Dive Brief:
- The American Hospital Association (AHA) is warning that patient care may be disrupted if IV solution shortages caused by Hurricane Maria’s impact on Puerto Rico are not resolved.
- Despite actions to address the shortages by the federal government, only 10-15% of hospital and health system demand might be met, the group says.
- lt appears the rationing has not disrupted care at hospitals yet, but many are facing rationing of IV bags from one of the largest manufacturers of the product, NPR reported.
Dive Insight:
Nearly two months after Hurricane Maria slammed into Puerto Rico, the island is struggling to recover, and more drug shortages could be on the horizon if its power grid is not restored quickly, experts warn.
The Food and Drug Administration (FDA) has granted one of the largest manufacturers of IV solutions, Baxter, permission to import IV bags from its facilities in Ireland, Australia, Canada, Mexico and England. But immediate action by the federal government is needed to ensure patients will continue to receive needed care, AHA wrote in a Nov. 9 letter to House Energy & Commerce Oversight and Investigations Subcommittee Vice Chair Morgan Griffith (R-Va.) and Ranking Member Diana DeGette (D-Colo.).
FDA Commissioner Scott Gottlieb has warned Congress that if Puerto Rico’s electrical grid is not repaired by 2018, more drug shortages are on the horizon. Gottlieb also has said that FDA will be expediting review of drug applications that could help relieve shortages. Multiple manufactures are operating at significantly below full capacity, and are still relying on generator power.
"Power, in particular, remains a critical concern. Many of the generators were not meant to operate for long periods of time. But, electrical power grid restoration is likely to take many months," Gottlieb said in testimony before the E&C subcommittee late last month.
AHA argued that a lack of transparency by pharmaceutical companies in disclosing what drugs are manufactured at plants, and geographic data on where the plants are located, contributes to the healthcare system being unprepared to proactively handle drug shortages.
“The current system results in a reactive approach, which is usually short-notice and has a rapid downstream effect, leaving hospitals at a loss to meet patient needs. As we have seen with Hurricane Maria, the current pharmaceutical infrastructure allows for a significant number of manufacturers to be geographically located in an area that is at high risk for natural disasters,” AHA wrote.
According to the Bureau of Economic Analysis, pharmaceuticals manufactured in Puerto Rico constitute almost 10% of all drugs consumed by Americans. At least 33% of Puerto Rico's gross domestic product is from its pharmaceutical sector, according to Gottlieb.