EpiPen shortage persists for some

When he was 13 months old, Keenan Oswald's mom gave him a taste of a new treat: peanut butter toast.

"He stuck it on his tongue, spit it out, and then his head just swelled up with hives all over," said his mom, Alanna Oswald.

A doctor told the Oswalds, who live in West Duluth, to keep their son away from peanut butter. A couple of years later Keenan was diagnosed with asthma and a severe peanut allergy.

Since then, the Oswalds have relied on an EpiPen, an automatic injection device designed to safely and simply deliver an exact amount of the drug epinephrine as a first-line defense should Keenan, now 18, have an allergic reaction.

But his current EpiPen is out of date. The yearly visit to the allergist in June resulted in the annual prescription for an EpiPen. Roughly three months later, that prescription still hasn't been filled, said Alanna Oswald, who is a Duluth School Board member.

A nationwide shortage of EpiPens created a furor in August, with parents alarmed that they might have to send their children to school without an EpiPen, or with one that has expired.

The devices are made by pharmaceutical giant Pfizer and distributed by Mylan.

The shortage seems to be waning, said Richard Krikava, an on-site supervisor at the outpatient pharmacy in Essentia Health's First Street Building.

"It is still kind of short," Krikava said. "Right now, my wholesaler got in a big shipment of them, and they're rationing them out. So I'm going to get four, and I might normally order six or eight."

Even at the height of the shortage, Krikava said he was able to fill EpiPen prescriptions within a few days or refer customers to another pharmacy that could supply them.

Earlier this week, Doug White of LTC Prescription Providers in Proctor had one two-pack of EpiPens in stock. The device always comes in twos because a second dose might be required before EMTs arrive, Krikava said. White's wholesaler was out, though, so if he needed more there would be a back order. "So in summary supply is sporadic," he wrote in an email.

But like Krikava, he felt the problem was "on the way to being resolved."

Jason Varin, an associate professor in the University of Minnesota's College of Pharmacy, isn't so sure. The shortage existed long before the flurry of attention it got in August, Varin said, and four pharmacists he spoke with - two at chain drug stores and two at independents - said EpiPens continue to be hard to find. One hadn't received a shipment in six weeks.

It hasn't been resolved yet for the Oswalds, whose health insurance requires that they have prescriptions filled through the mail-order service Express Scripts, Alanna Oswald said.

As for turning to another source for an EpiPen, that would mean paying full price or close to it, and that would be cost-prohibitive, she said.

The price is high, Krikava agreed, even after an uproar over EpiPen prices two years ago led to congressional action.

Sen. Amy Klobuchar, D-Minn., in a 2016 letter to the Federal Trade Commission, cited news reports that the cost of a two-pack of EpiPens had risen from $100 in 2009 to $500 and even as much as $600 in 2016.

Today?

The current going rate is between $730 and $800, Varin said. The generic equivalent, also distributed by Mylan, costs about half as much.

That has little to do with the price of epinephrine.

"The cost of that drug is pennies," Krikava said. "You're paying for the device and the packaging and the convenience."

Why so much then?

"Because they've got you over a barrel," Varin said of Mylan. "It's increased almost constantly since 2007 when Mylan got the rights to this. You can look at them and say that's obscene and shame on them. Well, their role is to make money for their shareholders, not to improve public health."

There is a device called AUVI-Q made by a different manufacturer that costs less and does the same thing as an EpiPen, Varin said. But brand familiarity drives people to the EpiPen, especially when the customer is a parent and the device could be the difference between life or death for his or her child.

It's the device, not the drug, that's in short supply, Krikava said. Hospital emergency rooms and ambulances have an ample supply of epinephrine.

As to why there's a shortage, we don't know, Varin said, because the manufacturer and the distributor aren't required to tell us. He posited a cynical explanation: "It appears that sometimes shortages occur on important things and the product gets 500 percent more press because of the shortage."

Keenan Oswald, who graduated from high school this year and is enrolled in the carpentry program at Lake Superior College, has never had to use an EpiPen, his mother said. They are banking on the expired device he carries now still having some potency and taking solace in the fact that the liquid isn't cloudy.

They may be right on both counts, pharmacists say.

If a replacement EpiPen isn't available immediately, he tells patients not to throw away the old one, Krikava said. "Of course, drugs don't deteriorate in an instant. They deteriorate slowly over a period of time."

In fact, the Food and Drug Administration announced safe-use dates beyond the original expiration dates for certain EpiPens. For example, Lot number 7GM048, with an original expiration date of Sept. 18, can be used safely through Jan. 19. The complete list is available at fda.gov/Drugs/DrugSafety/DrugShortages. The extensions don't apply to generic versions or to EpiPen Jr.

The Oswalds are right to pay attention to what the liquid looks like, Varin said. Regardless of the expiration date, the liquid shouldn't be cloudy, and it should be colorless.

Some studies have shown that epinephrine, if stored properly, can retain up to 90 percent of its potency years past its expiration date, Varin said.

To get help

If you're having trouble getting an EpiPen prescription filled, call Mylan consumer relations at (800) 796-9526. Hours are 6 a.m. to 7 p.m. Monday through Friday.