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A Method for Targeted 16S Sequencing of Human Milk Samples
Published on: March 23, 2018
Quantification of illicit and prescription drug residues in pasteurized donor human milk: a comprehensive analytical
Michelle Brenner1, Kaytlin Krutsch2, Ashlynn Baker3
1The King's Daughters Milk Bank, Children's Hospital of The Kings Daughters, Department of Pediatrics, Macon & Joan Brock Virginia Health Sciences at Old Dominion University, Norfolk, VA, USA. michelle.brenner@chkd.org.
Insights
Pasteurized donor human milk (PDHM) is safe for infants, with no clinically significant drug residues found. Rigorous screening and processing ensure the safety of donated milk for neonatal consumption.
Area of Science:
- Neonatal nutrition
- Drug safety analysis
- Human milk banking
Background:
- Infant feeding safety is paramount, especially for vulnerable neonates.
- Donor human milk is a critical resource for infants unable to receive maternal milk.
- Concerns exist regarding potential drug residues in processed milk.
Purpose of the Study:
- To evaluate the safety of infant-ready pooled, pasteurized donor human milk (PDHM).
- To assess infant exposure risk to illicit and prescription drug residues in PDHM.
- To validate donor screening and milk processing protocols.
Main Methods:
- Analyzed 150 PDHM samples (742 donor contributions) for 15 drug analytes.
- Utilized liquid chromatography-tandem mass spectrometry (LC-MS/MS) for precise detection.
- Assessed detected concentrations against established infant safety standards.
Main Results:
- No residues of marijuana, amphetamines, benzodiazepines, fentanyl, hydrocodone, or morphine were detected.
- Trace oxycodone (<0.6 ppb) found in 2% of samples, representing <0.022% of the infant safety threshold.
- All samples demonstrated negligible drug residue levels, well below safety limits.
Conclusions:
- Infant-ready PDHM shows no clinically relevant illicit or prescription drug residues.
- Current donor screening and pasteurization effectively ensure milk safety for neonates.
- PDHM is a safe and reliable option for neonatal nutrition.
Objective:
To assess the risk of infant exposure to illicit and prescription drug residues, from infant-ready, pooled, pasteurized donor human milk (PDHM) provided by healthy, screened, voluntary non-remunerated donors to a not-for-profit milk bank.
Study Design:
A total of 150 pooled samples, representing 742 donor contributions, were analyzed for 15 illicit and prescription drug analytes using liquid chromatography-tandem mass spectrometry (LC-MS/MS). Detected concentrations were evaluated for clinical significance.
Result:
All 150 PDHM samples tested negative for residues of marijuana, amphetamines, benzodiazepines, fentanyl, hydrocodone, and morphine. Three samples (2%) contained trace amounts of oxycodone (<0.6 parts per billion), yielding exposures over 455 times lower than established standards for infant safety (Relative Infant Dose: <0.022%; standard safety threshold 10%).
Conclusion:
Comprehensive analysis detected no clinically relevant illicit or prescription drug residues in infant-ready pasteurized donor human milk, supporting both its safety for neonatal consumption and the effectiveness of current donor screening protocols and milk processing practices.
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