Lifelines for Health (vol 6): Who Takes Care of You

A CHES Publication

Winter 2015 I Volume 6

Who Takes Care of YOU 504 or IEP:

When Good Plans Go Wrong

Deciphering the Clinical Trial:

Emergent Inhibitors in Untreated Patients

Consumer Councils, Pt. One: Someone’s Listening...

Isn’t Home Infusion the Standard of Care for Hemophilia?

Is It Time to be Kind to Yourself?

10 Steps Toward Self-Compassion

Small Steps, Courageous Acts: A Participant’s Review of LEVERAGETM Inhibitor Family Camp: Bull’s-Eyes, All-Around NHF’s 2015 Inhibitor Summit: The Top of the Ferris Wheel

“Imagine...”

A Poem For You

TAYLOR, JACK, BOB, HENRY, SID, JUSTIN, CHASE, AND KALI (Clockwise from top right) Taylor has congenital FVII deficiency; Jack, Bob, Sid, Justin, and Chase have congenital hemophilia with inhibitors; Kali has Glanzmann’s thrombasthenia

Rooted in effective bleed control Reaching to help more patient types than any other factor product • 30 years of research and long-term clinical experience has gone into NovoSeven® RT – Compassionate use, also known as expanded access, began in 1988 – FDA approval received in 1999 • NovoSeven® RT is used to treat more patient types than any other factor product – Treatment of bleeding and prevention of bleeding for surgeries and procedures in adults and children with: – Hemophilia A or B with inhibitors – Congenital factor VII deficiency – Glanzmann’s thrombasthenia with a decreased or absent response to platelet transfusions – Treatment of bleeding and prevention of bleeding for surgeries and procedures in adults with acquired hemophilia • More than 70 trials and registries completed, with a commitment to ongoing research

Visit NovoSevenRT.com today to learn more.

Indications and Usage NovoSeven® RT (Coagulation Factor VIIa [Recombinant]) is used for: • Treatment of bleeding and prevention of bleeding for surgeries and procedures in adults and children with hemophilia A or B with inhibitors, congenital Factor VII (FVII) deficiency, and people with Glanzmann’s thrombasthenia who have a decreased or absent response to platelet transfusions • Treatment of bleeding and prevention of bleeding for surgeries and procedures in adults with acquired hemophilia

Important Safety Information WARNING: BLOOD CLOTS • Serious blood clots that form in veins and arteries with the use of NovoSeven® RT have been reported.

• Your healthcare provider should discuss the risks and explain the signs and symptoms of blood clots to you.

Some signs of a blood clot may include pain, swelling, warmth, redness, or a lump in your legs or arms, chest pain, shortness of breath, or sudden severe headache and/or loss of consciousness or function.

• Your healthcare provider should monitor you for blood clots during treatment with NovoSeven® RT. Warnings and Precautions • NovoSeven® RT should be used with caution if you have an increased risk for blood clots, such as with disseminated intravascular coagulation (DIC), clogged arteries, crush injury, septicemia (an infection in the blood), uncontrolled bleeding after giving birth, history of heart disease, liver disease, limited movement following surgery, in elderly people, in newborns, or if you are taking aPCCs/PCCs (activated or nonactivated prothrombin complex concentrates) with NovoSeven® RT. • Allergic reactions, including serious whole body allergic reactions, have been reported with NovoSeven® RT. Tell your healthcare provider if you are allergic to NovoSeven® RT, any of its ingredients, or mice, hamsters, or cows.

If you think you are having an allergic reaction, call your healthcare provider right away. Some signs of allergic reaction may include shortness of breath, rash, itching, redness of the skin, and fainting/dizziness.

• People with Factor VII deficiency should be monitored by their healthcare provider for antibodies, which can cause NovoSeven® RT to stop working properly.

Side Effects • The most common and serious side effects are blood clots.

• Tell your healthcare provider about any side effects that bother you or do not go away.

Use with Other Drugs • Blood clots may occur if NovoSeven® RT is given with Coagulation Factor XIII (13).

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

NovoSeven® RT is a prescription medicine. Novo Nordisk provides patient assistance for those who qualify.

Please call 1-877-NOVO-777 (1-877-668-6777) to learn more about Novo Nordisk assistance programs.

Please see Brief Summary of Prescribing Information on the following pages.

Novo Nordisk Inc., 800 Scudders Mill Road, Plainsboro, New Jersey 08536 U.S.A. NovoSeven® is a registered trademark of Novo Nordisk Health Care AG. Novo Nordisk is a registered trademark of Novo Nordisk A/S. © 2015 Novo Nordisk All rights reserved. 0715-00027616-1 September 2015

NovoSeven ® RT Coagulation Factor VIIa (Recombinant) Rx only BRIEF SUMMARY. Please consult package insert for full prescribing information.

WARNING: THROMBOSIS: Serious arterial and venous thrombotic events following administration of NovoSeven ® RT have been reported. Discuss the risks and explain the signs and symptoms of thrombotic and thromboembolic events to patients who will receive NovoSeven ® RT. Monitor patients for signs or symptoms of activation of the coagulation system and for thrombosis. [See Warnings and Precautions] INDICATIONS AND USAGE: NovoSeven® RT (Coagulation Factor VIIa [Recombinant]) is a coagulation factor indicated for: Treatment of bleeding episodes and peri-operative management in adults and children with hemophilia A or B with inhibitors, congenital Factor VII (FVII) deficiency, and Glanzmann’s thrombasthenia with refractoriness to platelet transfusions, with or without antibodies to platelets; Treatment of bleeding episodes and peri-operative management in adults with acquired hemophilia CONTRAINDICATIONS: None known.

WARNINGS AND PRECAUTIONS: Thrombosis: Serious arterial and venous thrombotic events have been reported in clinical trials and postmarketing surveillance. Patients with disseminated intravascular coagulation (DIC), advanced atherosclerotic disease, crush injury, septicemia, or concomitant treatment with aPCCs/PCCs (activated or nonactivated prothrombin complex concentrates) and uncontrolled post-partum hemorrhage have an increased risk of developing thromboembolic events due to circulating tissue factor (TF) or predisposing coagulopathy [See Adverse Reactions and Drug Interactions]. Exercise caution when administering NovoSeven ® RT to patients with an increased risk of thromboembolic complications. These include, but are not limited to, patients with a history of coronary heart disease, liver disease, disseminated intravascular coagulation, postoperative immobilization, elderly patients and neonates. In each of these situations, the potential benefit of treatment with NovoSeven® RT should be weighed against the risk of these complications. Monitor patients who receive NovoSeven ® RT for development of signs or symptoms of activation of the coagulation system or thrombosis. When there is laboratory confirmation of intravascular coagulation or presence of clinical thrombosis, reduce the dose of NovoSeven ® RT or stop the treatment, depending on the patient’s condition. Hypersensitivity Reactions: Hypersensitivity reactions, including anaphylaxis have been reported with NovoSeven® RT. Administer NovoSeven ® RT only if clearly needed in patients with known hypersensitivity to NovoSeven ® RT or any of its components, or in patients with known hypersensitivity to mouse, hamster, or bovine proteins. Should symptoms occur, discontinue NovoSeven ® RT, administer appropriate treatment and weigh the benefit/risks prior to restarting treatment with NovoSeven ® RT. Antibody Formation in Factor VII Deficient Patients: Factor VII deficient patients should be monitored for prothrombin time (PT) and factor VII coagulant activity before and after administration of NovoSeven ® RT. If the factor VIIa activity fails to reach the expected level, or prothrombin time is not corrected, or bleeding is not controlled after treatment with the recommended doses, antibody formation may be suspected and analysis for antibodies should be performed. Laboratory Tests: Laboratory coagulation parameters (PT/INR, aPTT, FVII:C) have shown no direct correlation to achieving hemostasis. Assays of prothrombin time (PT/INR), activated partial thromboplastin time (aPTT), and plasma FVII clotting activity (FVII:C), may give different results with different reagents. Treatment with NovoSeven ® has been shown to produce the following characteristics: PT: As shown below, in patients with hemophilia A/B with inhibitors, the PT shortened to about a 7-second plateau at a FVII:C level of approximately 5 units per mL. For FVII:C levels > 5 units per mL, there is no further change in PT. The clinical relevance of prothrombin time shortening following NovoSeven ® RT administration is unknown.

PT (sec) PT versus FVII:C INR: NovoSeven® has demonstrated the ability to 14 normalize INR. However, INR 13 values have not been shown 12 to directly predict bleeding 11 outcomes, nor has it been 10 possible to demonstrate the 9 impact of NovoSeven® on 8 bleeding times/volume in 7 models of clinically-induced 6 bleeding in healthy volunteers who had received Warfarin, 5 when laboratory parameters 4 (PT/INR, aPTT, thromboelas3 togram) have normalized.

2 aPTT: While administration of 1 NovoSeven® shortens the 0 30 40 prolonged aPTT in hemo0 10 20 philia A/B patients with FVII:C (unit per mL)

inhibitors, normalization has usually not been observed in doses shown to induce clinical improvement. Data indicate that clinical improvement was associated with a shortening of aPTT of 15 to 20 seconds. FVIIa:C: FVIIa:C levels were measured two hours after NovoSeven ® administration of 35 micrograms per kg body weight and 90 micrograms per kg body weight following two days of dosing at two hour intervals. Average steady state levels were 11 and 28 units per mL for the two dose levels, respectively.

ADVERSE REACTIONS: The most common and serious adverse reactions in clinical trials are thrombotic events. Thrombotic adverse reactions following the administration of NovoSeven ® in clinical trials occurred in 4% of patients with acquired hemophilia and 0.2% of bleeding episodes in patients with congenital hemophilia. Clinical Trials Experience: Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug product cannot be directly compared to rates in clinical trials of another drug, and may not reflect rates observed in practice. Adverse reactions outlined below have been reported from clinical trials and data collected in registries.

Hemophilia A or B Patients with Inhibitors: In two studies for hemophilia A or B patients with inhibitors treated for bleeding episodes (N=298), adverse reactions were reported in ≥2% of the patients that were treated with NovoSeven® for 1,939 bleeding episodes (see Table below).

Table: Adverse Reactions Reported in ≥2% of the 298 Patients with Hemophilia A or B with Inhibitors Body System Reactions Body as a whole Fever Platelets, Bleeding, and Clotting Fibrinogen plasma decreased Cardiovascular Hypertension

# of adverse reactions (n=1,939 treatments)

(n=298 patients)

16

13

10

5

9

6

# of patients

Serious adverse reactions included thrombosis, pain, thrombophlebitis deep, pulmonary embolism, decreased therapeutic response, cerebrovascular disorder, angina pectoris, DIC, anaphylactic shock and abnormal hepatic function. The serious adverse reactions of DIC and therapeutic response decreased had a fatal outcome.

There have been no confirmed reports of inhibitory antibodies against NovoSeven ® or FVII in patients with congenital hemophilia A or B with alloantibodies. In two clinical trials evaluating safety and efficacy of NovoSeven ® administration in the perioperative setting in hemophilia A or B patients with inhibitors (N=51), the following serious adverse reactions were reported: acute post-operative hemarthrosis (n=1), internal jugular thrombosis adverse reaction (n=1), decreased therapeutic response (n=4) Congenital Factor VII Deficiency: Data collected from the compassionate/ emergency use programs, the published literature, a pharmacokinetics study, and the Hemophilia and Thrombosis Research Society (HTRS) registry showed that 75 patients with Factor VII deficiency had received NovoSeven® : 70 patients for 124 bleeding episodes, surgeries, or prophylaxis; 5 patients in the pharmacokinetics trial. The following adverse reactions were reported: intracranial hypertension (n=1), IgG antibody against rFVIIa and FVII (n=1), localized phlebitis (n=1). As with all therapeutic proteins, there is a potential for immunogenicity. Patients with factor VII deficiency treated with NovoSeven ® RT should be monitored for factor VII antibodies. The incidence of antibody formation is dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to NovoSeven ® RT with the incidence of antibodies to other products may be misleading. Acquired Hemophilia: Data collected from four compassionate use programs, the HTRS registry, and the published literature showed that 139 patients with acquired hemophilia received NovoSeven ® for 204 bleeding episodes, surgeries and traumatic injuries. Of these 139 patients, 6 patients experienced 8 serious adverse reactions. Serious adverse reactions included shock (n=1), cerebrovascular accident (n=1) and thromboembolic events (n=6) which included cerebral artery occlusion, cerebral ischemia, angina pectoris, myocardial infarction, pulmonary embolism and deep vein thrombosis. Three of the serious adverse reactions had a fatal outcome. Glanzmann’s Thrombasthenia: Data collected from the Glanzmann’s Thrombasthenia Registry (GTR) and the HTRS registry showed that 140 patients with Glanzmann’s thrombasthenia received NovoSeven® RT for 518 bleeding episodes, surgeries or traumatic injuries. The following adverse reactions were reported: deep vein thrombosis (n=1), headache (n=2), fever (n=2), nausea (n=1), and dyspnea (n=1). Postmarketing Experience: The following adverse reactions have been identified during post approval use of NovoSeven®.

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship.

Table: Post Marketing Experience MedDRA System Preferred Term Organ Class Immune system Hypersensitivity (including anaphylactic shock, disorders flushing, urticaria, rash, angioedema) Vascular disorders Thromboembolic events (including hepatic artery thrombosis, myocardial infarction, cerebral infarction, intestinal infarction, intracardiac thrombus, peripheral ischemia, portal vein thrombosis, myocardial ischemia, renal artery thrombosis) DRUG INTERACTIONS: Avoid simultaneous use of activated prothrombin complex concentrates or prothrombin complex concentrates. The risk of a potential interaction between NovoSeven ® RT and coagulation factor concentrates has not been adequately evaluated in preclinical or clinical studies. Do not mix NovoSeven ® RT with infusion solutions. Thrombosis may occur if NovoSeven ® RT is administered concomitantly with Coagulation Factor XIII. USE IN SPECIFIC POPULATIONS: Pregnancy: Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. NovoSeven ® RT should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Treatment of rats and rabbits with NovoSeven ® in reproduction studies has been associated with mortality at doses up to 6 mg per kg body weight and 5 mg per kg body weight respectively. At 6 mg per kg body weight in rats, the abortion rate was 0 out of 25 litters; in rabbits at 5 mg per kg body weight, the abortion rate was 2 out of 25 litters. Twenty-three out of 25 female rats given 6 mg per kg body weight of NovoSeven® gave birth successfully, however, two of the 23 litters died during the early period of lactation. No evidence of teratogenicity was observed after dosing with NovoSeven ®. Labor and Delivery: There are no adequate and well-controlled studies in labor, delivery, and postpartum periods. NovoSeven® RT has caused thrombosis when used to control post-partum hemorrhage. Nursing Mothers: It is not known whether NovoSeven ® RT is excreted in human milk.

Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Pediatric Use: Clinical trials enrolling pediatric patients were conducted with dosing determined according to body weight and not according to age. Hemophilia A or B with Inhibitors: During the investigational phase of product development NovoSeven ® was used in 16 children aged 0 to <2 years for 151 bleeding episodes, 27 children aged 2 to <6 years for 140 bleeding episodes, 43 children aged 6 to <12 for 375 bleeding episodes and 30 children aged 12 to 16 years for 446 bleeding episodes. In a double-blind, randomized comparison trial of two dose levels of NovoSeven ® in the treatment of joint, muscle and mucocutaneous hemorrhages in hemophilia A and B patients with and without inhibitors 20 children aged 0 to <12 and 8 children aged 12 to 16 were treated with NovoSeven ® in doses of 35 or 70 micrograms per kg dose. Treatment was assessed as effective (definite relief of pain/tenderness as reported by the patient and/or a measureable decrease of the size of the hemorrhage and/or arrest of bleeding within 8 hours [rated as excellent = 51%], within 8-14 hours [rated as effective = 18%] or after 14 hours [rated as partially effective = 25%]) in 94% of the patients. NovoSeven® was used in two trials in surgery. In a dose comparison 22 children aged 0 to 16 years were treated with NovoSeven ®. Effective intraoperative hemostasis (defined as bleeding that had stopped completely or had decreased substantially [rated as effective = 86%] or bleeding that was reduced but continued [rated as partially effective = 9%]) was achieved in 21/22 (95%) patients. Effective hemostasis was achieved in 10/10 (100%) patients in the 90 mcg/kg dose group and 10/12 (83%) in the 35 mcg/kg dose group at 48 hours; effective hemostasis was achieved in 10/10 (100%) in the 90 mcg/kg dose group and 9/12 (75%) in the 35 mcg/kg dose group at 5 days. In the surgery trial comparing bolus (BI) and continuous infusion (CI) 6 children aged 10 to 15 years participated, 3 in each group. Both regimens were 100% effective (defined as bleeding has stopped completely, or decreased substantially) intra-operatively, through the first 24 hours and at day 5. At the end of the study period (Postoperative day 10 or discontinuation of therapy) hemostasis in two patients in the BI group was rated effective and hemostasis in one patient was rated as ineffective (defined as bleeding is the same or has worsened). Hemostasis in all three patients in the CI group was rated as effective. Adverse drug reactions in pediatric patients were similar to those previously reported in clinical trials with NovoSeven ®, including one thrombotic event in a 4 year old with internal jugular vein thrombosis after porta-cath placement which resolved. Congenital Factor VII deficiency: In published literature, compassionate use trials and registries on use of NovoSeven ® in congenital Factor VII deficiency, NovoSeven ® was used in 24 children aged 0 to <12 years and 7 children aged 12 to 16 years for 38 bleeding episodes, 16 surgeries and 8 prophylaxis regimens. Treatment was effective in 95% of bleeding episodes (5% not rated) and 100% of surgeries. No thrombotic events were reported. A seven-month old exposed to NovoSeven® and various plasma products developed antibodies against FVII and rFVIIa [see Clinical Trials Experience and Overdosage]. Glanzmann’s Thrombasthenia: In the Glanzmann’s Thrombasthenia Registry, NovoSeven ® was used in 43 children aged 0 to 12 years for 157 bleeding episodes and in 15 children aged 0 to 12 years for 19 surgical procedures. NovoSeven® was also used in 8 children aged >12 to 16 years for 17 bleeding episodes and in 3 children aged >12 to

16 years for 3 surgical procedures. Efficacy of regimens including NovoSeven ® was evaluated by independent adjudicators as 93.6% and 100% for bleeding episodes in children aged 0 to 12 years and >12 to 16 years, respectively. Efficacy in surgical procedures was evaluated as 100% for all surgical procedures in children aged 0 to 16 years. No adverse reactions were reported in Glanzmann’s thrombasthenia children. Geriatric Use: Clinical studies of NovoSeven ® RT in congenital factor deficiencies and Glanzmann’s thrombasthenia did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

OVERDOSAGE: Dose limiting toxicities of NovoSeven ® RT have not been investigated in clinical trials. The following are examples of accidental overdose.

One newborn female with congenital factor VII deficiency was administered an overdose of NovoSeven ® (single dose: 800 micrograms per kg body weight).

Following additional administration of NovoSeven ® and various plasma products, antibodies against rFVIIa were detected, but no thrombotic complications were reported. One Factor VII deficient male (83 years of age, 111.1 kg) received two doses of 324 micrograms per kg body weight (10-20 times the recommended dose) and experienced a thrombotic event (occipital stroke). One hemophilia B patient (16 years of age, 68 kg) received a single dose of 352 micrograms per kg body weight and one hemophilia A patient (2 years of age, 14.6 kg) received doses ranging from 246 micrograms per kg body weight to 986 micrograms per kg body weight on five consecutive days. There were no reported complications in either case.

More detailed information is available upon request.

For information contact: Novo Nordisk Inc. 800 Scudders Mill Road Plainsboro, NJ 08536, USA 1-877-NOVO-777 www.NovoSevenRT.com Manufactured by: Novo Nordisk A/S 2880 Bagsvaerd, Denmark License Number: 1261 Novo Nordisk® is a registered trademark of Novo Nordisk A/S. NovoSeven® is a registered trademark of Novo Nordisk Health Care AG. © 2015 Novo Nordisk 0715-00027826-1 8/15

Integrity, Accuracy, Empathy...

CONTENTS

FEATURE 15 I Who Takes Care of You

Parents and caregivers, who manage inhibitors, make sacrifices everyday. Time, money, relationships, and careers are the possessions that caregivers take a loss on too often. But the most tragic loss is their own health and sanity. Families rely on caregivers way too much for illness to stand in the way. Learn how to restore your health so you can maintain your loved ones.

COMMUNITY CHATTER

INSURANCE CORNER

8 I LEVERAGE: New Pilot Program Unveiled

22 I Isn’t Home Infusion the Standard of Care for Hemophilia? - UPDATE

This fall, CHES launched a new program created for adults with inhibitors to promote self-reliance, confidence, new friendships, and a whole lot of fun.

9 I Small Steps, Courageous Acts: A Participant’s Review of LEVERAGE Chris Weiss, a participant of LEVERAGE, provides his vision of what this program is like to experience. If you’re a young adult with inhibitors and looking for adventure, this is a must-read!

10 I Inhibitor Family Camp: Bull’s-Eyes, All-Around

In our Summer issue, we reported on a life-altering decision from a governing agency disallowing select individuals from infusing in their own homes. These are the updates to that ruling.

23 I The Pharmaceuticals’ Consumer Councils, Pt.One: Someone’s Listening...

Many of our pharma companies have much more to offer than just medication. With the use of consumer councils and advisory boards they can help identify our needs. Find out more to become a member.

Cindy Meide, mother of a child with inhibitors, highlights her weekend at Inhibitor Family Camp, from archery to the infusion chair, finding that her son is becoming a marksman in more ways than one.

FAMILY MATTERS

12 I NHF’s 2015 Inhibitor Summit: The Top of the Ferris Wheel

We are our own worst enemies. Dr. Gary McClain has some suggestions for us to rid those nasty thoughts and quiet the selfcriticism in our heads.

NHF’s Inhibitor Summits have thrived in various parts of the country, and it certainly has it’s followers (for good reasons).

Cazandra Campos-McDonald was more than just a routine guest this year, as she stood in front of the entire group to testify her struggles as a mother. This is her inspiring story.

BLOODLINES 28 I Deciphering the Clinical Trial: Emergent Inhibitors in Untreated Patients We’ve been questioning it for years now. How does recombinant vs plasma-derived products influence the emergence of inhibitors? Finally, more than 5 years later, the results are out on SIPPET (Survey of Inhibitors in Plasma-Product Exposed Toddlers).

4

n

LIFELINES for HEALTH

n

Winter 2015

24 I Is It Time to be Kind to Yourself?

10 Steps Toward Self-Compassion

FUN & INSPIRATION 29 I Imagine...

Artists are among us. But this one paints his pictures with words.

Gerod Similien (a young adult with inhibitors) shares with us a poem of inspiration.

WHAT’S the PLAN? 30 I 504 Plans: When Good Plans Go Wrong With over 20 years of experience in the world of special education, Janet Brewer, M.Ed gives you some trouble-shooting tips to get your 504 running like new again.

CONTENTS

Puzzling Questions?

Talk to your doctor to see if Koate ˉ ®-DVI is right for you

Achieve response with the stability of the FVIII/vWF Complex*

FVIII

von Willebrand

Koate ˉ ®-DVI1,2: * Ko ate ˉ ®-DVI has not been investigated • Is indicated for the treatment of classical for efficacy in the treatment of von Willebrand disease, and hence hemophilia A is not approved for such usage • Demonstrates a mean biologic half-life of 16.12 hours ** A total of 306 bleeding episodes were • Contains naturally occurring vWF* treated. 82% of the bleeding episodes • Is well-tolerated with low risk (0.7%) of adverse reactions were treated adequately with a single infusion of FVIII • Is effective in a single dose** Important Safety Information Koate ˉ ®-DVI is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent that can cause disease. There is also the possibility that unknown infectious agents may be present in such products.

Hepatitis B vaccination is essential for patients with hemophilia A; vaccination is recommended at birth or at the time of diagnosis. Hepatitis A vaccination is also recommended for hemophilia patients who are hepatitis A seronegative.

When large or frequently repeated doses are required, patients of blood groups A, B, or AB should be monitored for signs of progressive anemia. ©2015 Kedrion Biopharma, Inc. All Rights Reserved. November 2015 KT-0077-01-2015

Allergic-type reactions may result from the administration of Antihemophilic Factor (Human) preparations. Reactions include tingling in the arm, ear, and face, blurred vision, headache, nausea, stomach ache, and jittery feeling.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see next page for Brief Summary of Koate ˉ ®-DVI Product Information. For Full Product Information, please visit www.koate-dviusa.com.

References: 1. Koate ˉ ®-DVI [prescribing information]. 2012. 2. Powell JS, Bush M, Harrison J, Abildgaard C, Vosburgh E, Thompson AR, Hurst D. Safety and efficacy of solvent/detergent- treated antihaemophilic factor with an added 80 degrees C terminal dry heat treatment in patients with haemophilia A. Haemophilia. 2000;6(3):140-9.

Koˉate®-DVI [Antihemophilic Factor (Human)] Brief Summary: Please see Koate ˉ ®-DVI Full Prescribing Information for complete product details.

Koate ˉ ®-DVI [Antihemophilic Factor (Human)] is a sterile, stable, purified, dried concentrate of human Antihemophilic Factor (AHF, Factor VIII) used to treat classical hemophilia (hemophilia A) in which there is a demonstrated deficiency of activity of the plasma clotting factor, Factor VIII. Koate-DVI ˉ contains naturally occurring von Willebrand factor, but has not been approved for the treatment of von Willebrand disease.

Warnings Koate-DVI ˉ is made from human plasma. It may contain infectious agents that can cause disease, such as viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. The risk that the product will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating and/or removing certain viruses.

Despite these measures, the product may carry a risk of transmitting infectious agents, including unknown infectious agents.

Individuals who receive infusions of blood or plasma products may develop signs and/or symptoms of some viral infections, particularly hepatitis C. Hepatitis B vaccination is essential for patients with hemophilia and it is recommended that this be done at birth or diagnosis. Hepatitis A vaccination is also recommended for hemophilic patients who are hepatitis A seronegative.

Precautions Koate-DVI ˉ is intended for the treatment of bleeding disorders arising from a deficiency in Factor VIII. This deficiency should be proven prior to administering Koate-DVI. ˉ Koate-DVI ˉ should be administered within 3 hours after reconstitution and should not be refrigerated after reconstitution. Administer only by the intravenous route, and use a filter needle prior to administering.

Koate-DVI ˉ contains levels of blood group isoagglutinins, which are not clinically significant when controlling relatively minor bleeding episodes. When large or frequently repeated doses are required, patients of blood groups A, B, or AB should be monitored by means of hematocrit for signs of progressive anemia, as well as by direct Coombs’ tests.

Product administration and handling of the infusion set

and needles must be done with caution. Place needles in sharps container after single use and discard all equipment including any reconstituted Koate-DVI ˉ product in accordance with biohazard procedures. Percutaneous puncture with a needle contaminated with blood can transmit infectious viruses including HIV (AIDS) and hepatitis. Obtain immediate medical attention if injury occurs.

Some viruses, such as parvovirus B19 or hepatitis A, are particularly difficult to remove or inactivate at this time.

Parvovirus B19 most seriously affects pregnant women and immune-compromised individuals. Symptoms of parvovirus B19 infection include fever, drowsiness, chills, and runny nose followed about 2 weeks later by a rash and joint pain. Evidence of hepatitis A may include several days to weeks of poor appetite, tiredness, and low-grade fever followed by nausea, vomiting, and pain in the belly.

Dark urine and a yellowed complexion are also common symptoms. Patients should be encouraged to consult their physician if such symptoms appear.

Pregnancy Category C Animal reproduction studies have not been conducted with Koate-DVI. It is also not known whether Koate-DVI ˉ can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Koate-DVI ˉ should be given to a pregnant woman only if clearly needed.

Pediatric Use Koate-DVI ˉ has not been studied in pediatric patients.

However, the previous formulation, Koate-HP, ˉ had been used extensively in pediatrics. Spontaneous adverse event reports with Koate-HP ˉ for pediatric use was similar to those reported for adult use.

Adverse Reactions Allergic-type reactions may result from the administration of Antihemophilic Factor (Human) preparations.

In clinical studies, 0.7% of infusions were associated with adverse reactions. All reactions were mild and included paraesthesia (numbness), blurred vision, headache, nausea, abdominal pain, and feeling jittery.

The information provided in this brief summary should not replace a conversation with your physician. It is important to talk to your physician about treatments that are appropriate for you.

For Koate ˉ ®-DVI Full Prescribing Information, please visit www.koate-dviusa.com.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Letter From the Editors Well, we are at the close of 2015, how did that happen? Life seems to zoom by faster and faster. Here at CHES, it occurred to us mid-year that we have been in business for six years! We have been so busy, we never found the time to celebrate our fifth anniversary of providing programs and the only newsletter dedicated to the inhibitor community! For Eric and I, it is such a blessing to be able to continue to provide information that is pertinent and specific to your lives. As individuals who live with hemophilia and an inhibitor, we understand the many challenges, triumphs and struggles you face on a daily basis. That feeling when things are going well, however, you keep wondering when the other shoe will drop? The reality is we all know it will drop, but instead of waiting for it, celebrate that it hasn’t hit the floor yet.

Live in this moment and take in the blessings you have, even if it is as simple as you are still breathing and were able to get out of bed.

In 1975, Helen Reddy released a song about women’s empowerment titled; “I am Woman Hear Me Roar”. Most days I feel like, I am Woman, Hear Me Snore. Our feature in this edition addresses the issue of Caregiver Stress. The statistics are startling regarding the effects of long-term stress on our bodies. When my children were young, I would read all those women’s magazines that suggested taking time out for you. All I could think of was, “seriously, where I am going to find time for that?” Well, it is important to your long-term health and maybe even critical to carve some moments in your day out for you and we will show you how.

In our Community Chatter section, as always we bring you news of events and programs specific to the inhibitor community written by community members.

We know we love that moment when all of you arrive at one of programs full of excitement! We look forward to our writer’s perspective in every edition. We share that same excitement with you! Our BloodLines section features a summation of the long awaited SIPPET trial, which was presented at the American Society of Hematologists the first weekend in December. This VERY important trial has produced information that many of us in the trenches have suspected all along regarding the rate of inhibitor development.

In our Insurance Corner section we reported a disturbing decision made by Novitas, on April 5, 2015. Novitas, a government oversight agency for Medicare/ Medicaid determined that patients who infuse FVII would have to do so in a hospital setting in thirteen different states. We have an update on that decision. In addition, we will be providing information in each publication regarding factor manufacturers that provide opportunities for individuals with an inhibitor to serve on Advisory Boards/Consumer Councils.

Do you have any idea who your worst critic is? Well, the answer may (or not) surprise you. In Family Matters, we discuss how many times in a day is that little voice in your head correcting you, berating you, suggesting you could have done more, better, sooner? Dr. McClain outlines 10 strategies to quiet that aggravating voice.

For every time that I have done workshops on 504s and IEPs, I am always horrified by at least one story where a child’s civil rights have been violated. How I wish I had created a journal of these stories. In What’s the Plan, we will discuss what to do when a carefully crafted plan, goes wrong. The Fun and Inspiration section is meant to provide the levity and triumphs we need and to celebrate as we navigate this sometimes-bumpy path called our lives.

We hope that this winter brings you time to reflect and rejuvenate, or sip hot chocolate maybe sitting by a fire. Above all else, we hope that the days are uneventful and if they are not, you gain strength from each experience. Have an idea, comment or suggestion? We always love to hear from you!

- Janet Brewer & Eric Lowe “Always laugh when you can. It is cheap medicine.”

-Lord Byron jbrewer@comphealthed.com l elowe@comphealthed.com

Did YOU Know?

CHES Presented two new programs in 2015 for adult men with inhibitors.

The first was hosted last spring in Las Vegas for those ages 18 and up. It was created to provide information and support to manage inhibitors. Supported by an educational grant from Kedrion.

The second program; LeverageTM, occurred in October. Also for those 18 and up - this 5-day camp program offered many outdoor adventures to challenge participants.

Read more about LeverageTM on page 8.

LifeLines for HealthSM Disclaimers The views and opinions of our writers are not a reflection of Comprehensive Health Education ServicesTM, Inc. (CHES), 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 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 CHES. In every publication of LifeLines for HealthSM, we will provide links to other websites that are not owned or controlled by CHES 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.

LEVERAGE

TM

New Pilot Program Unveiled

L

everage is defined, when used as a verb, as using something for maximum gain. Leverage: The Ultimate Inhibitor Adventure is designed specifically with that definition in mind. So often, inhibitors live up to their name as well, inhibiting our ability to fully experience places, activities and friendships.

Leverage changes all that. When you step onto the forested carpet of Oregon’s Camp Collins, all those stereotypes about what you can or can’t do recede into the fog of the river, and the first time you find yourself 60 feet off the ground, you realize that this week is going to change what “living” with an inhibitor means.

Over the course of five days, you will live, laugh, zip line, rappel, fish, float and camp out under the stars with a small group of new friends, all of whom have an inhibitor. Campfires, great meals, sharing stories and reflecting on your list of “firsts” each day with other guys that have shared a lot of the same experiences is what it’s all about.

Every time you do something that you haven’t done before, or that you didn’t think you could do, your world gets a little bit bigger, your confidence builds, and your community of support expands. Having an inhibitor can be incredibly isolating. Your inhibitor doesn’t define you, but it does affect you. Friends that

know where you’re at and what you’ve been through, even if you’re not always talking about it, make some of the struggle of an inhibitor seem less lonely.

If you want to find out what you’re really made of, and build friendships that will last your lifetime, Leverage is for you. If you want to know what it feels like to wake up on the banks of a wild river after an awesome night of campfire stories and laughter, Leverage is for you. If you want to experience landing a wild Chinook salmon on the Columbia that you’ll be eating for dinner that night, Leverage is for you. If you want to rethink how your inhibitor plays into your life, come stand on a platform 50 feet up in the trees…. and find out.

-Jacose Bell, GutMonkey

Presented by:

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Kevin Finkle with his catch off of the Columbia River

an Innovative CHES Program

Small Steps, Courageous Acts

A Participant’s Review of Leverage

by Chris Weiss

I

recently had the pleasure of attending a special program co-led by CHES (Comprehensive Health Education Services) and Gutmonkey. It was a 4-night, 5-day retreat at Camp Collins in Oregon. The camp is nestled amid large majestic trees with the cabins built amongst them. At first when I found out about the program, I was unsure. As someone with severe hemophilia A with an inhibitor I am naturally cautious. Yet, I decided to give it a chance.

Upon arrival, I knew the outline of the program, but I wasn’t sure what exactly to expect. Needless to say, being with others who had hemophilia with an inhibitor, I knew there would be a support system of people who were sensitive to my needs.

On our first day I was faced with my biggest fear… heights! As hard as it was, I decided to throw any hesitations and fears I was having out the window. Not only did myself, but every single member of our team repelled backwards down a sixty-foot drop. I got the chance to see first-hand how other people with inhibitors, could do courageous things. I had not always had the chance to meet others with an inhibitor and for a long time kept quiet about my condition to others.

As the week progressed, I had the chance to spend time interacting with everyone who attended the retreat.

Knowing no one judged me when it was time to infuse or questioned me if I felt I couldn’t do a certain activity really made the week go by with such relief.

The program was oriented towards those with an inhibitor, but the truth is, I think any person would have enjoyed the thrill seeking adventures we faced. Whether it was fishing the Columbia River Gorge, learning survival skills and putting them to use during the camp out, whittling by the fire, cooking the salmon we caught, or any of the other exciting adventures

Chris Weiss just before his rappel down a 60-ft tower

that gave us the chance to bond with one another and share our stories. Building relationships has always been a big part of my life, however I had not always had the opportunity to meet others with my condition. I feel that programs like Leverage are so important in our inhibitor community; not only does one get to see first-hand what others with a similar condition go through and learn how they deal differently with their struggles, but it provides the opportunity to meet fun and interesting people who I now call my friends.

Learn more at: CompHealthEd.com/index.php/leverage/, or GutMonkey.com/leverage Notification sign-up is available on the CompHealthEd site if you’d like to receive updates.

This program was sponsored by Baxalta & Novo Nordisk.

COMMUNITY CHATTER

Inhibitor Family Camp: Victory Junction

T

Bull’s-Eyes, All-Around

his was my family’s second year coming to Inhibitor Family Camp (IFC) at Camp Victory Junction. Since our experience was so amazing, I wanted to share some of the highlights with you. The fall weather in North Carolina is so crisp, cool and refreshing coming from the hot, humid weather in Florida. Our family was one of the first to arrive at camp, so we enjoyed looking at the fall colors that we don’t get to experience in Florida. After meeting up with some good friends we met earlier in the year, we anxiously awaited the arrival of my son’s friends that he met the year before. Once everyone arrived, we went to the Pit Stop for dinner. The end of meal times are so much fun, because we get up and have a dance party!

Archery is always one of our favorite activities at IFC. Larry, the archery instructor, is someone my 8-year-old son, Charlie, looks up to. Charlie got his first bull’s-eye of the day so everyone joined in and did the bull’s-eye dance! After his second bull’seye, he received a gold medal for his achievement. Afterwards, we visited the resident goats and llamas, and then made our way to the Superdome. We played a fun game of kickball and enjoyed the time to free play.

One of my favorite sessions for the parents was on grief. It never occurred to me that in addition to the joys in life, I was also experiencing grief on a daily basis because I have a child with hemophilia and inhibitors. As parents we have hopes, dreams and expectations for our children, and a diagnosis of inhibitors can shatter those hopes and dreams.

I learned that grief only gets worse over time, and that it is

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Winter 2015

Written by: Cindy Meide

important to recognize and deal with it in a healthy way. We received a book called The Grief Recovery Handbook and the author Russell Friedman led the session. I am grateful for this experience.

Another great session was on Section 504 plans for our children. It is always helpful to hear what we can do to help our children have a safe learning environment in the school setting. Listening to other parents’ share about their experiences is always helpful to me.

The self-infusion class for the parents was life changing for me. Very knowledgeable nurses taught me how to infuse my son peripherally. I took very good notes and watched as the nurses demonstrated the proper technique. After persuading my significant other that it would only hurt for a second, it was my turn. I was successful at my first needle poke! I had achieved what I have been dreading for years…and it was a lot easier than I thought! After my class, my 8-year-old son, Charlie, successfully accessed a vein in his hand right in front of my eyes.

Watching the joy on his face when he realized he had a blood return was priceless! I have never been more proud as a parent.

IFC helped my son and I overcome our fears of self-infusion.

We will now take what we have learned home and continue to practice.

The weekend ended with a talent show put on by all of the kids. What a fun time that was! We have such a very talented group of children in our hemophilia community.

Thank you CHES for an amazing experience at camp this year!!

We will see you next year!

COMMUNITY CHATTER

an Innovative CHES Program

Everyone deserves a camp to call their own This program is specially designed to meet the needs and limitations of children with both, hemophilia & inhibitors. Immediate family members are also invited because we understand that chronic illness affects the whole family. We play, learn, and grow while we build a stronger community.

To register, applicants must have an active inhibitor, or a history of an inhibitor within the last 12 months, and are between the ages of 6-18. If you’re interested, please act now. Space is limited, and slots are filled on a first come, first-served basis for those who qualify.

Questions? Don’t hesitate to call at: 781.878.8561 Supported by an educational grant from

SPRING SESSION

Date: Friday, April 15th - Monday, April 18th, 2016 Loction: The Painted Turtle, located in Lake Hughes, CA Registration Opens: Friday, January 8th, 2016

FALL SESSION

Date: Friday, Oct. 7th - Monday, Oct. 10th, 2016 Loction: Victory Junction, located in Randleman, NC Registration Opens: Friday, July 1st, 2016

To learn more or register visit: InhibitorFamilyCamp.org

Customized Care Management for All Bleeding Disorders We ensure patients get the care they need across all stages of life • A personal team of bleeding disorder experts • Help day or night • Connect directly to a clinician with hemophilia treatment experience • Broad insurance coverage • A dedicated inhibitor management team

To learn more, call 866.436.4376 En español, llame al 800.456.1923 We’re there to extend your care Option Care locations are ACHC accredited.

HHA #20881096, HHA #20885096, HHA #299991678, HHA #299992580, HHA #299992912, HHA #299994060, HHA #299994066 ©2015 Option Care Enterprises, Inc. All rights reserved. 15OC2171

Presented by

NHFâ&#x20AC;&#x2122;s 2015 Inhibitor Summit:

The Top of the Ferris Wheel

by Cazandra Campos-MacDonald

concludes on page 14

T

he view from the top of the ferris wheel in downtown Atlanta was pretty amazing. It was glassed in and air conditioned with an audio tour! I had never been to Atlanta and was alone for the Inhibitor Summit. I am the kind of person who will normally keep to myself and enjoy the evening with room service and the Food Network, but this evening I ventured out from the hotel with my friend, Kari, and her son, Beau. I was desperately missing my family but as Kari and Beau and I walked to the ferris wheel I realized that I was with family; my inhibitor family.

The

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family who have been by my side for years, the family who helped me survive living with an inhibitor. The family who I have always been able to depend on day or night.

Julian, is 19 and was diagnosed with a low titer inhibitor right before his first birthday. We started Immune Tolerance immediately and for two and a half years we accessed

My oldest son,

Winter 2015

COMMUNITY CHATTER

COMING

SOON KOVALTRY

TM

Antihemophilic factor (recombinant)

Register for updates at www.KOVALTRY.com Bayer and the Bayer Cross are registered trademarks of Bayer. KOVALTRY is a trademark of Bayer. © 2015 Bayer HealthCare Pharmaceuticals Inc. All rights reserved. Printed in USA 08/15 PP-675-US-0032

his port daily (the port that never had a single infection). Ever since he has been on prophylaxis and has only had one joint bleed. Not too bad for a kid with severe hemophilia and an inhibitor.

When Julian was diagnosed with hemophilia my head seemed to be spinning. I think it felt like that for at least a year. I remember seeing the word “inhibitor” but it didn’t make sense, so I ignored it. It wasn’t until Julian was diagnosed with his inhibitor that I went back to my resource materials and did some more reading. For some reason I didn’t grasp the severity of an inhibitor. I never understood just how complicated and devastating his inhibitor could have become.

an inhibitor rap session (did you notice I said sitting and not “participating”). The mom leading the session (who eventually became a trusted friend) was talking about Rituximab. I heard her talking about this chemo drug being used to help eradicate an inhibitor and I thought, “She must be crazy! I’d never do that!” Well, I must say that after hearing her talk about Rituximab

The most wonderful surprise of my life came when I found out I was pregnant with my second child. This was the child I was told I would never have. Ten years after Julian and here came Caeleb. He was my surprise baby boy named after the mighty warrior Caeleb in the Bible.

The biggest surprise of my life was when Caeleb was diagnosed with hemophilia.

I was devastated and I just knew that Caeleb’s journey with hemophilia was going to be very different. I didn’t know then how fitting his name would be.

When Caeleb was circumcised at 11 months of age, he would not stop oozing from his sutures. He was diagnosed with a high titer inhibitor a week after his surgery. What I didn’t understand about inhibitors so many years ago was now coming to haunt me. I needed information and I needed it quickly!

Inhibitor levels can be over 2,000 Bethesda units?! Are you kidding?!

My husband, Joe, and I began to quickly learn how difficult and life changing an inhibitor diagnosis could actually be for someone. Julian was a “walk in the park” not only with his inhibitor but hemophilia in general. I was definitely having a hard time understanding the world of inhibitors. When Caeleb turned three is when the inhibitor started to rear its ugly head. It was around that time that Julian and I attended a National Hemophilia Foundation Annual Meeting in Orlando, Florida. I vividly remember sitting in

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it came to be a reality in our lives. I’ve learned to never say never.

It was not too long after that rap session that we attended our first NHF Inhibitor Summit. Hemophilia had gotten really ugly and the trip to the summit was extremely difficult. I ended up spending many hours in the emergency room in San Diego that trip. The most important thing I learned from that first summit was to remember that not all hematologists understand inhibitors. Wow! It made perfect sense and all of a sudden my husband and I felt empowered like we never had before and we began to speak up and ask questions much differently.

Our sense of empowerment led to getting a second opinion from an out of state Hemophilia Treatment Center. I feel like that was the moment I moved from being a mom who spoke up for her child to truly advocating for my child and family.

That was when our battle with inhibitors truly began. We held on tight, continued to go to Summits and came back armed with information. It wasn’t that we always learned new information from the clinicians who were presenting, but we learned about new protocols from members of the community.

Unfortunately, our inhibitor community is growing.

Our community. Our family.

Six ports, an allergy to Factor VIII, PTSD from needle phobia, over a hundred days of missed school and two target joints later and Caeleb’s inhibitor is registering zero.

I know that there is a chance that Caeleb’s inhibitor may come back. But there is also a chance that it may not. Throughout this battle with a high titer inhibitor and allergy to Factor VIII, I’ve learned several things.

1. There are times when the doctor does not always know what is best for your child.

2. You have the right to ask for a second opinion.

3. You may have to think outside of the box for treatment options.

4. There is always another option.

5. Hope can be the only thing left to hold on to.

Even through the worst of times with an inhibitor I knew that hope was right in front of me. I could spend all night sitting up with my child screaming in pain and I would hold on to hope knowing that the morning would come, the bleed would eventually get better and the pain would subside. I would look forward to the “other side” of the miserable stuff and start to breathe again.

And then I get to the top of the ferris wheel…

Winter 2015

COMMUNITY CHATTER

Who Takes Care of YOU?

By Janet Brewer, M.Ed

A

s I write this now in November, National Caregivers Month, I have some time to reflect on the multiple years I have spent (and still do) as a caregiver. Within our community, we are bombarded with information on factor products, maintaining a healthy lifestyle, healthcare and insurance changes; the list goes on and on. But where are the articles and information on how to manage your emotional and physical health when you are the primary caregiver of a child with a bleeding disorder and an inhibitor? It makes “just having hemophilia”, look like a cakewalk. This isn’t to depreciate their daily struggles, but what all of us would give to be back in the “just hemophilia” crowd. As we all know, inhibitors are a totally different diagnosis.

IDENTIFYING AN EPIDEMIC “Caregiver stress is defined as the emotional strain of caregiving”1. The impact of caregiving effects us economically, physically, and emotionally. Not to mention the effects it has on our jobs and our relationships. The statistics are as overwhelming as we are overwhelmed.

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FEATURE

The National Center on Caregiving indicates that an estimated 59%-75% of caregivers are female. Females spend 50% more of their time providing care than men. Working women caregivers are likely to suffer a higher level of economic hardship due to caregiving.

Most caregivers are employed. Among baby boomer caregivers (aged 50-64 years old), an estimated 60% are working fullor part-time. With these statistics it is no wonder these women are stressed out.

They are often juggling their own work schedule demands; their child’s caregiving demands and many are taking care of their elderly parents as well. This often involves using personal days, sick days or vacation time to schedule appointments or when their loved one is in need of treatments or if they are ill (if they are fortunate enough to have a job that provides paid time off).

Working women caregivers may suffer a particularly high level of economic hardships due to their caregiving.

The impact on the physical and mental health of the caregiver takes its toll.1 A number of studies have found that female caregivers are more likely than males to suffer from anxiety, depression, and other symptoms associated with emotional stress due to caregiving. As many as 20%-50% of caregivers report depressive disorders or symptoms. Caregivers use more prescription and psychotropic drugs than non-caregivers.1 While researchers have long known that caregiving can have deleterious mental health effects for caregivers, research shows that caregiving can

have serious physical health consequences as well. Studies have shown that caregivers may have increased blood pressure and insulin levels, may have impaired immune systems and may be at increased risk for cardiovascular disease among other adverse outcomes.

HITTING CLOSE TO HOME Reflecting on these statistics leaves me not only staggered, but all too aware that care-giving is now a big part of my identity. Do these statistics sound all too familiar to you? Has caregiving now become your identity? When we have children, our identity is forever linked with our child’s, “Oh, you’re Robert and Edward’s mom.”

Our endless “To Do” List looks like anyone else’s, until you add a chronic illness. We are in serious caregiver stress territory. So a show of hands please (be honest now): Do you put off your own health and emotional needs to care for a loved one? Studies show that by doing this we often end up feeling angry, isolated, and anxious.

•

Do you have problems sleeping or want to sleep all the time?

•

How are your eating habits-have you lost or gained too much weight?

•

Are you tired or feel like you have no energy?

•

Have you lost interest in activities that you used to enjoy?1

•

Do you feel the need to control all aspects of yours and your loved ones lives?

• Do you even remember the activities that you used to enjoy?

• Do you turn down offers for help, even from your family members or your partner, further isolating

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yourself and establishing your identity as “THE CAREGIVER”?

Many of us are well acquainted with these truths. Honest answers to these questions may help you to recognize the impact caring for your loved one is taking on you. Identifying, acknowledging, and embracing the role you play, as the family caregiver is the first step to creating a more balanced life.

Now the hard part... how do we learn to create a space where caregiving doesn’t become your reality?

Accept that your family member has a chronic disorder. Their diagnosis will affect you too and it is understandable to feel upset, angry, disappointed and maybe even helpless at times. Know that you must allow yourself to go through a grieving process as your hopes and dreams for your child or loved one is now very different than what you anticipated. It is perfectly appropriate to express these feelings and recognize that this may put a dent in your future activities, or plans.

While you absorb the feelings of those around you, don’t forget to acknowledge that as a caregiver you have emotions as well and you may not be able to fix other’s feelings. And sometimes, it might be better to let them figure out some of them with someone else rather than you.

DO YOUR HOMEWORK As the primary caregiver, you will learn unfamiliar and out of the ordinary things; like gauze soaked in black tea can help with oozing teeth. High school biology had nothing on what we need to learn! Ensure that you are aware and well- versed on your loved one’s diagnosis, severity, recommended product, as well as all product choices available to you, treatment protocols, physician/HTC information, and medical alert identification. Educate yourself, read everything provided to you and seek out more information. Search the web, find and attend support groups, educate members of your extended family so they may be a source of support for you.

Insufficient knowledge breeds fear!

What we don’t understand is scary.

Arming yourself with as much information as you can helps to mitigate some of the fear and allows you to take back control.

Know that you are not alone; your feelings are NORMAL and try not to be afraid.

Fear paralyzes us. There is hope that you can and will balance your life. Recognize that you ALSO are affected with all the same mentally, physically, socially and spiritually. The active role that you will now play in their life is truly a gift that requires openness of the mind and willingness of the heart. It is important to note that caring for another person can also create positive emotional change.

Aside from feeling stress, many caregivers say their role has had many positive effects on their lives. For example, caregivers report that caregiving has given them a sense of purpose. They say that their role makes them feel useful, capable and that they are making a difference in the life of a loved one.2

COMMUNICATE, COMMUNICATE, COMMUNICATE Communication is the single most important way to learn anything.

Communication will make a situation with no possible resolution seem easier to figure out. As the caregiver, part of your role is to communicate with your affected loved one in a positive manner. They need to know they have an outlet, but be aware of how many roles you may play in your loved ones’ life. Trying to fill too many roles are detrimental to both of you. Initially, it will be your role to explain to the doctor and other health professionals what symptoms they might be experiencing, as well as sharing your observations and thoughts. Remember to allow your loved one to express their own symptoms and care as often as possible. The medical staff is only as good as you help them to be in treating your specific disorder. If you have questions, ask. If you have a difference of opinion or information that you have learned from outside resources, respectfully share this with the physician.

As the caregiver, you become the expert as you live your daily life with your loved one’s disorder. Teaching and modeling these skills for your child will allow them to become successful adults who will be better equipped to manage their own care.

tasks that others can do for you... Meals?

Picking up other children? Someone to sit beside your child or loved one at the hospital so you can take a shower? Write these needs down or put them in a chart so that when someone asks during the next crisis (and there will be another one), you can easily hand it to them.

When we are stressed or overwhelmed, it is so easy to develop a mind set that it is easier to do it yourself rather than going through the steps of explaining what is needed. By adopting that mind-set, two negative things occur: you shut out the very people who are trying to help you which makes them feel inadequate and less willing to provide assistance in the future, and you become more angry and resentful.

By opening lines of communication and letting others help you, you allow them to feel good about themselves and deepen the relationship between yourself, the other person, your loved one and your family.

As Barbra Streisand once sang, “People who need people are the luckiest people in the world.”

The second part of communicating is to ask for what you need from your spouse, significant other, trusted friend, or family member.

Try to remember that those around you care about you and in most circumstances, genuinely want to help. They won’t know what you need unless you tell them. When we are in the middle of a crisis, we don’t even know what we need. Our mind is flooded in crisis mode, making it difficult to communicate. When the dust settles, reflect on the crisis and write a list of

FEATURE

TAKING CARE Taking care refers to not only the loved one with the bleeding disorder, but treatment of the individual who is caring for them. If you don’t take care of yourself, who else is going to do it? The equally important question is, if you become unable to perform the “duties” of caregiver, who is going to take care of your loved ones? The best gift that you can provide your loved one is an emotionally, spiritually and physically healthy you. “The research is very clear; the affect of stress on the family caregiver has been shown to affect our immune system making us more prone to chronic illness ourselves.”3 Depression and anxiety can affect our ability to not only make informed decisions, but it affects concentration, stamina and the ability to function on a daily basis.

Left undiagnosed and untreated it may impact our overall desire to live.

Putting yourself first is not selfish; it is self-less. The relationship and bond you have created with your loved one is one of complete trust.

They trust you to always be there when they need you; taking time to do something relaxing for yourself affords you the opportunity to return more energized and relaxed.

It also serves as a way for them to see you as a person beyond

themselves. This in turn affects their perception of themselves.

FINDING RELIEF So how do you work on your treatment? First and foremost – Be flexible. Bleeds and injuries happen and they usually happen at the worst possible moment. Holidays, planned activities, and family gatherings are the most popular times!

Modeling flexibility creates resiliency in a family. If someone is laid up with a bleed and the family can’t go to grandma’s to celebrate that big birthday, why not switch the party to your house? Remember, it’s about spending time together, where you spend it isn’t important.

What lesson will they take from the party coming to your house? That family and loved ones care enough to make sacrifices for the greater good.

Keep your priorities straight. Is it more important that your home looks like something out of a home and garden magazine when everyone comes to celebrate grandma’s birthday at your house in our above example? No, life happens on a daily basis, which includes a house that may not meet everyone’s standards. We need to remember as caregivers not to allow our own guilt to bleed into what we think others are thinking of us. I once saw a sign that read, “If you came to see megreat! If

you came to see my house, make an appointment.”

Organize your day. Sometimes in the most stressful of times, we look at the whole of a day and get so overwhelmed it can be paralyzing.

Break your day down, if you can only get through ten minutes at a time, so be it, concentrate on getting through those ten minutes. Then, take a deep breath, pat yourself on the back and get through the next ten minutes or maybe the confidence you gained from managing those ten minutes will inspire you to tackle twenty minutes!

Banish the phrases of “What if ” or “I could/should” from your vocabulary. Dealing with what IS can be more than enough to deal with. The here and now is the reality, not what MIGHT happen or what COULD have happened or what SHOULD have happened. My children used to ask me “What If ” questions all the time when they were younger and my response was, “I can only deal with what is”. We often spend our days trying to protect our child from that next bleed, when the reality is-they bleed. Spontaneous bleeding is the reality for individuals with hemophilia and an inhibitor, so if they are going to bleed doing nothing, why not at least try to let them enjoy life a little (within acceptable limits of course!) Stressing over what we can’t control only creates more stress.

Exercise - even if it is only doing some type of physical activity for ten minutes, three times per day. There are 24 hours in a day; we spend about 16-17 hours of them awake. How is it not possible to find at least 10 minutes for yourself in there somewhere? Hide in the bathroom. Walk through your neighborhood with your child in a stroller, wagon, or wheelchair. It will be good for both of you. Can’t get outside?

Power walk through or around your house, run up and down the stairs, jump rope in your kitchen, tackle the chores you can that day with a little more zest. Do a body scan. Are your shoulders up around your ears? Teeth concludes on page 21

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FEATURE

A clinical study showed*

72%

FEWER BLEEDS1

28.7

median Annual Bleed Rate (ABR) with on-demand treatment1,2 629 bleeding episodes occurred during on-demand treatment1,2

74%

7.9

median ABR with prophylaxis treatment1,2 196 bleeding episodes occurred during prophylaxis treatment1,2

ABR for joint bleeds was reduced from 22.9 in the on-demand arm to 6.0 in the prophylaxis arm

FEWER JOINT BLEEDS2

* Based on the results from the FEIBA PROOF clinical study of 36 hemophilia A and B patients with inhibitors receiving FEIBA for prophylaxis or on-demand treatment for 12 months.2

Routine prophylaxis with FEIBA may help you have more options and more bleed-free days as compared to on-demand treatment.

Indications for FEIBA [Anti-Inhibitor Coagulant Complex]

FEIBA is an Anti-Inhibitor Coagulant Complex indicated for use in hemophilia A and B patients with inhibitors for: • Control and prevention of bleeding episodes • Use around the time of surgery • Routine prophylaxis to prevent or reduce the frequency of bleeding episodes.

FEIBA is not indicated for the treatment of bleeding episodes resulting from coagulation factor deficiencies in the absence of inhibitors to coagulation factor VIII or coagulation factor IX.

Detailed Important Risk Information for FEIBA WARNING: EVENTS INVOLVING CLOTS THAT BLOCK BLOOD VESSELS • Blood clots that block blood vessels and their effects have been reported during postmarketing surveillance following infusion of FEIBA, particularly following the administration of high doses and/or in patients with a risk of forming blood clots.

• If you experience any of these side effects, call your doctor right away.

You should not use FEIBA if: • You had a previous severe allergic reaction to the product (reactions causing discomforts that are damaging and life threatening) • You have signs of development of small blood vessel clots throughout the body • You have sudden blood vessel clots or blocked blood vessels, (e.g., heart attack or stroke) Events involving blood clots blocking blood vessels can occur with FEIBA, particularly after receiving high doses and/or in patients with risk factors for clotting.

Infusion of FEIBA should not exceed a dose of 100 units per kg body weight every 6 hours and daily doses of 200 units per kg of body weight. Maximum injection or infusion rate must not exceed 2 units per kg of body weight per minute.

At first sign or symptom of a sudden blood vessel clot or blocked blood vessel (e.g., chest pain or pressure, shortness of breath, altered consciousness, vision, or speech, limb or abdomen swelling and/or pain), stop FEIBA administration promptly and seek emergency medical treatment.

Allergic-type hypersensitivity reactions, including severe, sometimes fatal allergic reactions that can involve the whole body, can occur following the infusion of FEIBA. Call your doctor or get emergency treatment right away if you get a rash, hives or welts, experience itching, tightness of the throat, vomiting, abdominal pain, chest pain or tightness, difficulty breathing, lightheadedness, dizziness, nausea or fainting.

Because FEIBA is made from human plasma it may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

The most frequent side effects observed during the prophylaxis trial were anemia, diarrhea, bleeding into a joint, signs of hepatitis B surface antibodies, nausea, and vomiting.

The serious side effects seen with FEIBA are allergic reactions and clotting events involving blockage of blood vessels, which include stroke, blockage of the main blood vessel to the lung, and deep vein blood clots.

Call your doctor right away about any side effects that bother you during or after you stop taking FEIBA. Please see next page for FEIBA Brief Summary of Prescribing Information.

To see the Full Prescribing Information, including Boxed Warning, go to www.FEIBA.com.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

References: 1. FEIBA Prescribing Information. Westlake Village, CA: Baxter Healthcare Corporation; November 2013. 2. Antunes SV, Tangada S, Stasyshyn O, et al.

Randomized comparison of prophylaxis and ondemand regimens with FEIBA NF in the treatment of haemophilia A and B with inhibitors. Haemophilia. 2014;20(1):65-72.

Baxalta and Feiba are trademarks of Baxalta Incorporated October 2015 USBS/145/15-0036

FEIBA [Anti-Inhibitor Coagulant Complex] For Intravenous Use, Lyophilized Powder for Solution Brief Summary of Prescribing Information. Please see package insert for full Prescribing Information.

WARNING: THROMBOEMBOLIC EVENTS • Thromboembolic events have been reported during post-marketing surveillance following infusion of FEIBA, particularly following the administration of high doses and/or in patients with thrombotic risk factors.

• Monitor patients receiving FEIBA for signs and symptoms of thromboembolic events.

INDICATIONS AND USAGE FEIBA is an Anti-Inhibitor Coagulant Complex indicated for use in hemophilia A and B patients with inhibitors for: • Control and prevention of bleeding episodes • Perioperative management • Routine prophylaxis to prevent or reduce the frequency of bleeding episodes.

FEIBA is not indicated for the treatment of bleeding episodes resulting from coagulation factor deficiencies in the absence of inhibitors to coagulation factor VIII or coagulation factor IX. CONTRAINDICATIONS • Known anaphylactic or severe hypersensitivity reactions to FEIBA or any if its components, including factors of the kinin generating system.

• Disseminated intravascular coagulation (DIC).

• Acute thrombosis or embolism (including myocardial infarction).

WARNINGS AND PRECAUTIONS Thromboembolic Events Thromboembolic events (including venous thrombosis, pulmonary embolism, myocardial infarction, and stroke) can occur with FEIBA, particularly following the administration of high doses (above 200 units per kg per day) and/or in patients with thrombotic risk factors [see ADVERSE REACTIONS].

Patients with DIC, advanced atherosclerotic disease, crush injury, septicemia, or concomitant treatment with recombinant factor VIIa have an increased risk of developing thrombotic events due to circulating tissue factor or predisposing coagulopathy. Potential benefit of treatment with FEIBA should be weighed against the potential risk of these thromboembolic events.

Monitor patients receiving more than 100 units per kg of body weight of FEIBA for the development of DIC, acute coronary ischemia and signs and symptoms of other thromboembolic events. If clinical signs or symptoms occur, such as chest pain or pressure, shortness of breath, altered consciousness, vision, or speech, limb or abdomen swelling and/or pain, discontinue the infusion and initiate appropriate diagnostic and therapeutic measures.

Hypersensitivity Reactions Hypersensitivity and allergic reactions, including severe anaphylactoid reactions, can occur following the infusion of FEIBA. The symptoms include urticaria, angioedema, gastrointestinal manifestations, bronchospasm, and hypotension. These reactions can be severe and systemic (e.g., anaphylaxis with urticaria and angioedema, bronchospasm, and circulatory shock). Other infusion reactions, such as chills, pyrexia, and hypertension have also been reported. If signs and symptoms of severe allergic reactions occur, immediately discontinue administration of FEIBA and provide appropriate supportive care.

Transmission of Infectious Agents Because FEIBA is made from human plasma it may carry a risk of transmitting infectious agents, e.g., viruses, and the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. The risk has been minimized by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections and by inactivating and removing certain viruses during the manufacturing process [see DESCRIPTION in full Prescribing Information]. Despite these measures, the product may still potentially transmit human pathogenic agents. There is also the possibility that unknown infectious agents may still be present.

All infections thought by a physician to have been possibly transmitted by this product should be reported by the physician or other healthcare providers to Baxter Healthcare Corporation, at 1-800-423-2862 (in the U.S.) and /or to FDA Med Watch (1-800-FDA-1088 or www.fda.gov/medwatch).

ADVERSE REACTIONS The most frequently reported adverse reactions observed in >5% of subjects in the prophylaxis trial were anemia, diarrhea, hemarthrosis, hepatitis B surface antibody positive, nausea, and vomiting.

When Malysa Hadland talks about her six-year-old son, the conversation quickly moves to hockey: “Connor loves hockey!

He plays it on XBOX and watches a lot of Detroit Red Wings games at home with my husband, Alex. It was hard having to tell him that he couldn’t play hockey. Fortunately, Connor enjoys other activities, such as playing outside with our dogs, playing Baxalta and Feiba are trademarks of Baxalta Incorporated.

Lego is a registered trademark of Lego Juris A/S. Xbox is a registered trademark of Microsoft Corporation.

October 2015 USBS/145/15-0036

The serious adverse reactions seen with FEIBA are hypersensitivity reactions and thromboembolic events, including stroke, pulmonary embolism and deep vein thrombosis.

Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The safety assessment of FEIBA is based on the review of the data from two prospective clinical trials in which FEIBA was used for the treatment of acute bleeding episodes and a prospective trial that compared the use of FEIBA prophylactically versus on-demand treatment.

The adverse reactions reported from two prospective clinical trials in which FEIBA was used for the treatment of acute bleeding episodes were chills, chest pain, chest discomfort, dizziness, dysgeusia, dyspnea, hypoesthesia, increase of inhibitor titer (anamnestic response), nausea, pyrexia, and somnolence. Specifically, the first trial was a multicenter randomized, double-blind trial in 15 hemophilia A subjects with inhibitors to factors VIII. The second trial was a multicenter FEIBA study conducted in 44 hemophilia A subjects with inhibitors, 3 hemophilia B subjects with inhibitors and 2 acquired factor VIII inhibitor subjects. Of the 489 infusions used to treat acute bleeds during the second trial, 18 (3.7%) caused minor transient reactions of chills, fever, nausea, dizziness and dysgeusia. Out of 49 subjects, 10 (20%) had a rise in their inhibitor titers after treatment with FEIBA. Five of these subjects (50%) had increases that were, tenfold or more, and 3 (30%) of these subjects received factor VIII or IX concentrates within 2 weeks prior to treatment with FEIBA. These anamnestic rises were not associated with decreased efficacy of FEIBA. Table 2 lists the adverse reactions in >5% of subject reported in the randomized, prospective prophylaxis trial comparing FEIBA prophylaxis with on-demand treatment in 36 hemophilia A and B subjects with inhibitors to factors VIII or IX. The trial population included 33 (92%) subjects with hemophilia A and 3 (8.3%) subjects with hemophilia B. Four (11%) subjects were ≥7 to <12 years of age, 5 (14%) were ≥12 to <16 years of age, and 27 (75%) were ≥16 years of age. A total of 29 (80.6%) subjects were Caucasian, 3 (8.3%) Asian, 2 (5.6%) Black/African American, and 2 (5.6%) other. The subjects received a total of 4,513 infusions (3,131 for prophylaxis and 1,382 for ondemand). Adverse reactions were defined as adverse events that occurred (a) within 24 hours after being infused or (b) adverse events assessed related or possibly related or (c) adverse events for which the investigator’s or sponsor’s opinion of causality was missing or indeterminate.

Table 2 Prophylaxis Study Adverse Reactions (ARs) in >5% of Subjects MedDRA System Organ Class Blood And Lymphatic System Disorders Gastrointestinal Disorders Investigations Musculoskeletal And Connective Tissue Disorders

Number of ARs

Preferred Term

Number of Subjects

Percent of Subjects (N=36)

Anemia

2

2

5.6

Diarrhea Nausea Vomiting Hepatitis B Surface Antibody Positive

2 2 2

2 2 2

5.6 5.6 5.6

4

4

11.1

Hemarthrosis

5

3

8.3

Post-Marketing Experience Because post-marketing reporting of adverse reactions is voluntarily and from a population of uncertain size, it is not always possible to reliably estimate the frequency of these reactions or establish a causal relationship to product exposure.

BLOOD AND LYMPHATIC SYSTEM DISORDERS: disseminated intravascular coagulation CARDIAC DISORDERS: tachycardia, flushing RESPIRATORY, THORACIC, AND MEDIASTINAL DISORDERS: bronchospasm, wheezing GASTROINTESTINAL DISORDERS: abdominal discomfort SKIN AND SUBCUTANEOUS TISSUE DISORDERS: pruritus GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS: malaise, feeling hot, injection site pain DRUG INTERACTIONS Concomitant Medications Consider the possibility of thrombotic events when systemic antifibrinolytics such as tranexamic acid and aminocaproic acid are used during treatment with FEIBA. No adequate and wellcontrolled studies of the combined or sequential use of FEIBA and recombinant factor VIIa or antifibrinolytics have been conducted. Use of antifibrinolytics within approximately 6 to 12 hours after the administration of FEIBA is not recommended.

with LEGO blocks, swimming, and this past spring Connor joined a bowling league!”

Young Connor has severe hemophilia A with inhibitors. In July 2014 Connor started on a prophylactic treatment using FEIBA [Anti-Inhibitor Coagulant Complex}.

When Malysa talks with others about managing inhibitors, her

message is simple: “Don’t ever give up, there’s always hope.

We felt like it was a never-ending battle, but now there is a light at the end of the tunnel.”

This afternoon, meet Malysa, other caregivers and patients at Baxalta’s Inhibitor Suite at the National Hemophilia Foundation Annual Conference.

clenched? Muscles tight? Take those ten minutes to sit upright in a chair by yourself and mindfully will those muscles from the top to the bottom to unclench. And if that doesn’t work there is always chocolate!

There are two types of rice, and I’m not talking about the brown and white varieties.

•

•

Loved ones need RICE when a bleed occurs.

- Rest, Ice, Compression and Elevation Successful caregivers need RICE too.

- Rest, Inspiration, Compassion and Energy

So while they’re resting on the couch, you rest too. Pop in a movie, rock out to your favorite music, read a book, take a nap, practice yoga, mindfulness or simple breathing exercises to help you refocus and relax. (Refer to LFH Winter Volume 4: Exploring the Science of Mindfulness). Start a journal, writing down your thoughts and feelings give you the opportunity to release and let go of them. Practice gratefulness. Each day find three (3) things you were grateful for in the day. Studies show that after just one month of doing this, you will become a bit less stressed and a happier person.

“I’ve been able to show that fear closes down our minds and our hearts, whereas positive emotions literally open our minds and hearts... they really change our mindsets and our biochemistry” Dr. Barbara Fredrickson Professor of Psychology, University of North Carolina3 http://www. actionforhappiness.org Speaking of biochemistry, don’t be afraid to seek out professional help for yourself or your loved one, or both. Whether you make an appointment with your spiritual advisor or a trained counselor, there will be times when the stress of your daily lives

can and will overwhelm you. There is no shame in seeking an outside, unbiased professional to let all of those feelings out.

Anger, frustration, resentment and despair are all naturally occurring emotions as your family attempts to cope on a daily basis with the challenges of chronic illness. Sometimes it is better to discuss those feelings outside of the home where words cannot be misinterpreted.

Be sure that you and your loved one are seeing different professionals or allow separate time for each person to speak privately. Sometimes, we may need more than a counselor. Remember our statistics show that 20%-50% of caregivers report depressive disorders or symptoms? Stress changes the neurotransmitters in our brains, so it would make complete sense that you or your loved one may need to speak to your doctor(s) about using a medication to treat those symptoms. Some may need it long term, some for short term. A word of caution; never go off of these prescribed medications without your doctor’s knowledge.

Find a friend. As a member of the inhibitor community you are part of one big family. Inhibitor Summits provided by NHF, Inhibitor Family Camp, Leverage and Momentum provided by Comprehensive Health Education Services provide opportunities to share, relate and have fun. Find a person or family that you connect with. Face Time, Skype, become friends on Facebook, Twitter or whatever social networking method works for you.

We are living in a society that is sometimes overwhelmingly connected. Reach out.

The whole process of sharing and caring is a two way street. Allow the support you receive from the community to empower you to remember that you control the

bleeding disorder, it doesn’t control you!

There are numerous challenges to providing our loved one optimal care but we can be successful when we prioritize.

Keeping ourselves healthy and organized puts us in a better position to care for our love ones. Therefore, by eliminating room for stress we make space for the success and rewards of being the caregiver so that it doesn’t become our identity. above all else, maintain a sense of humor; you won’t get through this without one! Many of us have developed some really quirky (but necessary senses of humor!) As a family that deals with chronic illness on a daily basis, you may need to dig deep sometimes to find something to laugh about. Is it possible to look back at the annual Christmas picture when your child had a black eye and shake your head and laugh?! It will just become part of your family’s norm and it makes a great story to tell! Bruises, needle sticks, infections, bleeds and hospitalizations are part of our “normal”. By taking a deep breath and finding that “silver lining in the cloud”, over time, you’ll become more aware of yours

and your loved one’s ability to cope and become resilient.

1 Source: U.S. Department of Health and Human Services, Informal Caregiving: Compassion in Action. Washington, DC: 1998, and National Family Caregivers Association, Random Sample Survey of Family Caregivers, Summer 2000, Unpublished 2 Source: Medicinenet.com, Caregiving. http://www.medicinenet. com/caregiving/article.htm 3 Source: Action for Happiness: Take Action, Find Three Good Things Each Day. http://www.actionforhappiness.org

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FEATURE

Isn’t Home Infusion the Standard of Care for Hemophilia?

I

n our 2015 summer edition of LifeLines for Health, Barb Forss, founder and director of the LadyBugs Foundation for women with bleeding disorders, shared her compelling letter to Novitas. On April 9, 2015 Novitas, a government oversight agency, determined that a patient who infuses NovoSeven RT could no longer do so, unless they went to a Hemophilia Treatment Center to be infused under the supervision of a hematologist for individuals who live in the following states, and are a patient on Medicare/Medicaid, the Veterans Administration, or Indian Health Service (IHS and Veteran’s Affairs (VA)

letters of advocacy) and conversations between Novitas and our national organizations, NHF and HFA; they reversed their decision on July 17, 2015 that they would remove the NovoSeven language that requires direct supervision.

We are pleased to announce that with public outcry (never doubt your personal

Although this situation yielded a positive outcome, we must never be

• • • • • • • • • • • • •

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Pennsylvania New Jersey Maryland Delaware Washington D.C. The Medicare Administrative Contract (MAC) Jurisdiction H (JH), spans: Colorado Oklahoma New Mexico Texas Arkansas Louisiana Mississippi

LIFELINES for HEALTH

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complacent with other issues that may arise in our community. In the words of Helen Keller, “I am only one, but I am still one. I cannot do everything, but still I can do something. And because I cannot do everything, I will not refuse to do the something that I can do.”

- Janet Brewer, M.Ed This maps is for illustrative purposes only, and does not guarantee accuracy.

This decision set the standard of home care back nearly 50 years. As individuals and families who use NovoSeven RT on a regular basis to treat inhibitors or FVII deficiency this presented a nearly impossible standard of care. For many living in remote regions, or an inhibitor, this would mean being treated inpatient and as we all know treating bleeds for those with an inhibitor can take days, maybe weeks.

K

edrion Biopharma Inc., hosts an advisory board for persons with hemophilia A that meets twice per year. Board members include both patients and parents.

Advisors share the challenges and opportunities they face as persons living with hemophilia or caretakers and serve as a critical resource to Kedrion in its commitment to enhance the lives of people with hemophilia and their families. Participants have stated that the board provides a critical venue for discussing the emotional, social, and economic resources and demands unique to hemophilia patients and their families.

I

n 2001 Novo Nordisk created their Inhibitor Consumer Council. At that time, they established themselves as being patient focused and an industry leader that truly wants to learn from the communities they serve. This is a unique opportunity created to discuss community needs and gaps and then brainstorm ways that Novo Nordisk can help fulfill the need. Over the years, the consumer councils have been the springboard for innovative programs such as their HemaGo management system and the NovoSecure Patient Support Program.

Both Eric and I have served as Novo Nordisk Consumer Council members and it was truly an eye-opening experience into the behind the scenes workings of a pharmaceutical company. It was empowering to see our ideas put to life that would help fill the gaps in managing and living day to day with an inhibitor. Learning others around the country with differing needs, including adults, younger adults and caregivers of children, were one of the best parts of the meeting. Many of those council members have become part of our extended inhibitor family.

The Council is currently accepting applications for the 2016-2018, 2-year term. Patients and caregivers are welcome to apply. Eligibility requires a currently active inhibitor, and the ability to attend 1 – 2 live meetings/year.

For more information please contact Comprehensive Health Education Services at info@comphealthed.com.

Look for our Spring Issue in 2016 for part 2 of this series to discover more great consumer councils and advisory boards.

INSURANCE CORNER

The Pharmaceuticals’

The pharma companies offer some great products to improve our quality life. But for some of them, that’s not enough. These select few want to make our lives even better using unique avenues, like educational and networking resources, product improvement, financial support, and various other ways not yet thought of. But they don’t know what we need if we don’t tell them. Hence, the beginning of consumer councils and patient advisory boards.

Consumer Councils, Pt . One

Someone’s Listening...

Is It Time to Be Kind to Yourself?

Ten Steps Toward Self-Compassion

by Dr. Gary McClain, PhD

“You knew that would happen!”

“Can’t you do anything right?”

Or how about: “Idiot!”

W

ho’s saying all those mean things to you? Most likely, your own harshest critic. YOU!

We human beings sure can be tough on ourselves. Pointing out our own mistakes.

Our misjudgments. Anything we do that falls short of a demand we didn’t meet. All too often demands we created for ourselves and that weren’t realistic in the first place.

And just where does that critical voice come from? I suspect it’s a voice we hear as children, maybe from parents who criticized and scolded when we were judged as not having met the demands that were placed on us. Or teachers. Maybe other kids. Somewhere along the way we learn that when we make a mistake, or can’t quite perform as well as someone else thinks we should, we’re going to hear about it. Often with some pretty harsh words.

Sure, criticism can make us better. That’s probably what was behind all that criticism that came your way as a child. Or at least that’s what you were told.

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FAMILY MATTERS

Turn Off the Self-Criticism and Replace It With Kindness But what happens is that, as we become adults, that baton magically gets passed to us. And unfortunately we latch onto it. By doing so, we invite those critical voices into our minds, and give them free reign to sound off at will. And do they ever take advantage of every opportunity! While compassion for ourselves gets pushed off into the corner.

If you’re living with a chronic condition, or have a family member with a chronic condition, you know about demands. The chronic condition places all kinds of demands on you, every day, even throughout the night.

And with each demand, another reason to be hard on yourself when your performance doesn’t quite measure up.

Let me ask you something: Have you ever thought about the toll it takes on you when the person in the mirror always has a good scolding at the ready, just waiting to unleash it? That’s a lot of pressure to live with. And another question: Is it possible that you might be demanding a little too much of yourself in some areas of your life? And how about this: Is all the scolding the only way you have to keep yourself motivated?

You’ve heard that expression, with friends like you, who needs enemies?

So I have to ask: Are you being a friend to yourself?

And I have to add something here. When you’re that hard on yourself that becomes your view of the world. And that can translate into being hard on other people, too.

Compassion starts with being kind to yourself. Here’s how to get started.

Set priorities Sit down with yourself and think about what you really need to do to take the best possible care of yourself. Focus on the basics, what you need to do to maintain your optimal health, physically, emotionally, and in your relationships. Make a list. And a schedule. These are your priorities.

(And don’t forget: If you are taking good care of yourself, you are all that more able to take care of others.)

Remind yourself that not everything is a crisis One of the best ways to give yourself a rough time is to look at anything less than perfection as an absolute catastrophe and then make yourself at fault. Take a step back and consider the situation. Let’s say you slipped up on your compliance, or made a mistake in judgment. Is this something that can be fixed? Do you know how to get things back on track? And if not, is there someone who can help? All that energy spent on self-criticism can be channeled toward finding a solution.

Focus on the big picture Who knows, you may even decide that what felt like a crisis at the moment was only a bump in a much longer road. What a relief, right?

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Look for the lesson Here’s where you have a choice. You can look at a mistake or a setback as a reason for punishment, and call yourself lazy, stupid, etc. Or you can turn this into an opportunity for learning. Try this: “Oh, so that’s what happens if I…. At least I know how to avoid this problem in the future.”

And then move forward, that much more educated.

Watch your self-talk We spend our waking hours talking to ourselves. Evaluating, predicting, explaining… judging. And it’s that judgment talk that can make us very unhappy. So be more aware of your self-talk. When you feel the critical voice gearing up to let loose with a good old scolding, tell him/her to be quiet. And then engage that kindly, compassionate voice that’s been cowering in the corner for too long.

Give yourself a break Ask that voice of kindness for a little pep talk. Remind yourself: “I’m human. I’m trying hard. This is not an easy road.

And I am doing the best I can, even if not everything I do is perfect.” Having trouble conjuring up that voice? It might help

to sit down with a sheet of paper and do some journaling. Give yourself a positive self-talk script you can read when you need a lift. Try some affirmations. Start out with: “I am a work in progress. I get better every day.”

And let yourself feel One of the ways we punish ourselves is by telling ourselves that we shouldn’t be feeling the way we feel. But there is no right or wrong way to feel. So as emotions come up, don’t swallow them. Let yourself feel, whether that judging voice approves or not. Sad, mad, afraid. It’s all part of being human. That’s being kind to yourself.

Replace punishment with rewards Chances are, if you are letting loose on yourself with that critical voice, you may also be punishing yourself in some way. Avoiding people. Not doing things you know you would enjoy. Pushing yourself to overwork. What if you gave yourself some rewards when you meet an expectation you have for yourself?

This is a way to shift your focus to what’s going well, and to give yourself some encouragement to keep up whatever you’re doing that got you there. Indulge in

something you enjoy that promotes your wellness, a little break, a favorite activity, some fun with a loved one. You deserve it!

Let somebody help Limit your time with people who take away the need to criticize yourself because they are so good at doing it for you.

Instead, try to surround yourself with people who bring out the best in you.

Be kind back. Kindness leads to more kindness. And it sure feels a whole lot better than criticism!

Smile at your imperfections Nobody’s perfect. Now, how do such imperfect people manage to dress themselves in the morning? It’s a mystery.

We’re all so imperfect that we just have to shake our heads and laugh at ourselves sometimes. How’s that for lightening up?

You’re dealing with a lot. So how about giving yourself credit for doing the best you can? Show yourself some compassion.

And some love while you’re at it. Be kind to yourself.

Gary McClain, PhD, LMHC, is a therapist, patient advocate, and author, specializing in helping clients deal with the emotional impact of chronic and life-threatening illnesses, as well as their families and professional caregivers. He works with them to understand and cope with their emotions, to learn about their lifestyle and treatment options, to maintain compliance with medical regimens, to communicate effectively with the medical establishment, and to listen to their own inner voice as they make decisions about the future. His email is: gary@JustGotDiagnosed.com. He welcomes your questions and comments.

FAMILY MATTERS

Deciphering the Clincal Trial:

Emergent Inhibitors in Untreated Patients

by Christopher Brewer

S

ince 2010, The Fondazione Angelo Bianchi Bonomi Center in Italy has been probing into a ground-breaking study on the emergence of inhibitors in severe hemophilia A patients. What makes this study so unique is that the conditions and treatment variables had not been specifically examined before, making this a “first of its kind” trial, so to speak. The need behind this clinical trial focuses on the long theorized influence of inhibitor development with the use of recombinant factor VIII (rFVIII) versus plasma-derived factor VIII (pdFVIII) in the severe hemophilia A community.

The controls for this study were as follows: • • • • •

Male patients under the age of six (6) Severe Hemophilia A with less than 1% detectable clotting factors Must be PUPs (previously untreated patients) - Never having been exposed to any factor products No detectable inhibitor Minimally treated (<5 Exposure Days) with blood components

Overall there were 251 participants that were followed for three years, or 50 exposure days (ED’s).

Participants ranged in age from 0-81 months, and were demographically treated and surveyed from 42 different locations in Africa, the Americas, Asia and Europe. These participants as a group were split in half, 125 patients treated with pdFVIII and 126 patients treated with rFVIII.

Treatment Protocol & Standards

Drawn Conclusions & Percentiles

The primary objective of the study was to determine the frequency of FVIII inhibitor formation in patients treated with pdFVIII compared to patients treated with rFVIII. Patients were followed for 3 years, 50 ED’s, or formation of an inhibitor. If one of these values were satisfied, the trial ended for that particular participant and inhibitor titre levels in emergent patients were recorded for the remainder of the trial. A positive inhibitor detection constituted any titre level equaling or above 0.4BU(Bethesda Units), a high level inhibitor titre being equal to or above 5BU.

It was found that of those PUPs that did not develop an inhibitor from either product, 70% of those patients had been exposed for more than 20 EDs; whereas 90% of the inhibitors 251 Patients, development (from 76 Inhibitor either product) Developed occurred within 20 EDs of treatment.

Seventy-six percent of the PUPs

developed an inhibitor, fifty of which were high-titered.

Further calculations and percentages revealed that 26.7% of patients receiving pdFVIII developed an inhibitor, compared to 44.5% that developed an inhibitor while being treated with rFVIII. Though a difference of 17.8% may not seem large on this small of a scale, the ratios are eye-opening for the larger hemophilia A community.

PUPS treated with rFVIII experienced an 87% higher incidence of inhibitors than pdFVIII along with high-titre inhibitors occurring in 70% more patients.

In summation, rFVIII products represented a 1.87 fold increase in inhibitors as compared to pdFVIII products. The results of this study has the potential to significantly impact product selection choice for new patients with severe hemophilia A.

125 Patients pdFVIII 126 Patients rFVIII

29 Inhibitors Developed, 20 High Titre 47 Inhibitors Developed, 30 High Titre

Fondazione Angelo Bianchi Bonomi. Survey of Inhibitors in Plasma-Product Exposed Toddlers (SIPPET). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [2015Nov17]. Available from: http://clinicaltrials.gov/show/NCT01064284 NLM Identifier: NCT01064284.

Flora Peyvandi, MD, PhD. 5 Source of Factor VIII Replacement (PLASMATIC OR RECOMBINANT) and Incidence of Inhibitory Alloantibodies in Previously Untreated Patients with Severe Hemophilia a: The Multicenter Randomized Sippet Study. Presented at: ASH 57th Annual Meeting and Exposition; December 5-8, 2015; Orlando, FL. https://ash.confex.com/ash/2015/webprogram/Paper82866.html. Accessed November 15, 2015.

Publication and Trial Information: This article is a brief summary of the SIPPET study that was presented at the American Society of Hematologists annual meeting December 5-8, 2015. Information and data were provided from the following sources.

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BLOODLINES

QUALITY WHERE IT COUNTS IN 25 YEARS, we’ve developed a reputation. To families, we’re a team who offers the highest-quality care. And to bleeding disorders organizations, we’re a supporter whose commitment and contributions have never stopped.

We’re not here to boast. We’re here to promise: Another 25 years of good care—and good character.

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Imagine

Just imagine...

A Poem by Gerod Similien How many of us can truly say we know what it’s like? How many of us know what it’s like to be in captivity to our mind and body physically wanting to do something, but not able because we have our physical limitations?

Well to every little boy and little girl that has ever been stuck in this world of medication, poking and screaming. I just want to let you know you can get stronger mentally.

So, with every pain and every cry do a mental push-up until you are strong enough to let your mind wonder and imagine.

I want you to imagine a field of cotton candy flowers. I want you to imagine chocolate raindrops and pools overflowing with honey.

To the little girl: I want you to imagine a sparkling unicorn galloping under the rays of the sun.

To the little boy: I want you to imagine gliding, better yet soaring through the air just like your favorite super hero.

Just imagine!

Imagine going, so let us go to a place where we can escape, escape IV poles, escape hospital bed rails, escape nurse call bells Escape this pain filled stigma of life.

So let us go to a place where we can be free.

So to the little girl who doesn’t have strength to brush her doll’s hair, there is hope.

And to the active little boy that is tired of being told stop moving because the IV pole

Gerod is an adult with hemophilia and inhibitors, who resides in southeast, FL. He plans to release a book of poetry in the summer of 2016.

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is beeping from a down occlusion there is hope.

For every boy and girl that has spent countless holidays, birthdays and childhood memories confined to a bed. There is hope.

So again let us go to a place where we can be free. Free from sadness, free from pain, free from everyone saying, “it’s all right and it’s going to be okay”, as tears run down our face. So join me and let us truly go to a place where we are free. All you have to Do is close your eyes and IMAGINE!

FUN & INSPIRATION

504 Plans: When Good Plans Go Wrong, Part One S

o, you have worked closely with your school’s team to develop a carefully crafted 504 accommodation plan for your child (and if you haven’t, do so!) The accommodations seem reasonable and the school has agreed that it is their responsibility to make sure it is followed across all content areas, including specials. Everything seems to be going fine then, ROAD BLOCK - your child is struggling.

Some potential struggles: • • • •

The substitute doesn’t let your child go to the nurse if s/he is in pain resulting in a bleed that takes longer to recover.

Your child is told they “can’t go out for recess because it is too dangerous.”

Your child’s class is going on a field trip and your child is told s/he can’t go because “they can’t provide a nurse, or the building isn’t wheelchair accessible, or it might be too risky.”

The second semester teacher won’t provide your child with an extra book saying, “there aren’t enough.”

by Janet Brewer, M.Ed

The list of reasons, aka “excuses”, could be endless! By now, you probably get the picture and most likely have dealt with at least one these scenarios or a more severe scenario! (I have heard many of your stories and they make me shudder). Each of these examples is a violation of your child’s civil rights. Yes, civil rights. Remember, a 504 accommodation plan is developed under the Americans for Disabilities Act, a federal law designed to remove barriers, prevent discrimination and to provide your child the same experiences as every other child in their classroom, school or school district.

Section 504 of the Rehabilitation Act of 1973

This Act’s focus is on non-discrimination. It maintains that, “no otherwise qualified individual with a disability will be excluded from participation in, be denied the benefits of, or be subjected to discrimination under any program or activity receiving Federal financial assistance”.

In addition, the Office for Civil Rights also has responsibilities under Title II of the Americans with Disabilities Act (http:// www2.ed.gov/about/offices/list/ocr/disabilityoverview.html) of 1990 (ADA) that prohibits discrimination based on disability in any program or activity operated by recipients of federal funds and prohibits discrimination based on disability by public entities, regardless of whether they receive federal financial assistance.

This may have the potential to apply to children who are in private school (http://www.ada.gov/t2hlt95.htm).

Americans with Disabilities Act 1990

ADA is an extension of Section 504. It provides for the elimination of barriers related to accessibility for the disabled to buildings, transportation, and communication.

Both 504 and ADA provide related services and accommodations to qualified individuals with a diagnosed disability through a 504 plan. Its’ intent is to provide access or remove barriers to participation. It provides students with the same rights and services as their “NON Disabled Peers”.

What does this look like?

If your child’s friend Sean can go on a field trip or play on the playground, it is the school’s FEDERAL obligation to provide the related services and accommodations so that your child can participate in the same activities. What is available to one student is available to all! Equality!

Concludes on page 33 30

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WHAT’S the PLAN?

THE FIRST AND ONLY FACTOR VIII WITH A PROLONGED HALF-LIFE Learn how a prolonged half-life may affect your infusion schedule

Meet your CoRe Manager Nikita Lyons Murry E: nikita.lyonsmurry@biogen.com T: 615-525-1003 This information is not intended to replace discussions with your healthcare provider.

Indications ELOCTATE [Antihemophilic Factor (Recombinant), Fc Fusion Protein] is a recombinant DNA derived, antihemophilic factor indicated in adults and children with Hemophilia A (congenital Factor VIII deficiency) for: control and prevention of bleeding episodes, perioperative management (surgical prophylaxis), and routine prophylaxis to prevent or reduce the frequency of bleeding episodes. ELOCTATE is not indicated for the treatment of von Willebrand disease.

Important Safety Information Do not use ELOCTATE if you have had an allergic reaction to it in the past.

Tell your healthcare provider if you have or have had any medical problems, take any medicines, including prescription and non-prescription medicines, supplements, or herbal medicines, have any allergies, are breastfeeding, are pregnant or planning to become pregnant, or have been told you have inhibitors (antibodies) to Factor VIII. Allergic reactions may occur with ELOCTATE. Call your healthcare provider or get emergency treatment right away if you have any of the following symptoms: difficulty breathing, chest tightness, swelling of the face, rash, or hives.

Your body can also make antibodies called, “inhibitors,” against ELOCTATE, which may stop ELOCTATE from working properly.

Common side effects of ELOCTATE are joint pain and general discomfort. These are not all the possible side effects of ELOCTATE. Talk to your healthcare provider right away about any side effect that bothers you or that does not go away, and if bleeding is not controlled after using ELOCTATE. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see Brief Summary of full Prescribing Information on the next page.

© 2015 Biogen. All rights reserved. Printed in U.S.A. ELO-US-0492 6/15

FDA-Approved Patient Labeling Patient Information ELOCTATE™ /el’ ok’ tate/ [Antihemophilic Factor (Recombinant), Fc Fusion Protein] Please read this Patient Information carefully before using ELOCTATE and each time you get a refill, as there may be new information.

This Patient Information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

What is ELOCTATE? ELOCTATE is an injectable medicine that is used to help control and prevent bleeding in people with Hemophilia A (congenital Factor VIII deficiency).

Your healthcare provider may give you ELOCTATE when you have surgery.

Who should not use ELOCTATE? You should not use ELOCTATE if you had an allergic reaction to it in the past.

What should I tell my healthcare provider before using ELOCTATE? Talk to your healthcare provider about: • Any medical problems that you have or had.

• All prescription and non-prescription medicines that you take, including over-the-counter medicines, supplements or herbal medicines.

• Pregnancy or if you are planning to become pregnant. It is not known if ELOCTATE may harm your unborn baby.

• Breastfeeding. It is not known if ELOCTATE passes into the milk and if it can harm your baby.

How should I use ELOCTATE? You get ELOCTATE as an infusion into your vein. Your healthcare provider will instruct you on how to do infusions on your own, and may watch you give yourself the first dose of ELOCTATE. Contact your healthcare provider right away if bleeding is not controlled after using ELOCTATE. What are the possible side effects of ELOCTATE? Common side effects of ELOCTATE are joint pain and general discomfort.

Allergic reactions may occur. Call your healthcare provider or emergency department right away if you have any of the following symptoms: difficulty breathing, chest tightness, swelling of the face, rash or hives.

Your body can also make antibodies called, “inhibitors,” against ELOCTATE, which may stop ELOCTATE from working properly. Your healthcare provider may give you blood tests to check for inhibitors.

How should I store ELOCTATE? • Keep ELOCTATE in its original package.

• Protect it from light.

• Do not freeze.

• Store refrigerated (2°C to 8°C or 36°F to 46°F) or at room temperature [not to exceed 30°C (86°F)], for up to six months.

• When storing at room temperature: • Note on the carton the date on which the product is removed from refrigeration.

• Use the product before the end of this 6 month period or discard it.

• Do not return the product to the refrigerator.

Do not use ELOCTATE after the expiration date printed on the vial or, if you removed it from the refrigerator, after the date that was noted on the carton, whichever is earlier.

After reconstitution (mixing with the diluent): • Do not use ELOCTATE if the reconstituted solution is not clear to slightly opalescent and colorless.

• Use reconstituted product as soon as possible • You may store reconstituted solution at room temperature, not to exceed 30°C (86°F), for up to three hours. Protect the reconstituted product from direct sunlight. Discard any product not used within three hours.

What else should I know about ELOCTATE? Medicines are sometimes prescribed for purposes other than those listed here. Do not use ELOCTATE for a condition for which it was not prescribed. Do not share ELOCTATE with other people, even if they have the same symptoms that you have.

Manufactured by: Biogen Idec Inc. 14 Cambridge Center, Cambridge, MA 02142 USA U.S. License # 1697 44279-01 ELOCTATE™ is a trademark of Biogen Idec.

Issued June 2014

The Office for Civil Rights is the governing body whose mission is to ensure equal access to education and to promote educational excellence through vigorous enforcement of civil rights in our nation’s schools. A complaint of discrimination can be filed by anyone who believes that an education institution that receives federal financial assistance has discriminated against someone on the basis of race, color, national origin, sex, disability, or age. The person or organization filing the complaint need not be a victim of the alleged discrimination, but may

complain on behalf of another person or group. (http://www.hhs. gov/ocr/civilrights/complaints) Examples of the types of discrimination prohibited include inequitable access to educational programs and facilities, denial of a free appropriate public education for elementary and secondary students, and refusal to implement or inappropriate implementation of academic adjustments in higher education.

Fig. 1

The Office of Civil Rights (OCR) operates through 12 enforcement offices throughout the country.

These enforcement offices are organized into 4 divisions carrying out OCR’s core work -- preventing, identifying, ending, and remedying discrimination against America’s students. (See Fig.1, left)

The HOPE is that you never reach a point where you need to contact the Office for Civil Rights. If you feel as though the accommodations or related services in your child’s 504 plan are not being provided, you must act in a calm, controlled manner to rectify the situation by: 1. Speak with your child’s teacher. There is a “chain of command” that is an unspoken tenant of most school systems. The first point of reference is the classroom teacher (at lower grade levels). If your child has more than one teacher, you may want to contact the 504 coordinator. If you remain unsatisfied, the principal would be next.

2. Schedule a meeting with the building principal and outline your concerns.

Remember, documentation is your friend! Keep a notebook, document all conversations with a date & time stamp and always keep your email communications!

Keep in mind, stay calm, be professional and always refer to the situation as a team approach!

“How will we as a TEAM provide the services to my child with a disability to be successful?”

If you continue to encounter resistance, inform the principal that you will be speaking with

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the district’s ADA coordinator and/or superintendent.

Schedule your meeting with the ADA Coordinator and use your notes and an open communication style. Explain why you believe your child’s rights are being violated.

Make it clear that you have exhausted all steps with the school district and have no recourse but to contact your local Office for Civil Rights. In the majority of cases, the situation will be rectified at the level of the OCR, ADA Coordinator, or Superintendent. The school district will be subjected to an investigation by OCR that could potentially reduce federal funding for the school district.

WHAT’S the PLAN?

89 E. Washington Street Hanson, MA 02341-1125

CHES 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: Jacose Bell Christopher Brewer Janet Brewer, M.Ed Cazandra Campos-McDonald Dr. Gary McClain, PhD Cindy Meide Gerod Similien Chris Weiss

Contributing Editor: Lisa Cossaboom

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