Medication Prescribing for Type 2 Diabetes in the US Long-Term Care Setting: Observational Study.

OBJECTIVES: To characterize prescribing of glucose-lowering medication annually and to quantify the annual frequency of hypoglycemia among residents in long-term care (LTC) facilities with type 2 diabetes mellitus (T2DM). DESIGN: Serial cross-sectional study using a deidentified real-world database comprising electronic health records from LTC facilities. SETTING AND PARTICIPANTS: Individuals eligible for this study were ≥65 years old with T2DM and recorded stay of ≥100 days at an LTC facility in the United States in any of 5 study years (2016-2020), excluding individuals receiving palliative or hospice care. METHODS: Drug orders (prescriptions) for glucose-lowering medications for each LTC resident with T2DM in each calendar year were summarized by administration route (oral or injectable) and by drug class as ever-prescribed (ie, multiple prescriptions were included once), overall and stratified by age subgroup, <3 vs ≥3 comorbidities, and obesity status. We calculated the annual percentage of patients ever prescribed glucose-lowering medication each year, overall and by medication category, who experienced ≥1 hypoglycemic events. RESULTS: Among 71,200 to 120,861 LTC residents with T2DM included each year from 2016 to 2020, 68% to 73% (depending on the year) were prescribed ≥1 glucose-lowering medications, among them oral agents for 59% to 62% and injectable agents for 70% to 71%. Metformin was the most commonly prescribed oral agent, followed by sulfonylureas and dipeptidyl peptidase 4 inhibitors; basal plus prandial insulin was the most commonly prescribed injectable regimen. Prescribing patterns remained relatively consistent from 2016 to 2020, both overall and by patient subgroup. During each study year, 35% of LTC residents with T2DM experienced level 1 hypoglycemia (glucose ≥54 to <70 mg/dL), including 10% to 12% of those prescribed only oral agents and ≥44% of those prescribed injectable agents. Overall, 24% to 25% experienced level 2 hypoglycemia (glucose concentration <54 mg/dL). CONCLUSIONS AND IMPLICATIONS: Study findings suggest that opportunities exist for improving diabetes management for LTC residents with T2DM.

Leveraging Partnerships to Reduce Insulin Needlestick Injuries: Nurse-Led System-Wide Quality Improvement Project.

BACKGROUND: Percutaneous injuries from needlesticks are a major occupational hazard for nurses. LOCAL PROBLEM: Reducing subcutaneous insulin-related needlestick injuries was part of a nurse-led comprehensive sharps injury-reduction program at an integrated, not-for-profit health system. METHODS: The incident rate of needlestick injuries was compared between 1 year before and 1 year after introducing this quality improvement project. INTERVENTIONS: A system-wide educational program instituting changes in subcutaneous insulin administration practices was combined with supply chain standardization using a single type of safety-engineered insulin syringe. RESULTS: The average monthly incidence of needlestick injuries per 10 000 subcutaneous insulin injections fell significantly from year to year (incidence rate ratio, 0.49; 95% CI, 0.30-0.80; Poisson regression P = .004). One-year cost savings for supplies totaled $3500; additional annual median savings were $24 875 (2019 US dollars) in estimated costs of needlestick injuries averted. CONCLUSIONS: The effectiveness of this multifaceted project provides a practical template to reduce subcutaneous insulin-related needlestick injuries.

Hypoglycemia upon hospital admission from long-term care: health care resource use.

OBJECTIVES: Residents with diabetes in long-term care (LTC) settings often have recognized risk factors for developing hypoglycemia, including advanced age, dementia, and polypharmacy; however, data regarding hypoglycemia in LTC and associated hospitalizations are lacking. Our aim was to describe health care resource use and costs for patients with diabetes and hypoglycemia upon hospital admission. STUDY DESIGN: Retrospective, descriptive study using a US hospital billing database, October 2015 through September 2019. METHODS: Eligible patients were those 18 years and older with type 1 or 2 diabetes who (1) were hospitalized with hypoglycemia upon admission from LTC or from home and (2) received insulin during hospitalization. We described the percentages of patients admitted from LTC or from home with hypoglycemia and their characteristics, length of hospitalization, and hospital costs (2019 US$). RESULTS: Of 106,602 patients with diabetes admitted from LTC and 4,315,571 from home, 6609 (6%) and 182,756 (4%), respectively, presented with hypoglycemia on hospital admission. Mean ages of patients admitted with hypoglycemia from LTC and home were 73 and 66 years, respectively. The percentages of patients in LTC and home cohorts with dementia were 34% and 12%, respectively; with renal disease, 60% and 52%; and with type 2 diabetes, 95% and 89%. Mean hospital stays were 8.0 days for patients admitted from LTC and 6.7 days for those admitted from home; mean total hospital costs were $19,800 and $16,800, respectively. CONCLUSIONS: These findings highlight the importance of providing optimal diabetes management for patients in LTC settings to prevent hypoglycemia and potential hospitalizations and costs.

Linking drugs to obscure illnesses: lessons from pure red cell aplasia, nephrogenic systemic fibrosis, and Reye's syndrome. a report from the Southern Network on Adverse Reactions (SONAR).

Identification of serious adverse drug reactions (sADRS) associated with commonly used drugs can elude detection for years. Reye's syndrome (RS), nephrogenic systemic fibrosis (NSF), and pure red cell aplasia (PRCA) among chronic kidney disease (CKD) patients were recognized in 1951, 2000, and 1998, respectively. Reports associating these syndromes with aspirin, gadodiamide, and epoetin, were published 29, 6, and 4 years later, respectively. We obtained primary information from clinicians who identified causes of these sADRs and reviewed factors contributing to delayed identification of these toxicities. Overall, 3,500 aspirin-associated RS cases in the United States, 1,605 gadolinium-associated NSF cases, and 181 epoetin-associated PRCA cases were reported. Delays in FDA regulation of over-the- counter medications and administration of aspirin to children contributed to development of RS. For NSF, in 1996, the Danish Medicine Agency approved high-dose gadodiamide administration to chronic kidney disease (CKD) patients undergoing MR scans. Overall, 88 % of Danish NSF cases were from two hospitals and 97 % of United States' NSF cases were from 60 hospitals. These hospitals frequently administered high-doses of gadodiamide to CKD patients. Another factor was the decision to administer linear chelated contrast agents versus lower risk macrocyclic chelated agents. For PRCA, increased use of subcutaneous epoetin formulations to CKD patients, in part due to convenience and cost-savings considerations, and a European regulatory requirement requiring removal of albumin as a stabilizer, led to toxicity. Overall, 81, 13, and 17 years elapsed between drug introduction into practice and identification of a causal relationship for aspirin, erythropoietin, and gadodiamide, respectively. A substantial decline in new cases of these sADRs occurred within two years of identification of the offending drug. Clinicians should be vigilant for sADRs, even for frequently-prescribed pharmaceuticals, particularly in settings where formulation or regulatory changes have occurred, or when over-the-counter, off-label, or pediatric use is common.

A tale of two citizens: a State Attorney General and a hematologist facilitate translation of research into US Food and Drug Administration actions--a SONAR report.

PURPOSE: Pharmaceutical safety is a public health issue. In 2005, the Connecticut Attorney General (AG) raised concerns over adverse drug reactions in off-label settings, noting that thalidomide was approved to treat a rare illness, but more than 90% of its use was off label. A hematologist had reported thalidomide with doxorubicin or dexamethasone was associated with venous thromboembolism (VTE) rates of 25%. We review US Food and Drug Administration (FDA) and manufacturer responses to a citizen petition filed to address these thalidomide safety issues. METHODS: Case study. RESULTS: The AG petitioned the FDA requesting thalidomide-related safety actions. Coincidentally, the manufacturer submitted a supplemental New Drug Approval (sNDA), requesting approval to treat multiple myeloma with thalidomide-dexamethasone. FDA safety officers reviewed the petition and the literature and noted that VTE risks with thalidomide were not appropriately addressed in the existing package insert. In the sNDA application, the manufacturer reported thalidomide-associated toxicities for multiple myeloma were primarily somnolence and neurotoxicity, and a proposed package insert did not focus on VTE risks. In October, the FDA informed the Oncology Drug Division that VTE risks with thalidomide were poorly addressed in the existing label. After reviewing this memorandum, an Oncology Drug Division reviewer informed the manufacturer that approval of the sNDA would be delayed until several thalidomide-associated VTE safety actions, including revisions of the package insert, were implemented. The manufacturer and FDA agreed on these actions, and the sNDA was approved. CONCLUSION: New approaches addressing off-label safety are needed. The conditions that facilitated the successful response to this citizen petition are uncommon.