Southern Arizona Fibromyalgia Friends

FOR IMMEDIATE RELEASE

October 18, 2013

Contact:

Lauren Stiles, Esq
President, Dysautonomia International

Phone: 631-871-9673
lstiles@dysautonomiainternational.org

or

Coppelia Tarantal
Phone: 520-449-5235
coppeliat@gmail.com

Local event raises funds for dysautonomia research and awareness

Tucson, Arizona:  While “thinking pink” this October for breast cancer awareness, don’t forget to “make some noise for turquoise,” as October is also Dysautonomia Awareness Month and turquoise is the awareness color for this little known condition.

Dysautonomia is a group of medical conditions that result from a malfunction of the autonomic nervous system.  The autonomic nervous system controls most of the essential functions of the body that a person does not consciously control–such as heart rate, blood pressure, digestion, and temperature control.  People living with dysautonomia have trouble regulating these systems, which can cause lightheadedness, fainting, too high or too low heart rate, and unstable blood pressure, among other problems.

Tucson resident Coppelia Tarantal knows first-hand how life altering dysautonomia can be. Coppelia was diagnosed with Postural Orthostatic Tachycardia Syndrome (POTS), a form of dysautonomia, in 2010.  ”It really put my life in a tailspin.  I went from running after kids at work and juggling in my spare time to not being able to stand up and prepare a meal for myself.  It was really challenging to go from completely healthy to severe vertigo every time I stood up.” Through a variety of treatments, including dietary changes and specific exercises, Coppelia is doing much better.  She started a support group for those dealing with POTS in Southern Arizona’s and is hoping to help others get diagnosed and find the treatment that works for them.

Lauren Stiles, Dysautonomia International President, notes, “POTS is not rare, it’s just not well known.   There are an estimated 1 Million POTS patients in the U.S.  Mayo Clinic estimates that 1 in 100 teenagers develops POTS before adulthood, and many adult patients are impacted as well.  About 80% of POTS patients are female, and most are under the age of 40.”

To celebrate Dysautonomia Awareness Month and raise funds for medical research there will be a “Pizza with a Purpose” Event on November 7^th, all day at the California Pizza Kitchen in Tucson. California Pizza Kitchen will donate 20% of the proceeds from your meal to Dysautonomia International, a non-profit that funds dysautonomia research, if you bring their special flyer with you to the restaurant.

To RVSP for the event and obtain a copy of the flyer, please contact Coppelia Tarantal at 520-449-5235.Dysautonomia International is an all-volunteer 501(c)(3) non-profit. You can learn more about the different forms of dysautonomia by visiting their website, www.dysautonomiainternational.org.        

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Here’s the flier to take with you to the event: www.dysautonomiainternational.org/pdf/CPKtuscon.pdf

On December 10, 2013, from 1-5 PM, the FDA will obtain patient and patient stakeholder* input on the symptoms of fibromyalgia that matter most to patients and on current approaches to treating these fibromyalgia symptoms.

The FDA is interested in obtaining a better understanding of the fibromyalgia patients’ perspectives on:

1. The severity of the disease and the impact on your life (both function and quality);
2. The symptoms of fibromyalgia that matter most to you (explaining those you experience); and
3. Your perspective on the available therapies used to treat your fibromyalgia symptoms.

Patients who are interested in presenting comments as part of the panel discussions will be asked to indicate in their registration which topic(s) they wish to address. These patients will also be asked to send a brief summary of responses to the topic questions as part of their application to be a panelist to the FDA. Panelists will be notified of their selection soon after the close of registration on November 27, 2013. FDA will try to accommodate all patients who wish to speak, either through the panel discussion or through audience participation. Comments will be limited by time constraints.

To help patient advocates understand the FDA process and how to prepare to make public comments, the National Fibromyalgia & Chronic Pain Association (NFMCPA) is developing three public webinars and additional reference materials. To advocate at the December 10th meeting, an application must be sent to FDA through their online portals. The NFMCPA is available for more information and can offer suggestions on how to relay your comments and experiences through efficient and effective testimony before FDA.

This is a unique opportunity to create a change in how fibromyalgia is understood and viewed by the FDA. Through the use of the webinar presentations the NFMCPA will help to empower and enhance your understanding of the many aspects of this important event:

1. “Understanding the Drug Development Overview” - Tuesday, November 5th;
2. “Preparing Your Public Testimony” - Tuesday, November 12th; and
3. “How is Safety and Effectiveness Evaluated?” - Tuesday, November 19th

These webinar presentations will be easy to access and help you, the fibromyalgia patient advocate for advancement in research and treatments addressing pain and additional symptoms. We look forward to preparing with you for this important meeting.

Best regards,

Jan Chambers, President & Founder (NFMCPA)
National Fibromyalgia & Chronic Pain Association

FDA Topic 1 questions:
Disease Symptoms and Daily Impacts that Matter Most to Patients

1. Of all the symptoms that you experience because of your condition, which 1-3 symptoms have the most significant impact on your life? (Examples may include chronic pain, fatigue, difficulty concentrating, sleep issues, crawly skin etc.)
2. Are there specific activities that are important to you but that you cannot do at all or as fully as you would like because of your condition? (Examples of activities may include sleeping through the night, daily hygiene, driving, household chores, etc.)
   1. How do your symptoms and their negative affects impact your daily life on the best days?
   2. On the worst days?
3. How have your condition and its symptoms changed over time?
   1. Do your symptoms come and go? If so, do you know of anything that makes your symptoms better? Worse?
4. What worries you most about your condition?

FDA Topic 2 questions:
Patients’ Perspectives on Current Approaches to Treating Fibromyalgia

1. What are you currently doing to help treat your condition or its symptoms? (Examples may include prescription medicines, over-the-counter products, and other therapies including non-drug therapies such as exercise or acupuncture.)
   1. What specific symptoms do your treatments address?
   2. How has your treatment regimen changed over time, and why?
2. How well does your current treatment regimen treat the most significant symptoms of your disease?
   1. How well do these treatments improve your ability to do specific activities that are important to you in your daily life?
   2. How well have these treatments worked for you as your condition has changed over time?
3. What are the most significant downsides to your current treatments, and how do they affect your daily life? (Examples of downsides may include bothersome side effects, going to the hospital for treatment, restrictions on driving, etc.)
4. What specific things would you look for in an ideal treatment for your condition?

The “secret” checklist that was never intended to be public knowledge.

Do you fill prescriptions at Walgreen’s Pharmacy? If so, you may have already experienced the effects of Walgreen’s new “Good Faith Dispensing” Policy, which was never intended to become public knowledge. Thanks to one Walgreen’s pharmacy tech, this policy was leaked to news media.

This relatively new policy (implemented this past summer) allows Walgreens’ pharmacists to refuse a prescription written for a controlled medication – which includes meds such as oxycodone, adderall, Ambien, and Klonopin – based on your fill history at Walgreens, doctor information, and even the length of time you’ve been consecutively filling that same medication. If a Walgreen’s pharmacist believes that filling your prescription will be feeding an addiction, they can (and are) refusing to fill medications, whether they are correct in their deduction or not.

This means that if you are being treated for a sleep disorder with a combination of a night-time sedative (such as lunesta or ambien), and a morning amphetamine (such as adderall or ritalin), and you’ve been successfully on this therapy for more than six months, all scripts filled at Walgreens, you could be refused your medications. If you’re being treated for a chronic pain problem with controlled medications like oxycodone, morphine, or fentanyl for more than six months, even successfully, you could be denied your medications, which may mean another trip back to your doctor’s office for a new prescription if the Walgreens’ pharmacist refuses to return your paper prescription or transfer it to another pharmacy.

Pharmacists DO have a professional obligation to refuse filling a prescription if they believe the medication is being abused and/or report the abuse to the proper authorities. That is nothing new. And for chronic pain patients, that is actually a good thing. What is new is Walgreens’ apparent over-reaction to some trouble they got into with the DEA last spring at a Florida Walgreens that was traced back to an influx of controlled painkillers being sold on the black market (http://www.nytimes.com/2013/06/12/business/walgreen-to-pay-80-million-settlement-over-painkiller-sales.html?_r=0).

Walgreens pharmacists now use the checklist above to determine whether to “red flag” the patient or not. Any patient who is determined to be filling prescriptions at too many different Walgreens pharmacies, filling prescriptions for the same drug from too many different doctors, paying cash, filling at a Walgreens that is inexplicably too far from a home address, or even filling a prescription for the same drug for more than six months can be red flagged, which is then sent on to the DEA. And even worse, it appears that it’s possible that you may be prohibited from filling any controlled substances at any Walgreen’s locations after you’ve been red-flagged.

What can patients do? The obvious step is to switch to another pharmacy. If you are on controlled substances, you’re already visiting your doctor’s office once a month to pick up paper scripts (per DEA rules). If you do plan on switching pharmacies, let your doctor know. You can call in this information for their records in many cases. Many pain contracts require you to list your pharmacy with your doctor’s office to help identify addicts.

The other thing you can do is fill out the survey below if you’ve been refused medications at a Walgreen’s pharmacy: https://www.surveymonkey.com/s/N3WGGNW. This survey was put together by the National Fibromyalgia and Chronic Pain Association to help determine how many patients have been affected by this new policy.

Another option is to write a letter to Walgreens, letting them know what you think of this new policy. You can do this online by visiting their corporate “Contact Us” page at: http://www.walgreens.com/mktg/contactus/contact-us-forms.jsp?tier3Id=1075.

For Further Reading:

Walgreens’ “secret checklist” reveals controversial new policy on pain pills

Backlash Against Walgreen’s New Painkiller Crackdown

Walgreen to Pay $80 Million Fine in D.E.A. Inquiry

Access to Pain Medication Survey - National Fibromyalgia and Chronic Pain Association

Walgreen’s Corporate “Contact Us,” webpage

DEA Drug Schedules