Patient Education and Treatment Compliance in Allergic Rhinitis in the United States

Michael S. Blaiss, MD

Clinical Professor of Pediatrics and Medicine

University of Tennessee Health Science Center

Memphis, Tennessee

AAAAI. The Allergy Report. Available at: http://www.theallergyreport.com/reportindex.html. Accessed February 12, 2008; Dykewicz MS, Fineman S. Ann Allergy Asthma Immunol. 1998;81(5, pt 2):478-518.

Basic Approaches to the Basic Approaches to the Management of Allergic RhinitisManagement of Allergic Rhinitis

Environmental Control Measures

Education

PharmacotherapyAllergen

Immunotherapy

Medication adherence

“The degree to which the person’s behavior corresponds with the agreed recommendations from a health care provider.”

– World Health Organization

Definitions of Adherence and Compliance

• Adherence is the term used to describe the patient’s behavior of taking drugs correctly – in the right dose, with the right frequency, and at the correct time

• A critical aspect of adherence is the patient’s involvement in deciding whether or not to take the drugs

• Compliance means the patient does what he or she has been told to do by the doctor/pharmacist

7

Nonadherence to Prescription Medications:“America’s Other Drug Problem”1

The nonadherence epidemic– In the United States, about 15% of new prescriptions are never filled.2

– Of those filled, about 50% of patients stop their therapy in the first 6 months.3

– Nonadherence is also a problem among children; a median adherence rate of 58% has been reported.4

Public health implications: Nonadherence is associated with a higher risk of mortality, hospitalizations5,6, and failure to reach health goals.7

Direct medical costs related to nonadherence could be up to $300 billion/year.8

ED=emergency department.1. National Council on Patient Information and Education. talkaboutrx.org/documents/enhancing_prescription_medicine_adherence.pdf. Accessed February 2, 2011. 2. GadkariAS et al. Curr Med Res Opin. 2010;26:683–705. 3. McHorney CA. Curr Med Res Opin. 2009;25:215–238. 4. Matsui D. Peditr Drugs. 2007;9:283-88. 5. Hershman DL et al. Breast Cancer Res Treat. 2010; doi: 10.1007/s10549-010-1132-4. 6. Malhotra S et al. Postgrad Med J. 2001;77:703–707. 7. Ho PM et al. BMC Cardiovasc Disord. 2006;6:38–56. 8. DiMatteo MR. Med Care. 2004;42:200–209.

8

Nonfulfillment and Nonadherence Epidemics: “A Worldwide Problem of Striking Magnitude”1

Nonfulfillment and nonadherence– Transcend geographic and political boundaries2

– Are observed across all demographic groups2

– Are observed across all therapeutic areas and all medications2,3

– Have rates that have not changed appreciably over the last 25 years4

1. World Health Organization. whqlibdoc.who.int/publications/2003/9241545992.pdf. Accessed February 2, 2011. 2. McHorney CA. et al. Clin Ther. 2009;31:2584–2607. 3. McHorney CA et al. Health Expectations. 2010. doi:10.1111/j.1369-7625,2010,00619.x. 4. van Dijk L et al. BMC Health Serv Res. 2007;7:51–62.

8

6

Medication Nonadherence Encompasses Many Kinds of Patients and Medication-Taking Behaviors

• Patients who do not go to the pharmacy to pick up a new prescription1

• Patients who stop taking a prescribed drug without the advice oftheir health care provider1

• As widely reported in the literature, patients may not follow the drug’s usage instructions (eg, taking a drug less frequently than prescribed, taking an extra dose or lower-than-prescribed dose)2

1. Gadkari AS et al. Curr Med Res Opin. 2010;26:683–705. 2. Osterberg L et al. N Engl J Med. 2005;353:487–497.

NonNonNon---fulfillmentfulfillmentfulfillment

NonNonNon---persistencepersistencepersistence

Improper Improper Improper UseUseUse

8

The Educated Patient

Takes a more active role in medical care

Is often more compliant with treatment programs

Is better informed about how to maintain a healthy state

Adherence in Pharmacologic Therapy

• 61,655 adults in 31,470 households screened for AIA• 2500 subjects18 yrs and older current allergies were interviewed by

telephone about their condition and treatment (average time about 35 minutes)

• Criteria for participation in the survey• Diagnosed by healthcare practitioner with allergic rhinitis,

nasal allergies, or “hay fever”• Symptomatic (yes or no)• Received treatment for their nasal allergies within

the previous 12 months • In parallel, healthcare practitioners were interviewed • Interviews were conducted 2006• Funded and maintained by an educational grant through Nycomed and

Sunovion

Allergies in America-Study Design

Reason Stopped Taking Nasal Allergy Prescription

Q94. Have you ever stopped taking a nasal allergy medicine prescribed by your doctor because…. N=2,500

Failed to Follow Physician Instructions

Q108. People with nasal allergies sometimes fail to follow their physician’s instructions about their medicines for allergies. Have you ever failed to take an allergy medicine as prescribed because of …… N=2,500

Why Changed Medicine for Nasal Allergies

Q81b. Why have you changed nasal allergy medicines? Anything else? Base: Have changed nasal allergy medicines N=1,723

Nasal Allergy Patients Request New Medications When They Are Dissatisfied

Q82a. Have you ever asked your doctor to change your nasal allergy medication because you were dissatisfied with it? N=2,500

No, 66%

Yes, 34%

Side Effects of Allergy Medicines

Q90. How many of the medicines that you have taken for allergy had the following types of side effects --- all, most, some, few or none? N=2,500

Severity of Side Effects ofNasal Allergy Medicines Are Moderatelyto Extremely Bothersome

Patients Get Monies Worth from Rx Medicines

Q30. Overall, do your patients feel they get their money’s worth out of prescription medicines for nasal allergies? N=400

PQ97. Overall, do you feel that patients get their money’s worth out of prescription medicines for nasal allergies? N=2,500

Nasal Allergy Patients Agree in a Need for Patient Education

Q45. How much need do you think there is for better education of PEOPLE WITH NASAL ALLERGIES about their condition and its treatment? Do you think there is a… N=400

PQ113. How much need do you think there is for better education of people with nasal allergies about their condition and its treatment? N=2,500

Meltzer EO. Allergy Asthma Proc. 2005;26(6):445-451.Shah SR. Clin Ther. 2003;25:2198-2214.Shimoda N. Biol. Pharm. Bull. 1995;18:734-739. INCS: Intranasal corticosteroid

Importance of Formulation Characteristics in Intranasal Corticosteroid Delivery

• Additives and preservatives can cause tolerability issues by irritating the mucosal membranes and causing nasal drying, and they can confer an unpleasant odor or taste to an INCS formulation

• Characteristics such as delivery device and spray volume can affect a patient’s perception and experience with a particular INCS

• The relative osmotic pressure, or tonicity, of an INCS can modulate nasal absorption and retention, thereby potentially influencing the clinical efficacy

INS Tonicity BKCPotassium

sorbate AlcoholPoly-

sorbatePropylene

glycol CMC

Ciclesonide Hypotonic ─ + ─ ─ ─ +

Fluticasone propionate Isotonic + _ +* + ─ +

Triamcinolone acetonide Isotonic + ─ ─ + ─ ─

Flunisolide Isotonic + ─ + † + + +

Mometasone furoate Isotonic + ─ ─ + ─ +

Budesonide Isotonic ─ + ─ + + +

Fluticasone Furoate Isotonic + ─ ─ + + +

Abbreviations: BKC, benzalkonium chloride; CMC, carboxymethylcelluloseSymbols: ─, negative; +, positive* Phenylethyl alcohol†Sorbitol

Meltzer EO. Ann Allergy Asthma Immunol. 2007;98:12-21. VERAMYST® (fluticasone furoate) Prescribing Information. 2007, GlaxoSmithKline

Formulation Components of INCS Products

CMC to increase viscosityPPG to act as a moisturizer

Symptom Improvement With ≥50% WMC

Loh CY, et al. Allergy. 2004;59(11):1168-1172.

Patient Education: Adherence%

Pa

tien

ts

100

Forgot Medication(1-5 times)

<50% Compliance

(WMC)

Nasal Itch

78

50

n=49 n=7

11

N=63

Rhinorrhea NasalObstruction

7870

67

WMC = weight of medication consumed.

% S

ym

pto

m Im

pro

ve

me

nt

65

Sneezing0 0

100

50

Epistaxis and INS Technique

• Of 559 consecutive patients using an intranasal steroid for more than 3 months• 28 patients (5%) reported epistaxis within the prior 2

months

• Of the 32 reported sides of bleeding (unilateral and bilateral combined)• 25 episodes (78%) were on the same side as the hand

used to apply the spray.

• A strong correlation was found between the side of bleeding and both the hand used (p < 0.001) and the handedness of the patient (p < 0.002)

Benninger MS. Ear Nose Throat J. Aug 2008;87(8):463-465.

How to Use a Nasal Spray

Adherence in Allergen Immunotherapy

The charts of the 381 patients enrolled in an AIT program at Wilford Hall Medical Center as of September 2000 were retrospectively evaluated for compliance with their AIT regimen.

Compliance was defined as receiving an allergy injection within the past 3 months at the time of chart review, a similar criterion used by previous studies.

Dropout Rate from SCIT• Allergy Clinic in Eau Claire, WI-dropout rate from SCIT

before completion of SCIT for 3-5 years• Before 3 years-12% failed to complete SCIT• Five most common reasons for stopping SCIT

• Concurrent medical problem• Noncompliance• Change of residence• Inconvenience• Allergic reactions

• One percent quit early due to reactions to immunotherapy

Rhodes BJ. Ann Allergy Asthma Immunol 1999;82:281–286.

Increasing Adherence to Treatment

• Keep it simple• Deliver it effectively• Avoid its problems• Call it medicine• Provide it readily

• Review its usage

• Link it with lifestyle

• Put it in writing

• Support it psychosocially

• Minimize the cost

Meltzer EO. J Allergy Clin Immunol. 1995;95:1097-1110.

Conclusions• There are numerous factors that led to poor adherence in

the treatment of allergic rhinitis in the USA• We need to do a better job in educating patients about

this condition• We need to develop new strategies to partnership with our

patients to improve buy-in for medical management and immunotherapy

• REMEMBER-no matter how great the treatment is, the outcome will be poor if the patient is non-adherent