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Int Health. 2019 Mar 21. pii: ihz006. doi: 10.1093/inthealth/ihz006. [Epub ahead of print]

Assessment of developmental risk information on medicines for inclusion on the WHO's Essential Medicines List.

Author information

1
Division of Developmental Medicine, Department of Pediatrics, University of Washington School of Medicine, Seattle, WA, USA.
2
Center for Epidemiology and Environmental Health, CEOH, LLC, Washington, DC, USA.
3
Department of Epidemiology and Biostatistics, Milken Institute School of Public Health, George Washington University, Washington, DC, USA.
4
Department of Pediatrics, Georgetown University School of Medicine, Washington, DC, USA.
5
Department of Health Policy and Management, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.

Abstract

BACKGROUND:

The WHO develops biannually an Essential Medicines List (EML) of medications proposed for national formularies to be safe, effective and cost-effective. This satisfies the priority healthcare needs of most adult populations, but it does not consider the unique toxicological risks that occur from exposures during pregnancy.

METHODS:

Developmental toxicity risk information for the 451 specific agents on the 2017 EML were identified from four well-recognized compendia of teratological assessments. On this basis, each agent was classified as having known, suggested, or little to no developmental risk, or as having insufficient information.

RESULTS:

Thirteen (3%) EML agents posed known developmental risks, and 115 (25%) had evidence suggesting risk. For 170 (38%) agents, there was little or no evidence of such risk. Thus, risk classification could be determined for 66% of the agents. For an additional 153 (34%) agents, the information was insufficient for classification.

CONCLUSION:

It is feasible to expand the classification of most of the EML agents to include the risks from exposure during pregnancy.

KEYWORDS:

Essential Medicines List; WHO; birth defects; developmental toxicity; drugs in pregnancy

PMID:
30916305
DOI:
10.1093/inthealth/ihz006

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