Lifelines for Health (vol. 2): Pain Management: A Variety of Choices

A CHES Publication

Winter 2013 I Volume 2

HERBS

PILLS

Feature

Pain Management:

A Variety of Approaches

$

Extras

Clinical Trials:

Just for You NEW! FDA Approved

Insurance Corner

Assist Programs:

Community Chatter:

for Bleeding Disorders TRAVEL

EXERCISE

Inhibitor Family Camp The Inhibitor Summits

Integrity, Accuracy, Empathy...

CONTENTS FEATURE 8 I Pain Management: A variety of approaches

In the conclusion of our two-part series on pain, our authors discuss the management of pain from NSAIDS to opioids, as well as non-pharmacological treatment approaches.

COMMUNITY CHATTER

INSURANCE CORNER

4 I Inhibitor Family Camp: A Safe Haven

12 I Patient Assist Programs for Bleeding Disorders

A humbling reminder that even the strongest and most experienced of us may need some help every now and then.

PSI’s Director of Marketing and Public Relations, Mandy Herbert gives you a simple breakdown of your options.

6 I Inhibitor Summits 2013: Always Evolving Since 2005, the Inhibitor Summits continue to be an invaluable resource of information provided by experts in the community.

FUN & INSPIRATION 7 I Ten Fun Uses for a Syringe If the everyday-syringe-life has got you down, try these creative uses to release your wild side.

BLOODLINES 14 I Clinical Trials: Just for You Don’t spend all of your time searching for clinical trials relevant to inhibitors. Let us do that for you.

Here are a few of the best ones!

15 I Clinical Trials: with a Happy Ending Baxter’s FEIBA receives a new FDA indication that could change the lifestyle for many.

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CONTENTS

As you know, Living with an Inhibitor can be complicated & difficult.

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LifeLines for HealthTM Disclaimers

Letter From the Editors Welcome to our winter edition of the first and only newsletter dedicated to the inhibitor community! We are thrilled to be able to bring you information that is pertinent and specific to your lives. As individuals who live with hemophilia and an inhibitor, we understand the challenges, struggles and concerns that are very different than having “regular hemophilia”.

Although each one of us face issues that are individually unique, what unifies us is that sense of knowing each other’s battles and triumphs.

This edition of LifeLines for HealthTM features the conclusion of our two-part series on pain from a management approach. One thing we can count on as a member of the inhibitor community; pain will always be something that requires a treatment plan. Unfortunately for many, it can be a daily, lifelong battle. A good plan needs to have a variety of supports so as not to become overly dependent upon one method of management. The overuse and misuse of pain medication in our society as a whole is difficult to ignore. Pharmacological intervention is often a necessary part of the plan, but complimentary methods of pain management are just as essential.

In our Community Chatter section, we have news of events and programs specific to the inhibitor community written by community members. Our BloodLines section has information on new treatments, products and trials. In this edition of Insurance Corner, we offer information on the various patient assist programs available from the major manufacturers.

Fun and Inspiration - well, is just fun!

We are thrilled to be able to provide this as a resource to the inhibitor community! It is our hope that the New Year is a healthy, uneventful one filled with simple daily joys. When the storms arise, we wish you strength, perseverance and peace.

- Janet Brewer & Eric Lowe

The views and opinions of our writers are not a reflection of Comprehensive Health Education ServicesTM, Inc. (CHESTM), or its’ sponsors.

This newsletter is designed to provide a forum for community members to express their views from an open and honest platform. It is meant to provide a sharing of knowledge and experience meant to help one another. Nothing in this newsletter is meant to replace the advice of your HTC, medical professional team or insurance provider.

You are always urged to seek the opinion of a healthcare professional for treatment and your specific insurance provider for information.

We take your privacy very seriously. We would never disclose your personal health information without your express written consent. We would never sell nor make available our secure database to anyone.

Articles and pictures may not be reproduced, published, and/or placed on websites without the express written permission of CHESTM. In every publication of LifeLines for HealthTM, we will provide links to other websites that are not owned or controlled

by CHESTM or its sponsors. We cannot be responsible for privacy practices of other website owners, nor can we be responsible for the accuracy of the information provided.

Inhibitor Family Camp 2013:

A Safe Haven

W

hat Inhibitor Family Camp at Victory Junction did for my family this year was amazing and, honestly, quite unexpected. If I had to sum it up in just one word I would say it made me feel safe. It’s important to say that I’m a well-seasoned inhibitor mom. I’ve got four boys - three of them have hemophilia with high-titer, highresponding, tolerant-resistant inhibitors. My oldest is now 24, so we’ve been doing this a very long time and have been through so much. That is why I was feeling mildly ambivalent about the trip. Of course, I knew we would have fun! My husband Ron, my two younger sons, Collin 13 (unaffected) and Stephen 10, and I were really looking forward to camp. The truth though, is that I’ve been doing this stuff for so long that, as happy as I was to be going, I didn’t feel like I really needed camp - just that it would be fun.

However, just one week before we were supposed to leave, Stephen got sick and that started to change. We had a rough couple of years with hospitalizations and line infections, missing birthdays, holidays, work, and school, but this would be the first time we might have to cancel major travel arrangements.

Once it was confirmed that his line was infected, the rest of the week was spent waiting to see if we could go on the trip to camp. We were prepared to be heart broken.

All of a sudden, it seemed much more important to go than it had before.

Over the next week the verdict about whether or not we could travel changed almost daily. When I mentioned that we were considering not putting in another line the infectious disease doctor said, that if we went that route and switched to veins, we could use an oral antibiotic and would have no problem traveling. We could still make our trip but only if I could hit a vein the next morning to prove that I could give Stephen his factor while we were traveling. The scary part was that I hadn’t done an infusion with a butterfly needle for about three years and Stephen has notoriously difficult veins.

From the beginning we’d been in touch with the CHES staff. They were cheering us on! “It’s like riding a bicycle!” Janet Brewer (of CHES) said. Stephen was a trooper and I hit the vein. Everyone was so excited we were going to be able to go. I, however, was also really nervous. I knew that one stick wasn’t enough.

We had planned our trip so that we would be spending five days before camp visiting with family in several different cities. We were going to be flying for twelve

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hours then driving, tired, dehydrated, in strange places with weird lighting and awkward tables and I knew just how tough Stephen’s veins were to hit even in the best circumstances.

For the first three days of our trip we did manage his daily infusion. Each one took numerous sticks though and we repeatedly went back to the same vein. With every infusion Stephen’s and my anxiety increased and my confidence decreased. Finally on the fourth night we couldn’t get it. We stayed up until 1:00 am in our hotel room trying and finally gave up. Stressed and upset we went to bed. We tried again in the morning and once again failed. By then the idea that I could not give Stephen his factor had me scared to death, feeling like a complete failure, and berating myself for saying it would be okay to take this trip.

That morning, after the second failed infusion attempt, I emailed Janet to give her a heads up. Both to let her know not only how stressed I was and to tell her what an awful person I was for putting my child in this situation, but also to ask if someone there would be able to help us infuse. Her reply was heartwarming and optimistic but there was no way I would be able to relax until Stephen’s infusion was done.

It felt like it took forever to finally get to camp and for staff nurse Kathy Byrne come to our cabin to do Stephen’s infusion. What a relief at last! I could finally relax.

The comfort of knowing that we had help and support Top to bottom: Ron & Kerry Halter with sons, Collin & Stephen Fatula

from people who knew exactly what we had just gone through was indescribable.

We could truly relax, let go of the worry, and finally enjoy everything and everyone that makes camp the wonderful place it is.

The agenda was a perfect balance of grown-up time and family time. The kids would be off doing their own fun thing while parents had some really fantastic opportunities to talk and share and really connect and support each other.

Stephen really enjoyed meeting other boys his age with inhibitors and he commented on how it was different from meeting kids who “just have hemophilia”, where he still feels a little bit like an outsider. He is comforted knowing that he has friends out in the world who are just like him.

For Collin, one of the best things about camp was that the hemophilia didn’t stop us from doing anything fun that weekend.

The camp experience is built to make sure that doesn’t happen!

For my husband and I, the parent’s sessions gave us time to really connect with other moms and dads, to share all of our feelings without fear of any judgment or criticism. For Ron,

who is relatively new to hemophilia, it was the first chance he’d had to really connect with other parents. At times he was overwhelmed with a sense of relief and appreciation for the fact that we’re not alone. We were able to share the really hard stuff like guilt and fear in an atmosphere of complete understanding.

We could also find humor in our shared experiences of living with inhibitor kids and silver linings behind many of the clouds. The support and validation that the parents in those sessions gave to each other was exactly what we needed, when we needed it most. It helped us to begin feeling - again, like we are doing okay as parents, and made us feel like we were at camp with a great, big, extended family.

Looking back, I realize how vulnerable I felt in that short time traveling and trying to make the transition from a central line to veins. It was temporary, but it was still scary. We were alone, far from home, in a strange place, with no support. I didn’t

feel that we were safe… until we got to camp. It reminded me how alone we can feel in this world without our inhibitor family.

Inhibitor Family Camp was a blast, but it was much more than just fun. It was a place that gave us comfort and support and lifted us back up when we were really feeling beaten down. We were physically, mentally, and emotionally safe. We could enjoy the activities, the company of wonderful people, and truly relax and feel, at least for a few days, like it was going to be okay. Camp reminded me and my family that there is a whole community of people out there that we can turn to when we need help and that no matter how long you’ve been managing this inhibitor stuff, there will eventually be a time when you need help. Inhibitor Family Camp is a place where we can go, find that help, and feel safe.

- Kerry Halter

Kerry (Fatula) Halter is the former executive director of the Western Pennsylvania Chapter of NHF. She is the mother of 4 sons, 3 with severe hemophilia A, who are or have been affected by an inhibitor. She lives in Kodiak, Alaska with her husband Ron Halter and her son Steve.

Editor’s note: In our summer edition of LFH, we reported that the PowerHouse wild fire had devastated The Painted Turtle on May 31, 2013. Sadly, they had to cancel not only all sessions of summer camp, but fall family weekends as well. In true camper fashion, they created Camp on the Move and brought camp to 2,000 campers in 25 off-site locations. Many thanks to those of you who have kept them in your prayers or made donations. We look forward to seeing you there with all of our favorite camp staff and volunteers for Inhibitor Family Camp in April 2014!

COMMUNITY CHATTER

Inhibitor Summits

I

2013:

n 2005 our family was given the blessing of being selected as one of the approximately 50 families to attend the first Inhibitor Education Summit in Philadelphia, PA. As the father of a recently diagnosed child with an inhibitor and a second child that had “regular” hemophilia, my wife and I were doing a lot of research to determine the best course of action to help care for our son with the inhibitor and make sure, if there was anything that we do about it, that our other son did not end up with an inhibitor.

While we had been able to get some information from the Internet, the summit provided access to a number of experts in the field of hemophilia and inhibitors with varied opinions on treatment protocols.

It wasn’t just expertise from those doing treatment at clinics and hospitals, but also those doing the day to day care at home.

In ways that we could not even begin to understand at the time, a number of the families we have met through that and subsequent summits have become our extended family.

Granted some of the basic information regarding hemophilia and inhibitors has not changed substantially in the past decade, but a lot has especially in the area of treatment strategies. The Summit Planning Committee works very diligently to make sure that the meeting content is relevant and current. I am sure that some wish that even more could be done, but at the end of the day (or weekend in this case) there are only so many hours.

Looking back over the years of going to the summits, quite a bit has happened since I was pushing a stroller with a three year old down the streets of Philadelphia at 4 a.m. looking for the nearest hospital,

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Always Evolving...

but that is a story for another time. The purpose of this article is to discuss some of the recent additions to the summit itself.

The 2013 Inhibitor Summits were hosted in Nashville and Seattle. There were several new additions to the educational tracks this year. For those not familiar with the summit, there are four main educational tracks: Inhibitors 101, Inhibitors 201, Young Adults (Teen) with Inhibitors and Siblings & Adults with Inhibitors and their Support Network.

These tracks cover various topics from the basics of hemophilia to the complexities of therapies and pain management.

Along with the usual staple of the basic inhibitor topics, this year several notable sessions were introduced: Laboratory Testing; All About Elbows; All About Knees; All About Ankles; Muscle Bleeds; Spirituality; Understanding the ACA and Exchanges; Fostering Independence; Sex, Tattoos and Piercings; and Behind the Bedroom Door.

The session on Laboratory Testing was led by Dr. Neufeld and was presented from the standpoint of patients and caregivers that are interested and invested in their lab results. He covered some of the technical specifics of the Bethesda Assay including modifications, the importance of performing factor survival studies over two days (presuming that your factor lasts more than a couple of hours total!), and some of the other techniques that are being used to determine a patient’s response to bypassing agents.

To provide a more comprehensive overview of the various physical issues that can occur with joints and muscles, the summit planning team invited four physical therapists to address these in various sessions. In addition to the Gizmos and Gadgets session that is updated, a number of All About …

Winter 2013

Eric Walker with his dauughter, Abi (3)

sessions were introduced. I didn’t get to attend either of the Knees, Ankles or Elbows sessions, but opted instead for Muscle Bleeds because we all know how much of a pain in the gluteus maximus they can be! These sessions were deep dives into the nitty-gritty details of the function of the joints and muscles to help patients and caregivers understand how to manage their long-term care after a bleed.

A session on Spirituality was added to the lineup in an effort to broaden the holistic to not only treatments, but also how we view and process them. These sessions were co-lead by a social worker and a pastor.

As many of us are faced with insurance changes in the coming months if not already, the summit introduced a session specifically targeted at helping us in Understanding the Affordable Care Act and Exchanges (or the Health Insurance Marketplace). This was a very detailed approach to the changes in healthcare law presented by the advocacy staff from NHF. I think they did a great job in presenting what is currently understood, but I think in general there is still a long way to go to understand the ACA for the average person.

Eric Walker is an aerospace technologist at NASA’s Langley Research Center. He and

his wife Amy have four children (two sons and two daughters.) Both of their sons have hemophilia A, and one with an inhibitor. Eric and his family live in Hampton, Virginia.

The Fostering Independence session was a discussion lead by social workers to help encourage parents and the greater support network to encourage independence for patients.

It was primarily geared toward helping children develop a sense of responsibility with respect to their health. This was a well-led discussion that encouraged and garnered great audience participation.

Sessions for Sex, Tattoos and Piercings and Behind the Bedroom Door are somewhat self-explanatory and will have to stay well… what happens at the summit stays… on Facebook!

When all is said and done, the 2013 Inhibitor Summit was one of the best I have attended from a content standpoint and other aspects as well. Thanks to all the volunteers and staffers that work to put everything together. It was great to see some of our extended family again!

10 FUN

Uses for a

SYR NGE

1. Science experiment pipette substitute (great for mixing colors) 2. Medical role play for infusing stuffed animals/dolls 3. Food droppers for baby animals 4. Seasoning injector for cooking 5. Bathtub toys for the kids 6. Snowman painting 7. Medicine Dropper 8. Cake decorating 9. Turkey Baster 10. Squirt guns Have other uses of your own? We’d love to hear them! Email or write to us using the contact info on the back of this newsletter, and they just might get published.

-by Eric Walker, PhD

COMMUNITY CHATTER

FUN & INSPIRATION

Pain Management:

A variety of approaches

By ANGELA LAMBING, MSN, NP-C

MICHELLE WITKOPF, DNP

Pharmacologic aspect of pain management

I

n 2009 a multidisciplinary panel of experts from the American Pain Society (APS) and the American Academy of Pain (AAPM) convened to develop guidelines for the use of opioids in the chronic non-cancer pain (CNCP) population. With so few studies addressing the pharmacologic management of pain in the bleeding disorders population these guidelines, coupled with the stepwise approach for analgesic administration recommended by the World Health In 2011, Cupido, Hayes & Campbell released opioid guidelines for CNCP in children Organization (WHO), are the closest and youth that could also be used in the pediatric bleeding disorder setting. recommendations providers currently have to assist them in the management These include: and treatment of pain in the bleeding • Whenever a patient is being considered for pharmacologic management of pain, disorders community. The World universal precautions of pain management should be reviewed.

Health Organization (WHO) ladder was • A multimodal approach referred to as the 3 P’s of Pain Management – psychologioriginally designed to guide the care cal, physical, and pharmacologic is important when treating any type of pain. of patients with cancer pain through • Multimodal care addresses the bio psychosocial aspects of pain by targeting both the appropriate section of an analgesic the underlying pain mechanisms as well as the associated symptoms while focusing for the pain intensity along with on the goal of maximizing function and improving quality of life. individualized dose titration. In more • See WHO pain ladder; Diagram 1. recent years, it has also been utilized for those with persistent pain.

Editor’s Note: This is the conclusion of a 2-part series, which began in our Summer 2013 issue. This section will focus on both, the pharmacological and non-pharmacological methods of pain management.

Visit LifelinesForHealth.org to read part 1. Also available, all article citations for parts 1 and 2.

Diagram 1

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Acetaminophen The first level of the WHO ladder identifies acetaminophen and non-steroidal anti-inflammatory drugs (NSAIDs) for mild pain. The literature shows the most frequently used medications by PWH are acetaminophen and NSAIDs (some examples include: ibuprofen, naproxen, celecoxib). Both of these classes of analgesics have a ceiling effect (more drug does not equal increased pain relief – their doses are limited).

When using acetaminophen, caution needs to be taken in those who also have liver disease (such as hepatitis), with the co-administration of alcohol, or in combination medications that also have acetaminophen to avoid overdose. In 2006, Watkins studied healthy subjects using

Winter 2013

TREATING MILD PAIN acetaminophen for 14 days. He noted a significant increase in liver function tests in more than 30% of the participants. Based on this study, the American Liver Foundation recommended limiting daily dosages of acetaminophen to 4 grams per day.

Wallny describes an analgesic effect from factor that cannot be explained. Recent literature suggests micro-hemorrhages into the joints that may be causing low level bleeding and subsequently joint pain/discomfort that responds to factor administration. As support of this theory, factor was reported as a method of persistent pain management by 38% of respondents in a study of pain in Region V-E and 58% of respondents in a National Pain Study.

Initiating Opioids

TREATING MODERATE & SEVERE PAIN

When pain has become moderate to severe in nature, is adversely impacting a person’s function or quality of life, previous trials of non-opioid strategies have failed, and the benefits of opioid treatment have been determined to outweigh the burdens of treatment, the WHO ladder suggests an opioid trial. If the provider and the patient agree that the benefits of opioid therapy outweigh the risks then the option of a trial should be considered.

This trial involves the use of opioids either as single agents or in combination with adjuvants. Chou recommend all patients considered for opioid therapy undergo a thorough evaluation including a history and physical, appropriate diagnostic testing and imaging, and screening for the potential of substance abuse or misuse using the Screener and Opioid Assessment for Patients with Pain (SOAPP, Version 1 or R-revised) or the Opioid Risk Tool (ORT). Previous unsuccessful trials of non-opioid medications and non-pharmacologic strategies should be documented thoroughly.

A medication or treatment agreement should be signed outlining the goals of therapy, risks and benefits of treatment

(including complications and side effects), and responsibilities and expectations of both the patient, parents (if a pediatric patient) and provider. The main goals of therapy should be improvement in function (physical, psychological, social, and occupational) as well as improvement in quality of life. It should be noted that all patients, pediatric as well as adult, exhibit wide variability to opioid dosage and metabolism.

As new research emerges, new drugs and new classifications of drugs are becoming available. These include different formulations, different methods of administration, and different mechanisms of action. It is important to understand the formulation of the long acting drug and educate yourself to avoid any potential drug related mishaps (such as cutting or crushing a medication that shouldn’t be cut).

ADJUVANTS Previously pain in PWH was always thought to be nociceptive in nature.

But due to the constant irritation of the nervous system from frequent joint bleeds, many PWH may experience neuropathic pain. While many drugs are not FDA approved for pain syndromes, adjuvant medications such as tricyclic antidepressants (amitriptyline, nortriptyline, doxepin), anti-convulsants (gabapentin, pregabalin), and SNRI (duloxetine, venlafaxine) medications have been shown in studies to be effective in various types of neuropathic pain syndromes.

Anti-depressants and SNRI medications have been shown to be effective in pain management independent of their effect on depression. When a person describes pain as sharp, shooting, or burning – a trial of one of these medications may be useful.

Pathophysiology of Pain

Opioid Side Effects

Most opioid side effects (sleepiness, dizziness, nausea, vomiting, itching, etc.) may resolve with time and are minimized with slow dose increases. Constipation is the most common side effect of chronic opioid use and will not resolve with time.

It is important to always use a bowel

Non-Steroidal Anti-Inflammatory Drugs NSAID use in the bleeding disorder population remains controversial.

Sparse evidence is available evaluating the risks and benefits of standard NSAIDs (ibuprofen, naproxen, etc.) alone vs. COX-II inhibitors (celecoxib) alone vs. NSAIDs compared to COXII inhibitors. As with other studies, COX-II inhibitors have been shown to have less incidence of GI bleeding in the hemophilia population. A few studies, including some from outside the United States, have demonstrated a reduction in pain, a decrease in factor use, and relief of chronic synovitis with the use of COX-II inhibitors.

If NSAIDs (non-COX-II) are used, the provider may consider adjusting

program when starting and using opioids.

the factor replacement to reflect the use of this medication. Liver and kidney laboratory studies should be monitored on a regular basis. Based on newer clinical trials as well as clinical observation, the American Geriatric Society recommends that NSAIDs and COX-IIs be considered rarely, and with extreme caution, in highly selected individuals. The AGS guidelines recommend that all patients with moderate-severe pain or diminished quality of life due to pain should be considered for opioid therapy, which may be safer for many patients than long-term use of NSAIDs.

MANAGEMENT OF PAIN WITH THE USE OF OPIOIDS Several definitions need to be understood before the use of opioids in any population.

Tolerance This can occur with the use of medication where decreasing effects are noted of a drug at a constant dose. There is a need for a higher dose of a drug to maintain effect. This is considered a physiological response that is expected. THIS IS NOT ADDICTION. Physical Dependence This is an expected physiologic phenomenon manifested by development of withdrawal syndrome after abrupt discontinuation of therapy. A withdrawal syndrome can be produced by abrupt cessation, rapid dose reduction, and decreasing blood level of the drug.

AGAIN, THIS IS NOT ADDICTION.

FEATURE

TREATING MODERATE & SEVERE PAIN MANAGEMENT OF PAIN WITH THE USE OF OPIOIDS Addiction

Breakthrough pain

Addiction is a primary, chronic neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. Characterized by behaviors that include one or more of the following:

This condition occurs when a patient currently on a pain management program experiences a transient flare of severe pain.

a) Impaired control over drug use b) Compulsive use, craving, continued use despite harm Pseudoaddiction Abuse-like behaviors that may develop in response to the under-treatment of pain - When pain is appropriately managed with the correct dosage of medication, this behavior disappears. This is commonly mistaken for addiction.

1. Incident pain – Pain related to an increase in activity. Treated with a short acting rescue pain medication administered as closely to the event as possible. a) Volitional Incident Pain – pain

caused by an activity that can be anticipated and controlled. Example: To increase activity after an acute bleed, a patient may need to take an immediate release opioid prior to physical therapy knowing it will be painful.

2. End of Dose Pain – Pain experienced frequently at the end of a scheduled dose of an opioid. Example: A patient on sustained release morphine every 12 hours experiences a pain increase at the 10th hour consistently. This is treated with a dose adjustment.

3. Idiopathic Pain – When all other areas are explored and an answer is not forthcoming, occasionally patients can experience higher than usual pain experiences. Disease progression is a consideration that should be investigated.

CONCERNS OF SUBSTANCE ABUSE (Aberrant Behavior) Pasero and McCafferty report “the likelihood that addictive disease will develop as a result of the administration of opioids to treat pain in a population of patients with no history of addiction or abuse is likely to be below 1%.”. There is no reason to believe this would be different for persons with bleeding disorders. Substance abuse is most often associated with traumatic illness/chronic pain syndrome. Most persistent pain patients on long-term opioid therapy do not develop addiction.

There are many potential predictors of misuse and abuse of opioids: a history of mental health diagnosis, family history of abuse, previous history of substance abuse (alcohol, tobacco, cocaine, cannabis. This is the most consistent predictor of opioid abuse & misuse), age (literature & validated tools suggest younger age more at risk but does not mean any age is free of risk), gender is not always a predictor, chaotic family/social environment.

TOOLS FOR MONITORING PATIENTS ON OPIOIDS Any time a person is initiated on opioid therapy for persistent pain, close monitoring is essential. A commitment on the part of the HTC is necessary to be available for patients as they are assessed and reassessed during therapy. Some of the things you may expect from your provider as you receive opioid therapy: Pain agreements: This format provides clear guidelines for providers and caregivers with respect to responsibilities of each party. This tool also demonstrates a commitment on the part of the HTC in recognizing the patient’s pain and willingness to address and manage the pain. Key components include: a) Clear treatment goals b) Use of one provider to order pain medication c) Use of one pharmacy to dispense pain medication d) Close monitoring will occur e) Safe storage of medication f) Taking medication only as prescribed g) Review the potential side effects of opioid use h) Clear consequences if non-adherence is identified

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TREATING MODERATE & SEVERE PAIN Pain log: This tool can be particularly helpful for the provider as well as patients to document their pain level, effects of the pain medication prescribed, and the duration of its effects. A written review can help patients visualize the improvement of their pain.

It can also help the provider with dose adjustments regarding the frequency or dose of the medications for optimal effects.

State monitoring programs: These programs provide an electronic monitoring system for quick review of a patient’s opioid use within the state; name of medication, date prescribed, amount prescribed, prescriber information, and which pharmacy filled. Most states have some type of monitoring program.

Urine drug screening: The use of drug screening can be twofold; ensure that the medication prescribed is being utilized and screen for other medications or illicit drugs. Drug screenings do carry risks in that false positives can occur. Utilizing an expert in this area should be employed for appropriate interpretation of the results. Decisions should not be made on one positive drug screen due to the possible risk of false positives and should be used to

Non-Pharmacological Pain Management Strategies

T

he exact nature of a patient’s pain experience can be multi-faceted. In order to address these issues, pain management should encompass a “multi-modal” approach, which may include non-pharmacologic interventions, lifestyle changes, complementary and alternative medicine, and physical medicine and rehabilitation. All treatment strategies should include the support of the HTC and be individualized for patients to relieve pain. Non-pharmacological approaches are divided into several categories.

MANIPULATIVE AND BODY-BASED

MIND-BODY MEDICINE

Massage

Acupuncture

Massage therapy involves the manipulation of the soft tissues of the body for the purpose of normalizing those tissues. There are many techniques, which include: applying pressure, holding, and/or causing movement of or to the body. There is a concern that deep muscle/tissue massage may increase the risk of bleeding in persons with hemophilia. Limited research exists to offer guidance. Explore these options with an established massage therapist who is familiar with a bleeding disorder. The use of a prophylaxis factor dose prior to initiation of massage may be needed.

Known as Traditional Chinese vs. Western Medicine Theories which “work with natural vital energy inherent within all living things to promote the body’s ability to heal itself”. This therapy can be included in the mind-body, manipulative or energy domains of CAM therapy. It is felt that energy flows through pathways call meridians. Each pathway is associated with particular

Chiropractic Therapy Very little is known about the use of chiropractic therapy in the bleeding disorders population. It involves the manipulation of the spine used to treat issues related to the muscles, joints, bone, and connective tissue. There is a risk of manipulation with the neck. If you are considering chiropractic therapy you should discuss this option with your provider and consider if prophylaxis factor may be indicated.

detect ongoing confirmation of diversion of the opioids prescribed.

Pill Counts: Regular counting of prescribed medications can ensure that patients are taking the medication as prescribed.

Limited prescriptions with regular office visits: 1 month, 2 week supply, 1 week supply. This can be an effective tool for the potential substance abuser.

REMS (Risk Evaluation Mitigation System): A communication plan developed to inform key

physiological system & internal organs. Disease arises due to imbalance of energy or disruption

of energy flow. A few studies have been performed with persons with hemophilia demonstrating some positive responses.

Biofeedback Biofeedback is initially taught by a certified specialist. The goals of therapy include: performance of self-relaxation without feedback equipment to use as needed to minimize distress and discomfort.

A machine is attached to the patient using audible tones and an immediate digital readout provides instant feedback and control for the patient. It requires frequent sessions that allows the attainment of a general state of relaxation. It is non-invasive, and considered safe in persons with bleeding disorders, although there are no studies to support its use in this population.

audiences about the risks of a drug.

Websites are set up to assist providers in a number of areas; a a) Proper education of the drug being prescribed; b) Proper patient selection; c) Proper surveillance and monitoring of the medication usage; d) Provision of relevant safety messages; e) An intervention when a signal (deviation from protocol) is detected.

ASSESSMENT OF PERSONS ON OPIOID THERAPY Prior to any refills of medications, a regular scheduled assessment with your provider is key. Review of the documentation requirements each and every time will provide necessary information that appropriate effects are achieved as well as monitoring for any potential aberrant behaviors. Persons who are at higher risk, should have a more structured environment, providing additional monitoring strategies outlined above and more frequent office visits for closer observation.

Spiritual Healing Rigorous controlled studies indicate there are factors related to spiritual healing beyond suggestion and self-healing that can reduce pain.

Spiritual healing is helpful in reducing: headache, back pain, arthritis pain, and post-operative pain.

A person’s faith can provide a powerful impact on the pain experience. There are no studies evaluating spiritual healing within the hemophilia population.

Concluded on pg. 15

FEATURE

A P

for Bleeding Disorders

ssistance

rograms

I

by Mandy Herbert Director of Marketing and Public Relations

n the PSI spring newsletter Dr. Dana Kuhn, PSI President, mentioned that for the past three years, PSI has been PSI administers researching, surveying, and working collaboratively with pharmaceutical companies to ascertain the need for and determines copayment assistance among the bleeding disorders community. The justification for many of the oncology eligibility for all and lysosomal storage conditions clearly support the need for copayment assistance as many patients have high programs listed deductibles, coinsurance, and copayments. If this were true for these conditions, why wouldn’t it be true for the on page 12. bleeding disorders community?

Our surveys revealed that the bleeding disorders community was having challenges affording their deductibles, coinsurances, and premiums. Thus, PSI convinced a number of companies to develop programs with us to confirm the need. Our current copayment assistance programs have proven to be successful and we continue to accept new applications. If eligible for one of the programs outlined below, financial support may be provided for up to 12 months!

HEMOPHILIA INSURANCE FINANCIAL ASSISTANCE PROGRAM Key Benefit: Helps patients in need with their out-of-pocket expenses for Baxter hemophilia products. To apply for assistance, visit www.patientservicesinc.org.

Patients are eligible to apply for the program if: • They meet specific financial criteria for enrollment • They have mild, moderate, or severe Hemophilia A or have an inhibitor • They currently have private health insurance Who is not eligible to apply?

• Residents of Massachusetts are prohibited by law and are not eligible to apply for the program.

• Presently, patients on public insurance including, but not limited to, Medicare, Medicaid, TriCare, DOD, and PCIP, are not eligible to apply.

A

s we transition into 2014, PSI is actively pursuing the expansion of copayment assistance for the bleeding disorders community (public and privately insured patients). We encourage all pharmaceutical companies to develop a copayment assistance program with PSI to assist patients in affording

BAYER COPAY/COINSURANCE ASSISTANCE PILOT PROGRAM Key Benefit: Funds provided by PSI can (only) be used towards a patient’s copay/coinsurance expenses for Bayer’s product. If eligible, financial assistance may be provided for up to 12 months or as long as funding is available.

This program is available to patients who meet the program criteria including the requirements outlined below.

• They have Hemophilia A • They meet specific financial criteria for enrollment • Currently have private health insurance For inquiries regarding the Bayer Copay/Coinsurance Assistance Pilot Program, please contact Bayer’s Factor Solutions at 1-800-288-8374.

their out-of-pocket expenses for bleeding disorders products.

In addition to the copayment programs noted above, PSI also offers premium assistance to patients who have insurance and are diagnosed with moderate to severe Hemophilia, vWD, or an Inhibitor. Each premium assistance program currently offered is outlined below.

BLEEDING DISORDERS PREMIUM ASSISTANCE (Hemophilia and vWD) Key Benefits: If approved for assistance can receive up to $11,000 in premium assistance. Assistance is provided for 3 years. Can apply online via the PSI website.

INHIBITORS IN BLEEDING PREMIUM ASSISTANCE Key Benefits: If approved for assistance can receive up to $11,000 in premium assistance. Assistance is provided for 2 years. Can apply online via the PSI website.

A person is eligible to apply if they meet the specific program criteria for enrollment outlined below: • Moderate or severe • Public or private insurance • Federal Poverty Level is set at 400%

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A person is eligible to apply if they meet the specific program criteria for enrollment outlined below: • Moderate or severe • Public or private insurance • Federal Poverty Level is set at 350%

n order to determine if you qualify to apply for premium assistance please visit our website at www.patientservicesinc.org. Wishing you the best of health in the New Year!

-Mandy Herbert

T

he majority of manufacturers offer factor assist programs that can hold you over for a specific period of time during an insurance change, or to try their product to see if it works for you. Factor assist programs can be a lifeline for families in the middle of a strict immune tolerance regimen. In addition to factor assist programs, some manufacturers are now providing financial assistance to cover co-pays, out of pockets (OOP), and in some cases premium assistance. Each program has its’ own set of criteria that can be somewhat confusing, so we urge you to visit their websites or call the numbers listed. In this edition of Insurance Corner, we have compiled as much data allowed to keep you up to date on what’s available.

The newly launched NAVA Program that offers resources on a variety of topics to include: • Work and insurance • Tips for parents • Summer camp • Health information • Scholarships • Info on Baxter’s community programs, & more!

The CARE Program, short for Coverage, Assistance, Resources, Education, sponsors the Bleeding Disorders Legal Information Hotline created and operated by the Lone Star Chapter of NHF.

The variety of topics is very comprehensive. You must become a member to access the site. There is an option for an online chat with a NAVA guide.

For more info, call: 1-888-229-8379 Visit: http://thereforyou.com/ hemophilia-and-health-insurance/

For more information on the NAVA program: 1-855-322-NAVA or 1-855-322-6282 https://nava.baxter.com/nava/redirectThereForYou.jsp

The AlphaNine SD Savings Card Program is designed to help patients taking AlphaNine® SD with their out-of-pocket prescription costs. The program covers up to $500 per month for a total savings of up to $6000 per year.

Eligibility rules apply, so please go to www.alphaninecard.com or call 1-855-355-2574 to receive more information and to apply for a card.

The CARE and NAVA programs are in addition to their Hemophilia Insurance Financial Assistance Program that provides patients with private health insurance assistance with out of pocket expenses for Baxter products. This program is administered by PSI.

Bayer has an umbrella program called Factor Solutions for patients using their factor product.

They provide support with Insurance questions, such as: • Understanding your plan • Identifying resources to help with co-pay or OOP expenses • Dependents’ coverage and, • How you might get factor when insurance coverage is lost Factor Assistance Program provides information about maintaining access to treatment if you experience a lapse in insurance coverage.

• PAP-short term assistance program for uninsured patients or who lack third-party coverage • GAP-short term assistance program for patients who experience a lapse in their private insurance plan coverage Co-Pay Assistance Program is need based • Uses a sliding scale based on income • Eligible members may receive up to $6,000.00 per year 1-800-288-8374 FactorSolutionsSupport.com

NovoNordisk has an extensive patient assistance program called SevenSECURE® that offers a wide range of support, and is administered by Rx Crossroads. There are specific criteria and considerations for all of the above support programs. You must create an account on the Changing Possibilities site for complete access to the SevenSECURE® program.

Medical Expense Reimbursement • Dental work and cleaning • Compression devices • Physical Therapy • Outpatient medical evaluation and treatment • Up to three (3) months of nonfactor related prescription drug assistance • Physical activity reimbursement (i.e. Classes, health club membership, fitness equipment) • Travel reimbursement for medical appointments • Financial assistance to attend educational meetings

Insurance • Appeal denials • Track caps • Coverage assistance • Premium assistance* (administered by PSI) • Assistance with mobility device expenses not covered by insurance Education • Scholarships: Professor Ulla Hedner Scholarship up to $7,000.00 for HS senior, college or vocational students • Tutoring or lesson grants • Further education grants for primary caregiver

Rx Crossroads: 877-668-6777 http://www.changingpossibilities-us.com/

Disclaimer: This is a collaborative list of patient assist programs for bleeding disorders. Not all programs mentioned are specifically tailored for individuals with inhibitors. We encourage you to carefully review all details of any program in order to choose the best one for the patient. Enrollment of any program cannot be guaranteed.

Please be mindful of all eligibility requirements mentioned for each of them.

INSURANCE CORNER

Clinical Trials A Just for You

search on clinicaltrials.gov for hemophilia and inhibitors yields 157 studies at various phases from active and recruiting to completed or withdrawn. Here we have highlighted some that may be of interest to you.

A Covalent Tolerance Induction to FVIII: Prediction of Inhibitors in Hemophilia

Hemophilia Inhibitor Previously Untreated Patient Study (HIPS)

Identifier Number: NCT00178607

Purpose: To understand individual and environmental risk factors to prevent and possibly treat inhibitors. This study will look at individual and treatment characteristics in babies with severe hemophilia A, who have not yet received treatment with FVIII (factor 8.) Subjects in the study will be asked to provide diaries of treatments, medications, and illnesses. Subjects will receive Advate (a thirdgeneration recombinant FVIII product) and have labs drawn, which include studies of the immune system and genetic studies of the FVIII mutation, before and after treatment with FVIII. The duration of the study will be first 50 treatments or 3 years, whichever comes first.

Purpose: To predict inhibitor development at an individual level by correlating the HLA type and genetic defect with hemophilia A. Subjects: Males with Hemophilia A, and a positive inhibitor Sponsor: The University of Texas Health Science Center, Houston Phase: Observational Only Link: http://clinicaltrials.gov/ct2/show/NCT00 178607?term=NCT00178607&rank=1

Subjects: Males or Females, previously untreated patients with Severe Hemophilia A Sponsor: The University of Texas Health Science Center, Houston Phase: Observational Only

Survey of Inhibitors in Plasma-Product Exposed Toddlers (SIPPET)

Link: http://clinicaltrials.gov/ct2/show/NCT01652027?term=NCT01652027&rank=1

Identifier Number: NCT01064284 Purpose: To assess the immunogenicity (a substance’s ability to provoke an immune response) of factor containing both, VWF (von Willebrand factor) and FVIII (factor 8) and of rFVIII (recombinant factor 8) concentrates by determining the frequency of inhibitor development in PUPs (previously untreated patients) or MBCTPs (minimally blood component-treated patients).

Subjects: Male Subjects, ages 6 and under, no inhibitor at time of screening Phase: 4 Link: http://clinicaltrials.gov/ct2/show/ NCT01064284?term=SIPPET&rank=1

B

Identifier Number: NCT01652027

Rescue Immunotolerance Study in ITI - Experienced Patients Other names: RES.I.S.T. Experienced, or RESIST EXP Identifier Number: NCT01051076 Purpose: To evaluate whether a concentrate containing both FVIII and VWF given at a high dose will induce immune tolerance induction (ITI) in subjects who have already experienced and failed ITI with VWF-free FVIII concentrates.

Subjects: Males any age, FVIII with high responding inhibitors above 5 BU with a previous ITI course of at least 9 months with a VWF-free FVIII concentrate at any dosage, such as rFVIII Sponsors: Grifols Biologicals Inc, CSL Behring, Biotest Pharmaceuticals Corporation, Grifols Therapeutics Inc. (Talecris Biotherapeutics) Link: http://clinicaltrials.gov/ct2/show/NCT01051076?term=NCT01051076&rank=1

a Clinical Trial

with a Happy Ending

axter receives FDA approval of FEIBA for prophylactic treatment of hemophilia A&B patients with inhibitors.

The Phase III study, known as FEIBA PROOF, treatment with a FEIBA prophylactic regimen showed a

72% REDUCTION in median annual bleed rate (ABR) compared to treatment with an on-demand regimen.

Find the press release in its entirety for more details. http://www.baxter.com/press_room/press_ releases/2013/12_19_13_feiba.html

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BLOODLINES

Non-Pharmacological Pain Management Strategies Cognitive Behavioral Therapy

TREATING MODERATE & SEVERE PAIN

The purpose of cognitive behavioral therapy is to examine and clarify the appraisal of pain. With the guidance of a certified therapist, the goal is to change negative beliefs (catastrophizing) to active coping by reviewing past achievements in pain management and encourage ability over disability. This guides the patient to “reframe” the pain experience.

Mind Body Technique This incorporates the use of guided imagery or distraction to “distract” one’s self from the pain experience. It includes the use of sight, sound, or a combination of senses to imagine a state different than what currently exists. It is completed usually with someone trained in this technique, in a comfortable position in a peaceful setting using the power of the mind to assist with healing. Also incorporated in this technique are relaxation exercises, controlled breathing, and use of distraction. Many of

these techniques are available in tape or CD format. With practice, the patient can master this technique.

NATURAL PRODUCTS Herbal therapies (botanicals), vitamins, minerals, probiotics, etc. can encompass a wide range of oral supplements that can be obtained without a prescription. It is important to ask the patient if these substances are used as they can interfere with other medications or carry an increased risk of bleeding.

Natural products do not carry the same rigorous scientific process with testing and development as pharmaceuticals. They have been known to contain a varied strength of the herbal supplement as well as may be contaminated with other supplements. Several websites, such as painedu.org, can be used to explore any herbal therapies that patients may trial in an effort to reduce pain.

C

hronic, persistent pain affects physical, psychological, and social dimensions of a patient’s life. It is important to assess a person’s level of stress, anxiety, and/ or depression. Additional therapies may be helpful as you continue to manage the pain experience.

Visit LifeLinesForHealth.org to learn about them!

FEATURE

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CHESTM Mission To Inspire awareness and selfreliance for patients with chronic health conditions, their families, and their communities.

Editors in Chief Janet Brewer, M. Ed. Eric Lowe

Publication Designer Eric Lowe

Contributing Writers: Kerry (Fatula) Halter Mandy Herbert Angela Lambing, MSN, NP-C Carri Nease Eric Walker, PhD Michelle Witkopf, DNP

Contributing Editors: Kathy Arnaldo Stephen Brewer

Contributing Content and Production: Joan Ward

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