Professional responsibilities and industry role in QUM MCQs With Answer

Introduction: This question bank on Professional responsibilities and industry role in Quality Use of Medicines (QUM) is designed for M.Pharm students to deepen understanding of how pharmacists and the pharmaceutical industry contribute to safe, effective, and rational medicine use. It covers ethical duties, regulatory obligations, pharmacovigilance, clinical trial responsibilities, promotional practices, quality assurance, and stewardship activities. The MCQs include scenario-based and knowledge-based items aimed at fostering critical thinking about industry–healthcare relationships, evidence-based prescribing, risk management, and post-marketing surveillance. Use these questions for revision, self-assessment, and as a discussion springboard in seminars or journal clubs.

Q1. Which of the following best describes a pharmacist’s primary professional responsibility in promoting Quality Use of Medicines?

• Maximizing sales of prescribed medicines
• Ensuring individual patient therapy is safe, effective, and appropriate
• Representing the pharmaceutical industry in hospital committees
• Developing new chemical entities

Correct Answer: Ensuring individual patient therapy is safe, effective, and appropriate

Q2. Under Good Manufacturing Practice (GMP), which industry responsibility most directly supports QUM?

• Conducting aggressive marketing to prescribers
• Ensuring consistent product quality and batch-to-batch uniformity
• Minimizing clinical trial costs
• Delaying adverse event reporting to protect reputation

Correct Answer: Ensuring consistent product quality and batch-to-batch uniformity

Q3. Which document is primarily used by industry to describe known risks and proposed risk minimization strategies for a marketed medicine?

• Investigator’s Brochure
• Risk Management Plan (RMP)
• Good Clinical Practice manual
• Marketing authorization application summary

Correct Answer: Risk Management Plan (RMP)

Q4. What is the main ethical concern when pharmaceutical industry funds continuing medical education (CME)?

• Improving clinician knowledge
• Potential bias in educational content favoring sponsor products
• Reducing costs of CME for attendees
• Increasing access to educational venues

Correct Answer: Potential bias in educational content favoring sponsor products

Q5. Which activity is a key component of post-marketing pharmacovigilance performed by industry?

• Preclinical toxicology studies
• Adverse event signal detection and safety reporting
• Phase I dose-finding trials
• Brand-focused advertising campaigns

Correct Answer: Adverse event signal detection and safety reporting

Q6. In the context of QUM, what is a primary role of pharmacoeconomics for the industry?

• Convincing regulators to approve unsafe drugs
• Demonstrating relative value and cost-effectiveness to payers and clinicians
• Reducing production costs irrespective of quality
• Increasing list prices without justification

Correct Answer: Demonstrating relative value and cost-effectiveness to payers and clinicians

Q7. Which guideline or code most directly addresses ethical promotion practices by the pharmaceutical industry?

• ICH E6 Good Clinical Practice
• IFPMA/PhRMA codes of practice on pharmaceutical promotion
• OECD Principles of Corporate Governance
• WHO GMP Annex 11

Correct Answer: IFPMA/PhRMA codes of practice on pharmaceutical promotion

Q8. When managing a conflict of interest between clinicians and industry, the best practice is to:

• Conceal financial relationships to preserve collaborations
• Disclose relationships and manage or avoid conflicts where they could bias decisions
• Allow industry to make formulary decisions
• Permit unlimited gifts to clinicians to ensure goodwill

Correct Answer: Disclose relationships and manage or avoid conflicts where they could bias decisions

Q9. Which industry responsibility most directly reduces inappropriate antimicrobial use?

• Marketing broad-spectrum antibiotics as first-line agents
• Supporting antimicrobial stewardship programs and appropriate labeling
• Offering discounts for higher-volume antibiotic sales
• Preventing access to diagnostics to increase empiric prescriptions

Correct Answer: Supporting antimicrobial stewardship programs and appropriate labeling

Q10. Which regulatory submission typically contains data on relative bioavailability and interchangeability relevant to generics and QUM?

• New Drug Application (NDA) for a new chemical entity
• Abbreviated New Drug Application (ANDA) or bioequivalence dossier
• Periodic Safety Update Report (PSUR)
• Clinical Study Report of Phase III trial only

Correct Answer: Abbreviated New Drug Application (ANDA) or bioequivalence dossier

Q11. What is the primary purpose of a company’s pharmacovigilance system master file (PSMF)?

• To list marketing strategies for different regions
• To document the organization’s pharmacovigilance system and processes for regulatory inspection
• To provide pricing information to payers
• To replace the clinical study protocols

Correct Answer: To document the organization’s pharmacovigilance system and processes for regulatory inspection

Q12. Which of the following best describes industry obligations during clinical trials to support QUM principles?

• Prioritize recruitment speed over informed consent
• Ensure participant safety, informed consent, transparent reporting, and data integrity
• Suppress negative trial outcomes to protect market potential
• Delegate all safety monitoring to marketing departments

Correct Answer: Ensure participant safety, informed consent, transparent reporting, and data integrity

Q13. Which practice helps industry contribute to evidence-based prescribing by clinicians?

• Providing balanced, peer-reviewed clinical summaries and supporting independent comparative research
• Restricting access to clinical trial data
• Promoting off-label uses without evidence
• Incentivizing prescribers to favor one product financially

Correct Answer: Providing balanced, peer-reviewed clinical summaries and supporting independent comparative research

Q14. In product lifecycle management, which is an industry responsibility that aligns with patient-centered QUM?

• Withholding safety updates to delay label changes
• Updating product labeling with new safety and efficacy data and improving patient information leaflets
• Removing all contraindications to increase market share
• Using complex medical jargon in leaflets to avoid questions

Correct Answer: Updating product labeling with new safety and efficacy data and improving patient information leaflets

Q15. Which measure best demonstrates industry support for rational medicine selection at the health system level?

• Providing formulary committees with independent comparative effectiveness and cost-effectiveness data
• Pressuring committees with sales representatives to add products
• Offering high rebates only for high-cost medicines
• Limiting data to proprietary marketing summaries

Correct Answer: Providing formulary committees with independent comparative effectiveness and cost-effectiveness data

Q16. What is an important industry obligation when a serious unexpected adverse reaction emerges after marketing?

• Delay public communication until litigation risks are assessed
• Rapidly notify regulators, update safety communications, and implement risk minimization measures
• Only inform major customers to avoid panic
• Reduce pharmacovigilance activities to limit case reports

Correct Answer: Rapidly notify regulators, update safety communications, and implement risk minimization measures

Q17. Which approach by industry most undermines QUM and public trust?

• Transparent disclosure of clinical trial data and funding sources
• Ghostwriting articles and undisclosed authorship to influence evidence
• Collaborating with independent academic researchers for unbiased studies
• Publishing negative as well as positive trial results

Correct Answer: Ghostwriting articles and undisclosed authorship to influence evidence

Q18. Which activity should industry prioritize to facilitate safe use of complex therapies in routine practice?

• Develop comprehensive training materials, prescriber guides, and patient support programs
• Rely solely on sales representatives to train clinicians
• Limit educational activities to sponsored symposiums with promotional focus
• Provide no post-approval educational support to reduce costs

Correct Answer: Develop comprehensive training materials, prescriber guides, and patient support programs

Q19. Which of the following best defines “duty of care” for pharmaceutical companies in the context of QUM?

• Obligation to maximize shareholder profit above all else
• Responsibility to ensure products are developed, manufactured, and promoted in ways that protect patient safety and public health
• Requirement to withhold negative safety information
• Freedom to prioritize marketing strategies over evidence

Correct Answer: Responsibility to ensure products are developed, manufactured, and promoted in ways that protect patient safety and public health

Q20. Which regulatory requirement strengthens industry contribution to QUM by ensuring transparency of benefit–risk information?

• Mandatory disclosure of clinical trial results in public registries and timely submission of safety reports
• Allowing selective publication of only positive outcomes
• Permitting indefinite confidentiality of trial data
• Requiring companies to withhold adverse event summaries

Correct Answer: Mandatory disclosure of clinical trial results in public registries and timely submission of safety reports

Download