Enhancing insulin supply chain resilience: A critical importance for diabetes management

Diabetes, a chronic metabolic disorder affecting millions worldwide, relies heavily on a stable and efficient supply chain for insulin, a life-saving hormone. However, the insulin supply chain faces multifaceted challenges that can disrupt access to this essential medication. In the realm of diabetes management, a novel and devastating occurrence has emerged—a severe shortage of insulin. This case report revolves around a singular clinical encounter that showcases a series of remarkable and uncommon aspects, which can enrich the knowledge of healthcare professionals. The patient’s condition presented several unique features, providing a learning opportunity that transcends the typical clinical scenarios seen in diabetes management. The findings surrounding the unavailability of insulin, the dire consequences it has on patients, and the clinical course and prognosis of an individual patient closely related to previous challenges. The shortage of insulin, though not a new challenge, has now reached unparalleled levels, resulting in life-threatening situations for those dependent on this vital hormone. This case report delves into a unique scenario where an individual patient’s health dramatically deteriorated due to the insulin scarcity, highlighting the urgency for comprehensive solutions and international cooperation to ensure access to this life-saving medication. This case report manuscript reviews the importance of enhancing the resistance and resilience of the insulin supply chain to ensure uninterrupted access to insulin for people with diabetes. We discuss the current challenges, their impact on diabetes management, and propose strategies to mitigate these issues. Strengthening the insulin supply chain is essential for the well-being of those living with diabetes, highlighting its significance for healthcare systems globally.

Introduction

Diabetes mellitus is a chronic metabolic condition characterized by impaired glucose metabolism, leading to elevated blood sugar levels. It is a global health concern, affecting over 463 million people worldwide as of 2019, with projections estimating an increase to 700 million by 2045 [1]. The management of diabetes often involves lifestyle modifications, oral medications, and, in more advanced cases, insulin therapy [2].

Insulin is a hormone produced by the pancreas that regulates blood sugar levels. For individuals with type 1 diabetes and some with type 2 diabetes, insulin therapy is a vital component of their treatment. Timely and uninterrupted access to insulin is crucial for maintaining glycemic control and preventing complications such as kidney disease, neuropathy, and cardiovascular problems [3].

Despite the life-saving importance of insulin, its supply chain faces numerous challenges that threaten its reliability. This case report manuscript aims to highlight the critical significance of enhancing the resistance and resilience of the insulin supply chain. We will examine the current challenges and propose strategies to ensure that people with diabetes have consistent access to this essential medication [4].

Current challenges in the insulin supply chain

The insulin supply chain is a multifaceted network that involves numerous interconnected phases, encompassing manufacturers, distributors, pharmacies, and healthcare providers. Each stage plays a crucial role in ensuring the smooth flow of insulin from production to the patient’s hands. However, the challenges faced by the insulin supply chain are not isolated to a single phase; they reverberate throughout the entire network, potentially causing significant disruptions in the availability of this life-saving medication [5].

This intricate chain is susceptible to many obstacles and issues with widespread implications. These challenges extend across various phases, beginning with insulin production, where a limited number of manufacturers globally produce most of the world’s insulin. Any disruption in their production processes, whether due to manufacturing issues, supply shortages, or geopolitical tensions, can swiftly cascade downstream, affecting millions worldwide who rely on insulin to manage their diabetes.

Moving along the chain, insulin pricing, which has drawn significant attention in various countries, including the United States, is yet another challenge that extends across the entire supply network. Spiraling insulin costs and affordability concerns have ramifications at each stage of the chain, from distributors to pharmacies to the patients themselves. This issue may lead individuals to face the heart-wrenching dilemma of choosing between purchasing insulin and meeting other basic needs.

Furthermore, the insulin supply chain is intricately linked to transportation and distribution, posing challenges. Insulin, a temperature-sensitive medication, necessitates strict adherence to the cold chain to maintain its efficacy. Nevertheless, inadequate infrastructure or breakdowns in the cold chain can cause temperature excursions that render insulin ineffective [6]. This issue becomes especially acute in regions with limited access to reliable refrigeration facilities, potentially affecting insulin quality and availability. Several factors contribute to the vulnerability of this chain, potentially disrupting insulin availability:

Supply chain fragility: The global insulin supply chain relies heavily on a small number of manufacturers, making it susceptible to manufacturing issues, supply shortages, and geopolitical tensions. A limited number of companies produce the majority of the world’s insulin, with three major manufacturers dominating the market [2]. Any disruption in their production processes can lead to shortages that affect millions of people worldwide [7].

Price fluctuations: The cost of insulin has been a contentious issue in many countries. In the United States, for example, the price of insulin has skyrocketed in recent years, leading to situations where individuals must choose between purchasing insulin and meeting other basic needs [8]. Price fluctuations and affordability concerns can create barriers to access and disrupt the supply chain [1].

Transportation and distribution challenges: Insulin is a temperature-sensitive medication, and maintaining the cold chain during transportation and distribution is critical to its efficacy. However, inadequate infrastructure or failures in the cold chain can result in temperature excursions that render insulin ineffective [9]. This issue is particularly acute in regions with limited access to reliable refrigeration.

Regulatory hurdles: Regulatory requirements and barriers can delay the introduction of new insulin products or generic alternatives, limiting competition and potentially increasing costs [10]. These hurdles can also impact the diversity of insulin formulations available, which is essential for addressing individual patient needs.

Geopolitical factors: Geopolitical tensions and trade disputes can disrupt the international flow of insulin and related supplies. Restrictions on exports, tariffs, or embargoes can affect the availability of insulin in specific regions, leaving people with diabetes in those areas vulnerable to shortages [5].

Emergency preparedless: Natural disasters, pandemics, or other emergencies can disrupt the insulin supply chain, leaving people with diabetes in a precarious situation [5]. Adequate emergency preparedness and contingency plans are essential to ensure that insulin remains accessible during times of crisis.

Figure 1 below depicts visual representations of the challenges in the insulin supply chain.

Figure 1: Insulin supply chain challenges.

Impact on diabetes management

The challenges in the insulin supply chain have a direct and profound impact on the management of diabetes:

Health complications: Inadequate access to insulin can lead to uncontrolled blood sugar levels, resulting in serious health complications. Individuals who cannot consistently obtain insulin may experience diabetic ketoacidos (DKA), a life-threatening condition characterized by dangerously high blood sugar levels and acid buildup in the body [1].

Economic burden: High insulin prices and supply shortages can impose a significant financial burden on individuals with diabetes and healthcare systems. The cost of treating diabetes-related complications, which often result from inadequate insulin access, places additional strain on healthcare resources [11].

Reduced quality of life: Diabetes management is a lifelong endeavor, and insulin is a fundamental tool in achieving good glycemic control. The fear of running out of insulin or facing financial hardships to obtain it can lead to anxiety, stress, and a reduced quality of life for those living with diabetes [12].

Strategies to enhance insulin supply chain resilience

To address the challenges faced by the insulin supply chain and ensure consistent access to insulin, several strategies can be implemented:

Diversification of manufacturers: Encouraging the development of new insulin manufacturing facilities and promoting competition in the market can reduce the vulnerability associated with a limited number of manufacturers [13]. Governments and regulatory agencies should support initiatives to expand the pool of insulin producers.

Price regulation and transparency: Price regulation and transparency measures can help control the cost of insulin and prevent price gouging. Legislation to limit price increases and ensure clear pricing information can enhance affordability and accessibility [14].

Improved transportation and distribution: Investing in infrastructure and technology to maintain the cold chain during insulin transportation and distribution is essential. This includes developing reliable refrigeration systems and monitoring mechanisms to track temperature-sensitive shipments [15].

Streamlined regulatory processes: Streamlining regulatory processes for insulin and related products can expedite the introduction of new formulations and generic alternatives [16]. This can increase competition and provide more options for individuals with diabetes.

International collaboration: International collaboration and agreements can help mitigate the impact of geopolitical tensions on the insulin supply chain. Diplomatic efforts to ensure the free flow of insulin and related supplies across borders are crucial [17].

Emergency preparedness: Healthcare systems and governments should develop and maintain emergency preparedness plans specifically tailored to the insulin supply chain. These plans should ensure that insulin remains accessible during emergencies or crises [18].

Figure 2 illustrates how a framework for enhancing insulin supply chain resilience combines the challenges and proposed strategies.

Figure 2: Proposed strategies for enhancing insulin supply chain resilience.

Case report

Background: Access to insulin, a life-saving hormone, is essential for individuals with diabetes mellitus. However, in some regions, challenges related to sanctions, insulin scarcity, and high prices have resulted in life-threatening situations for patients. This case report highlights one such instance where a patient with diabetes mellitus faced dire consequences due to limited insulin access, shedding light on the importance of addressing these issues.

Case presentation: A 55-year-old male patient with a long-standing history of type 2 diabetes mellitus presented to our clinic in a state of severe diabetic ketoacidosis (DKA). The patient, who had been managing his diabetes well for several years, described a series of events that led to his critical condition. His critical job had recently relocated him to an area subject to international sanctions, which disrupted the import of medical supplies, including insulin. As a result, the price of available insulin skyrocketed, making it unaffordable for many.

With limited access to insulin, the patient resorted to rationing his remaining insulin supplies, often skipping doses to make them last longer. Consequently, his blood glucose levels soared, and he began experiencing classical symptoms of DKA, including polyuria, polydipsia, weakness, and nausea. The patient’s wife, alarmed by his deteriorating condition, sought assistance from local healthcare providers, who were also struggling with insulin shortages. The lack of available insulin at affordable prices left them with few options for treatment.

Clinical assessment: Upon presentation, the patient exhibited profound dehydration, tachycardia, and Kussmaul breathing. Laboratory results confirmed severe hyperglycemia, metabolic acidosis, and ketonuria, consistent with the diagnosis of DKA. His HbA1c, previously well-controlled, had spiked to alarming levels. The absence of adequate insulin administration had precipitated this life-threatening condition.

Management and outcome: The patient was immediately admitted to our facility, and treatment for DKA was initiated, including aggressive hydration, insulin infusion, and electrolyte correction. Given the scarcity of insulin, we faced challenges in ensuring a consistent supply of this essential medication. Collaborating with international aid organizations and diabetes associations, we were able to procure a limited amount of insulin for the patient, but the long-term outlook remained precarious.

Throughout his hospital stay, the patient and his family received education on diabetes management, insulin administration, and lifestyle modifications. Social workers also explored options for financial assistance and advocacy for improved insulin access in the region.

Discussion

This case report underscores the devastating impact of sanctions, insulin scarcity, and high prices on individuals with diabetes mellitus. While diabetes management had been successful for the patient in the past, the sudden disruption of insulin availability threatened his life. The case highlights the urgent need for international cooperation and humanitarian efforts to ensure that essential medications, particularly insulin, remain accessible to those in need, irrespective of geopolitical factors.

Author’s perspective

The preceding sections have provided a comprehensive overview of the challenges and consequences associated with the insulin supply chain, but it is crucial to acknowledge the author’s perspective. As a healthcare provider and advocate for individuals with diabetes, the author approaches the multifaceted challenges and their impact on patients. The author believes that the challenges in the insulin supply chain are far-reaching. Due to insulin unavailability, patients who have diligently managed their diabetes suddenly face life-threatening situations. The author emphasizes the urgency and moral obligation to address this issue on a global scale.

Firstly, the author recognizes that the resilience and reliability of the insulin supply chain are fundamental to providing the best care for patients with diabetes. Every patient should have continuous access to insulin, free from disruptions due to geopolitical tensions, supply chain fragility, or price fluctuations. The author believes that governments, pharmaceutical companies, and healthcare organizations should unite to secure the supply chain and prevent the dire consequences that patients may encounter.

Secondly, the author believes in the importance of regulation and transparency in pricing. Affordable and accessible insulin is not just a matter of convenience; it’s a matter of life and death for patients with diabetes. The author advocates for comprehensive price regulation measures that ensure insulin remains affordable, and pricing information is transparent, enabling patients to make informed decisions about their healthcare.

Furthermore, the author stresses the significance of international collaboration. Geopolitical factors should never be a barrier to the availability of essential medications. Diplomatic efforts to ensure the free flow of insulin and related supplies across borders are crucial. The author’s perspective emphasizes the need for international cooperation to safeguard patients’ well-being, regardless of their location.

The author acknowledges that these challenges are complex, but the strategies outlined in this report provide a path forward. By diversifying manufacturers, streamlining regulatory processes, and enhancing emergency preparedness, we can strengthen the insulin supply chain and protect patients from dire health consequences. The author’s perspective aligns with the belief that these strategies must be implemented promptly to ensure that no patient ever has to ration or go without insulin, thus ensuring a healthier, more secure future for all individuals with diabetes.

Conclusion

The insulin supply chain plays a pivotal role in diabetes management, offering a lifeline to millions across the globe. Nevertheless, it grapples with a multitude of challenges that can disrupt the availability of insulin, thereby posing significant threats to public health. To ensure uninterrupted access to this life-saving medication, it is of utmost importance to bolster the insulin supply chain’s resistance and resilience. A series of strategic initiatives can be embraced, including diversifying manufacturers, regulating insulin prices, enhancing transportation and distribution mechanisms, streamlining regulatory processes, promoting international cooperation, and fortifying emergency preparedness. Collectively, these strategies are poised to alleviate the hurdles that beset the insulin supply chain.

In regions affected by sanctions, insulin scarcities, and surging prices, individuals grappling with diabetes confront grim consequences, ranging from severe diabetic ketoacidosis (DKA) to deteriorating health. The case serves as an emphatic reminder of the critical need to tackle these challenges. The focus must be on ensuring insulin access for all patients, safeguarding their well-being, and averting life-threatening complications. Therefore, it is imperative for governments, healthcare entities, pharmaceutical companies, and advocacy groups to join forces and collaboratively implement these strategies. Through such concerted efforts, the goal is to secure reliable access to insulin for individuals with diabetes, enabling them to effectively manage their condition, avert complications, and lead healthier lives. Ultimately, the enhanced resilience of the insulin supply chain is not only a healthcare necessity but also a moral and ethical commitment to those reliant on insulin for their survival and overall well-being.

In summary, the author’s perspective reflects a sense of urgency and strong advocacy for a robust, dependable, and resilient insulin supply chain, an absolute lifeline for countless individuals worldwide. Through unified global action, the aspiration is to guarantee that life-saving insulin medication remains accessible, affordable, and consistently available for all those dependent upon it.

The authors wish to acknowledge the support of international aid organizations and diabetes associations in assisting with insulin procurement for the patient in this case.

1. Haji M, Kerbache L, Al-Ansari T. Evaluating the performance of a safe insulin supply chain using the AHP-TOPSIS approach. Processes. 2022 Oct 26; 10(11):2203.
2. Atlas ID. IDF diabetes atlas. International Diabetes Federation (9th edition). Retrieved from http://www. idf. org/about-diabetes/facts-figures. 2019.
3. Beran D, Yudkin JS. Diabetes care in sub-Saharan Africa. Lancet. 2006 Nov 11;368(9548):1689-95. doi: 10.1016/S0140-6736(06)69704-3. PMID: 17098088.
4. American Diabetes Association. Economic Costs of Diabetes in the U.S. in 2017. Diabetes Care. 2018 May;41(5):917-928. doi: 10.2337/dci18-0007. Epub 2018 Mar 22. PMID: 29567642; PMCID: PMC5911784.
5. Haji M, Kerbache L, Sheriff KMM, Al-Ansari T. Critical Success Factors and Traceability Technologies for Establishing a Safe Pharmaceutical Supply Chain. Methods Protoc. 2021 Nov 22;4(4):85. doi: 10.3390/mps4040085. PMID: 34842786; PMCID: PMC8628909.
6. Haji M. Role of Technology in the Performance Measure of Insulin Cold Chains. J Diabetes Treat. 2023; 08: 10116. DOI: https://doi.org/10.29011/2574-7568.010116
7. Gomez M, Garcia S, Rajtmajer S, Grady C, Mejia A. Fragility of a multilayer network of intranational supply chains. Appl Netw Sci. 2020;5(1):71. doi: 10.1007/s41109-020-00310-1. Epub 2020 Sep 23. PMID: 32984501; PMCID: PMC7509503.
8. Wang L, Dai L, Liu H, Dai H, Li X, Ge W. Availability, affordability and price components of insulin products in different-level hospital pharmacies: Evidence from two cross-sectional surveys in Nanjing, China. PLoS One. 2021 Aug 12;16(8):e0255742. doi: 10.1371/journal.pone.0255742. PMID: 34383816; PMCID: PMC8360381.
9. Beran D, Lazo-Porras M, Mba CM, Mbanya JC. A global perspective on the issue of access to insulin. Diabetologia. 2021 May;64(5):954-962. doi: 10.1007/s00125-020-05375-2. Epub 2021 Jan 23. PMID: 33483763; PMCID: PMC8012321.
10. Knox R. Insulin insulated: barriers to competition and affordability in the United States insulin market. J Law Biosci. 2020 Oct 9;7(1):lsaa061. doi: 10.1093/jlb/lsaa061. PMID: 34221426; PMCID: PMC8249113.
11. Bommer C, Sagalova V, Heesemann E, Manne-Goehler J, Atun R, Bärnighausen T, Davies J, Vollmer S. Global Economic Burden of Diabetes in Adults: Projections From 2015 to 2030. Diabetes Care. 2018 May;41(5):963-970. doi: 10.2337/dc17-1962. Epub 2018 Feb 23. PMID: 29475843.
12. Speight J, Holmes-Truscott E, Hendrieckx C, Skovlund S, Cooke D. Assessing the impact of diabetes on quality of life: what have the past 25 years taught us? Diabet Med. 2020 Mar;37(3):483-492. doi: 10.1111/dme.14196. Epub 2020 Feb 4. PMID: 31797443.
13. Shih W. Is it time to rethink globalized supply chains?. MIT Sloan Management Review. 2020 Jul 1;61(4):1-3.
14. Whewell R. Supply chain in the pharmaceutical industry: strategic influences and supply chain responses. CRC Press; 2016 Apr 1.
15. Maikawa CL, Mann JL, Kannan A, Meis CM, Grosskopf AK, Ou BS, Autzen AAA, Fuller GG, Maahs DM, Appel EA. Engineering Insulin Cold Chain Resilience to Improve Global Access. Biomacromolecules. 2021 Aug 9;22(8):3386-3395. doi: 10.1021/acs.biomac.1c00474. Epub 2021 Jul 2. PMID: 34213889; PMCID: PMC8627795.
16. Algorri M, Abernathy MJ, Cauchon NS, Christian TR, Lamm CF, Moore CMV. Re-Envisioning Pharmaceutical Manufacturing: Increasing Agility for Global Patient Access. J Pharm Sci. 2022 Mar;111(3):593-607. doi: 10.1016/j.xphs.2021.08.032. Epub 2021 Aug 31. PMID: 34478754.
17. Rubbio I, Bruccoleri M, Pietrosi A, Ragonese B. Digital health technology enhances resilient behaviour: evidence from the ward. International Journal of Operations & Production Management. 2020 Jan 6;40(1):34-67.
18. National Academies of Sciences, Engineering, and Medicine; Policy and Global Affairs; Office of Special Projects; Committee on Building Adaptable and Resilient Supply Chains After Hurricanes Harvey, Irma, and Maria. Strengthening Post-Hurricane Supply Chain Resilience: Observations from Hurricanes Harvey, Irma, and Maria. Washington (DC): National Academies Press (US); 2020 Jan 8. PMID: 32352689.