When Hurricane Maria made landfall in Puerto Rico in September 2017, it caused drug production on the island to grind to a halt, significantly impacting the availability of small volume parenteral (SVP) products in the United States. In the wake of the storm, manufacturing challenges continued for months, causing US hospitals to scramble to implement contingency plans to address the shortage of these crucial products, which serve as the foundation of basic IV compounding for hundreds of drugs that need further dilution.1
A report released by the FDA Commissioner in early 2018 stated that the IV saline shortage would begin to improve in Q2, with full resolution expected by July.2 In December 2017, the SVP manufacturer’s facilities in Puerto Rico returned to the commercial power grid,2 and SVP production reached pre-hurricane levels by late April 2018.3 Indeed, shortages of SVP products have clearly improved in recent months.
The SVP shortages are resolved for the most part; however, other supply chain challenges persist. For example, large-volume fluids, DEHP- and PVC-free products, and dextrose in small bags can still be difficult to obtain. Likewise, access to some ready-to-use IV products may continue to be challenging. Because some products are not yet available through the traditional supply chain, inventory management requires additional flexibility. When organizations are purchasing medications directly from the manufacturer, those orders are typically for larger quantities than usual. Thus, in the wake of shortages, medication storage may prove challenging.
Defining Practice Moving Forward
Many organizations instituted practice changes to address the SVP shortage. In light of the time and resources required to implement these changes—as well as the similar time and effort required to revert to previous practice—the question arises: Should organizations keep these alternate practices in place?
The crucial determinant in whether to revert to previous practices must be ensuring medication safety. While some organizations may consider maintaining certain practices established in response to the shortage in order to avoid EHR changes that require a significant investment in time and nursing reeducation, safety must be the ultimate arbiter of these critical decisions.
After careful consideration, organizations may decide to keep certain practices in place. Nonetheless, it is important to identify those situations where reverting to the previous approach is best practice. Consider antibiotics, for example; the shortage prompted some hospitals to employ IV push administration. Because many antibiotics are most efficacious when infused over a period of time, switching back to pre-shortage practice is recommended in many cases. In addition, to conserve saline during the shortage, organizations may have reserved small volume bags for medication use only, and not permitted use for starting or flushing IV lines. In light of the resolution of the shortage, this practice may no longer be required. Finally, review medications such as dexamethasone; to prevent side effects from administering this medication too quickly, it is best infused slowly in a bag or by using a syringe pump. As such, the safest approach is to revert to previous practice.
The FDA allowed use of imported products to assuage the SVP shortage in US hospitals and continues this allowance now that the shortage has abated. One manufacturer has capitalized on this strategy and is moving forward in investing in factories outside of the United States. The company’s plan is to gain FDA approval of foreign manufacturing sites, leverage global production, and ship saline to the US. For example, it has a plant in Mexico that supplies the western half of the US with large volume saline bags. In addition, its Puerto Rico plant is now fully operative.
Addressing Future SVP Shortages
Cultivate Rapid Adaptation
Predicting the recent SVP shortage was virtually impossible; likewise, mitigating it by storing a large quantity of saline in the hospital would be impractical. However, pharmacists should have a plan in place detailing how to quickly make changes in the event of various shortages. The ability to deftly implement changes should be fostered as a tactic to manage shortages. An organization that can effect swift change will be in an excellent position to weather shortages.
Developing a close relationship with the IT team is crucial to effective shortage management. While the ability to make rapid changes should be a goal, all parties must also maintain realistic expectations for how quickly changes can be made when a shortage occurs.
Saline: A National Security Issue?
One of the challenges unveiled by the hurricane in Puerto Rico is the lack of contingency plans to address such a natural disaster. At this time, saline is not included in national stockpiles, so it would be prudent for pharmacy to begin thinking about its saline supply as a national security issue. In fact, due to the critical nature of a saline shortage, the assistant secretary for emergency preparedness, Office of Emergency Management, may consider treating a saline shortage as a national security issue moving forward.4 If saline is considered part of our critical infrastructure, strong redundancies, backup plans, and business continuity plans would be in place. This would be a positive step in preventing future saline shortages. To advocate for this change, pharmacists should contact their congressional representatives (see Reference 4 for additional recommendations).
- ASHP and the University of Utah Health. Small-Volume Parenteral Solutions Shortages Suggestions for Management and Conservation. www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM582461.pdf. Accessed June 12, 2018.
- US FDA. Statement by FDA Commissioner Scott Gottlieb, MD, update on recovery efforts in Puerto Rico, and continued efforts to mitigate IV saline and amino acid drug shortages. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm591391.htm. Accessed June 12, 2018.
- Baxter Dear Valued Customer Letter. Scott P. Luce, General Manager, U.S. Hospital Products, Baxter Healthcare Corporation. April 19, 2018.
- ASHP. Drug Shortages Roundtable: Minimizing Impact on Patient Care. www.ashp.org/-/media/assets/drug-shortages/docs/drug-shortages-nov-2017-shortage-meeting-report.ashx. Accessed June 12, 2018.
Erin R. Fox, PharmD, BCPS, FASHP, is senior director, drug information and support services, at the University of Utah Health, and adjunct associate professor at the University of Utah College of Pharmacy Department of Pharmacotherapy.
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