As Michelle Cruz readies her son Benicio for the new school year, books and binders aren’t the only items on her back-to-school list.
The East Meadow family's most pressing need is actually for EpiPens, which experts say are in short supply on Long Island. EpiPens are injected into the thigh to stop severe reactions triggered by food allergies or bee stings.
Eleven-year-old Benicio, a seventh-grader, has a serious peanut allergy.
“The EpiPen is his lifeline,” Cruz, 43, said.
The device's scarcity is caused by manufacturing issues and supply disruptions, said Dr. Dean Mitchell, an immunologist and allergist with an office in Rockville Centre. Supplying this medication is a major concern, he said, including at hospitals, which are also facing shortages.
When Cruz visited her pharmacy in Westbury earlier this month to purchase EpiPens, which her son's school requires, her pharmacist told her they were on back order with no supply date.
A widespread shortage of the device could mean some children will return to school without the medication that prevents them from going into anaphylactic shock if they are exposed.
Cruz said she has enough to last her through January, when her son's medications expire.
"The good news is there are some alternatives to the EpiPen," Mitchell said.
Among them: Auvi-Q injector pen, made by Kaléo, which is in stock.
Patients can also request their doctors prepare ampuls of epinephrine — the same medication inside an EpiPen, which is far less expensive than Auvi-Q. The ampuls can vary in dosage and must be refrigerated. They are sensitive to sunlight, so Mitchell recommends those prescribed ampuls store them in an eyeglass case. It is the cheapest of the medical options for those who typically carry EpiPens.
“It’s a lot like patients who are diabetic that use insulin,” Mitchell said. “It’s an option that can give patients peace of mind.”
EpiPens expire 18 months from the day they are manufactured. Sales of the pens typically spike this time of year, experts say, as parents purchase required doses to leave at school and to keep with children and themselves.
The Cruz family fills two EpiPen prescriptions a year. Each prescription contains two injectors. Benicio is required to supply his school with three injectors, one to be stored and one each for him and the school nurse to carry.
There are 15 million adults and 6 million children with food allergies, Mitchell said. Of those, 2.4 million children have had a life-threatening incident, he said. Three companies currently make the epinephrine devices, and Mylan, which is manufactured by Pfizer, dominates the market, Cruz said.
The Food and Drug Administration on Thursday approved the first generic version of EpiPen made by Teva Pharmaceuticals USA, providing new competition that could help drive down the cost.
Last year, Cruz dealt with a steep price hike of the EpiPen. Mylan’s decision to raise the price 500 percent to more than $600 for a two-pack sparked national outrage. Cruz said she spent six times the amount to fill a single two-pack prescription than she did four years ago.
Cruz said Benicio has never required an EpiPen injection, which she attributes to carefulness and preparation. But as September quickly approaches, anxiety is setting in for the Cruz family.
“It’s unfair for families to have to worry about this,” Cruz said.
How EpiPen works
EpiPen is an injection device containing epinephrine, a chemical that narrows blood vessels and opens airways in the lungs.
The drug can reverse severe low blood pressure, wheezing, severe skin itching, hives and other symptoms of an allergic reaction.
The medication is used in emergencies to quickly treat serious allergic reactions to insect bites/stings, foods, drugs or other substances.
During a severe allergic reaction, a person's blood pressure plummets because the blood vessels relax and dilate. Epinephrine causes the blood vessels to constrict, raising blood pressure.
The thigh is the ideal injection site because it results in the fastest rise of epinephrine in blood levels.
Source: Mylan, maker of EpiPens