This lecture by Dr. Bruce Clayton occurred on Friday, August 28th. return to the RX 413 Class page

Study MaterialsEdit

Required Reading Dr. Clayton's lecture on Adverse Drug Reactions and Drug Interactions

  • Link to PPT
  • Link to Handout
  • Link to Panopto

Suggested ReadingEdit

  • Tsouronis, C; Adverse Drug Reactions and Drug-Induced Diseases, In Helms, RA and Quan, DJ, eds. Textbook of Therapeutics, Drug and Disease Management, 8th ed., Lippincott, Williams and Wilkins, Philadelphia, 2006: 31-44
  • Middleton, RK; Drug Interactions. In Helms, RA and Quan, DJ, eds. Textbook of Therapeutics, Drug and Disease Management, 8th ed., Lippincott, Williams and Wilkins, Philadelphia, 2006: 47-68


Define “adverse drug reaction” according to the Rawlins and Thompson Classification and the ASHP definition of a significant event.Edit

  • Rawlins and Thompson Classification:
    • Type A = Predictable (e.g. a side effect—a dose-related, predictable reaction to a drug) particularly likely to occur with narrow therapeutic index drugs: (e.g. bleeding from warfarin; hypoglycemia from sulfonylureas.)
    • Type B = Unpredictable; not to be expected from the known pharmacological action of a drug when given in the usual therapeutic doses to a patient whose body handles the drug in the normal way (e.g., malignant hyperthermia during anesthesia; immune (allergy) reactions; teratogenicity; carcinogenicity).
  • ASHP definition of a significant events
    • any unexpected, unintended, undesired, or excessive response to a drug that:
1. Requires discontinuing the drug (therapeutic or diagnostic)
2. Requires changing the drug therapy
3. Requires modifying the dose (except for minor dosage adjustments)
4. Necessitates admission to a hospital
5. Prolongs stay in a health care facility
6. Necessitates supportive treatment
7. Significantly complicates diagnosis
8. Negatively affects prognosis, or
9. Results in temporary or permanent harm, disability, or death

List & define predictable and unpredictable causes of non-immunologic drug reactions.Edit

Predictable (non-immunologic)

  • pharmacological side effect - dry mouth from antihistamines
  • secondary pharmacological - diarrhea from taking antibiotics
  • drug toxicity - rhabdomyolysis from taking statins

List the types and clinical manifestations of drug hypersensitivity reactions according to Gell and Coombs (Table 2). List whether the drug may be used again with the patient in the future.Edit

Describe the primary signs and symptoms of anaphylaxis and list appropriate treatment (table3).Edit

Differentiate between: a side effect, drug intolerance, an idiosyncratic reaction, pseudoallergy and anaphylaxis.Edit

Define minor, moderate, severe and lethal adverse drug reactions.Edit

Describe factors that are primary causes of adverse drug reactions.Edit

List risk factors that make patients more prone to non-immune and immune drug reactions.Edit

List variables associated with drug products that contribute to the potential for ADRs.Edit

For each organ system described in V B-I, list at least 3 commonly prescribed drugs or drug classes that may induce disease within the organ system.Edit

Identify causes of photosensitivity reactions, and differentiate between photoallergy and phototoxicity.Edit

Define “drug interaction”.Edit

Define “objective drug” and “precipitant drug”.Edit

Differentiate between pharmacokinetic and pharmacodynamic interactions and list the monitoring parameters for each.Edit

Define “enzyme substrate”.Edit

Differentiate between enzyme induction and inhibition, list time courses, and cite 4 classic examples each of drugs well known to be enzyme inhibitors or inducers.Edit

Describe the role of the pharmacist in preventing adverse drug reactions and drug interactions.Edit

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