Sex, Gender, and the Regulation of Prescription Drugs: Omissions and Opportunities.

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.

Sex, Gender, and Alcohol Use: Implications for Women and Low-Risk Drinking Guidelines.

Alcohol use is coming under increasing scrutiny with respect to its health impacts on the body. In this vein, several high-income countries have issued low-risk drinking guidelines in the past decade, aiming to educate the public on safer levels of alcohol use. Research on the sex-specific health effects of alcohol has indicated higher damage with lower amounts of alcohol for females as well as overall sex differences in the pharmacokinetics of alcohol in male and female bodies. Research on gender-related factors, while culturally dependent, indicates increased susceptibility to sexual assault and intimate partner violence as well as more negative gender norms and stereotypes about alcohol use for women. Sex- and gender-specific guidelines have been issued in some countries, suggesting lower amounts of alcohol consumption for women than men; however, in other countries, sex- and gender-blind advice has been issued. This article reports on a synthesis of the evidence on both sex- and gender-related factors affecting safer levels of drinking alcohol with an emphasis on women's use. We conclude that supporting and expanding the development of sex- and gender-specific low-risk drinking guidelines offers more nuanced and educative information to clinicians and consumers and will particularly benefit women and girls.

A Sex- and Gender-Based Analysis of Adverse Drug Reactions: A Scoping Review of Pharmacovigilance Databases.

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.

Where Sexual Orientation Has No Name: Sexual Orientation Missing Data in the Canadian Community Health Survey (2005-2014).

This study used data from the Canadian Community Health Survey (CCHS) (2005-2014) to analyze the relationships between sexual orientation item nonresponse and interview language, conversation language, migration status (migrant-non-migrant), cultural background, sex, age, education level, and marital status in a cross-sectional sample over 18 (n = 351,713 participants). Item nonresponse rates oscillated between 0.87% in 2007 and 1.4% in 2014. Individuals who self-declared as belonging to cultural groups such as Chinese, South Asian, South East Asian, Arab, Indigenous and Other had higher nonresponse odds compared to people who self-identified as Whites. The results showed significant higher nonresponse odds among immigrants. Women had higher nonresponse rates. The likelihood of non-answer increased with age and decreased with education. French interviews, interviews in other languages and speaking both English and French produced less nonresponse. Contrary to common beliefs, sexual orientation questions are not too controversial. Sexual orientation nonresponse is low and stable over time suggesting that research participants are willing to answer sexual orientation questions. These findings highlight that immigrants and people who self-declare as belonging to different cultural groups may interpret the sexual orientation questions differently.

Sex- and Gender-Based Analysis in Cannabis Treatment Outcomes: A Systematic Review.

There is evidence that sex- and gender-related factors are involved in cannabis patterns of use, health effects and biological mechanisms. Women and men report different cannabis use disorder (CUD) symptoms, with women reporting worse withdrawal symptoms than men. The objective of this systematic review was to examine the effectiveness of cannabis pharmacological interventions for women and men and the uptake of sex- and gender-based analysis in the included studies. Two reviewers performed the full-paper screening, and data was extracted by one researcher. The search yielded 6098 unique records-of which, 68 were full-paper screened. Four articles met the eligibility criteria for inclusion. From the randomized clinical studies of pharmacological interventions, few studies report sex-disaggregated outcomes for women and men. Despite emergent evidence showing the influence of sex and gender factors in cannabis research, sex-disaggregated outcomes in pharmacological interventions is lacking. Sex- and gender-based analysis is incipient in the included articles. Future research should explore more comprehensive inclusion of sex- and gender-related aspects in pharmacological treatments for CUD.

Reliability Generalization as a Seal of Quality of Substantive Meta-Analyses: The Case of the VIA Inventory of Strengths (VIA-IS) and Their Relationships to Life Satisfaction.

Reliable test scores are essential to interpret the results obtained in statistical analyses correctly. In this study, we used the Values in Action Inventory of Strengths (VIA-IS) as an example of a widely applied assessment instrument to analyze its metric quality in what is known as reliability generalization (RG). In addition, we conducted a meta-analysis of the correlations between character strengths and life satisfaction to examine the potential relationship between the reliability of test scores and the intensity of these correlations. The overall variability of alpha coefficients supports the argument that reliability is sample dependent. Indeed, there were statistically significant mean reliability differences for scores across the 24 scales, with the highest level of reliability observed for Creativity and the lowest for scores on Self-regulation. Significant moderators such as the standard deviation of the scores and the sample type contribute to understand the high variability observed in the reliability estimation. The second meta-analysis showed that Zest, Hope, Gratitude, Curiosity, and Love were the character strengths that were highly related to life satisfaction, while Modesty and Prudence were less related to life satisfaction. Furthermore, the high heterogeneity between samples might be an indicator of the relationship between the variability of reliability of character strengths' scores and the intensity of their correlations with life satisfaction. Those character strengths with high-potential RG are related or unrelated to life satisfaction, whereas character strengths with less-potential RG showed unstable correlation patterns. The results of both studies point out the role of the relationship between the reliability of test scores and substantive studies, such as Pearson's correlations meta-analysis.