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MedDRA Coding in Pharmacovigilance: Professional Knowledge Assessment

Test your understanding of the concepts covered by MedDRA Coding in Pharmacovigilance: A Practical Guide.

Question 1 of 10Pass mark: 80%

Question 1 of 10 Several teams code equivalent source descriptions to different PTs without a clear clinical reason. What is the most likely downstream effect?

The PT counts will be fragmented, potentially diluting a signal across terms. The cases will automatically be consolidated under one PT during transmission. The variation will improve specificity without affecting aggregate analysis. The primary SOC assignment will correct the inconsistency.

Question 2 of 10 An automated coding tool matches “chest pain” in the sentence, “The patient denies chest pain.” What control is most important?

Accept the match because the phrase appears verbatim. Have a trained reviewer assess context, including negation, before finalising the term. Code both chest pain and its negation as separate terms. Exclude all automated suggestions from further review.

Question 3 of 10 Which set of dimensions provides the most useful basis for assessing coding quality?

Medical accuracy, consistency and traceability. Speed, number of terms selected and database size. Regulatory seriousness, expectedness and causality. Narrative length, number of SOCs and vendor turnaround time.

Question 4 of 10 A report says that serum potassium was “abnormal” but does not say whether it was high or low. What should the coder do?

Choose decreased potassium because low results are more commonly reported. Choose increased potassium because it is more clinically significant. Use a term that reflects the reported abnormality without inferring its direction. Code both increased and decreased potassium to ensure complete retrieval.

Question 5 of 10 A legacy case uses an LLT that has since become non-current. What is the most appropriate interpretation?

The term must be deleted from the historical record immediately. The term may remain in historical data under the organisation's versioning strategy, but it should not be selected for new coding. The term remains suitable for new coding if its meaning is unchanged. The case must be recoded to an HLT because the LLT is no longer current.

Question 6 of 10 A report states that a patient received a definitive diagnosis of pneumonia after developing fever, cough and dyspnoea. The symptoms are described as characteristic of the pneumonia. Which coding approach is generally preferred?

Code the diagnosis rather than automatically coding every characteristic symptom as a separate event. Code only the symptoms because they are more directly observable than a diagnosis. Code the diagnosis and every symptom in all cases to maximise retrieval. Code the symptoms as a single HLT.

Question 7 of 10 A report explicitly states that a medication error occurred but caused no clinical consequence. Which approach is generally appropriate?

Omit the case from coding because there was no adverse event. Code the medication error; use a “no adverse effect” concept only as appropriate under the coding convention. Code an unspecified injury to ensure the error is counted. Convert the error to a potential medication error because the patient was unharmed.

Question 8 of 10 A physician intentionally prescribes a medicine for an indication that may be outside the authorised product information in one region. What must be considered before coding off-label use?

Whether the use is outside the authorised information relevant to the region and whether the source supports that interpretation. Whether the indication is unusual compared with the physician's other prescriptions. Whether any adverse event occurred after treatment began. Whether the medicine is authorised in any country for any indication.

Question 9 of 10 A report states, “Possible pulmonary embolism; sudden dyspnoea and pleuritic chest pain.” Which approach best preserves the reported information?

Code only pulmonary embolism because diagnoses take precedence over symptoms. Code the provisional diagnosis and the reported symptoms. Code pulmonary embolism as definitive because the symptoms support it. Code only the symptoms and discard the provisional diagnosis.

Question 10 of 10 The term “hypertension” appears in a case as the reason for prescribing a medicine, not as a newly reported event. What should the reviewer verify?

That the term is placed in the indication field rather than automatically treated as a current reaction. That hypertension is removed from all case fields because it is not a reaction. That the term is coded under the primary SOC for the medicine's indication. That a different LLT is selected so it cannot be confused with an event.

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MedDRA Coding in Pharmacovigilance: Professional Knowledge Assessment

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