Empirical assessment of case-based methods for identification of drugs associated with upper gastrointestinal bleeding in the French National Healthcare System database (SNDS).
Nicolas H ThurinRégis LassalleMartijn SchuemieMarine PénichonJoshua J GagneJeremy A RassenJacques BenichouAlain WeillPatrick BlinNicholas MooreCécile Droz-PerroteauPublished in: Pharmacoepidemiology and drug safety (2020)
SCCS adjusting for multiple drugs and using a 30-day risk window has the potential to generate UGIB-related alerts in the SNDS and hypotheses on its potential population impact. Negative control implementation highlighted that low systematic error was generated but that protopathic bias and confounding by indication remained unaddressed issues.