ABSTRACT
The regulation of prescription drugs is an important health, safety, and equity issue. However, regulatory processes do not always consider evidence on sex, gender, and factors such as age and race, omissions that advocates have highlighted for several decades. Assessing the impact of sex-related factors is critical to ensuring drug safety and efficacy for females and males, and for informing clinical product monographs and consumer information. Gender-related factors affect prescribing, access to drugs, needs and desires for specific prescribed therapies. This article draws on a policy-research partnership project that examined the lifecycle management of prescription drugs in Canada using a sex and gender-based analysis plus (SGBA+) lens. In the same time period, Health Canada created a Scientific Advisory Committee on Health Products for Women, in part to examine drug regulation. We report on grey literature and selected regulatory documents to illustrate the extent to which sex and gender-based analysis plus (SGBA+) is utilized in regulation and policy. We identify omissions in the management of prescription drugs, and name opportunities for improvements by integrating SGBA+ into drug sponsor applications, clinical trials development, and pharmacovigilance. We report on recent efforts to incorporate sex disaggregated data and recommend ways that the management of prescription drugs can benefit from more integration of sex, gender, and equity.
Subject(s)
Prescription Drugs , Male , Humans , Female , Sex Factors , Advisory Committees , Prescriptions , CanadaABSTRACT
Drug-related adverse events or adverse drug reactions (ADRs) are currently partially or substantially under-reported. ADR reporting systems need to expand their focus to include sex- and gender-related factors in order to understand, prevent, or reduce the occurrence of ADRs in all people, particularly women. This scoping review describes adverse drug reactions reported to international pharmacovigilance databases. It identifies the drug classes most commonly associated with ADRs and synthesizes the evidence on ADRs utilizing a sex- and gender-based analysis plus (SGBA+) to assess the differential outcomes reported in the individual studies. We developed a systematic search strategy and applied it to six electronic databases, ultimately including 35 papers. Overall, the evidence shows that women are involved in more ADR reports than men across different countries, although in some cases, men experience more serious ADRs. Most studies were conducted in higher-income countries; the terms adverse drug reactions and adverse drug events are used interchangeably, and there is a lack of standardization between systems. Additional research is needed to identify the relationships between sex- and gender-related factors in the occurrence and reporting of ADRs to adequately detect and prevent ADRs, as well as to tailor and prepare effective reporting for the lifecycle management of drugs.
ABSTRACT
Comparative research involving consensually non-monogamous (CNM) relationships and outcomes related to well-being continues to grow as an area of interest within sexual science. However, claims of sameness and/or difference between groups rely on two critical, yet widely under-appreciated assumptions: that the concepts being compared between groups are the same (i.e., measurement invariance), and that logically and statistically coherent procedures are used for evaluating sameness (i.e., equivalence testing). We evaluated the state of measurement invariance and equivalence across three studies, involving different types of CNM comparisons (i.e., relationship types, partner types) and designs (analysis of primary individual data, primary dyadic data, and secondary data). Our invariance tests of CNM compared to monogamous individuals (Study 1) and "primary" compared to "secondary" partners in dyadic appraisal of CNM individuals (Study 2) revealed that many measures of well-being failed to replicate their measurement models and were not generalizable across relationship types or partner types. Our reanalyses of existing comparative CNM effects using individual and meta-analyzed equivalence tests (Study 3), meanwhile, indicated that this literature requires more consistent reporting practices and larger samples, as most studies produced uninformative tests of equivalence. Our results illustrate the importance of auxiliary hypothesis evaluation and statistical procedure selection for generating informative comparative tests. Our findings also highlight potential divergences in social construction of well-being. We offer suggestions for researchers, reviewers, and editors in terms of needed methodological reforms for future comparative CNM research.