QPPV.COM KNOWLEDGE ASSESSMENT

WHODrug Coding in Pharmacovigilance: Professional Knowledge Assessment

Test your understanding of the concepts covered by WHODrug Coding in Pharmacovigilance.

Question 1 of 10Pass mark: 80%

Question 1 of 10 A reporter says a patient takes 30 mg of a medicine each day but does not identify the strength of each tablet or unit. Which action is most appropriate?

Code the 30 mg product strength because daily dose and product strength are equivalent. Do not infer product strength from the daily dose; use other supported product details or seek clarification. Assume the patient takes three 10 mg tablets. Select the highest available strength and record the daily dose as the product strength.

Question 2 of 10 An ICSR reports a suspect medicine and a second medicine alleged to have interacted with it. What is the correct relationship between WHODrug coding and those case roles?

Assign a different WHODrug product identity to the second medicine because it is interacting. Code each medicine according to its identity and record its suspect or interacting role separately. Code only the medicine considered more likely to have caused the event. Use the interacting role to determine which active substance should be selected.

Question 3 of 10 A medicinal product is known to be legitimate, but no matching record can be found in the installed WHODrug release after an adequate search. Which response best supports standardisation?

Create an unofficial identifier in the WHODrug namespace. Replace the reported product with the closest brand by spelling. Use the organisation's controlled temporary approach and consider the UMC Change Request process. Delete the product from the case until a new release is implemented.

Question 4 of 10 Which approach best describes an appropriate use of automated WHODrug coding?

Automatically accept every result whenever a valid identifier is returned. Use automation for suitable matches, with confidence-based controls and human review for ambiguous or context-dependent cases. Disable all automation because it cannot support any reliable matching. Allow the algorithm to infer missing country, strength and brand from market prevalence.

Question 5 of 10 An analyst wants to compare a product-specific safety pattern with a pattern shared across several brands containing the same substance. What is a key analytical implication of WHODrug structure?

Only exact brand-level analysis is valid; substance-level aggregation should not be used. Structured product and substance relationships can support both product-level and broader substance-level analyses, depending on the safety question. ATC classification replaces product and substance coding for both analyses. The analyst should discard product-specific information before any aggregate review.

Question 6 of 10 A reporter identifies a brand but not the country. The same brand has different compositions in several markets. Which principle should guide country selection?

Infer country from the reporter's language. Infer country from the MAH's headquarters. Use country only when supported by the source or reliable contextual evidence; do not guess it. Select the record for the country where the brand was first marketed.

Question 7 of 10 A report identifies a trade product, its country, form and strength. How should a coder generally choose between B3 and C3 when the system supports both?

Use B3 because it is always more detailed than C3 for marketed products. Use C3 when the available information supports identifying a more specific product record. Use either format interchangeably because they contain identical product attributes and identifiers. Use C3 only if the product is a combination; otherwise, use B3.

Question 8 of 10 A product has an ATC classification associated with a particular therapeutic use, but the patient's indication is not reported. What should the case processor conclude?

The patient must have received the product for the indication implied by its ATC classification. The ATC classification characterises the medicine but does not establish the patient's reported indication. The ATC code should replace the patient's indication field. The product should be recoded to a different substance until the indication is known.

Question 9 of 10 A patient develops an adverse event after taking one product and receives a different medicine to treat the event. Which interpretation is most appropriate?

Both medicines must be coded as suspect because both appear in the ICSR. Both products may be coded, but the treatment medicine's role should be distinguished from the suspected exposure. The treatment medicine should not be coded because it cannot be relevant to pharmacovigilance. The treatment medicine should be coded as concomitant, regardless of the case fields.

Question 10 of 10 A reporter states only that a patient took a named active substance. No trade name or product-specific details are available. What is the most appropriate coding approach?

Assign the market-leading brand containing that substance. Select a C3 product based on the patient's indication, even if several products remain possible. Use a substance-level record supported by the report and retain the source wording. Create separate entries for every brand containing that substance.

WHODrug Coding in Pharmacovigilance: Professional Knowledge Assessment

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