A systematic review on maternal-to-infant transfer of drugs through breast milk during the treatment of malaria, tuberculosis, and neglected tropical diseases
Exclusive breastfeeding of infants under 6 months of age is recommended by the World Health Organization. In 2021, over 300 million combined incident cases of malaria, tuberculosis, and neglected tropical diseases (NTDs) were reported, predominantly in low-income countries. For many of the drugs use...
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Veröffentlicht in: | PLoS neglected tropical diseases 2023-07, Vol.17 (7), p.e0011449-e0011449 |
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description | Exclusive breastfeeding of infants under 6 months of age is recommended by the World Health Organization. In 2021, over 300 million combined incident cases of malaria, tuberculosis, and neglected tropical diseases (NTDs) were reported, predominantly in low-income countries. For many of the drugs used as first-line treatments for these conditions, there is limited knowledge on infant exposure through breastfeeding with poorly understood consequences. This review summarized available knowledge on mother-to-infant transfer of these drugs to inform future lactation pharmacokinetic studies.
A list of first-line drugs was generated from the latest WHO treatment guidelines. Using standard online databases, 2 independent reviewers searched for eligible articles reporting lactation pharmacokinetics studies and extracted information on study design, participant characteristics, and the mathematical approach used for parameter estimation. A third reviewer settled any disagreements between the 2 reviewers. All studies were scored against the standardized "ClinPK" checklist for conformity to best practices for reporting clinical pharmacokinetic studies. Simple proportions were used to summarize different study characteristics.
The most remarkable finding was the scarcity of lactation pharmacokinetic data. Only 15 of the 69 drugs we listed had lactation pharmacokinetics fully characterized. Most studies enrolled few mothers, and only one evaluated infant drug concentrations. Up to 66% of the studies used non-compartmental analysis to estimate pharmacokinetic parameters rather than model-based compartmental analysis. Unlike non-compartmental approaches, model-based compartmental analysis provides for dynamic characterization of individual plasma and breast milk concentration-time profiles and adequately characterizes variability within and between individuals, using sparsely sampled data. The "ClinPK" checklist inadequately appraised the studies with variability in the number of relevant criteria across different studies.
A consensus is required on best practices for conducting and reporting lactation pharmacokinetic studies, especially in neglected diseases such as malaria, tuberculosis, and NTDs, to optimize treatment of mother-infant pairs. |
doi_str_mv | 10.1371/journal.pntd.0011449 |
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A list of first-line drugs was generated from the latest WHO treatment guidelines. Using standard online databases, 2 independent reviewers searched for eligible articles reporting lactation pharmacokinetics studies and extracted information on study design, participant characteristics, and the mathematical approach used for parameter estimation. A third reviewer settled any disagreements between the 2 reviewers. All studies were scored against the standardized "ClinPK" checklist for conformity to best practices for reporting clinical pharmacokinetic studies. Simple proportions were used to summarize different study characteristics.
The most remarkable finding was the scarcity of lactation pharmacokinetic data. Only 15 of the 69 drugs we listed had lactation pharmacokinetics fully characterized. Most studies enrolled few mothers, and only one evaluated infant drug concentrations. Up to 66% of the studies used non-compartmental analysis to estimate pharmacokinetic parameters rather than model-based compartmental analysis. Unlike non-compartmental approaches, model-based compartmental analysis provides for dynamic characterization of individual plasma and breast milk concentration-time profiles and adequately characterizes variability within and between individuals, using sparsely sampled data. The "ClinPK" checklist inadequately appraised the studies with variability in the number of relevant criteria across different studies.
A consensus is required on best practices for conducting and reporting lactation pharmacokinetic studies, especially in neglected diseases such as malaria, tuberculosis, and NTDs, to optimize treatment of mother-infant pairs.</description><identifier>ISSN: 1935-2735</identifier><identifier>ISSN: 1935-2727</identifier><identifier>EISSN: 1935-2735</identifier><identifier>DOI: 10.1371/journal.pntd.0011449</identifier><identifier>PMID: 37440491</identifier><language>eng</language><publisher>United States: Public Library of Science</publisher><subject>Analysis ; Babies ; Best practice ; Best practices ; Bioavailability ; Biology and Life Sciences ; Breast Feeding ; Breast milk ; Breastfeeding & lactation ; Breasts ; Check lists ; Chemical kinetics ; Contamination ; Drug dosages ; Drug therapy ; Drugs ; Female ; Health aspects ; Health services ; Human diseases ; Humans ; Infant ; Infants ; Infections ; Knowledge management ; Lactation ; Malaria ; Mathematical models ; Medicine and Health Sciences ; Methods ; Milk ; Milk, Human ; Neglected Diseases - drug therapy ; Online data bases ; Parameter estimation ; Parasitic diseases ; People and Places ; Pharmacokinetics ; Plasma ; Review ; Systematic review ; Tropical diseases ; Tuberculosis ; Tuberculosis - drug therapy ; Variability ; Vector-borne diseases</subject><ispartof>PLoS neglected tropical diseases, 2023-07, Vol.17 (7), p.e0011449-e0011449</ispartof><rights>Copyright: © 2023 Ojara et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.</rights><rights>COPYRIGHT 2023 Public Library of Science</rights><rights>2023 Ojara et al. This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2023 Ojara et al 2023 Ojara et al</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c559t-dc142e247042950e11a7b9e4d3bb63aaace98fcf2ea3b1762f8b2e01634e61553</citedby><cites>FETCH-LOGICAL-c559t-dc142e247042950e11a7b9e4d3bb63aaace98fcf2ea3b1762f8b2e01634e61553</cites><orcidid>0000-0002-6425-6828 ; 0000-0003-0134-5855</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC10343098/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC10343098/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,315,729,782,786,866,887,2930,23873,27931,27932,53798,53800</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/37440491$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><contributor>Lopes, Fernando</contributor><creatorcontrib>Ojara, Francis Williams</creatorcontrib><creatorcontrib>Kawuma, Aida N</creatorcontrib><creatorcontrib>Waitt, Catriona</creatorcontrib><title>A systematic review on maternal-to-infant transfer of drugs through breast milk during the treatment of malaria, tuberculosis, and neglected tropical diseases</title><title>PLoS neglected tropical diseases</title><addtitle>PLoS Negl Trop Dis</addtitle><description>Exclusive breastfeeding of infants under 6 months of age is recommended by the World Health Organization. In 2021, over 300 million combined incident cases of malaria, tuberculosis, and neglected tropical diseases (NTDs) were reported, predominantly in low-income countries. For many of the drugs used as first-line treatments for these conditions, there is limited knowledge on infant exposure through breastfeeding with poorly understood consequences. This review summarized available knowledge on mother-to-infant transfer of these drugs to inform future lactation pharmacokinetic studies.
A list of first-line drugs was generated from the latest WHO treatment guidelines. Using standard online databases, 2 independent reviewers searched for eligible articles reporting lactation pharmacokinetics studies and extracted information on study design, participant characteristics, and the mathematical approach used for parameter estimation. A third reviewer settled any disagreements between the 2 reviewers. All studies were scored against the standardized "ClinPK" checklist for conformity to best practices for reporting clinical pharmacokinetic studies. Simple proportions were used to summarize different study characteristics.
The most remarkable finding was the scarcity of lactation pharmacokinetic data. Only 15 of the 69 drugs we listed had lactation pharmacokinetics fully characterized. Most studies enrolled few mothers, and only one evaluated infant drug concentrations. Up to 66% of the studies used non-compartmental analysis to estimate pharmacokinetic parameters rather than model-based compartmental analysis. Unlike non-compartmental approaches, model-based compartmental analysis provides for dynamic characterization of individual plasma and breast milk concentration-time profiles and adequately characterizes variability within and between individuals, using sparsely sampled data. The "ClinPK" checklist inadequately appraised the studies with variability in the number of relevant criteria across different studies.
A consensus is required on best practices for conducting and reporting lactation pharmacokinetic studies, especially in neglected diseases such as malaria, tuberculosis, and NTDs, to optimize treatment of mother-infant pairs.</description><subject>Analysis</subject><subject>Babies</subject><subject>Best practice</subject><subject>Best practices</subject><subject>Bioavailability</subject><subject>Biology and Life Sciences</subject><subject>Breast Feeding</subject><subject>Breast milk</subject><subject>Breastfeeding & lactation</subject><subject>Breasts</subject><subject>Check lists</subject><subject>Chemical kinetics</subject><subject>Contamination</subject><subject>Drug dosages</subject><subject>Drug therapy</subject><subject>Drugs</subject><subject>Female</subject><subject>Health aspects</subject><subject>Health services</subject><subject>Human diseases</subject><subject>Humans</subject><subject>Infant</subject><subject>Infants</subject><subject>Infections</subject><subject>Knowledge management</subject><subject>Lactation</subject><subject>Malaria</subject><subject>Mathematical models</subject><subject>Medicine and Health Sciences</subject><subject>Methods</subject><subject>Milk</subject><subject>Milk, Human</subject><subject>Neglected Diseases - drug therapy</subject><subject>Online data bases</subject><subject>Parameter estimation</subject><subject>Parasitic diseases</subject><subject>People and Places</subject><subject>Pharmacokinetics</subject><subject>Plasma</subject><subject>Review</subject><subject>Systematic review</subject><subject>Tropical diseases</subject><subject>Tuberculosis</subject><subject>Tuberculosis - drug therapy</subject><subject>Variability</subject><subject>Vector-borne diseases</subject><issn>1935-2735</issn><issn>1935-2727</issn><issn>1935-2735</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><recordid>eNptkttu1DAQhiMEoqXwBggsISEumsWO7SS-qlYVJ6kSN3BtOc4k6-LYi-0U9WV4Vhw1rXZR5Qufvv-f8XiK4jXBG0Ib8vHaz8Epu9m71G8wJoQx8aQ4JYLysmoof3qwPilexHiNMRe8Jc-LE9owhpkgp8XfLYq3McGkktEowI2BP8g7lPew2JfJl8YNyiWUgnJxgID8gPowjxGlXfDzuENdABUTmoz9hfo5GDfmK8gCUGmCLM2KSVkVjDpHae4g6Nn6aOI5Uq5HDkYLOkGfFX5vtLKoNzFbQnxZPBuUjfBqnc-Kn58__bj8Wl59__LtcntVas5FKntNWAUVazCrBMdAiGo6AaynXVdTpZQG0Q56qEDRjjR1NbRdBZjUlEFNOKdnxds7333OS66ljbJqORG5Vm2diYuVmLsJep2fFZSV-2AmFW6lV0Ye3zizk6O_kQRTRrFos8OH1SH43zPEJCcTNVirHPh5CUbbitU1xxl99x_6eEorNSoLMv-Sz4H1Yiq3DReUCUGbTG0eofLoYTLaOxhMPj8SvD8Q7EDZtIvezsl4F49Bdgfq4GMMMDxUg2C59Oh91nLpUbn2aJa9Oazkg-i-Kek_mPznFg</recordid><startdate>20230701</startdate><enddate>20230701</enddate><creator>Ojara, Francis Williams</creator><creator>Kawuma, Aida N</creator><creator>Waitt, Catriona</creator><general>Public Library of Science</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7QL</scope><scope>7SS</scope><scope>7T2</scope><scope>7T7</scope><scope>7U9</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8C1</scope><scope>8FD</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>C1K</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>F1W</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>H94</scope><scope>H95</scope><scope>H97</scope><scope>K9.</scope><scope>L.G</scope><scope>M0S</scope><scope>M1P</scope><scope>M7N</scope><scope>P64</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0002-6425-6828</orcidid><orcidid>https://orcid.org/0000-0003-0134-5855</orcidid></search><sort><creationdate>20230701</creationdate><title>A systematic review on maternal-to-infant transfer of drugs through breast milk during the treatment of malaria, tuberculosis, and neglected tropical diseases</title><author>Ojara, Francis Williams ; Kawuma, Aida N ; Waitt, Catriona</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c559t-dc142e247042950e11a7b9e4d3bb63aaace98fcf2ea3b1762f8b2e01634e61553</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Analysis</topic><topic>Babies</topic><topic>Best practice</topic><topic>Best practices</topic><topic>Bioavailability</topic><topic>Biology and Life Sciences</topic><topic>Breast Feeding</topic><topic>Breast milk</topic><topic>Breastfeeding & lactation</topic><topic>Breasts</topic><topic>Check lists</topic><topic>Chemical kinetics</topic><topic>Contamination</topic><topic>Drug dosages</topic><topic>Drug therapy</topic><topic>Drugs</topic><topic>Female</topic><topic>Health aspects</topic><topic>Health services</topic><topic>Human diseases</topic><topic>Humans</topic><topic>Infant</topic><topic>Infants</topic><topic>Infections</topic><topic>Knowledge management</topic><topic>Lactation</topic><topic>Malaria</topic><topic>Mathematical models</topic><topic>Medicine and Health Sciences</topic><topic>Methods</topic><topic>Milk</topic><topic>Milk, Human</topic><topic>Neglected Diseases - drug therapy</topic><topic>Online data bases</topic><topic>Parameter estimation</topic><topic>Parasitic diseases</topic><topic>People and Places</topic><topic>Pharmacokinetics</topic><topic>Plasma</topic><topic>Review</topic><topic>Systematic review</topic><topic>Tropical diseases</topic><topic>Tuberculosis</topic><topic>Tuberculosis - drug therapy</topic><topic>Variability</topic><topic>Vector-borne diseases</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Ojara, Francis Williams</creatorcontrib><creatorcontrib>Kawuma, Aida N</creatorcontrib><creatorcontrib>Waitt, Catriona</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Entomology Abstracts (Full archive)</collection><collection>Health and Safety Science Abstracts (Full archive)</collection><collection>Industrial and Applied Microbiology Abstracts (Microbiology A)</collection><collection>Virology and AIDS Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Public Health Database</collection><collection>Technology Research Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>Environmental Sciences and Pollution Management</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>ASFA: Aquatic Sciences and Fisheries Abstracts</collection><collection>Engineering Research Database</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>Aquatic Science & Fisheries Abstracts (ASFA) 1: Biological Sciences & Living Resources</collection><collection>Aquatic Science & Fisheries Abstracts (ASFA) 3: Aquatic Pollution & Environmental Quality</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Aquatic Science & Fisheries Abstracts (ASFA) Professional</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>Access via ProQuest (Open Access)</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>PLoS neglected tropical diseases</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Ojara, Francis Williams</au><au>Kawuma, Aida N</au><au>Waitt, Catriona</au><au>Lopes, Fernando</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A systematic review on maternal-to-infant transfer of drugs through breast milk during the treatment of malaria, tuberculosis, and neglected tropical diseases</atitle><jtitle>PLoS neglected tropical diseases</jtitle><addtitle>PLoS Negl Trop Dis</addtitle><date>2023-07-01</date><risdate>2023</risdate><volume>17</volume><issue>7</issue><spage>e0011449</spage><epage>e0011449</epage><pages>e0011449-e0011449</pages><issn>1935-2735</issn><issn>1935-2727</issn><eissn>1935-2735</eissn><abstract>Exclusive breastfeeding of infants under 6 months of age is recommended by the World Health Organization. In 2021, over 300 million combined incident cases of malaria, tuberculosis, and neglected tropical diseases (NTDs) were reported, predominantly in low-income countries. For many of the drugs used as first-line treatments for these conditions, there is limited knowledge on infant exposure through breastfeeding with poorly understood consequences. This review summarized available knowledge on mother-to-infant transfer of these drugs to inform future lactation pharmacokinetic studies.
A list of first-line drugs was generated from the latest WHO treatment guidelines. Using standard online databases, 2 independent reviewers searched for eligible articles reporting lactation pharmacokinetics studies and extracted information on study design, participant characteristics, and the mathematical approach used for parameter estimation. A third reviewer settled any disagreements between the 2 reviewers. All studies were scored against the standardized "ClinPK" checklist for conformity to best practices for reporting clinical pharmacokinetic studies. Simple proportions were used to summarize different study characteristics.
The most remarkable finding was the scarcity of lactation pharmacokinetic data. Only 15 of the 69 drugs we listed had lactation pharmacokinetics fully characterized. Most studies enrolled few mothers, and only one evaluated infant drug concentrations. Up to 66% of the studies used non-compartmental analysis to estimate pharmacokinetic parameters rather than model-based compartmental analysis. Unlike non-compartmental approaches, model-based compartmental analysis provides for dynamic characterization of individual plasma and breast milk concentration-time profiles and adequately characterizes variability within and between individuals, using sparsely sampled data. The "ClinPK" checklist inadequately appraised the studies with variability in the number of relevant criteria across different studies.
A consensus is required on best practices for conducting and reporting lactation pharmacokinetic studies, especially in neglected diseases such as malaria, tuberculosis, and NTDs, to optimize treatment of mother-infant pairs.</abstract><cop>United States</cop><pub>Public Library of Science</pub><pmid>37440491</pmid><doi>10.1371/journal.pntd.0011449</doi><orcidid>https://orcid.org/0000-0002-6425-6828</orcidid><orcidid>https://orcid.org/0000-0003-0134-5855</orcidid><oa>free_for_read</oa></addata></record> |
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subjects | Analysis Babies Best practice Best practices Bioavailability Biology and Life Sciences Breast Feeding Breast milk Breastfeeding & lactation Breasts Check lists Chemical kinetics Contamination Drug dosages Drug therapy Drugs Female Health aspects Health services Human diseases Humans Infant Infants Infections Knowledge management Lactation Malaria Mathematical models Medicine and Health Sciences Methods Milk Milk, Human Neglected Diseases - drug therapy Online data bases Parameter estimation Parasitic diseases People and Places Pharmacokinetics Plasma Review Systematic review Tropical diseases Tuberculosis Tuberculosis - drug therapy Variability Vector-borne diseases |
title | A systematic review on maternal-to-infant transfer of drugs through breast milk during the treatment of malaria, tuberculosis, and neglected tropical diseases |
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