MCQ on Rational Drug Use and Pharmacovigilance

🟢 Easy (1–20)

1. What does Rational Drug Use (RDU) mean?
   a) Prescribing the most expensive drugs
   b) Using antibiotics in all conditions
   c) Using the right drug, dose, and duration ✅
   d) Letting patients choose their own drugs
   Explanation: RDU ensures appropriate therapy based on clinical needs.
2. Which organization promotes Rational Drug Use globally?
   a) UNESCO
   b) WHO ✅
   c) FAO
   d) ILO
   Explanation: WHO advocates for rational and safe use of medicines.
3. Pharmacovigilance mainly deals with:
   a) Clinical diagnosis
   b) Monitoring adverse drug reactions ✅
   c) Drug pricing
   d) Drug manufacturing
   Explanation: Pharmacovigilance focuses on drug safety after approval.
4. An Adverse Drug Reaction (ADR) is:
   a) A drug marketing technique
   b) A desired therapeutic effect
   c) A harmful or unintended drug response ✅
   d) A placebo effect
   Explanation: ADRs are harmful, unintended responses to normal doses.
5. Which term means overuse or misuse of antibiotics?
   a) Rational use
   b) Antimicrobial resistance ✅
   c) Pharmacogenomics
   d) Pharmacokinetics
   Explanation: Overuse of antibiotics leads to drug resistance.
6. Who can report an ADR?
   a) Only doctors
   b) Only pharmacists
   c) Only patients
   d) Any healthcare professional or patient ✅
   Explanation: All stakeholders in healthcare can report ADRs.
7. What is the purpose of an Essential Medicines List (EML)?
   a) For emergency storage
   b) To confuse prescribers
   c) To promote rational prescribing ✅
   d) For advertisement
   Explanation: EML guides the use of cost-effective and essential drugs.
8. The first country to implement pharmacovigilance was:
   a) India
   b) Sweden ✅
   c) USA
   d) China
   Explanation: Sweden initiated the first structured pharmacovigilance program.
9. Which tool helps monitor RDU in healthcare settings?
   a) Blood test
   b) Drug utilization studies ✅
   c) Vital signs
   d) CT scan
   Explanation: These studies analyze patterns in prescribing and usage.
10. Which is an irrational drug use example?
    a) Prescribing antibiotics for viral infections ✅
    b) Giving paracetamol for fever
    c) Antihypertensives for high BP
    d) Antacids for gastritis
    Explanation: Antibiotics are ineffective against viruses.
11. Which of the following is NOT an objective of RDU?
    a) Cost-effectiveness
    b) Safety
    c) Promoting branded drugs ✅
    d) Efficacy
    Explanation: RDU aims at generic, safe, and effective drug use.
12. Which Indian body is responsible for pharmacovigilance?
    a) AIIMS
    b) IPC ✅
    c) ICMR
    d) CSIR
    Explanation: Indian Pharmacopoeia Commission coordinates PvPI.
13. What is the full form of PvPI?
    a) Pharmaceutical Vigilance Program of India
    b) Pharmacovigilance Program of India ✅
    c) Pharmacology Vigilant Institute
    d) Pharmacy Vaccine Policy India
    Explanation: PvPI monitors drug safety nationwide in India.
14. The Yellow Card Scheme is associated with:
    a) India
    b) Australia
    c) UK ✅
    d) USA
    Explanation: The UK uses this system to collect ADR reports.
15. Which is a non-serious ADR?
    a) Death
    b) Hospitalization
    c) Nausea ✅
    d) Congenital anomaly
    Explanation: Nausea is common and typically not life-threatening.
16. Which of these enhances rational prescribing?
    a) Gifts from pharma companies
    b) Continuing medical education ✅
    c) Peer pressure
    d) Advertisements
    Explanation: Education keeps prescribers updated on best practices.
17. What type of drug use is common in irrational prescribing?
    a) Polypharmacy ✅
    b) Monotherapy
    c) Herbal therapy
    d) Nutritional supplements
    Explanation: Using multiple drugs unnecessarily increases risks.
18. The first step in ADR management is:
    a) Continue the drug
    b) Ignore symptoms
    c) Stop or adjust the offending drug ✅
    d) Prescribe antibiotics
    Explanation: Removing the suspected drug prevents further harm.
19. Which is a signal in pharmacovigilance?
    a) A clinical trial result
    b) A consistent trend in ADR reports ✅
    c) Marketing message
    d) Patient refusal
    Explanation: A signal indicates a potential new drug safety issue.
20. ADR reporting in India is done via:
    a) ADR Gazette
    b) VigiFlow software ✅
    c) Medline
    d) News articles
    Explanation: VigiFlow is the WHO-recommended ADR database.

🟡 Moderate (21–40)

21. Which class of drugs often causes hypersensitivity reactions?
    a) Vitamins
    b) Antibiotics ✅
    c) Sedatives
    d) Antacids
    Explanation: Penicillins and other antibiotics can trigger allergic responses.
22. Polypharmacy increases the risk of:
    a) Rapid recovery
    b) ADRs and drug interactions ✅
    c) Compliance
    d) Cost reduction
    Explanation: More drugs = more chances of unwanted interactions.
23. Which ADR type is dose-dependent and predictable?
    a) Type A ✅
    b) Type B
    c) Type C
    d) Type D
    Explanation: Type A reactions are related to known drug actions.
24. Which of the following promotes rational use?
    a) Generic prescribing ✅
    b) Brand loyalty
    c) Pharmaceutical marketing
    d) Patient self-medication
    Explanation: Generics are cheaper and equally effective.
25. Which drug class requires close therapeutic monitoring?
    a) Vitamins
    b) Anticoagulants ✅
    c) Antacids
    d) Laxatives
    Explanation: Anticoagulants like warfarin have a narrow safety margin.
26. What is the main purpose of pharmacovigilance centers?
    a) Drug sale
    b) Drug trial
    c) ADR detection and reporting ✅
    d) Pharmacy marketing
    Explanation: These centers ensure ongoing drug safety surveillance.
27. Over-the-counter (OTC) drug misuse can result in:
    a) Improved health
    b) Controlled therapy
    c) Serious ADRs ✅
    d) Reduced costs
    Explanation: Unmonitored use increases risks.
28. What is a spontaneous ADR report?
    a) From a lab test
    b) Proactively collected data
    c) Voluntary report by healthcare provider ✅
    d) Report from clinical trial
    Explanation: These are unsolicited reports sent to authorities.
29. Which drug class is known for causing nephrotoxicity?
    a) NSAIDs ✅
    b) Antacids
    c) Antiemetics
    d) Laxatives
    Explanation: NSAIDs can impair renal function.
30. Pharmacovigilance helps identify:
    a) Expensive drugs
    b) Ineffective marketing
    c) Rare and delayed ADRs ✅
    d) Patient food preferences
    Explanation: Post-marketing surveillance reveals rare side effects.
31. Signal detection in pharmacovigilance involves:
    a) Coding errors
    b) Sales monitoring
    c) Statistical review of ADR data ✅
    d) Internet surfing
    Explanation: Trends in large data sets can highlight hidden risks.
32. Which is a challenge in rational drug use?
    a) Electronic prescribing
    b) Drug shortages
    c) Lack of updated knowledge ✅
    d) Clinical guidelines
    Explanation: Outdated or poor knowledge leads to poor choices.
33. The ideal prescription contains:
    a) Drug name and cost
    b) Drug name, dose, frequency, duration ✅
    c) Brand name only
    d) Patient gender only
    Explanation: Complete details ensure safe administration.
34. Which of the following is a pharmacovigilance activity?
    a) Drug promotion
    b) Dose calculation
    c) Risk-benefit assessment of drugs ✅
    d) Therapy selection
    Explanation: Safety evaluation is central to pharmacovigilance.
35. Which government body oversees drug approval and PvPI in India?
    a) NABH
    b) CDSCO ✅
    c) FSSAI
    d) NPCI
    Explanation: CDSCO regulates safety and efficacy of medicines.
36. How often should prescribers be trained on RDU?
    a) Once in a lifetime
    b) Yearly ✅
    c) Every decade
    d) Never
    Explanation: Frequent updates promote rational practice.
37. Which is a key indicator of irrational use?
    a) Generic prescriptions
    b) Use of fixed-dose combinations unnecessarily ✅
    c) Use of EML
    d) Use of dosage forms
    Explanation: Many FDCs are unnecessary and risky.
38. Which drug needs patient-specific monitoring?
    a) Paracetamol
    b) Digoxin ✅
    c) Vitamin C
    d) Ibuprofen
    Explanation: Digoxin has a narrow therapeutic index.
39. What is the first step in signal management?
    a) Public announcement
    b) Signal detection ✅
    c) Product withdrawal
    d) Clinical trial
    Explanation: Identifying a potential issue starts the process.
40. Which country manages VigiBase for WHO?
    a) India
    b) USA
    c) Sweden ✅
    d) Germany
    Explanation: Uppsala Monitoring Centre in Sweden manages VigiBase.

🔴 Hard (41–50)

41. What is causality assessment in pharmacovigilance?
    a) Cost analysis
    b) Identifying counterfeit drugs
    c) Establishing drug-event relationship ✅
    d) Labeling errors
    Explanation: It links a drug to an ADR scientifically.
42. Which is a structured causality assessment method?
    a) Venn diagram
    b) Naranjo algorithm ✅
    c) ADR card
    d) Pie chart
    Explanation: Naranjo algorithm quantifies likelihood of ADRs.
43. A Type B ADR is:
    a) Predictable
    b) Dose-dependent
    c) Unpredictable and rare ✅
    d) Common
    Explanation: Type B is bizarre, not related to dose.
44. Pharmacovigilance planning is mandatory during:
    a) Clinical trials phase I
    b) Pre-marketing phase
    c) New drug application submission ✅
    d) Drug manufacturing
    Explanation: Authorities require safety plans before approval.
45. A black triangle symbol on medicine indicates:
    a) Banned drug
    b) High price
    c) Newly approved and under additional monitoring ✅
    d) OTC product
    Explanation: It’s used in the UK to signal new drugs.
46. Which is not an expected ADR?
    a) From known drug label
    b) From product leaflet
    c) From patient history
    d) Not listed in official sources ✅
    Explanation: Unexpected ADRs aren’t in product info.
47. Pharmacovigilance differs from pharmacoepidemiology in:
    a) Data collection method ✅
    b) Drug type
    c) Dosage form
    d) Route of administration
    Explanation: Pv focuses on individual case reports, while epidemiology uses population data.
48. Which is a limitation of spontaneous reporting?
    a) Too many reports
    b) Timely detection
    c) Underreporting ✅
    d) Free reporting
    Explanation: Many ADRs go unreported.
49. Which tool is used in India to report ADRs digitally?
    a) Medsafe
    b) SUGAM
    c) PvPI mobile app ✅
    d) DIGIhealth
    Explanation: The app facilitates easy ADR submission.
50. Which of these indicates a good RDU policy in hospitals?
    a) Drug advertisement policy
    b) Formulary based prescribing ✅
    c) Free samples
    d) Stock clearance sales
    Explanation: Formulary systems promote evidence-based drug use.