Review of Objective Structured Clinical Examination Practices Within Pharmacy Programs Throughout the United States.

OBJECTIVE: To update the description of current objective structured clinical examination (OSCE) practices within pharmacy schools in the United States and identify barriers to OSCE implementation and expansion. METHODS: A survey was deployed to all accredited Doctor of Pharmacy programs within the United States. The survey was designed to collect information regarding the curricular mapping of OSCEs, OSCE design, OSCE delivery, assessment of OSCE performance, and barriers to OSCE implementation and expansion. RESULTS: Of the 135 US-accredited programs identified, 109 (81%) programs completed the survey. In total, 93 (85%) programs reported using OSCEs to assess students; however, implementation throughout the curriculum and current practices varied by institution. Most programs place OSCEs within specific courses (96%), with the applied skills coursework being the most used (80%). The most common number of OSCEs that occur throughout a curriculum is 6 (18%), however, 20 (22%) programs execute 10 or more OSCEs throughout their curriculum. Forty (43%) programs use OSCEs as high-stakes assessments where poor performance could prevent a student from progressing to advanced pharmacy practice experiences. Of the responding programs, over half (56%) use teaching objective structured examinations to enhance learning. Common barriers to OSCE expansion exist and are related to resource utilization. CONCLUSION: Significant expansion of OSCE development and implementation has occurred over the last decade. There is substantial variability in implementation and utilization among programs. Although standards of best practice for OSCEs exist for other health professions, best practices in pharmacy education have not been widely accepted or adopted.

Zuranolone: The First FDA-Approved Oral Treatment Option for Postpartum Depression.

OBJECTIVE: The objective of this study was to review the characteristics, efficacy, and safety of zuranolone in the management of postpartum depression (PPD). DATA SOURCES: Literature was identified using PubMed (1966-August 2023) and EMBASE (1973-August 2023) and clinicaltrials.gov. Search terms included zuranolone, SAGE-217, and PPD with further limitation of those published in English. STUDY SELECTION AND DATA EXTRACTION: Articles selected for inclusion included trials evaluating zuranolone for the treatment of PPD. DATA SYNTHESIS: Zuranolone was evaluated for the treatment of moderate to severe PPD in 2 phase III trials. Both studies resulted in statistically significant improvement in depressive symptoms at day 15 (P = 0.003 and P < 0.001). Sustained differences in remission rates favoring zuranolone were found in both studies at day 45 compared with placebo (P = 0.01 and P < 0.05). Zuranolone was well tolerated, with somnolence, dizziness, headache, and sedation reported as the most common side effects. RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE IN COMPARISON TO EXISTING DRUGS: Zuranolone is only the second medication approved by the Food and Drug Administration (FDA) for PPD and offers an advantage over brexanolone in that it can administered orally in the outpatient setting. The rapid onset of effect of zuranolone is advantageous to traditional antidepressant therapy which can be weeks to months; however, limited information is available on safety during lactation. CONCLUSIONS: The recent FDA approval of oral zuranolone for PPD offers a second rapid-acting treatment for PPD, extending the opportunity for treatment to patients in the outpatient setting.

Survey of colleges and schools of pharmacy to determine restrictions for teaching, research, and advocacy related to contraception.

INTRODUCTION: The pharmacist's role in reproductive health is evolving. Since 46 states allow providers to refuse to provide reproductive health services, it is important to consider whether learning is impacted by institution restrictions on contraception teaching, advocacy, and research. METHODS: An electronic survey was emailed to deans of all pharmacy schools on the American Association of Colleges of Pharmacy Institutional Membership list with a request to share with faculty teaching women's health content within their curriculum. The survey collected information about contraception teaching, research, and advocacy. RESULTS: Of 145 schools contacted, 39 (27%) provided complete responses. Of these, 22 (56%) were public, not religiously-affiliated, seven (18%) were private, not religiously-affiliated, six (15%) were private, currently religiously-affiliated, and four were (10%) private, historically religiously-affiliated. All respondents taught hormonal contraception in the required curriculum and 15 (39%) taught miscarriage management/abortifacients. None reported restrictions on contraception teaching or research. One respondent cited an advocacy restriction for contraception methods due to violation of the school's beliefs, and another cited an advocacy restriction for miscarriage management/abortifacients. Respondents noted students expressed ethical questions/concerns about refusing to dispense contraception (59%), dispensing certain contraceptives (54%), dispensing to minors (46%), and dispensing all contraceptives (21%). Additionally, respondents reported pharmacists/faculty expressed ethical questions/concerns about refusing to dispense contraception (31%), dispensing to minors (21%), dispensing certain contraceptives (15%), and all contraceptives (13%). CONCLUSIONS: Overall, respondents reported no restrictions in contraception teaching and scholarship and minimal advocacy restrictions. Faculty should consider ethical questions/concerns from students, faculty, and pharmacists when teaching this material.

Ibrexafungerp in the Treatment of Vulvovaginal Candidiasis.

OBJECTIVE: To review the pharmacology, efficacy, and safety of ibrexafungerp in the management of vulvovaginal candidiasis (VVC). DATA SOURCES: Literature was sought using PubMed (1966-February 2022) and EMBASE (1973-February 2022), and clinicaltrials.gov. Search terms included ibrexafungerp, SCY-078, and VVC. STUDY SELECTION AND DATA EXTRACTION: All studies including humans and published in English with data assessing the efficacy and safety of ibrexafungerp for the treatment of VVC were evaluated. DATA SYNTHESIS: A phase 2 dose-finding study found ibrexafungerp had similar efficacy to fluconazole in the clinical cure of VVC (51.9% vs 58.3%, respectively). Two phase 3 clinical trials demonstrated ibrexafungerp had statistical superiority over placebo for clinical cure in moderate to severe VVC (P < 0.001 and P = 0.023, respectively). The most frequently reported adverse reactions in the clinical trials were gastrointestinal-related symptoms. To date, data comparing efficacy of ibrexafungerp and topical imidazoles in the treatment of VVC are nonexistent. RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE: Topical imidazoles and oral fluconazole are effective for the treatment of uncomplicated VVC. Due to increased resistance, limited fluconazole coverage for non-Candida albicans species, and potential for significant drug interactions associated with fluconazole use, alternative treatments for VVC are needed. Ibrexafungerp is a new oral triterpenoid antifungal agent indicated for the treatment of VVC. Additional clinical trials are needed to evaluate long-term safety data as well as efficacy and safety in specialty populations. CONCLUSION: Ibrexafungerp, a recently approved triterpenoid antifungal agent, is an effective and well-tolerated option for the treatment of VVC.

Peripartum Pharmacotherapy: A Pharmacist's Guide.

Complications throughout the peripartum period may be caused by preexisting conditions or pregnancy-induced conditions and may alter pharmacotherapy management. Pharmacotherapy management during late pregnancy and delivery requires careful consideration due to changing hormones, hemodynamic status, and pharmacokinetics, and concerns for potential maternal and/or fetal morbidity. Increased maternal and fetal monitoring are often required and may lead to therapy changes. Pharmacists, as key members of the interprofessional team, can contribute essential perspective to the management of postpartum pharmacotherapy through assessment and recommendation of appropriate and judicious use of medications.

Curricular Considerations for Preparing Student Pharmacists to Prescribe Hormonal Contraception.

In 2014, the pharmacist's role in the United States expanded to include prescribing hormonal contraception, and this practice is currently addressed by policy in 14 states and the District of Columbia. Training and education requirements for this expanded scope of practice vary between states and are changing rapidly. The objective of this review is to examine how student pharmacists are taught to provide contraceptive care, specifically for prescribing ongoing hormonal contraception and emergency contraception, and to identify potential gaps in the United States pharmacy curricula related to contraception. Despite steady adoption into community pharmacy practice, there is sparse literature assessing educational methods used to teach contraceptive care. This review offers recommendations to promote consistent and comprehensive student pharmacist education in providing contraceptive care across institutions, regardless of state policy status.

Ospemifene in the treatment of vulvovaginal atrophy.

OBJECTIVE: To review the pharmacology, efficacy, and safety of ospemifene in the management of dyspareunia. DATA SOURCES: Literature was sought using PubMed (1966-January 2014) and EMBASE (1973-January 2014). Search terms included ospemifene, FC-1271a, dyspareunia, vulvovaginal atrophy, and vaginal atrophy. STUDY SELECTION AND DATA EXTRACTION: All studies, including studies on humans, published in English with data assessing the efficacy and safety of ospemifene in the management of dyspareunia were evaluated. DATA SYNTHESIS: Ospemifene is a new oral estrogen receptor agonist/antagonist indicated for moderate to severe dyspareunia. Clinical trials evaluating efficacy have shown a significant improvement in superficial cells, parabasal cells, vaginal pH, vaginal dryness, and dyspareunia. The most frequently reported adverse drug reactions in the clinical trials included hot flashes, vaginal discharge, muscle spasms, and hyperhidrosis. Similar to systemic estrogen, boxed warnings with ospemifene include risk for thromboembolism and cerebrovascular disease. Additionally, patients with a uterus still need to use a progestogen with ospemifene to reduce the risk of hyperplasia. CONCLUSIONS: Ospemifene has been effective in improving symptoms of vulvovaginal atrophy when compared with placebo; however, no studies comparing ospemifene with estrogen products exist. Additional clinical trials are needed to evaluate the efficacy and safety in specialty populations, and long-term safety data are needed to assess the potential for serious adverse events. With the risks being similar to that for systemic estrogen therapy, ospemifene appears to be an alternative agent to estrogen therapy but does not have any advantages over estrogen.

Use of compounded bioidentical hormone therapy in menopausal women: an opinion statement of the Women's Health Practice and Research Network of the American College of Clinical Pharmacy.

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.

The use of galactogogues in the breastfeeding mother.

OBJECTIVE: To review data regarding the efficacy of galactogogues available in the US to increase breast milk production in postpartum mothers. DATA SOURCES: Literature was sought using PubMed (1966-June 2012) and EMBASE (1973-June 2012). Search terms included breastfeeding, breast milk, lactation, galactogogue, metoclopramide, oxytocin, fenugreek, milk thistle, silymarin, growth hormone, thyroid releasing hormone, medroxyprogesterone, domperidone, goat's rue, beer, Asparagus racemosus, shatavari, Medicago sativa, alfalfa, Onicus benedictus, blessed thistle, Galega officinalis, brewer's yeast, and herbals. STUDY SELECTION AND DATA EXTRACTION: All studies including humans and published in English with data assessing the efficacy of galactogogues for increasing breast milk production were evaluated. DATA SYNTHESIS: Breast milk is considered the optimal food source for newborns through 1 year of age. Many factors influence overall maternal production, including maternal pain, illness, balance of time when returning to work, anxiety, or emotional stress. Although a variety of herbal and pharmaceutical options have anecdotal evidence of their ability to improve breast milk production, peer-reviewed studies proving their efficacy are lacking. Metoclopramide, oxytocin, fenugreek, and milk thistle have shown mixed results in improving milk production; however, the trials were small and had a variety of limitations. CONCLUSIONS: Nonpharmacologic recommendations should be exhausted before adding therapy. Although anecdotal evidence encourages the use of metoclopramide, fenugreek, asparagus, and milk thistle for their galactogogue properties, efficacy and safety data in the literature are lacking. Oxytocin and domperidone are potentially available for compounding purposes, but safety data are limited. More studies are needed to evaluate the effects of available galactogogues on breast milk production.

Bevacizumab for the treatment of neovascular age-related macular degeneration.

OBJECTIVE: To review data regarding the efficacy and safety of bevacizumab for the treatment of neovascular age-related macular degeneration (nARMD). DATA SOURCES: Literature was searched using MEDLINE (1976-September 2011) and EMBASE (1973-September 2011). Search terms included bevacizumab, Avastin, neovascular macular degeneration, age-related macular degeneration, vascular endothelial growth factor, intravitreal, and safety. Reference citations were reviewed for relevant information. STUDY SELECTION AND DATA EXTRACTION: All randomized clinical trials published in English with data assessing the safety and efficacy of bevacizumab for nARMD were evaluated. DATA SYNTHESIS: The only Food and Drug Administration-approved treatments for nARMD are photodynamic therapy (PDT) with verteporfin, intravitreal pegaptanib, and ranibizumab. However, bevacizumab has gained attention as a potential agent in treating nARMD and is now widely used in practice. PDT with verteporfin and pegaptanib has shown only stabilization of visual acuity (VA). When the efficacy of bevacizumab was compared to these therapies, bevacizumab clinically and statistically improved VA outcomes. When compared to ranibizumab, which has also been shown to improve VA, bevacizumab showed no significant difference in VA outcomes and was associated with a decrease in average annual cost of $22,805. CONCLUSIONS: Bevacizumab administered intravitreally is appropriate for prevention of vision loss and recovery of VA in patients with nARMD. Although further analysis of long-term effects of bevacizumab on VA and safety is needed, it is potentially a more cost-effective option than ranibizumab for the treatment of nARMD.