Medication Use In Pregnancy Research Articles

Topical antibiotics in pregnancy: A review of safety profiles.

Medications should be used with caution in women of childbearing age who are pregnant, or are contemplating pregnancy. Although topical medications are considered safer than oral or parenteral agents, their safety data in pregnancy must be assessed carefully. The available information on medication use in pregnancy is limited, and not always aided by the FDA pregnancy letter category system. Thus, in this article, we aggregate human studies, animal studies, and pharmacokinetics data to provide recommendations on utilizing topical antibiotics in pregnancy.

Where does the Pregnant Women Searching for Their Information Need?

Pregnant women tend to be more concern with the health and food issue. During pregnancy, women will have physiological changes, such as intestinal disorders, metabolic diseases, and obesity. They tend to reduce consume of food with pregnancy-related health risk. In order to achieving healthy pregnancy, information related to health and food issue are needed. Pregnant women were actively seek information from a variety of sources. The research method used is literature review, we would like to identify which source of information that most used by pregnant to meet their information need and how is their belief about the sources. The conclusion of this study that information required by pregnant women related with information regarding medicine or medication use in pregnancy, nutrition, and health disorders. Dominant information used by pregnant women were health practitioners, online information, and family/friends. Although used by many pregnant women, the internet believed as an unreliable source of health information. Health practitioners were the main trusted information sources. This study is essential for information provider in designing healthy living information and educating health literacy for pregnant women.

The Relationship Between Pregnancy Exposure to Antidepressant and Atypical Antipsychotic Medications and Placental Weight and Birth Weight Ratio: A Retrospective Cohort Study.

Psychotropic medication use in pregnancy has been associated with altered fetal growth. The aim of this study was to investigate the relationship between placental weight and placental weight-to-birth weight (PBW) ratio, as a potential marker of placental efficiency, and medication use in a cohort of women with severe mental illness in pregnancy. A retrospective database analysis was carried out on a cohort of pregnant women with severe mental illness (242 singleton pregnancies) and grouped according to their psychotropic medication use. Demographic, obstetric, neonatal, and psychiatric variables were analyzed using t tests, χ, analysis of variance, univariate, binary, and multiple regression adjusting for potential confounders. Multiple regression analysis demonstrated a mean adjusted increase in placental weight of 114 g (95% confidence interval [CI], 60.2-165.6 g) in women taking antidepressant medication and 113 g (CI, 65.1-162.8 g) in women taking combined antidepressant and atypical antipsychotic medication in pregnancy. There was also a significantly elevated PBW ratio in these 2 medication groups (B 0.02: CI, 0.006-0.034; and B 0.025: CI, 0.012-0.038). Binary regression, adjusted for sex and gestational age, showed a significant odds ratio of 4.57 (95% CI, 2.17-9.62) for PBW ratio of greater than 90% in those taking antidepressant medication, either alone or in combination, compared with unmedicated women. The use of antidepressant medication, alone or in combination, has a significant effect on placental weight and PBW ratio after adjusting for confounding variables. Given that this may reflect adverse effects on intrauterine growth and have possible long-term implications for the fetus, further research is warranted to confirm these findings.

First trimester medication use in pregnancy in Cameroon: a multi-hospital survey

BackgroundThere is a paucity of epidemiological data on medication use in pregnancy in Cameroon.MethodsBetween March and August 2015, 795 pregnant women attending 8 urban and 12 rural hospitals in Cameroon for antenatal (ANC) or other care were interviewed on first trimester medication use using structured questionnaires. Multivariate logistic regression was used to analyse the association of 18 sociodemographic factors with medication use.ResultsA total of 582 (73.2%) women took at least one orthodox (Western) medication during the first trimester, 543 (68.3%) women a non-pregnancy related orthodox medication, and 336 (42.3%)women a pregnancy related orthodox medication. 44% of the women took anti-infectives including antimalarials (33.6%) and antibiotics (20.8%).The other most common medications were analgesics (48.8%) and antianaemias (38.6%). Sulfadoxine/pyrimethamine, contraindicated in the first trimester of pregnancy, was the most commonly used antimalarial(13% of women).0.2% of women reported antiretroviral use. Almost 80% of all orthodox medications consumed by women were purchased from the hospital. 12.8% of the women self-prescribed. Health unit and early gestational age at ANC booking were consistent determinants of prescribing of non-pregnancy related, pregnancy related and anti-infective medications. Illness and opinion on the safety of orthodox medications were determinants of the use of non-pregnancy related medications and anti-infectives. Age and parity were associated only with non-pregnancy related medications.ConclusionThis study has confirmed the observations of studies across Africa indicating the increasing use of medications during pregnancy. This is an indication that access to medicine is improving and more emphasis now must be placed on medication safety systems targeting pregnant women, especially during the first trimester when the risk of teratogenicity is highest.

Uso de medicación antipsicótica durante el embarazo

The use of medication in pregnancy is always a problematic issue, given the lack of sufficient data on which to base clinical decisions, as well as the associated uncertainty. Except in clear cases of teratogenicity, such as thalidomide, or in the case of psychotropic drugs —valproic acid—, the use of medication in pregnancy is always a matter of common sense, and above all, of a careful risk-benefit evaluation. In mental illness, the risks to the mother and the foetus in the absence of treatment can far exceed those arising from exposure to medication, especially in the case of serious mental disorders such as schizophrenia, bipolar disorder, or severe depression.In the case of antipsychotic medication, the available knowledge about its effects on foetal development, the neonatal period, and long-term neurological and behavioural development is limited. This makes it difficult to establish a general criterion for its use, especially if it is taken into account that the conclusions and recommendations derived from the available studies are not always coincident. This forces the clinician to weigh the advantages and disadvantages of these drugs under conditions of uncertainty, including the risks that the interruption of treatment would entail, and to do so in a context of clear information and shared decisions for the patient.

Prevalence, knowledge and attitudes of healthcare professionals toward herbal medication use in pregnancy

Tumor necrosis factor-alpha inhibitors (TNFα-I) are biological agents used in the treatment of rheumatologic disorders. TNFα-I have been associated with demyelinating disorders mimicking multiple sclerosis. The goal of this report is to illustrate cases of myelopathy which developed during the use of TNFα-I.We describe the clinical, neuroimaging and laboratory features of 4 cases of myelopathy associated with TNFα-I.The mean period of TNFα-I exposure was 27 [12–36] months. Three of the four patients exhibited active inflammatory myelopathy as the spinal cord MRI lesions enhanced with gadolinium and CSF pleocytosis or oligoclonal bands were present. All patients had normal brain MRIs at the time of presentation.TNFα-I may play a role in the development of myelopathies in absence of brain involvement or other features of demyelinating disease. TNFα-I associated myelopathy should be considered in patients with history of treatment with TNFα-I who exhibit symptoms of myelopathy.

The new FDA labeling rule: impact on prescribing rheumatological medications during pregnancy.

After several decades of deliberation, the US Food and Drug Administration updated the Pregnancy and Lactation Labeling Rule in 2015, eliminating the prior A, B, C, D, X grading system for medication use in pregnancy. Although physicians and patients liked the relative ease of use of this system, it was often misconstrued and not updated to include new data suggesting greater compatibility of medications with pregnancy. The new label is designed to include more clinically relevant data, including data from human studies and registries, and fewer animal data. A key goal of the new label is to assist physicians and patients as they weigh the risks and benefits of medications vs the risks of pregnancy in a woman with a chronic, untreated illness. As such, each label now includes a section outlining the pregnancy risks of the diseases that the medication treats. This review includes a historical perspective on the label change and a guide to the interpretation of the new label. It also includes an assessment of the baseline risk of pregnancy in women with SLE and RA, to help balance the consideration of medication risks and benefits in pregnancy.

Trends in prescription drug use during pregnancy and postpartum in Norway, 2005 to 2015.

To explore trends in use of maternal medication 3months prior to, during and 3months after pregnancy. Data on births from the Medical Birth Registry of Norway were linked to the Norwegian Prescription Database, identifying women's use of medications around pregnancy. All women giving birth in Norway during 2005 to 2015 (638532 singleton births to 414567 women) were included. Proportions of pregnant women using different medications in association with pregnancy, and annual relative change in medication use during 2005 to 2015, were calculated. In Norway, 60% of pregnant women used prescription medications during pregnancy (2005-15), increasing from 57% in 2005 to 62% in 2015. The annual relative increase was 0.9% (95% CI: 0.8-1.0). In the first trimester, approximately 17% of the women used medications regarded as potentially teratogenic during 2005 to 2015, increasing from 15% to 19%. Overall, this proportion was higher in the first than in the second (8.9%) and third (8.0%) trimesters, and higher than in the 3months after pregnancy (14%). The annual relative increase of medications regarded as potentially teratogenic in the first trimester was 2.5% (95% CI: 2.3-2.7). The proportion of women using potentially teratogenic medications in the first trimester of pregnancy have increased during the last decade. Clinicians need to be aware of the possibility of pregnancy when prescribing potentially teratogenic medication to women of fertile age and focus this in the consultations. The increasing trends call for the need of routine surveillance of adverse birth outcomes linked to medication use in pregnancy.

Implementation and evaluation of a women's reproductive health pharmacy elective

Background and purposeTo create, implement and evaluate an elective course for pharmacy students focusing on women's reproductive health topics. Educational activity and settingA course was developed that included lectures discussing contraception, infertility, preconception care, pregnancy, and postpartum health. Active learning provided in the forms of journal article review and review of drug information resources for medication use in pregnancy were utilized. Workshops provided hands-on experiences with prescription contraceptives and over-the-counter fertility products. Knowledge and skills were assessed with in-class quizzes, journal article presentations, class participation, patient cases, and a final exam. A 46-item survey was administered to students pre- and post-course to assess self-perceived knowledge and confidence in women's reproductive health. FindingsA total of 33 students were enrolled in the course. The response rate for the pre-course survey was 100% (n = 33) and for the post-course survey was 91% (n = 30). Students’ confidence in counseling on women's reproductive health topics significantly increased after the course (mean scores 2.62 pre-course and 3.75 post-course, p < 0.0001). Similar results were seen in students’ self-perceptions of their overall knowledge in women's health (mean scores 2.63 pre-course and 3.92 post-course, p < 0.0001). Preferred methods of learning included product workshops, and journal club presentations were the least preferred learning method. Discussion and summaryA women's reproductive health course was well received by students and increased their self-perceived knowledge and confidence in the areas of prescription contraceptives and over-the-counter fertility products.

Prescription and Other Medication Use in Pregnancy

To characterize prescription and other medication use in a geographically and ethnically diverse cohort of women in their first pregnancy. In a prospective, longitudinal cohort study of nulliparous women followed through pregnancy from the first trimester, medication use was chronicled longitudinally throughout pregnancy. Structured questions and aids were used to capture all medications taken as well as reasons they were taken. Total counts of all medications taken including number in each category and class were captured. Additionally, reasons the medications were taken were recorded. Trends in medications taken across pregnancy and in the first trimester were determined. Of the 9,546 study participants, 9,272 (97.1%) women took at least one medication during pregnancy with 9,139 (95.7%) taking a medication in the first trimester. Polypharmacy, defined as taking at least five medications, occurred in 2,915 (30.5%) women. Excluding vitamins, supplements, and vaccines, 73.4% of women took a medication during pregnancy with 55.1% taking one in the first trimester. The categories of drugs taken in pregnancy and in the first trimester include the following: gastrointestinal or antiemetic agents (34.3%, 19.5%), antibiotics (25.5%, 12.6%), and analgesics (23.7%, 15.6%, which includes 3.6%; 1.4% taking an opioid pain medication). In this geographically and ethnically diverse cohort of nulliparous pregnant women, medication use was nearly universal and polypharmacy was common. ClinicalTrials.gov, NCT01322529.

Essential Medication Prescription and Associated Maternal Characteristic among Hospitalized Pregnant Women: A Retrospective Population Based Study

: Objective: There are limitations of Food and Drug Administration pregnancy risk classification system and pregnancy information, surplus resources are essential to evaluate the safety and to assess the risk-benefit ratio of medication use in pregnancy. The aim of the study is to characterize medication use in hospitalized pregnant women during antenatal period and correlate maternal characteristics in this population. Methods: It is a retrospective cross-sectional survey. Data of hospitalized pregnant women was collected. The FDA pregnancy risk classification was categorized for the prescribed drugs. Descriptive analysis was performed for demographic and maternal characteristics. Pearson Chi-square Fisher’s exact tests are used to observe the association between the independent variables and outcome variables. Adjusted odds ratios (ORs) and 95% CIs were also estimated. Each outcome variables whose levels were with a P (< 0.05) was significant. Results: Among 505 pregnant women, 75.24% were hospitalized during third trimester, and 3.17% were having comorbid conditions. 60.59% of the pregnant women received more than or equal to five drugs. 39.86% are exposed to FDA C, D or X categories of drugs during pregnancy. Category B drugs are frequently prescribed. Women whose parity is ≥ 2, length of hospital stay and with at least five medications prescribed are the factors associated to prescription of FDA C, D or X drugs during pregnancy. Conclusion: There was considerable use of medicines among the pregnant women as per the essential drug list complying fully with World Health Organization recommendations by using their international non-proprietary names.Key words: Pregnancy, Classification, Drug utilization, Public health hospital, Retrospective study.

Guide for Drug Selection During Pregnancy and Lactation: What Pharmacists Need to Know for Current Practice.

To provide guidance for clinicians on risk assessment of medication use during pregnancy and lactation. Authors completed PubMed searches to identify articles focused on the use of medications in pregnancy, including fetal development, drug transfer across the placenta, trimester exposure, chronic conditions in pregnancy, medications in lactation, and lactation and chronic disease. Articles were reviewed to provide overall guidance to medication selection during pregnancy. The following information was reviewed: medication use in pregnancy, including fetal development, drug transfer across the placenta, trimester exposure, chronic conditions in pregnancy, medications in lactation, and lactation and chronic disease. This article will provide an overview of medication safety considerations during pregnancy and lactation. Information was interpreted to help clinicians predict the potential risk and benefit in each patient to make an evidence-based decision. The article concludes with guidance on risk assessment and how pharmacists may support fellow health care providers and their patients when considering medication use. Information about the effects of medication use during reproductive periods is limited. With the removal of the Food and Drug Administration pregnancy categories, clinicians will be relying on pharmacists to aid in the appropriate selection of therapies for patients. It is critical that pharmacists keep abreast of resources available and be able to assess data to help prescribers and their patients.

Medication Use in Pregnancy and Risk Evaluation: Do Not Categorize Me

Medication use in pregnancy is a common problem and question. Nearly half of pregnant women (30% -90%) use at least one prescription medication during pregnancy. In addition to prescription drugs, pregnant women use over the counter drugs for which are limited data in pregnancy. Pregnant patients exposed to drugs should be informed about potential effects of medications. The United States- Food and Drug Administration’s (US- FDA) pregnancy categories (A, B, C, D, and X), which provide short and practical data, have recently been removed and replaced with an evidence-based approach. An overall classification for pregnancy is not sufficient when used alone. A research-based risk evaluation of potential adverse health effects resulting from drug use in pregnancy has three important parts: risk assessment, risk communication and risk management. An accurate risk evaluation about drug safety in pregnancy and informing women exposed to drugs may help reduce maternal concerns and prevent unnecessary pregnancy terminations.

ADHD medication use in pregnancy and risk of congenital malformation

ADHD medication use in pregnancy and risk of congenital malformation

Knowledge and practice characteristics of pharmacists in Qatar towards medication use in pregnancy: a cross-sectional survey

Medication use during pregnancy is common. Pharmacists have an important role in improving medication use during pregnancy. There is a lack of empirical evidence on pharmacists' knowledge and practice characteristics towards medication use in pregnancy. This study aimed to determine the knowledge and practice characteristics of pharmacists in Qatar about medicines use in pregnancy. A cross-sectional, questionnaire-based study was conducted over a period of 6 months in 2010. Questionnaires were distributed to 400 of 800 licensed pharmacists employed in Qatar (in government and private sectors). Data were collected on: demographics and practice characteristics of the pharmacists; their knowledge and perception about medication use in pregnancy; their confidence in dealing with pregnant women and physicians; and their source of the drug information. Of the 400 questionnaires distributed, 207 were returned (52% response rate). Most pharmacists (71%) had not participated in any educational activities on medication use in pregnancy. About 50% reported that < 10% of their workload involved dispensing medications to pregnant women. A lack of available resources and unknown pregnancy status were the main concerns about dispensing medication to pregnant women. The majority of the respondents had average knowledge about medication use in pregnancy. There was a significant association between knowledge, and continuing education and years of experience (P < 0.05). Pharmacists in Qatar had an average level of knowledge about medications use in pregnancy. Continuous educational programmes are needed for pharmacists in Qatar to enhance their knowledge and practice of medicine use during pregnancy.

Online social network response to studies on antidepressant use in pregnancy

BackgroundAbout 8% of U.S women are prescribed antidepressant medications around the time of pregnancy. Decisions about medication use in pregnancy can be swayed by the opinion of family, friends and online media, sometimes beyond the advice offered by healthcare providers. Exploration of the online social network response to research on antidepressant use in pregnancy could provide insight about how to optimize decision-making in this complex area. MethodsFor all 17 research articles published on the safety of antidepressant use in pregnancy in 2012, we sought to explore online social network activity regarding antidepressant use in pregnancy, via Twitter, in the 48h after a study was published, compared to the social network activity in the same period 1week prior to each article's publication. ResultsOnline social network activity about antidepressants in pregnancy quickly doubled upon study publication. The increased activity was driven by studies demonstrating harm associated with antidepressants, lower-quality studies, and studies where abstracts presented relative versus absolute risks. ImplicationsThese findings support a call for leadership from medical journals to consider how to best incentivize and support a balanced and clear translation of knowledge around antidepressant safety in pregnancy to their readership and the public.

Birth outcomes after inadvertent use of category X drugs contraindicated in pregnancy: Where is the real risk?

Öztürk Z, Ölmez E, Gürpınar T, Vural K. Birth outcomes after inadvertent use of category X drugs contraindicated in pregnancy: Where is the real risk? Turk J Pediatr 2018; 60: 298-305. Drugs contraindicated in pregnancy are medicines that should be avoided by pregnant women, since they carry a concern for teratogenicity or there is no indication for their use during pregnancy. It does not mean that exposures to these drugs always cause harm. The aim of the present study was to investigate the risk of adverse outcomes following maternal exposure to the drugs contraindicated in pregnancy. We retrospectively analyzed prenatal drug exposure records of the pregnant patients referred to the clinical pharmacology consultation service in a tertiary-level university hospital from January 2007 until December 2012. Exposures to category X drugs (CXD) contraindicated in pregnancy were evaluated. After the expected date of delivery, we collected data about pregnancy complications and the outcomes. For comparison the women in the exposed group (N=52) were matched with a control group (N=162) of pregnant women without teratogenic exposure. We observed only one baby born with a birth defect (congenital cryptorchidism) in CXD group (2.6%) and four in control group (RR 0.91; 95% CI 0.10- 7.94). The rates of adverse pregnancy outcomes including miscarriage, preterm birth and congenital abnormality were not significantly different from controls. However, the rate of elective termination of pregnancy was higher in women exposed to CXD while pregnant (RR 2.54; 95% CI 1.11- 5.80, p = 0.027). Contraceptive failure and unintended pregnancy are the reasons for inadvertent drug exposure and choosing abortion. The high perception of teratogenic risk among pregnant women may cause terminations of pregnancies. Individual risk assessment and avoiding the phrase `CXD` or `contraindicated in pregnancy` in counseling may help to reduce maternal concerns about medication use in pregnancy.

Knowledge, attitude and practices of Ghanaian midwives regarding the use of ophthalmic medications among pregnant women

BackgroundMidwives are the primary healthcare attendants of pregnant women and have per their mandate among others to detect and manage minor ailments presented by pregnant women including ocular disorders. This study was, therefore aimed at assessing the knowledge, attitude, and practices (KAP) of Midwives regarding the use of topical ophthalmic medications in managing common ocular diseases in pregnancy. MethodsSimple proportionate sampling was used to recruit midwives across the ten regions of Ghana. Participants completed a semi-structured questionnaire. KAP scores were computed as frequencies and percentages. Data were analyzed using Cross tabulations and Spearman’s non-parametric correlation to determine associations. ResultsA total of 273 registered midwives aged between 20 and 68 years participated in the study. The results indicated that 56.8% of midwives had low knowledge on ophthalmic medication use and 60.4% scored below average on their practice regarding ophthalmic medication use among pregnant women. This reflected the “dispassionate attitude” (78.6%) of the midwives towards the use of ophthalmic medications. Red eyes (58.2%) were the most reported ocular symptom with bacterial conjunctivitis being the most (55.7%) diagnosed ocular disease by the participants. Most referrals made by the midwives were to ophthalmologists (59.9%) and ophthalmic nurses (38.8%). ConclusionThe study revealed that midwives had low knowledge on ophthalmic medications and for that matter their practice of ophthalmic medication use in pregnancy was unsatisfactory. This had influenced their laissez-faire attitude towards the administration of ophthalmic medications despite they receiving complaints of ocular symptoms and subsequent diagnosis.

Discussing Appropriate Medication Use and Multivitamin Intake with a Healthcare Provider: An Examination of Two Elements of Preconception Care Among Latinas.

Counseling for appropriate medication use and folic acid consumption are elements of preconception care critical for improving pregnancy outcomes. Hispanic women receive less preconception care than women of other race/ethnic groups. The objective of this analysis is to describe differences in these two elements of preconception care among Hispanic subsegments. Porter Novelli's 2013 Estilos survey was sent to 2,609 U.S. Hispanic adults of the Offerwise QueOpinas Panel. Surveys were completed by 1,000 individuals (calculated response rate 42%), and results were weighted to the 2012 U.S. Census Hispanic proportions for sex, age, income, household size, education, region, country of origin, and acculturation. Responses were analyzed with weighted descriptive statistics, linear regression, and Rao-Scott chi-square tests. Of the 499 female respondents, 248 had a child under the age of 18 years and were asked about healthcare provider discussions concerning medication use before or during their last pregnancy. Timing of discussions varied by maternal age, marital status, income, youngest child's country of birth, and acculturation. Discussions before pregnancy were reported by 47% of the female respondents; high acculturated women more often reported never having such discussions. Among female respondents, 320 were of reproductive age, and 27% of those reported daily multivitamin use. Multivitamin use varied by pregnancy intention and youngest child's country of birth, but did not vary significantly by acculturation. Differences in discussions concerning medication use in pregnancy and multivitamin use exist among Hispanic subsegments based on pregnancy intention, marital status, income, youngest child's country of birth, and level of acculturation.

Inclusion of pregnant and breastfeeding women in research - efforts and initiatives.

Pregnant and breastfeeding women have been rendered therapeutic orphans as they have been historically excluded from clinical trials. Labelling for most approved drugs does not provide information about safety and efficacy during pregnancy. This lack of data is mainly due to ethico-legal challenges that have remained entrenched in the post-diethylstilbestrol and thalidomide era, and that have led to pregnancy being viewed in the clinical trial setting primarily through a pharmacovigilance lens. Policy considerations that encourage and/or require the inclusion of pregnant or lactating women in clinical trials may address the current lack of available information. However, there are additional pragmatic strategies, such the employment of pharmacometric tools and the introduction of innovative clinical trial designs, which could improve knowledge about the safety and efficacy of medication use during pregnancy and lactation. This paper provides a broad overview of the pharmacoepidemiology of drugs used during pregnancy and lactation, and offers recommendations for regulators and researchers in academia and industry to increase the available pharmacokinetic and -dynamic understanding of medication use in pregnancy.