The usual answer is “too few manufacturers.” Joining four FDA datasets shows that isn’t what the data says. Two other signals do, and in a one-year backtest they were visible well before the shortage notice.
When a drug goes short, a hospital pharmacy finds out from a wholesaler, then spends days finding substitutes, rewriting order sets and warning clinicians. The facts that might have warned them sit in separate FDA datasets that don’t reference each other: the shortage list, the drug directory and the recall reports.
The cost isn’t only hours. In the same survey, 38% of hospitals reported at least one medication error tied to a shortage in six months.
It’s a question that needs data joined, not just read, and I know how drugs are made and regulated well enough to spot a join that looks right and isn’t. It also let me test a belief almost everyone repeats.
The ideaJoin the shortage list, the drug directory and recall reports on exact FDA identifiers. Test each popular theory against the result, keep only what holds, and backtest it.
Sources: openFDA drug shortages, NDC directory, Drugs@FDA and enforcement reports, downloaded September 26, 2026; Vizient, “Drug shortages and labor costs,” June 2019.
Signals as of September 26, 2025, for medicines that had never been on the shortage list. The outcome is whether any shortage or discontinuation notice was posted in the following year.
Injectable medicines not on the shortage list today whose own record, or a maker’s record, shows a manufacturing-quality recall in the past three years. A signal, not a prediction.
For one hospital pharmacy that gets an early warning on the shortages this signal would have caught. The catch rate is measured in the backtest above.
Today, pharmacy buyers and shortage coordinators react: a notice arrives, and the scramble starts. Here is how a year of shortage work shifts.
Some of the scramble goes away for the shortages seen coming. Two-thirds still arrive without warning, and deciding what to stock, what to substitute and how to tell clinicians stays with the pharmacy.
The backtest is one year and the counts are small, so treat the lift as a direction, not a precise number. The rule catches about a third of new notices and most flags never become shortages. Plant-level FDA inspection results would sharpen it, but they sit behind a registered API I haven’t connected. The outcome also counts discontinuation notices, which aren’t the same as a shortage. And compounders and repackagers, most of the unmatched recalls, aren’t manufacturers of record, so they’re deliberately left out.