Policies for inclusion of drugs in hospital formulary MCQs With Answer

Hospital formulary policies guide selection and ongoing inclusion of medicines to ensure safe, effective, and cost‑effective pharmacotherapy. For B.Pharm students, understanding formulary governance, P&T committee roles, evidence‑based drug evaluation, therapeutic interchange, generic substitution, and pharmacoeconomic assessment is essential for clinical pharmacy practice. Formulary inclusion relies on drug efficacy, safety, quality, bioequivalence, budget impact, and antimicrobial stewardship. Clear policies for restricted use, non‑formulary requests, and adverse‑event monitoring maintain patient safety and resource stewardship. This topic combines clinical pharmacology with health‑systems management, preparing graduates to contribute to formulary reviews, drug utilization evaluation, and policy development. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the primary purpose of a hospital formulary policy?

  • To list every marketed drug available nationally
  • To regulate pharmacy staff schedules
  • To standardize safe, effective, and cost‑effective medication use within the hospital
  • To increase purchases from a preferred vendor

Correct Answer: To standardize safe, effective, and cost‑effective medication use within the hospital

Q2. Which committee is mainly responsible for formulary decisions in a hospital?

  • Infection Control Committee
  • Pharmacy and Therapeutics (P&T) Committee
  • Ethics Committee
  • Marketing Committee

Correct Answer: Pharmacy and Therapeutics (P&T) Committee

Q3. Which of the following is the most important clinical criterion for including a drug in the formulary?

  • Manufacturer reputation
  • Evidence of efficacy and safety from clinical studies
  • Extent of direct-to-consumer advertising
  • Color of the tablet

Correct Answer: Evidence of efficacy and safety from clinical studies

Q4. What does a formulary monograph typically contain?

  • Only the drug price and supplier contact
  • Comprehensive summary of clinical evidence, dosing, safety, and cost
  • Patient testimonials about the drug
  • Marketing claims without references

Correct Answer: Comprehensive summary of clinical evidence, dosing, safety, and cost

Q5. Which policy allows pharmacists to substitute a chemically equivalent product for a prescribed brand?

  • Therapeutic interchange policy
  • Non‑formulary request policy
  • Generic substitution policy
  • Adverse drug reaction policy

Correct Answer: Generic substitution policy

Q6. Therapeutic interchange is best defined as:

  • Switching the route of administration without consulting prescriber
  • Substituting a drug with another in the same therapeutic class according to an approved protocol
  • Replacing a drug with a placebo for cost saving
  • Allowing patients to choose any medication

Correct Answer: Substituting a drug with another in the same therapeutic class according to an approved protocol

Q7. Which economic evaluation compares costs and health outcomes expressed in natural units (e.g., life-years gained)?

  • Cost‑benefit analysis
  • Cost‑utility analysis
  • Cost‑effectiveness analysis
  • Budget impact analysis

Correct Answer: Cost‑effectiveness analysis

Q8. Which factor is least appropriate to consider when deciding formulary inclusion?

  • Strength of clinical evidence
  • Drug safety profile
  • Budget impact and cost per outcome
  • Manufacturer marketing budget

Correct Answer: Manufacturer marketing budget

Q9. What is a “restricted formulary”?

  • A formulary with only over‑the‑counter drugs
  • A list where certain drugs require special approval or criteria for use
  • A formulary that contains only injectable drugs
  • A list that cannot be modified

Correct Answer: A list where certain drugs require special approval or criteria for use

Q10. Which process monitors prescribing patterns and identifies inappropriate drug use in a hospital?

  • Drug utilization review (DUR)
  • Market research
  • Manufacturing quality control
  • Pharmaceutical sales auditing

Correct Answer: Drug utilization review (DUR)

Q11. What does “non‑formulary” mean?

  • Drugs selected as first-line therapy
  • Medications not approved for routine use in the facility
  • Drugs that are the cheapest option
  • All herbal supplements

Correct Answer: Medications not approved for routine use in the facility

Q12. Which document should prescribers use to request use of a non‑formulary drug?

  • Formulary exception or non‑formulary request form
  • Patient consent for surgery
  • Purchase order for supplies
  • Marketing authorization application

Correct Answer: Formulary exception or non‑formulary request form

Q13. What is the primary goal of antimicrobial stewardship within formulary policy?

  • To maximize use of newest antibiotics
  • To restrict all antimicrobials regardless of need
  • To optimize antibiotic selection, dosing, and duration to reduce resistance and harm
  • To eliminate culture testing

Correct Answer: To optimize antibiotic selection, dosing, and duration to reduce resistance and harm

Q14. Which assessment estimates the financial impact of adding a drug to the hospital budget over a defined period?

  • Cost‑utility analysis
  • Budget impact analysis
  • Randomized controlled trial
  • Cross-sectional study

Correct Answer: Budget impact analysis

Q15. Bioequivalence data are most important when evaluating which type of product for formulary inclusion?

  • New biological agent with novel mechanism
  • Generic small‑molecule drugs intended to replace a brand product
  • Complementary herbal mixtures
  • Medical devices

Correct Answer: Generic small‑molecule drugs intended to replace a brand product

Q16. Which stakeholder group should always be involved in formulary decision‑making?

  • Only hospital finance staff
  • Multidisciplinary stakeholders including physicians, pharmacists, nurses, and administrators
  • Only patients without clinical input
  • Only pharmaceutical sales representatives

Correct Answer: Multidisciplinary stakeholders including physicians, pharmacists, nurses, and administrators

Q17. Which policy helps manage potential bias or undue influence in formulary decisions?

  • Pharmacovigilance reporting
  • Conflict of interest disclosure and management policy
  • Automatic inclusion of all advertised drugs
  • Patient satisfaction surveys only

Correct Answer: Conflict of interest disclosure and management policy

Q18. Which metric indicates how well prescribers follow formulary recommendations?

  • Antibiotic resistance rate
  • Formulary compliance rate
  • Number of manufacturer visits
  • Pharmacy staff turnover

Correct Answer: Formulary compliance rate

Q19. Which safety activity is essential after adding a new drug to the formulary?

  • Stop all monitoring for adverse events
  • Implement targeted pharmacovigilance and monitor adverse drug reactions
  • Allow unrestricted use without training
  • Remove the drug after one week regardless of outcome

Correct Answer: Implement targeted pharmacovigilance and monitor adverse drug reactions

Q20. What is therapeutic duplication?

  • Prescribing a drug at twice the recommended dose
  • Prescribing two drugs with similar therapeutic effects unnecessarily
  • Using two routes of administration for the same patient
  • Switching brands frequently

Correct Answer: Prescribing two drugs with similar therapeutic effects unnecessarily

Q21. Which of the following best describes a formulary “restricted” antimicrobial?

  • Available for empirical use by any prescriber without oversight
  • Requires prior authorization or infectious disease consultation for use
  • Must be used for all infections regardless of culture data
  • Allowed only in outpatient settings

Correct Answer: Requires prior authorization or infectious disease consultation for use

Q22. Who typically prepares the evidence summary and recommendation for a new drug considered by the P&T committee?

  • Hospital marketing team
  • Clinical pharmacists or pharmacy formulary subcommittee
  • External patients only
  • Cleaning staff

Correct Answer: Clinical pharmacists or pharmacy formulary subcommittee

Q23. Which element is essential in a formulary inclusion policy for high‑cost specialty drugs?

  • Unconditional automatic inclusion
  • Clear criteria for patient selection, prior authorization, and outcomes monitoring
  • Allowance of off‑label use for all prescribers
  • No requirement for documentation

Correct Answer: Clear criteria for patient selection, prior authorization, and outcomes monitoring

Q24. During formulary review, which study type provides the highest quality evidence for efficacy?

  • Randomized controlled trials (RCTs)
  • Case reports
  • Cross‑sectional surveys
  • Expert opinion without data

Correct Answer: Randomized controlled trials (RCTs)

Q25. What is a common frequency for formal formulary review and update in many hospitals?

  • Every 50 years
  • Annually
  • Every day
  • Never; formulary is permanent

Correct Answer: Annually

Q26. Which action supports antimicrobial stewardship and formulary control?

  • Promoting unrestricted use of broad‑spectrum agents
  • Implementing prospective audit and feedback plus formulary restrictions
  • Avoiding culture and sensitivity testing
  • Eliminating all formulary restrictions

Correct Answer: Implementing prospective audit and feedback plus formulary restrictions

Q27. Which is a direct benefit of an evidence‑based hospital formulary?

  • Increased variability in prescribing across departments
  • Standardized therapy, improved patient outcomes, and cost control
  • Guaranteed elimination of all adverse drug reactions
  • Immediate approval of all new drugs

Correct Answer: Standardized therapy, improved patient outcomes, and cost control

Q28. Which process evaluates whether a generic product is interchangeable with a brand product?

  • Bioequivalence testing
  • Market analysis
  • Advertising review
  • Brand loyalty survey

Correct Answer: Bioequivalence testing

Q29. What is an appropriate action when a P&T committee identifies safety concerns with a formulary drug?

  • Immediately remove it without communication
  • Issue prescribing alerts, restrict use, and review risk mitigation strategies
  • Ignore the concerns until pressured by manufacturers
  • Replace it with the same drug from a different brand without review

Correct Answer: Issue prescribing alerts, restrict use, and review risk mitigation strategies

Q30. Which statement about formulary documentation and transparency is correct?

  • Formulary decisions should be documented with rationale and made accessible to relevant staff
  • Formulary lists should be secret and unavailable to clinicians
  • Decisions should be based solely on promotional materials
  • Documentation is unnecessary if the head pharmacist decides

Correct Answer: Formulary decisions should be documented with rationale and made accessible to relevant staff

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