Drug Shortage Endures

A couple of years ago, we wrote about the complicated problem of drug shortages and an effort on behalf of both the executive and legislative branches of the federal government to address it.

So what happened? A lot, and not much, it appears, according to a recent story in the New York Times. Although the FDA has more muscle to understand and wrestle with the issue, “[S]hortfalls have persisted,” the newpaper says, “forcing doctors to resort to rationing in some cases or to scramble for alternatives, … The number of annual drug shortages – both new and continuing ones – nearly tripled from 2007 to 2012.”

A report last month by the U.S. Government Accountability Office (GAO) was the result of a 2012 law empowering the FDA to manage shortages, and the GAO was charged with evaluating that agency’s work.

It found that although the FDA was able to prevent many more shortages now than in years past (154 potential shortages in 2012 compared with 35 in 2010), the total number of shortages is growing. In 2012, the number of drugs in short supply was 456, versus 154 in 2007.

The hard-to-find medications include nitroglycerin (for heart problems) and cisatracurium, (muscle paralyzer for surgical patients on ventilators).

But the most common drugs in short supply are those for generic versions of sterile injectable drugs, partly because their manufacturing facilities are old and prone to breaches of quality.

That prompts temporary shutdown of production.

But sometimes, the cause of a shortage is a mystery. The drug industry seldom gives a clear reason, rationalizing that to do so would compromise competitive trade information.

The 2012 legislation requires manufacturers to alert the FDA of a potential shortage before it happens, and also the general reason for it. But some experts say that’s too general to enable observers to understand specific causes, and that makes it more difficult to address them.

If the problem relates to an aging factory, some drug companies are reluctant to update them because their profit margin on the product is too small. And because many generic drugs are made by few companies, a shortage at one has a big impact. The GAO report found only three manufacturers produced 7 in 10 of the country’s sterile injectable cancer drugs in 2008.

Also, generic drug makers have increased the number of drugs they produce on a given production line. That stretches limited factory capacity, invites quality problems and, if the line goes down, compounds the issue.

One study the GAO analyzed found that the sterile injectable market had increased by half between 2006 and 2010, but that manufacturing capability didn’t grow along with it.

Manufacturers often choose to increase production of higher profit drugs at the cost of a shortage of less profitable drugs.

The GAO said the FDA was responding well, but that it couldn’t force manufacturers to produce anything they don’t want to. But it also said that the agency must use its drug databases more thoroughly, to identify patterns to prevent shortages, not just to track drugs in short supply.

Erin Fox, a drug expert whose data was included in the report, told The Times, “We are at a public health crisis when we don’t have the medicines to treat acutely ill patients and we don’t have the basics like intravenous fluids.”

To see the drug shortages identified by the FDA, link here.

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