Over-prescription of short-acting β₂-agonists remains a serious health concern in Kenya: results from the SABINA III study

Asthma, one of the most common chronic respiratory diseases, is estimated to affect 339 million people worldwide [1, 2], with current trends suggesting that an additional 100 million people may have asthma by 2025 [3]. Notably, the prevalence of asthma has increased across Africa over the past two decades [4], primarily due to rapid urbanization and increased exposure to environmental and lifestyle factors [5, 6], and stood at over 119 million across the continent in 2010 [4]. While the epidemiology of asthma in Kenya has not been comprehensively described to date, it is estimated that approximately 10% of the Kenyan population, nearly 4 million people, have asthma [7], with a higher prevalence in urban than in rural areas [8].

In Kenya, as in many parts of Africa, fragile healthcare systems overburdened by infectious diseases, a lack of trained staff and diagnostic apparatus, and the absence of public-supported asthma care programs have contributed to the high burden of asthma [7, 9, 10]. Despite improvements in healthcare delivery, the availability and affordability of drugs for the management of asthma remains a significant barrier to optimal care in Kenya [11‐14], with 82% of women and 79% of men lacking health insurance coverage [15]. High rates of out-of-pocket expenditure for outpatient services, accounting for approximately 78% of the total household expenditure in Kenya [16], have further reduced the affordability of essential asthma medications, such as inhaled corticosteroids (ICS). Moreover, easy access to short-acting β₂-agonist (SABA) relievers, coupled with the nonavailability of ICS-containing controller medication in many African countries, including Kenya [17], may explain the low levels of asthma control reported across Africa [18‐21]. Notably, SABA overuse is globally associated with an increased risk of exacerbations, hospitalizations, and even mortality [22‐25]. Consequently, following a landmark update in 2019 [26], the Global Initiative for Asthma (GINA) no longer recommends SABA monotherapy, and instead now recommends low-dose ICS-formoterol as the preferred, as-needed reliever for adults and adolescents at GINA treatment steps 1 and 2, and for patients prescribed ICS-formoterol maintenance therapy at GINA treatment steps 3–5 [27]. However, efforts to update the Guidelines for Asthma Management in Kenya [7], which were developed in 2011 based on regularly updated international guidelines and recommendations, such as GINA, have been lacking over the past decade, with an update not due to be published until the end of 2022.

An understanding of how access to medication and its use impacts asthma outcomes is of vital importance, particularly in Kenya, where improving the availability and affordability of all asthma medications represents an unmet need [28]. Furthermore, an assessment of asthma medication trends, particularly SABA prescription patterns, will bring clinicians and healthcare policymakers to a better understanding of the extent of SABA overuse in Kenya, and thus ensure that treatment practices align with the latest evidence-based treatment recommendations. Therefore, the SABA use IN Asthma (SABINA) program [29] was undertaken to describe SABA prescription patterns through a series of real-world observational studies that applied a harmonized approach to data collection, evaluation, and interpretation. The SABINA III study was conducted across 23 countries in Asia–Pacific, Africa, the Middle East, Latin America, and in Russia [30]. Here, we present the results from the Kenyan cohort of the SABINA III study to provide real-world evidence on asthma treatment practices in this country.

Results from the Kenyan cohort of the SABINA III study provide valuable real-world evidence on asthma management practices in this country, which until now has received relatively little attention. Notably, 71.9% of patients overall were prescribed SABA in excess of current treatment recommendations (≥ 3 SABA canisters/year), which translated into a high disease burden, emphasizing an urgent need for improvements in asthma care.

In general, the overall sociodemographic and disease characteristics of patients from Kenya were consistent with those in SABINA III [30], although a few notable differences were observed. In Kenya, 54.8% of patients were treated in primary care, which was considerably higher than that observed in SABINA III (17.2%). Consequently, a higher proportion of patients in SABINA Kenya had mild asthma compared with those in SABINA III (76.5% vs 23.4%, respectively) [30]. Strikingly, only 19.5% of patients in Kenya reported fully reimbursed healthcare compared with 47.2% of patients in SABINA III [30]. Interestingly, only 7.7% of patients in primary care reported full healthcare reimbursement compared with 33.9% in specialist care. This finding may be attributable to the fact that patients under specialist care are more likely to have private healthcare insurance. Moreover, in specialist care, 48.2% of patients with moderate-to-severe asthma were fully reimbursed for healthcare compared with only 22% of patients with mild asthma. This could be explained by the observation that patients with moderate-to-severe asthma are more likely to claim their healthcare insurance than those with mild asthma due to rising healthcare costs associated with increasing asthma severity [14, 22]. However, the high percentage of patients with mild asthma who reported  ≥ 1 severe exacerbation in the previous 12 months in this study underscores the need for patients to reconsider how they utilize their healthcare insurance to ensure optimal treatment.

Overall, a high proportion of patients in Kenya were prescribed SABA treatments. Although only 15.3% of patients were prescribed SABA monotherapy, 85.5% of these were prescribed  ≥ 3 SABA canisters in the preceding 12 months, which is considered over-prescription. Similarly, of the 72.6% of patients who were prescribed SABA in addition to maintenance therapy, 81.0% were overprescribed SABA. Worryingly, 43.5% and 38.8% of patients were prescribed ≥ 10 canisters of SABA as monotherapy and with maintenance treatment, respectively. Therefore, taken together, nearly three-quarters (71.9%) of all patients were prescribed  ≥ 3 SABA canisters in the 12 months prior, with 34.8% prescribed  ≥ 10 SABA canisters. This is of concern as aggregated SABINA III data from 24 countries suggested an association between high SABA prescriptions and poor clinical outcomes, with prescriptions of  ≥ 3 SABA canisters (vs 1 − 2) being associated with increasingly lower odds of controlled or partly controlled asthma, and higher rates of severe exacerbations [30]. Although SABA over-prescription occurred in both primary and specialist care, this trend was more apparent in primary care, likely reflecting the inherent challenges faced by primary care clinicians, including limited consultation times and a lack of diagnostic resources [34‐36]. Other potential explanations for this observation are the fact that most asthma guidelines are generally biased toward a secondary care perspective, thereby limiting their implementation in a primary care setting; unfamiliarity of primary care clinicians with GINA recommendations [35]; and a time lag between revisions to GINA and subsequent updates of local guidelines. Notably, SABA over-prescription was more common in patients with mild asthma; in line with previous reports in the literature, this may be due to the potential underestimation of patients with milder disease [37‐39], resulting in inappropriate management of patients with mild asthma, leading to poor symptom control. However, discrepancies between clinical and objective assessments of asthma may also have led to a misclassification of asthma severity [40], resulting in a proportion of patients with moderate-to-severe asthma not being adequately captured.

Notably, not all SABAs were obtained with prescriptions; over one-third of patients (38.8%) from Kenya purchased SABA OTC, of whom 66.2% purchased  ≥ 3 canisters. Alarmingly, in nearly all cases (98.1%), these SABA canisters were purchased in addition to those prescribed by clinicians, with 95.5% and 57.1% of these patients already receiving prescriptions for  ≥ 3 SABA and  ≥ 10 SABA canisters, respectively, in the previous 12 months. Although limited literature is currently available on the use of OTC medications to treat asthma in Kenya, these findings were not entirely unexpected as the purchase of OTC drugs, particularly painkillers, antibiotics, and antimalarials, is widespread across the country [41‐43]. In addition, the fact that nearly 60% of patients in this study reported no healthcare reimbursement, combined with high levels of out-of-pocket expenditure for medicines for noncommunicable diseases reported across Kenya [16, 44], likely further contributed to the high levels of SABA purchase observed in this study. However, this is a matter of concern because SABA purchase is associated with infrequent clinician consultations; low use of prescription medication, particularly ICS; and overall undertreatment of asthma [45‐47]. Indeed, the Kenyan government is currently striving to outlaw the sale of OTC drugs in an attempt to encourage citizens to seek medical attention from qualified healthcare practitioners [43]. Therefore, our findings provide further impetus for reform, highlighting an urgent need to drive policy changes to regulate SABA purchase without prescriptions and provide affordable care for all patients with asthma in Kenya.

Altogether, over half of all patients (58.8%) were prescribed ICS, which was in alignment with the fact that the majority of patients (76.0%) had mild asthma; however, over three-quarters of patients (76.8%) received medium-dose ICS instead of the recommended low-dose ICS [27]. Reassuringly, patients were prescribed a mean of 9.6 ICS canisters in the preceding 12 months. On the basis that one canister per month is considered appropriate, this quantity suggests good clinical practice and may be indicative of automatic repeat prescriptions. However, it could not be conclusively determined whether patients took their medication as prescribed. In line with the fact that 24.0% of patients had moderate-to-severe asthma, 24.7% of patients were prescribed an ICS/LABA fixed-dose combination. Interestingly, 22.7% of patients were prescribed an OCS burst, presumably for the management of exacerbations. However, this was lower than anticipated, given that 61.5% of patients reported  ≥ 1 severe asthma exacerbation in the previous 12 months. While this finding may reflect ongoing concerns around the use of short courses of OCS with growing evidence now suggesting that even brief dosing periods of 3–7 days may increase the risk of adverse events, including loss of bone density, hypertension, and gastrointestinal ulcers/bleeds [48], it may also be a consequence of the substantial work that has been undertaken in Kenya to reduce the prescription of OCS bursts for exacerbations. Following this success, similar efforts are now required to tackle the over-prescription of SABAs. Despite the fact that GINA does not support the routine use of antibiotics for asthma unless there is strong evidence of lung infection [27], 14.1% of patients from Kenya were prescribed antibiotics for asthma. While this may be explained in part by a lack of familiarity with asthma guidelines, it may also reflect prescribing practices in Kenya, where considerable antibiotic prescriptions for numerous conditions have been reported [49], resulting in high rates of antimicrobial resistance [50] and culminating in recent research to evaluate optimal strategies for the development of stewardship programs [49].

Crucially, asthma control in Kenya was poor, with less than a quarter of patients having well-controlled asthma compared with 43.3% of patients in the overall SABINA III cohort [30]. Consequently, the burden of asthma in Kenya was high, with 61.5% of patients experiencing  ≥ 1 severe exacerbation in the previous 12 months. However, our findings are aligned with previous reports from Africa documenting suboptimal asthma control [21, 51‐53]. Indeed, results from the Epidemiological Study on the Management of Asthma in Asthmatic Middle East Adult Population, a large-scale cross-sectional epidemiological study in 7236 patients that included three African countries (Algeria, Egypt, and Tunisia), reported that asthma was only controlled in approximately one-third of all patients [54]. While organizations such as the National Asthma Education Program [55] aim to promote the goals of asthma management, including the complete clinical control of asthma through the education of healthcare professionals, patients, and the general public across Africa [56], our study clearly demonstrates the need for similar country-wide clinician- and patient-centered awareness programs to improve asthma outcomes in Kenya.

The results of this study should be viewed in light of several limitations. SABA prescription data do not always reflect medication use and do not provide information on treatment adherence. The use of GINA 2017 guidelines (which were in place at the time this study was conducted) for classifying disease severity may have accounted for some of the observed high levels of SABA prescriptions. Furthermore, since data entry into the eCRFs relied on clinician assessments, findings may have been impacted by misinterpretation of instructions and incorrect patient classification or treatment. Patient-reported data on SABA OTC purchase may have been subject to recall and nonresponse bias [57, 58]. Additionally, only the number of comorbidities (categorized as 0, 1–2, 3–4, and  ≥ 5) were recorded in the eCRF, while data on the type and rate of comorbidities were not captured. Moreover, the impact of comorbidities and a range of other factors, such as gender, BMI, smoking status, patient education, healthcare reimbursement status, inhaler technique, and patient-physician communication, on asthma control were not examined in this study. Information on the management of asthma exacerbations and whether the correct treatment was prescribed was not collected. Finally, as the primary focus of this study was on SABA canister prescriptions, the potential overuse of oral (tablets) and nebulized dosage forms of SABA was not captured.

Despite these limitations, this study is the first to describe SABA prescription patterns in Kenya. Furthermore, the collection of these real-world data on SABA over-prescription in patients equally distributed across primary and specialist care provides a true representation of how asthma is currently being managed in Kenya. Overall, the pattern of high SABA over-prescription and OTC purchase indicates that urgent action is required to update national guidelines and drive policy change in Kenya. Crucially, our study highlights the need to align clinical practices with the latest evidence-based recommendations to improve asthma outcomes across the country.

Results from the Kenyan cohort of the SABINA III study demonstrated SABA over-prescription (≥ 3 canisters in the previous 12 months) in nearly three-quarters of all patients (71.9%). Furthermore, over one-third of patients (38.8%) purchased SABA OTC without a prescription, of whom 66.2% purchased  ≥ 3 canisters of SABA. Almost all patients (98.1%) who purchased SABA OTC had also received SABA prescriptions. Overall, asthma control was low, with 61.5% of patients experiencing  ≥ 1 severe asthma exacerbation in the previous 12 months. Therefore, SABA over-prescription remains a major public health concern in Kenya, requiring urgent action from HCPs and policymakers to work together to update national guidelines, regulate SABA purchase without prescription, and ensure that clinical practices are aligned with the latest evidence-based recommendations.