6 things to know about the EpiPen shortage

The nationwide EpiPen shortage is being felt, especially as children head back to school.

Back-to-school season is the most common time to restock EpiPens because schools often require students with serious allergies to have two EpiPens in the nurse's office in case of allergen exposure, and parents also want to have some at home.

But here's the issue: The pens have a short expiration date, and they are in short supply.  

Here are six things to know about the EpiPen shortage:

1. When did it start? The FDA issued a supply shortage alert for EpiPen and other epinephrine auto-injectors May 9, after patients and pharmacists in 45 states reported it was difficult to find the lifesaving allergic reaction treatment. The supply shortage has worsened in recent weeks as demand for the pen spiked.

2. Why is there a shortage? Mylan, which markets and distributes EpiPen, attributed the supply shortage to manufacturing delays by its manufacturing partner, Pfizer. The two pharmaceutical companies say they are working with the FDA to find solutions to the shortage.

3. What other factors contribute to the shortage? EpiPens, which contain the notoriously unstable drug epinephrine, have a typical shelf life of about 18 months. If epinephrine is exposed to light, heat or air, the drug can disintegrate and turn rust-colored. This means consumers must restock about once a year.  In addition, as demand increases during the back-to-school push, the shortage worsens.

4. What has been done to combat the shortage? To combat the shortage, the FDA extended the expiration date of some lots of EpiPen and its authorized generic by four months. The extension applies to 0.3 milligram doses of EpiPen and its generic with current expiration dates between April and December of this year. The decision to extend shelf life came after the FDA reviewed epinephrine stability data presented by Mylan.

5. What are Pzifer and Mylan doing to alleviate the shortage? Mylan said it is working closely with Pfizer to help stabilize supply. The company said in a news release it is "expediting shipments upon receipt from Pfizer" and staying "informed of anticipated shipments."  Pfizer said it is "working tirelessly to increase production and expedite shipments as rapidly as possible."

6. What about the new generic? On Aug. 16, the FDA approved Teva's generic version of both EpiPen and EpiPen Jr. — the first generic competitor to Mylan's EpiPen. In 2016, Mylan introduced its own generic version of EpiPen after a public outcry over the branded version's price, which has jumped more than 450 percent since 2004. The generic version costs $300 for a two-pack, compared to the brand-name version which costs $600. While this generic version brings hope, it may not launch soon enough for the families urgently looking for supply now. Teva said it is applying "its full resources to this important launch in the coming months and is eager to begin supplying the market,"  but it didn't specify a launch date or price.

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