How Chicago’s top pharmacies are keeping up with historic drug shortages
by Patrick Kenney
Representatives from Rush University Medical Center, NorthShore University HealthSystem, Northwestern Memorial Hospital and University of Chicago Medical Center recently sat down together to devise a plan; what to do if the medicine runs out.
“In the past, it wasn’t part of our daily job to worry about this kind of shortage,” says George Carro, senior director of oncology pharmacy services at NorthShore. “We always knew we could get these drugs on short notice.”
But in the last few years, drug shortages nationwide have reached a crisis point. Kevin Colgan, corporate director of pharmacy at Rush, explains what his department has had to deal with. “In December of 2009, we were managing about 12 drug shortages. The next December , we managed 42. This December , we managed 172.”
That’s a 400 percent increase of shortages in just one year. But Colgan has the same staff and the same resources he had in 2009, which poses a problem. Each shortage adds another 40–60 hours of work. “There is probably an extra cost of a quarter of a million dollars in manpower,” says Colgan. “And that time could be put toward improving service.”
“In the past, there were one or two people [concerned] with ordering,” says Carro, Now? It’s everyone. All the pharmacists, technicians – even the physicians – have to consider what the hospital has in stock when determining a treatment plan for a patient.
Drugs, especially generics, used in cancer treatments are among those in critically short supply. Last year, supplies of cisplatin, an often-used cancer treatment, dropped to dangerously low levels.
“We actually had to come up with a prioritization list,” says Kathryn Schultz, hematology/oncology clinical pharmacist at Rush. “You are essentially forced to pick and choose which patients you treat. It is one of the most gut-wrenching processes I’ve ever had to go through.”
Fortunately, the prioritization list never had to be enacted. The coalition of hospitals has agreed to “share openly with each other up to the last dose,” Colgan says, to make sure that patients don’t go untreated. Had Rush needed its prioritization list, it would not have been the only hospital in town making those gut-wrenching decisions.
The shortage is a confusing and multifaceted problem. But perhaps the single most frequently cited reason, listed over and over on the FDA’s current drug shortages list, is manufacturing delays. Such is the case with leucovorin; a generic cancer drug that protects healthy cells while another drug kills the cancer cells.
In a written response to Chicago Health, Shelly Burgess, a public affairs specialist at the FDA, points out, “In 2010, 74 percent of the shortages involved sterile injectable drugs, of which approximately 54 percent were due to quality problems at the manufacturing facility.”
Burgess points out that manufacturing problems “are also to some extent a reflection of economic forces – an insufficient investment by manufacturers to support commitment to quality.” Additionally, “Supply disruptions result, in many cases, from economic decisions. Firms discontinue unprofitable products.”
In 2008, The FDA approved the use of the drug levoleucovorin, a slightly different version of leucovorin, not proven to be more effective, but many times more expensive. In November 2011, the New England Journal of Medicine cited the cost of levoleucovorin as being 58 times that of leucovorin.
And insurance companies regularly deny a more expensive drug when a cheaper one that is just as effective is available, even if it is in short supply. Regardless of the cost, patients must be treated.
Changes in the drug supply come with increased health risks as well. Different drugs require different dosing and administering regimens, which can become difficult to keep up with when shortages are so rampant.
“When something changes, the chance of making an error is much greater, so you have to be really careful with it,” says Carro.
Changes in the drug supply are often not gradual, and major adjustments need to be made in a short amount of time. Both Carro and Colgan point out that there’s been a consolidation of the industry, at times resulting in drugs being manufactured by only one or two companies. “When one drug company goes down, it causes a tsunami within the marketplace,” says Colgan.
On a day-to-day basis, in the pharmacy departments of Chicago’s major hospitals, resolving an economic crisis can only take up so much of your time. Patients need care, and they rely on the physicians and pharmacists who work with them to provide it.
“I wish I had some answers, but I don’t,” says Carro. “I think we’re all in the same situation. But we have spent an unprecedented amount of time and effort, and the thing we’ve done very well is communicate.”
“It takes a while to ramp up production,” Colgan says. “[A manufacturer has] to make sure [it has] adequate raw materials… you just can’t do it overnight.”
In a time when they can’t rely on the marketplace, those in charge of the area’s drug supply rely on each other. When Provena Saint Joseph hospital in Joliet needed to borrow 12 grams of the cancer drug methotrexate, Rush sent it to them.
“It’s going to dramatically drop our supply,” says Schultz, “but it means they’re going to be able to treat that patient.” Colgan adds, “That happens weekly, if not daily. That’s what our life looks like in terms of managing drug shortages.”
Sometimes, a hospital can find the drug it needs by going directly to the manufacturer rather than the distributor. But even then, the manufacturer can only release a minimum amount, based on the volume of the hospital’s previous use and orders. So, if there’s a surge of patients needing a certain drug that is in shortage, the hospital might be able to get some, but not all, of the necessary meds.
“You have to be flexible every day and modify your resources and work flow,” says Carro. “You have to adjust to it.”