Drug Shortages

What are the major causes influencing drug shortages?

Quality control issues, supply and demand imbalances, economic pressures, and natural disasters are major causes. Quality issues may include contamination, equipment breakdowns, and raw material shortages.

What manufacturing issues commonly lead to drug shortages?

Issues such as contamination, foreign material presence, equipment failures, and raw material shortages can interrupt drug production and supply.

What regulatory actions has the FDA taken to manage drug shortages?

The FDA’s Strategic Plan includes early shortage notification, quality improvement oversight, alternative supply options, and incentivizing manufacturing improvements.

What did the CARES Act (2020) require from drug manufacturers to manage shortages?

The CARES Act requires manufacturers to notify the FDA of supply issues, create risk management plans, and submit annual production data reports.

What are best practices for overcoming drug supply issues in healthcare settings?

Best practices include interdisciplinary daily huddles, shortage tracking systems, and consistent staff updates to maintain informed and coordinated responses.

How does daily interdisciplinary management help address drug shortages?

Daily management huddles allow for real-time communication among pharmacy staff, clinical managers, and IT pharmacists to quickly adjust plans, update inventories, and manage substitutions.

What are some clinical strategies to address drug shortages?

Clinical strategies include switching to alternative medications, changing drug forms or concentrations, and implementing IV-to-PO conversions to conserve supplies.

What operational strategies are used to manage drug shortages?

Operational strategies include daily tracking of inventory, CPOE updates, automated dispensing cabinet adjustments, and real-time communication with stakeholders.

Which regulation was passed recently to improve drug shortage management?

The CARES Act (2020) mandates early notification, risk management planning, and annual production reports to help the FDA mitigate shortages.

What is a best practice for tracking drug shortages?

A comprehensive shortage tracking system, accessible to all stakeholders, helps monitor inventory, usage rates, and ordering statuses to proactively manage supplies.

Why is transparent communication important in managing drug shortages?

Transparent communication helps ensure all staff are aware of shortages, alternative options, and any adjustments in workflows, which improves organizational resilience.