We all know that prescriptions and other meds affect people differently, in no small part because of each person’s underlying health conditions, interactions with others meds, weight, activity level, and how they metabolize drugs based on their genetic profile. That’s why we at RxLive offer comprehensive, individual medication management consulting and, whenever possible, pharmacogenomic testing (PGx).
But since May 10 (Mother’s Day) through May 16 is National Women’s Health Week in the U.S., the observance reminds me that while we’re busy drilling down to the unique needs of each individual patient, it’s important to remember that gender also impacts how we respond to medications.
Not enough sex in clinical studies
No, I don’t mean it like that! But unfortunately, it’s generally acknowledged that too few clinical trials and studies in the past have adequately enrolled women or analyzed gender-specific differences in the data. This has certainly hindered the progress of understanding women’s therapeutic and pharmacodynamic response to medications, though better inclusion and reporting has been seen in recent years that’s leading to an increasing understanding of women’s health.
Gender-based medicine is important for so many reasons. A serious one alone is the fact that women have been shown to experience more adverse reactions to treatment with therapeutic drugs than men.
Here are just a few of the trends the medical scientific community has determined across trials over the past decade or so:
- Prescribed doses should often be adjusted for weight (especially for women, who tend to be less heavy than men overall), versus a standard one-size-fits-all dosage. An example of a clinically significant pharmacokinetic difference includes dosing recommendations for Ambien (zolpidem). It’s been found that the same dose in women vs. men caused females to experience an average of two times the drug levels due to differences in metabolism.
- Other variations seen between the sexes — not only weight but also body composition and size, muscle mass, body fat, metabolic enzymes and plasma proteins — may also impact the pharmacokinetic parameters of a particular drug. Additional variations include protein binding, biotransformation and even pharmacodynamic characteristics related to receptor and enzyme levels.
- Hormones, including the use of hormone replacement therapy (HRT), can definitely affect pharmacokinetic or pharmacodynamic parameters. Of course, along with the impact on how a woman’s body reacts to a drug as absorbed, reaches therapeutic levels, and is eliminated,, HRT also carries potential risks ranging from heart attack, stroke, breast cancer, and blood clots in the lungs and legs. A woman’s menstruation cycle itself can also alter the impact of a woman’s drug metabolism and response, both prescribed and OTC, as does pregnancy.
Helping keep women in their best health
I know, as do you, that the bottom-line answer is: women’s health is tricky. Not that it’s easy to manage men’s health, mind you. But with a relative dearth of gender-based clinical trials and data analysis, it’s been acknowledged as an additional challenge to prescribe and periodically adjust medications for women based on so many factors…both general across the female population as well as specific to each patient’s unique factors of genetics, health history and more.
The clinical pharmacists and care coordinators at RxLive are glad to join your extended team and support both patients and busy practitioners by providing comprehensive medication management consulting. If you’d like more information at any time, please call us.
Women’s involvement in clinical trials: historical perspective and future implications (Pharmacy Practice, 2016)
HRT (Women’s Health Concern, patient fact sheet, 2020)
Medication Safety for Women (patient resource, FDA Office of Women’s Health)