Availability, cost, and affordability of asthma and chronic obstructive pulmonary disease medications in The Gambia

INTRODUCTION

Asthma and chronic obstructive pulmonary disease (COPD) are leading causes of morbidity and mortality globally with a large proportion of deaths occurring in low- and middle-income (LMICs) like The Gambia.^[1-7] Global asthma mortality is estimated at 250,000 deaths annually, while COPD-related mortality is estimated 18/100,000.^[8-10]

Although population prevalence estimates are lacking in Gambia, in 2016, asthma was the third leading cause of outpatient visits and the sixth leading cause of death at public health facilities in the Gambian Health Service.^[8,11] Recent studies in Nigeria estimate the prevalence of asthma and COPD at 6.4% and 7%, respectively;^[12] and both conditions account for between 25% and 82% of patients seen at some specialist clinics in Burkina Faso and Senegal.^[13,14] Treatment of both diseases remains a challenge in the region with between 70% and 90% of asthma patients having poor symptom control.^[13-16] Accurate diagnosis is also limited due to a lack of pulmonologists, absence of spirometry, peak expiratory flow (PEF) meters, and a lack of context appropriate evidence-based treatment guidelines.^[17-19]

Data on asthma and COPD medication availability and affordability in Sub-Saharan Africa are sparse, however, two recent studies in Nigeria and Uganda highlight important gaps in access.^[2,12] Out of 128 pharmacies surveyed across a wide geographic area in Nigeria, inhaled corticosteroids (ICSs) were unavailable at any of the surveyed public pharmacies, with other guideline recommended medications including long-acting muscarinic antagonist (LAMA), and ICS – combination inhalers failing to meet an availability threshold of 80%.^[12] Similarly, in Uganda, a nationwide random survey of 130 facilities including a mixture of public and private hospitals and pharmacies found a low availability of asthma and COPD medicines and diagnostic tests.^[2] In both studies, public hospitals had lower availability than private pharmacies.

In The Gambia, national treatment guidelines published in 2017 recommend Salbutamol for the treatment of mild asthma; while Salbutamol, Prednisolone, and intravenous Aminophylline are recommended as first-line treatments for acute asthma exacerbations. The guidelines make no recommendation for ICS-based maintenance therapy for asthma; while for COPD, smoking cessation and antibiotic treatment with Amoxicillin and Erythromycin are the only treatment recommendations.^[20]

While smoking cessation and vaccination are important in disease management, pharmacotherapy using a symptom-driven stepwise approach is the mainstay of treatment.^[21,22] This is important because treatment guidelines for both asthma and COPD have undergone significant changes recently.^[23-25] ICSs either alone or in combination with a long-acting beta2-agonist (LABA) are now the first-line treatment for asthma, while short-acting beta2 agonist (SABA) is reserved for rescue therapy.^[23] Updated COPD treatment guidelines also recommend LAMA alone or in combination with LABAs as first-line therapy, while triple therapy (LAMA/LABA/ICS) is reserved for patients with an eosinophilic phenotype or in some patients with advanced disease.^[22]

These changes have significant implications for countries like The Gambia where the burden or respiratory diseases are high, resources are limited, and the government is expanding access to healthcare in a bid to achieve universal health coverage.^[26] The World Health Organization (WHO) has prioritized the prevention and control of chronic respiratory diseases including asthma and COPD as part of a Global Action Plan with a specific aim of achieving a threshold access of 80% to essential medicines by 2025.^[27] Achieving this objective across Sub-Sahara Africa will require contemporary data on availability, cost, and affordability of medicines to design and implement evidence-based pragmatic treatment guidelines as a cost-effective way of improving patient outcomes.^[28,29] Access as measured by availability and affordability is an established benchmark for developing health priorities in countries like The Gambia.^[30]

In this study, we report findings on the availability, cost, and affordability of asthma and COPD medications in The Gambia.

MATERIALS AND METHODS

RESULTS

All 18 pharmacists listed on the PCG register were sent an electronic or printed copy of the questionnaire. There were responses from eight pharmacists, resulting in a response rate of 44%. The respondents who completed the questionnaire were responsible for stocking 19 of the 26 registered pharmacies in the country.

DISCUSSION

To the best of our knowledge, this is the first study that looked at the availability, cost, and affordability of medicines for asthma and COPD in The Gambia. Key findings of this survey are that Salbutamol and low-dose beclometasone 50 mcg are available in the CMS responsible for national procurement for public health facilities, while high-dose ICS inhalers, combination of ICS/LABA, LAMA, and LAMA/ LABA inhalers are neither available nor affordable both in the public and private sector. Medications that are not available at government health facilities must be purchased out of pocket by patients at private pharmacies, putting it out of the reach of most Gambians.

Our findings are similar to those of a multinational drug pricing survey including 52 LMICs (excluding The Gambia) by Babar et al.^[37] In that survey, beclometasone 100 mcg inhaler was available in 41% of private pharmacies and 17% of national procurement centers. Using the same affordability criteria employed in the present study, Babar et al. found that affordability of a single beclometasone 100 mcg inhaler ranged from 0.5 days’ to 14 days’ wages. In the present study, however, the lower dose formulation (beclometasone 50 mcg) was available at the national procurement facility (CMS) and at one private pharmacy, at an unaffordable cost of 15 days’ wages. Similarly, Babar et al. reported a Budesonide 200 mcg affordability of 0.5–107 days’ wages, while the present survey reports a Budesonide 100 mcg inhaler affordability of 28 days’ wages.

In Uganda, Kibirige et al. reported similar SABA monotherapy availability to the present study (75%), but significantly higher availability for ICS monotherapy, ICS/ LABA, and oral LTRA (45.4%, 46.9%, and 60.8%, respectively, compared to 13% for each drug class in the current study).^[2] Fixed-dose combination ICS/LABA inhaler affordability data were not reported in the study by Babar et al., however, in Uganda, Kibirige et al. reported affordability ranging from 6.4 days’ to 17.1 days’ wages compared to 26 day’s wages in the present study.

The unavailability and prohibitive cost of ICS and ICS/LABA containing inhalers in The Gambia can be attributed to several factors. First, the Gambian SDTGs do not emphasize the primary role of ICS (either alone or as a fixed-dose combination with a LABA) as the first-line treatment for asthma. The same holds true for COPD, where LAMA inhalers (alone or combination with a LABA) are not in the treatment guidelines. Failure to include these medications in treatment guidelines leads to their absence on the EML at the Ministry of Health, resulting in their exclusion in procurement by government at the national level. Private pharmacies do not stock maintenance inhalers in part because they are not regularly prescribed by clinicians (personal communication), indicating a knowledge gap among providers in the health system who have a preference for oral Salbutamol over ICS-containing maintenance inhalers.^[38] A similar knowledge gap in guideline concordant management was reported by among Nigerian physicians, where a majority of surveyed doctors were not familiar with guideline recommended use of ICS in the management of asthma.^[18,19,39] Fawibe et al. also reported a low level of awareness among general practitioners across several states in Nigeria, with only 16.4% of being able to correctly state guideline consistent asthma treatment.^[40]

Another important factor is an inefficient supply chain for the delivery of medications from the CMS to government health facilities at the periphery. Even when medications are available at the CMS, delivery to, and storage at health facilities can be challenging. The lack of updated evidence-based guidelines is not unique to The Gambia. A recent systematic review of national COPD guidelines found that 30% of people residing in LMICs did not have guidelines and where guidelines were available, they were targeted to fewer healthcare professional groups, and less often addressed important aspects of diagnosis, comorbidity management, and smoking cessation.^[19,40,41]

Medications for the management of acute exacerbations of asthma and COPD are generally available and affordable. This is to a large extent attributable to their inclusion in both the SDTGs and EML. Long-term macrolide therapy has been shown to reduce the risk of exacerbations in high-risk patients and it is also recommended for the management of acute exacerbations.^[21-25] One agent in this drug class – erythromycin was widely available, affordable and recommended in the SDTG for the management of acute exacerbations.

PEF meters were unavailable at the CMS and only one private pharmacy had this device at an unaffordable cost of 27 days’ wages. Similarly, spacers were not available at the CMS, and the cost at private pharmacies was unaffordable. Patients use improvised spacers made from plastic bottles (personal communication).

The low availability of asthma and COPD medications is indicative of a series of challenges in the health system. As stated earlier, there are currently no trained specialists in pulmonology, and medical officers may not be familiar with the updated treatment guidelines. The SDTG is also outdated as it does not stipulate the primary role of maintenance (preventative) inhalers in the treatment of asthma and COPD. The local guidelines, however, include the recommendation for the use of aminophylline for the treatment of acute asthma exacerbation, in contravention with Global Initiative for Asthma (GINA) guidelines. This has also been reported in other parts of West Africa where more than half of physicians surveyed (59.4%) considered aminophylline as the first-line medication in exacerbation.^[19] The consequences of the aforementioned deficiencies in patient care among patients with asthma and COPD in The Gambia include poor quality of life, frequent acute pulmonary exacerbations, an over reliance on SABA, long-term use of corticosteroids, and increased mortality.

Improving asthma and COPD outcomes in The Gambia can be achieved through a multifaceted approach. First, the national SDTG needs to be updated to reflect current evidence, especially in regard to the use of ICS as the mainstay for asthma management, and LAMA (either alone or in combination with long acting beta agonists) for preventative disease management in COPD. Updated GINA asthma guidelines also provide an opportunity to improve asthma treatment with the advent of single maintenance and reliever therapy, a simplified regimen in which an ICS (alone or in combination with a LABA) is used simultaneously as both a maintenance and rescue inhaler. This approach is simpler compared to prior recommendations where patients are required to use two inhalers.^[42,43] The prohibitive cost of preventative inhalers can be mitigated by government funded procurement through the Asthma Drug Facility, a project of the International Union Against Tuberculosis and Lung Disease (The Union), which helps LMICs obtain quality-assured essential medicines at affordable prices.^[44]

Second, there is an urgent need to train pulmonary specialists as The Gambia currently has no pulmonologists. Medical officers and other clinicians can be trained on the correct diagnosis and management of asthma and COPD, emphasizing the central role of spirometry and PEF measurements as required diagnostic and monitoring tests. Although some progress has been made in Gambia with spirometry training of health care workers at KGH, more training targeting health care workers at primary health facilities are needed as most patients will initially present at such facilities. Doing so will facilitate referrals to dedicated chest clinics for evaluation of such patients. The cost of single-use mouth pieces is a significant barrier to making spirometry widely available as to the best of our knowledge; this is not subsidized for LMICs. An alternative and more environmentally friendly approach is the manufacture of reusable mouth pieces as most spirometers on the market today have plastic single-use mouth pieces. Standardization of asthma management can be achieved by adopting a Practical Approach to Lung Health which is a primary health-care strategy for the integrated management of respiratory conditions developed by the WHO and has been pilot tested in four West African countries with positive outcomes demonstrating feasibility, cost-effectiveness, and a reduction in asthma severity in patients after implementation of this program.^[45,46]

Third, disease monitoring and data capture of patients with asthma and COPD will enable the study of the epidemiology and clinical outcomes of patients with these diseases, leading to a better understanding of the true burden of respiratory illnesses in the country.

This study has several limitations. First, the response rate was low, among pharmacists surveyed, and drug stock records were not assessed to confirm availability of drugs reported by the pharmacists surveyed; however, because most medications were unavailable, it is less likely that respondents will report that a medication is absent when it is actually stocked. Second, availability is relevant to the day on which each facility was surveyed, without accounting for stockouts. Third, using the calculated daily wage of the lowest paid government civil servant will result in an overestimation of affordability as more than 70% of the Gambian population is employed in the informal sector and earn less than government civil servants. These limitations notwithstanding, this study employed similar validated methods used in other countries in Sub-Saharan Africa which can facilitate cross-country comparisons across the region. Finally, we did not survey the UK – Medical Research Council Clinical Services department which offers free health care to many Gambians.

CONCLUSION

This survey found that medications for the management of asthma and COPD in The Gambia are unavailable, expensive, and unaffordable, due to outdated standard treatment guidelines, absence of maintenance ICS and LAMA/LABA inhalers on the EML. Recent updates in asthma and COPD treatment guidelines provide a unique opportunity to improve patient outcomes through a simplified treatment regime.