This project assessed the impact and importance of sex, gender and equity-related factors in the lifecycle management of prescription drugs. This has a direct impact on:
- Providing more precise and personalized medicine and health care
- Determining the sex-specific safety, effectiveness, and risk of adverse effects for males and females
- Transmitting accurate information on to both clinicians and consumers
What did we do?
We conducted a sex and gender based analysis plus (SGBA+) of current regulatory decision making process documents and developed recommendations for improving guidance, regulation, and knowledge translation on the impact of sex, gender and equity on drug safety, efficacy and clinical trial development. We reviewed relevant academic and grey literatures to understand sex and gender related factors affecting the use and effects of prescription drugs, and engagement in clinical trials. The incorporation of sex, gender, diversity and equity factors into the following levels of the lifecycle management of drugs was assessed:
- Clinical trials
- Monitoring and Intervention
- Post market surveillance
Integrating sex and gender considerations into prescription drug lifecycle management processes will ultimately improve the health of men, women, boys, girls, and gender diverse people.
Who was involved?
A CEWH team led by Dr. Lorraine Greaves, partnered with policy leads at Health Canada, Dr. Alysha Croker and Matt Stock. In addition, two members of the Scientific Advisory Committee on Health Products for Women (SAC-HPW), of which Dr. Greaves is the appointed Chair, were consulted. Dr. Sherif Eltonsy and Madeline Boscoe have expertise in pharmacology, advocacy and knowledge transfer. Dr. Eltonsy is a faculty member of the College of Pharmacy at the University of Manitoba and Madeline Boscoe is Executive Director of Marineview & Chesterfield Housing Societies, an RN, and former leader of the Canadian Women’s Health Network.
This research-policy partnership was a collaborative initiative between the Canadian Institutes of Health Research (CIHR) – Institute of Gender and Health (IGH) and Health Canada’s Gender Health Unit, aimed at integrating SGBA+ into health policy.
- Full report on study findings: Risk Reviewed: Integrating sex and gender into the lifecycle management of prescription drugs
- Journal articles:
- Considering Sex and Gender in Therapeutics throughout the Product Life Cycle: A Narrative Review and Case Study of Gilteritinib
- Sex, Gender, and the Regulation of Prescription Drugs: Omissions and Opportunities
- A Sex- and Gender-Based Analysis of Adverse Drug Reactions: A Scoping Review of Pharmacovigilance Databases
- See the presentation slides that capture the project and it’s findings
- See the report and presentation slides from a complementary project on Applying an SGBA+ Lens to Medical Device Regulation led by Dr. Anna Gagliardi
- Globe & Mail article quoting Project Lead, Dr. Lorraine Greaves, in recent updates to drug regulation in Canada: Health Canada to call for better data from drug trial sponsors to address gaps affecting women, racialized populations
- Women and Health Protection
- SGBA+ Health-Policy Research Partnerships