July 24, 2023 – The End Drug Shortage Alliance announced recommended actions healthcare industry stakeholders should immediately take to help minimize supply chain disruptions of sterile injectable medications in the wake of the tornado that hit Pfizer’s Rocky Mount, North Carolina facility. The plant was both a production facility and a warehouse for finished products including anesthesia, analgesia, therapeutics, anti-infectives and neuromuscular blocker product categories.
Pfizer’s website currently states that 200 million units are shipped globally every year from their Rocky Mount facility. Pfizer’s press release from earlier today also states that the Rocky Mount facility currently manufactures nearly 8% of all sterile injectable medication utilization in U.S. hospitals. However, overall market share for each individual product or presentation (vial size) can vary and the impact to supply remains unknown at this time.
Sterile injectable manufacturers and 503b compounders of impacted products categories should evaluate their ability to increase production in order to help meet current demand levels for products. As impacted product lists become available 503bs should review their formularies and shift production to impacted essential medications where possible.
Wholesalers should communicate with manufacturers and establish proactive protective 120% allocations for medications in the product categories to ensure the product is available for patient care and refine as more information is available. We also suggest establishing a small reserve inventory in the event emergency supply is needed.
The FDA is encouraged to expedite the review and evaluation of the impacted plant. As information becomes available of impacted products, expedite the approval of any applications for the products affected by this plant disruption. Expedite the review and update the FDA Drug Shortage Database to allow for prompt 503b production.
Group Purchase Organizations (GPOs) should consider novel sourcing strategies to provide their members with additional redundancy for essential medications to minimize potential patient care disruption. Further, we recommend they communicate regularly with supply chain leaders to support access and resiliency.
Providers and clinicians should exercise a stewardship mindset when ordering, prescribing and administering medications affected by supply constraints to preserve availability for vulnerable patient populations. Alert your regulatory community with any price gouging or predatory activity.
The End Drug Shortages Alliance’s Rapid Response Team will continue to continue to closely monitor this situation and the products that may be impacted and share updates as new information becomes available.