Articles related to Clinical Pharmacology

Unraveling the ALS Treatment Landscape: An Insightful Webinar Pharmacists, step into an enlightening discussion about the ALS treatment landscape on June 14th from 2:00 – 3:00 PM EST. Unearth key insights from AMCP’s Market Insights Roundtable and explore strategies to navigate patient access barriers, ultimately enriching ALS patients’ quality of life. Firstly, the webinar presents a golden opportunity for pharmacists to deepen their understanding of Amyotrophic Lateral Sclerosis (ALS), a rapidly progressing neurodegenerative disease. Our distinguished speakers will guide you through the current and evolving ALS treatment landscape, emphasizing the differences between clinical trial environments and real-life experiences. Further along, you’ll gain invaluable insights into the patient journey and the burden associated with ALS. In highlighting the current access barriers that patients face, the webinar focuses on a health plan’s concerted effort to mitigate these hurdles, providing valuable lessons for all healthcare stakeholders. Lastly, the importance of collaboration in the decision-making process to minimize access to care barriers will be underscored. With panelists like Ryan Haumschild, Director of Pharmacy at Emory Healthcare and Winship Cancer Institute, and Ryan Bitton, Senior Director of Pharmacy Services at Health Plan of Nevada, this is a conversation you won’t want to miss. Join us […]

Join us as we explore the dynamic world of compounding pharmacies tackling the challenging semaglutide shortages head-on. Compounding pharmacies have stepped up to address the shortage of two semaglutide products, Ozempic and Wegovy. Consequently, they’re facing increased scrutiny from federal and state regulators, as well as Novo Nordisk, the manufacturer of these products. Novo Nordisk is actively monitoring and taking action against entities unlawfully selling compounded semaglutide. The company has sent cease-and-desist letters to some 503A pharmacy compounders. This move is seen as the first step towards potential legal actions. The Alliance for Pharmacy Compounding has defended the rights of 503A pharmacies to compound active pharmaceutical ingredients (APIs) in brand-name medications for specific patients, as long as the brands are on the FDA’s “currently in shortage” list. However, the distinction between legitimate 503A pharmacy compounders and shady operators has been blurred. These operators have rushed to fill the semaglutide gap without proper oversight of their compounding safety processes, source of APIs, or marketing techniques. This negligence could potentially cause serious patient harm. Kristina Bryowsky, PharmD, MBA, Vice President of Pharmacy Services for SSM Health Care, Missouri Region, believes that 503A compounding pharmacies should be allowed to make a product for […]

Explore a course created to equip pharmacists with the knowledge and abilities to assist patients who identify as transgender or gender nonconforming (TGND). The educational program “Gender-Affirming Care in Pharmacy Practice” is a comprehensive guide for pharmacists to better serve transgender and gender-diverse (TGD) patients. It provides a deep understanding of the terminology related to TGD patient populations, including definitions of gender identity, gender expression, and various gender identities. The program emphasizes the importance of gender-affirming care, which includes social, medical, psychological, and behavioral care that aligns with a person’s gender identity. It also provides guidance on how to communicate inclusively with TGD patients, such as introducing oneself with name and pronouns, asking open-ended questions, and avoiding unnecessary or invasive questions. Furthermore, the program highlights the health disparities faced by TGD individuals seeking gender-affirming care, such as higher levels of unemployment and healthcare discrimination. It also discusses the coverage of gender-affirming care by Medicaid, which varies across states. The program provides detailed information on hormone therapy for TGD patients, including testosterone and estrogen hormone therapy. It discusses the potential side effects, contraindications, and the importance of contraception for patients at risk of becoming pregnant while on testosterone therapy. Lastly, the […]

Investigating how an insulin bolus affects the management of diabetic ketoacidosis reveals startling new information. In the diabetes field, experts widely use insulin as a core treatment for diabetic ketoacidosis (DKA). However, the debate over the best dosage and method of administration, specifically concerning the use of an initial insulin bolus, continues. This study evaluates the safety and effectiveness of this insulin bolus in DKA treatment. Employing a retrospective chart review, researchers examined patient outcomes for DKA treatment with and without an insulin bolus. They included 59 patients in the bolus group, and 108 in the non-bolus group. The study primarily tracked whether the administration of insulin had to be interrupted, or if patients experienced hypoglycemia or hypokalemia within eight hours of starting insulin. Comparing baseline characteristics, the groups showed no significant differences. Most patients exhibited mild DKA. Results revealed that adverse effects—particularly hypokalemia—occurred significantly more often in the bolus group (45.8% versus 25%, P = .003). Additionally, while time to anion gap closure was shorter in the bolus group, this did not reach statistical significance (6:39 versus 9:00, P = .063). Similarly, non-significant differences emerged in time to discontinuation of insulin infusion and time to ICU and hospital discharge. […]

Explore how neighborhood pharmacists are tackling the Gender-Affirming Care Guide’s difficulty of comprehension and application. The study provides a critical analysis of community pharmacists’ awareness and use of the Gender-Affirming Care Guide. Unveiled by the American Pharmacists Association and Human Rights Campaign in March 2021, the guide represents a pivotal tool for delivering competent and respectful care to transgender and gender-diverse patients. Nonetheless, reports on pharmacists’ familiarity with, and adherence to, the guide are currently lacking. To examine this, an anonymous survey, structured around the guide’s principles, was sent to 700 Ohio community pharmacists. Of the 688 recipients, a mere 12% responded, revealing a stark lack of awareness about the guide – only 10% knew of its existence. Moreover, their self-reported ability to define key terminologies varied widely. Indeed, 95% could correctly define “transgender,” but only 14% knew “intersectionality.” The report underscores the importance of adopting the guide’s suggested practices. Notably, it found that 61% collected patients’ preferred names, and 54% considered transgender, gender-diverse, or non-heterosexual patients during staff training. Nevertheless, less than half claimed their pharmacy software managed critical gender-related data effectively. Despite these shortcomings, the surveyed pharmacists displayed a substantial interest in learning more about the guide’s contents. […]

Unveiling a new path in osteoarthritis pain management, the FDA’s Breakthrough Therapy designation for resiniferatoxin marks a promising development. The FDA has granted Breakthrough Therapy designation to resiniferatoxin for treating osteoarthritis knee pain. Extracted from a cactus-like plant, resiniferatoxin, a potent TRPV1 agonist, boasts similarities to capsaicin. Notably, its potency sets it apart. Resiniferatoxin is administered through intra-articular injection, promoting pain relief by temporarily disabling TRPV1-expressing nociceptors. This unique mechanism targets one of the most profound symptoms of osteoarthritis: pain. Its potential benefits are eagerly awaited by millions of patients struggling with this relentless disease. Stepping up to the challenge, Grünenthal, the company behind resiniferatoxin, is launching a global Phase 3 program. They aim to enroll more than 1,800 patients with knee osteoarthritis who haven’t found sufficient relief from existing non-surgical treatments. With a focus on improved pain and physical function scores according to the WOMAC osteoarthritis index, the program’s efficacy endpoints are set for up to 52 weeks. Turning the tide in osteoarthritis treatment, the Breakthrough Therapy Designation offers an expedited path for this non-opioid therapy option. As Grünenthal’s Chief Scientific Officer, Jan Adams, optimistically noted, it is hoped that this designation will speed up resiniferatoxin’s availability to patients.