MCQ Quiz-Adverse Drug Reactions

MCQ Quiz: Adverse Drug Reactions

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Adverse drug reactions (ADRs) are a significant cause of morbidity and mortality, making their detection, management, and prevention a core professional responsibility for pharmacists. From predictable side effects to bizarre idiosyncratic reactions, understanding ADRs is key to ensuring patient safety. This quiz, designed for PharmD students, will test your knowledge on classifying ADRs, assessing causality using tools like the Naranjo Algorithm, and the pharmacist’s role in pharmacovigilance.

1. Which of the following best defines an adverse drug reaction (ADR)?

  • Any unexpected event that occurs while a patient is taking a medication.
  • A harmful or unpleasant reaction resulting from an intervention related to the use of a medicinal product.
  • An error in the prescribing or dispensing of a medication.
  • A therapeutic failure where the drug does not produce its intended effect.

Answer: A harmful or unpleasant reaction resulting from an intervention related to the use of a medicinal product.

2. An ADR that is dose-dependent and predictable based on the drug’s known pharmacology is classified as what type?

  • Type A (Augmented)
  • Type B (Bizarre)
  • Type C (Chronic)
  • Type D (Delayed)

Answer: Type A (Augmented)

3. An unpredictable, non-dose-related ADR, such as an anaphylactic reaction to penicillin, is classified as what type?

  • Type A (Augmented)
  • Type B (Bizarre)
  • Type E (End of Use)
  • Type F (Failure of Therapy)

Answer: Type B (Bizarre)

4. The Naranjo Algorithm is a tool used in pharmacovigilance to:

  • Calculate the appropriate dose of a medication.
  • Determine the probability of a causal relationship between a drug and an adverse event.
  • Predict a patient’s risk of developing an ADR.
  • Report an ADR to the FDA.

Answer: Determine the probability of a causal relationship between a drug and an adverse event.

5. A patient develops a persistent, dry cough weeks after starting lisinopril. This is a classic example of what type of ADR?

  • A predictable, Type A reaction.
  • An unpredictable, Type B reaction.
  • A medication error.
  • A sign of therapeutic failure.

Answer: A predictable, Type A reaction.

6. The primary system in the United States for voluntary reporting of adverse drug reactions is:

  • The CDC’s Morbidity and Mortality Weekly Report.
  • The FDA’s MedWatch program.
  • The Drug Enforcement Administration’s (DEA) database.
  • The Institute for Safe Medication Practices (ISMP).

Answer: The FDA’s MedWatch program.

7. A patient taking simvastatin reports unexplained muscle pain and weakness. The pharmacist recognizes this as a potential ADR known as:

  • Hepatotoxicity
  • Nephrotoxicity
  • Statin-associated myopathy.
  • Peripheral neuropathy

Answer: Statin-associated myopathy.

8. Which of the following patient populations is generally at the highest risk for experiencing an ADR?

  • Healthy young adults.
  • Pediatric patients.
  • Athletes.
  • Elderly patients with polypharmacy and multiple comorbidities.

Answer: Elderly patients with polypharmacy and multiple comorbidities.

9. A “prescribing cascade” occurs when:

  • A prescriber orders a medication that is not on the formulary.
  • An ADR is misinterpreted as a new medical condition, leading to the prescription of another drug to treat the ADR.
  • A patient takes a medication that was prescribed for someone else.
  • A pharmacist dispenses the wrong medication.

Answer: An ADR is misinterpreted as a new medical condition, leading to the prescription of another drug to treat the ADR.

10. A pharmacist identifies a potential ADR during a comprehensive medication review (CMR). What is the most appropriate first step?

  • Immediately tell the patient to stop the medication.
  • Report the event to the FDA MedWatch program.
  • Gather more information from the patient to assess causality and severity.
  • Ignore the event unless the patient brings it up again.

Answer: Gather more information from the patient to assess causality and severity.

11. Pharmacogenomic testing for HLA-B alleles is used to prevent severe cutaneous adverse reactions (SCARs) for drugs like:

  • Aspirin
  • Metformin
  • Atorvastatin
  • Carbamazepine and allopurinol.

Answer: Carbamazepine and allopurinol.

12. Opioid-induced constipation is considered:

  • A rare and unpredictable ADR.
  • An expected, predictable Type A reaction that should be anticipated and managed prophylactically.
  • A sign of an allergic reaction.
  • An indication that the opioid is not working.

Answer: An expected, predictable Type A reaction that should be anticipated and managed prophylactically.

13. When using the Naranjo Algorithm, a score of 9 would classify the ADR as:

  • Doubtful
  • Possible
  • Probable
  • Definite

Answer: Definite

14. What is a key difference between an adverse drug reaction and a side effect?

  • The terms are perfectly interchangeable.
  • A side effect is always harmful, while an ADR is not.
  • A side effect is often a known, non-deleterious effect, while an ADR implies a noxious or unintended response.
  • Side effects are not dose-related, while ADRs are.

Answer: A side effect is often a known, non-deleterious effect, while an ADR implies a noxious or unintended response.

15. A patient receiving vancomycin develops flushing, erythema, and pruritus, particularly on their upper body, during the infusion. This is most likely:

  • Anaphylaxis.
  • Vancomycin-associated nephrotoxicity.
  • Vancomycin infusion reaction (formerly “Red Man Syndrome”).
  • A therapeutic effect of the drug.

Answer: Vancomycin infusion reaction (formerly “Red Man Syndrome”).

16. Which of the following is an example of a medication error that could lead to an ADR?

  • Dispensing a medication with the correct instructions.
  • Counseling a patient on potential side effects.
  • Dispensing a 100 mg tablet when a 10 mg tablet was prescribed.
  • Performing a drug utilization review.

Answer: Dispensing a 100 mg tablet when a 10 mg tablet was prescribed.

17. The pharmacist’s role in pharmacovigilance includes:

  • Detection of ADRs.
  • Management and resolution of ADRs.
  • Reporting of ADRs.
  • All of the above.

Answer: All of the above.

18. A patient on multiple serotonergic agents (e.g., an SSRI and tramadol) develops agitation, confusion, and hyperthermia. The pharmacist should be concerned about:

  • A hypertensive crisis.
  • Serotonin syndrome.
  • A common bacterial infection.
  • A typical drug-food interaction.

Answer: Serotonin syndrome.

19. Which document is the best initial source for a pharmacist to consult for a comprehensive list of known ADRs for a specific drug?

  • A patient-run internet forum.
  • The drug’s official prescribing information (package insert).
  • A general medical textbook.
  • A newspaper article.

Answer: The drug’s official prescribing information (package insert).

20. A “dechallenge” in causality assessment refers to:

  • Administering a higher dose of the suspected drug.
  • Withdrawing the suspected drug and observing the patient’s response.
  • Giving the patient a different drug from the same class.
  • Having the patient continue the drug at the same dose.

Answer: Withdrawing the suspected drug and observing the patient’s response.

21. A positive “rechallenge,” where an ADR recurs after the drug is re-administered, provides strong evidence for:

  • Causality.
  • A medication error.
  • A lack of drug effect.
  • A new disease state.

Answer: Causality.

22. Long-term use of corticosteroids is associated with which of the following ADRs?

  • Osteoporosis and hyperglycemia.
  • Dry cough.
  • Metallic taste.
  • Constipation.

Answer: Osteoporosis and hyperglycemia.

23. Non-steroidal anti-inflammatory drugs (NSAIDs) can cause which significant ADRs, especially in at-risk patients?

  • GI bleeding and nephrotoxicity.
  • Hypoglycemia and weight gain.
  • Hair loss and skin discoloration.
  • Sedation and dizziness.

Answer: GI bleeding and nephrotoxicity.

24. The FDA’s requirement for a “Black Box Warning” on a drug label signifies that:

  • The drug has no known side effects.
  • The drug carries a significant risk of serious or life-threatening adverse effects.
  • The drug is available over-the-counter.
  • The drug is a new formulation.

Answer: The drug carries a significant risk of serious or life-threatening adverse effects.

25. A pharmacist counseling a patient on a new medication should discuss common and serious ADRs in order to:

  • Frighten the patient into not taking the drug.
  • Empower the patient to recognize and report potential problems early.
  • Fulfill an optional counseling task.
  • Take the place of the written medication guide.

Answer: Empower the patient to recognize and report potential problems early.

26. Identifying patient-specific risk factors (e.g., renal impairment, age) is a key strategy for ADR:

  • Promotion
  • Reporting
  • Prevention.
  • Publication

Answer: Prevention.

27. Anaphylaxis is a severe, life-threatening allergic reaction that is classified as a:

  • Type A ADR
  • Type B ADR.
  • Type C ADR
  • Type D ADR

Answer: Type B ADR.

28. Why are case reports and case series important in pharmacovigilance?

  • They can establish the true incidence of an ADR.
  • They often provide the first signal of a new, previously unknown ADR.
  • They are the strongest form of evidence.
  • They are used to approve new drugs.

Answer: They often provide the first signal of a new, previously unknown ADR.

29. Chemotherapy-induced nausea and vomiting (CINV) is an ADR that is:

  • Rare and unexpected.
  • An MTM core element.
  • Predictable and often managed with prophylactic antiemetic therapy.
  • A sign that the chemotherapy is not working.

Answer: Predictable and often managed with prophylactic antiemetic therapy.

30. The primary purpose of a Risk Evaluation and Mitigation Strategy (REMS) program is to:

  • Increase the sales of a medication.
  • Ensure the benefits of a drug with known serious risks outweigh the risks.
  • Make a drug more difficult for patients to access.
  • Provide a direct-to-consumer advertising platform.

Answer: Ensure the benefits of a drug with known serious risks outweigh the risks.

31. Angioedema is a serious potential ADR associated with which drug class?

  • Statins
  • ACE inhibitors.
  • Beta-blockers
  • Thiazide diuretics

Answer: ACE inhibitors.

32. A patient with a documented, true allergy to penicillin should avoid which of the following?

  • Ciprofloxacin
  • Doxycycline
  • Amoxicillin.
  • Metronidazole

Answer: Amoxicillin.

33. What is the role of a medication guide that is dispensed with certain prescriptions?

  • It replaces the need for verbal pharmacist counseling.
  • It is FDA-approved patient labeling that explains how to use the drug safely and highlights serious risks.
  • It is a marketing brochure from the drug manufacturer.
  • It is a coupon for the patient’s next refill.

Answer: It is FDA-approved patient labeling that explains how to use the drug safely and highlights serious risks.

34. A drug-drug interaction leading to a supratherapeutic level of one drug can result in what type of ADR?

  • An unpredictable, idiosyncratic reaction.
  • A dose-related, Type A reaction.
  • A delayed, carcinogenic effect.
  • A therapeutic failure.

Answer: A dose-related, Type A reaction.

35. A pharmacist is an essential part of the healthcare team in minimizing ADRs because of their expertise in:

  • Pathophysiology
  • Pharmacology and therapeutics.
  • Surgical procedures
  • Medical billing

Answer: Pharmacology and therapeutics.

36. Tardive dyskinesia, a movement disorder involving involuntary, repetitive body movements, is a delayed (Type D) ADR associated with long-term use of:

  • Antihypertensive agents.
  • Antipsychotic agents.
  • Anti-infective agents.
  • Anticoagulant agents.

Answer: Antipsychotic agents.

37. If a patient reports an allergy to a medication, what is the most important follow-up question for the pharmacist to ask?

  • “What was the price of the medication?”
  • “What was the name of the pharmacy where you got it?”
  • “What kind of reaction did you have?”
  • “Why were you prescribed that medication?”

Answer: “What kind of reaction did you have?”

38. The process of reporting an ADR to MedWatch is:

  • Mandatory for all healthcare professionals for all ADRs.
  • A voluntary process that is crucial for post-marketing surveillance.
  • Only done by physicians.
  • A complex, multi-day procedure.

Answer: A voluntary process that is crucial for post-marketing surveillance.

39. Grapefruit juice is famous for inhibiting the CYP3A4 enzyme, which can lead to ADRs by:

  • Increasing the metabolism of CYP3A4 substrates.
  • Decreasing the metabolism of CYP3A4 substrates, leading to higher drug levels.
  • Preventing the absorption of all medications.
  • Directly damaging the liver.

Answer: Decreasing the metabolism of CYP3A4 substrates, leading to higher drug levels.

40. When an ADR is identified, the pharmacist’s management plan may include:

  • Recommending discontinuation of the drug.
  • Recommending a dose reduction.
  • Recommending a medication to treat the ADR itself (e.g., an antihistamine for a rash).
  • All of the above.

Answer: All of the above.

41. The term “pharmacovigilance” refers to:

  • The process of compounding sterile preparations.
  • The science and activities relating to the detection, assessment, understanding, and prevention of adverse effects.
  • The management of a pharmacy’s budget.
  • The dispensing of controlled substances.

Answer: The science and activities relating to the detection, assessment, understanding, and prevention of adverse effects.

42. Which of the following is an example of an ADR?

  • A patient takes ibuprofen for a headache, and the headache resolves.
  • A patient takes diphenhydramine and feels drowsy.
  • A patient takes lisinopril for hypertension and develops a dry, hacking cough.
  • A patient correctly uses an albuterol inhaler for shortness of breath.

Answer: A patient takes lisinopril for hypertension and develops a dry, hacking cough.

43. The “post-marketing surveillance” phase of drug development is where:

  • The drug is tested in animals for the first time.
  • The drug is tested in a small group of healthy volunteers.
  • The drug is tested in large randomized controlled trials for efficacy.
  • ADRs are monitored in the general population after the drug is approved and on the market.

Answer: ADRs are monitored in the general population after the drug is approved and on the market.

44. A key component of the MTM process that helps identify potential ADRs is:

  • Asking the patient about any new or bothersome symptoms since starting a medication.
  • Reviewing the pharmacy’s daily sales reports.
  • Confirming the patient’s address.
  • Checking the medication’s expiration date.

Answer: Asking the patient about any new or bothersome symptoms since starting a medication.

45. Stevens-Johnson Syndrome (SJS) is a rare but life-threatening ADR that primarily affects the:

  • Liver and kidneys
  • Heart and lungs
  • Skin and mucous membranes.
  • Central nervous system

Answer: Skin and mucous membranes.

46. Which drug class is NOT commonly associated with a high risk of ADRs in the elderly?

  • Anticholinergics
  • Benzodiazepines
  • Vitamins
  • Opioids

Answer: Vitamins

47. A “drug-disease” interaction occurs when:

  • Two drugs interact with each other.
  • A drug interacts with a food item.
  • A medication has an adverse effect on a patient’s comorbid condition.
  • A patient is allergic to a drug.

Answer: A medication has an adverse effect on a patient’s comorbid condition.

48. An example of a drug-disease interaction is giving a non-selective beta-blocker to a patient with:

  • Hypertension
  • Asthma.
  • Migraines
  • Anxiety

Answer: Asthma.

49. Polypharmacy is a major risk factor for ADRs because:

  • Taking multiple medications increases the statistical probability of drug-drug interactions and cumulative side effects.
  • Patients on multiple medications are always elderly.
  • It is difficult to get insurance to cover multiple medications.
  • It makes the pharmacist’s job too easy.

Answer: Taking multiple medications increases the statistical probability of drug-drug interactions and cumulative side effects.

50. The ultimate goal of understanding and managing ADRs is to:

  • Document problems for legal reasons.
  • Improve patient safety and quality of life.
  • Increase the number of prescriptions dispensed.
  • Create more work for healthcare providers.

Answer: Improve patient safety and quality of life.

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