Chronic drug shortages challenge health care providers & patients

08/21/2014 12:00 AM

08/20/2014 7:06 PM

Deep in the belly of Greenville Memorial Hospital, around the corner from its bustling pharmacy, Fred Bender pages through a report outlining the antibiotics, pain killers and other medications that are in short supply.

The list includes about 40 drugs on any given day, said Bender, director of pharmacy services. And it could top 100 or more over the course of a year, he said.

“This is a significant problem for hospitals not only in Greenville,” he told The Greenville News, “but all over the country.”

And retail pharmacies are in much the same situation, according to Ronna Hauser, head of regulatory affairs for the National Community Pharmacists Association.

Shortages have been a fact of life for the past decade or so. The situation has improved a bit from an all-time high of 251 shortages in 2011 to 117 in 2012, according to the U.S. Food and Drug Administration.

But these drug shortages can negatively impact treatment, compromise or delay medical procedures, and result in medication errors, according to the American Society of Health-System Pharmacists.

In fact, nine out of 10 health care providers responding to a recent survey by Premier Inc. said they’d had a shortage of at least one drug that could have caused a medication safety problem.

Among those drugs were IV fluids and nutrition, cardiovascular medicines such as nitroglycerin, and surgical anesthetics such as propofol, according to the Charlotte-based alliance of hospitals and health-care organizations.

Supply chain

The process of making a drug starts out with raw ingredients that are shipped to manufacturers that prepare them as tablets, capsules, injectables or other medicines, Bender said.

And a problem can occur at any point along the way.

There could be a shortage of raw materials, for example, or other problems like mechanical failures that delay production, according to the FDA.

Quality problems, which can range from the wrong expiration date to foreign particles in the drug, are a major reason for shortages, the FDA reports.

One of the most notorious cases involved an outbreak of fungal meningitis linked to steroid injections produced at the New England Compounding Center in 2012. It led to 751 infections and 64 deaths in 20 states.

“FDA has increased surveillance and supervision,” Bender said, “so when they see problems, they shut plants down right away.”

Another top reason is a company’s decision to stop making a drug, sometimes in favor of more profitable medicines, the FDA reports.

And when a manufacturer quits producing a drug, there may be only one or two others left that make it, which can lead to an overnight shortage because they can’t pick up the slack, Bender said.

“The volume goes down significantly,” he said. “It’s like Ford Motors going out of business and all you have left is GMC or Chrysler.”

Common drugs

About 90 percent of the shortages involve cheaper generic drugs as opposed to costly brand-name drugs, Bender said. Because generics have a lower profit margin, there’s less interest in producing them, he said.

“There’s no shortage of really expensive drugs,” he said.

Common classes of drugs are in short supply and many are the “work horses of therapy” that are used every day, said Michael Hunnicutt, administrative director of pharmacy at Bon Secours St. Francis Health System.

“One problem we’re facing now is IV solutions,” he said. “It’s a critical area across the country for something as simple as normal saline. We use cases and cases of it throughout the hospital.”

Ralph G. Neas, CEO of the Generic Pharmaceutical Association, said shortages are complex and multifaceted.

“Some therapies in shortage are only made by one or two manufacturers. Others are the result of unplanned disruptions in manufacturing for any variety of reasons,” he told The News. “There is no single cause and no single solution.”

But he said the FDA and stakeholders at all levels of the supply chain are working to make sure treatments are within reach for patients.

To deal with the shortages, most hospitals have back-up inventories for critical drugs, beef up communications about shortages to staff, and restrict the use of certain drugs, according to Premier.

Coping mechanisms

Managing the shortages requires a lot of staff time and resources, Bender said, adding that Greenville Health System holds a weekly conference with all its hospitals to deal with them.

If the prescribed drug isn’t available, hospitals use alternatives, he said. But that starts a domino effect. Are the drug and dose comparable? Will it cause interactions with other drugs the patient is taking? Does it have more side effects? Is the patient allergic to that drug?

So order sets and protocols have to be changed, he said.

“It’s a huge problem for us within the system,” he said.

And sometimes, the alternate is a more expensive drug. Those substitutes added at least $230 million to hospital pharmacy bills a year between 2011 and 2013, Premier said.

Like other hospitals, St. Francis deals with shortages by monitoring inventory, looking for alternative suppliers or drugs, and getting drugs from other Bon Secours hospitals when necessary, such as a critical chemotherapy agent for a cancer patient, Hunnicutt said.

“It’s not easy and there’s always a different drug every week,” he said. “But so far we’ve been able to work around those issues with an alternative supplier or drug product. And we haven’t run into a situation where we couldn’t treat a patient with a different therapy.”

GHS also shares drugs between its hospitals, Bender said, and buys drugs in smaller doses to avoid wasting medications that come in single-use containers.

Gray market

One option GHS doesn’t use is the gray market, a sometimes shady supply chain that sells hard-to-find medicines at exorbitant markups, he said, adding that counterfeit drugs also are a problem with that source.

“We need to ensure the pedigree of the drug,” Bender said. “And for financial reasons, we do not want to buy drugs at five to 10 times the cost. We cannot afford to do that.”

St. Francis doesn’t use the gray market either, Hunnicutt said.

Though it’s never been used, an ethics committee has been empaneled at GHS to resolve situations involving shortages of life-saving drugs, Bender said.

“God forbid we get to the point where we run out of a critical life-saving drug we have no substitute for and you have to get down to rationing,” he said.

“The committee can address those types of decisions case by case,” he added. “Fortunately, we’ve been able to work out a mechanism where we could have that drug for patients who need it.”

Drug shortages mean a juggling act for retail drug stores, and thus their customers, as well, NCPA’s Hauser said.

“It does happen quite frequently that a patient comes in with a prescription and we can’t fill it because of not being able to procure the product,” she said. “So we work with the physician to find an appropriate alternative in stock.”

‘A big problem’

In the past year or so, a shortage of thyroid medication forced pharmacists to give patients just a few at a time, she said. A shortage of Ritalin, meanwhile, led them to switch to another drug. Sometimes druggists also will get a medication from another pharmacy or send a patient to another store that still has the medicine, she said.

And there seems to be a shortage of some drugs regularly, like Adderall, for Attention Deficit Disorder, because there are manufacturing quotas for controlled substances, Hauser said.

“It seems like just about every year at the end of the year or the first of the year we have problems getting that,” said Charles Turner, pharmacist at Shaw’s Pharmacy in Greenville.

In general, he said, the pharmacy sometimes goes months without some drugs.

When there are comparable products, the original drug can be replaced with another medication by the physician, he said. But sometimes the only alternative is a high-priced brand-name drug. So the patient pays the higher price or goes without, he said.

And sometimes when a drug becomes available again, he said, the price has skyrocketed. One antibiotic, for example, soared from $18 for a bottle of 500 to $125 for a bottle of 50. It can take insurers a month to plug in the new price so pharmacists get reimbursed at the old rate for a time, he said.

In some cases, Turner said, he just absorbs the cost. But that’s not always possible, so the increase is passed on to the patient, who either pays or goes without, he said.

“It’s created a big problem for us,” he said.

Finding solutions

The Generic Pharmaceutical Association’s Neas said the only way to alleviate shortages is through collaboration between regulators and manufacturers, and improving the review and approval process.

“GPhA and its members enthusiastically support the full implementation of actions that can be provided by generic industry-generated fees from the Generic Drug User Fee Act, which total nearly $300 million annually,” he said.

“This includes expediting the approval process, completing site inspections, reducing the Abbreviated New Drug Application backlog and other critical functions of the FDA, each of which plays a role in getting generics to patients as quickly and safely as possible.”

The FDA says it has been working on the problem.

Last October, it debuted a plan designed to improve its response to shortages and address the underlying causes. Manufacturers are now required to tell FDA about shortages and plans to discontinue a drug, for example, so the agency can work to find an alternate supply.

And while the agency can’t force companies to increase production, it can help prevent shortages by expediting approvals or reviews so a manufacturer can ramp up production.

It can also approve extending an expiration date of a drug where appropriate until new medicines are produced. And when the situation is severe, like the recent propophol shortage, the FDA can permit a drug to be imported from approved countries with adequate supply.

Using these strategies, the FDA says it helped prevent 195 drug shortages in 2011 and 282 in 2012. Neas said that shows progress is being made and that fewer new products are going on the shortage list.

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