Nails of newborns in monitoring drug exposure during pregnancy

This project was developed to investigate the usefulness of newborn nails for monitoring in utero drug exposure. Cocaine, benzoylecgonine, morphine, methadone, caffeine, nicotine, and cotinine were determined in nail samples from the first 3 months of life of 25 newborns abandoned immediately after birth (group 1) and of 33 babies born at the local maternity hospital whose families were recruited on a voluntary basis (group 2). All substances were measured by gas chromatography-mass spectrometry (detection limit: 0.025 ng/mg). Moreover, analytical results were compared with mothers' self-reported habits when the information was available. In group 1, 12 nails were found positive for caffeine and 13 for both nicotine and cotinine. Six samples tested cocaine- (range, median: 0.14-0.25, 0.175 ng/mg) and benzoylecgonine-positive (range, median: 0.12-0.20, 0.165 ng/mg). Both nicotine and cocaine were always retrieved together with their main metabolite. Morphine was found in four samples (range, median: 0.10-0.15, 0.125 ng/mg), methadone in five samples (range, median: 0.12-0.26, 0.170 ng/mg) that were found negative for all other compounds. In group 2, two samples tested positive for methadone (0.16, 0.17 ng/mg). The mothers self-report of the use of coffee always corresponded to caffeine positivity in the newborn nails (n=6), whereas six samples tested positive for nicotine and/or cotinine with a non-smoking mother. Sixteen out of the 33 samples of group 2 tested negative for all compounds. In conclusion, for the first time, results showed that, once that sample collection problems are solved, nails of the first period of life can be a very interesting indicator of in utero drug exposure.     

The legal effect of EU Regulations

The EU institutions are increasingly addressing harmonisation by means of regulation rather than the traditional use of directives. This is particularly impacting areas such as data protection, financial services regulation and European standardisation in Information and Communications Technology. More broadly, using directly applicable regulations which may have horizontal and vertical direct effect rather than directives has important administrative and constitutional implications for their application in national law and impacts on Member States' discretion to implement supplementary legislation which falls within the remit of the regulation in question. This is of particular concern where governments implement policies which might be in contravention of these rules. This may be the case in relation to the UK government's public procurement policy which mandates royalty free standards rather than royalty bearing standards with the option for the licence holder to licence royalty free.