Compounded incretins in clinical practice: An opinion of the endocrine and metabolism practice and research network of the American College of Clinical Pharmacy.

Type 2 diabetes mellitus (T2DM) carries a high prevalence in the United States and worldwide. Therefore, the number of medication classes being developed and studied has grown. The individualized management of diabetes is accomplished by evaluating a medication’s efficacy, safety, and cost, along with the patient’s preference and tolerance to the medication. Sodium glucose co-transporter 2 inhibitors are a new therapeutic class indicated for the treatment of diabetes and have a unique mechanism of action, independent of beta-cell function. The first agent approved by the Food and Drug Administration (FDA) was canagliflozin in March 2013. Two agents – dapagliflozin and empagliflozin – were FDA-approved in January and July 2014, respectively. A clear understanding of the new class is needed to identify its appropriate use in clinical practice. Members of the American College of Clinical Pharmacy Endocrine and Metabolism Practice and Research Network reviewed available literature regarding this therapeutic class. The article addresses the advantages, disadvantages, emerging role, and patient education for sodium glucose co-transporter 2 inhibitors. Key limitations for this article include limited access to clinical trial data not published by the pharmaceutical company and limited data on products produced outside the United States.

Diabetes mellitus has reached epidemic proportions worldwide, eliciting extensive research on both the disease process and its treatment. Regardless of diabetes type, the progressive nature of the disease makes insulin the long-term mainstay of diabetes management. Recently, the insulin analog glargine was reported in several epidemiologic studies to be associated with an increased risk of cancer. Inconsistent study results and media attention have caused much angst and concern to health care professionals and the general population. A clear understanding of the current evidence is needed to adequately develop a patient-oriented risk:benefit assessment. Members of the Endocrine and Metabolism Practice and Research Network of the American College of Clinical Pharmacy evaluated available evidence to provide guidance and discussion on the risk of cancer with insulin glargine use. We believe the current link between insulin glargine and cancer is tenuous but merits further evaluation. An independent analysis of all available glargine clinical trial data should be performed, and a vigorous postmarketing safety study of glargine should be conducted. Until more substantial data are available, however, neither the choice of initial insulin therapy nor insulin maintenance regimens should be influenced by the current information linking insulin glargine to cancer.

The objective of this practice and research network opinion paper was to identify literature for pharmacist‐led services with obesity management, summarize clinical evidence for this disease state, and describe the role of a clinical pharmacist among patients who are overweight or have obesity. Clinical pharmacists play a critical role in the safe and effective management of obesity in both the inpatient and outpatient settings. In an outpatient setting, the role of the clinical pharmacist includes a comprehensive patient interview to design an individualized therapeutic plan involving nonpharmacological interventions with or without pharmacological interventions or surgical options. A clinical pharmacist conducts a risk‐benefit analysis for pharmacological interventions. Furthermore, the potential of medications to contribute to weight gain or prevent weight loss can be reviewed by a clinical pharmacist when managing comorbid conditions. In an inpatient setting, a clinical pharmacist conducts medication reconciliation, determines appropriate supplements for nutritional deficiencies, and provides medication management for people with obesity who may or may not be undergoing bariatric surgery. In addition, a clinical pharmacist can provide thorough patient education with monitoring for transitions from hospital to the outpatient setting and subsequent follow‐up visits.

The objective of this opinion paper was to identify and describe the role of pharmacists in ensuring safe and optimal management of patients with glycemic excursions in the inpatient setting. The role of the pharmacist includes involvement in admission medication history and reconciliation, formulary management of glucose‐lowering medications and devices, individual patient medication management, discharge transition of care, and interprofessional collaboration with other health care providers. Recommendations are based on review of published guidelines and literature focusing on the management of patients with hypo‐ and hyperglycemia in the hospital as well as during the time of transition to and from the inpatient setting.

ABSTRACTThe popularity of incretin‐based therapies has increased substantially over the past several years due to their clinically significant efficacy for weight loss and positive impact on weight‐related comorbid conditions, yet, few clinical practice guidelines for the management of overweight and obesity have been updated to incorporate these agents. The increased demand for incretin‐based therapies for weight management has revealed barriers to their implementation related to cost, availability, and emerging safety concerns. This opinion paper aims to briefly review the available literature on the current role of incretin‐based therapy for chronic weight management in persons with overweight or obesity and provide recommendations for clinical pharmacists utilizing these agents. The intent of this opinion paper is to discuss the benefits and risks of incretin‐based therapy for weight management, review approaches for clinical pharmacists to overcome barriers to their implementation, and address ongoing questions related to their use. Finally, the authors suggest an approach to the management of people with overweight or obesity with incretin‐based therapy using the Pharmacists' Patient Care Process along with actions clinical pharmacists can take to ensure best practices with these agents.

A rising percentage of patients are electing medication abortion over procedural abortion for increased safety and privacy. Access to medication abortion is essential healthcare, but many Americans face unsurmountable barriers when pursuing this option. This has been in large part due to unnecessary restrictions imposed by the United States Food and Drug Administration (FDA) Risk Evaluation and Mitigation Strategy (REMS) for mifepristone, used in combination with misoprostol for medication abortion. Moreover, many states have imposed additional restrictions on abortion, further impeding access to care. Since its original approval in 2000, mifepristone can only be prescribed by certified prescribers. Until recently, mifepristone could only be dispensed by certified prescribers, whereby more accessible community and mail‐order pharmacies were prohibited from dispensing mifepristone. During the Coronavirus disease 2019 public health emergency, there was a temporary allowance for certified prescribers to utilize mail or mail‐order pharmacies to deliver medications to patients. In January 2023, the FDA approved modifications to the mifepristone REMS to allow certified pharmacies to dispense the medication. Given the established safety and effectiveness of mifepristone, the evidence supports its distribution via pharmacies and leveraging pharmacists to expand medication abortion access. Pharmacists are one of the most widely accessible healthcare providers and their responsibility centers on patient and medication safety and improving health outcomes. This article, an opinion of the American College of Clinical Pharmacy Women's Health Practice and Research Network, adds the voice of members of the pharmacy profession to the collective efforts to ensure access to medication abortion, including pharmacist dispensing of mifepristone. We encourage pharmacists to embrace this fresh opportunity to provide medication abortion care in their communities.

The Centers for Disease Control and Prevention revised their Clinical Practice Guideline for Prescribing Opioids for Pain in 2022. This opinion paper was prepared by members of the American College of Clinical Pharmacy (ACCP) Pain and Palliative Care Practice and Research Network (PRN) and provides an overview of updates to the 2022 guidelines, highlighting major changes from the 2016 guidelines and calling attention to the opportunities and challenges for pharmacists in providing patient‐centered care with opioids for pain management. While this paper represents the opinion of the ACCP Pain and Palliative Care PRN, it does not necessarily represent an official ACCP commentary, guideline, or statement of policy or position.

A letter and a questionnaire were sent to members of the American College of Clinical Pharmacy (ACCP) proposing the formation of a new outcomes and economics practice and research network (PRN). Members were requested to indicate their willingness to join the PRN by returning the questionnaire. More than 10% of the members (327/3007) expressed interest in joining the new PRN; the majority (309) also completed the questionnaire. They were most concerned with increasing their competence in outcomes and economics; developing, or having available, guidelines and standards for research methodologies; properly applying the methodologies to satisfy the informational needs of their institutions; and strengthening and advancing the position of clinical pharmacy.

PurposeThe time to complete oncology pharmacist tasks is needed to determine workload and productivity. The Hematology/Oncology Pharmacy Association (HOPA) and the Hematology/Oncology Practice and Research Network (PRN) of the American College of Clinical Pharmacy (ACCP) partnered with the aim of establishing consensus on the time required to complete oncology pharmacy tasks.MethodsFifteen patient care tasks and 9 non-patient care tasks, commonly completed by oncology pharmacists were each assigned an average amount of time to be completed. This list was then converted into 24 statements and the Delphi survey method was utilized with an expert panel to arrive at consensus between December 2023 and February 2024. Consensus was defined as at least 75% agreement. The complete manuscript was endorsed by HOPA and ACCP Hematology/Oncology PRN.ResultsThirty-three pharmacist-experts agreed to participate in this survey with all participating in round 1, and 29 (87.9%) participating in round 2. In round 1, 9 tasks achieved consensus, with 7 of these being classified as patient care associated. Seven statements reaching 65% but less than 75% agreement were deemed to reach borderline consensus. Eight statements failed to achieve at least 65% agreement and were modified based on respondent feedback. In round 2, 15 statements were included with all achieving consensus. At the completion of round 2, all 24 statements reached consensus, and the survey was deemed complete.ConclusionThis project produced the first comprehensive consensus statements for the average time for a US-based oncology pharmacist to complete common patient and non-patient care-related tasks.

The pharmacist's role in pediatric care is critical for the provision of safe medication use secondary to differences in physical development, frequent off label use of medications, need for dose calculations, and the lack of standard dosage forms. Many regulatory agencies, health care organizations, and professional societies support the pharmacist as a member of the interdisciplinary team. However, specific details showcasing how pharmacists impact the care of pediatric patients in a quantifiable and meaningful way have not been well described. The purpose of this article is to provide a review of evidence demonstrating measurable clinical outcomes directly resulting from pharmacist participation in pediatric patient care. This report is an opinion paper of The American College of Clinical Pharmacy (ACCP) Pediatrics Practice and Research Network and has been endorsed by the Pediatric Pharmacy Association (PPA). This article represents the opinion of the Pediatrics Practice and Research Network of ACCP. It does not necessarily represent an official ACCP commentary, guideline, or statement of policy or position.

APhA advances provider status initiative

Menopausal symptoms affect a significant portion of women. Traditional treatment with manufactured hormone therapy can alleviate these symptoms, but many women and their health care providers are concerned about the risks, such as venous thromboembolism and certain types of cancer, demonstrated with manufactured hormone therapy. Compounded bioidentical hormone therapy has been proposed and is often used as a solution for these concerns. Despite this use, no data are currently available to support the claims that compounded bioidentical hormone therapy is a safer or more efficacious option compared with manufactured hormone therapy. A common misperception is that all manufactured products consist of synthetic hormones and all compounded medications consist of natural hormones; however, in fact, significant overlap exists. Several key stakeholder organizations have issued statements expressing concern about the lack of evidence regarding the efficacy and safety of compounded bioidentical hormone therapy, in addition to concerns regarding prescribing patterns. The Women's Health Practice and Research Network of the American College of Clinical Pharmacy recommends against the consistent use of compounded bioidentical hormones as a safer option compared with manufactured therapy and supports the statements of other key organizations, acknowledging the need for more robust clinical studies to evaluate the potential advantages and disadvantages of compounded bioidentical products compared with manufactured products.

As artificial intelligence (AI) continues to rapidly reshape health care, there is a critical need for clear frameworks for clinicians to ensure ethical, equitable, and effective integration and use of AI in patient care. Key integrations of AI include enhancing health communications, patient engagement, clinicians' training, pharmaceutical advertising, clinical decision‐making, and automation of clinical operations and workflow. However, there are growing concerns related to regulatory gaps, the spread of misinformation, security threats, patient and data privacy leaks, and widening health disparities gaps. These concerns are exacerbated by limited institutional infrastructure and limited AI literacy of clinicians and patients. Recent policy developments reflect efforts to guide responsible AI development and use. While progress has been made, the lack of standardized human oversight remains a critical gap, particularly as policies may not fully consider the challenges and complexities at institutional, societal, technical, and individual levels. Thus, herein, the Drug Information Practice and Research Network (DI PRN) of the American College of Clinical Pharmacy (ACCP) : (1) explores current and emerging multifaceted challenges, a call to action, and opportunities of AI integration in health care including examination of the regulatory, ethical, operational, and health equity implications; and (2) provides practical recommendations for responsible use of AI through DI PRN‐developed example case‐based approaches and best practices infographics to enhance AI literacy for diverse learners including clinicians, trainees, and patients. This DI PRN opinion paper highlights the importance of proactive governance frameworks and equips and empowers diverse learners with practical AI literacy tools to confidently engage with AI technologies in patient care.

Most change in a profession or organization occurs on an evolutionary rather than a revolutionary basis, and is incremental. The seeds for the recognition of pharmacotherapy as a pharmacy practice specialty were planted by the founding members of the American College of Clinical Pharmacy (ACCP) in 1979. The ACCP was formed to advance excellence in clinical pharmacy practice, education, and research. One initial goal was to obtain recognition of clinical pharmacy as a distinct practice specialty. A 1980 ACCP Task Force on Specialty Recognition recommended that the College pursue this goal through a petition to the Board of Pharmaceutical Specialties (BPS). It further suggested that the petition be prepared with a broad base of representation from the profession. The ACCP initiated communications in 1981 with other pharmacy organizations, which eventually led to appointment of the Committee on Clinical Pharmacy as a Specialty. The committee began its work in November 1981. Many individuals within clinical pharmacy contributed to the development of the petition that was eventually submitted by the committee with ACCP sponsorship to the BPS in April 1986. The BPS conducted a formal review of the petition and concluded that clinical pharmacy as defined in the petition was too general to be recognized as a specialty. It encouraged ACCP to define the proposed specialty more narrowly and

Children warrant access to care from clinical pharmacists trained in pediatrics. The American College of Clinical Pharmacy Pediatrics Practice and Research Network (ACCP Pediatrics PRN) released an opinion paper in 2005 with recommendations for improving the quality and quantity of pediatric pharmacy education in colleges of pharmacy, residency programs, and fellowships. Although progress has been made in increasing the availability of pediatric residencies, there is still much to be done to meet the direct care needs of pediatric patients. The purpose of this joint opinion paper is to outline strategies and recommendations for expanding the quality and capacity of pediatric clinical pharmacy practitioners by elevating the minimum expectations for pharmacists entering pediatric practice, standardizing pediatric pharmacy education, expanding the current number of pediatric clinical pharmacists, and creating an infrastructure for development of pediatric clinical pharmacists and clinical scientists. These recommendations may be used to provide both a conceptual framework and action items for schools of pharmacy, health care systems, and policymakers to work together to increase the quality and quantity of pediatric training, practice, and research initiatives.