Original Research

Hypoglycemia Safety Initiative: Working With PACT Clinical Pharmacy Specialists to Individualize HbA1c Goals

Clinical pharmacy specialist interventions after patient consultation resulted in statistically significant increases in HbA1c levels in patients at risk for hypoglycemia who relaxed their therapy.

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Intensive glycemic lowering for the treatment for type 2 diabetes mellitus (T2DM) has been shown to decrease microvascular and macrovascular outcomes in the UK Prospective Diabetes Study (UKPDS) without any risk of increased harm.1,2 Over the past decade, evidence has shown that the outcomes and risk do not hold true in an older population with additional comorbidities and longer duration of DM. Both the Action to Control Cardiovascular Risk in Diabetes (ACCORD) and Veterans Affairs Diabetes Trial (VADT) trials showed no decreased incidence of macrovascular or microvascular complications of DM with intensive glucose lowering but an additional risk of hypoglycemia and even death.2-4

Patient-specific risk factors, such as age, impaired renal function, and cognitive impairment, have been shown to lead to an increased risk of hypoglycemia independent of hemoglobin A1c (HbA1c). Dementia and cognitive impairment are associated with a 2.42 and 1.72 times greater risk of hypoglycemia, respectively, compared with a patient without dementia or cognitive impairment.5 A post-hoc analysis of the ACCORD trial that analyzed the risk of hypoglycemia in subgroup populations showed an increased risk of hypoglycemia in those with a serum creatinine (SCr) level > 1.3 mg/dL (hazard ratio, 1.66, P < .01) and increasing age. Risk of hypoglycemia was highest in those aged ≥ 75 years but increased by 3% for every subsequent year (P < .01).6 These risk factors should be addressed and considered in individual patients with DM to safely guide therapy.

The evidence from these landmark trials has led to increased HbA1c goals for specific patient populations in the most recent 2017 VA/DoD Clinical Practice Guideline (CPG) for the Management of Type 2 Diabetes Mellitus in Primary Care.7 The majority of patients with T2DM now qualify for HBA1c goals > 7.0%. According to the 2017 VA/DoD CPG, younger patients with the absence of a major comorbidity and life expectancy of > 10 to 15 years with mild or absent microvascular complications is the only group of patients who should be treated to an A1c goal of 6.0 to 7.0%.7 The use of shared decision making and patient education to set glycemic goals based on “patient capabilities, needs, goals, prior treatment experience, and preferences” also should be used to increase patient education and satisfaction.7

In December 2014, the VA introduced the Hypoglycemia Safety Initiative (HSI). The goal of the HSI is to “enable veterans living with diabetes to work more closely with their VA clinicians to personalize health care goals and improve self-management of the disease.”8 This goal also aligns with the US Department of Health and Human Services National Action Plan for Adverse Drug Event Prevention. One of 3 initial targets of this plan includes DM agents and the prevention of hypoglycemia.9

To combat the risk of hypoglycemia and potentially negative outcomes, as part of the HSI, the VA is implementing a clinical reminder within the Computerized Patient Record System (CPRS) that will prompt the primary care team to screen select patients at risk for hypoglycemia. The purpose of this project was to identify patients at high risk of hypoglycemia, individualize HbA1c goals, and consider de-escalation in therapy, using shared decision making.


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