Death and Disability Reported with Cases of Vaccine Anaphylaxis Stratified by Administration Setting: An Analysis of the Vaccine Adverse Event Reporting System from 2017 to 2022.

The serious nature of post-vaccination anaphylaxis requires healthcare professionals to be adequately trained to respond to these hypersensitivity emergencies. The aim of this study was to compare outcomes reported with cases of vaccine anaphylaxis stratified by administration setting. We queried reports in the Vaccine Adverse Event Reporting System (VAERS) database from 2017 to 2022 and identified cases involving anaphylaxis with an onset within one day of vaccine administration. The primary outcome was the combined prevalence of death or disability for each setting while the secondary outcome was the prevalence of hospitalization. Adjusted (age, sex, prior history of allergy, vaccine type) odds ratios (aOR) and associated 95% confidence intervals (CI) were calculated using logistic regression analysis. A total of 2041 cases of anaphylaxis comprised the primary study cohort with representation in the sample from all 50 US states and the District of Columbia. The mean age was 43.3 ± 17.5 years, and most cases involved women (79.9%). Cases of anaphylaxis were reported after receiving a coronavirus vaccine (85.2%), influenza vaccine (5.9%), tetanus vaccine (2.2%), zoster vaccine (1.6%), measles vaccine (0.7%), and other vaccine (4.5%). Outcomes associated with reports of vaccine anaphylaxis included 35 cases of death and disability and 219 hospitalizations. Compared with all other settings, the aOR of death and disability when anaphylaxis occurred was 1.92 (95% CI, 0.86-4.54) in a medical provider's office, 0.85 (95% CI, 0.26-2.43) in a pharmacy and 1.01 (95% CI, 0.15-3.94) in a public health clinic. Compared with all other settings, the aOR of hospitalization when anaphylaxis occurred was 1.02 (95% CI, 0.71-1.47) in a medical provider's office, 1.06 (95% CI, 0.72-1.54) in a pharmacy, and 1.12 (95% CI, 0.61-1.93) in a public health clinic. An analysis of a national database across six years revealed no significant differences in the odds of death/disability and odds of hospitalization associated with post-vaccination anaphylaxis in the medical office, pharmacy, and public health clinic compared with all other settings. This study expands our understanding of the safety of immunization services and reinforces that all settings must be prepared to respond to such an emergency.

Oriahnn: New Drug Approved for Treating Heavy Menstrual Bleeding in Women With Uterine Fibroids.

OBJECTIVE: To review data of elagolix plus estradiol and norethindrone acetate as add-back therapy for the treatment of heavy menstrual bleeding (HMB) in premenopausal women with uterine fibroids. DATA SOURCES: Literature search of PubMed/MEDLINE and SCOPUS was performed using the search terms Oriahnn; elagolix, estradiol, norethindrone AND heavy menstrual bleeding; elagolix AND heavy menstrual bleeding; and gonadotropin-releasing hormone receptor antagonist AND heavy menstrual bleeding between January 1, 1996, to March 2, 2021. Additional data were obtained from prescribing information, references of identified articles, and abstracts from scientific meetings. STUDY SELECTION/DATA EXTRACTION: Clinical trials and articles discussing elagolix plus add-back therapy for the management of HMB in women with leiomyomas were included. DATA SYNTHESIS: Phase 3 trials met the primary end point of menstrual blood loss (MBL) less than 80 mL at month 6 and at least a 50% reduction in MBL from baseline to the final month in 68.5% of women taking elagolix plus add-back therapy enrolled in UF-1 (8.7% placebo) and 76.5% of women in UF-2 (10% placebo). The most common adverse effects include hot flushes, nausea, headache, and night sweats. RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE: Women with symptomatic uterine fibroids can experience significant HMB resulting in distress, depression, and anxiety. Surgical intervention remains the most commonly recommended and chosen treatment. Elagolix plus add-back therapy is a nonsurgical, oral option. CONCLUSIONS: Elagolix plus add-back therapy is effective in reducing menstrual bleeding associated with uterine fibroids. However, there are several warnings and precautions that must be considered.

Effect of a Simulated Activity on Student Ability, Preparedness, and Confidence in Applying the Pharmacists' Patient Care Process to Contraceptive Prescribing.

Several states now permit pharmacists to prescribe hormonal contraception. Consequently, some schools of pharmacy now incorporate activities intending to prepare students to offer this service. This study aimed to assess the impact of a simulated activity on student pharmacists' readiness for, ability to use, and confidence in applying the Pharmacists Patient Care Process along with the United States Medical Eligibility Criteria to a patient seeking contraception. Students completed a contraceptive-prescribing simulation with standardized patients. Scores were analyzed for safe and appropriate prescribing practices. Pre- and post-workshop surveys measured confidence and perceived preparedness. Chi-square and Mann-Whitney U tests were used to analyze categorical variables and Likert-scale data, respectively.The mean activity score was 86% (median 90%), with significant change in student confidence of ability to complete the process (p < 0.0001). The majority of students at baseline (52.2%) and follow up (53.2%) reported needing more practice during advanced pharmacy practice experiences (APPEs) to feel prepared. There was a significant change pre/post in students who agreed that their curriculum prepared them (15% to 28.7%, p = 0.0014). This study suggests that students are able to safely and appropriately prescribe contraception in a simulated activity. The activity increased student reported confidence and moved some students towards readiness for contraceptive prescribing.

Bremelanotide: New Drug Approved for Treating Hypoactive Sexual Desire Disorder.

Objective: To review data regarding bremelanotide, a recently approved therapy for hypoactive sexual desire disorder (HSDD). Data Sources: Literature search of Medline, SCOPUS, and EMBASE was performed using the search terms bremelanotide, bremelanotide injection, Vyleesi, and melanocortin 4 receptor agonist between January 1, 1996, and December 15, 2019. Reference lists from included articles were also reviewed for pertinent citations. Study Selection/Data Extraction: We included phase 2 and 3 trials of bremelanotide. There were 2 reports of phase 3 trials and 2 reports of phase 2 trials. Additional information from supplementary analyses was also referenced. Data Synthesis: Bremelanotide demonstrates significant improvement in desire and a significant decrease in distress related to lack of desire. The most common adverse effects include nausea (39.9%), facial flushing (20.4%), and headache (11%). Relevance to Patient Care and Clinical Practice: Bremelanotide is the second Food and Drug Administration-approved medication for the treatment of HSDD. Bremelanotide's place in therapy is unknown, as the HSDD guidelines were last updated in 2017. Although the trials met statistical significance for change in sexual desire elements and distress related to sexual desire, the clinical benefit may only be modest. Conclusion: Bremelanotide is a subcutaneous injection that can be administered as needed approximately 45 minutes prior to sexual activity. Bremelanotide is safe and has limited drug-drug interactions, including no clinically significant interactions with ethanol. Prescribing guidelines recommend no more than 1 dose in 24 hours and no more than 8 doses per month. Individuals should discontinue use after 8 weeks without benefit.

Assessment of a simulated contraceptive prescribing activity for pharmacy students.

BACKGROUND AND PURPOSE: The role of the pharmacist has been shifting rapidly. One example of change is the passage of legislation allowing pharmacists to independently initiate self-administered hormonal contraceptives in several states. There is no evidence of this specific topic being covered in pharmacy school curricula, and many states are requiring additional post-graduate training. This activity was designed to determine the utility of a contraceptive prescribing simulation activity for pharmacy students. EDUCATIONAL ACTIVITY AND SETTING: Pharmacy students enrolled in a women's health elective learned about relevant state legislation and attended a clinical skills center simulation activity where they utilized an available prescribing algorithm. Students completed two scenarios and received grades based on their clinical decision-making and patient interaction skills. An electronic survey was distributed post-activity to assess student satisfaction and confidence when prescribing contraceptives. Responses and grades on the assignment were analyzed to determine the activity's utility. FINDINGS: Students finished with median scores of 15, 14.8, and 14.5 out of 15 possible points for the three scenarios. Students reported overall satisfaction with the activity, with general agreement that the activity was realistic and made them feel like they were prepared to prescribe contraceptives. SUMMARY: Independently initiating contraceptives is a novel practice area for pharmacists. This activity introduced students to the process of prescribing using realistic forms and scenarios. The utility of the activity was twofold - it introduced students to the changing environment of pharmacy practice and allowed students to apply their knowledge of contraceptives and women's health. Students performed well on the activity and reported high levels of satisfaction.