IDEAS home Printed from https://ideas.repec.org/a/gam/jijerp/v20y2023i4p2962-d1061560.html
   My bibliography  Save this article

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

Author

Listed:
  • 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
    as

    Download full text from publisher

    File URL: https://www.mdpi.com/1660-4601/20/4/2962/pdf
    Download Restriction: no
    File URL: https://www.mdpi.com/1660-4601/20/4/2962/
    Download Restriction: no
    ---><---

    References listed on IDEAS

    as
    1. Lorraine Greaves & Stacey A. Ritz, 2022. "Sex, Gender and Health: Mapping the Landscape of Research and Policy," IJERPH, MDPI, vol. 19(5), pages 1-13, February.
    2. Fisher, J.A. & Kalbaugh, C.A., 2011. "Challenging assumptions about minority participation in US clinical research," American Journal of Public Health, American Public Health Association, vol. 101(12), pages 2217-2222.
    3. Corine Ekhart & Florence Hunsel & Joep Scholl & Sieta Vries & Eugene Puijenbroek, 2018. "Sex Differences in Reported Adverse Drug Reactions of Selective Serotonin Reuptake Inhibitors," Drug Safety, Springer, vol. 41(7), pages 677-683, July.
    4. Alison M. Kim & Candace M. Tingen & Teresa K. Woodruff, 2010. "Sex bias in trials and treatment must end," Nature, Nature, vol. 465(7299), pages 688-689, June.
    5. Anna Nowogrodzki, 2017. "Inequality in medicine," Nature, Nature, vol. 550(7674), pages 18-19, October.
    6. Lorraine Greaves & Natalie Hemsing, 2020. "Sex and Gender Interactions on the Use and Impact of Recreational Cannabis," IJERPH, MDPI, vol. 17(2), pages 1-15, January.
    7. Herrera, A.P. & Snipes, S.A. & King, D.W. & Torres-Vigil, I. & Goldberg, D.S. & Wenberg, A.D., 2010. "Disparate inclusion of older adults in clinical trials: priorities and opportunities for policy and practice change," American Journal of Public Health, American Public Health Association, vol. 100(S1), pages 105-112.
    Full references (including those not matched with items on IDEAS)

    Most related items

    These are the items that most often cite the same works as this one and are cited by the same works as this one.
    1. Lorraine Greaves & Nancy Poole & Andreea C. Brabete, 2022. "Sex, Gender, and Alcohol Use: Implications for Women and Low-Risk Drinking Guidelines," IJERPH, MDPI, vol. 19(8), pages 1-16, April.
    2. Giovanni Polverino & Upama Aich & Jack A Brand & Michael G Bertram & Jake M Martin & Hung Tan & Vrishin R Soman & Rachel T Mason & Bob B M Wong, 2023. "Sex-specific effects of psychoactive pollution on behavioral individuality and plasticity in fish," Behavioral Ecology, International Society for Behavioral Ecology, vol. 34(6), pages 969-978.
    3. Susan J. Yousufzai & Adam G. Cole & Mika Nonoyama & Caroline Barakat, 2023. "Changes in Quantity Measures of Various Forms of Cannabis Consumption among Emerging Adults in Canada in Relation to Policy and Public Health Developments," IJERPH, MDPI, vol. 20(13), pages 1-17, June.
    4. Mulinari, Shai & Vilhelmsson, Andreas & Ozieranski, Piotr & Bredström, Anna, 2021. "Is there evidence for the racialization of pharmaceutical regulation? Systematic comparison of new drugs approved over five years in the USA and the EU," Social Science & Medicine, Elsevier, vol. 280(C).
    5. Yatra N. Patel & Riya J. Patel & Lauren Bates & Susan Gertz & Susan Hershberger & Melinda Butsch Kovacic, 2024. "Cultural Insiders and Graphic Stories to Promote Research Readiness Among the South Asian Community: A Focus on Purpose, Protection, and Participation," IJERPH, MDPI, vol. 21(10), pages 1-14, October.
    6. Connor, Jade & Madhavan, Sarina & Mokashi, Mugdha & Amanuel, Hanna & Johnson, Natasha R. & Pace, Lydia E. & Bartz, Deborah, 2020. "Health risks and outcomes that disproportionately affect women during the Covid-19 pandemic: A review," Social Science & Medicine, Elsevier, vol. 266(C).
    7. William T. Hu & Stephanie M. Bergren & Dana K. Dychtwald & Yiming Ma & XinQi Dong, 2023. "Variations in racial and ethnic groups’ trust in researchers associated with willingness to participate in research," Palgrave Communications, Palgrave Macmillan, vol. 10(1), pages 1-10, December.
    8. Diana Poli & Paola Mozzoni & Silvana Pinelli & Delia Cavallo & Bruno Papaleo & Lidia Caporossi, 2022. "Sex Difference and Benzene Exposure: Does It Matter?," IJERPH, MDPI, vol. 19(4), pages 1-17, February.
    9. Liat Ayalon, 2020. "Life in a world for all ages: From a utopic idea to reality," Journal of Elder Policy, John Wiley & Sons, vol. 1(1), pages 39-67, June.
    10. Lorraine Greaves, 2020. "Missing in Action: Sex and Gender in Substance Use Research," IJERPH, MDPI, vol. 17(7), pages 1-7, March.
    11. Jennifer S. Williams & Jenna C. Stone & Stacey A. Ritz & Maureen J. MacDonald, 2023. "Letter to the editor: Laxdal (2023) “The sex gap in sports and exercise medicine research: who does research on females?”," Scientometrics, Springer;Akadémiai Kiadó, vol. 128(7), pages 4155-4160, July.
    12. Natalie Hemsing & Lorraine Greaves, 2020. "Gender Norms, Roles and Relations and Cannabis-Use Patterns: A Scoping Review," IJERPH, MDPI, vol. 17(3), pages 1-31, February.
    13. Danièle Meulders & Natalie Simeu & Sile Padraigin O'Dorchai, 2012. "Alma Mater, Homo Sapiens II: Les inégalités entre femmes et hommes dans les universités francophones de Belgique," ULB Institutional Repository 2013/135731, ULB -- Universite Libre de Bruxelles.
    14. Divyanshu Raheja & Evelyn P. Davila & Eric T. Johnson & Rijalda Deović & Michele Paine & Nadine Rouphael, 2018. "Willingness to Participate in Vaccine-Related Clinical Trials among Older Adults," IJERPH, MDPI, vol. 15(8), pages 1-12, August.
    15. Kirstin Mittelstrass & Janina S Ried & Zhonghao Yu & Jan Krumsiek & Christian Gieger & Cornelia Prehn & Werner Roemisch-Margl & Alexey Polonikov & Annette Peters & Fabian J Theis & Thomas Meitinger & , 2011. "Discovery of Sexual Dimorphisms in Metabolic and Genetic Biomarkers," PLOS Genetics, Public Library of Science, vol. 7(8), pages 1-12, August.
    16. Stacey A. Ritz & Lorraine Greaves, 2022. "Transcending the Male–Female Binary in Biomedical Research: Constellations, Heterogeneity, and Mechanism When Considering Sex and Gender," IJERPH, MDPI, vol. 19(7), pages 1-11, March.
    17. Shim, Janet K. & Bentz, Michael & Vasquez, Emily & Jeske, Melanie & Saperstein, Aliya & Fullerton, Stephanie M. & Foti, Nicole & McMahon, Caitlin & Lee, Sandra Soo-Jin, 2022. "Strategies of inclusion: The tradeoffs of pursuing “baked in” diversity through place-based recruitment," Social Science & Medicine, Elsevier, vol. 306(C).
    18. Mwale, Shadreck, 2020. "‘Becoming-with’ a repeat healthy volunteer: Managing and negotiating trust among repeat healthy volunteers in commercial clinical drug trials," Social Science & Medicine, Elsevier, vol. 245(C).
    19. Valérie Seegers & Ludovic Trinquart & Isabelle Boutron & Philippe Ravaud, 2013. "Comparison of Treatment Effect Estimates for Pharmacological Randomized Controlled Trials Enrolling Older Adults Only and Those including Adults: A Meta-Epidemiological Study," PLOS ONE, Public Library of Science, vol. 8(5), pages 1-5, May.
    20. Torin Monahan & Jill A Fisher, 2020. "Sacrificial Labour: Social Inequality, Identity Work, and the Damaging Pursuit of Elusive Futures," Work, Employment & Society, British Sociological Association, vol. 34(3), pages 441-456, June.

    Corrections

    All material on this site has been provided by the respective publishers and authors. You can help correct errors and omissions. When requesting a correction, please mention this item's handle: RePEc:gam:jijerp:v:20:y:2023:i:4:p:2962-:d:1061560. See general information about how to correct material in RePEc.

    If you have authored this item and are not yet registered with RePEc, we encourage you to do it here. This allows to link your profile to this item. It also allows you to accept potential citations to this item that we are uncertain about.

    If CitEc recognized a bibliographic reference but did not link an item in RePEc to it, you can help with this form .

    If you know of missing items citing this one, you can help us creating those links by adding the relevant references in the same way as above, for each refering item. If you are a registered author of this item, you may also want to check the "citations" tab in your RePEc Author Service profile, as there may be some citations waiting for confirmation.

    For technical questions regarding this item, or to correct its authors, title, abstract, bibliographic or download information, contact: MDPI Indexing Manager (email available below). General contact details of provider: https://www.mdpi.com .

    Please note that corrections may take a couple of weeks to filter through the various RePEc services.

    IDEAS is a RePEc service. RePEc uses bibliographic data supplied by the respective publishers.