Sandra L. Kane-Gill

Objective: Between 2012 and 2017, the U.S. Food and Drug Administration (FDA) approved 10 antidiabetic indicated therapies. Due to the limited literature on voluntarily reported safety outcomes for recently approved antidiabetic drugs, this study investigated adverse drug reactions (ADRs) reported in the FDA Adverse Event Reporting System (FAERS). Research Design and Methods: A disproportionality analysis of spontaneously reported ADRs was conducted. FAERS reports from January 1, 2012 to March 31, 2022 were compiled, allowing a 5-year buffer following drug approval in 2017. Reporting odds ratios were calculated for the top 10 ADRs, comparing new diabetic agents to the other approved drugs in their therapeutic class. Results: 127,525 reports were identified for newly approved antidiabetic medications listed as the primary suspect (PS). For sodium-glucose co-transporter-2 (SGLT-2) inhibitors, the odds of blood glucose increased, nausea, and dizziness being reported was greater for empagliflozin. Dapagliflozin was associated with greater reports of weight decreased. Canagliflozin was found to have a disproportionally higher number of reports for diabetic ketoacidosis, toe amputation, acute kidney injury, fungal infections, and osteomyelitis. Assessing glucagon-like peptide-1 (GLP-1) receptor agonists, dulaglutide and semaglutide were associated with greater reports of gastrointestinal adverse drug reactions. Exenatide was disproportionally associated with injection site reactions and pancreatic carcinoma reports. Conclusion: Pharmacovigilance studies utilizing a large publicly available dataset allow an essential opportunity to evaluate the safety profile of antidiabetic drugs utilized in clinical practice. Additional research is needed to evaluate these reported safety concerns for recently approved antidiabetic medications to determine causality.

Critical care (CC) pharmacists have been contributing to patient outcomes, team effectiveness, education, research and quality improvement for approximately 50 years. Current CC specialists are evolving the practice, science and scholarship into new and exciting areas as described in the series of articles collected for a special series in this journal. To summarize past accomplishments and contemplate how next level achievements may develop, brainstorming by experienced CC specialists, researchers, educators, and scholars was done to establish a foundation for this paper and three of that group summarized it into an overview of the challenges of the past and opportunities that are shaping the future. A small group of CC pharmacists identified need and opportunity to improve patient care in a limited number of settings but subsequent CC pharmacists have expanded into numerous specialties and subspecialties. Comprehensive medication management of CC patients and survivors of their critical illness is now a standard, but delivery may be influenced by new technology and equipment. Improved quality of care and outcome measures are being developed and measured. The imperative to move practice forward and adopt new practices while maintaining a core set of guideline‐based practices may be facilitated by technology such as wearable devices, personalized medicine, machine learning or artificial intelligence. However, these new tools may create new obstacles. Similar changes in education and expansion into administrative roles afford new opportunities and challenges. CC pharmacists have created a solid foundation, but continued growth in number and expansion of roles requires the next generation to continue to push ahead and continue to demonstrate value in key areas.