US struggles to cope with drug shortage

It may not be widely known, but in the United States, which spends more per capita on health care than any other industrialized country, 85 drugs are currently in such short supply that they are classified as "in shortage" by the government's Federal Drug Administration (FDA). The American Society of Health-System Pharmacists list of drug shortages is even more extensive — it currently contains 159 drugs.      

Both lists include widely used basic necessities like antibiotics, blood thinners, multi-vitamin infusions and saline bags — the simple but critically important mixture of sodium chloride and water routinely given to patients intravenously for hydration or to dilute other medications.

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The saline bag shortage has gotten so bad that the Trump administration last month announced new measures to try to ease the growing problem by considering extending expiration dates and ramping up imports.

'Looming threat to public health'

The move came after the American Hospital Association warned the FDA in November it was "concerned that the shortages of widely-used and critical products are quickly becoming a crisis and looming threat to the public's health."

Which begs the question, how did it get so bad?

The short answer is that Hurricane Maria, which devastated Puerto Rico, a key production site for the US pharmaceutical industry, coupled with an ongoing flu epidemic that has led to the highest hospitalization rate in nearly a decade and killed more than 50 children, has dramatically escalated an already festering problem.

"It made everything worse," said Erin Fox, who tracks nationwide drug shortages and heads the University of Utah's drug information service. The reason, she explained, is that there are often only one or two companies in the US who produce certain medical necessities like small saline bags.

Powerless production site

In this case, Baxter International, a large American health care company, "made the majority of all those products for the entire United States all in one place in Puerto Rico."

Hurricane Maria hit Puerto Rico in September, leaving the island without power for weeks and disrupting the production of saline bags at Baxter's three plants. US hospitals have struggled to cope since then.

"Saline is a huge issue right now and that is a result of the hurricane in Puerto Rico," said Bonnie Levin, who heads pharmacy services at MedStar, which operates 10 hospitals in the Washington and Baltimore region.

While Levin insisted that patient care has not been comprised at the hospitals as she and her staff work hard to find strategies to circumvent the saline shortage, she acknowledged that it complicates things.

"The small bags serve a pretty unique function in acute care hospitals and that is to deliver medications, typically antibiotics, and some other drugs," she said. "It is just an easy way to safely administer drugs to patients."

Old problem

Drug shortage expert Fox agreed: "In a lot of cases we have an alternative to use, but it increases the risk for medication errors because people might get the wrong dose or the wrong amount because they are unfamiliar with the alternatives."

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While the current saline shortage is acute now, crippling drug shortages are nothing new to the US.

Seven years ago, then-President Barack Obama issued an executive order to reduce drug shortages stating that their number had nearly tripled between 2005 to 2010, with the problem "becoming more severe as well as more frequent."

The presidential directive did little to remedy the problem.

"Drug shortages are endemic in the US," said hospital manager Levin. "Over the last five or six years we have seen a constant list of between 50 and 100 drugs that are short. At any given day there is some kind of drug shortage that we are dealing with here at MedStar."

If anything, the situation has become more intractable, with the average drug shortage now lasting eight months to one year, said Fox, who has been tracking national shortages since 2001. "So these are not short-term things."

Fragile supply chain

Asked to explain the reason behind the drug shortages, Fox pointed to the increasing consolidation in the health care industry in recent years. "We used to have multiple suppliers and now these companies have bought and sold each other and now we only have one or two companies."

When one of the few companies left after consolidation experiences a manufacturing problem, which usually is the result of a quality issue, there are no other suppliers to make up the difference, Fox explained. "Our supply chain is very very fragile that way and so we end up with drug shortages."

Fox offered some ideas for a solution to the drug shortage problems, saying that, for instance, when the government approves mergers of drug companies, the impact on public health should be taken into account.

What's more, she said, "our politicians could require that some products be considered critical infrastructure for our country, things like saline, and they could mandate that these companies have a business continuity plan and have some redundancies in their system if they chose to only have one single manufacturing plant for something so critical. It's almost a national security issue."