INTERNATIONAL classification: ICD and INN usage MCQs With Answer

Introduction: This MCQ set covers INTERNATIONAL classification focusing on ICD and INN usage tailored for M.Pharm students specializing in Clinical Research and Pharmacovigilance. The questions emphasize practical understanding of how ICD (International Classification of Diseases) supports epidemiology, coding of diagnoses and external causes, and its evolving features in ICD-11, while the INN (International Nonproprietary Names) system ensures unambiguous identification of active pharmaceutical substances worldwide. Expect items on coding principles, differences between ICD and adverse-event terminologies (e.g., MedDRA), INN naming stems, biosimilar naming issues, and real-world application in safety reporting and clinical research. These MCQs are designed to deepen conceptual knowledge and aid exam preparation.

Q1. Which of the following best describes the primary purpose of the ICD (International Classification of Diseases)?

• To provide standardized nonproprietary drug names for active substances
• To classify findings from laboratory assays only
• To provide a standardized system for coding diseases, disorders, and causes of death for morbidity and mortality statistics
• To define pharmaceutical formulation standards for regulatory approval

Correct Answer: To provide a standardized system for coding diseases, disorders, and causes of death for morbidity and mortality statistics

Q2. Which organization is responsible for maintaining both the ICD and the INN systems?

• European Medicines Agency (EMA)
• World Health Organization (WHO)
• Food and Drug Administration (FDA)
• International Council for Harmonisation (ICH)

Correct Answer: World Health Organization (WHO)

Q3. What does INN (International Nonproprietary Name) primarily provide?

• A legal trademark for a drug marketed in a specific country
• A unique, universally recognized generic name for an active pharmaceutical substance
• A classification code for diseases and external causes
• An international price list for medicines

Correct Answer: A unique, universally recognized generic name for an active pharmaceutical substance

Q4. In INN nomenclature, which suffix/stem denotes a monoclonal antibody?

• -statin
• -mab
• -pril
• -olol

Correct Answer: -mab

Q5. For coding adverse events in clinical trials and pharmacovigilance databases, which terminology is generally preferred over ICD?

• SNOMED CT
• ICD-10
• MedDRA
• ATC classification

Correct Answer: MedDRA

Q6. Which statement correctly describes the basic structure of an ICD-10 code?

• Purely numeric digits only, fixed 5-digit length
• Begins with a letter followed by two digits for the category, with optional decimal and additional digits for subcategories
• Starts with two letters followed by three numerals and a checksum
• Uses only Roman numerals to indicate chapter and category

Correct Answer: Begins with a letter followed by two digits for the category, with optional decimal and additional digits for subcategories

Q7. A major technical advance in ICD-11 compared with ICD-10 is:

• Removal of all alphanumeric codes and replacement with plain text only
• Introduction of post-coordination (extension codes) allowing clinical detail to be combined with base codes
• Limiting codes to only 3 characters to simplify data entry
• Replacing disease names with drug names for faster pharmacovigilance

Correct Answer: Introduction of post-coordination (extension codes) allowing clinical detail to be combined with base codes

Q8. Which of the following correctly describes a typical step in the INN assignment process?

• Names are created by national patent offices without international consultation
• WHO publishes draft proposed INNs for public comment before final adoption by an expert committee
• Drug manufacturers unilaterally assign INNs and inform WHO later
• INNs are assigned by selecting the lowest-cost trade name available

Correct Answer: WHO publishes draft proposed INNs for public comment before final adoption by an expert committee

Q9. Using INN (instead of brand names) on prescriptions mainly helps to:

• Increase the cost of medicines
• Reduce medication errors and improve international clarity on the active substance
• Limit availability of generic medicines
• Obscure the active ingredient from healthcare providers

Correct Answer: Reduce medication errors and improve international clarity on the active substance

Q10. Which INN stem is commonly associated with angiotensin-converting enzyme (ACE) inhibitors?

• -olol
• -pril
• -prazole
• -statin

Correct Answer: -pril

Q11. In ICD coding, “external cause” codes are used to record which of the following?

• The chemical formula of a pharmaceutical compound
• Mechanism and intent of injury, such as fall, motor vehicle crash, or assault
• The synonym of a disease name
• Prescription dosing regimen

Correct Answer: Mechanism and intent of injury, such as fall, motor vehicle crash, or assault

Q12. How are pharmaceutical salts and esters usually represented relative to the INN?

• The INN always includes the salt/ester in its core form and never lists the base separately
• The INN denotes the active moiety; salts or esters are indicated by adding the salt/ester designation after the INN
• The INN is only used for salts and esters, not for parent active substances
• INNs prohibit any mention of salts or esters

Correct Answer: The INN denotes the active moiety; salts or esters are indicated by adding the salt/ester designation after the INN

Q13. Which statement best describes the role of ICD coding in pharmacovigilance datasets?

• ICD is the authoritative terminology for coding adverse events in clinical trials and must replace MedDRA
• ICD primarily supports epidemiology and diagnosis classification; MedDRA is preferred for detailed adverse event reporting, though ICD data are useful for comorbidities and population-level analyses
• ICD codes are exclusively used to name active pharmaceutical substances
• ICD and INN are interchangeable in pharmacovigilance case report forms

Correct Answer: ICD primarily supports epidemiology and diagnosis classification; MedDRA is preferred for detailed adverse event reporting, though ICD data are useful for comorbidities and population-level analyses

Q14. Which body publishes the official INN lists and maintains the INN programme?

• International Organization for Standardization (ISO)
• World Health Organization (WHO)
• European Directorate for the Quality of Medicines & HealthCare (EDQM)
• United States Pharmacopeia (USP)

Correct Answer: World Health Organization (WHO)

Q15. Which of the following is the INN for the analgesic commonly known as acetaminophen in the United States?

• Ibuprofen
• Paracetamol
• Acetylsalicylic acid
• Metamizole

Correct Answer: Paracetamol

Q16. In hospital coding practice, the “primary diagnosis” generally refers to:

• The most likely future diagnosis a patient might develop
• The main condition established after study to be chiefly responsible for occasioning the patient’s admission to the hospital
• The cheapest condition to treat
• A secondary comorbidity that did not lead to admission

Correct Answer: The main condition established after study to be chiefly responsible for occasioning the patient’s admission to the hospital

Q17. Which regulatory authority implemented a policy of adding a unique, meaningless four-letter suffix to nonproprietary names of biological products to distinguish them?

• World Health Organization (WHO)
• European Medicines Agency (EMA)
• U.S. Food and Drug Administration (FDA)
• International Nonproprietary Names Expert Committee

Correct Answer: U.S. Food and Drug Administration (FDA)

Q18. To integrate diagnosis data coded in ICD with adverse event data coded in MedDRA, what is generally required?

• Direct use of ICD codes as MedDRA preferred terms without transformation
• Translation using mapping tables or crosswalks and clinical review to reconcile differences in granularity and purpose
• Deletion of all ICD-coded records before analysis
• Replacement of MedDRA with ICD in all pharmacovigilance systems

Correct Answer: Translation using mapping tables or crosswalks and clinical review to reconcile differences in granularity and purpose

Q19. Which INN stem is characteristic of beta-adrenergic blocking agents (beta-blockers)?

• -pril
• -olol
• -mab
• -azole

Correct Answer: -olol

Q20. When was ICD-11 endorsed by the World Health Assembly (WHA), marking formal acceptance for member states to adopt?

• 2000
• 2019
• 1995
• 2025

Correct Answer: 2019

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