Addition and deletion procedures for formulary drugs are essential components of formulary management in hospital and community settings, guiding safe, effective, and cost‑effective medication use. B. Pharm students must understand the role of the Pharmacy and Therapeutics (P&T) committee, drug monograph preparation, evidence‑based evaluation, pharmacoeconomic analysis, therapeutic interchange, generic substitution, and policies for restricted or emergency additions. Key concepts include safety, efficacy, cost‑effectiveness, clinical guidelines, conflict of interest disclosure, and medication use evaluation (MUE). Mastering these procedures helps ensure rational drug selection, inventory control, and regulatory compliance. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. Which committee is primarily responsible for making formulary addition and deletion decisions in most hospitals?
- Infection Control Committee
- Pharmacy and Therapeutics (P&T) Committee
- Ethics Committee
- Nursing Executive Council
Correct Answer: Pharmacy and Therapeutics (P&T) Committee
Q2. Which of the following is the most important criterion when evaluating a drug for formulary addition?
- Manufacturer marketing support
- Prescriber popularity
- Demonstrated safety, efficacy, and cost‑effectiveness
- Availability of samples
Correct Answer: Demonstrated safety, efficacy, and cost‑effectiveness
Q3. What document summarizes clinical data, pharmacoeconomics, dosing, monitoring, and formulary recommendation for a drug?
- Patient consent form
- Drug monograph
- Purchase order
- Adverse event report
Correct Answer: Drug monograph
Q4. Which analysis focuses on comparing costs and health outcomes of two or more therapies to inform formulary decisions?
- Quality assurance audit
- Pharmacoeconomic analysis
- Microbiological sensitivity testing
- Patient satisfaction survey
Correct Answer: Pharmacoeconomic analysis
Q5. What is therapeutic interchange in the context of formulary management?
- Substituting a brand drug for a generic without approval
- Replacing a prescribed drug with an alternative equivalent agent according to formulary policy
- Discontinuing all non‑formulary drugs
- Automatically switching therapy every 30 days
Correct Answer: Replacing a prescribed drug with an alternative equivalent agent according to formulary policy
Q6. Which group is typically responsible for preparing the initial drug monograph for P&T review?
- Hospital administration
- Pharmacy department or clinical pharmacy staff
- Patient advocacy group
- Pharmaceutical sales representatives
Correct Answer: Pharmacy department or clinical pharmacy staff
Q7. Which of the following justifies deletion of a drug from the formulary?
- Persistent supply shortages with no reasonable alternatives
- High-quality evidence showing superior safety of the drug
- Frequent appropriate prescribing with good outcomes
- Increased patient preference for the drug
Correct Answer: Persistent supply shortages with no reasonable alternatives
Q8. What is a common mechanism to allow urgent use of a non‑formulary drug prior to formal P&T review?
- Automatic deletion from inventory
- Emergency or provisional formulary approval
- Permanent addition without documentation
- Returning the order to the prescriber
Correct Answer: Emergency or provisional formulary approval
Q9. Which process evaluates real‑world prescribing and outcomes after a drug is added to the formulary?
- Medication Use Evaluation (MUE)
- Preclinical trial
- Marketing analysis
- Batch release testing
Correct Answer: Medication Use Evaluation (MUE)
Q10. When assessing bioequivalence for generic substitution in the formulary, what is most important?
- Packaging color matching
- Therapeutic equivalence and proven bioequivalence
- Lower shelf life
- Manufacturer advertising
Correct Answer: Therapeutic equivalence and proven bioequivalence
Q11. What role does conflict of interest disclosure play in formulary decision‑making?
- It is optional for committee members
- It helps ensure unbiased, evidence‑based decisions
- It allows vendors to influence votes
- It prevents any clinician participation
Correct Answer: It helps ensure unbiased, evidence‑based decisions
Q12. Which category often classifies drugs that are recommended but require prior authorization or restricted prescribing?
- Non‑formulary unrestricted
- Formulary with restrictions
- Over‑the‑counter only
- Withdrawn from market
Correct Answer: Formulary with restrictions
Q13. What is the purpose of a class review during formulary maintenance?
- To review one single drug only
- To compare all agents within a therapeutic class for formulary placement
- To audit pharmacy staff performance
- To select vendors for procurement contracts
Correct Answer: To compare all agents within a therapeutic class for formulary placement
Q14. Which documentation is essential when removing a drug from the formulary to inform clinicians and ensure patient safety?
- Deletion memo with rationale, effective date, and alternatives
- Simple removal from inventory without notice
- Verbal announcement only
- Marketing brochure
Correct Answer: Deletion memo with rationale, effective date, and alternatives
Q15. Which factor is LEAST likely to be considered in formulary decision‑making?
- Clinical trial evidence
- Cost and budget impact
- Regulatory approval and safety warnings
- Sales representative charisma
Correct Answer: Sales representative charisma
Q16. For controlled substances, what additional consideration is critical before formulary addition?
- Therapeutic class only
- Abuse potential, regulatory controls, and storage/security requirements
- Whether it has a brand name
- Manufacturer profit margin
Correct Answer: Abuse potential, regulatory controls, and storage/security requirements
Q17. What is a “formulary exception” process?
- A method for deleting multiple drugs at once
- A procedure to request and document approval for non‑formulary drug use for a specific patient
- Automatic substitution of cheaper drugs
- Annual formulary renewal
Correct Answer: A procedure to request and document approval for non‑formulary drug use for a specific patient
Q18. Which quality measure helps assess the impact of a formulary decision after implementation?
- Number of sales calls from vendors
- Clinical outcomes, adverse event rates, and cost savings
- Color of medication packaging
- Frequency of staff meetings
Correct Answer: Clinical outcomes, adverse event rates, and cost savings
Q19. What is the significance of therapeutic guidelines and clinical pathways in formulary decisions?
- They are irrelevant to formulary choices
- They provide evidence‑based context for preferred agents and standardize care
- They only restrict nursing responsibilities
- They replace the need for a P&T committee
Correct Answer: They provide evidence‑based context for preferred agents and standardize care
Q20. When performing a pharmacoeconomic evaluation, which metric compares cost per unit of health outcome (e.g., cost per QALY)?
- Adverse event rate
- Incremental cost‑effectiveness ratio (ICER)
- Daily defined dose (DDD)
- Stock turnover ratio
Correct Answer: Incremental cost‑effectiveness ratio (ICER)
Q21. Which action helps maintain transparency in formulary meetings?
- Excluding minutes from records
- Documenting minutes, disclosures, and votes
- Allowing undisclosed vendor presentations during votes
- Keeping membership secret
Correct Answer: Documenting minutes, disclosures, and votes
Q22. What should be reviewed when a drug receives a safety alert or boxed warning after being on the formulary?
- Immediate deletion without review
- Reassessment of risk‑benefit, monitoring requirements, and possible restriction or deletion
- Ignore and continue current use
- Switch to the most expensive alternative
Correct Answer: Reassessment of risk‑benefit, monitoring requirements, and possible restriction or deletion
Q23. Which sampling of prescribed drugs helps verify appropriate formulary use and compliance with restrictions?
- Medication Use Evaluation (MUE)
- Inventory stock count only
- Marketing audit
- Monthly staff lunches
Correct Answer: Medication Use Evaluation (MUE)
Q24. What is a common voting requirement for formulary decisions in many institutions?
- Unanimous approval by all hospital staff
- Majority of a quorum of P&T committee members
- Decision by the pharmacy technician only
- Approval by a single vendor representative
Correct Answer: Majority of a quorum of P&T committee members
Q25. Which of the following best describes “restricted formulary agent”?
- Available over the counter
- Requires specific prescriber qualifications or prior authorization for use
- Never stocked in the hospital
- Automatically interchangeable with all others
Correct Answer: Requires specific prescriber qualifications or prior authorization for use
Q26. During formulary addition, why is consideration of comparator drugs important?
- To find the most expensive option
- To compare efficacy, safety, dosing, monitoring, and cost against existing alternatives
- To increase brand loyalty among prescribers
- To shorten the monograph length
Correct Answer: To compare efficacy, safety, dosing, monitoring, and cost against existing alternatives
Q27. How often should a formulary typically undergo formal review or updates?
- Never after initial creation
- Regularly, often annually or as new evidence emerges
- Only when a drug is recalled
- Only when pharmacy staff change
Correct Answer: Regularly, often annually or as new evidence emerges
Q28. Which element is essential in a drug deletion communication to prescribers and pharmacy staff?
- Effective date, reason for deletion, and recommended alternatives
- Only the manufacturer name
- Confidential internal comments
- Unexplained removal without notice
Correct Answer: Effective date, reason for deletion, and recommended alternatives
Q29. What is the role of real‑world evidence (RWE) in formulary decisions?
- It has no role compared to randomized trials
- It supplements clinical trial data by providing information on effectiveness, safety, and utilization in routine practice
- It replaces regulatory approval requirements
- It only assesses manufacturing quality
Correct Answer: It supplements clinical trial data by providing information on effectiveness, safety, and utilization in routine practice
Q30. Which practice supports ongoing cost control after adding a drug to the formulary?
- Unlimited prescribing without oversight
- Periodic pharmacoeconomic review, utilization monitoring, and negotiated purchasing or formulary contracting
- Eliminating alternatives to force use
- Refusing to monitor adverse events
Correct Answer: Periodic pharmacoeconomic review, utilization monitoring, and negotiated purchasing or formulary contracting
I am a Registered Pharmacist under the Pharmacy Act, 1948, and the founder of PharmacyFreak.com. I hold a Bachelor of Pharmacy degree from Rungta College of Pharmaceutical Science and Research. With a strong academic foundation and practical knowledge, I am committed to providing accurate, easy-to-understand content to support pharmacy students and professionals. My aim is to make complex pharmaceutical concepts accessible and useful for real-world application.
Mail- Sachin@pharmacyfreak.com