© 2013 aptalis pharma7/13zp182-0113j-1 nutrition and digestive health in cystic fibrosis 11 © 2013...

© 2013 Aptalis Pharma 7/13 ZP182-0113J-1

Nutrition and Digestive Health in Cystic Fibrosis

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© 2013 Aptalis Pharma 5/13 ZP182-0113J


Faculty Disclosures

Deborah Kaley, RN, MSN, AE-C, CCRC

Nurse Case Manager

Bay Area Pediatric Pulmonary

Oakland, California

This interactive discussion is given on behalf of Aptalis Pharma™, which has provided compensation for this presentation.

Other Speaker Disclosures: None

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Learning Objectives

• Review clinical insights for digestive health management of patients with Cystic Fibrosis (CF) and Exocrine Pancreatic Insufficiency (EPI)

• Understand the challenges associated with transitions in care

• Review key components of nutrition for patients with CF and EPI

• Evaluate social and economic challenges encountered by patients with CF

• Review the unique offerings and rewards of the Live2Thrive™ Patient Support Program


Digestive Health Management in CF

• The gastrointestinal tract is often affected in CF:

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Rogers CL. Practical Gastroenterol. 2013(January):10-24.

Thick mucus secretion and inflammation

Progressive destruction of the pancreas

Insufficient amount of digestive enzymes

Diminished absorptive function in the small intestine

Poor digestion and absorption of food

Growth retardation and poor nutritional status


Adequate Nutrition in CF Is Fundamental

• Higher body weight has been shown to correlate with good lung function in CF patients1

• Many people with CF cannot digest/absorb nutrients and fat from food due to pancreatic insufficiency2

• CF patients require 110% to 200% more calories than people who do not

have CF3

• A balanced, high-calorie diet with salt, fat, and protein is crucial for people with CF2

• Good nutrition promotes a strong immune system to fight infections; fewer infections can minimize lung damage and extend life2

• The CF care team dietitian plays a critical role3

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1. Rogers CL. Practical Gastroenterol. 2013;37:10-24. 2. Cystic Fibrosis Foundation. http://www.cff.org/UploadedFiles/treatments/Therapies/Nutrition/ForTeen/Nutrition-For-Teens%2Epdf. Accessed March 30, 2013. 3. Stallings VA et al. J Am Diet Assoc. 2008;108:832-839.


Clinical Guidelines for Nutrition Management in Patients With CF

• Recommendations include1:

– High-calorie diet, including supplements when needed

– Behavioral intervention to encourage good eating habits in children

– Keeping track of nutritional indicators, such as body mass index (BMI)

– Appropriate doses of pancreatic enzymes when needed

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* In some circumstances, care may be shared with PCP; infants growing poorly may need to be seen more often; some stable infants can be seen every 6 weeks.C= consider doing at this visit; PERT = pancreatic enzyme replacement therapy; OFC = occipital frontal circumference; P&PD = percussion and postural drainage.

1. Stallings VA et al. J Am Diet Assoc. 2008;108:832-839. 2. Adapted from Borowitz D et al. J Pediatr. 2009;155:S73-S93.

Routine monitoring and care recommendations for the infant diagnosed with CF2


Pancreatic Enzyme Supplementation Is Critical in CF

• >90% of patients with CF have EPI, resulting in chronic nutrient malabsorption1 • Symptoms of malabsorption include2:

– Poor weight gain despite good appetite– Frequent, loose and/or large bowel movements– Mucus or oil in the bowel movements– Excessive gas and/or stomach pain– Distention or bloating

• CF patients with EPI should take pancreatic enzyme replacement therapy (PERT) with all meals and snacks in order to properly absorb carbohydrate, protein, and fat1

• Dosing guidelines for PERT are based on the North American CF Foundation consensus statement and the Consensus Conference on Enzyme Therapy and Fibrosing Colonopathy1

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Pancreatic Enzyme Dosage

1. Rogers CL. Pract Gastroenterol. 2013;37:10-24. 2. Cystic Fibrosis Foundation. http://www.cff.org/UploadedFiles/LivingWithCF/StayingHealthy/Diet/EnzymeReplacement/Nutrition-Pancreatic-Enzyme-Replacement.pdf. Accessed March 18, 2013. 3. Borowitz D et al. J Pediatr. 2009;155:S73-S93.

General recommendations1

Units lipase/kg/meal• Start with 500 U lipase/kg/meal• Increase to max of 2500 U lipase/kg/meal• Provide ½ meal dose with snacks• Caution with doses >2500 units lipase/kg/meal

Units lipase/grams of fat• Start with 500 units lipase/gram fat• Increase to max of 4000 units lipase/gram fat• Caution with doses >4000 units lipase/gram fat

Recommendations for infants with CF under 2 years of age3

Start in all infants with:•2 CFTR mutations associated with PI•Fecal elastase <200 μg/g or CFA <85% (in infants <6 months of age), or other objective evidence of pancreatic insufficiency•Unequivocal signs or symptoms of malabsorption, while awaiting confirmatory test results• Initiate at: 2000-5000 units lipase/kg at each feeding• Adjust to: ≤2500 units lipase/kg per feeding to maximum 10,000 units lipase/kg/day


Vitamins and Minerals Are Essential in CF

• Vitamins and minerals are necessary for normal growth, function, and health, but patients with CF need more for good health1

• Improvements in CF nutrition management are one factor that is believed to lead to an increase in life expectancy2

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Vitamin A Numerous roles including normal vision, bone and tooth formation, cell function, immunity, to help maintain healthy intestines

Vitamin D Involved in building and maintaining strong bones and teeth

Vitamin E Antioxidant, helps keep red blood cells healthy, helps fight infection, and helps maintain healthy intestines

Vitamin K Role in blood clotting and keeping bones healthy

Calcium Essential element involved in building strong bones and teeth; maintains nerves and muscles

Iron Essential element with a key role in carrying oxygen in blood cells

Sodium chloride Important in maintaining fluid balance

Zinc Many important functions in the body ranging from growth and healing to taste and appetite

1. Cystic Fibrosis Foundation. http://www.cff.org/LivingWithCF/StayingHealthy/Diet/Vitamins/#. Accessed March 18, 2013. 2 . Morton AM et al. Proc Nutr Soc. 2009;68:430-440.


Improvements in CF Care Have Increased Survival

• Patients with CF are living longer than ever (figure left)– In 2011, the median predicted survival age was 36.8 years compared with

<28 years in 1987

• In addition, the number of adults is increasing (figure right)– In 2011, >48% of patients were adults compared with >32% in 1991

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Cystic Fibrosis Foundation. http://www.cff.org/UploadedFiles/research/ClinicalResearch/2011-Patient-Registry.pdf. Accessed March 18, 2013

Median Predicted Survival Age, 1987-2011 in 5-Year Periods

40

36

32

28

241987-1991 1992-1996 1997-2001 2002-2006 2007-2011

Ag

e (Y

ears

)

86 87 88 89 90 91

15

12

92 93 94 95 96 97 98 99 00 01 02 03 04 05 06 07 08 09 10 11

9

6

3

0

Number of Children and Adults with CF, 1986-2011

Nu

mb

er o

f P

eop

le w

ith

CF

(T

ho

usa

nd

s)Children

Adults


Living Longer Poses New CF Care Challenges

• With advances in treatment, CF patients are living longer and thus creating new challenges in care

• New nutritional challenges associated with CF-related complications, such as diabetes and bone disease have emerged

– Bone disease is becoming more common in patients with CF

• The CF care team can play an important role in addressing CF-related life changes

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Cystic Fibrosis Foundation. http://www.cff.org/UploadedFiles/research/ClinicalResearch/2011-Patient-Registry.pdf. Accessed March 18, 2013

Common Complications by Age, 2011

50

30

20

10

0

Per

cen

t o

f P

eop

le w

ith

CF

40

<6 6-10 11-17 18-24 25-34 35-44 45+

Diabetes (CFRD)

Bone Disease Depression Arthritis Arthropathy

Age (Years)


Living Longer Also Affects Transition Management

• Because patients with CF are living longer and well into adulthood, there are unique issues that arise around the transition from pediatric to adult CF care– This period of time may be challenging for the care team, caregiver(s), and

the patient

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Cystic Fibrosis Foundation. http://www.cff.org/UploadedFiles/LivingWithCF/Webcasts/ArchivedWebcasts/Partnering-for-Care-Part-3-Slides-Adult-Transition.pdf. Accessed March 18, 2013.

Child

Age

Parents/Family

Ideal Transition to Adult CF Care

Re

sp

on

sib

ilit

y

21


Transition Can Be a Complex Process for CF Care Centers

• For CF care teams responsible for the transition from pediatric to adult CF care, the transition may be an ongoing process over a period of time– There are multiple components of care that must be addressed

– Each care team member has a unique role to play

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Component of care

Level 1:Always dependent

Level 2: Frequently dependent

Level 3: Sometimes dependent

Level 4: Fully independent

Physiotherapy and clearance

Caregiver manages care and routine

Individual initiates care Minimal supervision or assistance

Independent

Nutrition/enzyme management

Some knowledge Responsible for some aspects of nutrition

Independently manages Independently manages

Medication usage Maximal caregiver management

Moderate caregiver supervision

Independent or minimal supervision

Independent

Disease management

Knows general principles

Asks questions and knows genetic aspects

Knows when to seek help

Knows how to access help

General life skills Managed by caregiver

Becoming more independent

Increasing sense of control

Independent and actively involved

Sample CF Self-Management Scale

Towns SJ et al. Clin Resp J. 2011;5:64-75.


CF Care Team Perceptions May Not Align With Patients Regarding Transition

• Challenges for patients within adult services1:– Independence in decision

making, goal setting, and issues of confidentiality and privacy

– Implications of CF as an adult

– Establishing good communication and developing a good relationship

– Introduction of new staff

– Appropriately supporting caregivers

– Adult centers with appropriate resources

• Team member’s perceptions of patient concerns2:– Patient is not familiar with the

adult staff

– Concerned about adult staff being able to meet medical needs

– Patient has strong relations with pediatric staff

– Patient is reluctant to leave the pediatric care setting

– Patient has difficulty with taking on responsibilities for self-care

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1. Anderson DL et al. Pediatr Pulmonol. 2002;33:327–331. 2. Flume PA et al. Ped Pulmonol. 2004;37:4-7.


Nutrition Management May Be Particularly Challenging During Transition Period

• Nutrition and digestive health are essential components of care of the patient with CF1

• Achieving nutrition and digestive health may be challenging around the transition period, which is typically during the teen years1

• Dietitians at CF care centers can provide specially tailored dietary programs for each stage of life1

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1. Morton AM et al. Proc Nutr Soc. 2009;68:430-440. 2. Leonard A et al. J Ped Psychol. 2010;35:6-13.

100%

90%

80%

70%

60%

50%

40%

30%

20%

10%

0%2-5 (n=45) 6-10 (n=61) 11-15 (n=75) ≥16 (n=65)

Age (years) 2

Optimal

Acceptable

Concerning

At Risk

Failure


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Social and Economic Considerations

Social and Economic Considerations


The Cost of CF Care Is High

• CF imposes a burden on everyday life, particularly around cost of care– Lifetime cost of treatment for a person with CF: $2.3 million1

– Total annual medical care expenditures averaged $48,098 for people with CF, more than 22 times the average of $2,172 for people without CF.2

• 1 in 4 have delayed care or skipped treatments because of the cost3

• Costs associated with nonadherence may add to economic burden4

– Money wasted on unused medications or other therapies that are not followed

– An increase in clinic appointments, emergency room visits, and hospitalizations because of nonadherence

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1. Tur-Kaspa et al. Reprod Biomed Online. 2010;21:186-95. 2. Ouyang L et al. Ped Pulmonol. 2009;44:989-996. 3. Cystic Fibrosis Foundation. http://www.cff.org/Mobile/aboutCFFoundation/NewsEvents/9-21-Study-Finds-More-with-CF-Struggle-Afford-Care.cfm. Accessed March 30, 2012. 4. Rapoff MA. Springer Science+Business Media: New York, NY; 2010.


People With CF Face Unique Employment Challenges

• Improvements in care and life expectancy has led to a larger number of patients with CF seeking higher education, vocational training, and employment1

– According to the 2011 CF Patient Registry, 45% of adult patients with CF were employed full time or part time2

• Economic and health insurance considerations can impact employment decisions—particularly because US employers often offer health insurance1

• But employment for some people with CF may be challenging1

– Time required for daily treatment regimen, activity limitations due to disease, possibility of missed work days due to hospitalizations, concerns about disclosure to employers, risks of infection or pulmonary irritants in the work place

• Additionally, there may be a lack of formal job counseling from the CF clinician1

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1. Demars N et al. Disabil Rehab. 2011;33:922-926. 2. Cystic Fibrosis Foundation. http://www.cff.org/UploadedFiles/research/ClinicalResearch/2011-Patient-Registry.pdf. Accessed March 18, 2013.


Living Longer With CF Affects Health Insurance Coverage

• Some patients with CF are unable to maintain private insurance because of their disease• The Cystic Fibrosis Patient Assistance Foundation (CFPAF) helps people with CF living in

the United States get their prescribed FDA-approved drugs and devices, regardless of health insurance coverage or financial resources1

• However, additional resources may be needed—health care professionals can play an important role in helping CF patients obtain the insurance coverage and other financial assistance they need2

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1. Cystic Fibrosis Foundation. http://www.cff.org/UploadedFiles/research/ClinicalResearch/2011-Patient-Registry.pdf. Accessed March 18, 2013. 2. Cystic Fibrosis Foundation. http://www.cff.org/Adults/Insurance/Basics/Work/. Accessed March 24, 2013.

Percentage of People with CF by Type of Health Insurance Coverage, 2011*

Type of Insurance 17 Years and Younger

18 Years and Older

Health Insurance Policy (e.g. Private Insurance)

55.8 65.0

Medicare/Indian Health Service 0.6 16.6

Medicaid/State Programs 52.6 33.6

TriCare or Other Military Health Plan 2.7 2.1

Other 2.2 2.7

No Health Insurance** 0.4 1.8* Data are not mutually exclusive, except the “no health insurance” category, as people with CF may have more than one

type of insurance. ** The “no health insurance” category shows the percentage of people with CF who said they did not have any health

insurance in 2011.


CF Care Team Is Critical in Ensuring Transition Success

• The CF care team plays a pivotal role in transition solutions management

• Transition solutions can include:

1. Implementing standard programs in the CF care center for transfer of young adults from pediatric to adult care settings, including preparing the transitioning patient to1,2:– Interact with doctors on their own (without parent)– Advocate for themselves– Discuss “adult” issues, including the management of medical bills (working/affording to pay),

understanding insurance, and handling difficult information/”bad news”

2. Providing job support/counseling as part of self-management and health care transition programs3

3. Teaching patients how to save recipes, create a meal plan, build grocery lists, and cook to meet their nutritional needs

4. Helping patients navigate insurance obstacles via letters of medical necessity and prior authorization, insurance appeals, exceptions, and reconsiderations

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1. Flume PA et al. Ped Pulmonol. 2004;37:4–7. 2. Greene LC et al. http://www.happyheartfamilies.com/articles/article/7883882/154132.htm. Accessed April 3, 2013 3. Demars N et al. Disabil Rehab. 2011;33:922-926.


Resources

General:• The CFF Patient Assistance Resource Library provides CF care guidelines, evidence-based medical journal articles,

white papers for medical professionals:

http://www.cff.org/LivingWithCF/AssistanceResources/Library/ •Tools and tips for CF parents:http://www.happyheartfamilies.com/TipsForCFParents.html

Transition:• Transition checklists for 3 different age groups: http://www.harthosp.org/CysticFibrosis/PatientEducation/Transition/

TransitionCheckLists/default.aspx• Self-care checklist: http://www.harthosp.org/CysticFibrosis/PatientEducation/Transition/SelfCareChecklist/default.aspx • Additional resources about transition: http://www.happyheartfamilies.com/articles/article/7883882/150604.htm

Nutrition: • High calorie recipes:http://www.cysticfibrosisidaho.org/d/content/high-calorie-recipes

Insurance:• The Cystic Fibrosis Patient Assistance Foundation (CFPAF) provides information on a number of programs available to

help people with CF afford the care and medications they need: http://www.cfpaf.org or call 1-888-315-4154

• The CFF Patient Assistance Resource Library also provides sample letters of medical necessity and prior authorization; how-to guides to navigating common insurance obstacles; templates for insurance appeals, exceptions and reconsiderations:http://www.cff.org/LivingWithCF/AssistanceResources/Library/

CF Legal Hotline: • Phone: (800) 622-0385• Website: http://www.cff.org/livingwithcf/assistanceresources/cflegalhotline/• Email: [email protected]

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Case StudiesCase Studies


Case Study 1: Transition in Care

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Patient background:• 17 year-old Caucasian female• Height: 5’5”• Weight: 102 lb • BMI: 17• Current medical history

– Cystic fibrosis diagnosed at birth– Baseline FEV1: 85% of the predicted value • Past medical history‑ Hospitalized for respiratory infection 2 years ago• Labs: WNL• Notes:‑ CF is usually well controlled‑ Is able to participate in a number of extracurricular activities,

including dance and cross country ‑ Over the past 6 months she has been taking on more responsibility

for management of her treatments and has mentioned that she would like to be more independent. She will be going to college in a few months

Questions• How would your CF care team communicate with the adult CF care center?• What are some areas of concern?• How would you best mobilize care team members, such as nurses, social workers, and dietitians, to help the adult CF care team during the patient transition process?

Questions• How would your CF care team communicate with the adult CF care center?• What are some areas of concern?• How would you best mobilize care team members, such as nurses, social workers, and dietitians, to help the adult CF care team during the patient transition process?


Case Study 2: A Hospitalized Patient

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Questions• How would you communicate with the Emergency Department given he was

hospitalized 3 times in the last year?• How would you follow up with the patient?• What recommendations do you have for preventing a future hospitalization?

Questions• How would you communicate with the Emergency Department given he was

hospitalized 3 times in the last year?• How would you follow up with the patient?• What recommendations do you have for preventing a future hospitalization?

Patient background:• 23 year-old Caucasian male• Height: 5’6”• Weight: 125 lb • BMI: 19• Current medical history

– Diagnosed with cystic fibrosis at 18 months old– He presents to the hospital with a lung infection

(Pseudomonas aeruginosa)– FEV1: 65% of the predicted value – Labs: HbA1c: 6, WBC: 15, all else WNL• Past medical history‑ Hospitalized 3 times in the last year• Social history: full-time employment with irregular hours• Notes:‑ Recently graduated from college and living independently‑ Has been nonadherent to treatment plan


Case Study 3: New Diagnosis of CF

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Questions•In your center, what role does each member of the care team play (nurse, social worker, or dietitian) for parents with a newborn who is newly diagnosed with CF?• How would you train the parents?• What resources would you direct them to?

Questions•In your center, what role does each member of the care team play (nurse, social worker, or dietitian) for parents with a newborn who is newly diagnosed with CF?• How would you train the parents?• What resources would you direct them to?

Patient background:• 24 day-old Caucasian female• Current medical history

– NBS +– IRT +– Genetic test: CFTR mutation positive

• Notes:‑ Parents married 6 years; previously

unaware that they are carriers for CF‑ Both employed full time‑ No relatives living nearby‑ 4 year-old sibling without CF

LabsSweat Chloride (mmol/L) 62

Fecal elastase (µg/g) 175

WBC Wnl

HGB Wnl

HCT Wnl


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© 2013 Aptalis Pharma 5/13 ZP182-0113J


What’s It All About?

• Live2Thrive™ is a comprehensive support program for patients with CF, their loved ones, and caregivers

• One online community designed to help patients of all ages manage their condition


Engaging, Inspiring, and Informative

Goals of the program•Help educate patients and caregivers about living with CF—and the importance of good nutrition•Motivate and encourage members to keep up with their treatment


Joining the Program Is Easy

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Convenient enrollment online or by phone

Hassle-free system—no additional paperwork or forms to fill out or mail in

Toll-free number for program questions


One Community, Many Benefits

• Aptalis pancreatic enzyme product for eligible patients up to 24 months old

• Savings Card to offset copays up to $50 or allows patients to pay no more than a $40 copay

• Age-specific educational content for managing CF and supporting nutritional health

• vitamins and supplements shipped automatically each month

• Points-based reward redemption program

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Program is not available to patients 2 years of age or older who are on Medicare, Medicaid, or participating in any other state or federally subsidized pharmacy benefit program or where otherwise prohibited by law.


Helping Patients Save Money

As of March 2013, Aptalis has saved

patients an estimated $1.1 million*!

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*In the form of copay assistance and savings on the cost of supplements and vitamins.


Providing Patients With Free Vitamins and Supplements

• Choosing or changing vitamins and supplements is easy—online or through a toll-free number

– AquADEKS™*

A highly absorbable, antioxidant-rich nutritional supplement containing vitamins A, D, E, and K**– SCANDISHAKE®

A calorie-rich shake mix which can be mixed into many foods and beverages, including whole milk, juices, sauces, and desserts

– SCANDICAL® Calorie-rich powder that comes in a convenient and portable 8-ounce shaker-top can

– BOOST® VHC®

A calorically dense, nutritionally complete beverage- 2.25 kcal/mL3

• Automatic monthly shipments

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*Available in chewable tablets, pediatric drops, and softgels.

**This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.


Offering Diverse Educational and Interactive Content

• General content about living with CF – Designed to help patients and caregivers better understand the

disease

• Provides tips for managing the condition

• Age-specific interactive content such as quizzes and videos on CF and nutrition for– Tykes and Tweens (newborn - 12 years)– Teens (13 - 17 years)– Adults (18 and older)

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Knowledge Is Power

“Understanding CF”: General educational overview•What Is CF?•What to Expect With CF and EPI•Tips for Managing CF

– Lung care– Nutrition– Enzymes

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One of the pages most viewed by patients and

caregivers!


Content Designed With the User in Mind

Age Specific Interactive Content

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Tykes and Tweens(newborns to 12 years)

Teens(13 to 17 years)

Adults(18 and older)

Life with CF video Nutrition and CF video Nutrition quiz Chef cooking video Support groups and the CF healthcare team video Transitioning to an adult CF healthcare team video CF healthcare team quiz

The content tailored to tykes and tweens and to adults has been of particular interest to viewers.


• Tasty Treats– Downloadable Scandishake’s “Recipes for

Maintaining Weight” recipe book– Video of celebrity chef Fabio Viviani preparing

breakfast pizza– Downloadable recipe for breakfast pizza

Nutrition Information: What Teens Need to Know

Facts About Nutrition•Nutrition

– Nutrition information presented in teen-friendly language

– Videos capturing patient and parent discussions on nutrition and CF

– Quiz to reinforce learning and earn rewards points

•Food for Thought – Smart food choices for ages 13 to 17

•Pancreatic Enzymes– Video of parents discussing their children’s CF

treatments

– Video to see how teens manage pancreatic enzymes and treatment

– Tips for taking enzymes

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Making Learning Particularly Rewarding

• Members earn points through:– Taking educational quizzes– Watching supportive and encouraging

videos– Filling eligible pancreatic enzyme

prescriptions

• Members trade in points for health- and fitness-related items:– Omron HJ-112 Digital Pocket

Pedometer– VORTEXTM Holding Chamber– Bubbles the FishTM II Pediatric Aerosol

Mask– PARI Nebulizers– OMRON HR-100C Heart Rate Monitor

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A Brief Summary…

• Live2Thrive™ - a comprehensive program for patients with CF, their loved ones, and caregivers

• One online community designed to help patients of all ages manage their condition

• Benefits include

– Prescription copay savings– Aptalis pancreatic enzyme product

for eligible patients up to 24 months old– vitamins and supplements– Age-specific, interactive educational content

for managing CF and supporting nutritional health

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Summary

• The gastrointestinal tract is often affected in CF, leading to deficits in growth and poor nutritional status– 90% of people with CF have EPI, causing malabsorption and maldigestion

• Optimizing nutritional status in CF patients is critical to extending life expectancy– Clinical guidelines for nutrition management in CF recommend a high-

calorie diet along with appropriate doses of enzymes with every meal • Each member of the multidisciplinary CF care team plays an important role

in optimizing patients’ nutritional status• CF care advancements have led to an aging CF population, which poses

new challenges in care—particularly around CF-related complications and transition of care – from teen to adult

• Transition is a multistep, multidisciplinary, and ongoing process• The CF care team can provide effective transition solutions that address

the patient’s physical, emotional, and even financial concerns


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1Improve health and quality of care by providing specialty therapies for patients around the world. CONFIDENTIAL – © 2013 Aptalis Pharma

Easy to Enroll Online or By Phone

Online at:www.Live2Thrive.org

By Phone:1-866-520-8032

© 2013 aptalis pharma7/13zp182-0113j-1 nutrition and digestive health in cystic fibrosis 11 © 2013...

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