Remember me
ORIGINAL ARTICLE
Year : 2022 | Volume
: 13
| Issue : 5 | Page : 68-72
Inventory of insulin access in Tunisia, IDF-MENA Region
Mouna Elleuch1, Fatma Mnif2, Jackie Kassouf Malouf3, Mohamed Benlassoued4, Mesbah Sayed Kamel5, Mohamed Abid2
1 Department of Endocrinology, Hedi Chaker Hospital, Sfax, Tunisia; DiaLeb, Sfax, Tunisia
2 Department of Endocrinology, Hedi Chaker Hospital, Sfax, Tunisia; AEDS, Sfax, Tunisia
3 DiaLeb, Sfax, Tunisia
4 AEDS, Sfax, Tunisia
5 Department of Internal Medicine, Minia University, Minia, Egypt
Correspondence Address:
Prof. Fatma Mnif
Department of Endocrinology, Hedi Chaker Hospital, 3029 Sfax
Tunisia
Source of Support: None, Conflict of Interest: None
DOI: 10.4103/jod.jod_113_22
The prevalence of diabetes is rising faster in low- and middle-income countries. In IDF-Middle East and North Africa (MENA), one in six adults (73 million) are living with diabetes, and the number of adults with diabetes is expected to reach 95 million by 2030 and 136 million by 2045. Tunisia, a part of the IDF-MENA Region, is burdened with diabetes that is responsible for substantial morbidity and mortality, as well as considerable healthcare expenditure. The prevalence of type 2 diabetes has increased from 3.8% in 1976 to 18.2% in 2019. It is higher in men. In 2016, distribution by type of treatment analyzed that 22.1% of treated people with diabetes (PWD) were on insulin and 9% were on insulin and oral antidiabetic drugs (OADs). This study confirmed that 27.4% have had good control of diabetes. PWD receiving insulin do not have good control of diabetes as compared to PWD treated on oral antidiabetic drugs. The government controls all medicines pricing including insulin. The prescription of insulin depends on the organization of care. The patients can receive their treatment of diabetes either in the primary healthcare or in the hospital. Therefore, access to insulin is provided, for patients, in both rural and urban areas and in the public and private sectors. Additional challenges to insulin administration include the fact that some health professionals do not know how to use insulin analogs as they were training only on human insulins. Therefore, in Tunisia many efforts are needed to improve the prescription and the accessibility of insulin.
Keywords: Diabetes, insulin prescription, insulins, Tunisian pharmaceutical system
Diabetes is spiraling out of control. The International Diabetes Federation (IDF) reports in 2021 that 537 million of adults are living with diabetes.[1] Prevalence is now rising faster in low- and middle-income countries (LMICs) than in high-income countries. In the Middle East and North Africa (MENA), one in six adults (73 million) is living with diabetes, and the number of adults with diabetes is expected to reach 95 million by 2030 and 136 million by 2045.[1] To take care of diabetes, several medicines and diagnostic tools are needed, including insulin itself. For type 1 diabetes, the treatment requires multiple daily injections of insulin and multiple checks of blood glucose using invasive finger-prick sampling and continuous glucose monitoring. However, for type 2 diabetes mellitus (T2DM), treatment can initially be based on oral antidiabetics. Nevertheless, because of therapeutic inertia and the progressive nature of the disease, many people with T2DM need at least a basal insulin supplementation. In these cases, insulin analogs are the best choice as they become more suitable.[2] Achieving glycemic control and controlling cardiovascular risk factors have been conclusively shown to reduce diabetes complications. To accomplish these desired outcomes, many classes of medications and many formulations of insulin effectively manage the metabolic abnormalities of people with diabetes (PWD).[3] Nonetheless, the affordability of medications in general, and for insulin specifically, is currently of great concern to PWD, their families, insurers, and employers. This is because over three in four PWD live in middle- and low-income countries.[1] Given that 2021 marks the centenary of the discovery of insulin, it is necessary to ensure that the benefits of insulin reach to PWD all over the world. Tunisia, a part of MENA Region, is burdened with diabetes that is responsible for substantial morbidity and mortality, as well as considerable healthcare expenditure.
Prevalence of diabetes in the Tunisian populationThe Tunisian Association on Study and Research on Atherosclerosis (ATERA) and the International Atherosclerosis Society (IAS) conducted the first large national study, the ATERA-Survey between January 2016 and February 2019.[4] It was a cross-sectional, descriptive, and analytical study of Tunisians aged 25–75 years. The survey involved 11,955 individuals. The average age was 55 years. The prevalence of risk factors was hypertension (50. 5%), diabetes (18. 2%), and dyslipidemia (44%). The prevalence of T2DM has increased from 3.8% in 1976 to 18.2% in 2019. Burden of diabetes is multiplied by five times in 40 years[5][Figure 1]. This situation is explained by the modernization and change in lifestyle of Tunisians. They no longer follow the Mediterranean diet but consume more and more fast food. In addition, they have become more sedentary.
Characteristics of Patients Living with Diabetes in TunisiaTunisian Health Examination Survey 2016 showed that the prevalence of diabetes was higher in men. It increased significantly with age [Figure 2].[6] In fact, 84.5% of people living with diabetes (PLWD) reported being followed by a physician. The percentage was higher among women (89.1%) than men (79.2%). In Tunisian Health Examination Survey-2016 (THES-2016), distribution by type of treatment analyzed that 22.1% of treated PWD were on insulin and 9% were on insulin and OADs [Figure 3] and [Figure 4].
Figure 2: Distribution of the prevalence of diabetes according to age and gender
Figure 4: Distribution of the proportion of diabetes according to genderThis study confirmed that 27.4% have had good control of diabetes regardless of the treatment received. However, no significant differences were found in diabetes due to socioeconomic status. It was noted that 39.9% of PLWD were doing self-monitoring of blood glucose. This prevalence was higher in urban areas.
PLWD in TunisiaSeveral studies noted that the majority of patients had hemoglobin A1c (HbA1c) > 8%. Indeed, less than 25% of people with T2DM achieved the objectives of treatment with an HbA1c <7% (24.1%, 22.6%, and 22.4% in waves 1, 2, and 3, respectively). PWD receiving insulin were more frequently not controlled compared to those treated with OADs. In addition, only few PWD were treated by multiple injections with basal insulin and rapid insulin.[7] To better describe the characteristics of diabetes management in Tunisia and particularly insulin therapy, the International Diabetes Management Practices Study (IDMPS study) was conducted. The aim of this observational study was to assess the intensification of insulin therapy in patients with T2DM, uncontrolled on basal insulin or on mixed insulins. Overall 22 study centers were included between June 2015 and December 2015 with a total of 413 people with T2DM. Approximately 20 consecutive patients were included per center. The sociodemographic and clinical characteristics baseline of the study population is reported in [Table 1] with a summary of the biological parameters in the 3 months before the visit in [Table 2].
Table 1: Sociodemographic and clinical characteristics baseline of the study populationWith reference to previous insulin therapy, basal insulin was the most frequently prescribed for insulin intensification (75.3% [confidence interval, CI 95%: 71.1%–79.5%]), followed by premix insulin (10.2% [CI95%: 7.2%–13.1%]), then basal-bolus regimen (9.0% [CI95%: 6.2%–11.7%]) and basal plus (5.6% [CI95%: 3.3%–7.8%]).
An in-depth analysis to identify various strategies of insulin intensification showed that there was another important modality, including 142 patients (34.5% of total patients), without a change of initial insulin regimen and continuing with the same doses. Among these patients, 50.7% were treated previously with basal insulin, 30.2% with basal plus or basal-bolus, and 19.0% with premix insulin.
Regarding insulin intensification, 16.5% [CI95%: 12.9%–20.1%] received basal plus at the end of clinical consultation, 31.0% [CI95%: 26.5%–35.5%] basal bolus regimen, 42.6% [CI95%: 37.8%–47.4%] basal insulin, and only 9.9% [CI95%: 7.0%–12.8%] received premix insulin at the last visit. According to the previous insulin regimen, patients who previously used basal insulin regimen, more than 50% (54.1%) continued with the same regimen, and 42.7% were switched to basal plus or basal bolus. With regard to the patients who were previously under a premix insulin regimen, most of them (73.8%) were kept under the same regimen, and 19.2% were switched to basal plus or basal-bolus regimen [Table 3].
Table 3: Insulin regimen at the last clinical consultation according to the previous regimenFactors associated with intensification of insulin
Sociodemographic factors
On univariate analyses, the absence of intensification of insulin was significantly more common among patients with a university educational level (P = 0.01) and patients with a very satisfactory socioeconomic level (P < 0.001). However, no significant association was observed with gender, age, marital status, social security coverage, and area of residence.
Diabetes and insulin initiation durations
The absence of intensification of insulin was significantly more frequent in people whose insulin initiation started over 3 years ago (P < 0.001).
Personal history
The absence of intensification of insulin was significantly more frequent in PLWD with a personal history of hypertension (P = 0.03); in fact, the absence of intensification of insulin was often substantially higher (P = 0.04) among patients with treated hypertension (36.3%) or without hypertension (35.3%) in comparison to those with no treated hypertension (26.9%).
Observance of lifestyle, oral antidiabetic drugs, and insulin regimen
No significant association was observed regarding hygiene and insulin regimen rules (P = 0.29).
Clinical characteristics
No significant association was observed with patients’ clinical characteristics.
Availability and Accessibility to Medicinal Products in TunisiaThe Tunisian pharmaceutical sector is characterized by a strong public sector that has been actively developed by the state since 1960. The private sector is also active. It has always been, through the network of pharmacies, the main drug’s distribution sector.
Procurement
Imports: the role of the central purchasing body for Tunisian Central Pharmacy (TCP) for imported medicines has been endorsed by law, which has re-defined the legal characteristics of the TCP and its missions.
Local production: less than 8% of consumption was covered by local manufacturing in 1960. In 1990, the Tunisian pharmaceutical industry had 27 production units almost exclusively private capital with a coverage rate of 44%.[8]All types of medicines are exclusively imported and primarily regulated in Tunisia by the TCP for the last 40 years. This facility has gained knowledge of the global asset for the Tunisian pharmaceutical system.
Reimbursement of insulin in Tunisia
For the pricing system of medicines, a different action plan was adopted in LMICfor both the healthcare system and individuals.[9] In Tunisia, the government encourages the uptake of generic products and invites tenders at different levels of the health system. In fact, prices are not to be fixed by the market, the government controls all medicines pricing. This can result in reducing and controlling the prices of insulin. For example, the price of human insulin is fixed at US$ 2.3 per 10 mL vial of 100 U insulin but the prices of analog insulin range from US$ 27.7 to 47 US$. Evidence is required by the government for analogs to be considered as an essential medicine to treat diabetes and to reduce its cost.
In Tunisia,, the government-funded and insurance schemes provide some form of financial compensation and support, either ensuring that insulin is provided for free to the individual or, at least, that the person does not bear the full cost.
Insulin prescription
The prescription of insulin depends on the organization of care. The patients can receive their treatment for diabetes either in the primary healthcare or in the hospital. In Tunisia, the initiation of insulin therapy is usually decided by the specialists. But both the general practitioners and the specialists are able to prescribe insulin in the follow-up. Therefore, access to insulin is provided, for patients, in both rural and urban areas and in the public and private sectors. Additional challenges to insulin administration include the fact that some health professionals do not know how to use insulin analogs as they had their training only on human insulins.[10],[11],[12] They should be educated that Insulin Analogues can be made available for PLWD who may have a lot of glycemic fluctuations.
Provision
In Tunisia insulin is available in primary, secondary, and tertiary healthcare. Analog insulin is available only in private pharmacies where it is more expensive. Poor availability of analog insulin is not found only in the public and private sectors, but also at different levels of the healthcare system (the hospitals and the primary healthcare facilities). In Tunisia, patients, living with diabetes, do not have a problem with large distances between communities and health facilities that provide diabetes care with respect to human insulin but not the analog.
ConclusionThe use of insulin has increased worldwide, due to the increase in diabetes prevalence.[13],[14] Thus, it is rising faster in LMICs than in high-income countries. In many countries, people, living with diabetes, are not getting the treatment they need. A combination of factors, including high prices, challenging storage requirements, and complex treatment protocols, all contribute to preventing access. In Tunisia, access to human insulin seems to be well and possible for almost all PLWD. However, insulin analog is still too expensive and not available for all patients.
Financial support and sponsorship
Not applicable.
Conflicts of interest
There are no conflicts of interest.
References
Comments (0)