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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
Basic Approaches to the
Management of Allergic Rhinitis
Environmental
Control Measures
Education
Pharmacotherapy
Allergen
Immunotherapy
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.
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
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. Gadkari
AS 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.
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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.
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Medication Nonadherence Encompasses Many Kinds
of Patients and Medication-Taking Behaviors
Non
Non-fulfillment
fulfillment
Non
Non-persistence
persistence
Improper
Improper
Use
Use
• Patients who do not go to the pharmacy to pick up a new prescription1
• Patients who stop taking a prescribed drug without the advice of
their 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.
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The Educated Patient
Is better informed about how
to maintain a healthy state
Is often more compliant with
treatment programs
Takes a more active role in medical
care
Adherence in Pharmacologic Therapy
Allergies in America-Study Design
• 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
Reason Stopped Taking Nasal Allergy Prescription
None of these
Hard to administer
39%
3%
Dosing schedule was difficult
4%
11%
Co-pay was too high
Not covered
14%
Bothersome side effects
25%
32%
Didn't provide 24 hour relief
35%
Effectiveness began wearing off
37%
Didn't find it effective
0%
10%
20%
Q94. Have you ever stopped taking a nasal allergy medicine prescribed by your
doctor because…. N=2,500
30%
40%
50%
Failed to Follow Physician Instructions
Doctor's instructions
hard to follow
3%
Poor toleration
19%
Concern about long
term use
19%
Cost of drugs
21%
Worry about side effects
22%
Troublesome side
effects
27%
Lack of symptoms
35%
Loss of effectiveness
over time
37%
Lack of symptom relief
41%
0%
10%
20%
30%
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
40%
50%
Other
4%
Not sure
3%
Not fast enough
Why Changed Medicine for Nasal Allergies
1%
Haven't changed allergy medicines
2%
Taken off market
2%
Not long lasting enough
2%
Availability/ Convenience/ Free samples
3%
Developed an immunity
3%
Safety concerns
3%
Not covered
3%
Didn't treat symptoms
4%
Cost/co-pay
5%
Bothersome side effects
8%
11%
Patient wanted to try other
Doctor wanted to try other
23%
Not effective enough
37%
0%
10%
20%
30%
Q81b. Why have you changed nasal allergy medicines? Anything else?
Base: Have changed nasal allergy medicines N=1,723
40%
50%
Nasal Allergy Patients Request New Medications When They Are Dissatisfied
No, 66%
Yes, 34%
Q82a. Have you ever asked your doctor to change your nasal allergy medication
because you were dissatisfied with it? N=2,500
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 of
Nasal Allergy Medicines Are Moderately
to Extremely Bothersome
Dripping down throat
10%
Bad taste
12%
Burning
5%
Headaches
5%
Drowsiness
16%
7%
Drying feeling
4%
0
Extremely
Moderately
19%
8%
9%
8%
7%
10
20
30
Respondents, %
40
50
Patients Get Monies Worth from Rx Medicines
100%
91%
82%
87%
85%
80%
60%
55%
40%
20%
0%
ENT
Allergist
Primary care
Nurse
Prac./Physician
Asst.
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
Patients
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
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
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
Formulation Components of INCS Products
INS
Potassium
PolyPropylene
Tonicity BKC
sorbate
Alcohol sorbate
glycol
Ciclesonide
Hypotonic
─
+
─
─
─
+
Fluticasone
propionate
Isotonic
+
_
+*
+
─
+
Triamcinolone
acetonide
Isotonic
+
─
─
+
─
─
Flunisolide
Isotonic
+
─
+†
+
+
+
Mometasone
furoate
Isotonic
+
─
─
+
─
+
Budesonide
Isotonic
─
+
─
+
+
+
Fluticasone
Furoate
Isotonic
+
─
─
+
+
+
Abbreviations: BKC, benzalkonium chloride; CMC, carboxymethylcellulose
Symbols: ─, negative; +, positive
* Phenylethyl alcohol
†Sorbitol
Meltzer EO. Ann Allergy Asthma Immunol. 2007;98:12-21.
VERAMYST® (fluticasone furoate) Prescribing Information. 2007, GlaxoSmithKline
CMC
CMC to increase viscosity
PPG to act as a moisturizer
Patient Education: Adherence
% Patients
78
50
11
0
n=49
n=7
Forgot Medication
<50%
(1-5 times)
Compliance
(WMC)
WMC = weight of medication consumed.
Loh CY, et al. Allergy. 2004;59(11):1168-1172.
% Symptom Improvement
100
100
Symptom Improvement With
≥50% WMC
N=63
78
70
67
65
50
0
Rhinorrhea Nasal Itch
Nasal
Sneezing
Obstruction
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
• Review its usage
• Deliver it effectively
• Link it with lifestyle
• Avoid its problems
• Call it medicine
• Provide it readily
• 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