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Article ; Online: The Dutch Pregnancy Drug Register: Suitable to Study Paternal Drug Exposures?

van der Mijle, Annerose E / Woestenberg, Petra J / Kosse, Leanne J / van Puijenbroek, Eugène P

International journal of environmental research and public health

2023 Volume 20, Issue 23

Abstract: Paternal medication use around the time of conception is common, but information about its effects on pregnancy outcome and the health of the child is generally limited. The aim of this study is to examine the feasibility of studying paternal exposure in ...

Abstract	Paternal medication use around the time of conception is common, but information about its effects on pregnancy outcome and the health of the child is generally limited. The aim of this study is to examine the feasibility of studying paternal exposure in the Dutch Pregnancy Drug Register by using immunosuppressants as a proof of concept. In 113 of 15,959 pregnancies, long-term paternal immunosuppressant use was reported 3 months before conception. In total, 134 immunosuppressants were used. Pregnancy outcome was known for 54 cases and was in accordance with previous findings. Two spontaneous abortions, two premature births, six small for gestational age babies, and two major congenital malformations were reported. Time to pregnancy (TTP) was known for 9548 pregnancies, including 89 with paternal immunosuppressant use. TTP analysis did not show a difference in pregnancies with paternal immunosuppressant use compared to the control group. Moreover, the number of fertility treatments in the paternal immunosuppressant group was similar to the control group. In our opinion, it is feasible to use the Dutch Pregnancy Drug Register to study the effects of paternal exposure on pregnancy outcome. However, to study the potential effects on fertility, more information is needed, particularly since the beginning of pregnancy attempts.
MeSH term(s)	Male ; Female ; Child ; Pregnancy ; Humans ; Paternal Exposure/adverse effects ; Pregnancy Outcome/epidemiology ; Abortion, Spontaneous/epidemiology ; Premature Birth ; Immunosuppressive Agents/therapeutic use
Chemical Substances	Immunosuppressive Agents
Language	English
Publishing date	2023-11-24
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2175195-X
ISSN	1660-4601 ; 1661-7827
ISSN (online)	1660-4601
ISSN	1661-7827
DOI	10.3390/ijerph20237107
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: A case series of bacillus Calmette-Guérin scar reactivation after administration of both mRNA and viral vector COVID-19 vaccines.

van Balveren, Leontine / van Puijenbroek, Eugène P / Davidson, Linda / van Hunsel, Florence

British journal of clinical pharmacology

2023 Volume 89, Issue 7, Page(s) 2113–2121

Abstract: Aim: Reactivation of the scar resulting from intradermal injection of bacillus Calmette-Guérin (BCG) is a common specific reaction in Kawasaki's disease. It has also sporadically been associated with viral infections, multisystem inflammatory syndrome ... ...

Abstract	Aim: Reactivation of the scar resulting from intradermal injection of bacillus Calmette-Guérin (BCG) is a common specific reaction in Kawasaki's disease. It has also sporadically been associated with viral infections, multisystem inflammatory syndrome in children, influenza vaccination and mRNA COVID-19 vaccination. In this case series, characteristics of BCG scar reactivation after different COVID-19 vaccinations are presented and possible mechanisms are discussed. Methods: Data were collected from the spontaneous reporting system of the Netherlands Pharmacovigilance Centre Lareb. Descriptives were made for the case reports in which a BCG scar reactivation was detected. Results: Since the start of the COVID-19 vaccination campaign in January 2021, the Netherlands Pharmacovigilance Centre Lareb has received 22 case reports of BCG reactivation after vaccination with a COVID-19 vaccine. In 20 case reports, it concerned mRNA COVID-19 vaccines Moderna (14) and Pfizer (6). In two case reports, the viral vector COVID-19 vaccine AstraZeneca was administered. Erythema and pain were the most frequently reported symptoms and the size of the inflammation was between 1.5 and 5 cm. BCG scar reactivation occurred with a median time to onset of 2 days after the second or booster COVID-19 vaccination, whereas the median time to onset was 7 days after the first COVID-19 vaccination. None of the BCG scar reactivations were treated. Conclusions: The exact mechanism of the occurrence of BCG scar reactivation remains unknown, but involvement of heat shock protein 65 is suggested. BCG scar reactivation is a nonserious, self-limiting reaction that can occur after vaccination with both mRNA and viral vector COVID-19 vaccines.
MeSH term(s)	Child ; Humans ; COVID-19 Vaccines/adverse effects ; BCG Vaccine/adverse effects ; COVID-19/complications ; Cicatrix/etiology ; Vaccination/adverse effects ; Vaccination/methods
Chemical Substances	COVID-19 Vaccines ; BCG Vaccine
Language	English
Publishing date	2023-02-10
Publishing country	England
Document type	Case Reports ; Journal Article
ZDB-ID	188974-6
ISSN	1365-2125 ; 0306-5251 ; 0264-3774
ISSN (online)	1365-2125
ISSN	0306-5251 ; 0264-3774
DOI	10.1111/bcp.15678
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Article ; Online: Efficacy, Safety, and Economics of Innovative Medicines: The Role of Multi-Criteria Decision Analysis and Managed Entry Agreements in Practice and Policy.

Fens, Tanja / van Puijenbroek, Eugène P / Postma, Maarten J

Frontiers in medical technology

2021 Volume 3, Page(s) 629750

Abstract: Through the years, solutions for accelerated access to innovative treatments are implemented in models of regulatory approvals, yet with limited data. Besides efficacy data, providing adequate safety data is key to transferring conditional marketing ... ...

Abstract	Through the years, solutions for accelerated access to innovative treatments are implemented in models of regulatory approvals, yet with limited data. Besides efficacy data, providing adequate safety data is key to transferring conditional marketing authorization to final marketing authorization. However, this remains a challenge because of the restricted availability and transferability of such data. Within this study, we set up a challenge to analyze the answers of two questions. First, from regulatory bodies' point of view, we bring the question of whether multi-criteria decision analysis (MCDA) is an adequate tool for further improvement of health technology assessment (HTA) of innovative medicines. Second, we ask if managed entry agreements (MEAs) pose solutions for facilitating the access to innovative medicines and further strengthening the evidence base concerning efficacy and effectiveness, as well as safety. Elaborating on such challenges brought us to conclude that increasing the attention to safety in MCDAs and MEAs will increase the trust of the authorities and improve the access for the manufacturers and the early availability of safe and effective medicines for the patients.
Language	English
Publishing date	2021-04-28
Publishing country	Switzerland
Document type	Journal Article ; Review
ISSN	2673-3129
ISSN (online)	2673-3129
DOI	10.3389/fmedt.2021.629750
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Article: Legislation and current developments in adverse drug reaction reporting in Mongolia: how far are we?

Zulzaga, Zuzaan / Myagmarsuren, Erdenetuya / Woerdenbag, Herman J / van Puijenbroek, Eugene P

Journal of pharmaceutical policy and practice

2021 Volume 14, Issue 1, Page(s) 15

Abstract: Monitoring adverse drug reactions is a vital issue to ensure drug safety and to protect the general public from medication-related harmful effects. In order to properly monitor drug safety, a regulatory system needs to be in place as well as an ... ...

Abstract	Monitoring adverse drug reactions is a vital issue to ensure drug safety and to protect the general public from medication-related harmful effects. In order to properly monitor drug safety, a regulatory system needs to be in place as well as an infrastructure that allows for analyzing national and international safety data. In Mongolia, adverse drug reaction (ADR) reporting activities have been implemented in the past decade. During this period, the basic structure and legal basis of an adverse drug reaction monitoring system was established. Because of the fragmented but growing healthcare system and the complexity of pharmaceutical issues in Mongolia, a sustainable process for the development of the adverse drug reaction reporting system is a key issue. The aim of this article is to disclose the Mongolian situation for the rest of the world and to share experiences on how an ADR reporting system can be developed towards a higher and more advanced level to contribute to both national and international drug safety issues. In this article, we review the features of the Mongolian health care and pharmaceutical systems, as well as the current development of the adverse drug reaction reporting system.
Language	English
Publishing date	2021-03-08
Publishing country	England
Document type	Letter
ZDB-ID	2734772-2
ISSN	2052-3211
ISSN	2052-3211
DOI	10.1186/s40545-021-00298-8
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Article ; Online: Dilemma of belimumab therapy (dis)continuation during pregnancy: Results of a retrospective study in eudravigilance.

Ghalandari, Nafise / Crijns, Hubertina Jmj / Dolhain, Radboud Jem / Hazes, Johanna Mw / van Puijenbroek, Eugene P

Lupus

2022 Volume 32, Issue 2, Page(s) 189–197

Abstract: Introduction: The first biologic authorized for systemic lupus erythematosus (SLE) up to this date, belimumab, is currently not recommended for use during pregnancy due to lack of data. Provided that the health of the child begins with the health of the ...

Abstract	Introduction: The first biologic authorized for systemic lupus erythematosus (SLE) up to this date, belimumab, is currently not recommended for use during pregnancy due to lack of data. Provided that the health of the child begins with the health of the mother, pregnant patients face the dilemma of cessation or continuation of belimumab. If belimumab is stopped, there will be a risk of SLE flare and its consequences for the mother and the foetus. Continuation is also not optimal because of the lack of knowledge on safety for use during pregnancy. Aim: To compare the reported foetal outcomes in SLE patients who stopped scheduled belimumab within the first trimester (group A) and those who continued scheduled belimumab during the first trimester or thereafter (group B). Material and method: All belimumab-exposed pregnancy-related reports were extracted from the EudraVigilance (EV) database until March 11th, 2021. After case review, repeated cases, uninformative reports, non-medical elective abortions and foetal chromosomal abnormalities were excluded. Included pregnancies were divided into two groups (group A and B, as described above). Foetal outcomes were divided into live birth or foetal death (due to miscarriage or stillbirth) and were compared between both groups. Furthermore, neonatal outcomes, such as reporting rates of preterm birth, low birth weight and major congenital malformations were compared. Results: No statistical difference in foetal death was observed between group A and B (reported numbers (%) = 32 (46.4) and 11 (52.4), respectively). Odds ratio (OR, [95% Confidence Intervals (CIs)]) of foetal death in group B compared to group A was 1.27 [0.48, 3.32]. Reporting rates of preterm birth and low birth weight were higher - though not statistically different - in group A. Conclusion: The positive results of our study are supportive for the continuation of belimumab during pregnancy. Since the analysis is based on spontaneous reports/retrospective data, additional studies are needed to confirm the results.
MeSH term(s)	Pregnancy ; Female ; Child ; Humans ; Infant, Newborn ; Lupus Erythematosus, Systemic ; Retrospective Studies ; Premature Birth ; Immunosuppressive Agents/adverse effects ; Fetal Death ; Treatment Outcome
Chemical Substances	belimumab (73B0K5S26A) ; Immunosuppressive Agents
Language	English
Publishing date	2022-11-30
Publishing country	England
Document type	Journal Article
ZDB-ID	1154407-7
ISSN	1477-0962 ; 0961-2033
ISSN (online)	1477-0962
ISSN	0961-2033
DOI	10.1177/09612033221143286
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Article: Infections in Biological and Targeted Synthetic Drug Use in Rheumatoid Arthritis: Where do We Stand? A Scoping Review and Meta-analysis.

Bergmans, Barbara J M / Gebeyehu, Biniyam Y / van Puijenbroek, Eugène P / Van Deun, Katrijn / Kleinberg, Bennett / Murk, Jean-Luc / de Vries, Esther

Rheumatology and therapy

2023 Volume 10, Issue 5, Page(s) 1147–1165

Abstract: Introduction: The advent of biological and targeted synthetic therapies has revolutionized rheumatoid arthritis (RA) treatment. However, this has come at the price of an increased risk of infections. The aim of this study was to present an integrated ... ...

Abstract	Introduction: The advent of biological and targeted synthetic therapies has revolutionized rheumatoid arthritis (RA) treatment. However, this has come at the price of an increased risk of infections. The aim of this study was to present an integrated overview of both serious and non-serious infections, and to identify potential predictors of infection risk in RA patients using biological or targeted synthetic drugs. Methods: We systematically reviewed available literature from PubMed and Cochrane and performed multivariate meta-analysis with meta-regression on the reported infections. Randomized controlled trials and prospective and retrospective observational studies including patient registry studies were analyzed, combined as well as separately. We excluded studies focusing on viral infections only. Results: Infections were not reported in a standardized manner. Meta-analysis showed significant heterogeneity that persisted after forming subgroups by study design and follow-up duration. Overall, the pooled proportions of patients experiencing an infection during a study were 0.30 (95% CI, 0.28-0.33) and 0.03 (95% CI, 0.028-0.035) for any kind of infections or serious infections only, respectively. We found no potential predictors that were consistent across all study subgroups. Conclusions: The high heterogeneity and the inconsistency of potential predictors between studies show that we do not yet have a complete picture of infection risk in RA patients using biological or targeted synthetic drugs. Besides, we found non-serious infections outnumbered serious infections by a factor 10:1, but only a few studies have focused on their occurrence. Future studies should apply a uniform method of infectious adverse event reporting and also focus on non-serious infections and their impact on treatment decisions and quality of life.
Language	English
Publishing date	2023-06-26
Publishing country	England
Document type	Journal Article
ZDB-ID	2783278-8
ISSN	2198-6584 ; 2198-6576
ISSN (online)	2198-6584
ISSN	2198-6576
DOI	10.1007/s40744-023-00571-z
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Article ; Online: Development of a Framework Structuring Themes in the Course of Adverse Drug Reactions from a Patient's Perspective.

van Lint, Jette A / Sonnenberg, Marlieke / Vonkeman, Harald E / van den Bemt, Bart J F / van Puijenbroek, Eugene P / Jessurun, Naomi T

Drug safety

2023 Volume 46, Issue 10, Page(s) 1039–1047

Abstract: Introduction: There is a need for more extensive information about adverse drug reactions (ADRs) for patients than currently available, including information on the course of ADRs. Aspects characterising the course of ADRs from the patient perspective ... ...

Abstract	Introduction: There is a need for more extensive information about adverse drug reactions (ADRs) for patients than currently available, including information on the course of ADRs. Aspects characterising the course of ADRs from the patient perspective have not been identified before. Objective: We aimed to develop a framework based on common themes in the course of ADRs identified from patient descriptions in patient-reported ADRs. Methods: In this qualitative study, patient descriptions of the course of patient-reported ADRs were analysed by a thematic analysis with an inductive approach using three different existing datasets containing patient-reported ADRs. Two datasets included patient-reported ADRs from cohort event monitoring of biologics and direct oral anticoagulants and one dataset included spontaneous reports from patients concerning medication for lower urinary tract symptoms. A conceptual framework was developed from the identified main themes and subthemes. Results: Patient-reported data concerning 3888 ADRs were analysed. Six main themes with multiple subthemes were identified from patient descriptions of the course of ADRs. Four themes were descriptive: frequency of an ADR episode, duration of an ADR episode, moment or period of ADR occurrence, and development in the intensity of the ADR. Two themes concerned factors influencing the course of ADRs: triggering factors and improving factors. Conclusions: The presented framework illustrates that patients describe extensive details on the course and timeframe of ADRs. The identified themes provide a basis for improving the systematic data collection of more extensive details about ADRs from patients as a first step towards the provision of more comprehensive ADR information to patients.
MeSH term(s)	Humans ; Adverse Drug Reaction Reporting Systems ; Patients ; Data Collection ; Qualitative Research ; Drug-Related Side Effects and Adverse Reactions/epidemiology
Language	English
Publishing date	2023-08-31
Publishing country	New Zealand
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	1018059-x
ISSN	1179-1942 ; 0114-5916
ISSN (online)	1179-1942
ISSN	0114-5916
DOI	10.1007/s40264-023-01343-y
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Article ; Online: Switching pattern and dose adjustment of antidepressants before and during pregnancy.

Robiyanto, Robiyanto / Roos, Marjolein / Bos, Jens H J / Hak, Eelko / van Puijenbroek, Eugène P / Schuiling-Veninga, Catharina C M

Archives of women's mental health

2023 Volume 26, Issue 5, Page(s) 685–696

Abstract: The purpose of the study is to examine the switching pattern and dose adjustment of antidepressants (ADs) prescribed to women from six months before to six months during pregnancy in the Netherlands. The recorded dispenses or refills were collected from ... ...

Abstract	The purpose of the study is to examine the switching pattern and dose adjustment of antidepressants (ADs) prescribed to women from six months before to six months during pregnancy in the Netherlands. The recorded dispenses or refills were collected from the University of Groningen IADB.nl pregnancy subset for all singleton pregnancies in which the mother received ≥ 1 prescription of an AD dispensed before pregnancy and was present in the database at least six months after conception. The rates of continuation, discontinuation, and switching between 2001 and 2020 were assessed for the ADs studied. The mean number of Defined Daily Doses (DDDs) of the most frequently continued ADs used was calculated both before and during pregnancy, and a paired t-test was used to test for significant changes. The continuation rates for AD users, especially for SSRI and SNRI continued users, increased over time from 27% and 19% (2001-2005) to 65% and 65% (2016-2020). The switching rate between ADs remained consistently low from the start of the study (2001-2005) at 2.0% to the end of the study (2016-2020) at 2.3%. Most women who switched between antidepressants during pregnancy received a different SSRI monotherapy (85%), followed by an SNRI (6%), a TCA (4%), and an "other AD" (4%). In most cases observed, the dose adjustment for the mean DDDs during pregnancy compared to the mean DDDs before pregnancy only changed little (less than 10%). Continued use of SSRIs among singleton pregnancies doubled over the study period. The low rate of AD switching and little changes in the DDD adjustment for most AD continuers indicate that pregnant women prefer to continue their prepregnancy medication rather than switch it. Most observed findings cohere with the Dutch national guidelines for antidepressant use during pregnancy.
MeSH term(s)	Female ; Humans ; Pregnancy ; Serotonin and Noradrenaline Reuptake Inhibitors ; Antidepressive Agents/therapeutic use ; Selective Serotonin Reuptake Inhibitors ; Netherlands
Chemical Substances	Serotonin and Noradrenaline Reuptake Inhibitors ; Antidepressive Agents ; Selective Serotonin Reuptake Inhibitors
Language	English
Publishing date	2023-08-05
Publishing country	Austria
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	1463529-X
ISSN	1435-1102 ; 1434-1816
ISSN (online)	1435-1102
ISSN	1434-1816
DOI	10.1007/s00737-023-01355-8
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Article ; Online: Exposure to psychotropic drugs before and during pregnancy: what has changed over the last two decades?

Robiyanto, Robiyanto / Schuiling-Veninga, Catharina C M / Bos, Jens H J / Hak, Eelko / van Puijenbroek, Eugène P

Archives of women's mental health

2023 Volume 26, Issue 1, Page(s) 39–48

Abstract: Trends in prescribing psychotropic drugs before and during pregnancy may have changed over the years, but actual information is lacking. We therefore compared and assessed the exposure and acceptance rates of classes of antipsychotic (+ lithium), ... ...

Abstract	Trends in prescribing psychotropic drugs before and during pregnancy may have changed over the years, but actual information is lacking. We therefore compared and assessed the exposure and acceptance rates of classes of antipsychotic (+ lithium), anxiolytic, sedative/hypnotic, antidepressant, and psychostimulant before and during pregnancy in the past two decades. All singleton pregnancies with ≥1 prescription of psychotropic drug from six months before pregnancy until child's birthdate were identified in the pregnancy subset of the IADB.nl prescription database. The prescription patterns of psychotropics were distinguished as continuation rate (CR), initiation rate (IR), discontinuation rate (DR), total exposure rate (TER), and acceptance rate. Singleton pregnancies exposed to psychotropic drugs before and during pregnancy increased from 118.4 to 136.5 (per 1000 singleton pregnancies) between decades. Changing trends were observed in decade 2, including a high increase in the TER of antipsychotic class (3.3 to 6.8) and antidepressant class (23.0 to 40.6). A marked increase for individual drugs was seen for sertraline (TER: 0.6 to 6.6 and PAT: 35.3% to 82.5%), citalopram (TER: 2.3 to 10.0 and PAT: 51.1% to 74.6%), and quetiapine (TER: 0.4 to 3.1 and PAT: 57.1% to 66.0%). Although the total exposure rates of five classes of psychotropics in singleton pregnancies increased in decade 2, only antidepressant class had a higher acceptance rate during pregnancy. Certain SSRI antidepressants and atypical antipsychotics were more frequently prescribed in decade 2 than in decade 1, reflecting that treatment options were preferred for safer treatment choices.
MeSH term(s)	Pregnancy ; Child ; Female ; Humans ; Antipsychotic Agents/therapeutic use ; Psychotropic Drugs/therapeutic use ; Antidepressive Agents/therapeutic use ; Anti-Anxiety Agents/therapeutic use ; Drug Prescriptions
Chemical Substances	Antipsychotic Agents ; Psychotropic Drugs ; Antidepressive Agents ; Anti-Anxiety Agents
Language	English
Publishing date	2023-01-14
Publishing country	Austria
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	1463529-X
ISSN	1435-1102 ; 1434-1816
ISSN (online)	1435-1102
ISSN	1434-1816
DOI	10.1007/s00737-023-01290-8
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Article ; Online: Validation of a Novel Method to Assess the Clinical Quality of Information in Pregnancy-Related Pharmacovigilance Case Reports: A ConcePTION Project.

van Rijt-Weetink, Yrea R J / Egberts, Toine C G / van Hunsel, Florence P A M / Lewis, David J / Yates, Laura M / Winterfeld, Ursula / van Puijenbroek, Eugène P

Drug safety

2024 Volume 47, Issue 3, Page(s) 261–270

Abstract: Background: To assess the causal relationship between a medicinal product and a reported event, relevant information needs to be present. Information elements for assessing cases of exposure to medicinal products during pregnancy were predefined and ... ...

Abstract	Background: To assess the causal relationship between a medicinal product and a reported event, relevant information needs to be present. Information elements for assessing cases of exposure to medicinal products during pregnancy were predefined and used in a new tool to assess the quality of information. However, the extent in which the presence or absence of these predefined information elements is associated with the overall clinical quality of these cases, as evaluated by pharmacovigilance experts, remains uncertain. Objective: We aimed to validate a novel method to assess the clinical quality of information in real-world pregnancy pharmacovigilance case reports. Methods: The clinical quality of case reports regarding medicinal product exposure and pregnancy-related outcomes was appraised from spontaneous reports, literature, Teratology Information Services (UK and Switzerland), The Dutch Pregnancy Drug Register, the Gilenya pregnancy registry and the Enhanced PV programme of Novartis. Assessment was done by means of the novel standardised tool based on the presence and relevance of information, and by expert judgement. The novel tool was validated compared to the expert assessment as the gold standard expressed as the area under the receiver operating characteristic curves, after which the sensitivity and specificity were calculated using cross-tabulations. Inter-rater variability was determined by means of weighted Cohen's kappa. Results: One hundred and eighty-six case reports were included. The clinical quality score as assessed by the novel method was divided into three categories with cut-off values of 45% (poor to intermediate) and 65% (intermediate to excellent). Sensitivity was 0.93 and 0.96 for poor to intermediate and intermediate to excellent, respectively. Specificity was respectively 0.52 and 0.73. Inter-rater variability was 0.65 (95% confidence interval 0.53-0.78) for the newly developed approach, and 0.40 (95% confidence interval 0.28-0.52) for the gold standard assessment. Conclusions: The tool described in this study using the presence and relevance of elements of information is the first designed, validated and standardised method for the assessment of the quality of information of case reports in pregnancy pharmacovigilance data. This method confers less inter-rater variability compared with a quality assessment by experts of pregnancy-related pharmacovigilance data.
MeSH term(s)	Humans ; Pregnancy ; Female ; Drug-Related Side Effects and Adverse Reactions/epidemiology ; Pharmacovigilance ; Adverse Drug Reaction Reporting Systems ; Causality ; Judgment
Language	English
Publishing date	2024-01-06
Publishing country	New Zealand
Document type	Journal Article
ZDB-ID	1018059-x
ISSN	1179-1942 ; 0114-5916
ISSN (online)	1179-1942
ISSN	0114-5916
DOI	10.1007/s40264-023-01389-y
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