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Tag: Epipen

Dear Dr. K; 

Dear Dr. K; 

I heard on the news that there is a new nasal EpiPen, can it really work for anaphylaxis? 

The short, simple and sweet answer is “yes”.  But if you’ve read this newsletter previously you know how I like to elaborate on simple answers.    

The FDA did recently approve “Neffy” a single dose nasal spray containing epinephrine.  It can be used in adults and children who weigh 66 pounds or more.  There is a pediatric spray for smaller children that is also undergoing clinical trials.   

In addition to being “needle free” some additional advantages over the injectable forms (EpiPen and AuviQ) are its compact size, heat stability and ease of use.   

As you may know the mucus membranes in the mouth and nose provide a medium for almost instant absorption of medicines and recreational drugs.  Speaking of recreational drugs, far too many Americans die from opioid overdose.  In this regard the nasal spray Narcan has saved many lives.  Narcan (naloxone) is an opioid antagonist, and the spray is immediately absorbed and can prevent death from an overdose.   

In terms of medications Calcitonin nasal spray is an option for treating loss of bone density (osteopenia/osteoporosis).  It is a salmon derived bone building hormone that is absorbed intact through the nasal membrane.  If it were swallowed its breakdown in stomach would render it useless.   

Two commonly used “instant onset medications” that are absorbed in the mouth are nitroglycerine for angina/heart attacks and ondansetron for relief of nausea/vomiting.    

Currently 33 million Americans have a prescription for injectable epinephrine with this many people at potential risk for anaphylaxis it is not difficult to appreciate that unfortunately there have been some deaths due to fear of injection or due to inadvertent mishap while trying to inject the medicine.  The simple single dose nasal spray should prevent these issues.   

Because of its ease of use and safety it is also being studied for possible use to treat acute severe hives and acute severe asthma.  But the jury is still out in these applications.  However, if it is approved for these situations keep in mind that it is an urgent stop-gap, and as is true with its anaphylaxis application, immediate urgent care is still necessary.   

Prefilled Adrenalin Syringe

Prefilled Adrenalin Syringe

Adamis Pharmaceuticals has developed a prefilled epinephrine syringe as a cost-effective alternative to the automatic injectors.  Currently, the only two available injections for epinephrine to treat severe allergic reactions are Epipen and Auvi=Q.  Both work automatically to insert the needle and then deliver the medicine.  However, both are expensive and cost constraints have led to some adults and children going without the protection.

The new prefilled syringe requires the patient or a caregiver to remove the needle shield, insert the needle into a muscle, then push the syringe to deliver the medicine and finally to remove the needle.

When studies were conducted on volunteers with no medical background 99% were able to successfully administer the medicine.  This new tool called “Symjepi” has been FDA approved and provides a cost saving alternative to the auto-injectors.

Pharma companies give free meds for school adrenalin emergencies

Pharma companies give free meds for school adrenalin emergencies

The two pharmaceutical companies that produce the two available forms of auto-injector adrenalin to deal with anaphylactic (allergic) shock are offering a program of free epinephrine doses to schools. The companies are Mylan, which makes the EpiPen, and Kaléo, maker of Auvi-Q.

Epinephrine, as many know, must be on hand to treat food allergy and insect sting emergencies.

Even with insurance coverage, these drugs have become very expensive. For some families this expense limits the purchase of the adrenalin to a single unit at home, but not one at school. Through this program, the medication can be placed in a child’s school, but access would be allowed to any student in peril.

Each company will provide both doses of epinephrine – the .15mg and the .30mg.  Mylan offers the medicine to all schools — public or private — and to all grade levels. Kaléo offers it to public grade schools. To request the medications be placed at your child’s school, visit EpiPen’s site at info@bioridgepharma.com and you’ll find info on the EpiPen4Schools program. For Auvi-Q: https://www.allergicliving.com.

You’ll need to give the name and address of the school and send a physician’s prescription with the request.

Dear Doc: How long can I count on my Epipen?

Dear Doc: How long can I count on my Epipen?

Dear Dr. K: I keep an Epipen for “just in case,” but so far I have never had to use it. I keep replacing it when it expires, but it is expensive. Is it possible to use it past its expiration date? 

The answer is “yes, probably.”

The “probably” is based on the clarity of the liquid. If, when you look through the syringe and the medicine is clear, then it’s both safe and effective. If the liquid is yellow or cloudy, then discard it.

The Medical Letter, which is a nonprofit academic resource for physicians and hospitals seeking non-pharmaceutical company-biased information, actually addressed these issues in their December issue. They actually cited their research studies done on epipens.

The first study looked at pens that were from 1 to 90 months past their expiration. This showed a percentage reduction in potency correlated with the number of post-expiration months; i.e., pens one-month past expiration had 1 percent reductions in potency, while pens 90 months past had 90 percent reductions.

A second study evaluated pens 36 months past expiration and found them to be from 84 to 100 percent potent.

A third study looked at epipens stored on EMS vehicles that were from one to 11 years expired. These devices retained from 3 to 31 percent of their potency. The Medical Letter pointed out that exposure to greater heat in the ambulances will speed the degradation of the active medicine.

Data from the U.S. Department of Defense/FDA Shelf-Life Extension Program, which tests the stability of drugs past their expiration dates, showed that in a study of 3,000 different drugs 88 percent of them remained stable and fully active 66 months past expiration. High heat and humidity do accelerate degradation of many drugs.

This publication did say that ophthalmic (eye) medicines should never be used beyond expiration, even though the medication may be stable, because bacterial contamination occurs with repeat use. Authors also pointed out that certain dry powder inhalers such as Advair Diskus slowly absorb moisture once the device is removed from its foil container. This “gums up” the delivery in devices past expiration.