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Performance of the standardised MedDRA® queries for case retrieval in the French spontaneous reporting database

Hélène Géniaux1, Denise Assaf, Ghada Miremont-Salamé

  • 1Université de Bordeaux, Bordeaux, France, helene.geniaux@u-bordeaux.fr.

Drug Safety
|June 20, 2014
PubMed
Abstract

Insights

Standardised MedDRA® Queries (SMQs) show varied performance in identifying adverse drug reactions (ADRs), with specificity and negative predictive values consistently high. Performance depends on the specific condition being investigated.

Area of Science:

  • Pharmacovigilance
  • Drug Safety
  • Medical Informatics

Background:

  • Adverse drug reaction (ADR) identification is crucial for patient safety.
  • Standardised MedDRA® Queries (SMQs) are tools used to systematically retrieve ADR cases from databases.
  • Evaluating SMQ performance is essential for optimizing pharmacovigilance processes.

Purpose of the Study:

  • To assess the effectiveness of Standardised MedDRA® Queries (SMQs) in identifying specific adverse drug reactions (ADRs).
  • To quantify the sensitivity, specificity, and predictive values of narrow and broad SMQ searches for selected conditions.

Main Methods:

  • Utilized ADR cases from the French Pharmacovigilance database for the year 2009.
  • Tested four SMQs (agranulocytosis, demyelination, osteonecrosis, psychosis) using both narrow and broad search strategies.
  • Calculated sensitivity (Se), specificity (Sp), positive predictive value (PPV), and negative predictive value (NPV) with 95% exact confidence intervals (CI).

Main Results:

  • Included 337 agranulocytosis, 17 demyelination, 52 osteonecrosis, and 230 psychosis cases.
  • Narrow SMQ searches showed variable sensitivity and PPV: agranulocytosis (Se 62.9%, PPV 46.8%), demyelination (Se 88.2%, PPV 34.1%), osteonecrosis (Se 94.2%, PPV 74.2%), psychosis (Se 75.1%, PPV 87.8%).
  • Specificity and NPV exceeded 98% for all tested SMQs, regardless of search strategy.

Conclusions:

  • The performance of SMQs in retrieving ADR cases is heterogeneous.
  • SMQ performance appears influenced by the specific characteristics of the medical condition.
  • This suggests that the efficacy of other SMQs may also vary based on the condition under investigation.

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