Characterising asthma patients prescribed
off-license LAMA/LABA therapy without ICS
Dr Dermot Ryan
Honorary Clinical Research Fellow – University of Edinburgh
Clinical Strategic Director – Optimum Patient Care
Authors: Ryan D, Small I, Price D, Carter V, & Jones R.
Background
How this was interpreted by the media!
Across the UK, a further 22, 840 people with asthma, including 1, 903 children, “may
have been prescribed unlicensed medicine which puts them at a higher risk of death”
How the numbers were extrapolated?
Asthma UK Estimated Prevalence
QoF Recorded Prevalence
England
Northern Ireland Scotland
UK
Wales
Population
53,000,000
1,800,000
5,300,000
64,100,000
3,064,000
Prevalence
6.0%
6.1%
6.1%
6.0%
6.9%
Asthma Population
3,180,000
109,800
323,300
3,824,516
211,416
1.5 million difference for UK recorded prevalence vs Asthma UK est. prevalence (41%)
Asthma Prevalence 2010-2011 Varies from 7.07% to 3.48% median = 6.1%.
Aim
To characterise asthma patients prescribed unlicensed
Long-acting reliever therapy in UK primary care
For completeness we also searched for unlicensed LAMA use
OPC Research Database (OPCRD)
•
Patient-focused anonymous longitudinal database ( 550 practices)
•
Linkage of patient reported outcomes via patient questionnaires
OPC Research Database
Number of Anonymised Patients
2, 414, 621
Anonymised Asthma
Patients
Anonymised COPD
Patients
755, 693
134, 281
Asthma Patients
with Questionnaire Data
COPD Patients
with Questionnaire Data
32, 470
12, 673
Study Cohort
OPCRD Patients
n = 809,717
Asthma Diagnosis
n =297,956
No Asthma resolved code after last read code for
Asthma
n= 269 282
Extraction (2009 – 2012)
n= 212, 296
Registered at practice
n = 189 947
Receiving asthma therapy (1 year)
n = 103,845
Asthma patients with no COPD diagnosis
n = 95,399
Asthma patients over the age of 4
n = 94,288
Asthma patients prescribed long acting
bronchodilators with no ICS
n = 401*
*includes 28 patients on LTRA
(leukotriene receptor antagonist)
Results
Smoking Status & Lung Function
Characteristics of patients
receiving long-acting reliever
medication
Asthma patients
<40 years old
n = 92
Asthma patients
≥40 years old
n = 309
Total
Asthma patients
n = 401
8 (8.7)
0 (0.0)
8 (2.0)
Current Smoker
12 (13.0)
60 (19.4)
72 (18.0)
Ex-Smoker
10 (10.9)
102 (33.0)
112 (27.9)
Non-Smoker
62 (67.4)
147 (47.5)
209 (52.2)
Lung Function Unknown
86 (93.5)
270 (87.4)
356 (88.8)
FEV1/FVC <0.7
1 (1.1)
10 (3.2)
11 (2.7)
FEV1/FVC >0.7
5 (5.4)
29 (9.4)
34 (8.5)
Smoking Status Unknown
Results
Exacerbations & Control Status
Characteristics of patients
receiving long acting reliever
medication
Asthma patients
<40 years old
n = 92
Asthma patients
≥40 years old
n = 309
Total
Asthma patients
n = 401
0
18 (19.6)
74 (23.9)
92 (22.9)
1-5
53 (57.6)
165 (53.4)
221 (55.1)
5-11
18 (19.6)
70 (22.7)
88 (21.9)
12+
4 (4.3)
13 (4.2)
17 (4.2)
0 (0.0)
8 (2.5)
8 (2.0)
LABA
80 (86.9)
204 (66.1)
284 (70.8)
LAMA
5 (5.4)
80 (25.9)
85 (21.2)
LABA/LAMA + LTRA
7 (7.6)
17 (5.5)
24 (6.0)
SABA prescriptions in 12 months
Treatment regime (plus SABA)
LABA + LAMA
% of Practice Asthma Population
0.0%
0
0
5
10
15
20
25
30
35
40
45
50
55
60
65
70
75
80
85
90
95
100
105
110
115
120
125
130
135
140
145
150
155
160
165
170
175
180
185
190
195
200
205
210
215
220
225
Results
Practice Off-license Prescribing (LABA or LAMA with no ICS)
4.0%
4 %
3.0%
3 %
2.0%
2
%
1.0%
1%
Practices
ranges from 0.0% to 3.5%
Conclusions
Asthma UK Calculations
OPC Calculations
Asthma UK
Est. Cumulative Prevalence 5.4m
QOF
Cumulative Prevalence 3.89m
401 / 94,288 (point prevalence) =
0.4253% = 22,840
401 / 94,288 (point prevalence) =
0.4253% = 16,453
Cumulative Prevalence Calculation
401 / 297,956 (cumulative prevalence) = 0.1345% of 3.89m =5232
We estimate that the real number is between 5,232 and 16,543 or
approximately 1 in every 743 asthma patients
Across the UK, a further 22, 840 people with asthma, including 1, 903 children, “may
have been prescribed unlicensed medicine which puts them at a higher risk of death”
Summary
Potential explanations
•
•
•
•
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Patient preference/patient concerns
Side effects of β2 agonists
May have COPD
May have ACOS
Practice coding may be inaccurate
•
•
•
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Investigate data fully
Identify areas of education need
Facilitate support and education
Asthma review services
Support for High Prescribing Practices
Concerns
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•
How can we actually address this?
Patients not adequately reviewed
Diagnostic accuracy
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•
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Data verification
Expert clinical advice & support
OPC asthma review clinics
(free & subsidised)
Recommendations:
•
•
Need for lung function tests
Record reason for deviation