effect is typically considered unavoidable at therapeutic doses?
Which adverse drug effect is typically considered unavoidable at therapeutic doses?
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What distinguishes an idiosyncrasy from a typical drug intolerance?
What distinguishes an idiosyncrasy from a typical drug intolerance?
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What is the potential consequence of developing tolerance to a medication?
What is the potential consequence of developing tolerance to a medication?
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Which of the following best describes poisoning as an adverse drug effect?
Which of the following best describes poisoning as an adverse drug effect?
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Which of the following statements about side effects is accurate?
Which of the following statements about side effects is accurate?
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Study Notes
Adverse Drug Effects
- An adverse drug reaction (ADR) is a harmful and unintentional response to a drug administered in normal doses.
- ADRs can cause morbidity, mortality, and healthcare costs.
- Drug administration implies a risk: we must balance the benefits/risk of the administration of a drug.
- The study of ADRs is the responsibility of the branch known as pharmacovigilance.
Classification of Adverse Drug Effects
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Augmented pharmacological effects: Dose-dependent and predictable reactions.
- Intolerance: An exaggerated response to a normal dose of a drug.
- Side Effects: Common, unwanted effects that occur alongside the desired therapeutic effect.
- Bizarre effects (Idiosyncratic): Dose-independent and unpredictable reactions.
- Chronic effects: Effects that develop over time with prolonged drug use.
- Delayed effects: Effects that appear long after drug administration.
- End-of-treatment effects: Effects that appear after sudden withdrawal of treatment.
- Failure of therapy: Unexpected therapeutic failure, such as unplanned pregnancy despite correct contraceptive use or persistent infection despite antibiotic use.
Severity of Adverse Drug Reactions
- Minor: No therapy or action required.
- Moderate: Needs a modification in the drug therapy or other complementary actions (hospital, etc.).
- Severe: Life-threatening condition, causing permanent damage or requiring intensive medical treatment.
- Lethal: Producing the death of the patient directly or indirectly.
Types of Adverse Drug Reactions or Related Events
- Side effects: Unintended effects that occur alongside the desired therapeutic effect. They are common, unwanted, unavoidable, and occur at therapeutic doses.
- Secondary effects: Indirect consequences of the primary action of the drug. Examples: antibiotics causing superinfections.
- Toxic effects: Result of excessive pharmacological action due to an overdose or prolonged use or abuse. Examples: laxatives
- Poisoning: Can result from the use of high doses of a poison-drug, a life-threatening substance that severely alters vital functions. Examples: Opioid overdose causing respiratory depression.
- Intolerance: Adverse reaction to normal doses, often with an exaggerated response. It is the opposite of tolerance. Examples: Metamizole
- Tolerance: Decreased response to a drug over time, requiring higher doses to achieve the same effect.
- Idiosyncrasy: An unusual or unexpected reaction to a drug, often due to genetic factors.
- Dependence: A state in which the body relies on a drug to function normally. Withdrawal symptoms occur when the drug is discontinued.
Mechanisms of Drug Toxicity
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Hepatotoxicity: Drug-induced liver damage.
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Non-Covalent Interactions:
- Lipid peroxidation
- Generation of cytotoxic reactive oxygen species
- Depletion of reduced glutathione
- Modification of sulfhydryl groups on key enzymes and structural proteins
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Covalent Interactions:
- Adduct formation between a metabolite and cellular macromolecules.
- Covalent binding to protein can produce an immunogen; binding to DNA can cause carcinogenesis and teratogenesis.
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Non-Covalent Interactions:
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Nephrotoxicity: Renal tubular cells are exposed to high concentrations of drugs and metabolites when urine is concentrated. It can cause tissue necrosis.
- Examples: Inhibition of prostaglandin synthesis by non-steroidal anti-inflammatory drugs (NSAIDs) causes vasoconstriction and lowers glomerular filtration rate.
Teratogenic Effects of Drugs
- Teratogenesis: The disturbed growth process involved in the production of a malformed neonate.
- Mutagenesis: Modification of DNA, which can lead to cancer (carcinogenesis).
- Drugs are relatively uncommon causes of birth defects and cancers.
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Mechanism of Teratogenesis:
- The timing of the teratogenic insult in relation to fetal development is crucial in determining the type and extent of damage.
- Mammalian fetal development passes through three phases:
- Blastocyst formation
- Organogenesis
- Histogenesis and maturation of function.
- Teratogenic agent: Any factor that can cause abnormalities in the development of an embryo or fetus, leading to congenital malformations or birth defects.
Therapeutic Index
- The therapeutic index (TI) is a measure of the relative safety of a drug.
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TI = LD50 / ED50
- LD50: The lethal dose for 50% of the population
- ED50: The effective dose for 50% of the population
- A high TI indicates that a drug is relatively safe, as a large dose is needed to produce toxic effects.
- A low TI indicates that a drug is less safe and that toxic effects can occur at doses close to the therapeutic dose.
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Description
This quiz focuses on the concept of adverse drug reactions (ADRs), including their classification and implications in pharmacovigilance. It covers both predictable and unpredictable reactions, as well as the assessment of risks versus benefits in drug administration. Test your knowledge on the different types and effects of ADRs.
