More on Supply Chain

How hospitals are grappling with medical supply shortages caused by Hurricane Maria

Power grid instabilities persist. The FDA says improvements to medical supply availability are coming soon.

Beth Jones Sanborn, Managing Editor

It is now more than 100 days since the powerful Hurricane Maria made landfall in Puerto Rico, devastating the island's residents, infrastructure and industry including medical supply manufacturers such as Baxter, Medtronic, Stryker and Johnson and Johnson -- and hospitals across the contiguous U.S. are still facing related shortages of medical supplies.

"The reality is we are really struggling," said Ross Thompson, executive director of pharmacy at Tufts Medical Center. Michele Evink, pharmacy manager at Clarke County Hospital in Iowa, added that Clarke's staff has engaged in workarounds to compensate for lacking supplies.

[Also: AMA's new policies: Medicaid for Puerto Rico, paid leave for organ donors]

The shortages were not immediate and hospitals started to feel them at different times based on specific supplies. Here's a look at how Tufts and Clarke County are surviving, what the U.S. Food and Drug Administration is saying about an imminent end to the problems and what other hospitals should learn from the devastating hurricane.

Tufts and Clarke County Hospital

The biggest shock came upon realizing that all mini-bag and mini-bag plus products were coming from Puerto Rico, Thompson said. That was something they didn't know prior to Hurricane Maria. That realization came with a broader one, that greater knowledge of where crucial supplies come from is essential to plan for the future.

[Also: Low government reimbursement rates, crushing national debt fuels physician shortage in Puerto Rico]

The shortage in the fresh Mini-Bags caused a ripple effect. Some hospitals scrambled to buy frozen products that would need to be thawed out before use. Another product, empty IV bags which used to make a hospital's own sterile preparation that can be used to infuse into patient over a period of hours, also disappeared. Once they were gone, organizations turned to 1-liter IV bags so now those are in short supply too, Thompson explained.

He said they are on allocation and do get some supply, about 85 percent of normal orders. "It would be great if it was that predictable but we take what we can get. We need to remain agile and keep key personnel informed of what supply we have."

Tufts is making substitutions, like using the IV push method, which was a way to solve for the absence of Mini-Bag Plus. They looked at those medications and identified  25-30 products that were safe to administer via IV push.

"Now we are drawing vile of active medication into a 10CC syringe and standing at bedside pushing that 10CC's over 3-5 minutes. That's added work for nurses."

As a result of using this method, they have moved syringe production and loading of medications into pharmacy, another workflow disruption. However, that may not be a bad thing in the long run.

"It's not necessarily a bad practice and we might continue to practice that after the shortage is solved," Thompson said.

They have also been reminded that oral administration of medications is also a highly viable method and the safest way because a tablet can be ingested and doesn't have the same vulnerabilities in stability and sterility that the solution does.

However, there is not a lot of substitution for hydrating a dehydrated patient that can't ingest fluid, so the shortage of the mini-bags is the biggest issue.

Clarke County Hospital's Clarke said for the sake of conserving these small fluid bags, the hospital has been modifying some procedures like the amount of fluid used to flush IVs where it is safe to make such alterations.

Evink said the biggest issue is awareness, making sure all hospital staff are fully informed of the situation and why it is so necessary to be prudent with the use of supplies.

"The most critical is the mini-bag so once you open the bag it is only usable for 30 days. it's heartbreaking to waste any of it," Evink added. "Everyone needs to know that these are little golden nuggets right now."

FDA: Improvements are coming

The Food and Drug Administration announced that all companies that produce drugs that landed on the agencies initial critical list are now back on the commercial power grid in Puerto Rico -- marking a turning point in the struggle to meet healthcare provider demand for supplies manufactured on the hurricane-battered island.

"We expect that the shortage of IV saline fluids will improve in early 2018, with continuing improvements in the weeks ahead," the FDA said.

This includes Baxter, a major manufacturer whose operations in Puerto Rico have been badly stalled. Baxter said Wednesday that its manufacturing facilities in Puerto Rico are completely connected to the electric grid, though they are keeping backup diesel generation in case of power interruptions.

The company said it is still experiencing these interruptions "intermittently" but expects to return to normal supply levels for products made on the hurricane-ravaged island "in the coming weeks."

Such instability in the power grid is an issue for most, if not all, of the companies down there as they try to ramp up production to previous levels.

"We have in fact increased the amount of certain products available to customers thanks to increased production in Puerto Rico and the special importation products," Baxter said.

Baxter manufactures the Mini-Bag and Mini-Bag Plus Container Systems, which are small bags of fluid used to dilute drugs so that they can be delivered by a slow drip.

The company also produces amino acids and other pre-mixed products in Puerto Rico. Amino acids are critical for patients who are not able to eat and need to receive their nutrition intravenously.

Baxter is one of the largest manufacturers of this product serving the U.S. market, the FDA said, and the return to the grid for all Baxter facilities means that the dangerous shortages of both pediatric and adult formula amino acids is "also anticipated to improve in the coming weeks."

To help meet some of the demand, the company had gotten special permission from the FDA for the importation of certain products from Baxter plants in Ireland, Australia, Canada, Mexico, England and Italy.

"These imported products began reaching healthcare providers in late October and product continues to enter the supply pipeline. We also continue to work with the FDA to explore opportunities to leverage other Baxter manufacturing facilities to help address product demand," Baxter said.

Large volume solutions, often referred to as "saline," are not made in Puerto Rico, and are currently being produced "at capacity," Baxter said.

The FDA also approved IV solution products from Fresenius Kabi and Laboratorios Grifols to help with the shortage.

"Both of those companies have been working to increase production of saline products. Thanks to steps like these, we now believe that the shortage situation related to IV saline products will improve by the end of 2017," the FDA said in a statement.

The agency acknowledged there is a long way to go, however, calling the production situation in Puerto Rico "fragile" and acknowledging that providers are still suffering, having to make modifications to their operations to conserve supplies without jeopardizing patient care.

Thompson, of Tufts, added that they will continue to operate in the mode of preserving every bag and every product.

"The fact that the plants are back on the grid is encouraging but we don't know their level of production or output," Thompson said. "Nor do we know when that will translate to products showing up on our dock."

Hurricane Maria not the last time

The ongoing shortages also point to a greater issue, for the FDA, manufacturers and healthcare providers.

On any given day, the FDA keeps a list of different drugs that are in short supply. Thompson said that for as long as he can remember, that site has listed 70 to 100 medications on any. That begs the question why this is always the case, and more importantly, why more hasn't been done to address the perpetual shortages before now.

"In the world of healthcare we have gotten really good at managing tremendous volatility in the availability of product," Thompson said. "The question that I would pose is: What is it we need to do to make our overall supply and access to medication more reliable and to understand what is causing the shortages and how to correct that?"

Twitter: @BethJSanborn
Email the writer:

Shop Nike Apparel, Shoes and Accessories