Ultra-complex specialty medications: Meeting the challenges of significant medication requirements through an integrated specialty pharmacy model.

DISCLAIMER: In an effort to expedite the publication of articles, AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. PURPOSE: There is a growing number of specialty medications with accompanying requirements that exceed standard characteristics, which may be referred to as "ultra complex." This article details examples of ultra-complex specialty medications, including the characteristics that make them ultra complex, and strategies implemented by an integrated health-system specialty pharmacy (IHSSP) to maintain an optimal patient journey. SUMMARY: Before therapy initiation, ultra-complex specialty medications often require additional steps that go beyond what is required of traditional specialty treatments, such as ensuring patients have appointments scheduled and attended and coordinating medical procedures. At the time of initiation, ultra-complex therapy might require additional immunizations or dosing based on specific tests. Finally, specialty pharmacists managing ultra-complex medications often have to dedicate more time and effort to medication monitoring to ensure patients are able to stay on appropriate doses without treatment interruption. Manufacturers of ultra-complex medications must consider the resources and requirements that will be needed to ensure the success of these medications in the real world. Health systems must be aware of resource and staffing requirements necessary to ensure the success of ultra-complex medications. One consideration is the addition of a dedicated risk evaluation and mitigation strategy (REMS) pharmacist whose primary role is to ensure compliance with REMS requirements. CONCLUSION: Ultra-complex specialty medications provide unprecedented therapeutic advancements but demand multidisciplinary resources and workflows to enable safe medication initiation, appropriate dosing and monitoring, and achievement of desired therapeutic goals. IHSSPs are integrated into the care team and provide advanced monitoring capabilities, making them an ideal setting for managing ultra-complex specialty medications. External IHSSP partnerships working together before and after the launch of ultra-complex specialty medications allow for an optimal patient and provider journey from medication initiation through ongoing care coordination and monitoring.

Gender matters: condom use and nonuse among behaviorally bisexual men.

Although frequently cited as being at high risk for HIV/STI transmission, little is known about behaviorally bisexual men's patterns and experiences of condom use and nonuse with male and female sexual partners. Using a variety of recruitment techniques informed by a Community Advisory Committee, a total of 77 behaviorally bisexual men were recruited from Indianapolis, Indiana to participate in semi-structured interviews focused on sexual health. Qualitative data were collected containing detailed information on their patterns and experiences of condom use and nonuse with both male and female partners. Participants described numerous commonly reported barriers for consistent condom use, as well as distinct bisexual-specific barriers. The majority reported consistent condom use with male and female casual partners, but many who did not use condoms described doing so in the context of ongoing relationships. In addition, participants provided reasons for condom use and nonuse that varied based on the gender of the partner and the type of relationship with the partner. Future interventions focused on increasing condom use among behaviorally bisexual men should take into account the unique complexities of gender and relationship configurations in this distinct population.

Sexual behaviors and experiences among behaviorally bisexual men in the midwestern United States.

Research examining the sexual behaviors and experiences of behaviorally bisexual men is limited. Most studies focus primarily on highlighting sexual risk behaviors among groups of "men who have sex with men (MSM)" or "gay and bisexual men," which may not be appropriate in terms of behaviorally bisexual men's sexual repertoires with both men and women. This study aimed to assess a broad range of sexual behaviors and associated experiences among bisexual men living in the midwestern United States. An interviewer-administered questionnaire containing items from the National Survey of Sexual Health and Behavior assessed lifetime and recent (i.e., past 6 months and last event) sexual behaviors and experiences with both male and female partners among a diverse sample of 75 behaviorally bisexual men. Responses were quantified and analyzed using descriptive and multivariate statistics. A wide range of sexual behaviors with partners of both genders was found. Vaginal intercourse and oral sex with both men and women were the most commonly reported behaviors. Subjective reports of pleasure, arousal, and sexual function during sexual activity were similar with both male and female sexual partners. Many participants reported using condoms during insertive sexual behaviors with male and female partners, but less during oral sex. Unprotected receptive anal sex was less commonly reported. Overall, participants reported a variety of sexual behaviors and experiences; however, unlike other populations, they shared these with partners of both genders. Results have implications for interventions targeting the sexual behaviors and associated issues among behaviorally bisexual men.

Community involvement among behaviourally bisexual men in the Midwestern USA: experiences and perceptions across communities.

Limited research exists regarding community involvement and social support among behaviourally bisexual men. Previous studies suggest that bisexual men experience high levels of social stigma in both heterosexual and homosexual community settings. Research focusing on social support has demonstrated that individuals with limited access to similar individuals experience greater risk for negative health outcomes. Using a community-based research design, participants were recruited using multiple methods. Researchers conducted in-depth, semi-structured interviews with 75 men who reported having engaged in bisexual behaviour within the past six months. Interviews elucidated the experiences of behaviourally bisexual men in heterosexual and homosexual settings, as well as their perceptions of the existence of a bisexual community or bisexual spaces. All participants perceived a lack of a visible bisexual community and expressed difficulty with being comfortable, or a feeling of belonging, within a variety of heterosexual and homosexual community spaces. Findings suggest the need for interventions focused on community building among, as well as creating spaces specifically designed for, bisexual men in order to increase perceived social support and decrease isolation and possible negative health outcomes.

Individual and Social Factors Related to Mental Health Concerns among Bisexual Men in the Midwestern United States.

Research has not yet explored the potential impact of social stress, biphobia, and other factors on the mental health of bisexual men. In-depth interviews were conducted with a diverse sample of 75 men who engaged in bisexual behavior within the past six months. Interviewers explored potential mental health stressors and supports. Many participants reported personal and social challenges associated with bisexuality, which in turn influenced their mental health. Reported instances of stigma toward bisexuality, from both homosexual and heterosexual individuals, impacted participants' feelings regarding their own sexualities. Isolation was also commonly reported. Programs are greatly needed that focus on the specific mental health and other concerns voiced by these men. Based on our study findings, such programs should emphasize self-acceptance, social network and community building, and ways to maximize available social support, similar to community-level empowerment interventions that have shown success among gay-identified men.

Subjective Sexual Experiences of Behaviorally Bisexual Men in the Midwestern United States: Sexual Attraction, Sexual Behaviors, & Condom Use.

Studies concerning behaviorally bisexual men continue to focus on understanding sexual risk in according to a narrow range of sexual behaviors. Few studies have explored the subjective meanings and experiences related to bisexual men's sexual behaviors with both male and female partners. In-depth, semi-structured interviews were conducted with 75 men who engaged in bisexual behavior within the past six months. Participants were asked about their subjective sexual experiences with male and female partners. Findings suggest adherence to normative gender roles, with attraction to men and women conforming to these stereotypes, as well as a segregation of sexual behaviors along gendered lines. Overall, condom use was influenced by perceptions of potential negative consequences. Based on these findings, it remains critical that public health and other social and behavioral sciences continue to study bisexual men's sexual health issues as separate and distinct from their exclusively homosexual and heterosexual counterparts.

Sexual Behaviors and Experiences among Behaviorally Bisexual Latino Men in the Midwestern United States: Implications for Sexual Health Interventions.

The Midwestern United States (U.S.) has a high number of recent Latino migrants, but little information is available regarding their sexual behaviors. A total of 75 behaviorally bisexual men (25 Latino, 25 Black, and 25 White) participated in an exploratory study on sexual health. The data presented in this paper are restricted to the 25 self-identified Latino men. Qualitative in-depth interviews were conducted and optional self-administered sexual transmitted infection (STI) screening was provided. The measures used were taken from the National Survey of Sexual Health and Behavior (NSSHB), a probability study of the sexual behaviors of nearly 6000 individuals aged 14-94 in the U.S. In our sample of bisexual men, the most commonly reported sexual behaviors were masturbation, vaginal intercourse, and receiving oral sex from male and female partners. The majority of the participants were the insertive partner during anal sex with male partners. Many of the participants reported alcohol use during their most recent sexual activity. A fair number reported not using condoms during their last sexual event. Pleasure, arousal, orgasm, and erectile functioning were markedly similar despite partner gender. A small number of participants also engaged in sexual activities with transgender individuals. All of the Latino participants took part in the optional self-collection for STI specimens. The results of the study provide rich insights into the sexual behavior and related factors, as well as potential risk behaviors of bisexual Latino men that may be targeted for future sexual health promotion efforts.

The significance of privacy and trust in providing health-related services to behaviorally bisexual men in the United States.

Previous research suggests that bisexual men face unique health concerns in comparison to their exclusively homosexual and heterosexual counterparts. However, little is known about behaviorally bisexual men's experiences with health services, including ways of providing services that would be most appropriate to meet the health needs of this population. This study sought to understand preferences for health-related services among behaviorally bisexual men in the Midwestern United States. Using a community-based research approach, a diverse sample of 75 behaviorally bisexual men was recruited for in-depth interviews. Qualitative data were analyzed utilizing inductive coding through established team-based protocols to ensure reliability. Themes emerged involving the importance of privacy and trust when reaching, recruiting, and engaging behaviorally bisexual men in health services. Findings suggest that multifaceted approaches are needed, including those that provide relevant and confidential services while allowing for the development and ongoing maintenance of trust.

Rectal self-sampling in non-clinical venues for detection of sexually transmissible infections among behaviourally bisexual men.

Rectal sexually transmissible infections are a common health concern for men who have sex with men but little is known about these infections among men who have sex with both men and women. Self-obtained rectal specimens were collected from a diverse sample of behaviourally bisexual men. From a total sample of 75 bisexual men, 58 collected specimens. A relatively high prevalence of rectal Chlamydia trachomatis infection was found. Participants who collected specimens reported overall acceptability and comfort with self-sampling. Future efforts are needed focusing on increasing awareness of and options for rectal sexually transmissible infection testing among bisexual men.

Sexual health and life experiences: voices from behaviourally bisexual Latino men in the Midwestern USA.

Research on behaviourally bisexual Latino men in the USA has not yet examined sexual health issues among men living in diverse areas of the nation, including the Midwest. A community-based participatory research approach was used to engage a diverse sample of 75 behaviourally bisexual men (25 White, 25 Black and 25 Latino). Semi-structured interviews were conducted and standard qualitative analysis procedures were used to explore data from the 25 Latino participants. Men described their unique migration experiences as behaviourally bisexual men in this area of the USA, as well as related sexual risk behaviours and health concerns. Lack of culturally congruent public health and community resources for behaviourally bisexual men in the Midwestern USA were identified as significant barriers. As in other studies, familial and community relationships were significant for the participants, especially in terms of the decision to disclose or not disclose their bisexuality. Additionally, alcohol and other drugs were often used while engaging in sexual behaviours particularly with male and transgender, as well as female, partners. Behaviourally bisexual Latino men may benefit from receiving positive and affirmative individual- and structural-level support in regards to their unique experiences in this and other settings.