Special Report: Drug Shortages and Patient Risk

Published May 31, 2016

Although a trip to the local neighborhood pharmacy might suggest the shelves are groaning under the strain of a wide variety of medicines, the truth is the United States is suffering a shortage of prescription drugs, which is costing hospitals and increasing patient risk, according to a new study from the Premier Health Care Alliance.

In “Navigating Drug Shortages in American Healthcare,” researchers conclude the frequency and impact of drug shortages have risen to critical levels, more than tripling since 2005 and affecting all segments of health care. Besides increased costs, shortages affect the ability of providers to care properly for their patients, and as doctors use unfamiliar drugs to work around the shortages, risk to patients increase.


Shortages of Injectable Drugs

In 2010, more than 240 drugs were either in short supply or completely unavailable, and more than 400 generic equivalents were backordered for greater than five days. Many of the drugs so identified in 2010 remain unavailable or in short supply in 2011.

Some 77 percent of drugs in short supply in 2010 were sterile injectable products, critical in the acute care setting, the researchers found. At least 42 percent of injectable drug shortages in 2010 were due to contamination incidents that kept drugs from the market.

Problems included the presence of particulates, microbial contamination, impurities, and stability changes in drugs, according to Maya J. Bermingham, senior assistant general counsel for the Pharmaceutical Research and Manufacturers of America (PhRMA), which represents leading research-based pharmaceutical and biotechnology companies in the United States.

“Drug shortages can occur at any point of the supply chain and may be traced to a number of different causes,” said Bermingham. “Shifts in clinical practices, raw material shortages, and changes in hospital and pharmacy contractual relationships with suppliers and wholesalers can cause fluctuations in the availability of certain products.”


FDA Compliance a Problem

Manufacturers use what’s known as a just-in-time inventory, stocking fewer raw materials to save money and improve efficiency, but this approach creates some risk of instability in the pharmaceutical market. Also, some manufacturers have discontinued products rather than invest money to meet regulatory requirements of the U.S. Food and Drug Administration (FDA).

“Adhering to FDA-mandated distribution protocols can impact patients’ timely access to medicines,” Bermingham said.


Supply Chain at Risk?

In most instances these shortages did not progress to a critical level. But instabilities in the supply chain are a cause for national concern, says Erin Fox, who manages the Drug Information Service for the University of Utah Hospitals & Clinics. Her organization, which provides drug information to health care professionals, has been tracking drug shortages for the past decade.

“Over the last two years it’s just exploded,” Fox says. “Most of the shortages have been generics and hospital injectables. Right now the supply channels are really fragile, and often only one or two companies make these drugs, so whenever there is a problem it really exacerbates the situation,” says Fox.

In the past if a drug was in short supply, an alternative could be easily found. That’s no longer the case, she explains.

“If you’re in intensive care or are receiving chemotherapy for instance, and the drugs aren’t available, then it’s really bad because your life may depend upon it,” she says.


New Drug Shortage Each Day

One of the biggest problems, Fox maintains, is that so many manufacturers are shutting down.

“We have a free market, and these companies are free to stop doing business or move their manufacturing overseas, which may make sense for them economically. From our perspective, it would be helpful if they were making a decision to shut down or stop a product line, to give us notice so we could come up with an alternative,” said Fox.

Fox says in 2010 there were 211 drugs in shortage according to her tracking, and in the first quarter of 2011 there were 89.

“That puts us on pace for one new drug every day to be in shortage,” Fox said. “This is simply unmanageable.”

She recommends that with enough notice of a plant closure or the end of a product line, the FDA should go to a competitor and ask if they can ramp up their production of a shortage drug.

“I don’t think this a perfect solution. However, in 2010 the FDA prevented 40 shortages because they talked to other companies,” she says.

Other Countries Also Affected

Fox says other countries cannot make up the shortages.

“People sometimes ask why we can’t buy the drugs from another country, like Canada. Unfortunately, Canada is having its own drug shortage problem. Other countries just don’t have the surplus to send to us,” she explains.

Fox says more drugs are needed to meet demand, or problems will begin to impact patients seriously.

“As bad as things sound, patients should know that teams of pharmacists in hospitals scramble every day to make sure they have the medicines they need, but when so many are short, and so many critical medications are unavailable and there are no alternatives, this gets harder and harder,” Fox said. “I’m afraid the current crisis is going to start impacting patient care. Our supply chain is so fragile—we don’t have any resiliency to weather serious manufacturing problems like what we’re seeing today.”


Kenneth Artz ([email protected]) writes from Dallas, Texas.


Internet Info:


Premier, Inc: Navigating Drug Shortages in American Healthcare