Ibuprofen shortage: US hospitals are facing critically low supplies of liquid ibuprofen

In response to liquid ibuprofen shortages, the U.S. Food and Drug Administration has temporarily allowed manufacturers to manufacture and distribute non-FDA-approved medications for fever and pain relief.

To Grace Wade

Due to drug shortages, the U.S. Food and Drug Administration (FDA) is temporarily allowing medical manufacturers to produce unapproved alternatives to liquid ibuprofen for use in hospitals. This process, called compounding, mixes or alters pharmaceutical ingredients to produce near-identical substitutes, potentially easing pain reliever shortages in hospitals.

Many countries, including the US, UK, Canada and Australia, have been running out of medicines for months due to supply chain problems and increased demand. “Covid, flu and RSV are really taking a toll [on supplies]says Lisa Malloy of Northwell Health in New York. Due to shortages, hospitals and retailers have struggled to obtain liquid ibuprofen, which is used to reduce fever and pain in children and adults who are unable to swallow tablets.

“We have completely moved away from liquid formulations due to product unavailability,” says Emily Bennefield of Seattle Children’s Hospital, whose inventory ran out about two months ago. To continue treating patients, she and her colleagues have resorted to formulating ibuprofen themselves by crushing tablets and mixing them with liquids. This is a time and resource consuming process.

To alleviate some of this burden, the FDA announced on January 20 that it will allow designated manufacturing facilities to formulate ibuprofen in bulk and distribute it to hospitals. These products are not FDA approved, but comply with certain FDA regulations, such as the use of antimicrobial preservatives and sterile water. Manufacturers must also screen all ingredients for contaminants.

However, without FDA approval, which requires clinical trials to determine drug safety and efficacy, these products carry greater safety risks and may be less effective. “That said, we still have success treating pain and fever in our patients with these combined products,” Benefield says.

Mulloy says this is the first time he’s seen the FDA endorse a compound ibuprofen product. “This guidance shows just how big a problem this is. [shortage] ‘, says Benefield. “Compound interest is best avoided unless absolutely necessary.”

The problem is that the dispensed product cannot be sold at retail pharmacies, where there is the greatest shortage, says Mulloy. The FDA said it was working to increase retail access, but gave no indication of how it plans to do so.

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