Fall 2012, Vol. 10, Issue 3



DIY Asthma?

In March 2012, the Food and Drug Administration held a pubic hearing in which Janet Woodcock, MD, Director of the FDA’s Center for Drug Evaluation and Research, posed the following questions: Should there be more flexibility in FDA’s concept of non-prescription drugs? Can FDA broaden the assistance that a consumer gets, for example, by augmenting a drug facts box with new technology resources or by using pharmacists to help the consumer understand the condition or treatment better, thereby increasing the types of medications that could potentially be available over the counter?

Woodcock2Where the paradigm addressed asthma and anaphylaxis, FDA suggested that “rescue” medications could be available for emergency situations. This terminology and notion left AANMA shocked and perplexed. Was FDA suggesting there were asthma and anaphylaxis medications that could be used instead of calling 911? Are pharmacies soon to take the place of emergency departments? Would we soon see self-diagnostic testing for all the different possible causes of asthma? Was this a cruel trick to dump healthcare costs for prescription medications out of Medicaid and Medicare?

Allergy & Asthma Network Mothers of Asthmatics and other organizations spoke out against the proposal. However, our voices were drowned out by pharmacy and consumer product associations – that is until Dr. Woodcock invited AANMA President Nancy Sander and Sandra Fusco-Walker, Director of Patient Advocacy, to meet with her and 15 FDA staff members at FDA headquarters in Maryland. Also present by phone were AANMA board member Martha White, MD, and Bobby Lanier, MD, representing the American College of Allergy, Asthma and Immunology.

Here is a small sample of our conversation:

Nancy Sander: Where did the proposal come from? Who and what is behind it?

Janet Woodcock, MD: Let me start by taking full responsibility for it. FDA needs more flexibility in its tools to make it easier for patients to have access to certain drugs under certain conditions of safe use.

Sander: Most people think the paradigm is an attempt to shift federal healthcare costs for the most expensive chronic illness directly to consumers. Rather than co-pays for medications and non-urgent medical care, we’ll pay out-of-pocket for medications recommended by kiosks, computers and pharmacists. How can this be considered safe use?

Dr. Woodcock: That is not what FDA wants to do. We need a better framework than the ancient one we have that says a drug is either sold over-the-counter or with a prescription.
Sander: The way the notice is written, the general public and many medical associations came to different conclusions. Do you have examples that would help us better understand what you are getting at?

Dr. Woodcock: Look at the success of the flu vaccine program in pharmacies. Everyone thought the relationship between a patient and their doctor would be affected, but millions of patients have been successfully vaccinated.

And then you have non-sedating antihistamines. When we had a public hearing a decade ago, AANMA was there. You testified there would be problems if non-sedating antihistamines were sold OTC. Many people agreed with you, but it has been 10 years and there’s been no problem. FDA is looking for better ways to do the same thing.

Sander: The first example was a public health issue whereby the U.S. averted a pandemic. The second example was not a public health issue. A health insurance company – not patients – appealed to FDA to make non-sedating antihistamines OTC.

But are we better off today? My answer would be no. Consumer access does not equal understanding of how or when to use the medications. Did OTC antihistamine access improve school and work performance and absenteeism among patients with seasonal or chronic allergies? No one is counting.

Many families are confused as to which OTC antihistamine to buy out of the many on the store shelves.

Dr. Woodcock: This is something you may hear and see because you are a patient advocate. In all cases of Rx and OTC switches, the FDA looks at a number of different factors including the safety and effectiveness of the product, whether consumer studies support a patient’s ability to self-medicate, and whether the labeling for the product is written in such a manner as to instruct the patient to use the drug properly. In cases of both prescription and OTC medications, patients may not use their medications appropriately. This, as you know, can and does lead to problems.

Nancy3Sander: The average person does not know how to differentiate between seasonal and chronic allergies, a lingering cold or sinusitis. How long to tolerate symptoms before self-treating or calling a nurse for advice … most don’t know to start using non-sedating antihistamines before the allergy season starts. By the time they head in misery to the store allergy aisle, what they really need are prescription topical nasal sprays and eye drops, inhalers and creams and instructions for using them.

Dr. Woodcock: FDA has the authority to select drugs on a one-by-one basis to determine whether a drug should be OTC or Rx. But what we are seeking here is a tool so that if a patient is in a special situation to self-select a drug through a condition of safe use, they can get their medication without having to get a prescription. With electronic prescribing, healthcare providers including pharmacists are in a good position to know all the different types of medications a patient may be on and if the patient needs to obtain additional medical care.

Sander: We don’t see how this applies to asthma and anaphylaxis. We have to get past the idea that asthma is a little cough that comes along and treatment is a self-selected puff away or that when it happens, you just run to the pharmacy, buy an inhaler and life is good. Eleven people die of asthma every day. Patients need a comprehensive diagnosis to know how to treat and prevent the causes of symptoms. They deserve physician and specialist-directed care and should be taught that asthma is serious and to keep bronchodilators closer than their cell phones.

And for epinephrine auto-injector refills, nothing could be easier. After using the device, you are supposed to report to a hospital where upon discharge you are given a refill for two devices that can be filled at any pharmacy.

I think one of the biggest problems with FDA’s paradigm is it characterizes albuterol and bronchodilators in general as a “rescue” therapy as if it was a life jacket. Look at the package insert. It clearly states that albuterol should be used at the first sign of symptoms and before exercise. It will not re-inflate or reopen fluid-filled and mucous-plugged airways. It never claims it will rescue a patient although this misleading slang terminology has made it into advertising.

People should understand that when you die of asthma, you are drowning in mucous and fluid. It is no more possible to re-inflate clogged airways than it is to blow up a glue-filled balloon. The same is true of epinephrine auto-injectors for anaphylaxis.

Dr. Woodcock: It is our intention for patients to use their products as directed by their healthcare professional and as described in the product’s labeling. This is why we are seeking input on the use of new technologies that may facilitate patients’ ability to self-select their medications, allowing for greater access to those drugs.

Sander: The NHLBI Guidelines for the Diagnosis and Management of Asthma no longer use such terminology. We respectfully request that FDA also discontinue the use of the term “rescue” as a synonym for any bronchodilator and remove the term from FDA documents and patient information.

Dr. Woodcock: That is a discussion that can be explored with the Division of Pulmonary, Allergy and Rheumatology Products.

Sander: Thank you. So we are clear, FDA does not intend for pharmacists or kiosks to rescue patients in peril by selling them inhalers or epinephrine auto-injectors in pharmacies during asthma and anaphylaxis attacks?

Dr. Woodcock: Patients experiencing an asthma attack or anaphylaxis should seek emergency medical attention. FDA agrees that all healthcare professionals, including physicians, play a vital role in the healthcare system and in no way seeks to undermine that role.

Sander: I think we’ve made the case to eliminate asthma and anaphylaxis from FDA’s proposed paradigm.

Dr. Woodcock: Well, we’re also considering how to help patients who don’t have access to health care and need drugs for other chronic conditions or diseases, not just allergy and asthma. FDA recognizes that the availability of OTC drugs has empowered consumers with self-care options to better treat and manage conditions and diseases that can be self-diagnosed and self-treated. FDA believes it is worthwhile to explore whether there are tools that could be used to safely expand the scope of drugs that are available for OTC use and how expanding the scope could lead to improved public health.

Sander: OTC access to medication does not necessarily mean patients are going to be well. OTC access does not necessarily mean medications will be more affordable. For example, private and public charitable foundations provide free Rx medication, medical care and co-pays to patients in need. In FDA’s Rx-to-OTC paradigm, those benefits evaporate.

How does the paradigm protect poor and middle class families with health insurance who lose prescription and doctor visit co-pays when the paradigm becomes reality? As it is, IRS requires a prescription for our OTC purchases if we want to be reimbursed through our Health Savings Accounts and our Federal Savings Accounts.

Dr. Woodcock: These are important points you raise. All of us are here today because it is important to listen to patients’ concerns.

Sander: Patients are under-represented in this discussion. We already have the tools necessary to improve healthcare outcomes while reducing cost in allergy and asthma.

Dr. Woodcock: This change will not happen overnight. We will continue to work with the public and we encourage feedback on this paradigm from patients and consumers. Let’s continue to work together.


Going The Distance

RunAbout one in 10 people experience bronchospasm during physical activity, whether it’s running a marathon, bicycling a few miles or swimming laps in a pool. Many don’t recognize the problem and simply avoid strenuous exercise.

Healthcare professionals call it EIB – exercise-induced bronchospasm. Airway muscle spasms constrict airflow and cause shortness of breath, coughing, wheezing, chest tightness and fatigue. It may happen during exercise, or not until after you stop. Often these symptoms are a sign of underlying asthma and lung inflammation. Sometimes, they are a totally separate condition.

A doctor experienced in EIB can tell the difference and recommend a treatment plan that may include medication, hydration and modifying your exercise routine.

“Warming up, cooling down, pre-treatment with albuterol and hydration will help the body function better whether your EIB is caused by asthma or not,” according to Timothy J. Craig, DO, Vice Chairman of the Asthma Diagnosis and Treatment Committee of the American Academy of Allergy, Asthma & Immunology (AAAAI).

Craig says a proper exercise routine for those with EIB should include 15-20 minutes of warm-ups. “Also, cooling down after a run may decrease post-exercise bronchospasm,” he adds.

Staying hydrated can also minimize symptoms. “It’s the dryness of the airway that causes EIB, which is more prevalent in cold, dry weather,” Craig says. “Control your allergies and rhinitis since the humidity provided by your nose may decrease dryness of your lower airway.”

In cold weather, cover your mouth and nose with a scarf or heat-exchanging mask to help with humidity and warm your breath, he advises.

Exercise And Endurance

Running a marathon with asthma was once unthinkable. It’s now well within reach of otherwise physically fit patients who know how to manage their symptoms.

“Make sure your asthma is stable before long distance runs and that you use your routine daily controlled therapy regularly if indicated,” Craig says. “Albuterol inhalers should be used 10 to 20 minutes before any moderate to aggressive exercise, even in well-controlled asthma, since recurrent EIB can lead to frustration and even result in a loss of commitment to exercise. And always keep your albuterol with you during exercise, in case you need it as you go.”

Other medications may be prescribed to keep lung inflammation and asthma in control.

“Inhaled corticosteroids, if used regularly when indicated, can have a very positive effect on EIB,” Craig says. “Montelukast and other leukotriene receptor antagonists may also help. Do not use long-acting beta-agonists unless required and indicated for asthma
control.”


ACE Team Spotlight: Sharing the Know-How

Joyce Schoettler, MD, is always astonished when a child with anaphylaxis does not receive epinephrine – in some cases even after arriving at the emergency room.

Why? Too many people don’t take anaphylaxis seriously enough, Schoettler believes. Some turn to over-the-counter antihistamines as a first line of treatment.

This is “dangerous” – a point that Schoettler, Edward Buchsbalm, MD, and the nursing staff at South Bay Allergy & Asthma Associates in Torrance, Calif., drive home as part of AANMA’s Anaphylaxis Community Experts (ACEs) program.

Like other ACE teams around the country, South Bay Allergy & Asthma Associates hosts workshops for parents and teachers. They hold sessions with employees from area businesses as well as a local women’s charity organization.

“It’s shocking to our audiences when we tell them the average time to full respiratory and cardiac arrest after ingestion of a food allergen is only 30 minutes,” Schoettler says. “This does get their attention and helps make the case for epinephrine use.”

South Bay Allergy & Asthma Associates recently hosted a presentation at Discoveryland preschool in Torrance where they instructed 20 teachers how to recognize anaphylaxis and when to use an epinephrine auto-injector

After the presentation, Schoettler noted that teachers seemed to be more confident about what to do in a food allergy emergency – no more second-guessing themselves.

“Preparation is key,” she says. “Having epinephrine available is life-saving, but it also takes a calm and collected caregiver to know when to use it and to do so without hesitation.”

Lisa Lin, RN, Ruena Mantes, RN, and Anna Chocholek, RN, of South Bay Allergy & Asthma Associates are proactive when speaking with parents who are hesitant to administer epinephrine – or even carry it.

“I spoke with a mom who didn’t know the importance of keeping the two epinephrine auto-injectors in the twin-pack together,” Lin said. “She thought it was more convenient to carry one device in her purse and leave the other at school. She had no idea that her child could experience another anaphylactic episode requiring her to use the second device. It was an awesome ‘a-ha’ moment.”

Mantes hopes that the ACE presentations result in a “chain reaction of awareness” as parents and teachers pass on what they learned.

Said Schoettler: “By bringing the ACEs message to your community, you teach those on the front lines how to respond to an anaphylaxis emergency and you help save lives in a very real sense.”


Ask the Allergist: Little Ears, Big Infections

By Talal Nsouli, MD
Q: Why does my baby get so many ear infections?
A: Nasal inflammation and congestion spreads easily to the middle ear, causing fluid to accumulate behind the eardrum. If this becomes infected, we treat it with antibiotics. But it’s important to look for the underlying cause, which is often environmental or food allergies. So if a child is congested for long periods of time or has three or more ear infections per year, it’s time to see an allergist.

Q: What happens during the evaluation?
A: We start with a full history to understand the intensity of the symptoms, then a physical exam, looking in the nose and the ears and a test to detect the fluid in the ear. If the symptoms suggest allergy, I move on to allergy skin or blood testing. Contrary to what some believe, babies can be tested for allergies. So when we know what the child is allergic to and how severe the allergy is, we can put together a management plan. Recurrent fluid buildup and infections can cause hearing loss, so if symptoms continue the toddler may benefit from surgery. Unfortunately, many doctors wait too long to intervene and stop the cause of the congestion.


All in Good Taste: Raising the Bar on Breakfast

Michelle_Fall_2012_FruitBar Blueberry Sunrise Fruit Bars

By Chef Michelle Austin

Fall is a great time to get your color on! Local farmer’s markets burst with a rainbow variety of the freshest fruits and vegetables. From farm to table, show your kids where their food comes from.

My Blueberry Sunrise Fruit Bars are inspired by my Aunt Carol’s Crumbles. Growing up, her homegrown blueberries of bubbling goodness, served with hand-churned vanilla ice cream, capped off many a late-afternoon meal.

My fruit bar recipe is a fun and easy dish, perfect for breakfast or anytime. The fruit bars keep well up to three days refrigerated (if not devoured first).

Blackberries, strawberries, cherries, raspberries, peaches, mango, apple and even fig make tasty options, too.

Breakfast Bar

Bar Base

  • 1 1/4 cup all-purpose flour
  • 1 1/4 cup rolled oats
  • 1 cup brown sugar
  • 3/4 tsp salt
  • 3/4 tsp baking powder
  • 1/2 tsp cinnamon
  • 3/4 stick unsalted butter (or solid vegetable shortening)
  • 1/2 cup carob or semi-sweet chocolate chips

Filling:

  • 1/4 cup brown sugar
  • 1 tbl lemon zest
  • 1/2 tsp cinnamon
  • 2 tbl all-purpose flour
  • 1 lb mixed berries – blueberries, strawberries, raspberries
  • 1/4 cup lemon juice
  • 2 tbl unsalted butter

Directions:

  1. In food processor, mix ingredients while adding the butter and pulse. (This forms a loose crumb mixture.)
  2. Separate 1½ cups of pulsed mixture for the top of the bar.
  3. Press remaining in a sprayed, 11’’-by-7’’ baking dish. Bake at 350 degrees for 12-15 minutes.
  4. Let cool on a wire rack and set aside.
  5. For the filling, mix sugar, lemon zest, cinnamon and flour in a bowl, and then add fruit, sugar and lemon juice. Toss.
  6. Slightly melt butter in microwave and stir with a spoon into wet fruit mixture.
  7. Add to cooled crust and top with remaining crumble.
  8. Bake for 40 minutes.
  9. Let cool and cut into bars. Eat one or more and wrap the rest in wax paper.

My recipes are meant to become YOUR recipes! Let me know what works or what you did to substitute one ingredient for another. Send your creative cook comments to editor@allergyasthmanetwork.org.

Chef Michelle Austin is the founder of On Thyme Consulting and co-owner of Just to Please You Productions. She writes the “All In Good Taste” column exclusively for AANMA’s Allergy & Asthma Today magazine.

Reviewed by Carol Jones, RN, AE-C.