Ensuring glucagon access for people with diabetes: A case example from community pharmacy

Abstract

People with diabetes who are prescribed insulin or who are at high risk of recurrent level 2 or level 3 hypoglycemia should be prescribed glucagon. More than seven million Americans are prescribed insulin and prescriptions for glucagon were filled in 8.3% of people using short-acting insulin, 2.3% of people using long-acting insulin, and 0.4% of people not using insulin. Community pharmacy teams can identify individuals at high risk for hypoglycemia and play an important role in improving access to glucagon. Using Community Pharmacy Enhanced Services Network (CPESN®) USA as a model, we will describe opportunities for community pharmacies to improve glucagon access and patient health outcomes.

1 PATIENT SCENARIO

M.S., a 70-year-old female, is being treated with metformin 500 mg orally once daily, dapagliflozin 5 mg orally once daily, insulin glargine 6 units subcutaneously once daily, and insulin aspart 3 units subcutaneously three times daily with meals. Her provider is currently completing testing to determine a diagnosis of type 1 or type 2 diabetes mellitus; however, she has been treated for diabetes for at least 10 years. Her medical history is otherwise significant for hypertension, hyperlipidemia, gastroesophageal reflux disease (GERD), chronic pain, and heart disease. When meeting with the local community pharmacist, she describes a history of multiple trips to the emergency department (via ambulance) due to hypoglycemia. She experiences hypoglycemic unawareness.

M.S. enrolls in the pharmacy diabetes care program to receive continuous glucose monitor (CGM) training by the clinical pharmacist and community health worker (CHW). Due to a lack of transportation, she is scheduled for a home visit. At the time of the visit, M.S. did not answer the door. The pharmacist and CHW reached out to a family member who was able to open her apartment. M.S. was found unresponsive with a blood glucose of 24 mg/dL. As no glucagon was available in the apartment, the pharmacist began treating M.S. with table sugar while the CHW called emergency medical services (EMS) and quickly returned to the pharmacy for glucagon. The CHW returned within minutes, with glucagon administration by the pharmacist before EMS arrival. M.S.'s blood glucose began to normalize, and she became coherent—avoiding a trip to the emergency department. M.S. is now utilizing CGM to monitor for hypoglycemia, receives regular counseling from the pharmacy clinical team, and has access to glucagon that was dispensed with appropriate counseling.

2 BACKGROUND

Hypoglycemia is responsible for over 100 000 emergency room visits and more than $120 million in health care spending per year.¹ The risk of patients experiencing situations as described above can be significantly decreased by access to glucagon.^{2, 3} While pharmacists in a variety of settings have demonstrated an impact on glucagon access and prescribing and should continue with these efforts, integration of a CHW can elevate care beyond what a pharmacist can provide.^4-7 Community pharmacy teams with CHWs have additional expertise in identifying and resolving health equity barriers to care and may be better equipped to identify individuals at high risk for hypoglycemia and improve access to glucagon.^{8, 9} People with diabetes who are prescribed insulin or who are at high risk of recurrent level 2 or level 3 hypoglycemia should be prescribed glucagon.² Level 2 hypoglycemia is defined by the American Diabetes Association as a blood glucose less than 54 mg/dL, and level 3 hypoglycemia is a severe event with altered mental or physical status that requires assistance for treatment regardless of the blood glucose level.² For people with type 2 diabetes mellitus (T2D), the prevalence of severe hypoglycemia is 6%, and for people with type 1 diabetes mellitus (T1D), the prevalence ranges from 30% to 40%.^{10, 11} More than seven million Americans are prescribed insulin, with glucagon being significantly under-prescribed.¹² In a retrospective analysis of prescription claims data across 10 years (2011–2021), prescriptions for glucagon were filled in 8.3% of people using short-acting insulin, 2.3% of people using long-acting insulin, and 0.4% of people not using insulin.¹³ Documented disparities in glucagon show a higher rate of glucagon prescribing and fill rates in those who are female, White, have a high income, and are commercially insured compared to those who are not.^{14, 15}

Limited access to and utilization of glucagon is multifactorial including under-prescribing, out-of-pocket expense, and prescription-only status. Current models of care for glucagon access are shifting, with some states supporting legislation to allow for undesignated glucagon in schools and through pharmacy protocols or standing orders.^16-20 While this is an improvement in access, the benefit is limited to single states and is not widely applicable. Opportunities to expand access to glucagon (e.g., standing order, prescription-free dispensing, pharmacist scope of practice, value-based contracting) may mirror similar strategies that have improved access to contraception, tobacco cessation products, vaccines, and naloxone in pharmacies. An additional, novel approach that has not been identified in the literature is a pharmacist CHW collaboration focused on glucagon access.

Community Pharmacy Enhanced Services Network (CPESN®) USA is the first clinically integrated network (CIN) for community pharmacies. The Federal Trade Commission (FTC) regulates and defines CINs as “Structured collaboration between (health care providers) to develop clinical initiatives designed to improve the quality and efficacy of health care services.”²¹ In other words, CPESN's framework and organizational structure allow for independently owned pharmacies to contract for shared services beyond prescription dispensing. The CPESN USA CIN is a national network of networks, with pharmacies that are not fundamentally dispensaries but primarily providers of patient care services. CINs prioritize quality improvements for the providers. Through these organizational designs, CPESN pharmacies are currently the fourth largest pharmacy organization in the United States and have been able to achieve a high level of performance as a federal partner, as was demonstrated with the coronavirus disease 2019 (COVID-19) vaccine program.²²

CPESN USA is operationalized through state-based, or geographically focused, local networks.²³ Additionally, a Special Purpose Network, CPESN Health Equity, integrates CHWs, social determinants of health (SDOH) experts, navigators, and peer health mentors to support patients and resolve health-related social needs which keep them from attaining their highest possible level of health and is not geographically focused.²⁴ CPESN pharmacies have a history of successful improvements in patient care.²⁵ CPESN Health Equity pharmacies all participate with a community pharmacy measurement system, Choose My Pharmacy™ (Seguridad, Inc., Nashville, TN), which includes a diabetes safety quality measure, Improving Diabetes Safety. This measure evaluates the percentage of persons with diabetes prescribed bolus insulin (aspart, lispro, glulisine, or regular insulin) that also have a dispensed prescription of glucagon. CPESN Health Equity has prioritized improving glucagon access for their patient population to improve diabetes health outcomes due to the baseline performance on this measure, consistent with national trends of approximately 8%, as a quality improvement initiative within the CIN.

2.1 Program description

The patient described above (M.S.) was a client of L & S Pharmacy, a CPESN Health Equity family-owned pharmacy in a rural area of Southeastern Missouri that has provided longitudinal care for patients and their families for nearly 50 years. The community surrounding L & S Pharmacy faces many adverse SDOH, has high rates of diabetes and other chronic disease, and experiences the poorest health outcomes in the state.²⁶ To better serve their community, L & S Pharmacy integrated CHWs into their staff in 2018, with a focus on combining the clinical expertise of pharmacists with the community knowledge of the CHW to shift health care into local neighborhoods and patient homes. L & S Pharmacy offers a variety of clinical programs with a focus on advocacy and SDOH including diabetes education, medication therapy management, and pharmacogenomic counseling.²⁷ Currently, L & S Pharmacy has one of the highest measure rates (performance) on the Improving Diabetes Safety quality measure—double the network average—due in part to their holistic approach to diabetes care with pharmacist and CHW teams providing home visits and monthly care coordination and optimization.^{28, 29} High performance on the safety measure and quality improvement was related to implementation of L & S Pharmacy's new longitudinal care management CGM protocol that includes order-set requests for glucagon and recommended CGM therapy for eligible patients.³⁰ Under this protocol, the first appointment is focused on education about the device, receiver (or smartphone), sensor application and troubleshooting, CGM monitoring and results, hypoglycemia and hyperglycemia signs and symptoms, and optimization of supplies and therapy. The CHW and pharmacist team follow-up after 24 h and monthly thereafter. The CGM program had 14 enrolled patients at the time of the patient case. Four (29%) patients received glucagon in the program; common reasons for lack of glucagon included patient copayment cost and prescriber refusal.²⁸

3 DISCUSSION

The experience of M.S. with L & S Pharmacy illustrates many critical aspects of elevating diabetes care within the community pharmacy including the synergistic impact of collaboration with CHWs, the critical need for increased access to glucagon for people with diabetes, and the value of shifting the pharmacist into the community. An emerging area of practice advancement with a growing number of reports is highlighting the impact when pharmacy technicians are also trained as CHWs.^31-34 Pharmacy technicians who come from the surrounding community served by the pharmacy oftentimes have strong relationships and knowledge of available resources, particularly in rural settings. Some of these technicians who also demonstrate strong caring, empathic, compassionate, and nonjudgemental attributes lend themselves well to practicing as CHWs.

CPESN USA pharmacies are paving the way for community-centered patient care models. The case of M.S. is one example of the many person-centered ways independent pharmacies serve their communities and improve health outcomes. These pharmacies provide a blueprint for other community pharmacies as a way to increase community reach and improve pharmacist work satisfaction.³⁵ With less than 10% of US physicians practicing in rural areas, there is currently momentum for pharmacists to be recognized as providers in medically underserved/rural areas.^{36, 37} This is critically important as there is a 16% higher prevalence of T2D, 20% higher T2D-related hospital mortality, and smaller improvements in overall T2D-related mortality in rural areas.³⁸ Improved access to glucagon, CGM, and first-line medications are all opportunities for pharmacists to improve diabetes management in rural settings.

Strategies to promote better access to glucagon through the community can ensure timely and effective management of hypoglycemic emergencies to benefit people with diabetes and reduce barriers to life-saving treatment. These approaches can include prescription-free dispensing, modifying the pharmacists' scope of practice, and enacting a statewide standing order. Some states have authorized pharmacists to dispense, deliver, or administer glucagon without the need for a prescription, as permitted by a standing protocol.¹⁹ States should also consider expanding the scope of practice for pharmacists to provide glucagon as part of their routine responsibilities.³⁹ Based on experiences with other medications, such as naloxone, expanding pharmacy access to glucagon would be expected to increase the dispensing of glucagon and to reduce diabetes-related mortality.^{40, 41} However, little is known about the true impact of expanded glucagon access through these mechanisms. At an individual pharmacy level, a first step can be to cross-train technicians as CHWs as a way to increase access to guideline-recommended care.⁷ Additionally, improved financial access to glucagon and other therapies may be supported by enhanced pharmacoequity services and care coordination by pharmacy-based CHWs. Finally, a structured approach to counseling patients, caregivers, and household members on appropriate use of glucagon should be utilized with glucagon prescribing and dispensing.

CPESN USA initiatives and data can support the advancement of policies to increase access to glucagon and transform the payment models for service and product, and are actively working with academic partners to publish more data focused on outcomes associated with the integration of health equity and community pharmacy.⁴² Evaluating diabetes safety through standardized quality measures creates a model for value-based contracts, service payment, and sustainability of community pharmacies in all communities. Alternatively, Medicaid and Medicare CHW reimbursement mechanisms may also provide opportunities to enhance the sustainability of innovative care delivery models in community pharmacies.^{43, 44}

4 CONCLUSION

The US population with diabetes at risk for hypoglycemia needs improved access to glucagon. Community pharmacies are well positioned to meet this need, particularly in rural areas where community pharmacy services play a critical role in health care access. CPESN USA provides a model for other community pharmacies to follow through their focus on improving patient health outcomes.

CONFLICT OF INTEREST STATEMENT

Dr. Meredith is a member of the JACCP editorial board. The authors declare no conflicts of interest.

Open Research

DATA AVAILABILITY STATEMENT

Data sharing is not applicable to this article as no new data were created or analyzed in this study.