EpiPen shortage causing concerns

Q. What is the latest protocol for anaphylaxis reactions? How does that change with the recent problems in accessing Epi-pens?

A. The EpiPen has been the mainstay of treating sudden, severe and potentially fatal allergic reactions for decades. It has recently received a lot of media coverage due to the inability of its manufacturer to supply the necessary amounts to meet consumer’s needs throughout Canada and the United States. Before we address the reasons behind this shortage, and more importantly, how best to manage it,

I thought we should take minute to address just what an anaphylactic reaction actually is. They are generally characterized as extreme allergic reactions in response to exposure to an allergen (a substance that causes an allergic reaction) which are typically foods, insect stings or medications. In anaphylaxis, your immune system overacts to this allergen by releasing a cascade of chemicals that causes significant changes to occur suddenly to multiple parts of your body. Typically, this occurs within 5 to 30 minutes of coming into contact with the allergen but some cases may have a delayed response causing the reaction to hold off for more than an hour before presenting itself.

Symptoms usually affect more than one area of the body and may include:

* a red rash with hives/ welts that are usually itchy,
* a swollen throat or swelling in other areas of the body (e.g. tongue, lips..),
* wheezing,
* difficulty in breathing,
* a sensation of tightness in the chest,
* coughing,
* vomiting,
* difficulty in swallowing,
* a hoarse voice,
* a metallic taste in the mouth,
* upset stomach,
* diarrhea,
* a change in skin tone (typically the face or body can become paler or redder),
* headache,
* dizziness,
* a weak pulse,
* passing out (possibly due to a sudden drop in blood pressure),
* uterine cramps
* and an overall feeling of dread or anxiety.

Not surprisingly, given the range of possible symptoms listed, an anaphylactic reaction can vary a great deal in its presentation in different individuals and even within the same person from one reaction to the next. Regardless of presentation, anaphylaxis requires prompt medical treatment followed by a trip to the local emergency department. Yes, every episode needs to be followed up at an ER!

The drug of choice for many years has been an injection of epinephrine (one of the main naturally occurring neurotransmitters in our body) and this chemical has literally saved countless lives. Traditionally, this has come in the form of what we call an Epi-Pen.

This device is a user friendly, simple and quick mechanism for delivering the drug in a 2-step process that virtually anyone can follow and perform. All that is required is the removal of a blue safety cap (by pulling it off) and then pushing the orange tip firmly into the mid-outer thigh until you hear a click which indicates the needle hidden within has been “activated” and is now administering the medication. The EpiPen should be held in place for a few seconds (it is suggested to count to 10) before being removed from the leg and the orange cover will automatically extend to cover the needle to ensure no one else is accidentally “pricked”.

The EpiPen is designed to penetrate right through clothing and comes in a protective tube which helps ensure it doesn’t get damaged while it is being toted around in purses, cars, backpack.  The rule of thumb in treating a possible anaphylactic reaction is to use the EpiPen if there is even a shred of doubt as to how severe the reaction might be. Failure to promptly administer it can result in an avoidable death and a person is at no more risk of side effects from an EpiPen regardless of their actual need for it.

If the recipient has failed to respond within 5 minutes, “ideally” a second dose should be given (as the patient is being driven, or waiting for an ambulance if necessary, to the hospital of course). Side effects typically are minor and may include dizziness, a fast or pounding heartbeat, a feeling of nervousness, nausea, a headache amongst others. For the, vast, vast majority of people (there are a few drugs and heart conditions involving an abnormal rhythm which can cause the drug to have a more significant reaction) the drug can be administered without the need for a medical history which is great given how critical it is to give this as quickly as is possible.

Unfortunately, The EpiPen is in very short supply and pharmacies throughout Canada (and the States) are having to “manage” their supplies as best as they can. The reasons behind this shortage involve a number of problems (raw material shortages, recalls, slowdowns in production…) that have plagued the only plant that makes the EpiPen (located near St. Louis) and now our country is at risk of running out of the product entirely. This situation is expected to last months and may well drag into next year. There are also no competitors left anymore as these products have all left the market years ago for a variety of reasons.

Pharmacies are doing their best to deal with this shortage by:

* Only giving out one EpiPen per patient. Most people traditionally get, and should get, multiple EpiPens at a time as a study has shown that 12% of adults and 3% of children require a second injection before they reached the emergency department,

* Limiting EpiPens for people with a known history of severe allergic reactions. Normally we encourage people with even mild swelling (like on an arm that was stung) to carry an EpiPen as reactions frequently become more severe with repeated exposures to the same allergen

* Encouraging people who live close to a hospital and therefore can access medical treatment quickly there to try and do without.

None of these solutions is anything close to ideal and patients are rightfully frustrated and anxious about this. However, there is nothing your pharmacy (or doctor, or government) can do about this other than try to cope as best they can.

EpiPen’s have an expiry date printed on them and studies show that with proper storage (room temperature, out of direct light, not in a fridge) they remain effective for up to 4 years past this date so hold on to expired ones unless the fluid inside has turned from clear to a brownish-yellow colour (in which case it probably won’t work).  As well, some pharmacies have ampoules of epinephrine (also known as adrenalin) available and these can be broken (they come in a glass container), drawn up in a syringe (the amount used is very, very small (0.3ml) so training is critical) and “jabbed” into the thigh. This obviously is a slower and more complicated process than the EpiPen but is far better than nothing. Lastly EpiPen JR is still available at the moment.

The EpiPen Jr is made for children who weigh between 15 and 30kg (33 to 66 pounds) so most people require the dose contained within the regular EpiPen. Two EpiPen Jr.’s provides the same total dose as a single regular EpiPen. The price is double (since you’re using two and they cost the same) and you need to give two shots, obviously, but it works the same as the regular one so no new training is required.

As always, regardless of what you have to give, if anything, it is absolutely vital you head to the hospital as soon as is possible (note, if you have the allergy pill Benadryl on you then take it. If not, don’t bother taking the time to get it even if it’s upstairs.