U.S. Hospitals Wrestle with Shortages of Drug Supplies Made in Puerto Rico

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Something to keep in mind as you read this article from The New York Times, “Pharmaceutical products made in Puerto Rico account for nearly 10 percent of all drugs consumed by Americans, and about 80 firms make medical products there, the FDA has said.”

One of the workhorses of Clarke County Hospital, a 25-bed facility in rural Osceola, Iowa, is an unassuming product known as a Mini-Bag. It is a small, fluid-filled bag used by nurses to dilute drugs, like antibiotics, so that they can be dripped slowly into patients’ veins. [. . .] “It’s a safe, sterile, stable way to get medications to patients,” said Michele Evink, the pharmacy manager at Clarke County Hospital. Now, hospital pharmacists across the country are racing to find alternatives — which themselves are becoming scarce — after Hurricane Maria halted production at the factory in Puerto Rico where Baxter, the manufacturer, makes the product.

The bag shortage is the most significant to be directly linked to the effects of the hurricane but others are likely to follow. In addition to creating a humanitarian crisis on the island, the storm knocked out production at the Puerto Rican factories that make vital drugs, medical devices and medical supplies that are used around the world.

Some device and supply companies have already begun limiting shipments of certain items from the island, ranging from mesh for repairing hernias to surgical scalpels and tools used in orthopedic surgery.

On Monday, Dr. Scott Gottlieb, the commissioner of the Food and Drug Administration, questioned companies’ statements that their plants were back in operation: “We understand that manufacturing is running at minimal levels, and certainly far from full production,” Dr. Gottlieb said in prepared remarks published Monday by the House Energy and Commerce Committee. [. . .] In a recent interview, Dr. Gottlieb said he was worried that if conditions don’t improve, more shortages — of both drugs and medical devices — might follow by early next year.

Pharmaceutical products made in Puerto Rico account for nearly 10 percent of all drugs consumed by Americans, and about 80 firms make medical products there, the F.D.A. has said.

[. . .] Dr. Gottlieb says the F.D.A. is watching the supply of about 30 drugs that are made on the island, in addition to medical devices. Most companies are still running on diesel generators, and manufacturers that have been able to connect to the power grid are still encountering an unpredictable supply of electricity, he said.

Cathy Denning, the senior vice president of sourcing operations at Vizient, which negotiates with medical companies on behalf of its member hospitals, said several device manufacturers, including Medtronic, which makes surgical staples, and Stryker, which makes orthopedic surgery products, were shipping reduced supplies of some products to hospitals because of Hurricane Maria. “We here at Vizient had an ‘aha’ moment when we realized how much manufacturing actually takes place in Puerto Rico,” she said.

Last week, a Johnson & Johnson executive told investors that the company couldn’t rule out “intermittent” shortages of some formulations of its products, although he noted that many were made elsewhere. Johnson & Johnson makes Tylenol and the H.I.V. drug Prezista in Puerto Rico, as well as other products. [. . .]

The F.D.A. has been supplying logistical help to companies, providing fuel for the generators and assisting with moving finished products off the island. Dr. Gottlieb said some companies had gotten down to a 24-hour supply of diesel fuel, and representatives for the medical-device industry had said some generators were beginning to break down, requiring emergency repair.

Pharmacists at half a dozen hospitals, from Utah to North Carolina, said in interviews that the fluid bag shortage had had a domino effect, leading to scarcities of a range of products as administrators race to stock up on the supplies they need to keep their hospitals running smoothly. Even products like empty bags and plastic tubing, which are also made by Baxter in Puerto Rico, have been hard to come by, some said.

“With drug shortages, it is often a race to see who can find a supply of the drug on shortage and also any alternatives,” said Philip J. Trapskin, who is the program manager of medication use strategy and innovation at UW Health, the University of Wisconsin-Madison’s health system. “We have been able to get what we need to avoid disruptions in patient care, but the mix of products is not ideal and there are no guarantees we will continue to get the supplies we need.” [. . .]

Like Dr. Gottlieb, many of the hospital administrators said their eye was on the horizon. With so many drug companies manufacturing products in Puerto Rico, Mr. Rosner said, “I am fearful that this may not be the end of the shortages — it may only be the beginning.”

For full article, see https://www.nytimes.com/2017/10/23/health/puerto-rico-hurricane-maria-drug-shortage.html

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