A new program from the Office of Research on Women’s Health (ORWH) in the National Institutes of Health (NIH) is aiming to improve sex- and gender-specific training in science, medicine, and other health care professions by supporting curricula and courses that address the intentional integration of sex and gender considerations into NIH research. Specifically, as breakthroughs in women’s health research continue to occur at every stage of the biomedical research continuum, the paradigm shift from inclusion of women to the intentional integration of sex- and gender-related differences and information requires the development of new skills and innovative methodologies.
The program, called Galvanizing Health Equity Through Novel and Diverse Educational Resources (GENDER)R25, will fund courses and curricula for health care professionals at any career stage to help address issues related to how health is influenced by sex as a biological variable and/or gender as an identity, social, cultural, or structural variable. NIH officials will also host a technical assistance webinar on Wednesday, September 21, for all health care professionals who want to learn more; funded projects will result in the development of curricula, courses, and methods that can be utilized across disciplines and will be made available through the ORWH E-Learning webpage.
Specifically, Elizabeth Barr, PhD, an ORWH social and behavioral scientist administrator, explained further in an interview with Pharmacy Times that ORWH welcomes applications from pharmacy professionals, as well as other biomedical communities, as pharmacists are critical members of patient health care teams with direct impact on managing adverse effects (AEs), dosage, and polypharmacy—all of which can impact women more than men due to the limited nature of data on these subjects in relation to sex and gender-related differences.
“Despite concerted efforts, sex and gender remain underexplored in curricula within biomedical educational programs, including pharmacy programs,” Barr said. “As each health profession has its own discipline-specific language and accreditation standards, pharmacy professionals are ideally positioned to develop curricula to fill the gap within their field; we are hopeful that pharmacy professionals will consider submitting applications for the GENDER R25.”
With the understanding of the clear impacts sex and gender have on health, using clear terminology for sex and gender is essential to facilitate a more accurate study of human health and the delivery of health care by professionals in the field. The classification of sex—which is a multidimensional construct based on clusters of anatomical and physiological traits—can include external genitalia, secondary sex characteristics, gonads, chromosomes, and hormones. Gender, however, is often misunderstood as being an extension of or synonym for sex; instead, gender is a social and cultural variable that includes a variety of domains, including gender identity and expression, gender roles and norms, gender relations, structural sexism, power, and equity.
“Understanding the influence of gender on health…can facilitate the delivery of equitable care by all biomedical professionals,” Barr said. “Pharmacy professionals could all benefit from an enriched understanding of the domains of sex and gender [in their practices].”
By understanding the differences in terminology and the impact of both sex and gender on patient health, pharmacy professionals can better provide more effective individualized, patient-centered services. For example, at the individual level, health care professionals themselves can impact patient health care outcomes based on the results of 1-on-1 communication with patients regarding the patients experience of symptoms.
Moreover, gender can impact patient health on a relational and structural level as well. On the relational level, gender may have an impact on whether or not a patient may be experiencing intimate partner violence in their home setting, while structural impacts of gender can include varying levels of access to health care based on geographic location for certain female-specific conditions.
Federal law and NIH policy require clinical research funded by the NIH to include women, minorities, and individuals across the lifespan. Importantly, however, this does not only include enrolling women in studies, but must also require considering research design. Studies must be designed to detect the influence of sex on efficacy and safety. If women are included but sex-specific results are not collected and reported, women and health care professionals lack crucial knowledge that can influence patient health.
Further, sex differences can also have impacts on treatment outcomes, such as through varying levels of absorption, metabolism, and excretion of drugs. For example, women typically have different amounts of adipose tissue, different hormonal environments, and may have different kidney and liver functions compared with men, all of which can influence dosages and AEs. Despite these known impacts, women are often underrepresented in clinical trials, leading to results that may not be disaggregated by sex with potential drug distribution differences remaining unidentified.
Gender can also impact whether and how patients report AEs, as well as how those effects are perceived by health care professionals. Women have frequently reported that they experienced the dismissal of their reported symptoms in health care settings, with this experience confirmed in research published in professional journals. This dismissal of symptom experience can result in delayed dose adjustments, accumulative AEs, and even discontinuation of effective therapies.
Sex and gender issues also remain underexplored in biomedical education programs, including those in pharmacy schools. Due to their work with multiple specialists and health experts on patient care teams, pharmacists are perfectly positioned to have a critical role in impacting discussions of sex and gender differences and the use of appropriate terminology for patients by filling in gaps during communication with these professionals. GENDER R25 can help support pharmacists in these efforts by improving their education on these issues in pharmacy programs, which can also be utilized across other disciplines.
For pharmacists interested in learning more, the technical assistance webinar on Wednesday, September 21 will provide potential applicants a chance to learn about the scope, purpose, and requirements for the GENDER R25 program. Staff members at ORWH, participating NIH institutes and centers, and members from the NIH Center for Scientific Review will also be participating in the discussion to provide further details about the program and answer applicants’ questions. For those interested in applying for funding, non-AIDS-related applications are due by 5:00 pm EDT on October 27, 2022 and June 27, 2023, while HIV/AIDS-related applications are due January 7, 2023 and September 7, 2023.
“Discipline-specific training on sex and gender, such as what will be supported through the GENDER R25, provides pharmacy professionals with an opportunity to advance pharmacy education, research, and practice—and therefore improve human health,” Barr said. “The benefits of improved inclusion in clinical studies and enhanced integration of sex and gender in all aspects of pharmacy study and care are impressive and attainable.”
Additionally, ORWH will be offering other resources and programs for career development and interprofessional education, including:
Developed in partnership with the FDA Office of Women’s Health, the course explores sex- and gender-related differences in key disease areas. The 6 modules included provide biomedical researchers, clinicians, and students in health care professions with knowledge they can use when designing and conducting research and/or interpreting evidence for clinical practice.
Developed with funding support from the National Institute of General Medical Sciences, the course helps investigators understand and apply the NIH Policy on Sex as a Biological Variable (SABV) in research design, analyses, and reporting. The 4 modules of the course address basic, preclinical, clinical, and population health studies.
The 6-module course is designed for the biomedical research community to account for and appropriately teach the SABV policy.
A self-paced introductory training aimed at researchers, clinicians, and policymakers, the downloadable slide deck and accompanying facilitator’s guide can be used by individuals or teams to initiate a dialogue about how—and why—it may be beneficial to incorporate a sex-and-gender lens into research and clinical care.