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Studying Drugs in Human Milk: Time to Unify the Approach

Department of Clinical Pharmacology at Christchurch Hospital, Christchurch, New Zealand

Stephen B. Duffull, PhD, DipPharm, MPharm(Clin)

School of Pharmacy at the University of Queensland, St. Lucia, Australia

L. Peter Hackett, MRSC

Clinical Pharmacology and Toxicology Laboratory at the Western Australian Center for Pathology and Medical Research, Nedlands, Western Australia

Kenneth F. Ilett, PhD, BPharm

School of Medicine and Pharmacology, University of Western Australia, Crawley, 6009, Western Australia

The trend globally for mothers to breastfeed has highlighted the need for information on drug transfer into breast milk and the extent to which the suckling neonate may be exposed and affected. This reviewdiscusses robust study methodologies that will yield high-quality information on all aspects of this process. Methods for assessing drug transfer into breast milk are examined. The place of the milk/plasma ratio, the amount of drug in breast milk, and the volume of milk produced are discussed in the context of their utility in estimating both absolute and relative infant dose. The measurement of plasma drug concentrations and pharmacodynamic effects in the breastfed infant exposed to drugs are identified as important factors that can assist in deciding whether drug present in breast milk is a significant risk for the nursing infant.

Key Words: human milk • drug distribution and excretion • relative infant dose • absolute infant dose • milk/plasma ratio

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