Nicole E. Cieri- Hutcherson

Menopausal hormone therapy (MHT) remains the most effective treatment for vasomotor and genitourinary symptoms of menopause; however, its use declined sharply following the publication of the Women's Health Initiative (WHI). Misinterpretation and limitations of WHI findings have led to persistent misconceptions and underutilization of MHT. This expert opinion aims to clarify evidence‐based approaches to MHT selection, safety, and individualized management. This article was informed by a structured narrative review of the literature with the aim to contextualize evolving pharmacotherapeutic evidence and inform clinical decision‐making. PubMed/MEDLINE, Embase, and the Cochrane Library were searched for studies published from 2002 to 2025. Key opinion statements were developed through expert consensus and paired with a synthesis of contemporary evidence to form recommendations. A critical appraisal of the WHI and subsequent analyses demonstrates that age at initiation, timing since menopause, and hormone formulation utilized significantly influence outcomes. Contemporary data support the preferential use of transdermal estradiol due to its lower risk of venous thromboembolism and favor oral micronized progesterone (MP) over synthetic progestogens when endometrial protection is required. Individualization of therapy—including formulation, route, and dosing—is emphasized as central to optimizing the benefit–risk profile. Current evidence supports the safety of low‐dose vaginal estrogen for genitourinary syndrome of menopause including in cancer survivors. Further evidence highlights potential cardiovascular and cognitive benefits when MHT is initiated within 10 years of menopause. Clinicians caring for menopausal women should promote individualized, evidence‐based MHT through education, therapeutic selection, shared decision making, and ongoing monitoring. Continued research is needed to refine dosing targets, evaluate long‐term preventive outcomes, and expand evidence for modern formulations beyond WHI‐era therapies. Ultimately, MHT should be viewed not as a one‐size‐fits‐all therapy, but as a personalized, evidence‐informed strategy that supports the health and quality of life of menopausal women.

Background: With increasing involvement of pharmacists in clinical situations and expanding scope of practice, the expectation and management of uncertainty is a desirable component of pharmacy education, leading to improved uncertainty tolerance (UT) as pharmacists. Methods: The purpose of this pilot study was to determine whether an inpatient rounding simulation (IRS) that exposes student pharmacists to a level of uncertainty leads to changes in tolerance of ambiguity scale (TAS) scores and self-reflection comments. A pre-/post-observational, pilot survey study was conducted, including student pharmacists in their second professional year at the United States School of Pharmacy who were enrolled in an associated lab-based course in Spring 2024. Student teams completed a mock IRS and responded to clinical questions in a timed environment. Students completed pre-/post-simulation TAS and self-reflection on uncertainty/UT within the simulation. Pre-/post-simulation TAS scores were analyzed with a paired t-test. Qualitative analysis was used to identify themes in self-reflection. Results: 59 students responded (48% response rate). TAS was not different pre-/post-IRS (63.2 vs. 62.6, p = 0.63). When individual subscales were compared, a statistically significant difference was found in the insolubility subscale (10.5 vs. 9.5; p = 0.02). Themes of uncertainty that emerged during qualitative analysis of pre-simulation included the clinical question posed to the team. Student pharmacists overcame uncertainty pre-simulation by working with their team and relying on the availability of resources. Themes of uncertainty emerging during qualitative analysis of post-simulation included discerning the best answer. Student pharmacists overcame uncertainty post-simulation by working with their team and cited working with their team as a positive aspect of the IRS experience. Conclusions: In this pilot study, student pharmacists had high TAS scores both pre- and post-simulation. Students utilized their teams and cited this as a positive in an uncertain environment.

The objective of this systematic review was to characterize the literature regarding the risk factors associated with the development of toxic shock syndrome (TSS) secondary to the use of intrauterine contraceptives (IUCs), as well as patient outcomes. A literature search was conducted spanning origin through December 12, 2022, using Embase and MEDLINE ALL. Primary literature that discussed development of TSS along with the presence of an IUC were included. Extracted data included study and participant demographics, IUC data, and infection data. Reports were evaluated for risk-of-bias using the Joanna Briggs Institute critical appraisal tool for case reports. Thirteen reports met the eligibility criteria, all of which were case reports involving one patient per case who developed TSS following the insertion of an IUC or in the presence of an IUC. The patients included in the review were women aged 23 to 50 years old. Major outcomes reported included time of IUD insertion, bacteria cultured, and antibiotic therapies administered. A minority of the reports (n = 5) provided data related to recent or prior childbirth, miscarriages, or abortions, some of which were proposed to have contributed to development of TSS. Risk-of-bias assessments identified potential concerns in four domains. This systematic review characterized literature pertaining to IUC use and TSS. There may be a low but possible risk of TSS when using an IUC; generalizability is limited given the low quality of available studies. This study was neither registered nor funded.

The objective of this systematic review was to characterize the management of vaso-occlusive episodes (VOEs) in adult patients with SCD in the emergency department (ED) via implementation of a protocol or pathway intended to improve patient care for VOE-related pain. A literature search was conducted spanning origin through May 31, 2023, using Embase, MEDLINE ALL, and International Pharmaceutical Abstracts databases. Primary literature reporting on adult patients with SCD in a SCD-specific pathway or protocol in an ED setting was included. Data extracted included report design characteristics, patient demographics, descriptors of the pathway/protocol, pain outcomes, and hospital length of stay. The Cochrane Risk of Bias 2.0 tool was used to assess risk-of-bias in randomized controlled trials (RCTs). The Risk of Bias for Non-Randomized Studies of Interventions was used to assess risk-of-bias in nonrandomized trials (NRTs). Certainty of evidence was assessed via the Grading of Recommendations, Assessment, Development, and Evaluations tool. Nine reports met eligibility criteria: 2 reports of 1 RCT and 7 observational NRTs. The RCT had low risk-of-bias; 5 NRTs had moderate risk-of-bias, 2 had serious risk-of-bias. Improvements in time to first opioid, pain scores, length of ED treatment time, overall treatment time (length of stay), and inpatient readmission improved with policies/protocols for the management of VOEs in the ED setting. These 5 outcomes had a moderate certainty of evidence. Institutions should consider implementing protocols or pathways to improve management of VOEs in the ED.

Importance: Vasomotor symptoms (VMS) affect many postmenopausal persons and impact sleep and quality of life. Objective: This systematic review examines the literature describing the safety and efficacy of neurokinin-3 receptor antagonists approved and in development for postmenopausal persons with VMS. Evidence Review: A search of MEDLINE, EMBASE, and International Pharmaceutical Abstracts was conducted using the search terms and permutations of neurokinin-3 receptor antagonist, elinzanetant, fezolinetant, and osanetant. Inclusion criteria of reporting on efficacy or safety of fezolinetant, elinzanetant, or osanetant; studies in participants identifying as female; full record in English; and primary literature were applied. Abstract-only records were excluded. Extracted data were synthesized to allow comparison of reported study characteristics, efficacy outcomes, and safety events. Eligible records were evaluated for risk of bias via the Cochrane Risk of Bias 2 tool for randomized studies and the Grading of Recommendations Assessment, Development and Evaluation system was used. This study was neither funded nor registered. Findings: The search returned 191 records; 186 were screened after deduplication. Inclusion criteria were met by six randomized controlled trials (RCT), four reported on fezolinetant, and two reported on elinzanetant. One record was a post hoc analysis of a fezolinetant RCT. An additional study was identified outside the database search. Three fezolinetant RCT demonstrated a reduction in VMS frequency/severity, improvement in Menopause-Specific Quality of Life scores, and improvement in sleep quality at weeks 4 and 12 compared with placebo without serious adverse events. The two RCT on elinzanetant also showed improvements in VMS frequency and severity. All eight records evaluated safety through treatment-emergent adverse events; the most common adverse events were COVID-19, headache, somnolence, and gastrointestinal. Each record evaluated had a low risk of bias. There is a strong certainty of evidence as per the Grading of Recommendations Assessment, Development and Evaluation system. Conclusions and Relevance: Because of the high-quality evidence supporting the efficacy of fezolinetant and elinzanetant, these agents may be an effective option with mild adverse events for women seeking nonhormone treatment of VMS.

Introduction: Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality in the United States, and one in five COPD hospitalizations result in a readmission within 30 days. Pharmacists have been identified as key members of interdisciplinary teams to improve transitions of care.Objective: The objective of this study was to develop, implement, and evaluate outcomes for a pharmacist‐driven COPD transitions of care bundle at an academic medical center.Methods: A COPD care bundle was implemented for patients presenting with a COPD exacerbation from December 1, 2021 to February 28, 2022. A historical control group was created from patients who were discharged between December 1, 2020 and February 28, 2021. Patient characteristics, pharmacist‐driven interventions, and time required for the intervention were assessed descriptively. Inhaler technique was assessed before and after pharmacist education utilizing standardized rubrics. The percentage change in inhaler scores was assessed with a Wilcoxon signed‐rank test. Readmission outcomes were analyzed using a chi‐squared test.Results: There were 30 patients in the intervention group and 46 in the control group. There were 104 interventions requiring provider collaboration, of which 84 (81%) were accepted. A median (interquartile range, IQR) of 46 (37–55) min was spent per patient in the intervention group. At baseline, patients scored a median of 84.6% (75–100) of steps correctly across all inhaler device types. After pharmacist education, patient scores increased to a median of 100% [92.3–100] (p < 0.0001). There were eight (26.7%) 30‐day all‐cause readmission rates in the intervention group and 15 (32.6%) in the control group (p = 0.58).Conclusion: Most pharmacist recommendations were accepted by providers. Medication education led to improved understanding of inhaler technique, but there was no difference in 30‐day readmission rates. Further development of this service is warranted based on these findings.

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.