Articles for Advocacy

What’s Behind the Persistent Shortage of Lifesaving Epi-Pens©?

Big Pharma, get your act together! Since 2017, Epi-Pens© have been in short supply, causing much concern in the allergy community. Pfizer, which manufactures the product for Mylan, says their production is improving but supplies will continue to be tight. The problem began in 2017 when inspectors noticed chips in the glass cartridges and bent or broken needles. Fortunately there are now alternatives to Mylan’s Epi-Pen that you can read about in the article below. Teva, for example, reports they have a good supply, and Mylan Customer Service says they will help anyone find a pharmacy to fill their prescription. You can read all the details of this unfortunate situation below.

What’s Behind the Persistent Shortage of Lifesaving Epi-Pens©?

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[AP]
In this July 8, 2016, file photo, a pharmacist holds a package of Epi-Pen epinephrine auto-injectors, a Mylan product, in Sacramento, Calif. (AP Photo/Rich Pedroncelli, File)

By Bloomberg News
August 23, 2019

Mylan and Pfizer are still struggling with manufacturing issues for the EpiPen anti-allergy injector as the critical back-to-school season gets underway and a rival generic product hits the market.

Epi-Pens, which can help stop a severe or life-threatening allergic reaction, have been hard to get since at least May 2018, when the U.S. Food and Drug Administration said the device was in short supply. Former and current employees of Pfizer's Meridian Medical Technologies Inc., which makes the product for Mylan, said supply has been unsteady since at least 2017, when inspectors began noticing defects.

Pfizer spokeswoman Amy Rose said the drug maker is committed to resolving the supply problem.

"Our production output is improving," Rose said. "However, we anticipate supply to be tight as we enter the peak demand season."

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The Mylan Follies Starring Chief Executive Posts Closing Notice

After 12 years at the helm that included a 400% price increase in life-saving Epi-Pens plus a severe shortage, Chief Executive Officer Heather Bresch is retiring from Mylan. The company is now merging with Pfizer’s off-patent drug business to form a new company yet to be named. Read the article below about the good and the bad performance by Mylan under Bresch’s leadership. We can only hope for improvement in the future.

The Mylan Follies Starring Chief Executive Posts Closing Notice

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Mylan CEO Heather Bresch
Illustration by bigjon

The personal views of an activist for anaphylaxis prevention

Op-Ed opinion article written by Jon Terry
August 12, 2019

This article is a summary of recent business activities involving Mylan Pharmaceuticals and Chief Executive Officer Heather Bresch. All the text material was obtained from news sources readily available on the World Wide Web. The opinions expressed by Jon Terry are solely his own and are not necessarily endorsed by the Allergy Advocacy Association.

After a long run, the final curtain has fallen for Mylan Pharmaceuticals Chief Executive Officer Heather Bresch. And she might be thinking “… not a minute too soon, thank heaven.” Rave reviews for her performance may be few and far between.

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Mother Advocates for NYS Governor's Signature on Gio's Law

Gio's Law passes NYS legislature

It’s every allergy parent’s nightmare to lose a child due to anaphylaxis, but in memory of her son, Georgina Cornago Cipriano is determined to advocate for legislation to prevent this tragedy from happening to another family. “Gio’s Law” would authorize certain law enforcement officers and firefighters to possess and administer epinephrine. It was recently passed by the New York State legislature and is awaiting Gov. Cuomo’s signature. Read below about Georgina’s many efforts to encourage others to get educated and be proactive in creating an allergy treatment plan for their children.

Mother Advocates for NYS Governor's Signature on Gio's Law

Giovanni (left) and his mother Georgia Cipriano (right)
Giovanni (L) and his mother Georgia Cornago Cipriano (R)

By Kristen Stewart
July 15 th, 2019

Everything can change in an instant for anyone living with life threatening allergies. Georgina Cornago Cipriano knows this all too well — and is working hard to make sure other families don't have to experience the same heartbreak that hers has.

Her son Giovanni was a happy, healthy baby. Even as he grew and was diagnosed with allergies to peanuts, eggs, cats, dogs, mold and hay fever he remained active in school, sports and activities. He had a few encounters with peanuts over the years that resulted in vomiting, hives, and a bit of a tingly or scratchy throat but his issues resolved after a dose of an antihistamine.

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Albany Update in Light of Ongoing Epi Shortages and Possible Price Fixing

It was great to have the chance to meet in person with our legislators at our Food Allergy Awareness Day, and we are gratified for all their support of our efforts. However, we remain concerned about recent actions by large pharmaceutical companies who produce epinephrine and its generics. There are reports of possible price fixing, intentional shortages, and expiration dates that are much too brief. Read below about our specific concerns and what you can do to help.

2019 May 19 Albany Food Awareness Event-AM Thomas J. Abinanti, AM David Buchwald and Jon Terry
(R to L) AM Thomas J. Abinanti, AM David Buchwald and Jon Terry.
Photo by N. Kemp

Successful Food Allergy Awareness Day Event, but the Epi Crisis Becomes More Complicated

By Jon Terry
June 8th, 2019

Greetings from western New York. For the past few years, New York State lawmakers have enthusiastically sponsored Food Allergy Awareness Day at the state capitol in Albany. The Allergy Advocacy Association acted in concert with AM Thomas J. Abinanti and NYS Senator Gustavo Rivera with planning and scheduling for our event held on May 15th. We hosted more than thirty adults and children, most of them coping with life-threatening allergies each and every day. Our event featured many meetings with Senators, Assembly Members and their staffs; most lawmakers did express support for our program of action. At our exhibit booth in the Legislative Office Building, reporters for local media outlets conducted several interviews with lawmakers and visitors. In my opinion I think it was a great day! Our association firmly believes this annual event is very important for all individuals and families at risk for anaphylaxis in New York State.

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EAI Injectors Still in Short Supply

One of the main reasons we are traveling to Albany is to advocate for a bill that would allow pharmacists to dispense and offer training on the lowest cost EAI device to consenting patients, unless specifically prohibited by the allergist. Kristen Stewart gives us an update on Epi-PenTM availability at pharmacies in the Albany area, which is most likely similar to Rochester. Unfortunately the news is not great as shortages remain. David Bloom’s article provides a list of alternatives to brand name Epi-PenTM so be sure to discuss them with your doctor if you are having difficulties filling your prescription.

EAI Injectors Still in Short Supply

EpiPen World Wide Production Line cartoon

By Kristen Stewart
May 8th, 2019

The numbers are in and they aren't looking good for epinephrine auto-injector (EAI) availability.

As the EAI shortage passes the 18-month mark, many news outlets have covered the topic and moved on. At the Allergy Advocacy Association, however, we think we should be doing just the opposite. The fact that this life-saving medication is still so difficult to find even after all this time deserves more attention not less.

Toward that end, we conducted our own survey on availability. We contacted 10 pharmacies in the greater Albany area on March 7, April 11, and May 1 of this year to find out the status of their brand name and generic supplies. The news was not encouraging.

In March, four pharmacies had brand name Epi-PenTM while eight had generics. Only one had neither available.

The news was slightly better by April. One less pharmacy had the brand name but nine were carrying generics so something was available at almost every location. Unfortunately, again one pharmacy had neither — though it was a different pharmacy than the previous time indicating all were receiving some supplies and then running out again.

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Epi Near You New York Volunteers Spread the Word on Anaphylaxis

Educating the general public about preventing anaphylaxis is one of the main goals of the Allergy Advocacy Association. We are actively recruiting volunteers from the medical field to assist us in providing training to day care center teachers, recreation center staff, scouting organizations and school of nursing students, and are very appreciative of the volunteers we have thus far. This month we are spotlighting two of our volunteers who have had close calls with anaphylaxis themselves, so we hope this will inspire others to join us!

Damien Rzepka with daughter
Damien Rzepka with daughter
Sandy Glantz
Sandy Glantz

Epi Near You New York Volunteers Spread the Word on Anaphylaxis

By Suzanne Driscoll
May 7th, 2019

Your Allergy Advocacy Association is fortunate to have so many great volunteers for our Epi Near You New York anaphylaxis emergency training program. Many of them are from the healthcare field who donate their time and talents to training a variety of audiences in the Rochester area. They educate teachers at daycare centers, nursing students, and counselors at summer camps and recreation centers on the dangers of anaphylaxis and how to administer epinephrine. This month we would like to spotlight two of our volunteers, Damien Rzepka and Sandra Glantz. If you are interested in becoming one of our ENYNY trainers, please give Jon Terry a call at 585-319-6848.

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Food Allergy Awareness Day!

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Activists attending Food Allergy Awareness Day; May 2018 in Albany, NY

Our Association supports annual event at the New York State Capitol

April 15th, 2019

The Allergy Advocacy Association will be making our annual trip to Albany for Food Allergy Awareness Day on Wednesday, May 15, 2019 from 9am – 2pm. This event is sponsored by NYS Senator Gustavo Rivera and AM Thomas J. Abinanti. We will be there supporting individuals and families with life-threatening allergies, starting with a media event at 12:00pm followed by meetings with state legislators later in the afternoon. Please help our important program of AWARENESS, ALERTNESS and ACTION by joining us in our advocacy efforts. Here are all the location details as well as a few of the newly proposed bills intended to improve access to life-saving epinephrine in New York State.

Wish us luck and we hope to see you there!

Food Allergy Awareness Day!
NYS Capitol Albany, NY
Legislative Office Building
198 State St, Albany, NY 12210
Wednesday, May 15, 2019 9am-2pm
Exhibit Location: Glass doors
at the LOB entrance on the
Concourse level
 

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Allergy Advocacy Association Donates Funds for EAI devices at Roberts Wesleyan

When college students are living away from home for the first time, it becomes more of a challenge to avoid certain foods and other allergens. We were pleased to donate $1,100 to Roberts Wesleyan College recently for the purchase of three packs of epinephrine auto-injector (EAI) devices to be stocked at various locations throughout the campus. Health Center coordinator Blandine Burks was very grateful to receive our donation and describes how the pens will be used.

Roberts Wesleyan College logo

Our Association awards grant to stock NPS EAI devices on Campus

By Suzanne Driscoll
April 12th, 2019

“Thank you for your generosity, support and breath of life!” says Blandine Burks, Coordinator of the Health Center at Roberts Wesleyan College. The Allergy Advocacy Association was pleased to award Roberts Wesleyan College $1,100 for the purchase of three packs of epinephrine auto-injector (EAI) devices to be stocked, with one for the health center, one for the athletic trainer and one for campus safety.

As authorized by New York’s Emergency Allergy Treatment Act (EATA), the college is making epinephrine available for students, staff and visitors as needed. With a non-specific epinephrine prescription, trained college staff will be able to administer epinephrine to anyone suffering from anaphylaxis.

Ms. Burks heard about the Association’s grant program while attending a training session at St. John Fisher College last fall. Previously, the health center and the athletic trainer split an Epi-PenTM pack with each person taking one pen. At the training given by Dr. Syed Mustafa, they realized in a serious anaphylaxis situation a person usually needs to receive two applications of epinephrine, so they no longer share EAI device packs.

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EAIs Still in Short Supply

It’s a scary situation when you go to fill a prescription of a brand name EAI device and there are none available. With a shortage still going on particularly for pediatric dosages, there are some viable alternatives such generic brands and the AUVI-Q. For more information on alternatives to the Mylan Epi-PenTM and an editorial on the current situation, see the full article here:

EAIs Still in Short Supply

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Illustration by Jon Terry

March 15th, 2019
By Kristen Stewart

With spring almost here we can see changes all around us from warmer weather to longer days. Unfortunately, we are not seeing anything different when it comes to the availability of epinephrine auto-injectors (EAIs).

A recent survey of pharmacies in the Albany, New York area found 60% had no brand name EAIs in stock, and of those who did they were often in very short supply and/or didn't have all dosing options available. Generics fared a bit better with 80% of polled pharmacies reporting having one or more at their store in at least one dosing amount.

A similar situation was echoed by Dr. Steve Moore, President-Elect of the Pharmacists Society of the State of New York, and a pharmacist in Plattsburgh. "There is still a shortage from what we're seeing," he said. "The brand name EAIs are unavailable. There's an issue with the pediatric dose and some of the generics in particular are not available in either strength. We have one generic and it's the adult dose and we don't have any of the pediatric. So while we do have something we don't have everything."

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Standard Anaphylaxis Action Plans are a MUST

Your Allergy Advocacy Association was concerned to find out there is not a standard Anaphylaxis Action Plan form used by doctors to communicate with a child’s school. We were also surprised to learn that many pediatricians as well as allergists are recommending that Benadryl be administered first for any signs of an allergic reaction, serious or not. We interviewed school nurses as well as allergists for their opinion on the matter and uncovered a lot of issues with how schools are being informed about allergies in children.

Standard Anaphylaxis Action Plans are a MUST
for ALL NYS Central School Districts!

Action Plan sign

By Suzanne Driscoll March 15th, 2019

How to communicate effectively with your child’s school regarding life-threatening allergies remains a challenge for many parents. In addition to the school nurse and classroom teacher, there are coaches, after school activity leaders, bus drivers and substitute teachers who must be informed on what to do in an anaphylaxis emergency. Instructions from doctors range from information on an annual school physical form to specific orders and action plans. Even then nurses are often left guessing if the allergy is mild with a slight rash resulting—or is life-threatening.

The Allergy and Asthma Network developed an excellent form to give to all school and summer camp personnel called an Anaphylaxis Action Plan. (See below.) It clearly states that epinephrine should be administered FIRST for any signs of a severe allergic reaction. Your Allergy Advocacy Association became aware of this form and others like it at a recent conference and decided to ask school nurses whether a form such as this is ever used, and if not, how do they learn about a child’s allergies and what to do in an emergency. We were concerned to find out that many pediatricians as well as allergists are indicating that Benadryl be given first, even when signs of anaphylaxis are present.

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Now Is the Time for Generic Epinephrine in New York State

If you carry an Epi-Pen, you are likely very much aware of the worldwide shortage of epinephrine since November of 2017. The price has also been skyrocketing. The upside is that this has brought more competition into the marketplace, as well as an effort to pass legislation permitting a generic to be substituted by a pharmacist whenever a patient is prescribed a brand name EAI device. Unless the doctor notes the prescription must be “dispensed as written,” a generic could be easily dispensed as long as it is the same dosage and strength and contains the same active ingredients. Read here about current efforts to get this legislation passed and other alternatives to the Mylan Epi-Pen.

Now Is the Time for Generic Epinephrine in New York State

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February 14th, 2019
By Jon Terry

Greetings. Concerning the New York State legislature and the 2019 session, recent developments have encouraged the Allergy Advocacy Association in our ongoing efforts to improve access to life-saving epinephrine for all individuals with life-threatening allergies. Those developments include substitution of generic drugs for brand-name medications. If new laws are enacted encouraging the use of generics by patients and consumers, lives will almost certainly be saved.

Up to 15 million Americans have food allergies, according to Food Allergy Research and Education (FARE), including about 5.9 million children under age 18, or 1 in 13 children. Many others are allergic to medication, latex, insect stings, or other triggers that can cause a sudden, potentially life-threatening reaction called anaphylaxis. Prompt administration of epinephrine is essential in an anaphylaxis emergency. 

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