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Proportions of SABA purchases with or without prescriptions and SABA purchases with prescriptions (both reimbursable and non-reimbursable) stratified by prescriber
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IntroductionPreliminary results from the SABINA (SABA use IN Asthma) program showed lower overuse of short-acting β2-agonist (SABA) in Italy compared to other European countries. The aim of the present study was to ascertain whether SABINA’s results might have been affected by the Italian National Health System and pharmaceutical market dynamics, b...
Context in source publication
Context 1
... of SABA canisters/year we would observe in case the IQVIA LPD was able to track 100% of SABA consumption would be four. This fits with the finding that four canisters/year is the average number of SABA canisters purchased during 1 year resulting from the pop-up survey. LPD coverage in terms of SABA consumption tracking is 74% (40% ? 9% ? 25%) (Fig. ...
Citations
... Poor adherence is higher in LMICs [5,9,24] and in low-resource settings, reaching 80% [44]. In these countries and settings, the proper follow-up by physicians to adjust medication is difficult, with only 40% of children having regular assessment by primary care physicians and less than half receiving their prescribed inhaled controller agent [45]. The global low adherence to the regular use of ICS and the overuse of SABA, particularly in LMICs are some of the reasons that motivate the recommendation of the mandatory use of ICS every time a bronchodilator is used and the emergence of the concept of the AIR therapy. ...
There are no plausible arguments to consider that the best evidence-based asthma treatment should be different in low- and middle-income countries (LMICs). A few decades ago, the recognition of asthma as an inflammatory disease of the airways positioned the inhaled corticosteroids (ICS) as the cornerstone of the treatment of this disease, maintaining bronchodilators, especially the short-acting beta-agonists (SABA), as symptom-reliever medications for use as needed. However, adherence to regular use of ICS is very low, especially in LMICs, favoring the overuse of SABA, which has been related to an excess of exacerbations and mortality. Recently, the Global Initiative for Asthma (GINA) strategy has recommended the mandatory use of ICS every time a bronchodilator is used as needed (for symptoms relief), whether only as needed or with a background of regular dose of ICS, and has named it: anti-inflammatory reliever (AIR) therapy. This form of therapy, which has been related to a significant reduction of asthma exacerbations, is very attractive for LMICs where patients do not have guaranteed a proper medical follow-up and the access to on-the-counter medications is high. However, the implementation of AIR therapy in LMICs will face many of the already recognized barriers for the diagnosis and treatment of asthma in these countries, especially related to limited access to care in very different health systems, low education level of patients and communities, insufficient health personnel training in asthma in primary care, the unfordable cost of medications, and the lack of political commitment. This review analyzes some of these challenges and strategies for facing them in LMICs.
... The codification system of diagnoses follows the International Classification of Diseases 9th revision (ICD-9), while that of drugs complies with the Anatomical Therapeutic and Chemical (ATC) classification. Italian IQVIA LPD has been shown to be a reliable source of information in numerous previous studies and disease areas [14][15][16][17][18][19] and has been recently added to the European Medicine Agency (EMA) Real-World Data Catalogue [20]. IQVIA LPD relies on anonymous data which are not originated by any clinical trial. ...
To describe patients with anal fissure (AF) and their management in primary care. Retrospective study using the Italian Longitudinal Patient Database on 18 + years old subjects with AF records during ‘July 2016–June 2021’ (selection period). Index Date (ID) was the first AF record during selection period. Sub-cohorts were defined by presence/absence of prescriptions on ID of the combination of topical nifedipine 0.3% and lidocaine 1.5% (NIF/LID). Patients’ information on the 12-month period before (baseline) and after (follow-up) ID was analyzed. Subjects with AF were 8632: 14.0% had NIF/LID on ID. Mean age was 52 (± 17.2) years, there were more women in ‘ < 50 years’ group, and more men in ‘50–70’ one. Prevalences of pregnancy and immunodepression were around 5%; most common comorbidities were hypertension (29.6%) and heart disease (13.1%), while constipation and diarrhea were < 5%. Healthcare resources utilization (HRUs) increased during follow-up, but still few patients were prescribed NIF/LID (2.8%), other treatments for AF (10.3%), or proctological visits (7.7%). NIF/LID patients were younger (< 40 years people: 30.7% versus 23.9%; p value < 0.0001), and more likely to have constipation (4.3% versus 2.5%; p value < 0.001); patients without NIF/LID showed slightly higher prevalences of hypertension (30.0% versus 27.1%; p value: 0.039) and depression (4.0% versus**2.5%; p value: 0.009), and a little higher overall HRUs. Results show that general practitioners are used to manage AF. However, there is still a gap between guidelines’ recommendations and actual management. Educational campaigns on common anal problems in primary care might help further improving AF management and optimizing HRUs.
... Of the 22,201 patients enrolled, including all levels of asthma severity, a prevalence of 9% overuse of SABA was found [7]. However, this value might be underestimated as Italian regulations permit direct purchasing of SABA inhalers from pharmacies without a prescription [8]. Interestingly, 15% of participants acquired SABA without a prescription. ...
Short-acting bronchodilators are a class of medications commonly used to treat asthma, chronic obstructive pulmonary disease, and other respiratory conditions. The use of these medications has evolved over time as we have gained a better understanding of their effectiveness and safety in the pediatric population. This comprehensive review synthesizes the current understanding of short-acting β2-agonists and short-acting anticholinergics in children. It addresses indications, contraindications, safety considerations, and highlights areas where further research is needed to guide the most effective use of short-acting bronchodilators.
... Currently, about 900 GPs contribute to the database, providing data of approximately 1.2 million patients, who are representative of the Italian general population managed by GPs in terms of age and gender [10]. Italian IQVIA LPD has been shown to be a reliable source of information in numerous previous studies and disease areas [11][12][13][14], including neurology [6,15,16]. ...
Objective
This study is describing subjects with migraine interrupting or not receiving triptans for acute treatment and providing a national-level estimate of people who might benefit from different therapeutic approaches.
Methods
This is a retrospective analysis using IQVIA Longitudinal Patient Database. Starting from 18 + years old individuals with migraine, we selected two cohorts: subjects with triptans prescriptions before and no triptans prescriptions after Index Date (triptan withdraw) and subjects without triptans prescriptions both before and after Index Date (no triptan prescriptions). Index Date was the first record of a health encounter for migraine in 2019. Individuals with cardiovascular disease (CVD) within no triptan prescriptions group were also quantified.
Results
Triptan withdraw and no triptan prescriptions cohorts numbered 605 and 3270, respectively, 5% and 29% of subjects with migraine. Mean age was 47 and 51 years respectively; women were more represented (~ 80%). Hypertension and thyroid disease were most frequent comorbidities; non-steroidal anti-inflammatory drugs were among most frequently recorded treatments. Subjects with CVD within no triptan prescriptions cohort were 621 and with triptan withdraw cohort subjects represented the basis to estimate those who might benefit from alternative options for the acute treatment of migraine, who were around 60,000 and accounted for 11% of subjects seeking primary care due to migraine.
Conclusions
This analysis provides a real-word estimate of Italian people that might benefit from different therapeutic approaches as an alternative to triptans, which sometimes might be not effective and/or poorly tolerated. Such estimate should be intended as the lower limit of a wider range due to strict criteria adopted.
... Previous research has linked the excessive usage of SABAs, particularly when used without anti-inflammatory or preventer medications to adverse consequences such as the occurrence of asthma exacerbations, poorer control of symptoms, use of healthcare resources such as doctor visits or hospital admissions, and even asthma-related mortality [3][4][5][6][7]. The operational definition of SABA overuse in this study refers to the use of three or more SABA canisters in a year [8][9][10][11]. Based on robust evidence, the Global Initiative for Asthma Report (GINA, 2023), now recommends that adult patients with asthma (even with mild asthma) use a combination of a SABA and a low dose inhaled corticosteroid in the same or separate inhalers for symptom relief as the first step of asthma treatment [10]. This is a paradigm shift from previous GINA guidelines where SABA use alone was considered the initial treatment for asthma patients with mild symptoms [12,13]. ...
... Finally, 18 studies were included in this systematic review. The 18 studies reported data from various countries with different income levels based on World Bank classification [9,15,[35][36][37][38][39][40][41][42][43][44][45][46][47][48][49][50]. A total of 11 high-income countries were represented, in data collected from Australia, Chile, Italy, Kuwait, Oman, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, and The United Arab Emirates. ...
... It was noteworthy that the research design of all 18 studies was cross-sectional; Table 2 displays the study characteristics of all included articles. As seen in Additional file 1 Table S1, only three of the included studies were deemed to be of 'good' quality [4,46,50], with the remaining studies being of "fair" quality [9,35,38,39,45,47,49]. ...
The widespread use of short-acting beta-2 agonists (SABA) as an as-needed treatment for asthma is well-established. However, excessive use of SABA has been linked to undesirable outcomes such as increased risk of asthma attacks, exacerbations, and even death. The availability of SABA as an over-the-counter (OTC) medication has contributed to their overuse, leading to undertreated asthma and reduced access to asthma education.
This systematic review aimed to summarize the prevalence, characteristic features of, and factors contributing to over-the-counter SABA purchase or overuse.
... The SABA use IN Asthma (SABINA) program was initiated to describe asthma treatment prescription patterns, the extent of SABA use, and its subsequent impact on asthma-related clinical outcomes through a series of large observational cohort studies using a harmonized approach to data collection, evaluation, and interpretation. 23 Due to the diversity in healthcare systems, the SABINA program comprises 3 main pillars, which share a common objective and design principles from a granular core protocol to ensure scientific alignment: (i) SABINA I, a retrospective, observational database study conducted in the United Kingdom (UK); 24 (ii) SABINA II, a distributed harmonized set of multi-country, retrospective, observational database studies in Canada, France, Germany, Italy, Israel, the Netherlands, Spain, and Sweden; [25][26][27][28][29][30][31] and (iii) SABINA III, a multicenter, observational, crosssectional study in 8351 patients from 24 countries across the Asia-Pacific region, [32][33][34][35][36][37] Africa, [38][39][40] the Middle East, [41][42][43][44] Latin America, [45][46][47][48] and Russia, 49 which used electronic case report forms (eCRFs) to record data from individual patients (patient-level data) and from healthcare providers (HCPs). 50 Overall, results from the United Kingdom and Europe reported that SABA overprescription (or possession of !3 canisters/year) is common and associated with poor clinical outcomes. ...
Background
The extent of short-acting Beta-2-agonist (β2-agonist) (SABA) use across Asian countries is not well documented. As part of the SABA use IN Asthma (SABINA) III study, we assessed SABA prescriptions and clinical outcomes in patients with asthma from Asia.
Methods
This cross-sectional study recruited patients (aged ≥12 years) with asthma from 8 Asian countries. Data on disease characteristics and asthma treatments were collected using electronic case report forms. Patients were classified by practice type (primary or specialist care) and investigator-defined asthma severity (per Global Initiative for Asthma [GINA] 2017 recommendations). The association of SABA prescriptions with clinical outcomes was analyzed using multivariable regression models.
Results
Overall, 3066 patients were analyzed, with a mean (standard deviation) age of 51.8 (16.7) years; of these patients, 2116 (69%) were female, 2517 (82.1%) had moderate-to-severe asthma and 2498 (81.5%) and 559 (18.2%) were treated in specialist and primary care, respectively. In total, 1423 (46.4%) patients had partly controlled/uncontrolled asthma, with 1149 (37.5%) patients experiencing ≥1 severe asthma exacerbation in the previous year. Overall, 800 (26.7%) patients were prescribed ≥3 SABA canisters in the previous year, which is regarded as overprescription and was associated with a significantly decreased odds of at least partly controlled asthma and increased incidence rates of severe exacerbations (P < 0.01 for both associations).
Conclusion
The findings from this cohort of predominantly specialist-treated patients with asthma indicate SABA overprescription in at least 1 in every 4 patients, and this overprescription is associated with poor clinical outcomes. These data highlight the need for adherence to recently updated asthma treatment recommendations in Asia.
... 69 Several F I G U R E 3 Map of SABA overuse prevalence in European countries. 31,[39][40][41]47 studies have shown that proper characterization of patients is crucial for good management of the disease and to prevent life-threatening asthma exacerbations. 70 The incorporation of non-pharmacological patient insight approaches to symptom and exacerbation management is growing in regional asthma strategies 63,64 and has been shown to be useful in identifying uncontrolled asthma. ...
... Due to the difference regarding SABA use/prescription trends with the rest of Europe, and taking into account that SABA can be purchase directly in pharmacies without prescription, a recent analysis including SABA canisters acquired without prescription (from a pop-up survey on Pharmacies) and those prescribed by specialists (cross-sectional study) was performed.39 In the first case (n = 1136), ...
This review article provides an overview of short‐acting beta‐agonist (SABA) use and prescribing trends in Europe, summarizing updated data on the results from the industry‐funded SABINA program (SABA use IN asthma) and other studies on this matter. SABA use continues to increase worldwide. Overuse has been defined as ≥3 canisters/year. Almost a third of European patients with asthma, at all severity levels, overuse SABA. Guidelines recommend close monitoring of patients who overuse SABA and avoiding over‐reliance on SABA monotherapy. SABA overuse is associated with increased risk of asthma exacerbations and mortality, increased use of health services and negative physical and mental health outcomes. Reliance on SABA monotherapy can be unsafe and therefore it is necessary to change asthma treatment approaches and policies. Changes in physician and patient behaviours towards SABA use are required to ensure that patients with asthma are not over‐reliant on SABA monotherapy. Notwithstanding, the limitations of the studies on the use of SABA should be considered, taking into account that the prescription/purchase of medication canisters does not always represent the actual use of the medication and that associations between SABA overuse and poor asthma outcomes may not be directly causal. National health systems and asthma guidelines must align asthma management with global recommendations and adjust them to local needs. The use of SABA remains very common in Europe across all severities of asthma. SABA usage should be changed through educational campaigns targeted at clinicians and patients. It is crucial that national health systems align asthma management with global recommendations, while adapting to local needs for better and more effective implementation. More research is needed to find out how excessive use of SABA contributes to poor asthma control. GPs: general practitioners.
... For the purpose of their analysis, a severe exacerbation is defined as dispensation of a course of oral corticosteroids of ⩽10 days duration or hospitalisation or emergency department attendance with asthma as the primary complaint. Consistent with other studies in the SABINA programme [12,13,16], NOORDUYN et al. [8] identified a high prevalence of SABA overuse in both Canadian cohorts (28% in the Alberta cohort and 39% in the Nova Scotia cohort), and an association between SABA overuse and severe exacerbations, with the highest exacerbation rate observed in those with the highest SABA use. ...
In this issue of ERJOR, Noorduynet al. add data to the growing literature showing that SABA overuse in asthma is both common and associated with severe exacerbations. It is time to take note and act to tackle this global issue. https://bit.ly/3BfwhfS.
... Despite enrolling patients managed at tertiary-care centres, our study included multiple centres with wide geographical representation across China, and the frequency of SABA overprescription was substantially lower than that observed among patients managed at tertiary-care centres in other countries. 15,20,26,27 Despite the low prescription frequency of SABA therapy, more than half (54.5%) of the patients who were prescribed SABA experienced a severe exacerbation, indicating an increased risk of exacerbations in patients receiving this therapy. In addition, the long duration of SABA therapy (average duration of use: 97 days) indicates poor asthma control in these patients, which may have prompted increased prescriptions for SABA therapy. ...
Objectives
The SABINA CHINA study aimed to determine prescription data for asthma medication with a focus on SABA and ICS in a representative population of patients with asthma in China.
Methods
SABINA China was a multicentre, observational, cross-sectional study with data collected retrospectively from a convenience sample of 25 tertiary centres across China. Patients (age ⩾ 12 years) with ⩾3 consultations/year were enrolled. Data were collected on clinical characteristics, asthma severity, and symptom control (as per GINA 2017), treatment and history of severe exacerbations over the past year. SABA over-prescription was defined as ⩾3 SABA canisters/year. Descriptive statistics are presented.
Results
Between March and August 2020, 498 patients were included in the outcome analysis. Mean (SD) age was 48.7 (15.0) years, 57.9% were female and 91% had moderate-to-severe asthma ( n = 453). Overall, 12.5% ( n = 62) and 26.4% ( n = 131) of patients had uncontrolled and partly controlled asthma, respectively. SABA add-on was prescribed to 20.3% ( n = 101) of patients; one patient with moderate-to-severe asthma was prescribed SABA-alone. SABA over-prescription in the overall population was 4.0% ( n = 20; all with moderate-to-severe asthma) and 19.8% (20/101) among those prescribed SABA add-on. In the mild asthma group, 50% ( n = 22) were prescribed ICS/LABA and 43.2% ( n = 19) were prescribed LTRA. Among those with moderate-to-severe asthma, 97.4% ( n = 441) were prescribed ICS/LABA and 55.0% ( n = 249) were prescribed LTRA. Approximately 30% of patients ( n = 149) experienced ⩾1% and 6.6% ( n = 33) ⩾3 severe exacerbations in the preceding year; mean annual number of severe exacerbation/patient was 0.6 (1.2). Among those prescribed SABA add-on, ICS/LABA and LTRA (non-mutually exclusive groups due to overlapping prescriptions), 54.5%, 29.9%, and 35.3% had ⩾1 severe exacerbations, respectively.
Conclusion
Among patients with predominantly moderate-to-severe asthma managed in tertiary care and were prescribed SABA, 1 in 5 received ⩾3 canisters/year. Fewer patients who received ICS/LABA prescriptions experienced annual exacerbations than those prescribed SABA add-on.
... Currently, about 900 GPs contribute to the database, providing data from routinely collected records of about 1.2 million patients. The IQVIA Italian LPD has been shown to be a reliable source of information in numerous previous studies for several disease areas [32][33][34][35][36] , including hypertension 11,37 . ...
Objective:
Clinically describing hypertensive patients initiating nebivolol/zofenopril extemporaneous combination (NZ-EXC) and providing the number of patients currently receiving NZ-EXC and of those potentially eligible for the fixed-dose combination of the two molecules (NZ-FDC) in Italy.
Methods:
This retrospective observational study used data from IQVIA Italian Longitudinal Patient Database (LPD). Adult hypertensive patients firstly prescribed NZ-EXC between 01-July-2011 and 30-June-2020 were identified and their demographic and clinical characteristics were extracted. Treatment adherence was evaluated as proportion of days covered (PDC) and classified as low (PDC <40%), intermediate (PDC ≥40% and <80%) or high (PDC ≥80%). Two additional cohorts were identified on 2019 to provide the national-level yearly estimates of patients prescribed NZ-EXC and of patients eligible for NZ-FDC.
Results:
1,745 patients were prescribed NZ-EXC: 60% were women; mean age was 65 years. The most frequent comorbidities were dislypidemia (19.0%), diabetes (15.5%), and thyroid diseases (13.1%); the most common co-prescribed treatments were antithrombotics (29.1%), lipid-lowering agents (28.8%), nonsteroidal anti-inflammatory drugs (26.1%), and antihyperglycemic agents (13.5%). Mean PDC was 39%, and 57% of the patients had a PDC <40%. The yearly estimate of patients prescribed NZ-EXC in 2019 was 59,000, while potential users of NZ-FDC were estimated to be 29,000.
Conclusions:
NZ-EXC in hypertensive patients is a common practice in Italy and the development of a NZ-FDC can be a viable treatment option for hypertensive patients who are already receiving nebivolol and zofenopril through the concomitant assumption of two distinct pills. As supported by scientific literature, FDCs of antihypertensive drugs could simplify treatment, improve adherence, and potentially reduce health-care costs as related to a better control of blood pressure.
