Adverse drug reactions

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Questions and Answers

What differentiates drug abuse from drug addiction?

  • Drug abuse involves self-medication that deviates from accepted societal norms, while drug addiction is a compulsive pattern of drug use. (correct)
  • Drug abuse involves compulsive behavior while drug addiction is more controlled.
  • Drug abuse is characterized by overwhelming drug involvement, whereas drug addiction has less intense usage.
  • Drug abuse leads to physical dependence, while drug addiction does not.

What are the potential adverse effects of sudden withdrawal from certain drugs?

  • No significant effects unless the drug has been used for an extended period.
  • Worsening of the clinical condition for which the drug was prescribed. (correct)
  • Immediate physical harm regardless of the drug type.
  • Exclusively psychological effects with no impact on physical conditions.

During which stage of fetal development is an embryo most vulnerable to teratogenic effects?

  • Growth and development stage.
  • Fertilization and implantation stage.
  • All stages are equally vulnerable.
  • Organogenesis stage. (correct)

What is the primary concern when a drug is classified as having mutagenic properties?

<p>It causes genetic defects. (D)</p> Signup and view all the answers

What differentiates drug habituation from physical dependence?

<p>Habituation is less intense involvement without physical dependence symptoms. (A)</p> Signup and view all the answers

Which of the following drugs is known to cause teratogenic effects?

<p>ACE inhibitors (B)</p> Signup and view all the answers

What is one of the major characteristics of drug-induced diseases?

<p>They are also referred to as iatrogenic diseases. (B)</p> Signup and view all the answers

How long can chemical carcinogenesis generally take to develop?

<p>10-40 years (B)</p> Signup and view all the answers

Which type of allergic reaction is characterized by an immunologically mediated response that produces predictable symptoms?

<p>Drug allergy (B)</p> Signup and view all the answers

What is a defining feature of intolerance concerning drug reactions?

<p>It leads to toxic effects at therapeutic doses. (A)</p> Signup and view all the answers

Which type of drug reaction could potentially manifest as either therapeutic or side effects depending on the context?

<p>Side effects (C)</p> Signup and view all the answers

What distinguishes drug-induced diseases from other adverse drug reactions?

<p>They result from direct interactions leading to iatrogenic disorders. (C)</p> Signup and view all the answers

Which example best illustrates idiosyncrasy in drug reactions?

<p>Aplastic anemia from chloramphenicol (A)</p> Signup and view all the answers

What is a primary feature of both phototoxicity and photoallergy?

<p>They can both occur upon exposure to sunlight. (B)</p> Signup and view all the answers

Which of the following describes drug dependence?

<p>A condition where the body adapts to a drug's continued presence. (A)</p> Signup and view all the answers

Which of the following accurately describes the difference between an adverse drug reaction and a side effect?

<p>ADRs are harmful responses that are generally more unexpected than side effects. (A)</p> Signup and view all the answers

Which of the following is true regarding secondary effects of drugs?

<p>They are indirect consequences of the primary actions of drugs. (B)</p> Signup and view all the answers

In which scenario would toxicity be considered a dose-related effect?

<p>Overdose or prolonged use leading to side effects. (A)</p> Signup and view all the answers

What factor is NOT typically considered a patient-related factor affecting adverse drug reactions?

<p>Inherent toxicity of the drug (C)</p> Signup and view all the answers

Which of the following scenarios best illustrates a common cause of adverse drug reactions?

<p>Combining prescribed medications with an over-the-counter pain reliever without checking for interactions. (C)</p> Signup and view all the answers

Which of these conditions is NOT a risk associated with the use of medications during pregnancy?

<p>Increased metabolic rate in the mother due to drug use (D)</p> Signup and view all the answers

Which of the following factors does NOT influence the likelihood of developing adverse drug reactions in the elderly?

<p>Current economic status and healthcare access (D)</p> Signup and view all the answers

Which type of adverse drug reaction is characterized by being less common, unrelated to pharmacological action, and having high mortality risk?

<p>Type B (Bizarre) (A)</p> Signup and view all the answers

What is the appropriate management for a Type C adverse drug reaction?

<p>Reduce the dose or use alternate day therapy (A)</p> Signup and view all the answers

Which of the following is an example of a Type D adverse drug reaction?

<p>Tardive dyskinesia (B)</p> Signup and view all the answers

What features characterize Type E adverse drug reactions?

<p>Occurs soon after withdrawal of the medicine (A)</p> Signup and view all the answers

Which classification of adverse drug reactions is likely to result in permanent damage to the patient?

<p>Severe ADRs (C)</p> Signup and view all the answers

What is the common cause for a Type F adverse drug reaction?

<p>Unexpected failure of therapy due to drug interactions (A)</p> Signup and view all the answers

What management approach is advised for immunological reactions classified under Type B?

<p>Withhold the drug and avoid in the future (D)</p> Signup and view all the answers

Which of the following examples illustrates a potential outcome of Type D adverse drug reactions?

<p>Carcinogenesis after long-term medication use (A)</p> Signup and view all the answers

Which statement accurately describes Type C adverse drug reactions?

<p>They are uncommon but related to cumulative drug dosage. (B)</p> Signup and view all the answers

Which of the following management strategies is crucial for addressing withdrawal syndrome associated with Type E reactions?

<p>Reintroduce the drug and withdraw slowly (A)</p> Signup and view all the answers

Which of the following types of adverse drug reactions (ADRs) is characterized by predictable reactions at therapeutic doses and typically low mortality?

<p>Type A (Augmented) (B)</p> Signup and view all the answers

Which of the following examples correctly matches a serious adverse drug reaction to its drug type?

<p>Angioedema - Captopril (D)</p> Signup and view all the answers

Which class of ADRs is referred to as 'Bizarre' and usually occurs independently of the drug dose?

<p>Type B (Bizarre) (A)</p> Signup and view all the answers

What type of drug is most likely to cause respiratory depression as a Type A adverse drug reaction?

<p>Opioids (C)</p> Signup and view all the answers

Which drug combination is known to potentially result in Stevens-Johnson Syndrome or Toxic epidermal necrolysis?

<p>Metronidazole and Mebendazole (C)</p> Signup and view all the answers

Which medication is associated with dry mouth as a Type A adverse drug reaction?

<p>Tricyclic Antidepressants (B)</p> Signup and view all the answers

Which type of drug-related event requires a decrease in dosage or indicates caution for future use?

<p>Adverse drug reaction (ADR) (B)</p> Signup and view all the answers

Which of the following drugs is unlikely to be associated with bone fractures as an adverse reaction?

<p>Chloroquine (B)</p> Signup and view all the answers

What is a distinguishing feature of Type C adverse drug reactions?

<p>They are cumulative and related to long-term therapy (B)</p> Signup and view all the answers

Which of the following medications is known to cause confusion and drowsiness as a serious adverse reaction?

<p>Diphenhydramine (D)</p> Signup and view all the answers

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Study Notes

Drug Abuse

  • Using a drug outside of approved medical or social patterns
  • Deviates from generally accepted use within a specific culture

Drug Addiction

  • Compulsive drug use pattern
  • Involves an overwhelming preoccupation with the drug
  • Obtaining and using the drug takes priority over other activities

Drug Habituation (Psychological Dependence)

  • Less intensive involvement with a drug
  • Withdrawal causes only mild discomfort
  • Examples: tea, coffee, tobacco, social drinking

Drug Withdrawal Reactions

  • Adverse consequences from suddenly stopping therapy with certain drugs
  • Worsens the clinical condition the drug was treating

Teratogenicity

  • A drug's ability to cause fetal abnormalities when administered to a pregnant woman
  • Three stages of fetal development can be affected by drugs:
    • Fertilization and Implantation (0-17 days): May lead to pregnancy failure (often unnoticed)
    • Organogenesis (18 - 55 days): Most vulnerable period, leads to deformities
    • Growth and Development (56 days onward): Leads to developmental or functional abnormalities

Mutagenicity and Carcinogenicity

  • Mutagenicity: A drug's ability to cause genetic defects
  • Carcinogenicity: A drug's ability to cause cancer
  • Reactive intermediates affect genes and can cause chromosomal changes
  • Chemicals can promote malignant changes in genetically damaged cells (even without direct interaction with DNA)
  • Carcinogenesis typically takes 10 - 40 years to develop

Drug Induced Diseases (Iatrogenic Diseases)

  • Caused by medical treatment (physician induced)
  • Management: reduce drug dosage or withhold the drug, consider interactions of concomitant therapy

Type B (Bizarre) Adverse Drug Reactions

  • Less common
  • Not related to the drug's pharmacological action
  • Unpredictable
  • High mortality
  • Examples
    • Immunological reactions: Anaphylaxis with penicillin
    • Idiosyncratic reactions: Malignant hyperthermia with general anesthetics
    • Skin rashes with antibiotics
  • Management: Withhold the drug and avoid it in the future

Type C (Chemical) Adverse Drug Reactions

  • Uncommon
  • Persistent effects, lasting a relatively long duration
  • Related to cumulative drug dosage
  • Examples
    • Osteoporosis of jaw with bisphosphonates
    • Nephrotoxicity by NSAIDs
    • Hepatotoxicity by paracetamol
    • Hypothalamic-pituitary-adrenal axis suppression by corticosteroids
  • Management: Reduce the drug dosage, consider alternate day therapy (if possible), withdrawal needs to be prolonged

Type D (Delayed) Adverse Drug Reactions

  • Uncommon
  • Usually dose-related
  • Occurs or becomes apparent after the drug has been taken
  • Examples: Carcinogenesis, Teratogenesis, Tardive dyskinesia, Leucopenia with lomustine (after 6 weeks on medication)
  • Management: Often intractable

Type E (Exit/End of Treatment) Adverse Drug Reactions

  • Uncommon
  • Occurs shortly after stopping medication
  • Examples: Withdrawal syndrome with opioids or benzodiazepines (e.g., insomnia, anxiety)
  • Management: Reintroduce the drug and withdraw it slowly

Type F (Failure) Adverse Drug Reactions

  • Common
  • Dose related
  • Often caused by drug interactions
  • Examples: Inadequate dosage of an oral contraceptive (when used with an enzyme inducer), resistance to antimicrobial agents
  • Management: Increase the dosage, consider effects of concomitant therapy

Classification of Adverse Drug Reactions (ADRs) by Severity

  • Minor ADRs: Don't require therapy, antidote, or hospital stay extension
  • Moderate ADRs: Requires drug therapy changes, specific treatment, or hospital stay extension of at least 1 day
  • Severe ADRs: Potentially life-threatening, can cause permanent damage or require intensive medical treatment
  • Lethal ADRs: Directly or indirectly contribute to the patient's death

ADR Categories

  • Side effects
  • Secondary effects
  • Toxic effects
  • Intolerance
  • Idiosyncrasy
  • Drug allergy
  • Photosensitivity
  • Drug dependence, Drug withdrawal reactions, Teratogenicity
  • Mutagenicity and Carcinogenicity
  • Drug-induced diseases (Iatrogenic disorders or Iatrogenicity)

Side Effects

  • Unwanted, often unavoidable pharmacodynamic (PD) effects
  • Occur at therapeutic doses
  • Predictable
  • Examples
    • Benzodiazepines: Drowsiness, dizziness, confusion
    • H1 Anti-histaminics: Sedation
  • An effect can be therapeutic in one context, but a side effect in another
    • Example: Constipation with codeine - side effect, but can be therapeutic for diarrhea

Secondary Effects

  • Indirect consequences of a drug's primary action
  • Examples:
    • Corticosteroids (weaken host defense): Activation of latent tuberculosis
    • Tetracyclines (Alter bacterial flora): Superinfection

Toxic Effects

  • Occur due to overdose or prolonged use
  • Effects are predictable and dose-related
  • Examples:
    • High dose heparin: Bleeding
    • High dose paracetamol: Hepatic necrosis
    • Prolonged use of gentamicin: Ototoxicity, nephrotoxicity

Intolerance

  • Appearance of characteristic toxic drug effects at therapeutic doses
  • Indicates an individual's low threshold to the drug's action
  • Sensitivity to low drug doses
  • Unpredictable
  • Examples:
    • Carbamazepine (few doses): Ataxia in some individuals
    • Chloroquine (single tablet): Vomiting & abdominal pain in some individuals

Idiosyncrasy

  • Genetically determined abnormal reactivity to a chemical
  • Drug interacts with unique individual features (not found in most people)
  • Produces an uncharacteristic reaction
  • Unpredictable
  • Examples:
    • Chloramphenicol: Aplastic anemia (non-dose-related) in rare patients
    • Barbiturates: Excitement and mental confusion in some patients

Drug Allergy

  • Also called drug hypersensitivity
  • Immunologically mediated allergic reaction, producing stereotypical symptoms unrelated to the drug's PD profile
  • Occurs even with very small doses
  • Different onset and duration than PD effects
  • Unpredictable
  • Allergic reactions affect a small proportion of the population exposed to a drug

ADRs and Side Effects

  • ADRs and side effects are unintended medication responses
  • ADRs are harmful and more unexpected than side effects
  • Side effects are more predictable than ADRs
  • Side effects can be beneficial or harmful

Common Causes of ADRs

  • Incorrect drug dosage, timing, or regimens
  • Drug overdose
  • Drug allergies
  • Alcohol consumption while taking medication
  • Drug interactions (with other medications or substances)
  • Taking someone else's prescribed medication
  • Age
  • Sex
  • Genetics
  • Concurrent diseases (e.g., renal, liver, cardiac)
  • Previous ADRs
  • Drug regimen compliance
  • Number of medications
  • Miscellaneous: Diet, smoking, environmental exposures
  • Dosage
  • Duration of treatment
  • Drug inherent toxicity
  • Pharmacodynamic (PD) properties
  • Pharmacokinetic (PK) properties

FDA ADR Definition

  • Death
  • Life-threatening
  • Hospitalization required
  • Disability
  • Congenital anomalies
  • Intervention needed to prevent permanent injury

Metronidazole and Mebendazole (Vermox) Adverse Reactions

  • Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis

Type A (Augmented) Adverse Drug Reactions

  • Exaggerated/amplified effects of a drug's typical pharmacological actions at a normal therapeutic dose
  • Dose-dependent
  • Predictable
  • Low mortality
  • Examples:
    • Respiratory depression with opioids
    • Bleeding with warfarin
    • Dry mouth with tricyclic antidepressants
    • Bradycardia with beta-blockers
    • Headache with nitrates

Learning Objectives For ADRs

  • Define and classify ADRs
  • Assess characteristics of each ADR type
  • Describe examples of ADRS
  • Appraise stages of drug evaluation (pre- and post-marketing)

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