2021-09-30-兰德-评估美国和其他国家药品短缺之间的关系（英）_134页_1mb

Summary

This report analyzes drug shortages in the United States and their potential impact on other countries. The study combines the FDA and ASHP shortage databases with IQVIA MIDAS drug market data from the G7 countries plus Australia.

Key Findings:

1. Normalcy and Causes: Drug shortages are common in the U.S., often due to supply chain disruptions (e.g., manufacturing issues, API shortages, increased demand) or business decisions like discontinuing limited products.
2. Data Nuances: The FDA (regulatory-focused) and ASHP (perscription/pharmacy-focused) databases have definitional differences. This study combines them, finding more shortages listed in ASHP, often technology shortages (supply mismatch, not necessarily affecting patient care), while FDA focuses on broader, more clinically relevant (practical) shortages.
3. Annualized Findings: Overall U.S. shortages showed mixed but small changes in volume (-8.4%) and prices (+7.3%) around the shortage timeline (-4 quarters to +4 quarters). HHI (market concentration) showed slight increases. Manufacturer numbers showed little change.
4. Geographic Scope: Most U.S. drug shortages are domestic or regional. There are very few global events affecting multiple countries simultaneously or consecutively. Volume changes in other countries were rare and small, often not statistically significant. Price effects in other countries, while sometimes muted in the US, were minimal almost everywhere else.
5. Specific Cases: Certain high-profile cases (valsartan API issue, Hurricane Maria impact on heparin) show potential global effects, but these are exceptions. Most often, U.S. shortages do not spill over internationally in significant volume or price changes.
6. Shortage Categories: Shortage duration, form (injected/intravenous v. oral, etc.), and market category (innovator/MSO/generic) influence outcomes slightly under certain measurement periods. FDA-listed practical shortages showed the largest volume declines.
7. Antimicrobials/IGs: These notoriously shortage-prone drugs also showed no consistent volume or price effects across other countries. Some patterns were discernible within the U.S. but not globally.

Conclusion: The report concludes that U.S. drug shortages are predominantly domestic in nature. While isolated cases of truly global shortages exist and are worth studying further (e.g., valsartan), a national strategy for preventing shortages should focus primarily on measures taken within the U.S. itself, including enhanced supply chain visibility, regulatory flexibility, and market incentives.