Lolkje de Jong-van Den Berg (original) (raw)

Papers by Lolkje de Jong-van Den Berg

Research paper thumbnail of Insulin analogues use in pregnancy among women with pregestational diabetes mellitus and risk of congenital anomaly: a retrospective population-based cohort study

BMJ open, Feb 24, 2018

To evaluate the risk of major congenital anomaly associated with first-trimester exposure to insu... more To evaluate the risk of major congenital anomaly associated with first-trimester exposure to insulin analogues compared with human insulin in offspring of women with pregestational diabetes. A population-based cohort of women with pregestational diabetes (n=1661) who delivered between 1996 and 2012 was established retrospectively from seven European regions covered bythe European Surveillance of Congenital Anomalies (EUROCAT) congenital anomaly registries. The risk of non-chromosomal major congenital anomaly in live births, fetal deaths and terminations for a fetal anomaly exposed to insulin analogues in the first trimester of pregnancy was compared with the risk in those exposed to human insulin only. During the first trimester, 870 fetuses (52.4%) were exposed to human insulin only, 397 fetuses (23.9%) to insulin analogues only and 394 fetuses (23.7%) to both human insulin and insulin analogues. The risk of major congenital anomaly in fetuses exposed to insulin analogues only was ...

Research paper thumbnail of Prescribing of Antidiabetic Medicines before, during and after Pregnancy: A Study in Seven European Regions

PloS one, 2016

To explore antidiabetic medicine prescribing to women before, during and after pregnancy in diffe... more To explore antidiabetic medicine prescribing to women before, during and after pregnancy in different regions of Europe. A common protocol was implemented across seven databases in Denmark, Norway, The Netherlands, Italy (Emilia Romagna/Tuscany), Wales and the rest of the UK. Women with a pregnancy starting and ending between 2004 and 2010, (Denmark, 2004-2009; Norway, 2005-2010; Emilia Romagna, 2008-2010), which ended in a live or stillbirth, were identified. Prescriptions for antidiabetic medicines issued (UK) or dispensed (non-UK) during pregnancy and/or the year before or year after pregnancy were identified. Prescribing patterns were compared across databases and over calendar time. 1,082,673 live/stillbirths were identified. Pregestational insulin prescribing during the year before pregnancy ranged from 0.27% (CI95 0.25-0.30) in Tuscany to 0.45% (CI95 0.43-0.47) in Norway, and increased between 2004 and 2009 in all countries. During pregnancy, insulin prescribing peaked during...

Research paper thumbnail of Lamotrigine use in pregnancy and risk of orofacial cleft and other congenital anomalies

Neurology, May 6, 2016

To test previous signals of a risk of orofacial cleft (OC) and clubfoot with exposure to the anti... more To test previous signals of a risk of orofacial cleft (OC) and clubfoot with exposure to the antiepileptic lamotrigine, and to investigate risk of other congenital anomalies (CA). This was a population-based case-malformed control study based on 21 EUROCAT CA registries covering 10.1 million births (1995-2011), including births to 2005 in which the clubfoot signal was generated and a subsequent independent study population of 6.3 million births. A total of 226,806 babies with CA included livebirths, stillbirths, and terminations of pregnancy following prenatal diagnosis. First-trimester lamotrigine monotherapy exposure in OC cases and clubfoot cases was compared to other nonchromosomal CA (controls). Odds ratios (OR) were adjusted for registry. An exploratory analysis compared the proportion of each standard EUROCAT CA subgroup among all babies with nonchromosomal CA exposed to lamotrigine monotherapy with non-AED exposed pregnancies. There were 147 lamotrigine monotherapy-exposed b...

Research paper thumbnail of Direct-to-Patient Research: Piloting a New Approach to Understanding Drug Safety During Pregnancy

JMIR Public Health and Surveillance, 2015

Research paper thumbnail of Adverse drug reactions: more than a warning!

Research paper thumbnail of Foliumzuur rond de conceptieaangeboren afwijking preconceptionele advisering

Huisarts en Wetenschap, 2002

Research paper thumbnail of Hypertrichose: een bijwerking van inhalatie- corticosteroïden

Research paper thumbnail of Bromocriptine and lactation suppression: Are the risks acceptable?

Pharmacy World & Science, 1995

Research paper thumbnail of Drug utilization studies in pregnancy

Pharmacy World & Science, 1993

... 9 Cornel MC, De Jong-Van den Berg LTW, Koudstaal J, Wiegerinck MAHM, Te Meerman GL Ten Kate L... more ... 9 Cornel MC, De Jong-Van den Berg LTW, Koudstaal J, Wiegerinck MAHM, Te Meerman GL Ten Kate LP. Aanwijzin-gen voor een verhoogde kans op defecten van de neurate buis bij zwangerschappen ontstaan na ovulatie inductie en (of) in vitro-fertilisatie [indications for an ...

Research paper thumbnail of Healthcare databases in Europe for studying medicine use and safety during pregnancy

Pharmacoepidemiology and Drug Safety, 2014

Purpose The aim of this study was to describe a number of electronic healthcare databases in Euro... more Purpose The aim of this study was to describe a number of electronic healthcare databases in Europe in terms of the population covered, the source of the data captured and the availability of data on key variables required for evaluating medicine use and medicine safety during pregnancy. Methods A sample of electronic healthcare databases that captured pregnancies and prescription data was selected on the basis of contacts within the EUROCAT network. For each participating database, a database inventory was completed. Results Eight databases were included, and the total population covered was 25 million. All databases recorded live births, seven captured stillbirths and five had full data available on spontaneous pregnancy losses and induced terminations. In six databases, data were usually available to determine the date of the woman's last menstrual period, whereas in the remainder, algorithms were needed to establish a best estimate for at least some pregnancies. In seven databases, it was possible to use data recorded in the databases to identify pregnancies where the offspring had a congenital anomaly. Information on confounding variables was more commonly available in databases capturing data recorded by primary-care practitioners. All databases captured maternal co-prescribing and a measure of socioeconomic status. Conclusion This study suggests that within Europe, electronic healthcare databases may be valuable sources of data for evaluating medicine use and safety during pregnancy. The suitability of a particular database, however, will depend on the research question, the type of medicine to be evaluated, the prevalence of its use and any adverse outcomes of interest.

Research paper thumbnail of Influence of educational level on determinants of folic acid use

Paediatric and Perinatal Epidemiology, 2003

In The Netherlands, periconceptional folic acid use to prevent neural tube defects was promoted t... more In The Netherlands, periconceptional folic acid use to prevent neural tube defects was promoted through a national 'Folic Acid Campaign'. In two regions, a local campaign supplemented the national campaign to increase the chances of reaching women with low socio-economic status (SES). A framework of outcome criteria, defined as awareness knowledge, perceived safety, attitudes and subjective norms, was developed to evaluate the effectiveness of the two local campaigns. Data were gathered by means of two cross-sectional studies conducted just before and 1 year after the campaigns took place. Before the campaigns were conducted, there were already differences in all effect criteria and folic acid use between women of different educational levels, mostly in favour of women with a high level of education. Although both educational campaigns appeared to have a positive impact on all outcome criteria, they failed to reduce the existing differences in these outcome criteria between women of different educational levels. Folic acid use can be promoted effectively by mass media campaigns, certainly in a large group of women with no prior knowledge of the health benefits associated with periconceptional folic acid use. However, in order to achieve more equal health outcomes among women of low and high SES, it seems that more tailored interventions for women of low SES are needed.

Research paper thumbnail of Paternal drug use: before and during pregnancy

Expert Opinion on Drug Safety, 2012

Exploratory investigation on drug use by fathers before and during pregnancy with regard to the n... more Exploratory investigation on drug use by fathers before and during pregnancy with regard to the number of pregnancies. Data of Dutch community pharmacies were used in which fathers were linked to children. The prevalence of the 15 most prescribed drug groups were calculated per trimester for one trimester preconception and three trimesters during pregnancy. Drugs with possible harmful effect on the semen and/or embryo based on recent safety issues were analyzed for two trimesters before conception. Descriptive statistics was used. During the four trimesters, fathers had used one or more drugs in 73% of the pregnancies. Per trimester, drug use ranged from 35 to 39%, with the highest prevalence in the third trimester, statistically significant for the use of one or two drugs. Drugs used most frequently belong to 'anti-inflammatory and antirheumatic products'. Drugs such as SSRIs with possible harmful effect on the semen and/or embryo are used in 1.4% by fathers before conception. A proportion of 73% of fathers used drugs before and during pregnancy, increasing toward the third trimester. To increase the knowledge on possible effects, organizations like EUROCAT and (EN)(O)TIS might be encouraged to also collect paternal drug use.

Research paper thumbnail of Co-morbidity and patterns of care in stimulant-treated children with ADHD in the Netherlands

European Child & Adolescent Psychiatry, 2010

This study aimed at investigating the use of psychosocial interventions and psychotropic co-medic... more This study aimed at investigating the use of psychosocial interventions and psychotropic co-medication among stimulant-treated children with attention-deficit hyperactivity disorder (ADHD) in relation to the presence of psychiatric co-morbidity. Stimulant users younger than 16 years were identified in 115 pharmacies and a questionnaire was sent to their stimulant prescribing physician. Of 773 questionnaires sent out, 556 were returned and were suitable for analysis (72%). The results are based on 510 questionnaires concerning stimulant-treated children for whom a diagnosis of ADHD was reported. Of the 510 children diagnosed with ADHD, 31% had also received one or more other psychiatric diagnoses, mainly pervasive developmental disorder or oppositional defiant disorder/ conduct disorder. We found an association between the presence of co-morbidity and the use of psychosocial interventions for the child (P \ 0.001) and the parents (P \ 0.001). In the ADHD-only group, 26% did not receive any form of additional interventions, while psychosocial interventions varied from 8 to 18% in children with ADHD and psychiatric co-morbidity. The presence of diagnostic co-morbidity was also associated with the use of psychotropic co-medication (overall, P = 0.012) and antipsychotics (P \ 0.001). Stimulant-treated youths with ADHD and psychiatric co-morbidity received more psychosocial interventions and psychotropic co-medication than children with ADHD-only. The type of psychosocial interventions and psychotropic co-medication received by the children and their parents, depended on the specific co-morbid psychiatric disorder being present. Keywords Stimulants Á Co-morbidity Á Attention deficit hyperactivity disorder Á Co-medication Á Multimodal treatment Abbreviations ODD Oppositional defiant disorder CD Conduct disorder DSM Diagnostic and statistical manual of mental disorder MTA Multimodal treatment study of children with ADHD PDD Pervasive developmental disorder PDD-NOS Pervasive developmental disorder-not otherwise specified GP General practitioner During the study, Adrianne Faber and Hilde Tobi were working at the

Research paper thumbnail of Do Pregnant Women Report Use of Dispensed Medications?

Epidemiology, 2001

Surveillance of drug safety in pregnancy often draws on administrative prescription registries. N... more Surveillance of drug safety in pregnancy often draws on administrative prescription registries. Noncompliance in the use of prescribed medication may be frequent among pregnant women owing to their fear of fetotoxic side effects. To estimate compliance in the use of prescription drugs dispensed during pregnancy, we compared prescription data from the North Jutland Prescription Database with information on drug use provided by pregnant women to the Danish National Birth Cohort (DNBC), which is a health interview survey. We used the North Jutland Prescription Database to identify all prescription drugs dispensed during pregnancy for the 2,041 women who were enrolled in the DNBC in the County of North Jutland, Denmark. Compliance was defined as the probability of reporting drug use in DNBC after purchasing a dispensed prescription drug. The overall compliance to drugs purchased within 120 days before the interview was 43% (95% confidence interval = 40-46). Drugs used for treating chronic diseases, for example, beta-blockers, insulin, thyroid hormones, and diuretic and antiepileptic drugs, were always reported to be used, but compliance was low for drugs used for local or short-term treatment such as antihistamines, antibiotics, antacids, nonsteroid anti-inflammatory drugs, and gynecologic drugs. Thus, for the latter drug groups the prescription database may provide an incomplete identification of exposure. Neither data source is unbiased regarding actual drug intake. Nevertheless, our results indicate that for some drug groups risk assessment studies based on prescription data may produce false negative results as a result of noncompliance.

Research paper thumbnail of Prescribed doses of inhaled steroids in Dutch children: too little or too much, for too short a time

British Journal of Clinical Pharmacology, 2006

Aims To investigate the dosage and duration of inhaled steroids prescribed to children and to com... more Aims To investigate the dosage and duration of inhaled steroids prescribed to children and to compare the prescribed doses with recommended doses for the treatment of asthma in children. Methods For 2514 Dutch children aged 0-12 years who had used inhaled steroids in 2002, pharmacy dispensing data were obtained from the InterAction database, type of steroid (beclomethason, budesonide, fluticasone) and type of user (first time or existing) and the average prescribed doses according to age were determined and compared with the doses as recommended in the national Dutch Nederlands Huisar tsen Genootschap (NHG) guideline. Furthermore, for all first-time users the duration of therapy with inhaled steroids was determined using a Kaplan-Meier analysis. Results The major findings were that: (i) overall 43% of children starting inhaled steroids were prescribed doses that are half the recommended dose or less; (ii) overall 8% of the children starting inhaled steroids were prescribed doses that were twice the recommended dose or more, up to 50% in the 12-year-olds fluticasone group; and (iii) only 8% of the children who started with inhaled steroids used them continuously for a full year. Conclusions Doses of inhaled steroids for many children deviate from those recommended, with lower doses more frequently occurring than higher doses. Less than 10% of the children receive prescriptions for a prolonged period of time.

Research paper thumbnail of Drug use of children in the community assessed through pharmacy dispensing data

British Journal of Clinical Pharmacology, 2001

: To determine the extent of drug use in children and the types of drugs that children use. METHO... more : To determine the extent of drug use in children and the types of drugs that children use. METHODS Cross-sectional study and cohort study, using computerized pharmacy dispensing records for all children aged 0-16 years in the northern part of The Netherlands in 1998. The main outcome measures were proportion of children that used drugs (per sex and age group), mean number of drugs per child, 10 most widely used drug groups and cumulative proportions of drugs users (per drug group) during the first 2 years of life. Drug use was the highest among infants, decreased till adolescence and increased from there. Overall, approximately 60% of all children used at least one drug in 1998. At younger ages, boys used more drugs than girls and at older ages girls used more drugs than boys. Systemic antibiotics were used by 21% of the children and were by far the most widely used drugs. Other frequently used drugs were analgesics (10%), corticosteroids for dermatologic use (9%), anthistamines (8%) and antiasthmatics (7%). Approximately 10% of the children had used at least one drug at the age of 1 month and at the age of 2 years this proportion was 81%. The majority of children was exposed to one or more drugs and this exposure started at very young age. This shows the importance of good guidelines for drug use in children and emphasizes the necessity of research of pharmacokinetic and pharmacodynamic properties in children to obtain safety, efficacy and quality evidence of these drugs.

Research paper thumbnail of Influence of the third generation pill controversy on prescriptions for oral contraceptives among first time users: population based study

Research paper thumbnail of Prescribing during pregnancy and lactation with reference to the Swedish classification system, A population-based study among Danish women

Acta Obstetricia et Gynecologica Scandinavica, 1999

Aim. To assess the current prescribing pattern for 15,756 primiparae before, during, and after th... more Aim. To assess the current prescribing pattern for 15,756 primiparae before, during, and after their pregnancies with reference to fetal and neonatal risk. Method. A prescription database study with linkage to The Danish Medical Birth Registry from 1991 to 1996. The drug subsidy system in Danish retail pharmacies, made it possible to identify prescriptions by individual use. All 34,334 prescriptions were set against the Swedish classification of risk of drug use in pregnancy and lactation. Results. During pregnancy, safe (group A), potentially harmful (group B3, C, and D), and non-classifiable drugs accounted for 40.9%, 26.6% and 28.7% respectively. The proportion of women who redeemed drugs was 29.2%, 8.6%, 18.7% and 0.9% from drug groups A, B, C and D respectively. The proportion of prescriptions from high risk groups declined during the course of pregnancy. Postpartum, safe drugs (group I and II), drugs with possible harmful neonatal effects (group III), and non-classifiable drugs accounted for 43.5%, 4.8%, and 35.8% of the prescriptions, respectively. Conclusion. According to the Swedish classification system, we found that during pregnancy and lactation a high proportion of Danish women were exposed to one or more drugs in high risk groups; furthermore, knowledge regarding their safety for the fetus and neonate was limited for a large proportion of the prescriptions. Current evidence about long-term effects of prenatal exposure stresses the need for long-term follow-up of health and development among exposed children.

Research paper thumbnail of The Risk of Specific Congenital Anomalies in Relation to Newer Antiepileptic Drugs: A Literature Review

Drugs - real world outcomes, 2016

More information is needed about possible associations between the newer anti-epileptic drugs (AE... more More information is needed about possible associations between the newer anti-epileptic drugs (AEDs) in the first trimester of pregnancy and specific congenital anomalies of the fetus. We performed a literature review to find signals for potential associations between newer AEDs (lamotrigine, topiramate, levetiracetam, gabapentin, oxcarbazepine, eslicarbazepine, felbamate, lacosamide, pregabalin, retigabine, rufinamide, stiripentol, tiagabine, vigabatrin, and zonisamide) and specific congenital anomalies. We searched PubMed and EMBASE to find observational studies with pregnancies exposed to newer AEDs and detailed information on congenital anomalies. The congenital anomalies in the studies were classified according to the congenital anomaly subgroups of European Surveillance of Congenital Anomalies (EUROCAT). We compared the prevalence of specific congenital anomalies in fetuses exposed to individual AEDs in the combined studies with that of the general population in a reference da...

Research paper thumbnail of Results of a retrospective database analysis of adherence to statin therapy and risk of nonfatal ischemic heart disease in daily clinical practice in Italy

Clinical Therapeutics, 2010

Research paper thumbnail of Insulin analogues use in pregnancy among women with pregestational diabetes mellitus and risk of congenital anomaly: a retrospective population-based cohort study

BMJ open, Feb 24, 2018

To evaluate the risk of major congenital anomaly associated with first-trimester exposure to insu... more To evaluate the risk of major congenital anomaly associated with first-trimester exposure to insulin analogues compared with human insulin in offspring of women with pregestational diabetes. A population-based cohort of women with pregestational diabetes (n=1661) who delivered between 1996 and 2012 was established retrospectively from seven European regions covered bythe European Surveillance of Congenital Anomalies (EUROCAT) congenital anomaly registries. The risk of non-chromosomal major congenital anomaly in live births, fetal deaths and terminations for a fetal anomaly exposed to insulin analogues in the first trimester of pregnancy was compared with the risk in those exposed to human insulin only. During the first trimester, 870 fetuses (52.4%) were exposed to human insulin only, 397 fetuses (23.9%) to insulin analogues only and 394 fetuses (23.7%) to both human insulin and insulin analogues. The risk of major congenital anomaly in fetuses exposed to insulin analogues only was ...

Research paper thumbnail of Prescribing of Antidiabetic Medicines before, during and after Pregnancy: A Study in Seven European Regions

PloS one, 2016

To explore antidiabetic medicine prescribing to women before, during and after pregnancy in diffe... more To explore antidiabetic medicine prescribing to women before, during and after pregnancy in different regions of Europe. A common protocol was implemented across seven databases in Denmark, Norway, The Netherlands, Italy (Emilia Romagna/Tuscany), Wales and the rest of the UK. Women with a pregnancy starting and ending between 2004 and 2010, (Denmark, 2004-2009; Norway, 2005-2010; Emilia Romagna, 2008-2010), which ended in a live or stillbirth, were identified. Prescriptions for antidiabetic medicines issued (UK) or dispensed (non-UK) during pregnancy and/or the year before or year after pregnancy were identified. Prescribing patterns were compared across databases and over calendar time. 1,082,673 live/stillbirths were identified. Pregestational insulin prescribing during the year before pregnancy ranged from 0.27% (CI95 0.25-0.30) in Tuscany to 0.45% (CI95 0.43-0.47) in Norway, and increased between 2004 and 2009 in all countries. During pregnancy, insulin prescribing peaked during...

Research paper thumbnail of Lamotrigine use in pregnancy and risk of orofacial cleft and other congenital anomalies

Neurology, May 6, 2016

To test previous signals of a risk of orofacial cleft (OC) and clubfoot with exposure to the anti... more To test previous signals of a risk of orofacial cleft (OC) and clubfoot with exposure to the antiepileptic lamotrigine, and to investigate risk of other congenital anomalies (CA). This was a population-based case-malformed control study based on 21 EUROCAT CA registries covering 10.1 million births (1995-2011), including births to 2005 in which the clubfoot signal was generated and a subsequent independent study population of 6.3 million births. A total of 226,806 babies with CA included livebirths, stillbirths, and terminations of pregnancy following prenatal diagnosis. First-trimester lamotrigine monotherapy exposure in OC cases and clubfoot cases was compared to other nonchromosomal CA (controls). Odds ratios (OR) were adjusted for registry. An exploratory analysis compared the proportion of each standard EUROCAT CA subgroup among all babies with nonchromosomal CA exposed to lamotrigine monotherapy with non-AED exposed pregnancies. There were 147 lamotrigine monotherapy-exposed b...

Research paper thumbnail of Direct-to-Patient Research: Piloting a New Approach to Understanding Drug Safety During Pregnancy

JMIR Public Health and Surveillance, 2015

Research paper thumbnail of Adverse drug reactions: more than a warning!

Research paper thumbnail of Foliumzuur rond de conceptieaangeboren afwijking preconceptionele advisering

Huisarts en Wetenschap, 2002

Research paper thumbnail of Hypertrichose: een bijwerking van inhalatie- corticosteroïden

Research paper thumbnail of Bromocriptine and lactation suppression: Are the risks acceptable?

Pharmacy World & Science, 1995

Research paper thumbnail of Drug utilization studies in pregnancy

Pharmacy World & Science, 1993

... 9 Cornel MC, De Jong-Van den Berg LTW, Koudstaal J, Wiegerinck MAHM, Te Meerman GL Ten Kate L... more ... 9 Cornel MC, De Jong-Van den Berg LTW, Koudstaal J, Wiegerinck MAHM, Te Meerman GL Ten Kate LP. Aanwijzin-gen voor een verhoogde kans op defecten van de neurate buis bij zwangerschappen ontstaan na ovulatie inductie en (of) in vitro-fertilisatie [indications for an ...

Research paper thumbnail of Healthcare databases in Europe for studying medicine use and safety during pregnancy

Pharmacoepidemiology and Drug Safety, 2014

Purpose The aim of this study was to describe a number of electronic healthcare databases in Euro... more Purpose The aim of this study was to describe a number of electronic healthcare databases in Europe in terms of the population covered, the source of the data captured and the availability of data on key variables required for evaluating medicine use and medicine safety during pregnancy. Methods A sample of electronic healthcare databases that captured pregnancies and prescription data was selected on the basis of contacts within the EUROCAT network. For each participating database, a database inventory was completed. Results Eight databases were included, and the total population covered was 25 million. All databases recorded live births, seven captured stillbirths and five had full data available on spontaneous pregnancy losses and induced terminations. In six databases, data were usually available to determine the date of the woman's last menstrual period, whereas in the remainder, algorithms were needed to establish a best estimate for at least some pregnancies. In seven databases, it was possible to use data recorded in the databases to identify pregnancies where the offspring had a congenital anomaly. Information on confounding variables was more commonly available in databases capturing data recorded by primary-care practitioners. All databases captured maternal co-prescribing and a measure of socioeconomic status. Conclusion This study suggests that within Europe, electronic healthcare databases may be valuable sources of data for evaluating medicine use and safety during pregnancy. The suitability of a particular database, however, will depend on the research question, the type of medicine to be evaluated, the prevalence of its use and any adverse outcomes of interest.

Research paper thumbnail of Influence of educational level on determinants of folic acid use

Paediatric and Perinatal Epidemiology, 2003

In The Netherlands, periconceptional folic acid use to prevent neural tube defects was promoted t... more In The Netherlands, periconceptional folic acid use to prevent neural tube defects was promoted through a national 'Folic Acid Campaign'. In two regions, a local campaign supplemented the national campaign to increase the chances of reaching women with low socio-economic status (SES). A framework of outcome criteria, defined as awareness knowledge, perceived safety, attitudes and subjective norms, was developed to evaluate the effectiveness of the two local campaigns. Data were gathered by means of two cross-sectional studies conducted just before and 1 year after the campaigns took place. Before the campaigns were conducted, there were already differences in all effect criteria and folic acid use between women of different educational levels, mostly in favour of women with a high level of education. Although both educational campaigns appeared to have a positive impact on all outcome criteria, they failed to reduce the existing differences in these outcome criteria between women of different educational levels. Folic acid use can be promoted effectively by mass media campaigns, certainly in a large group of women with no prior knowledge of the health benefits associated with periconceptional folic acid use. However, in order to achieve more equal health outcomes among women of low and high SES, it seems that more tailored interventions for women of low SES are needed.

Research paper thumbnail of Paternal drug use: before and during pregnancy

Expert Opinion on Drug Safety, 2012

Exploratory investigation on drug use by fathers before and during pregnancy with regard to the n... more Exploratory investigation on drug use by fathers before and during pregnancy with regard to the number of pregnancies. Data of Dutch community pharmacies were used in which fathers were linked to children. The prevalence of the 15 most prescribed drug groups were calculated per trimester for one trimester preconception and three trimesters during pregnancy. Drugs with possible harmful effect on the semen and/or embryo based on recent safety issues were analyzed for two trimesters before conception. Descriptive statistics was used. During the four trimesters, fathers had used one or more drugs in 73% of the pregnancies. Per trimester, drug use ranged from 35 to 39%, with the highest prevalence in the third trimester, statistically significant for the use of one or two drugs. Drugs used most frequently belong to 'anti-inflammatory and antirheumatic products'. Drugs such as SSRIs with possible harmful effect on the semen and/or embryo are used in 1.4% by fathers before conception. A proportion of 73% of fathers used drugs before and during pregnancy, increasing toward the third trimester. To increase the knowledge on possible effects, organizations like EUROCAT and (EN)(O)TIS might be encouraged to also collect paternal drug use.

Research paper thumbnail of Co-morbidity and patterns of care in stimulant-treated children with ADHD in the Netherlands

European Child & Adolescent Psychiatry, 2010

This study aimed at investigating the use of psychosocial interventions and psychotropic co-medic... more This study aimed at investigating the use of psychosocial interventions and psychotropic co-medication among stimulant-treated children with attention-deficit hyperactivity disorder (ADHD) in relation to the presence of psychiatric co-morbidity. Stimulant users younger than 16 years were identified in 115 pharmacies and a questionnaire was sent to their stimulant prescribing physician. Of 773 questionnaires sent out, 556 were returned and were suitable for analysis (72%). The results are based on 510 questionnaires concerning stimulant-treated children for whom a diagnosis of ADHD was reported. Of the 510 children diagnosed with ADHD, 31% had also received one or more other psychiatric diagnoses, mainly pervasive developmental disorder or oppositional defiant disorder/ conduct disorder. We found an association between the presence of co-morbidity and the use of psychosocial interventions for the child (P \ 0.001) and the parents (P \ 0.001). In the ADHD-only group, 26% did not receive any form of additional interventions, while psychosocial interventions varied from 8 to 18% in children with ADHD and psychiatric co-morbidity. The presence of diagnostic co-morbidity was also associated with the use of psychotropic co-medication (overall, P = 0.012) and antipsychotics (P \ 0.001). Stimulant-treated youths with ADHD and psychiatric co-morbidity received more psychosocial interventions and psychotropic co-medication than children with ADHD-only. The type of psychosocial interventions and psychotropic co-medication received by the children and their parents, depended on the specific co-morbid psychiatric disorder being present. Keywords Stimulants Á Co-morbidity Á Attention deficit hyperactivity disorder Á Co-medication Á Multimodal treatment Abbreviations ODD Oppositional defiant disorder CD Conduct disorder DSM Diagnostic and statistical manual of mental disorder MTA Multimodal treatment study of children with ADHD PDD Pervasive developmental disorder PDD-NOS Pervasive developmental disorder-not otherwise specified GP General practitioner During the study, Adrianne Faber and Hilde Tobi were working at the

Research paper thumbnail of Do Pregnant Women Report Use of Dispensed Medications?

Epidemiology, 2001

Surveillance of drug safety in pregnancy often draws on administrative prescription registries. N... more Surveillance of drug safety in pregnancy often draws on administrative prescription registries. Noncompliance in the use of prescribed medication may be frequent among pregnant women owing to their fear of fetotoxic side effects. To estimate compliance in the use of prescription drugs dispensed during pregnancy, we compared prescription data from the North Jutland Prescription Database with information on drug use provided by pregnant women to the Danish National Birth Cohort (DNBC), which is a health interview survey. We used the North Jutland Prescription Database to identify all prescription drugs dispensed during pregnancy for the 2,041 women who were enrolled in the DNBC in the County of North Jutland, Denmark. Compliance was defined as the probability of reporting drug use in DNBC after purchasing a dispensed prescription drug. The overall compliance to drugs purchased within 120 days before the interview was 43% (95% confidence interval = 40-46). Drugs used for treating chronic diseases, for example, beta-blockers, insulin, thyroid hormones, and diuretic and antiepileptic drugs, were always reported to be used, but compliance was low for drugs used for local or short-term treatment such as antihistamines, antibiotics, antacids, nonsteroid anti-inflammatory drugs, and gynecologic drugs. Thus, for the latter drug groups the prescription database may provide an incomplete identification of exposure. Neither data source is unbiased regarding actual drug intake. Nevertheless, our results indicate that for some drug groups risk assessment studies based on prescription data may produce false negative results as a result of noncompliance.

Research paper thumbnail of Prescribed doses of inhaled steroids in Dutch children: too little or too much, for too short a time

British Journal of Clinical Pharmacology, 2006

Aims To investigate the dosage and duration of inhaled steroids prescribed to children and to com... more Aims To investigate the dosage and duration of inhaled steroids prescribed to children and to compare the prescribed doses with recommended doses for the treatment of asthma in children. Methods For 2514 Dutch children aged 0-12 years who had used inhaled steroids in 2002, pharmacy dispensing data were obtained from the InterAction database, type of steroid (beclomethason, budesonide, fluticasone) and type of user (first time or existing) and the average prescribed doses according to age were determined and compared with the doses as recommended in the national Dutch Nederlands Huisar tsen Genootschap (NHG) guideline. Furthermore, for all first-time users the duration of therapy with inhaled steroids was determined using a Kaplan-Meier analysis. Results The major findings were that: (i) overall 43% of children starting inhaled steroids were prescribed doses that are half the recommended dose or less; (ii) overall 8% of the children starting inhaled steroids were prescribed doses that were twice the recommended dose or more, up to 50% in the 12-year-olds fluticasone group; and (iii) only 8% of the children who started with inhaled steroids used them continuously for a full year. Conclusions Doses of inhaled steroids for many children deviate from those recommended, with lower doses more frequently occurring than higher doses. Less than 10% of the children receive prescriptions for a prolonged period of time.

Research paper thumbnail of Drug use of children in the community assessed through pharmacy dispensing data

British Journal of Clinical Pharmacology, 2001

: To determine the extent of drug use in children and the types of drugs that children use. METHO... more : To determine the extent of drug use in children and the types of drugs that children use. METHODS Cross-sectional study and cohort study, using computerized pharmacy dispensing records for all children aged 0-16 years in the northern part of The Netherlands in 1998. The main outcome measures were proportion of children that used drugs (per sex and age group), mean number of drugs per child, 10 most widely used drug groups and cumulative proportions of drugs users (per drug group) during the first 2 years of life. Drug use was the highest among infants, decreased till adolescence and increased from there. Overall, approximately 60% of all children used at least one drug in 1998. At younger ages, boys used more drugs than girls and at older ages girls used more drugs than boys. Systemic antibiotics were used by 21% of the children and were by far the most widely used drugs. Other frequently used drugs were analgesics (10%), corticosteroids for dermatologic use (9%), anthistamines (8%) and antiasthmatics (7%). Approximately 10% of the children had used at least one drug at the age of 1 month and at the age of 2 years this proportion was 81%. The majority of children was exposed to one or more drugs and this exposure started at very young age. This shows the importance of good guidelines for drug use in children and emphasizes the necessity of research of pharmacokinetic and pharmacodynamic properties in children to obtain safety, efficacy and quality evidence of these drugs.

Research paper thumbnail of Influence of the third generation pill controversy on prescriptions for oral contraceptives among first time users: population based study

Research paper thumbnail of Prescribing during pregnancy and lactation with reference to the Swedish classification system, A population-based study among Danish women

Acta Obstetricia et Gynecologica Scandinavica, 1999

Aim. To assess the current prescribing pattern for 15,756 primiparae before, during, and after th... more Aim. To assess the current prescribing pattern for 15,756 primiparae before, during, and after their pregnancies with reference to fetal and neonatal risk. Method. A prescription database study with linkage to The Danish Medical Birth Registry from 1991 to 1996. The drug subsidy system in Danish retail pharmacies, made it possible to identify prescriptions by individual use. All 34,334 prescriptions were set against the Swedish classification of risk of drug use in pregnancy and lactation. Results. During pregnancy, safe (group A), potentially harmful (group B3, C, and D), and non-classifiable drugs accounted for 40.9%, 26.6% and 28.7% respectively. The proportion of women who redeemed drugs was 29.2%, 8.6%, 18.7% and 0.9% from drug groups A, B, C and D respectively. The proportion of prescriptions from high risk groups declined during the course of pregnancy. Postpartum, safe drugs (group I and II), drugs with possible harmful neonatal effects (group III), and non-classifiable drugs accounted for 43.5%, 4.8%, and 35.8% of the prescriptions, respectively. Conclusion. According to the Swedish classification system, we found that during pregnancy and lactation a high proportion of Danish women were exposed to one or more drugs in high risk groups; furthermore, knowledge regarding their safety for the fetus and neonate was limited for a large proportion of the prescriptions. Current evidence about long-term effects of prenatal exposure stresses the need for long-term follow-up of health and development among exposed children.

Research paper thumbnail of The Risk of Specific Congenital Anomalies in Relation to Newer Antiepileptic Drugs: A Literature Review

Drugs - real world outcomes, 2016

More information is needed about possible associations between the newer anti-epileptic drugs (AE... more More information is needed about possible associations between the newer anti-epileptic drugs (AEDs) in the first trimester of pregnancy and specific congenital anomalies of the fetus. We performed a literature review to find signals for potential associations between newer AEDs (lamotrigine, topiramate, levetiracetam, gabapentin, oxcarbazepine, eslicarbazepine, felbamate, lacosamide, pregabalin, retigabine, rufinamide, stiripentol, tiagabine, vigabatrin, and zonisamide) and specific congenital anomalies. We searched PubMed and EMBASE to find observational studies with pregnancies exposed to newer AEDs and detailed information on congenital anomalies. The congenital anomalies in the studies were classified according to the congenital anomaly subgroups of European Surveillance of Congenital Anomalies (EUROCAT). We compared the prevalence of specific congenital anomalies in fetuses exposed to individual AEDs in the combined studies with that of the general population in a reference da...

Research paper thumbnail of Results of a retrospective database analysis of adherence to statin therapy and risk of nonfatal ischemic heart disease in daily clinical practice in Italy

Clinical Therapeutics, 2010