Table 2 Characteristics of the studies

[35]

Alzaabi et al.

The Gulf cluster of Kuwait, Oman, and The United Arab Emirates (UAE)

A multicounty, multicenter, cross-sectional study (SABINA III sub-analysis study)

May to December 2019

Study targets: patients aged ≥ 12 years with a confirmed asthma diagnosis, at least 3 annual consults with a HCP, with complete medical records available for ≥ 12 months prior to study visit, and with no other CRD besides asthma.

Number of participants:

301 patients from health clinics in Kuwait, Oman, and the UAE

Used ≥ 3 SABA canisters per year

13.3% of participants surveyed used OTC SABAs in 12 months prior to the study visit

Among 13.3% SABA over-the-counter purchasers, 52.2% purchased ≥ 3 SABA canisters (12 months prior to the study visit)

All SABA OTC purchasers had moderate-to-severe asthma. 92.5% OTC SABA users had also received SABA prescriptions. Among those patients, 51.4% were prescribed ≥ 3 SABA medications, while 13.5% were prescribed 10 or more SABA medications

This study provides a comprehensive assessment of SABA prescription volumes, SABA OTC purchases, and asthma outcomes in the 3 countries of Kuwait, Oman, and the UAE

[15]

Azzi et al.

Australia

A real-world cross-sectional observational study

October 2017 to October 2018

Study targets: individuals ≥ 16 years or older purchasing OTC SABA for themselves from community pharmacies.

Number of participants:

412 SABA users from 18 community pharmacies in the state of New South Wales, Australia

Used SABA more than twice a week in the previous one month

All patients as study targeted only OTC users

70.1% of participants were defined as over-users based on using their SABA inhalers > twice a week for symptom relief

Compared to non-over-users, a higher % of SABA over-users (59.0%) had uncontrolled asthma, with a ↑ likelihood of using OCS to manage exacerbations (26.2%), visiting the doctor for asthma in past 12 months (74.5%), and having moderate–severe nasal symptoms (80.8%)

73.6% reported not using a preventer daily and only 81.6% reported a doctor diagnosis of asthma

OTC SABA seekers probably have a higher burden of illnesses including rhinitis, need for OCS, frequent health care utilization

This study highlights the necessity of involving community pharmacists in directing appropriate use of SABAs in countries where SABA is available OTC

[37]

Bateman et al.

24 countries, i.e., Russia, Australia, South Africa, Kenya, Egypt, Turkey, Saudi Arabia, the United Arab Emirates, Kuwait, Oman, Mexico, Costa Rica, Columbia, Chile, Brazil, Argentina, Thailand, Taiwan, South Korea, Singapore, Philippines, Malaysia, Indonesia, and India

A multi-country, observational, cross-sectional study (SABINA III main study)

March 2019 to January 2020

Study targets: patients ≥ 12 years, with documented asthma diagnosis in their medical records, ≥ 3 prior consults with HCP /year complete medical records for ≥ 12 months prior to the study visit, and no other CRD except asthma.

Number of participants:

8,462 patients recruited from primary and specialist healthcare settings in 24 countries

Used ≥ 3 SABA canisters per year

18.0% of included participants were OTC SABA purchasers (12 months prior to the study visit)

48.8% of participants purchased ≥ 3 SABA canisters (12 months prior to the study visit)

Among those purchasing non -prescription SABA, 76.8% had also received SABA prescriptions, and 69.9% obtained ≥ 3 canisters and 35.8% obtained ≥ 10 canisters in the past 12 months using prescriptions

SABA OTC purchases need to be regulated and automatic repeat prescriptions may result in high and unnecessary prescriptions

[38]

Yorgancıoğlu et al.

Turkey

An observational, cross-sectional study (SABINA III sub-analysis study)

September 2019 to January 2020

Study targets: patients aged ≥ 12 years with a documented asthma diagnosis of asthma, ≥ three consults with a HCP and available complete medical records for ≥ 12 months prior to with no CRD except asthma.  Number of participants:

588 patients recruited from 24 centers in Turkey

Used ≥ 3 SABA canisters per year

10.2% of participants were OTC SABA users (12 months prior to the study visit)

27.1% of them purchased ≥ 3 SABA canisters (12 months prior to the study visit)

A higher proportion of patients with moderate-to-severe asthma than those with mild asthma purchased ≥ 3 SABA canisters without a prescription (29.4% vs 12.5%)

There is a non-representative asthma study population from specialist care, leading to a greater number of moderate-to-severe asthma patients being included in the study

[39]

Al-Jahdali et al.

Saudi Arabia

An observational, cross-sectional, cohort study (SABINA III sub-analysis study)

March 2019 and January 2020

Study targets: patients ≥ 12 years, with a documented asthma diagnosis of asthma, with at least 3 consults with HCP and complete medical records of these for past 12 months and with no other CRD except asthma. Number of participants: 502 patients recruited by pulmonologists or respiratory medicine physicians

Used ≥ 3 SABA canisters usage per year

21.9% participants in the 12 months prior to the study visit had used OTC SABAs

66.4% of participants had purchased ≥ 3 SABA canisters in 12 months prior to the study visit

Among patients who purchased ≥ 3 SABA canisters, 69.3% of patients experienced moderate-to-severe asthma and 33.3% had milder asthma. Most patients who purchased SABA over-the-counter also received SABA prescriptions (88.2%), and among these, 80.4% received ≥ 3 SABA prescriptions and 56.7% received ≥ 10 SABA prescriptions over the last 12 months

This study lends weight to the fact that prescribing SABAs in asthma may signal to patients that these are safe and catalyze OTC use (which then may or may not be disclosed other to HCPs)

Again, the role of pharmacists in instigating three way communication with patients and their doctors around SABA overuse is notably important

[40]

Douglass et al.

Australia

A real-world cross-sectional

observational study

June 2004 and July 2005

Study targets: individuals aged ≥ 16 years who purchased SABA medications for personal use recruited by community pharmacists. Number of participants: 316 asthma patients from 43 metropolitan and regional community pharmacies

Not stated, it may be noted that GINA definition of overuse was published later than this study

39.6% of participants surveyed used SABAs OTC

Not stated

45% of participants had impaired lung function with a forced expiratory volume (FEV1) less than 80% predicted, 34.7% of these purchased their SABA without a prescription. Moreover, individuals who purchased their SABA with a prescription were more likely to have used preventer medication in the past seven days

It appears a third of OTC SABA purchasers had less than normal healthy lung function. Prescription SABA use was associated with preventer use

It is likely that this situation may have been worse in regional -rural areas where HCP shortages are more likely – this study was metropolitan area based

[41]

Bao et al.

China

A multicenter, observational, cross-sectional study (SABINA III sub-analysis study)

March and August 2020

Study targets: patients ≥ 12 years with a documented asthma diagnosis confirmed by the presence of recurrent symptoms and spirometry with, at least 3 annual consultations with HCP, and no other CRD other than asthma.

Number of participants: 498 patients recruited from 25 tertiary centers (specialists) across China

Used ⩾ 3 SABA canisters per year

5.2% were OTC SABA purchasers in the 12 months prior to the study visit

50% of participants purchased ⩾ 3 SABA canisters (12 months prior to the study visit)

Not stated

This study was to assess the treatment patterns and clinical outcomes in patients with predominantly moderate-to-severe asthma, who were managed at tertiary centers at China

[36]

Azzi et al.

Australia

A real-world cross-sectional observational study

October 2017 and October 2018

Study targets:  SABA users who were aged 16 years or older, purchased over-the-counter SABA medication for themselves from community pharmacy, and were able to communicate in English. Number of participants: a total of 412 participants were recruited from 18 different community pharmacies

Used SABA > twice in the past one month

Not applicable

Not stated

Based on GINA-defined criteria, 47% of the participants had uncontrolled asthma in the previous 4 weeks. Recent high SABA users were found to be more likely to have uncontrolled asthma compared to recent non-high SABA users. Additionally, a significantly higher proportion of high SABA users agreed that asthma impacted their daily activities, aware of the social implications of their condition in comparison to non-high SABA users

Of the participants who considered their asthma to be completely or well-controlled, more than half (60.5%) reported overused SABA. A statistically significant proportion of high SABA users (49.8%) reported the need for additional information compared to non-high SABA users (27.6%). Furthermore, high SABA users (46.2%) were more likely to rate their asthma as somewhat controlled when compared to non-high SABA users (11.2%)

[42]

Montero-Arias et al.

Argentina, Brazil, Chile, Colombia, Costa Rica, and Mexico

A cross-sectional, multicounty, multicenter, observational study (SABINA III sub-analysis study)

Not stated

Study targets: patients with asthma aged ≥ 12 years with ≥ 3 HCP consults and complete medical records for ≥ 12 months before the study visit, and no other CRD other than asthma.

Number of participants: 1096 patients, recruited by primary care physician and specialists from medical settings in Argentina, Columbia, and Mexico

Used ≥ 3 SABA canisters per year

17.2% of participants purchased SABAs OTC in the 12 months prior to the study visit

38.8% and 7.4% purchased ≥ three and ≥ 10 canisters of SABA, respectively, in the 12 months prior to the study visit

Of the patients who purchased SABA over-the-counter, 80.3% were also prescribed SABA, either as monotherapy or in addition to maintenance therapy. Within the preceding 12 months, 73.5% were prescribed ≥ 3 SABA canisters, with 53.6% prescribed ≥ 10. Among the patients who overused SABA, 22.7% believed the medication to be safe to use. About half (49.5%) high SABA users expressed concern about the potential long-term effects of using inhaled corticosteroids, in comparison to non-high SABA users

SABA overuse appeared more prevalent in primary versus specialist care patients (29.2% vs 15.6%, respectively)

Higher SABA users may be resorting to SABs as nearly half had concerns about inhaled steroid preventers while a fifth believed that SABAs were safe. Education that helps patients accurately weigh benefit versus risks of both SABAs and steroid preventers may be useful in diluting SABA overuse

It was clear that

[43]

Avdeev et al.

Russia

A multi-country, cross-sectional observational study (SABINA III sub-analysis)

March 2019 to March 2020

Study targets:  participants aged 12 years or older, who had a diagnosis of asthma and had undergone at least 3 consultations with healthcare professionals with medical records available for at least 12 months prior to the study visit, and no other CRD other than asthma were recruited from 12 Russian centers. Number of participants: a total of 618 participants were included in the final analysis of the study

Used ≥ 3 SABA canisters per year

30.1% (12 months prior to the study visit)

14% purchased ≥ three canisters of SABA per year over-the-counter (12 months prior to the study visit)

The quantity of SABA purchased without a prescription was generally not associated with asthma severity. However, among those with mild asthma, 7% purchased ≥ 6 SABA canisters per year, which was a slightly higher percentage than those with moderate/severe asthma, of whom only 5% purchased six or more canisters annually. Of those who acquired SABA over-the-counter, 91% already received SABA prescriptions and 59% received prescriptions for three or more SABA canisters in the past year

Not stated

[44]

Price et al.

24 countries which include Russia, Australia, South Africa, Kenya, Egypt, Turkey, Saudi Arabia, the United Arab Emirates, Kuwait, Oman, Mexico, Costa Rica, Columbia, Chile, Brazil, Argentina, Thailand, Taiwan, South Korea, Singapore, Philippines, Malaysia, Indonesia, and India

A multi-country, cross-sectional observational study (SABINA III sub-analysis study)

Not stated

Study targets:  patients with asthma, aged 12 years or older, who had undergone at least three consultations with healthcare professionals, had medical records with at least 12 months of data prior to the study visit, and no other chronic respiratory disease other than asthma were recruited by primary care physicians and specialists from 24 countries across five continents. Number of participants: a total of 8351 participants were included in this study

Used ≥ 3 SABA canisters per year

21.5% (12 months prior to the study visit)

Not stated

Mild asthma patients preferred to purchase SABA over-the-counter than moderate-to-severe asthma (24.1% vs 18.4%). Among patients with both SABA over-the-counter purchase and prescriptions, most had already been prescribed ≥ three (72.7%) and ≥ 10 (39.1%) canisters

Not stated

[45]

Reddel et al.

Australia

A cross-sectional web-based survey

Not stated

Study targets: participants with current asthma, aged 16 years or older and residing in Australia, were recruited by Survey Sampling International (Melbourne, Australia) with the help of 224,898 panels. Number of participants: a total of 2686 participants were included in this study.

Not stated

24.3%

Not stated

Participants who only used relievers and purchased them over-the-counter had similar levels of symptom control compared to those who primarily purchased relievers using prescriptions, and there was little difference in urgent healthcare use. However, individuals who purchased their relievers over-the-counter were less likely to have visited a general practitioner for a non-urgent asthma review (27.0%) when compared to those who primarily used prescription-based relievers (44.0%)

Participants who had a medication concession card were significantly less likely to purchase their relievers over-the-counter compared to those without a concession card (20.8% versus 52.3%). In addition, individuals who only used relievers were more likely to purchase their relievers over-the-counter than those who used preventers

[9]

Marco et al.

Italy

A cross-sectional and retrospective study (SABINA II sub-analysis study)

June and July 2019

Study targets: 

asthma patients who purchased SABA inhalers from retail pharmacies Number of participants: data was collected from 1136 subjects using pop-up surveys across 200 Italian retail pharmacies. 

Used ≥ 2 SABA canisters per year

15%

Not stated

Not stated

Not stated

[46]

Campbell et al.

Australia

A cross-sectional study

1993

Study targets:  asthma patients who purchased SABA inhalers from eight community pharmacies in Adelaide were recruited. Number of participants: a total of 129 participants were included in the study

Not stated

Not stated

Not stated

9% of those who purchased SABA over-the-counter had been admitted to hospitals. 60% of purchasers reported that they have symptoms such as cough, wheeze, or shortness of breath, at least every day or night

Many people do not see much value in visiting a doctor only to obtain a prescription. They often have experiences where the only thing offered during consultations is a script for Ventolin, without any further discussion or review of their condition. Patients have expressed a desire for more information and to have more discussions with their general practitioners. Some people feel that their general practitioners should listen more to their concerns about asthma

Some patients choose to purchase SABA medications over-the-counter due to convenience, such as being too busy or living too far from healthcare settings. For others, visiting a doctor would result in additional charges, acting as another barrier to their decision. Some patients prefer to have personal control over their asthma by using SABA medications, as Ventolin is perceived to be an instantly effective medication for relieving symptoms. This sense of personal control is further facilitated and reinforced by using Ventolin

[47]

Shen et al.

Taiwan

An observational, cross-sectional s (SABINA III sub-analysis study)

June 2019 to December 2019

Study targets: patients who were aged 18 years or older, had a documented diagnosis of asthma, had undergone at least three healthcare provider consultations, had medical records with at least 12 months of data prior to the study visit, were eligible for enrollment, and no other chronic respiratory disease other than asthma. Number of participants: a total of 294 patients who met these criteria and were recruited from eight sites in Taiwan were included in the final analysis

Used ≥ three SABA canisters per year

1.4%

0.7% purchased one to two SABA canisters, 0.7% purchased ≥ three SABA canisters (12 months prior to the study visit)

Not stated

Not stated

[48]

Pedrozo-Pupo et al.

Columbia

An observational, cross-sectional study (SABINA III sub-analysis study)

August 2019 to December 2019

Study targets: patients aged 12 years or older with a documented diagnosis of asthma, who had undergone at least three consultations with a healthcare professionals or practice and had medical records with at least 12 months of data prior to the study visit, and no other chronic respiratory disease other than asthma were enrolled. Number of participants: a total of 250 patients who met these criteria and were recruited from seven medical centers across Columbia were included in the study

Used ≥ 3 SABA canisters per year

17.6%

43.2% purchased ≥ three SABA canisters (12 months prior to the study visit)

Not stated

Not stated

[49]

Modi et al.

India

A multicenter, observational, and cross-sectional study (SABINA III sub-analysis study)

August to December 2019

Study targets: adult and adolescent patients (aged ≥ 12 years) with a documented diagnosis of asthma and ≥ 3 consultations with the same healthcare practitioners during the 12 months preceding the study visit were included in the study. Number of participants: a total of 510 patients were included from 12 sites of India

Used ≥ 3 SABA canisters per year

8.0%

Among the 41 patients who purchased SABA over-the-counter, 38.9% (n = 16) had purchased ≥ three canisters in the 12 months preceding the study visit

Not stated

Not stated

[50]

Khattab et al.

Africa (Egypt, South Africa, and Kenya

A cross-sectional, multi-country, multi-center observational study (SABINA III sub-study)

Not stated

Study targets: patients aged ≥ 12 years, with a documented physician diagnosis of asthma in their medical records, ≥ 3 prior consultations with their healthcare professionals, and medical records containing data for ≥ 12 months before the study visit. Number of participants: a total of 1778 patients were included in the final analysis (49%, 28.2% and 22.8% of patients were recruited in Egypt, South Africa, and Kenya, respectively. Data of African cohort were exported using electronic case report forms

Used ≥ 3 SABA canisters per year

32.6%

51.8% and 6.0% purchased ≥ three and ≥ 10 SABA canisters, respectively (12 months prior to the study visit)

Of patients with both SABA over-the-counter purchase and SABA prescriptions, 71.9% had received prescriptions for ≥ three SABA canisters and 40.1% had received prescriptions for ≥ 10 SABA canisters in the previous 12 months. A higher proportion of patients treated in primary care had SABA over-the-counter purchases compared to those treated in specialist care (36.8 vs 29.6%)

Not stated