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.

The Nuances Surrounding Insulin Prescribing.

Knowledge of and expertise in insulin prescribing is crucial for health care providers who care for people with diabetes. This article reviews the available insulin preparations, how they are packaged, and nuances related to storage and use that inform the prescribing of this life-saving medication for patients. Insulin prescribing that is done correctly will save time and reduce problematic errors that could put patients at risk.

Administration Rates of the Tdap Vaccine in Obstetric Patients.

BACKGROUND: Infants younger than 6 months of age are at high risk for contracting pertussis because of not being fully vaccinated. The Advisory Committee on Immunization Practices (ACIP) recommends vaccinating all pregnant women with tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) between 27 and 36 weeks to offer passive immunity to the infant to help protect them until they are able to receive the full pertussis series. OBJECTIVE: To assess and compare compliance with the 2013 ACIP recommendation of vaccinating pregnant women with Tdap at 27 to 36 weeks' gestation in 2 obstetric clinics. METHODS: This cross-sectional, retrospective chart review evaluated Tdap vaccine compliance in a random sample of obstetric patients from October 2013 to September 2014. The primary outcome evaluated the proportion of patients who received Tdap between 27 and 36 weeks' gestation. Secondary outcomes included the proportion of patients who received Tdap at any point in pregnancy and within 30 days postpartum. RESULTS: The charts of 573 patients were reviewed, and 237 met inclusion criteria. For the primary outcome, 142 patients (59.9%) received the Tdap vaccine. Overall, 156 patients (65.8%) received Tdap at some point during the pregnancy. Factors associated with receiving the Tdap vaccination were insurance status, prenatal care risk level and site of prenatal care, receipt of the influenza vaccine, and preterm labor in the current pregnancy. CONCLUSION: The Tdap vaccine rate was 65.8%, with 59.9% of patients receiving the vaccine within the recommended ACIP timeframe. Further education, improvements in documentation, and chart reminders are needed to enhance administration.

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.

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.

Safety of the HPV Bivalent and Quadrivalent Vaccines During Pregnancy.

OBJECTIVE: To evaluate the safety of the human papillomavirus (HPV) bivalent and quadrivalent vaccines in pregnancy. DATA SOURCE: PubMed (1966-August 2010) was searched using the terms human papillomavirus, human papillomavirus vaccine, and pregnancy. References were reviewed for relevant information. STUDY SELECTION AND DATA EXTRACTION: All studies including humans that were published in English with data describing HPV vaccine administration in pregnancy were evaluated. DATA SYNTHESIS: Two combined analyses of 7 Phase 3 efficacy trials have retrospectively evaluated the safety of unintentional administration of either the bivalent (n = 1786) or quadrivalent (n = 2085) HPV vaccine during pregnancy. In addition, postmarketing pregnancy registry surveillance data (prospective, n = 787; retrospective, n = 76) for the quadrivalent HPV vaccine have been published. However, only 279 pregnancies from the studies and 90 pregnancies from the registry occurred within 30 days of receiving the vaccination. Overall, the vaccine does not appear to be associated with an increased risk of spontaneous abortion, fetal malformations, or adverse pregnancy outcomes beyond that found in the general population. Although the data are limited, neither HPV vaccine appears to be associated with an increased risk of adverse pregnancy outcomes. However, limitations of the data include small patient populations, minimal to no adjustments for factors known to influence pregnancy outcomes or malformations, and the majority of the available pregnancy data are from retrospective analysis of Phase 3 efficacy trials. CONCLUSIONS: Neither HPV vaccine should be routinely administered during pregnancy. If a pregnancy occurs midseries, the remaining vaccines should be given after pregnancy completion. Further studies are required to determine actual risk.

Pharmacists' Perspectives on Prescribing and Expanding Access to Hormonal Contraception in Pharmacies in the United States.

INTRODUCTION: Pharmacist prescribing of contraception is becoming increasingly available in selected states. The objective of this study was to assess US community pharmacists' perspectives on expanding access, barriers, and facilitators since states have begun pharmacist scope of practice expansions for prescribing contraception. METHODS: A survey study of US community pharmacists' support for expanded access models, pharmacist prescribing practices and interest, and importance of safety, cost, and professional practice issues for prescribing was conducted. RESULTS: Pharmacists are generally supportive of pharmacist prescribing and behind-the-counter models for hormonal contraception and generally opposed to over-the-counter access. A majority (65%) are interested in prescribing hormonal contraception. The top motivation for prescribing contraception is enjoying individual patient contact (94%). Safety concerns (eg, patients not obtaining health screenings) remained most important for pharmacist implementation, followed by cost (eg, lack of payment or reimbursement for pharmacists' services), and professional practice (eg, pharmacist time constraints and liability) issues. CONCLUSION: This study provides an updated understanding of attitudes toward models of expanded access to hormonal contraception, interest in prescribing, and barriers and facilitators to this service among community pharmacists. Many barriers such as time and reimbursement remain unchanged. This information can inform policy and implementation efforts.

The prophylactic role for the human papillomavirus quadrivalent vaccine in males.

OBJECTIVE: To determine the role of human papillomavirus (HPV) quadrivalent vaccine in males. DATA SOURCE: PubMed (1966-March 2010) was searched using the terms human papillomavirus, human papillomavirus vaccine, quadrivalent, males, cancer, and genital warts. Reference citations were reviewed for relevant information. STUDY SELECTION AND DATA EXTRACTION: All studies including humans and published in English with data describing HPV quadrivalent vaccine administration in males were evaluated. DATA SYNTHESIS: The HPV quadrivalent vaccine is currently recommended in females, but its role in males is still being defined. Three clinical trials evaluated the immunogenicity and tolerability of the vaccine in more than 1100 males 9-26 years of age. Greater than 99.5% of males seroconverted for HPV 6, 11, 16, and 18 at 1 month post-completion and titers were found to be numerically higher than those in females 16-26 years old. One study found that immune response persisted in >92.5% of males at 1 year. The results show high efficacy against detection of new anogenital lesions in males 29 months after receiving the quadrivalent HPV vaccine. In addition, the quadrivalent HPV vaccine appears to be well tolerated, with the most common adverse effects being syncope, fever, local site reactions, dizziness, nausea, and headache. CONCLUSIONS: The HPV quadrivalent vaccine appears to be safe and induces an effective immune response in males. It may also decrease the incidence of anogenital and penile cancer, although current data are limited in number and duration of follow-up. Further analysis of the long-term immunogenicity and effects on HPV-associated complications is needed.

Evaluation of the impact of body mass index on warfarin requirements in hospitalized patients.

BACKGROUND: Despite well established empiric dose adjustments for drug and disease-state interactions, the impact of body mass index (BM) on warfarin remains unclear. The objective of this study is to evaluate warfarin requirements in hospitalized patients, stratified by BMI. METHODS: This retrospective review included two cohorts of patients: cohort A (patients admitted with a therapeutic international normalized ratio (INR)) and cohort B (newly initiated on warfarin during hospitalization). Exclusion criteria included: age under 18 years, pregnancy, INR (goal 2.5-3.5), and warfarin thromboprophylaxis post orthopedic surgery. The primary outcome was mean total weekly dose (TWD) of warfarin based on weight classification: underweight (BMI <18 kg/m2), normal/overweight (BMI 18-29.9 kg/m2), obese (BMI 30-39.9 kg/m2), and morbidly obese (BMI ⩾ 40 kg/m2). Data were extracted from two community hospitals in reverse chronologic order during July 2015-June 2013 until both study institutions evaluated 100 patients per cohort in each BMI classification or until all patients had been evaluated within the prespecified timeframe. RESULTS: A total of 585 patients were included in cohort A (26 underweight, 200 normal/overweight, 200 obese, 159 morbidly obese). There was a statistically significant difference in TWD as determined by one-way analysis of variance ( p < 0.05). A Tukey post hoc test revealed a statistically significantly higher TWD in morbidly obese (41.5 mg) compared with underweight (25.6 mg, p < 0.05), normal/overweight (28.8 mg, p < 0.05) and obese patients (32.4 mg, p < 0.05). In cohort B, 379 patients were evaluated (9 underweight, 166 normal/overweight, 152 obese, 52 morbidly obese). Overall, 191 patients had a therapeutic INR on discharge (88.9% underweight, 52.4% normal/overweight, 44.1% obese, 55.8% morbidly obese, p = 0.035). Of those, there was a statistically significant difference in TWD ( p = 0.021) with a higher TWD in the morbidly obese (41 mg) compared with underweight patients (24.4 mg, p = 0.017). CONCLUSIONS: Based on the results of this study, morbidly obese patients may require higher TWD to obtain and maintain a therapeutic INR.

Utilization of external reviews by colleges of pharmacy during the promotion and tenure process for pharmacy practice faculty.

OBJECTIVE: To evaluate the use of external reviews by colleges of pharmacy (COP) during the promotion and tenure process for pharmacy practice faculty. METHODS: A 25-item web-based survey was sent to 112 Pharmacy Practice Department Chairs. Results were analyzed via descriptive statistics. RESULTS: Fifty-four of 112 colleges (48%) responded to the survey, although respondents had the option to skip questions. Of those who responded, 82% utilize external review in their Promotion and Tenure evaluation. At the majority of colleges that responded, reviewers are selected from a combination of sources including the candidates' personal list and in most circumstances someone other than the candidate contacts the reviewer to determine interest and availability. At almost all responding colleges, the reviewer receives the candidate's curriculum vitae and specific guidelines for completing the review. Based upon 40 respondents, colleges request the reviewer(s) to evaluate the candidate's research (100%), teaching (80%), clinical practice (73%) and external service (73%). CONCLUSION: The goal of this project was to examine the current use of external review during the Promotion and Tenure process for pharmacy practice faculty. This data is a sample of what is being done at the schools that responded. The majority of responding COP utilize external reviews, however methods and requirements vary considerably.

Pneumococcal vaccination process improvement in an acute care setting.

BACKGROUND AND OBJECTIVE: Despite the availability of the pneumococcal vaccine since 1977, the vaccine is greatly underutilised. Centers for Medicare and Medicaid Services, The Joint Commission and Healthy People 2010 have all listed the administration of the pneumococcal vaccine before hospital discharge as a standard of care and a quality initiative in the 21st century. SSM St Mary's Health Center chartered a multidisciplinary team to address a disappointing pneumococcal vaccination rate of 34.7% in the first quarter of 2005. METHODS: The team utilised the improvement model of Plan-Do-Study-Act to implement and monitor process changes. Changes were made to four key steps in the pneumococcal vaccination process: assessment, ordering, obtaining and administering. The team also implemented a concurrent review process. The team tracked the hospital's pneumococcal vaccination rate per the published Centers for Medicare and Medicaid Services and The Joint Commission guidelines. RESULTS: Over a 2-year period, the vaccination rate of pneumonia patients has improved incrementally from 34.7% and is now consistently greater than 90%. CONCLUSION: Utilising Plan-Do-Study-Act allows for continual improvement of the vaccination process. Multiple cycles are necessary to achieve standardisation and optimal process flow.