CSPT 2011- Drugs Indicated for Use During Pregnancy

Main Article Content

André B Lalonde

Keywords

Bioequivalence, intrasubject variability, sex-related differences, pregnancy, Society of Obstetricians and Gynaecologists of Canada (SOGC)

Abstract

The Society of Obstetricians and Gynaecologists of Canada (SOGC) advocates that drugs used during pregnancy be tested exclusively in women. The SOGC holds the opinion that drugs to be used exclusively in men or in women should not be tested in a small number of men and women.


The SOGC, always cautious with the choice of pharmacological treatments recommended for use during pregnancy, welcomes the increased options resulting from the introduction of generic formulations of drugs shown to be bioequivalent to currently available brand name products. These formulations provide less expensive options to Canadian women in need of drug therapy. However, the Society does not believe that drugs should be substituted without the patient and the physician both agreeing to such a change. Generic substitutions of some products may mean a potentially clinically significant difference in drug dose, possibly resulting in a changed patient effect. Furthermore, substituting a product on the basis of price alone is not acceptable.
The SOGC, as an organization with the role of advising its members on clinical practice, calls on Health Canada to review its guideline on testing of drugs for vulnerable populations, especially pregnant women.

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References

1. Health Canada. Drugs and Health Products. Guidance for Industry: Conduct and Analysis of Bioavailability and Bioequivalence Studies - Part A: Oral Dosage Formulations Used for Systemic Effects. (October 8, 1997) http://www.hcsc. gc.ca/dhp-mps/alt_formats/hpfbdgpsa/ pdf/prodpharma/bio-a-eng.pdf (July 15, 2011).
2. Chen M-L, Lee SC, Ng M-J, Schuirmann DJ, Lesko LJ, Williams RL. Pharmacokinetic analysis of bioequivalence trials: implication for sex-related issues in clinical pharmacology and biopharmaceutics. Clin Pharmacol Ther 2000;68(5):510-521.