Medication Use In Pregnancy Research Articles

Gold Award: Building the Capacity of Frontline Providers to Treat Mental and Substance Use Disorders Among Pregnant and Postpartum Women.

Gold Award: Building the Capacity of Frontline Providers to Treat Mental and Substance Use Disorders Among Pregnant and Postpartum Women.

Making Decisions About Medication Use During Pregnancy: Implications for Communication Strategies.

Objective To explore women's perceptions of the risks and benefits associated with medication use during pregnancy and to better understand how women make decisions related to medication use in pregnancy. Methods We conducted online focus groups with 48 women who used medication during pregnancy or while planning a pregnancy, and 12 in-depth follow-up interviews with a subset of these women. Results We found that women were aware of general risks associated with medication use but were often unable to articulate specific negative outcomes. Women were concerned most about medications' impact on fetal development but were also concerned about how either continuing or discontinuing medication during pregnancy could affect their own health. Women indicated that if the risk of a given medication were unknown, they would not take that medication during pregnancy. Conclusion This formative research found that women face difficult decisions about medication use during pregnancy and need specific information to help them make decisions. Enhanced communication between patients and their providers regarding medication use would help address this need. We suggest that public health practitioners develop messages to (1) encourage, remind, and prompt women to proactively talk with their healthcare providers about the risks of taking, not taking, stopping, or altering the dosage of a medication while trying to become pregnant and/or while pregnant; and (2) encourage all women of childbearing age to ask their healthcare providers about medication use.

Sick leave and medication use in pregnancy: a European web-based study

Background and objectiveA comparison of sick leave in pregnancy between countries is difficult as most studies have been conducted in single countries in Scandinavia. The objective of this study was...

Maternal Infections, Antibiotics, and Paracetamol in Pregnancy and Offspring Celiac Disease: A Cohort Study.

Infections in pregnancy are common, may affect fetal development, and have been linked to offspring autoimmunity. We aimed to determine whether maternal infections, the use of antibiotics, and use of paracetamol in pregnancy are associated with the risk of offspring celiac disease (CD). The nationwide Norwegian Mother and Child Cohort Study includes 84,274 children born in the period from 2000 to 2009 with prospectively collected questionnaire data on maternal infections and medication use in pregnancy. CD was identified through questionnaires and the Norwegian Patient Register. Logistic regression yielded odds ratios adjusted for age and sex (aORs). During a median follow-up of 8.5 years, 617 children (0.7%) were diagnosed with CD. The aOR for offspring CD per increase in number of maternal infections was 1.07 (95% confidence interval [CI] = 1.01-1.13), but not significantly increased for categories 1 infection (1.01 [95% CI = 0.82-1.25]) and ≥2 infections (1.22 [95% CI = 1.00-1.49]) versus no infection. We found the same pattern for respiratory tract infections, but not for gastrointestinal infections. The aORs were broadly consistent across pregnancy periods of exposure. The use of antibiotics and paracetamol was, compared with no use, not associated with offspring CD (aOR = 1.16 [95% CI = 0.94-1.43] and aOR = 1.13 [95% CI = 0.96-1.33], respectively; P values for trend >0.2). In this large pregnancy cohort we found no clear association between maternal infections in pregnancy and offspring CD, but considering the marginal significance in some of our results maternal infections cannot be ruled out as a risk factor. Reassuringly for both parents-to-be and clinicians, the use of antibiotics and paracetamol in pregnancy was not a significant risk factor.

Using insurance claims data to identify and estimate critical periods in pregnancy: An application to antidepressants.

Health insurance claims are a rich data source to examine medication use in pregnancy. Our objective was to identify pregnant women, their pregnancy outcomes, and date of their last menstrual period (LMP), and to estimate antidepressant dispensations in pregnancy. From a literature search, we identified diagnosis and procedure codes indicating the end of a pregnancy. Using Truven Health MarketScan® Commercial Claims and Encounters Databases, we identified all inpatient admissions and outpatient service claims with these codes. We developed an algorithm to assign: (1) pregnancy outcome (ectopic pregnancy, induced or spontaneous abortion, live birth, or stillbirth), and (2) estimated gestational age, to each inpatient or outpatient visit. For each pregnancy outcome, we estimated the LMP as the admission (for inpatient visits) or service (for outpatient visits) date minus the gestational age. To differentiate visits associated with separate pregnancies, we required ≥ 2 months between one pregnancy outcomes and the LMP of the next pregnancy. We used this algorithm to identify pregnancies in 2013 and to estimate the proportion of women who filled a prescription for an antidepressant from an outpatient pharmacy at various time points in pregnancy. We identified 488,887 pregnancies in 2013; 79% resulted in a live birth. A prescription for an antidepressant was filled in 6.2% of pregnancies. Dispensations varied throughout pregnancy and were lowest (3.1%) during the second trimester. This work will inform future efforts to estimate medication dispensations during critical periods of preconception, interconception, and pregnancy using health insurance claims data. Birth Defects Research (Part A) 106:927-934, 2016. © 2016 Wiley Periodicals, Inc.

Women's questions about medicines in pregnancy – An analysis of calls to an Australian national medicines call centre

For many medicines, safe use during pregnancy is not established and adherence is often poor due to safety concerns. Therefore, it is important to identify consumers' medicines information needs during pregnancy. A retrospective, mixed methods analysis was conducted on eight years of pregnancy-related calls to an Australian national medicines call centre. The call profile of pregnancy and non-pregnancy-related questions were compared. Medicines involved in pregnancy calls were categorised by class (Anatomical Therapeutic Chemical (ATC)3 level), and Therapeutic Goods Administration pregnancy category. Questions in these calls were also themed by pregnancy stage. We identified 4573 pregnancy-related and 118 547 non-pregnancy-related calls. The caller profile for pregnancy-related calls was female (93.7%), asking for herself (83.0%), and while 70.1% of questions involved one medicine, 9.6% involved three or more medicines. Pregnancy enquiries were prompted more often by conflicting information, inadequate information or desire for a second opinion. For 1166 calls, where the stage of pregnancy was available, most questions concerned safety. Medication classified as 'safe' during pregnancy accounted for 34% of these questions. After antidepressants, most calls were made about over-the-counter (OTC) medicines (paracetamol, dexchlorpheniramine, codeine). Safe treatment for everyday conditions was of increasing concern as the pregnancy progressed. Pregnant women are concerned about the safety of medication use in pregnancy and a significant proportion overestimate risk. Psychotropic medication and fertility are strong drivers to seek information during preconception. Everyday illnesses and self-medication with OTC medication are a common concern throughout pregnancy, even though many medicines are safe to use.

Women’s beliefs about medication use during their pregnancy: a UK perspective

Background Previous research has examined the number and extent of medicines taking in pregnant women but not their beliefs and risk perception surrounding their use. Objective To describe beliefs and risk perception associated with medicines use for the treatment of common acute conditions among UK women and explore whether this is related to actual medicines use. Settings Cross-sectional, web-based study in the UK. Methods Pregnant women and mothers within 1 year of giving birth were invited to participate in an online cross-sectional questionnaire-based study via a pregnancy website in the UK. Anonymous data were collected from women regarding their use of medicines (both over-the-counter and prescribed) and their beliefs regarding medicines use during pregnancy. Main outcome measures Pregnant women’s beliefs about medicines and their relation to pharmacological treatment of acute conditions in pregnancy. Results Pharmacological treatment of conditions in pregnancy ranged from 65.4 % for urinary tract infections (UTIs) to 1.1 % for sleeping problems. Almost three out of ten women avoided using some medications during pregnancy. For heartburn and UTIs, women who did not treat the condition viewed medicines in general as being overused, more harmful and less beneficial, than those who treated the condition. In general, UK pregnant women perceived medicines to be beneficial and slightly overused. Conclusions Women’s beliefs about medications impact on treatment of specific conditions in pregnancy such as heartburn and UTIs. Healthcare professionals should explore patient’s beliefs regarding medication at the first maternity care visit to promote appropriate medication use in pregnancy.Electronic supplementary materialThe online version of this article (doi:10.1007/s11096-016-0322-5) contains supplementary material, which is available to authorized users.

Médicaments et grossesse : une enquête menée auprès de 374 femmes en France

The objectives of this study were to describe drug use during pregnancy in a context of acute and chronic diseases during pregnancy. An additional aim was to analyze the maternal socio-demographic and lifestyle factors associated with medication use in pregnancy. Cross-sectional, web-based descriptive study conducted among French women using a 33-item web-based questionnaire. Multiple logistic regression analyzes were performed to assess the association between socio-demographic/lifestyle factors and medication use in pregnancy. A total of 374 women completed the questionnaire. Of these, 75.1% (n=280) and 12.6% (n=47) used medication for treatment for acute and chronic diseases, respectively. A total of 68.9% (n=258) of women surveyed have deliberately avoided taking non-prescribed drugs when they were pregnant. Non-users of folic acid were less often taking medications (78.9%) than folic acid users (89.5%) OR=0.44 [0.24; 0.79]. More than eight out of ten women have taken medication during pregnancy especially analgesics. The maternal socio-demographic and lifestyle factors do not seem to impact on the use of medication during pregnancy.

Medication use in pregnancy and the pregnancy and lactation labeling rule.

On 30 June 2015, the US Food and Drug Administration Pregnancy and Lactation Labeling Rule (PLLR) took effect. This rule sets new and improved standards for the inclusion of information about the use of prescription drugs and biological products during pregnancy and lactation. The new labeling requirements have important implications for clinical pharmacology as there is a subheading that is dedicated to inclusion of clinical pharmacology information that inform dosing during pregnancy and the postpartum period, if available.

Etiology of molar incisor hypomineralization - A systematic review.

Molar incisor hypomineralization (MIH) is a common developmental dental defect of permanent teeth, which can increase the risk of dental caries, infection and hospitalization. The etiology is currently unclear although prenatal or early childhood health factors are suspected. The aim of this systematic review was to assess the strength of evidence linking etiological factors with MIH. A systematic search was conducted using the Medline and Embase electronic databases for studies investigating environmental etiological factors of MIH. Two reviewers assessed the eligibility of studies. The level of evidence and bias was determined for all eligible studies according to Australian National Health and Medical Research Council guidelines for systematic reviews of etiology and the Newcastle-Ottawa Scale. From a total of 2254 studies identified through electronic and hand searching, 28 were eligible for inclusion. Twenty-five of these investigated MIH and three investigated a related condition in primary teeth, hypomineralized second primary molars (HSPM), and these were analysed separately. A limited number of studies reported significant associations between MIH and pre- and perinatal factors such as maternal illness and medication use in pregnancy, prematurity and birth complications. Early childhood illness was implicated as an etiological factor in MIH in several studies, in particular fever, asthma and pneumonia. The studies investigating HSPM revealed an association with maternal alcohol consumption, infantile fever and ethnicity. However, the validity of these findings is impaired by study design, lack of adjustment for confounders, lack of detail and consistency of exposures investigated and poor reporting. Childhood illness is likely to be associated with MIH. Further prospective studies of the etiology of MIH/HSPM are needed.

An International Study of the Ability and Cost-Effectiveness of Advertising Methods to Facilitate Study Participant Self-Enrolment Into a Pilot Pharmacovigilance Study During Early Pregnancy.

BackgroundKnowledge of the fetal effects of maternal medication use in pregnancy is often inadequate and current pregnancy pharmacovigilance (PV) surveillance methods have important limitations. Patient self-reporting may be able to mitigate some of these limitations, providing an adequately sized study sample can be recruited.ObjectiveTo compare the ability and cost-effectiveness of several direct-to-participant advertising methods for the recruitment of pregnant participants into a study of self-reported gestational exposures and pregnancy outcomes.MethodsThe Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium (PROTECT) pregnancy study is a non-interventional, prospective pilot study of self-reported medication use and obstetric outcomes provided by a cohort of pregnant women that was conducted in Denmark, the Netherlands, Poland, and the United Kingdom. Direct-to-participant advertisements were provided via websites, emails, leaflets, television, and social media platforms.ResultsOver a 70-week recruitment period direct-to-participant advertisements engaged 43,234 individuals with the study website or telephone system; 4.78% (2065/43,234) of which were successfully enrolled and provided study data. Of these 90.4% (1867/2065) were recruited via paid advertising methods, 23.0% (475/2065) of whom were in the first trimester of pregnancy. The overall costs per active recruited participant were lowest for email (€23.24) and website (€24.41) advertisements and highest for leaflet (€83.14) and television (€100.89). Website adverts were substantially superior in their ability to recruit participants during their first trimester of pregnancy (317/668, 47.5%) in comparison with other advertising methods (P<.001). However, we identified international variations in both the cost-effectiveness of the various advertisement methods used and in their ability to recruit participants in early pregnancy.ConclusionsRecruitment of a pregnant cohort using direct-to-participant advertisement methods is feasible, but the total costs incurred are not insubstantial. Future research is needed to identify advertising strategies capable of recruiting large numbers of demographically representative pregnant women, preferentially in early pregnancy.

Oral contraceptive exposure in newly pregnant women not linked to birth defects

University of California, San Francisco School of Pharmacy, told Pharmacy Today. “If a woman mistakenly continued using oral contraceptives during the early part of pregnancy, it didn’t increase the risk of birth defects.” Using Danish health registries, the researchers studied four exposure groups and found that prevalence of major birth defects—about 25 per 1,000 births—was consistent across each group. Nearly 70% of the mothers stopped using oral contraceptives more than 3 months before pregnancy; 21% never used oral contraceptives; 8% used oral contraceptives until 0 to 3 months

Assessment of YouTube videos as a source of information on medication use in pregnancy.

When making decisions about medication use in pregnancy, women consult many information sources, including the Internet. The aim of this study was to assess the content of publicly accessible YouTube videos that discuss medication use in pregnancy. Using 2023 distinct combinations of search terms related to medications and pregnancy, we extracted metadata from YouTube videos using a YouTube video Application Programming Interface. Relevant videos were defined as those with a medication search term and a pregnancy-related search term in either the video title or description. We viewed relevant videos and abstracted content from each video into a database. We documented whether videos implied each medication to be "safe" or "unsafe" in pregnancy and compared that assessment with the medication's Teratogen Information System (TERIS) rating. After viewing 651 videos, 314 videos with information about medication use in pregnancy were available for the final analyses. The majority of videos were from law firms (67%), television segments (10%), or physicians (8%). Selective serotonin reuptake inhibitors (SSRIs) were the most common medication class named (225 videos, 72%), and 88% of videos about SSRIs indicated that they were unsafe for use in pregnancy. However, the TERIS ratings for medication products in this class range from "unlikely" to "minimal" teratogenic risk. For the majority of medications, current YouTube video content does not adequately reflect what is known about the safety of their use in pregnancy and should be interpreted cautiously. However, YouTube could serve as a platform for communicating evidence-based medication safety information.

EUROmediCAT Recommendations for European Pharmacovigilance concerning safety of medication use in pregnancy.

EUROmediCAT Recommendations for European Pharmacovigilance concerning safety of medication use in pregnancy.

Actual Use of Medications Prescribed During Pregnancy: A Cross-Sectional Study Using Data from a Population-Based Congenital Anomaly Registry

Introduction and AimData from prescription databases are increasingly being used to study associations between maternal medications used in pregnancy and congenital anomalies. We therefore investigated the extent to which prescriptions reflect the actual use of medication during pregnancy, and whether medicines used during pregnancy are taken according to the prescribed dosage and duration.MethodsWe performed a cross-sectional study in a population-based congenital anomaly register (EUROCAT Northern Netherlands). We included 202 women who had at least one prescription during their pregnancy and who gave birth between 2009 and 2011. Compliance with the prescribed medication was verified by telephone interview. We calculated the compliance rates for several medication groups by dividing the number of mothers who confirmed they had taken the medication by the total number to whom it had been prescribed. Compliance was positive if the mother confirmed she took the medication, even if she only took one of several prescriptions from the same medication group. For each prescription taken, we also determined whether her use conformed to the prescribed dosage and duration.ResultsDuring the first trimester, the compliance rates ranged from 0.84 (for chronic diseases) to 0.92 (for pregnancy-related symptoms). Most of the medications actually taken were used at the prescribed dosage or lower. More than half of the medications actually taken were used for the duration prescribed or shorter.ConclusionPrescription records are generally a relatively reliable source of data for research into associations between medication use in pregnancy and congenital anomalies compared with other data sources. Pharmacy records of medication use in pregnancy might represent an overestimation, which should be taken into account. However, our results show that, except for ‘corticosteroids, dermatological preparations’; ‘ear, eye, nose and throat preparations’; and ‘anxiolytics, hypnotics and sedatives’, this overestimation generally seems minimal.Electronic supplementary materialThe online version of this article (doi:10.1007/s40264-015-0302-z) contains supplementary material, which is available to authorized users.

Fertility and Pregnancy in Inflammatory Bowel Disease

Inflammatory bowel diseases (IBDs) commonly affect women in their reproductive years; 25% of women with IBD become pregnant after the diagnosis. The relation of IBD to reproductive function often manifests in issues concerning fertility, antepartum pregnancy management, mode of delivery, and lactation as these can be influenced by disease activity, medications, perianal disease, and previous ileoanal pouch surgery. As disease location, activity, and complications can vary between patients, an individualized approach with multidisciplinary management is recommended. Pregnancy outcomes, recommended medication, nursing, managing IBD flares during pregnancy, and immune pathways are also discussed. Figures show issues discussed in preconception counseling and pregnancy guidelines. Tables list medication recommendations, Food and Drug Administration categories for the use of medications in pregnancy, adverse pregnancy outcomes PIANO registry, pregnancy and biological recommendations, thiopurine recommendations, safety of biologics in pregnancy, biologic guidelines, and sick pregnant patient recommendations. This review contains 2 highly rendered figures, 8 tables, and 29 references.

Medicines in Pregnancy Forum: Proceedings on Ethical and Legal Considerations.

To raise awareness and promote dialogue leading to action, this article provides proceedings on ethical and legal considerations associated with medicine use during pregnancy discussed during the 2014 DIA Medicines and Pregnancy Forum. A key focus of discussion at the forum was "When is it ethically appropriate to include or unethical not to include pregnant patients in clinical studies, and how can ethical barriers be addressed?" Also debated was the question "What are the most appropriate methods to collect and share data on medication use in pregnancy, and what is the best process for sharing such information?" Goals of the forum were to gain participant alignment on answers to these ethical questions, offer rationale for the answers, and provide insight into which stakeholders might be needed to facilitate discussion and action. Participants felt that under the right circumstances, drug research in pregnant women is justified and necessary. Multiple ideas and opinions on the handling of pregnant patients in clinical research, treating pregnant women in clinical practice, and communicating data to physicians and patients are presented.

Role of pharmacists in optimising medication management during pregnancy and lactation

AbstractPregnancy and lactation has a unique effect on decisions relating to medication use. Medication safety can often be a great source of concern for women and healthcare professionals alike, leading to decisions that can negatively impact on outcomes. Compounding this is that evidence regarding the benefits and risks of medication use in pregnancy and lactation can often be lacking, contradictory or difficult to interpret and apply to clinical practice. Pharmacists represent a key source of information on medication use in pregnancy and lactation and as such play an essential role in optimising medication use. Notably, the role of pharmacists extends well beyond that of addressing concerns relating to medication safety, and includes contributing towards therapeutic decision making, providing ongoing medication management, and influencing patterns of medication use. Opportunities for improving health outcomes for mothers and their babies are aplenty and the time has come for pharmacists to stand up to the challenge and play their role.

Health care providers’ use of a drug information service for pregnancy-related inquiries

ObjectivesTo characterize pregnancy and lactation-related medication inquiries to a drug information center to identify classes of medications of most concern to providers. A secondary objective was to identify any trends in provider inquiries over the study period. DesignA retrospective descriptive study of pregnancy and lactation-related inquiries to the University of North Carolina Health Care System Drug Information Center database between January 2001 and December 2010. SettingUniversity of North Carolina Health Care System Drug Information Center. InterventionProvider inquiries and responses were extracted and characterized by indication for treatment and reason for inquiry. Comparison of the first and second 5-year periods was performed to delineate trends. Descriptive statistics, Fisher's Exact and χ2 tests were used for analysis. Main outcome measuresInquiry origin, time, and subject. Results433 inquiries were retrieved over the study period from physicians (50%), pharmacists (21%), and nurses (18%). Inquiries were most often made during the antepartum period (34%), followed by the postpartum (28%) and preconception (22%) periods. The most frequent indications for inquiry were psychiatry (15%) and infectious diseases (14%), which remained constant throughout the study period. Safety was the most common reason for inquiry (52%). The responses provided to callers were limited due to lack of information availability 37% of the time. ConclusionPsychiatry and infectious disease-related indications are the most frequent subjects of provider inquiry regarding medication use in pregnancy. Rates of inquiry remained constant throughout the past decade in most therapeutic areas. These findings are consistent with previous observations in other developed countries and suggest high-yield areas for pharmacist education.

Developing a systematic approach to safer medication use during pregnancy: summary of a Centers for Disease Control and Prevention–convened meeting

To address information gaps that limit informed clinical decisions on medication use in pregnancy, the Centers for Disease Control and Prevention (CDC) solicited expert input on a draft prototype outlining a systematic approach to evaluating the quality and strength of existing evidence for associated risks. The draft prototype outlined a process for the systematic review of available evidence and deliberations by a panel of experts to inform clinical decision making for managing health conditions in pregnancy. At an expert meeting convened by the CDC in January 2013, participants divided into working groups discussed decision points within the prototype. This report summarizes their discussions of best practices for formulating an expert review process, developing evidence summaries and treatment guidance, and disseminating information. There is clear recognition of current knowledge gaps and a strong collaboration of federal partners, academic experts, and professional organizations willing to work together toward safer medication use during pregnancy.