Protected: Qi12 – Excessive use of SABA in asthma v0.2

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Operationalisation

Denominator

Individuals aged 12–45 years who were dispensed medications for obstructive airway diseases (ATC R03) during the examined year and had at least 1 other dispensation of these medications within 365 days of the first purchase (1,2)

Numerator

All defined in the denominator who were cumulatively dispensed ≥450 DDDs SABA (salbutamol, terbutaline, or fenoterol ATC R03AC02–4, or SABA in combination products R03AK04/13/15, R03AL01–02) within 365 days of the first purchased SABA product during the examined year.

Exclusions (Numerator, denominator)

  • Individuals <12 years of age and individuals >45 years of age at the end of the year.
  • Individuals who die or emigrate during the examined year.
  • Individuals with secondary care contact with diagnosis (any diagnosis field) of other obstructive pulmonary diseases: (ICD-10 J41-44.9, excluding J44.8) or cystic fibrosis (E85) during three preceding years (1095 days preceding the first R03 purchase) (3).

Notes

  • Assessment limited to younger age groups to mitigate the risk of capturing patients with other obstructive pulmonary diseases (e.g., COPD).
  • Asthma patients are identified using asthma medication prescriptions as a proxy.
  • Amount dispensed is examined in defined daily doses (DDDs). DDD is the assumed average maintenance dose per day for a medication used for its main indication in adults (4).

Sources of Data

  • Population register
  • Outpatient medication dispensations register
  • Secondary care patient registers

Information about the indicator set

Purpose

  • The quality indicator set is intended for comparison of effectiveness and/or safety aspects of prescribing across Nordic countries and subnational regions.
  • Further comparisons across population subgroups (e.g., socioeconomic position, immigration background) can inform equity considerations.
  • Further comparisons in relation to expenditures can inform efficiency considerations

Limitations

  • The indicators in the set use medication dispensings and/or sales data as a proxy for appropriate prescribing and medication use. This is to allow comparisons using register data, which have the advantage of being readily available and comprehensive in terms of population coverage and over time (5–7).
  • Register data are not without limitations. Medications may have been prescribed, but not collected from the pharmacy by the user. Collected medications may not have been (appropriately) used by the patient. Sales data may not be fully comparable across countries.
  • Register data are collected primarily for other purposes than quality assessment. Thus, discontinuities over time due to, e.g., legislative changes and administrative reforms need to be acknowledged in the interpretation of the results.
  • Indicators need to be updated regularly because clinical guidelines and the range of available medications change over time.
  • ATC-codes are based on WHO Collaborating Centre for Drug Statistics Methodology ATC/DDD Index version 2024

Background and literature related to the proposed indicator

Clinical guidelines

The Global Initiative for Asthma (GINA) 2024 Global Strategy for Asthma Management and Prevention (5):

  • Regular SABA use causes beta-receptor down-regulation and reduction in response which in turn leads to greater use.
  • For safety, GINA does not recommend treatment of asthma with SABA alone in adults, adolescents, or children aged 6–11 years. Instead, an inhaled corticosteroids (ICS) -containing treatment is recommended, to reduce the risk of serious exacerbations and to control symptoms.
  • Historically, frequency of SABA use and symptoms was used in treatment guidelines to guide treatment choices based on an assumption that patients with symptoms ≤2 days per week would not benefit from ICS but should be treated with SABA alone. Based on current evidence, even patients with intermittent asthma can have severe or fatal exacerbations, and this risk is reduced by treatment containing ICS versus SABA alone.
  • For patients with risk factor(s) for exacerbations, evidence supports switching to anti-inflammatory reliever (ICS-formoterol or ICS-SABA) to reduce the risk of severe exacerbations compared to using SABA alone as a reliever.
  • For adults and adolescents (12 years and older) GINA presents treatment pathways as two “tracks” based on the chosen reliever. Within each track, treatment may be stepped up or down. Track 1, the preferred option, includes ICS-formoterol as reliever in the first steps, and in further steps, also as regular daily treatment. In track 2, SABA and low-dose ICS are used together for symptom relief in step 1, and in further steps, a maintenance ICS ± LABA is included, and symptom relief may be SABA alone or ICS-SABA. Step 5 (difficult-to-treat and severe asthma) in both tracks includes further treatment options including biologic treatments.

Finnish current care guideline for asthma 2022 (21)

  • The guideline acknowledges GINA recommendation to avoid treatment with SABA alone, but considers it nevertheless as a step 1 treatment option for patients with normal lung function, no exacerbations and only rare daytime asthma symptoms.
  • Treatment initiation is recommended predominantly by step 2 or 3 treatments (including maintenance ICS ± further treatments).
  • Regular need for reliever medication is considered a sign of poor asthma management in which case the treatment should be reassessed. Reducing or removal of the need for reliver medication is an important indicator of treatment success and efficacy.

Similar or related indicators in international scientific literature

  • Inappropriate = >2 puffs/week of SABA if no ICS used, and ≥9 canisters of SABA / year and ≤100 microg (beclomethasone equivalent) / day of ICS. Appropriate = <2 puffs per week in the absence of ICS or filling prescriptions for ≤4 SABA canisters per year and at least 400 microg/day of ICS. “Grey zone” = either appropriate or inappropriate prescription criteria not satisfied. (22–24)
  • Filling prescriptions for ≥12 canisters of SABA /year, regardless of ICS use (22,24)
  • Scoping review on overuse of SABA: Definitions ranged between ≥3 to ≥12 canisters/year (8)
  • Appropriateness criteria: Patient who received ≥3 prescriptions of SABAs in last 12 weeks is also prescribed an inhaled corticosteroid (25)
  • Register study: High SABA use defined as dispensation of ≥3 canisters or ≥600 doses per 365 days (7,26,27)
  • Register study: High SABA use defined as dispensation 3–5, 6–10 and ≥11 canisters per year (9)

References

  1. Ekström M, Nwaru BI, Hasvold P, Wiklund F, Telg G, Janson C. Oral corticosteroid use, morbidity and mortality in asthma: A nationwide prospective cohort study in Sweden. Allergy. 2019;74(11):2181–90.
  2. Hansen S, Von Bülow A, Sandin P, Ernstsson O, Janson C, Lehtimäki L, et al. Prevalence and management of severe asthma in the Nordic countries: findings from the NORDSTAR cohort. ERJ Open Res. 2023 Mar;9(2):00687–2022.
  3. Skov IR, Henriksen DP, Madsen H, Pottegård A, Davidsen JR. Changes in oral corticosteroid use in asthma treatment—A 20-year Danish nationwide drug utilisation study. Basic Clin Pharmacol Toxicol. 2022;130(1):122–31.
  4. ATCDDD – Definition and general considerations [Internet]. [cited 2024 May 2]. Available from: https://atcddd.fhi.no/ddd/definition_and_general_considera/
  5. Global Initiative for Asthma – GINA [Internet]. [cited 2024 Aug 28]. 2024 GINA Main Report. Available from: https://ginasthma.org/2024-report/
  6. Amin S, Soliman M, McIvor A, Cave A, Cabrera C. Usage Patterns of Short-Acting β2-Agonists and Inhaled Corticosteroids in Asthma: A Targeted Literature Review. J Allergy Clin Immunol Pract. 2020 Sep 1;8(8):2556-2564.e8.
  7. Hansen S, Bülow A von, Sandin P, Ernstsson O, Janson C, Lehtimäki L, et al. Prevalence and management of severe asthma in the Nordic countries: findings from the NORDSTAR cohort. ERJ Open Res [Internet]. 2023 Mar 1 [cited 2024 Aug 28];9(2). Available from: https://openres.ersjournals.com/content/9/2/00687-2022
  8. Von Bülow A, Hansen S, Sandin P, Ernstsson O, Janson C, Lehtimäki L, et al. Severe asthma trajectories in adults: findings from the NORDSTAR cohort. Eur Respir J. 2023 Sep;62(3):2202474.
  9. Nwaru BI, Ekström M, Hasvold P, Wiklund F, Telg G, Janson C. Overuse of short-acting β2-agonists in asthma is associated with increased risk of exacerbation and mortality: a nationwide cohort study of the global SABINA programme. Eur Respir J [Internet]. 2020 Apr 1 [cited 2024 Aug 28];55(4). Available from: https://erj.ersjournals.com/content/55/4/1901872
  10. Davidsen JR, Hallas J, Søndergaard J, Christensen RD, Siersted HC, Hansen MP, et al. Association between prescribing patterns of anti-asthmatic drugs and clinically uncontrolled asthma: a cross-sectional study. Pulm Pharmacol Ther. 2011 Dec;24(6):647–53.
  11. Redmond C, Akinoso-Imran AQ, Heaney LG, Sheikh A, Kee F, Busby J. Socioeconomic disparities in asthma health care utilization, exacerbations, and mortality: A systematic review and meta-analysis. J Allergy Clin Immunol. 2022 May 1;149(5):1617–27.
  12. Cantarero-Arévalo L, Holstein BE, Andersen A, Kaae S, Nørredam M, Hansen EH. Inequalities in asthma treatment among children by country of birth and ancestry: a nationwide study in Denmark. J Epidemiol Community Health. 2013 Nov 1;67(11):912–7.
  13. Heibert Arnlind M, Wettermark B, Sjöborg B, Dahlén E, Loikas D, Wikström Jonsson E. Socioeconomic status and the quality of prescribing asthma drugs in Sweden. J Asthma. 2013 Oct 1;50(8):842–9.
  14. Davidsen JR, Søndergaard J, Hallas J, Siersted HC, Knudsen TB, Lykkegaard J, et al. Impact of socioeconomic status on the use of inhaled corticosteroids in young adult asthmatics. Respir Med. 2011 May 1;105(5):683–90.
  15. Socioeconomic status is associated with healthcare seeking behaviour and disease burden in young adults with asthma – A nationwide cohort study – Kjell Erik Julius Håkansson, Vibeke Backer, Charlotte Suppli Ulrik, 2022 [Internet]. [cited 2024 Aug 29]. Available from: https://journals.sagepub.com/doi/full/10.1177/14799731221117297
  16. Håkansson KEJ, Backer V, Ulrik CS. Socioeconomic biases in asthma control and specialist referral of possible severe asthma. Eur Respir J [Internet]. 2021 Dec 1 [cited 2024 Aug 29];58(6). Available from: https://erj.ersjournals.com/content/58/6/2100741
  17. Håkansson KEJ, Guerrero SC, Backer V, Ulrik CS, Rastogi D. Parental socioeconomic status, access to specialist care, and childhood asthma severity, control, and exacerbations. Eur Respir J [Internet]. 2022 Sep 4 [cited 2024 Aug 29];60(suppl 66). Available from: https://erj.ersjournals.com/content/60/suppl_66/4384
  18. Laugesen K, Ludvigsson JF, Schmidt M, Gissler M, Valdimarsdottir UA, Lunde A, et al. Nordic Health Registry-Based Research: A Review of Health Care Systems and Key Registries. Clin Epidemiol. 2021 Dec 31;13:533–54.
  19. Furu K, Wettermark B, Andersen M, Martikainen JE, Almarsdottir AB, Sørensen HT. The Nordic countries as a cohort for pharmacoepidemiological research. Basic Clin Pharmacol Toxicol. 2010 Feb;106(2):86–94.
  20. Rasmussen L, Wettermark B, Steinke D, Pottegård A. Core concepts in pharmacoepidemiology: Measures of drug utilization based on individual-level drug dispensing data. Pharmacoepidemiol Drug Saf. 2022;31(10):1015–26.
  21. Astma [Internet]. [cited 2024 May 3]. Available from: https://www.kaypahoito.fi/hoi06030#s20
  22. Tavakoli H, Mark FitzGerald J, Lynd LD, Sadatsafavi M. Predictors of inappropriate and excessive use of reliever medications in asthma: a 16-year population-based study. BMC Pulm Med. 2018 Feb 12;18(1):33.
  23. FitzGerald JM, Tavakoli H, Lynd LD, Al Efraij K, Sadatsafavi M. The impact of inappropriate use of short acting beta agonists in asthma. Respir Med. 2017 Oct 1;131:135–40.
  24. Sadatsafavi M, Tavakoli H, Lynd L, FitzGerald JM. Has Asthma Medication Use Caught Up With the Evidence?: A 12-Year Population-Based Study of Trends. CHEST. 2017 Mar 1;151(3):612–8.
  25. Dreischulte T, Grant AM, McCowan C, McAnaw JJ, Guthrie B. Quality and safety of medication use in primary care: consensus validation of a new set of explicit medication assessment criteria and prioritisation of topics for improvement. BMC Clin Pharmacol. 2012 Feb 8;12:5.
  26. von Bülow A, Kriegbaum M, Backer V, Porsbjerg C. The Prevalence of Severe Asthma and Low Asthma Control Among Danish Adults. J Allergy Clin Immunol Pract. 2014 Nov 1;2(6):759-767.e2.
  27. Vähätalo I, Lehtimäki L, Tuomisto LE, Karjalainen J, Niemelä O, Ilmarinen P, et al. Long-Term Use of Short-Acting β2-Agonists in Patients With Adult-Onset Asthma. J Allergy Clin Immunol Pract. 2022 Aug 1;10(8):2074-2083.e7.