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Pharmacoepidemiology
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Pharmacoepidemiology and Drug Safety in Pregnancy and Breastfeeding
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Pharmacoepidemiology and Drug Safety in Pregnancy and Breastfeeding

A special issue of Pharmacoepidemiology (ISSN 2813-0618).

Deadline for manuscript submissions: closed (31 December 2023) | Viewed by 7809

Special Issue Editors

Dr. Anna Cantarutti

E-Mail Website
Guest Editor
1. National Centre for Healthcare Research and Pharmacoepidemiology, 20126 Milan, Italy
2. Laboratory of Healthcare Research & Pharmacoepidemiology, Unit of Biostatistics, Epidemiology and Public Health, Department of Statistics and Quantitative Methods, University of Milano-Bicocca, 20126 Milan, Italy
Interests: population-based birth cohort study; pharmacoepidemiology and drug safety in pregnancy and breastfeeding; pharmacoepidemiology; healthcare research; real-world data
Special Issues, Collections and Topics in MDPI journals
Dr. Angela Lupattelli

E-Mail Website
Guest Editor
PharmacoEpidemiology and Drug Safety Research Group, Department of Pharmacy, Faculty of Mathematics and Natural Sciences, University of Oslo, 0316 Oslo, Norway
Interests: pharmacoepidemiology; healthcare research; real-world data; population-based birth cohort study; utilization, comparative safety and effectiveness of prescription medications in pregnant women and their offsprin
Dr. Cristina Canova

E-Mail Website
Guest Editor
Unit of Biostatistics, Epidemiology and Public Health, Department of Cardio-Thoraco-Vascular Sciences and Public Health, University of Padova, Padova, Italy
Interests: population-based birth cohort study; longitudinal studies; environmental epidemiology; pharmacoepidemiology; real-world data
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

Dear Colleagues,

Maternal and child health represents a fundamental component of public health, not only because pregnancy, childbirth, and the puerperium are the first cause of hospitalization, but also because the events “around” birth are used as indicators for assessing the quality of healthcare.

The World Health Organization stresses the importance of directing more resources to evaluate maternal and child health in order to (i) implement preventive interventions during pregnancy, childbirth, and the first years of the child's life, thus preventing avoidable deaths; and (ii) make qualified assistance and appropriate drug treatments more accessible.

Indeed, prescribing medications to pregnant or breastfeeding women is usually challenging as the drug benefit must be considered against its potential adverse effects to both mother and child. Medication use is common in pregnant or breastfeeding women, by chance or necessity, and it gives the opportunity to evaluate the consequences of prenatal drug exposure in real life through pharmacoepidemiologic studies.

Given the complexity of the set of issues and problems relating to the birth path and maternal–infant health, this Special Issue aims to investigate pharmacoepidemiology and drug safety in pregnancy or breastfeeding. Focus is also given to the methodological challenges related to assessing medication safety and effectiveness in the context of real-world pregnancy and breastfeeding research.

Dr. Anna Cantarutti
Dr. Angela Lupattelli
Dr. Cristina Canova
Guest Editors

Manuscript Submission Information

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Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Pharmacoepidemiology is an international peer-reviewed open access quarterly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 1000 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

  • population-based birth cohort study
  • pharmacoepidemiology and drug safety in pregnancy and breastfeeding
  • pharmacoepidemiology
  • healthcare research
  • real-world data

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Published Papers (4 papers)

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Research

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10 pages, 1019 KiB  
Article
Association of Receipt of Opioid Prescription for Acute Post-Delivery Pain Management with Buprenorphine Discontinuation among Postpartum People with Opioid Use Disorder
by Taylor N. Hallet, David T. Zhu, Hannah Shadowen, Lillia Thumma, Madison M. Marcus, Amy Salisbury and Caitlin E. Martin
Pharmacoepidemiology 2024, 3(2), 198-207; https://doi.org/10.3390/pharma3020012 - 16 Apr 2024
Viewed by 1181
Abstract
Buprenorphine is a safe and effective medication to treat opioid use disorder (OUD) in pregnant patients and is intended to be continued throughout pregnancy, delivery, and at least the one-year postpartum period. However, delivery often involves the need for acute pain management with [...] Read more.
Buprenorphine is a safe and effective medication to treat opioid use disorder (OUD) in pregnant patients and is intended to be continued throughout pregnancy, delivery, and at least the one-year postpartum period. However, delivery often involves the need for acute pain management with opioid medications, such as after a cesarean section. For patients receiving buprenorphine, the provision of prescription opioids may negatively impact OUD treatment outcomes; however, not optimally managing acute pain may also impede OUD treatment benefit. Evidence is needed to disentangle the impacts of opioid prescription provision and methods of pain management in the immediate postpartum period on OUD treatment trajectories, ultimately to inform clinical guidelines tailored to the unique needs of pregnant and postpartum people receiving buprenorphine. Accordingly, this study took an initial step towards this goal to conduct a secondary analysis of a retrospective cohort of pregnant patients taking buprenorphine for OUD at the time of delivery (n = 142) to determine whether receipt of an opioid prescription at birth hospitalization discharge was associated with the time of buprenorphine discontinuation within the 12 months following delivery. Among the sample, 26% (n = 37) were prescribed an opioid at the time of birth hospitalization discharge. The number of weeks post-delivery until buprenorphine discontinuation occurred was shorter amongst patients who were prescribed an opioid (median 11 weeks) compared to patients who were not prescribed an opioid (median 39 weeks; p < 0.001 by Mann–Whitney U test). However, a Cox regression model reported that receipt of an opioid prescription following delivery did not significantly increase the hazard ratio for buprenorphine discontinuation. In other words, OUD patients not prescribed an opioid at birth hospitalization discharge continued their buprenorphine for a longer median duration after delivery compared to their counterparts who received prescription opioids; yet, this finding did not reach statistical significance when taking into account additional clinical variables. The findings indicate how further research is warranted to inform evidence-based post-delivery pain practices for postpartum OUD treatment patients. Full article
(This article belongs to the Special Issue Pharmacoepidemiology and Drug Safety in Pregnancy and Breastfeeding)
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8 pages, 873 KiB  
Article
Drug Prescriptions during Pregnancy in Lombardy: Temporal Trends and the Impact of the Onset of the COVID-19 Pandemic
by Giovanna Esposito, Anna Cantarutti, Matteo Franchi, Giovanni Corrao and Fabio Parazzini
Pharmacoepidemiology 2023, 2(3), 249-256; https://doi.org/10.3390/pharma2030021 - 1 Aug 2023
Viewed by 1632
Abstract
This population-based study aimed at providing an overview of drug prescription patterns during pregnancy in the Italian region of Lombardy from 2010 to 2020. The cohort consisted of 780,075 deliveries identified from the regional healthcare utilization databases. The prevalence of drugs’ dispensed prescriptions [...] Read more.
This population-based study aimed at providing an overview of drug prescription patterns during pregnancy in the Italian region of Lombardy from 2010 to 2020. The cohort consisted of 780,075 deliveries identified from the regional healthcare utilization databases. The prevalence of drugs’ dispensed prescriptions was estimated as the proportion of pregnant women with at least one prescription out of the total deliveries over the entire pregnancy and by trimester. Drugs were classified according to the Anatomical Therapeutic Chemical code. In addition, interrupted time series analysis was conducted to investigate temporal trends of antibiotics’ use during the onset of the COVID-19 pandemic. A total of 497,515 women (63.8%) used at least a drug, including vitamins and minerals, at some point during pregnancy. Vitamins, minerals, and anti-anaemic preparations were prescribed in 20.8%, 13.3%, and 18.3% of deliveries over the trimesters of pregnancy. Folic acid was the most prescribed drug, with about one woman out of four, followed by iron preparations, progestogen, and antibiotics (prescription rate, respectively: 15.9%, 10.2%, and 9.8%). A decreasing trend in the dispensing of antibiotics emerged during the entire study period; however, a significant further decrease following the spread of the pandemic was observed. Further evidence is needed to monitor the use of drugs during pregnancy, determinants, and implications. Full article
(This article belongs to the Special Issue Pharmacoepidemiology and Drug Safety in Pregnancy and Breastfeeding)
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13 pages, 451 KiB  
Article
Birth Outcomes of Anticancer Drug Prescriptions during Pregnancy: A Case Series from a Japanese Claims Database
by Kentaro Tajima, Tomofumi Ishikawa, Masami Tsuchiya, Masafumi Kikuchi, Taku Obara and Nariyasu Mano
Pharmacoepidemiology 2023, 2(1), 13-25; https://doi.org/10.3390/pharma2010002 - 6 Jan 2023
Viewed by 2984
Abstract
We aimed to evaluate the adverse birth outcomes of anticancer drug prescription during pregnancy using a Japanese claims database from 2005 to 2019. We applied validated claims-based algorithms to identify pregnant women with birth outcomes, and evaluated drug prescription during pregnancy. The causal [...] Read more.
We aimed to evaluate the adverse birth outcomes of anticancer drug prescription during pregnancy using a Japanese claims database from 2005 to 2019. We applied validated claims-based algorithms to identify pregnant women with birth outcomes, and evaluated drug prescription during pregnancy. The causal relationship between anticancer drugs and adverse birth outcomes was evaluated using the Council for International Organizations of Medical Sciences Working Group VI criteria. Thirteen women with anticancer drugs prescription during pregnancy were identified (mean age: 34.6 years). Atrial/ventricular septal defect was observed in one infant after exposure to cyclophosphamide and doxorubicin for breast cancer in the second and third trimesters. One woman on several anticancer drugs (cyclophosphamide, cytarabine, daunorubicin, l-asparaginase, methotrexate, nelarabine, and vincristine) for acute lymphoblastic leukemia, one on imatinib for chronic myeloid leukemia, and one on cisplatin and fluorouracil for cervical cancer had miscarriages after exposure in the first trimester. A relationship between those anticancer drugs and miscarriage could not be ruled out, while no relationship was identified regarding the atrial/ventricular septal defect considering the period of exposure and organogenesis. Our results suggest increased risk of miscarriage with the use of several anticancer drugs such as methotrexate, imatinib, cisplatin, and fluorouracil in the first trimester. Full article
(This article belongs to the Special Issue Pharmacoepidemiology and Drug Safety in Pregnancy and Breastfeeding)
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Review

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14 pages, 1142 KiB  
Review
Maternal Medication Use in Pregnancy: A Narrative Review on Assessing and Communicating the “Risk” of Birth Defects to the Patient
by Sura Alwan and Kimberly S. Grant
Pharmacoepidemiology 2024, 3(4), 336-349; https://doi.org/10.3390/pharma3040023 - 5 Oct 2024
Viewed by 789
Abstract
The state of knowledge regarding the teratogenic effects of maternal use of medications during pregnancy is constantly evolving and is often uncertain. Timely access to high-quality information may reduce prolonged harmful exposures, decrease the number of preventable birth defects, empower patients with accurate [...] Read more.
The state of knowledge regarding the teratogenic effects of maternal use of medications during pregnancy is constantly evolving and is often uncertain. Timely access to high-quality information may reduce prolonged harmful exposures, decrease the number of preventable birth defects, empower patients with accurate information about the risks of exposure, and prevent unnecessary patient anxiety and pregnancy termination. In this narrative review, we describe the process by which the teratogenic risk of medications is assessed by experts in medicine, genetics, and epidemiology and how identifiable risks can be effectively communicated to patients. Risk assessment of birth defects in human pregnancy involves collecting and synthesizing available data through a proper and rule-driven evaluation of scientific literature. Expert consensus is a practical approach to determine whether a given exposure produces damage after careful consideration of gestational timing, dose and route of the exposure, maternal and fetal genetic susceptibility, as well as evidence for biological plausibility. The provision of teratogen risk counseling through appropriate interpretation of information and effective knowledge translation to the patient is critical for the prevention of birth defects and maximizing healthy pregnancies. Full article
(This article belongs to the Special Issue Pharmacoepidemiology and Drug Safety in Pregnancy and Breastfeeding)
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