Short-acting β2-agonist prescription patterns for asthma management in the SABINA III primary care cohort

This large cross-sectional study in 24 countries provides valuable real-world insights into the management of asthma in primary care at a global scale. Although most patients were prescribed maintenance therapy in the form of ICS or ICS/LABA fixed-dose combination, SABA over-prescription was common, even in patients with mild asthma. Approximately half (44.9%) of all patients were prescribed SABA in excess of current treatment recommendations (≥3 SABA canisters in the previous 12 months), which was associated with poor asthma-related health outcomes, both in terms of increased incidence of severe exacerbations and poor asthma control.

In line with previous studies19,20, SABA over-prescription in primary care was high, with a greater proportion of patients in the PCP cohort being prescribed ≥3 and ≥10 SABA canisters (both as monotherapy and in addition to maintenance therapy) compared with the overall SABINA III population27. Notably, SABA over-prescription was more common in patients with mild asthma, suggesting potential under-estimation of asthma severity in patients with milder disease or the inappropriate management of patients with ‘mild’ asthma, resulting in poor symptom control.

Additionally, OTC purchase of SABA was common in primary care, with 21.5% of patients purchasing SABA OTC without a prescription in the preceding 12 months. Among patients with both SABA OTC purchase and prescriptions, most had already been prescribed ≥3 (72.7%) and ≥10 (39.1%) canisters, a trend that was more apparent in patients with mild than moderate-to-severe asthma (24.1% vs 18.4%). Since SABA OTC purchase has been associated with under-treatment of asthma28, healthcare policy makers and national governments should collaborate effectively to improve access to affordable care and regulate SABA OTC purchase to ensure optimal asthma care.

The prescription of OCS bursts was common across all SABA prescription categories and asthma severities, especially in patients prescribed 1–2 SABA canisters and those with mild asthma. SABA overuse and high exposure to OCS have been associated with insufficient prescription of maintenance therapy29, whilst increasing OCS prescriptions (≥4 per year) is associated with deleterious adverse events regardless of dose, duration, or continuous sporadic use30. Hence, there is an urgent need to reduce inappropriate prescribing of both SABA and OCS and to accurately document prescriptions, dispensing and use of OCS for worsening asthma symptoms, and managing exacerbations. To this end, in those countries with adequate healthcare services and where physicians have sufficient time to engage in behaviour change counselling, PCPs could provide patients with self-management training to help them recognise symptom worsening and provide instructions on appropriate use of reliever and maintenance medication, as well as OCS3.

Findings from this PCP cohort revealed that higher SABA prescriptions were, with a few exceptions, significantly associated with an increase in the rate of severe exacerbations (10–12 and ≥13 canisters) and lower odds of achieving at least partly controlled asthma (6–9 and 10–12 canisters). Although results from the overall SABINA III study showed a statistically significant association between increasing SABA prescriptions and poor asthma-related outcomes across all SABA categories27, this was not observed in this PCP cohort, likely due to the smaller patient population. However, findings from a larger cohort of patients (>570,000) in the United Kingdom (UK) who were treated in primary care (SABINA I)18 were consistent with those reported in SABINA III. Nonetheless, SABA prescription patterns in the PCP cohort were in line with the overall SABINA III population, highlighting the importance of monitoring both SABA prescriptions and SABA use to identify patients at increased risk of exacerbations, especially those under-prescribed ICS. Indeed, over-prescription of SABAs and insufficient provision of ICS-containing treatments have been identified as preventable causes of death from asthma16. Following the National Review of Asthma Deaths (NRAD) in the UK, the Royal College of Physicians (London) in its report titled ‘Why asthma still kills’ recommends that PCPs have an oversight of the patient’s entire prescription history so that SABA over-prescription can be closely monitored31.

Most patients treated in primary care were prescribed maintenance medication, either ICS or fixed-dose combinations of ICS/LABA. However, patients were prescribed a mean of 7.2 canisters of ICS in the previous 12 months. This quantity suggests potential under-prescription on the basis that one canister per month is considered good clinical practice3, and most patients were not prescribed multiple maintenance treatments, although in some cases, single ICS inhalers provide a ≥2-month supply. In addition, the majority of patients with mild asthma were prescribed ICS at a medium dose (57.6%) instead of the recommended low dose3. Taken together, these findings demonstrate the need for better alignment of both reliever and maintenance medication prescription practices with GINA recommendations by adapting asthma management guidelines to the primary care setting. Most currently available guidelines are complex, long, and generally biased towards a secondary care perspective7, which may limit their utility and has led the GINA committee to acknowledge the difficulty in implementing their recommendations in primary care3; therefore, their adaptation for PCPs to ensure wider acceptance22,32 would be of considerable value.

Consistent with earlier studies33,34,35,36, the level of asthma control in patients treated by PCPs was poor, suggesting that identification of patients with suboptimal asthma control remains a challenge in primary care. Our findings revealed that 57.2% of patients with mild disease reported having uncontrolled/partly controlled asthma, potentially due to inadequate treatment, and suggestive of under-recognition of both disease control and underlying asthma severity. Indeed, both PCPs33,37,38 and patients5 tend to overestimate the level of asthma control, leading to under-treatment of the disease37. Moreover, patients often perceive control as symptom relief and/or management of exacerbations, reflective of crisis-oriented disease management39, which may further contribute to SABA over-reliance. This could also account for the high SABA OTC purchase observed in this cohort of patients treated by PCPs, particularly in those with mild asthma. Consequently, use of objective and validated tools, such as the Asthma Control Test (ACT) and the Asthma Control Questionnaire (ACQ)3, can assist PCPs in promptly identifying patients who may require a more detailed assessment, thereby addressing the discrepancy between perceived and actual disease control.

Poor asthma control translated into a high disease burden in this PCP cohort, with more than a third of patients (38.8%) experiencing ≥1 severe asthma exacerbation in the preceding 12 months. Moreover, 39.0 and 13.7% of patients with mild asthma experienced ≥1 and ≥3 severe asthma exacerbations, respectively. SABA over-prescription is a modifiable risk factor for exacerbations40, with results from a SABINA study conducted in the UK reporting that SABA over-prescription was associated with a 20% increased rate of exacerbations in patients with mild asthma, even after adjusting for various confounding factors18. Another possible explanation for this high disease burden is that healthcare reimbursement was not available to a substantial proportion of patients overall (35.5%), including a higher proportion of patients with mild than with moderate-to-severe asthma (43.1% vs 27.5%). Inadequate healthcare insurance coverage and limited access to healthcare continue to be major barriers in accessing cost-effective treatments in many of the countries included in this study1,41 and have been associated with a reduced use of regular preventive care, increased use of emergency care42, and consistently poorer quality of asthma care, including a lower likelihood of receiving ICS43. Furthermore, the high cost of maintenance medication, such as ICS/LABA combination inhalers, can limit its use, especially in low- and middle-income countries where access to affordable medicines represents an unmet need1,41.

Overall, our findings reveal that PCPs need to reconsider approaches for managing asthma effectively, particularly in relation to the regular monitoring of both asthma control and SABA prescriptions/use to identify patients at risk of poor health outcomes. Importantly, PCPs need to ensure an accurate evaluation of underlying asthma severity so that appropriate treatment may be initiated or maintained through a step-wise process.

Since many patients with mild asthma remain uncontrolled, frequently have poor treatment adherence and often underestimate the seriousness of their condition, some PCPs could play a role in establishing asthma action plans25, discussing treatment-related issues, providing educational support and, if available, referring patients to HCPs trained in asthma education3. Although patients recognise early signs of asthma worsening, their initial response is frequently to increase SABA rather than ICS intake. Therefore, symptom-based use of a fast-acting β2-agonist and ICS combination as the default reliever option44, which relies on patients’ inherent symptom relief–seeking behaviour45 and is supported by GINA3, offers a viable asthma management strategy to overcome poor adherence since these medications are available in most primary care and low-income settings44.

Dispensing/prescription of excess SABA inhalers should be identified as a sign of poorly controlled asthma31. Therefore, putting practice systems in place whereby PCPs receive notifications from pharmacies for SABA inhalers supplied without a prescription would serve as a useful reminder to proactively review asthma control31. Since PCP consultation times can adversely affect patient care11, approaches such as arranging appointments so that they do not occur simultaneously, organising regular reviews in advance, and improving the system for scheduling walk-in patients could further optimise efficiency in the primary care setting46.

Since poor asthma-related health outcomes in primary care have been attributed to gaps between evidence-based recommendations and clinical practice33,47, further improvements may be achieved by increasing awareness of the latest treatment recommendations and coordinating multidisciplinary care involving a closer collaboration between PCPs and other HCPs17,48. While pharmacists can help monitor prescriptions, educate patients on the benefits of ICS-containing medications, and encourage them to seek medical advice before dispensing SABA OTC, address factors such as poor adherence and incorrect inhaler technique, identify patients at risk of suboptimal control and teach self-management strategies to achieve asthma control17,49, a greater involvement of specialists can help with referrals48, especially following an exacerbation16. In addition, quality improvement strategies, including professional development initiatives, audits, and feedback interventions, can assist in closing the gap between best practices and care delivery, thereby improving treatment outcomes50 without impacting workload51.

Since primary care is the cornerstone of a strong healthcare system9, it is essential that PCPs build strong partnerships with patients through shared decision-making, provision of training on self-management3 and effective communication skills to increase patient satisfaction, improve health outcomes3 and reduce healthcare resource utilisation52 without increasing the consultation time53. Notably, compared with patients who receive usual care, those who have greater involvement in treatment-related decisions through shared decision-making, where clinicians and patients negotiate a treatment regimen that accommodates patient goals and preferences, report significantly better clinical outcomes, in terms of quality of life, asthma-related healthcare utilisation, rescue medication use, lung function, and the likelihood of well-controlled asthma54. Therefore, PCPs can play a major part in encouraging patients to participate in treatment-related decisions and communicate their expectations and concerns3.

This study is not without limitations. Prescription data were used as a surrogate for actual medication use and do not provide information on medication adherence, potentially leading to an under-estimation or over-estimation of SABA use. Although OCS bursts were likely prescribed for managing asthma exacerbations, the association between SABA prescriptions and OCS bursts was not analysed. As asthma severity was classified by investigators (guided by GINA 2017 treatment steps), the underlying disease severity may have been misdiagnosed in some patients. However, a global, 3-year, prospective observational study of patients with asthma and/or chronic obstructive pulmonary disease (COPD) from real-world clinical practice demonstrated that investigator-classified disease severity was associated with several clinical and spirometric factors, including exacerbation history and symptom burden, in patients with asthma55. Owing to its observational nature, the study may also be prone to bias, e.g. therapies may be differently prescribed depending on disease severity56. In addition, as data for OTC purchase of SABA were self-reported, these findings may also be prone to recall bias56. Finally, as patients at many sites were predominantly recruited by specialists, results may not reflect primary care practices across all participating countries. However, aggregated data from 1440 patients across 24 countries, with a balanced distribution of those with mild and moderate-to-severe asthma, provide an understanding of global asthma management practices in the primary care setting.

In conclusion, results from 1440 patients from the SABINA III study treated in primary care reported that SABA prescriptions were common, with approximately one in every two patients being prescribed ≥3 SABA canisters in the 12 months prior to the study visit (defined as over-prescription). Unregulated access to SABA was also common, with over one-fifth of patients purchasing SABA OTC, of whom approximately 40% purchased ≥3 SABA canisters in the previous 12 months. Among patients who purchased SABA OTC, most were already receiving SABA prescriptions, of whom over 70.0% received prescriptions for ≥3 SABA canisters. Higher SABA prescriptions (vs 1–2 canisters) were associated with poor asthma-related health outcomes. Prescription of OCS bursts was common across all SABA prescription categories, even in patients with low SABA prescriptions and mild asthma, regardless of asthma medications prescribed in the preceding 12 months. In addition, the level of asthma control was poor, with less than 50% of patients reporting well controlled asthma. Overall, these findings suggest misdiagnosis of disease severity and inappropriate prescribing practices, both of which are an important public health concern, necessitating professional development initiatives at the primary care level to reduce the burden of asthma. Policy changes to regulate SABA prescriptions and OTC purchase, while ensuring access to asthma medications, may help ensure that clinical practices are aligned with the current evidence-based treatment recommendations. Reducing SABA over-reliance at the primary care level and per current evidence-based guidelines may result in improved clinical outcomes.

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