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    Drugs associated with teratogenic mechanisms. Part I:dispensing rates among pregnant women in the Netherlands, 1998-2009

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    <p>What are the dispensing rates of drugs suspected to be associated with teratogenic mechanisms among pregnant Dutch women?</p><p>In a substantial proportion of pregnancies in our study population at least one drug associated with a teratogenic mechanism was dispensed in the first trimester of pregnancy.</p><p>The main teratogenic mechanisms of medical drugs that may affect fetal development in the first trimester of pregnancy have been described previously. However, information on the dispensing rate of such drugs among women at all stages of pregnancy is lacking.</p><p>To determine how often medications suspected to be associated with a teratogenic mechanism are used by pregnant women, we studied 32 016 pregnancies included in the IADB.nl database between 1998 and 2009.</p><p>We estimated dispensing rates of medical drugs suspected to be associated with teratogenic mechanisms in our study population. The IADB.nl database includes all pharmacy dispensings for an estimated population of 220 000 in 19941998 and c.500 000 since 1999. In addition, trends in first trimester dispensing rates over time and patterns of receiving multiple drugs associated with teratogenic mechanisms were evaluated. In addition, we determined the number of pregnancies in which multiple prescription drugs from one or more teratogenic categories were dispensed in the first trimester, and we evaluated the numbers of different medications dispensed that could be grouped within a specific teratogenic mechanism.</p><p>In 175 per 1000 pregnancies [95 confidence interval (CI), 171179] at least one drug associated with a teratogenic mechanism was dispensed in the first trimester. The total dispensing rate was 236 per 1000 pregnancies (95 CI 232241) in the 3 months before pregnancy and an increasing trend was seen in the second [214 per 1000 (95 CI 209218)] and third [327 per 1000 (95 CI 322332)] trimesters. The first trimester dispensing rates increased between 1998 and 2009 for selective serotonin-reuptake inhibitors (P 0.001) and serotonin receptor agonists/antagonists (P 0.001). In 71.8 of pregnancies in which drugs associated with teratogenic mechanisms were dispensed in the first trimester, women received drugs related to only one mechanism. Of the pregnancies in which drugs from multiple teratogenic categories were dispensed in the first trimester, 1148 (72.6) women received drugs from 2 categories, 317 (20.0) from three categories, 88 (5.6) from 4 categories, 28 (1.8) from 5 categories and 1 from 6 categories. Several women received multiple prescription medications grouped within a single teratogenic mechanism in the first trimester, ranging between 13.3 for cyclo-oxygenase inhibitors and 41.8 for serotonin receptor agonists/antagonists.</p><p>We used a dispensing database, therefore actual use of the medication prescribed is unknown and non-compliance could have led to overestimation of exposure prevalences.</p><p>Owing to the uncertainties concerning the safety of medication use during pregnancy, the results of this study stress the need for cautious prescription of medication associated with teratogenic mechanisms to women of reproductive age. This is further supported by our finding that women received multiple prescription medications grouped within a single teratogenic mechanism in the first trimester, which would theoretically increase strongly the risk of birth defects.</p><p>Marleen van Gelder was supported by the Netherlands Organisation for Scientific Research/NWO (grant no. 021.001.008). No competing interests are declared.</p><p>N/A.</p>

    The Bayley-III-NL special needs addition : a suitable developmental assessment instrument for young children with special needs

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    De meeste kinderen ontwikkelen zich in de eerste jaren van hun leven volgens verwachting. Bij een klein aantal is echter iets aan de hand. In dat geval is het belangrijk dat goede ontwikkelingsdiagnostiek plaatsvindt, zodat de begeleiding van het kind kan aansluiten bij de sterke en minder sterke punten in de ontwikkeling. Een veelgebruikt instrument voor ontwikkelingsdiagnostiek is de Bayley-III-NL. Deze blijkt echter niet voldoende geschikt voor veel kinderen met een verstandelijke en/of lichamelijke beperking. Het testmateriaal is niet afgestemd op deze doelgroep en de testresultaten leveren te weinig informatie op als basis voor de begeleiding. Dit proefschrift beschrijft de resultaten van een door ZonMw gefinancierd onderzoeksproject naar de Special Needs Addition (SNA) van de Bayley-III-NL. De SNA komt tegemoet aan de beperkingen van de Bayley-III-NL en bestaat uit de Low Motor/Vision versie voor kinderen met een motorische en/of visuele beperking, de Low Verbal versie voor kinderen met een spraak-/taalbeperking en de dynamische versie voor het vergroten van de handelingsgerichtheid. Uit de resultaten blijkt dat de SNA-versie de geschiktheid van de Bayley-III-NL voor kinderen met specifieke beperkingen verbetert en het instrument meer handelingsgericht maakt. Op basis daarvan wordt de Bayley-III-NL-SNA medio 2014 uitgegeven. Het instrument kan dus daadwerkelijk in de praktijk gebruikt gaan worden om de ontwikkeling van kinderen met een verstandelijke en/of lichamelijke beperking op een meer valide manier te onderzoeken dan tot nu toe mogelijk was. Most children develop according to expectations in their first few years of life. In some cases, however, early development is not trouble-free. Appropriate developmental assessment is then important to adjust early intervention to the developmental level of the child. A widely-used instrument for developmental assessment is the Bayley-III-NL. This instrument appears to be unsuitable in many cases of cognitive and/or physical impairment. The test materials are not adjusted to the abilities of children in this target group and the test results do not yield sufficient information as a basis for the intervention. This dissertation describes the results of a research project, funded by ZonMw, into the Special Needs Addition (SNA) to the Bayley-III-NL. The aim of the SNA is to solve the described problems related to the Bayley-III-NL. The SNA consists of the Low Motor/Vision version for children with motor and/or visual impairment, the Low Verbal version for children with speech/language impairment, and the dynamic version for obtaining a more intervention-oriented assessment. The results show that the SNA-version enhances the suitability of the Bayley-III-NL for children with specific impairments and that the dynamic version has substantial added clinical value. On the basis of these results, the Bayley-III-NL-SNA will be published mid-2014. The instrument will thus actually be used in early intervention practice in the Netherlands to assess the development of children with a cognitive and/or physical impairment more validly than was possible up to now.

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