A nationwide prescription drug shortage is being felt here in Maine.
Dozens of medications are in limited supply, including some used to treat cancer and life-threatening emergencies. Some patients have had to change or delay treatment. And pharmacists have been trying to manage a constantly evolving mix of substitutions and doses, which they say opens up a greater chance for errors.
A recent report from the Food and Drug Administration found that the problem has worsened in recent years and has no simple solution.
Wayne Davis always figured it would be his heart that would give him problems. But two years ago, the 83-year-old from Topsham discovered blood in his urine. He went to his doctor, who discovered the problem was with his kidney.
“They said it has to go, because it is cancerous,” Davis says.
The kidney was removed successfully. But Davis says that during the procedure, doctors discovered he also had bladder cancer. He underwent three more surgeries and began a regimen of immunotherapy to prevent a recurrence. But after several treatments, Davis says when he went in for the first of his final three infusions, his doctor delivered more bad news.
“He said, ‘We can’t do this. I can’t give you the serum anymore. You can’t have the last three infusions. I’m only allowed to dispense it to people who have cancer.’ Which in my mind, I was going a little nuts. What does that mean? If the cancer comes back, then all of a sudden you can give me the wonder drug again?” Davis says.
The treatment, it turns out, was being rationed due to a nationwide shortage. And it’s not the only drug that’s in short supply.
“We’re managing today about 40 different drug shortages across MaineHealth,” says Brian Marden, the chief pharmacy officer at MaineHealth.
Marden says the effects of these shortages are significant for patients and providers.
“When you look at pharmacy programs in hospitals, they’re confronted with it on daily basis, if not minute-to-minute basis as far as what they’re trying to manage,” he says.
In some cases, hospitals say they can’t get the amount they need. In other cases, they can’t get drugs in the form they need.
Karen Philbrick, the pharmacy director at LincolnHealth, says that’s the situation now with emergency syringes, which are filled with drugs like epinephrine and used in ambulances and emergency rooms.
“We simply cannot get our hands on these prefilled syringes currently,” she says.
Philbrick says pharmacists now have to create kits of the medication that providers have to mix in the moment when an emergency arises.
“So you’re standing over a patient who may not have a pulse, and you need to administer epinephrine. Seconds count in that scenario, so you really want to be able to grab a syringe that’s already ready for you to administer. You don’t want to have to grab a Ziploc bag in a kit form and read instructions on how to make it yourself,” she says.
It’s a situation that also opens up room for error, says Tom Moniz, pharmacy operations manager for Northern Light Eastern Maine Medical Center. He says the center’s pharmacists have to manage an ever-evolving mix of medications and doses.
“When you’re constantly changing the brand of product or the specific version of the drug that you have, the effort to maintain that safety is enormous,” he says.
An FDA report released in October found that the majority of drugs in short supply are generic injectables. The report also identified cost as a major factor in the shortage. Not high costs, but actually low costs, Marden says.
“They tend to be on average less than $9 a dose,” he says. “So these are not the drugs that are on the headlines for outrageous or astonishing price levels. These are drugs with a whole other economic market to them.”
And because they are less profitable, fewer manufacturers are motivated to make them. Marden says some drugs now have just one manufacturer, and when demand exceeds supply, there isn’t the capacity to ramp up production.
“I think it, from my perspective, is absolutely outrageous what certain drugs are priced at. But those lower cost drugs, certainly I think we’ve discovered what happens when you drive them down to certain price point. And it means that we’re just struggling to deliver every day care,” he says.
The FDA has recommended financial incentives for manufacturers to produce less-profitable drugs. And a bipartisan bill recently introduced by Republican U.S. Sen. Susan Collins of Maine aims to resolve the drug shortage in part by requiring manufacturers to report the cause and expected duration of shortages and to make contingency response plans.