Protected: Qi10 – Oral corticosteroids 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

Qi10_1: All defined in the denominator who were dispensed oral glucocorticoids (H02AB) at least once during the examined year.

Qi10_2: All defined in the denominator who were dispensed oral glucocorticoids (H02AB) at least once during the examined year and had at least one other dispensation of oral glucocorticoids (H02AB) within 365 days of the first dispensation.

Exclusions (Numerator, denominator)

  • Individuals aged < 12 years or > 45 years at the end of the examined year.
  • Individuals with secondary care contact with diagnosis 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)
  • Individuals with secondary care contact with diagnosis of other diseases commonly treated with oral corticosteroids: sarcoidosis (ICD-10 code D86), primary adrenocortical insufficiency (E271), pneumonitis (J67-70), inflammatory bowel disease (K50-51), inflammatory polyarthropathies (M05-14), systemic connective tissue disorders (M30-36), inflammatory spondylopathies (M45-46) during three preceding years (1095 days preceding the first R03 purchase) (3)
  • Individuals with current malignancy (C00-97) during the preceding year (365 days preceding the first R03 purchase) (1,3)

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 dispensations as a proxy.

Sources of Data

  • Secondary care patient registers
  • Outpatient medication dispensations register

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 (4):

  • Strategies to minimise need for OCS and their adverse events are a high priority.
    • Adverse effects of long-term or frequent OCS use are obesity, diabetes, osteoporosis, cataracts, hypertension, adrenal suppression, depression, and anxiety.
    • Adverse effects of short-term use include sleep disturbances, increased risk of infection, fracture and thromboembolism.
    • Even 4–5 lifetime OCS courses are associated with increased, dose-dependent risk of, e.g., diabetes, cataract, heart failure, osteoporosis.
  • The need for OCS can be reduced by optimising asthma management.
  • Short courses of OCS may be needed in the treatment of acute exacerbations. For a small proportion of asthma patients with severe asthma, long-term OCS may be needed.
    • OCS can be life-saving during severe asthma exacerbations, but there is increasing awareness on the risks of repeated courses.
    • Long-term OCS should be considered as a last resort because of the serious long-term side-effects. Patients should be referred to specialist review.

Finnish current care guideline for asthma 2022 (20)

  • 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. One of the key aims is to reduce the harms of corticosteroid burden by predominantly using small or medium inhaled corticosteroid doses, discontinuing long-term use of OCS, and reducing the length of short-term OCS courses.
  • OCS are effective for severe allergic and non-allergic eosinophilic asthma; however, frequent courses and continuous use should be avoided due to side-effects.
  • The side-effects of short-term OCS courses become evident with over 3 courses per year.

Similar or related indicators in international scientific literature

  • OCS use in asthma measured using OCS dispensings and classified based on mean daily dosage per year (prednisolone equivalent) of prednisolone or betamethasone: regular users (average ≥5 mg/day/year, corresponding to cumulative dosage of ≥1825 mg prednisolone within 1 year); periodic users (more than zero but <5 mg/d/y); nonusers (0 mg/d/y) (1)
  • Proportion of insured persons with respiratory diseases receiving long term therapy of systemic corticosteroids (=in two sequential quarter years) (21)
  • OCS use in asthma measured using OCS prescriptions (ATC code H02AB) converted into prednisolone-equivalent doses, and defining exposure groups: no-use; low-use (<1825 mg / year, corresponding to <5 mg OCS/day/year); high-use (corresponding to ≥5 mg OCS/day/year). (3)
  • Cumulative OCS exposure of ≥912.5 mg or ≥1825 mg (equivalent to 2.5 mg/day or 5 mg/day of prednisolone equivalent, respectively, over the course of 1 year), among patients with at least GINA step 4 treatments (medium to high dose ICS + LABA). Daily ICS dose calculated by dividing annual cumulative ICS dispensed by 365. Medium to high dose defined as per GINA guidelines (e.g., budesonide >400 micrograms per day (9)
  • Register study (2): Severe asthma in patients aged ≥12 years defined applying the European Respiratory Society (ERS)/American Thoracic Society (ATS) guidelines as:
    • high-dose ICS (dispensings with an average daily dose of ≥1600 μg budesonide or equivalent), and
    • at least one dispensed prescription with a second controller (long-acting β2-agonists (LABA), long-acting muscarinic antagonists (LAMA), xanthines or leukotriene receptor antagonists (LTRA)
    • and/or biological therapy (anti-IgE, anti-interleukin (IL)-5/IL-5r)
    • and/or high OCS exposure (dispensings of an average of ≥5 mg / day / year, corresponding to ≥1825 mg total OCS).
  • Register study (2): uncontrolled asthma defined as
    • two or more OCS dispensations and/or asthma-related ED visits
    • and/or one or more asthma-related hospital admission
    • and/or high SABA use (dispensing ≥600 doses per year).

References

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