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A pilot study to support prospective detection of emerging adverse drug events.
Background: The FDA conducts post-market drug safety surveillance by analyzing reports submitted to the FDA Adverse Event Reporting System (FAERS). To enhance prospective detection of emerging adverse drug events (ADE), we leveraged existing PubMed "MyNCBI" functionalities to survey the biomedical literature for the latest published safety information in the use case of the new oral hepatitis C drugs. Methods: Using PubMed "MyNCBI" cubby functionality, we established a search strategy to retrieve citations most recently added to PubMed and provide automated weekly emails (PubMed ‘Early Alerts’) with abstracts and links to available full text citations. The search strategy includes three criteria: (1) Drugs of interest; (2) Citation scope: MEDLINE journal citations, as soon as they are entered in PubMed (prior to indexing); (3) Time Period: week of interest. Results: A typical weekly PubMed "Early Alerts" email delivery includes abstracts with links for 12-15 recently published citations from MEDLINE journals spanning 5-8 oral hepatitis C drugs. Our search strategy is designed for recall. Its precision can be increased significantly by requiring specific words in the titles or abstracts ("safety", "toxicity", "adverse", and "tolerability"). Conclusions: By leveraging existing PubMed "MyNCBI" functionalities, we can canvass a broad range of MEDLINE journals for the latest drug safety data. This approach lessens reliance on time-consuming, inefficient ad hoc searches and complements traditional approaches to finding relevant safety information. FDA Medical Officers and Safety Evaluators are evaluating our strategy by manually reviewing the "Early Alerts" for new information that may portend an emerging ADE.