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

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  • Lorraine Greaves

    (Centre of Excellence for Women’s Health, Vancouver, BC V6H 3N1, Canada
    School of Population and Public Health, Faculty of Medicine, University of British Columbia, Vancouver, BC V6T 1Z3, Canada)

  • Andreea C. Brabete

    (Centre of Excellence for Women’s Health, Vancouver, BC V6H 3N1, Canada)

  • Mira Maximos

    (Centre of Excellence for Women’s Health, Vancouver, BC V6H 3N1, Canada
    Women’s College Hospital, Toronto, ON M5S 1B2, Canada
    School of Pharmacy, University of Waterloo, Kitchener, ON N2G 1C5, Canada)

  • Ella Huber

    (Centre of Excellence for Women’s Health, Vancouver, BC V6H 3N1, Canada)

  • Alice Li

    (Centre of Excellence for Women’s Health, Vancouver, BC V6H 3N1, Canada)

  • Mê-Linh Lê

    (Neil John Maclean Health Sciences Library, University of Manitoba, Winnipeg, MB R3M 3M1, Canada)

  • Sherif Eltonsy

    (College of Pharmacy, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, MB R3M 3M1, Canada)

  • Madeline Boscoe

    (Cochrane Sex/Gender Methods Group, Ottawa, ON K0A K4C, Canada
    Women and Health Protection, Ottawa, ON K0A K4C, Canada)

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.

Suggested Citation

  • Lorraine Greaves & Andreea C. Brabete & Mira Maximos & Ella Huber & Alice Li & Mê-Linh Lê & Sherif Eltonsy & Madeline Boscoe, 2023. "Sex, Gender, and the Regulation of Prescription Drugs: Omissions and Opportunities," IJERPH, MDPI, vol. 20(4), pages 1-19, February.
    • Handle: RePEc:gam:jijerp:v:20:y:2023:i:4:p:2962-:d:1061560
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    References listed on IDEAS

    as
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    2. Anna Nowogrodzki, 2017. "Inequality in medicine," Nature, Nature, vol. 550(7674), pages 18-19, October.
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    Full references (including those not matched with items on IDEAS)

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