Drugs indicated for use during pregnancy

Area of Science:

• Obstetrics and Gynecology
• Pharmacology
• Drug Safety

Background:

• The Society of Obstetricians and Gynaecologists of Canada (SOGC) emphasizes the importance of drug safety during pregnancy.
• Generic drug formulations offer more affordable treatment options for pregnant women.

Purpose of the Study:

• To advocate for exclusive drug testing in women for medications used during pregnancy.
• To address concerns regarding generic drug substitution and its potential impact on patient outcomes.
• To call for a review of Health Canada's guidelines on drug testing for vulnerable populations.

Main Methods:

• Policy statement and clinical practice recommendations.
• Review of current drug testing guidelines and generic substitution practices.
• Emphasis on patient and physician consent for drug substitution.

Main Results:

• The SOGC advocates for drugs used in pregnancy to be tested exclusively in women.
• Concerns are raised about potential clinically significant differences in drug dosage and patient effect with generic substitutions.
• Substitution based solely on price is deemed unacceptable.

Conclusions:

• Health Canada should review its guidelines for testing drugs in vulnerable populations, especially pregnant women.
• Physician and patient agreement is crucial before any drug substitution.
• Ensuring drug efficacy and safety in pregnant women is paramount.