The concordance between self-reported medication use and pharmacy records in pregnant women.

Accurate measurement of medication exposure is crucial for studying the safety of antiseizure medications (ASMs) during pregnancy. Pregnancy safety studies of ASMs frequently rely on secondary data from drug prescription registries to assess potential teratogenic effects and impact on fetal development. This study aimed to evaluate the agreement between dispensed prescriptions registered in a national database and self-reported ASM use by parents. The Norwegian Prescription Database (NorPD) was linked to the Norwegian Mother, Father, and Child Cohort Study (MoBa) and the Medical Birth Registry of Norway (MBRN). Participants included mothers and fathers in the MoBa-study between 2004 and 2009. Agreement between dispensed ASM prescriptions and self-reported use was assessed by calculating Cohen's kappa (κ), sensitivity, and specificity, with self-reported use as the reference standard. A total of 40 632 pregnant women and 42 247 fathers were included. Maternal dispensed ASM prescriptions during pregnancy showed strong overall agreement (κ = 0.81) with self-reported use, with a sensitivity of 80.6% and specificity of 99.9%. Paternal dispensed ASM prescriptions up to 7 months prior to conception also demonstrated strong agreement (κ = 0.81) with self-reported use. Analysis of individual ASMs revealed varying reliability: levetiracetam and lamotrigine had the highest agreement among maternal (κ = 0.92) and paternal (κ = 0.92) dispensed prescriptions, respectively. There is strong agreement between dispensed ASM prescriptions and self-reported medication use by parents, supporting the use of prescription data for evaluating the risks of ASM use during pregnancy.

“Ms. A” was a 35-year-old married Caucasian health care professional with a history of recurrent major depressive disorder that responded well to treatment with a selective serotonin reuptake inhibitor (SSRI). She discontinued her antidepressant prior to conception for a planned pregnancy because she did not want to expose her baby to medication. She soon relapsed, and by the first trimester of her pregnancy, she was in a major depressive episode. Her symptoms included anhedonia, tearfulness, irritability, insomnia, and diminished appetite. She presented for participation in an open-label pilot trial of omega-3 fatty acids for antenatal major depressive disorder (1). At intake, after hearing the risks and benefits of available treatment options, Ms. A declined antidepressant medication and a referral for psychotherapy and consented to participate in the study of omega-3 fatty acids, which she started at 16 weeks’ gestation. She was assessed every 2 weeks throughout pregnancy. At 8 weeks she had not responded to omega-3 fatty acids and was again presented with other treatment options, including medication and psychotherapy. She again declined these treatments and continued to do so throughout the remainder of her pregnancy. She was concerned about the safety of medications in pregnancy and believed that taking medication would make her a bad mother. She also declined referral for psychotherapy, stating that she was “too busy.”

BACKGROUND Clinical teratology studies often rely on patient reports of medication use in pregnancy with or without other sources of information. Electronic medical records (EMRs), administrative databases, pharmacy dispensing records, drug registries, and patients' self-reports are all widely used sources of information to assess potential teratogenic effect of medications. The objective of this study was to assess comparability of self-reported and prescription medication data in EMRs for the most common therapeutic classes. METHODS The study population included 404 pregnant women prospectively recruited from five prenatal care clinics affiliated with the University of New Mexico. Self-reported information on prescription medications taken since the last menstrual period (LMP) was obtained by semistructured interviews in either English or Spanish. For validation purposes, EMRs were reviewed to abstract information on medications prescribed between the LMP and the date of the interview. Agreement was estimated by calculating a kappa (κ) coefficient, sensitivity, and specificity. RESULTS In this sample of socially-disadvantaged (i.e., 67.9% high school education or less, 48.5% no health insurance), predominantly Latina (80.4%) pregnant women, antibiotics and antidiabetic agents were the most prevalent therapeutic classes. The agreement between the two sources substantially varied by therapeutic class, with the highest level of agreement seen among antidiabetic and thyroid medications (κ ≥0.8) and the lowest among opioid analgesics (κ = 0.35). CONCLUSIONS Results indicate a high concordance between self-report and prescription data for therapeutic classes used chronically, while poor agreement was observed for medications used intermittently, on an 'as needed" basis, or in short courses.

THU0513 MEDICATION BURDEN IN YOUNG ADULTS WITH JUVENILE IDIOPATHIC ARTHRITIS – RESULTS OF AN OBSERVATIONAL COHORT STUDY

Study question What is the difference in personal characteristics, pregnancy outcomes and medication use between pregnant women with and without Polycystic Ovary Syndrome (PCOS). Summary answer Pregnant women with PCOS use medication more often but are not at higher risk of mental health disorders than those without PCOS. What is known already PCOS is a common endocrine disorder that affects 8–13% of women in their reproductive years. Women with PCOS experience more depressive and anxiety complaints, have lower self-esteem, and experience a more negative body image compared to women without PCOS. A meta-analysis examining depression rates found median prevalence of almost 37% in women with PCOS compared to 14% in controls. As a result, women with PCOS tend to use more medication than women without PCOS. Unfortunately, for most medication it’s safety during pregnancy is not yet determined. Therefore, pregnant women often cease their medication, often for unnecessary reasons. Study design, size, duration This study used data from the Dutch Pregnancy Drug Register (DPDR), a nationwide prospective cohort in the Netherlands. Pregnant women self-reported health status, medication use, vaccinations, and pregnancy outcomes via six online questionnaires. Three were completed during pregnancy (enrollment, 17 and 34 weeks), and three postpartum (2, 6, and 12 months). The DPDR provides comprehensive insights into maternal and infant health. Participants/materials, setting, methods This study included 16,680 pregnant women in the Netherlands enrolled in the DPDR between January 2021 and June 2024. Participants, recruited via healthcare professionals, vaccination sites, and online channels, were eligible if they were over 18 and proficient in Dutch. Of these, 711 (4.3%) self-reported a PCOS diagnosis in the baseline questionnaire. Main results and the role of chance In our cohort, BM and time to pregnancy were significantly higher in women with PCOS compared to women without PCOS (P < 0.0001). Mental health disorders were not more prevalent in pregnant women with PCOS compared to women without PCOS (P = 0.283). Women with PCOS were more likely (P = 0.002) to use any kind of medication during pregnancy (93.3%) compared to women without PCOS (87.3%). A small group of women with PCOS were using antidepressant for mental health disorders and over 50% stopped their medication during pregnancy. There was no difference between women with PCOS and women without PCOS if we compared pregnancy complications like gestational diabetes mellitus (GDM), hypertension, induced labor and hospital admission. Also, mean birth weight was not significant different (P = 0.635). We found that women with PCOS more often used pain relief during labor (P = 0.029) compared to women without PCOS. Limitations, reasons for caution A limitation of our study could be that only women with PCOS who became pregnant are included in this study. Many women with PCOS struggle with fertility issues, hence our results do not show a complete picture of all women with PCOS. Wider implications of the findings This study provides valuable insights into medication use among pregnant women with PCOS. Preconceptional counselling is crucial for women with PCOS and mental health disorders. The use of antidepressants during pregnancy should be monitored closely, cessation of antidepressants is often not necessary. Trial registration number No

Hypertension Editors' Picks: Preeclampsia, Pregnancy, and Hypertension.

The medication history among hospitalized patients often relies on patients' self-reports due to insufficient communication between health care professionals. The aim of the present study was to estimate the reliability of patients' self-reported medication use. Five hundred patients admitted to an acute medical department at a Danish university hospital were interviewed on the day of admission about their recent medication use. Blood samples drawn immediately after admission were screened for contents of 5 drugs (digoxin, bendroflumethiazide, amlodipine, simvastatin, glimepiride), and the results were compared to the patients' self-reported medication history. Information on prescribed drugs dispensed from any Danish pharmacy was collected from nationwide real-time pharmacy records. The authors performed home visits in a subgroup of 115 patients 4 weeks after their discharge. Stored drugs were inspected, and patients were interviewed about their drug use. Additional blood samples were drawn for drug analysis. The median age of included patients was 72 years, and 298 patients (60%) were women. Patients reported use of 3 (median) prescription-only medications (range, 0-14) during the structured interview. The congruence between self-report and drug analysis was high for all 5 drugs measured (all kappa >0.8). However, 9 patients (2%) reported use of drugs that were not detected in their blood samples. In 29 patients (6%), the blood samples contained drugs not reported during the structured interview, but 14 of these drugs were registered in either hospital files or pharmacy records. Overall, the sensitivity of information from hospital files, structured interviews, and pharmacy records in identifying drug users was 87% to 93%, with no significant differences between methods. In conclusion, patients' self-reports are reliable when estimating recent use of cardiovascular and antidiabetic drugs.

Substance use disorders in pregnancy: clinical, ethical, and research imperatives of the opioid epidemic: a report of a joint workshop of the Society for Maternal-Fetal Medicine, American College of Obstetricians and Gynecologists, and American Society of Addiction Medicine

This study was conducted to assess the validity of parental reported use of inhaled corticosteroids (ICS) in children. ICS users were identified within the Prevention and Incidence of Asthma and Mite Allergy (PIAMA) birth cohort study and the PIAMA pharmacy sub-cohort which is nested within the PIAMA study. Complete medication histories were available for the first 8 years of life for children within the PIAMA pharmacy sub-cohort. Parental reported ICS use was measured by using data from questionnaires. ICS use in the pharmacy records was determined by using the Anatomical Therapeutic Chemical (ATC) codes. The proportion of overall agreement and kappa statistics with their corresponding 95% confidence intervals were calculated to quantify agreement between self-reported medication use and pharmacy prescription data. At all ages overall agreement was very high (>97%) and Cohen's kappa's ranged from 0.80 to 0.88 which also reflects excellent agreement between parental reported use of ICS and pharmacy prescription data. Our finding suggests that parental report of medication use is a reliable source of data to asses ICS use in children. The questionnaire-based medication data collected within the PIAMA study can be used to study asthma medication use in a large group of children.

BackgroundWhile self-reported data are commonly used as a source of medication use for pharmaco-epidemiological studies, such information is prone to forms of bias. Several previous studies showed that various factors like age, type of drug and data collection method may influence accuracy. We aimed to assess the concordance of the self-reported medication use that was documented at entry to the Lifelines Cohort Study, a three-generation follow-up study in the Netherlands that started in 2006 and included over 167,000 participants.Materials and methodsAs part of the PharmLines Initiative, we collected medication data from the Lifelines participants encoded according to the Anatomical Therapeutic Chemical (ATC) coding scheme and linked the data via Statistics Netherlands to the widely used and representative pharmacy prescription database of the University of Groningen, IADB.nl. Analyses were conducted at second level of ATC coding for all recorded medications as well as a top list of most used medications at drug-specific fifth level. Cohen’s kappa statistics were used to measure the concordance for all participants according to sex and age.ResultsThe level of concordance between the two data sources largely differed according to the therapeutic class. Medication used for the cardiovascular system and diabetes, thyroid therapy, bisphosphonates and anti-thrombotic drugs showed a very good agreement (κ>0.75). Medication as needed or prone to stigmatization bias showed a moderate agreement (κ=0.41–0.60), whereas medications used for short periods of time showed a fair agreement (κ=0.0–0.4). Concordance was similar for males and females, but younger adults tended to have lower concordance rates than older adults.ConclusionThe self-reported method was valid for capturing prevalent chronic medication use at one moment in time, but invalid for medication used for short periods of time. There is no effect of sex on the agreement, and more studies are needed on the influence of age. Future pharmaco-epidemiological studies should preferably combine the two data sources to achieve the highest accuracy of drug exposure rates.

Objective: To determine the validity of work-related self-reported exacerbation of asthma using the findings from serial peak expiratory flow (PEF) measurements as the standard. Methods: Adults with asthma treated in...

ObjectiveTo validate self-reported use of medications for secondary prevention of coronary heart disease (CHD) in a population-based health study by comparing self-report with pharmacy dispensing data, and explore different methods for defining medication use in prescription databases. Study design and settingSelf-reported medication use among participants with CHD (n = 1483) from the seventh wave of the Tromsø Study was linked with the Norwegian Prescription Database (NorPD). Cohen’s kappa, sensitivity, specificity, and positive and negative predictive values were calculated, using NorPD as the reference standard. Medication use in NorPD was defined in three ways; fixed-time window of 180 days, and legend-time method assuming a daily dose of one dosage unit or one defined daily dose (DDD). ResultsKappa-values for antihypertensive drugs, lipid-lowering drugs and acetylsalicylic acid all showed substantial agreement (kappa ≥0.61). Validity varied depending on the method used for defining medication use in NorPD. Applying a fixed-time window gave higher agreement, positive predictive values and specificity compared with the legend-time methods. ConclusionSelf-reported use of medication for secondary prevention of CHD shows high validity when compared with pharmacy dispensing data. For CHD medications, fixed-time window appears to be the most appropriate method for defining medication use in prescription databases.

To assess the validity of self-reported continuous medication use with drug metabolites measured in plasma by using untargeted mass spectrometric techniques. In a population-based cohort in Bonn, Germany, we compared interview-based, self-reported medication intake with drug-specific metabolites measured in plasma (based on participants who completed their study visits between March 2016 and February 2020). Analyses were done stratified by sex and age (<65 years vs ≥65 years). Cohen's kappa (κ) statistics with 95% confidence intervals (CI) were calculated. A total of 13 drugs used to treat hypertension, gout, diabetes, epilepsy and depression were analysed in a sample of 4386 individuals (mean age 55 years, 56.1% women). Eleven drugs showed almost perfect agreement (κ>0.8), whereas sitagliptin and hydrochlorothiazide showed substantial (κ=0.8, 95% CI 0.71-0.90) and moderate agreement (κ=0.61, 95% CI 0.56-0.66), respectively. Frequency of use allowed sex- and age-stratified analyses for eight and nine drugs, respectively. For five drugs, concordance tended to be higher for women than for men. For most drugs, concordance was higher among individuals aged ≥65 years than among individuals aged <65 years, but these age-related differences were not statistically significant. High concordance rates between self-reported drug use and metabolites measured in plasma suggest that self-reported drug use is reliable and accurate for assessing drug use.

Maternal vaccines are upcoming. A clear picture of the adverse events (AEs) after maternal vaccination and whether this is comparable to a nonpregnant population is important. The objective of our study was to compare perceived AEs after COVID-19 vaccination between pregnant and nonpregnant women and to study if it is feasible to compare AEs within two independent Dutch cohort studies. Data from the Dutch Pregnancy Drug Register (DPDR) and the cohort event monitoring (CEM) study on COVID-19 vaccines were used. At least one self-reported (solicited) AE, more than one AE, and specific self-reported AEs after the first doses of an mRNA COVID-19 vaccine were compared between pregnant and nonpregnant women using multivariable logistic regression analysis. The pattern of AEs was similar between pregnant (n = 2204) and nonpregnant (n = 2684) women, with the four most frequently reported AEs being: injection site reaction, myalgia, fatigue, and headache. Pregnant women reported less often at least one AE compared to nonpregnant women (65.9% vs. 72.3%; adjusted odds ratio [aOR] = 0.78; 95% confidence interval [CI] = 0.67-0.90), more than one AE, or specific AEs: nausea, chills, pyrexia, and arthralgia. Myalgia was more often reported among pregnant women compared to nonpregnant women. Pregnant women perceived comparable or less often AEs after the first mRNA COVID-19 vaccination compared to nonpregnant women. The results aid pregnant women in making an informed decision about vaccination. A comparison between the pregnancy registry and the CEM study was feasible and this method can be used to compare AEs for other/future maternal vaccines.

IntroductionOver-the-counter (OTC) medications are a popular choice for alleviating minor ailments during pregnancy. However, there are many risks associated with frequent and high use of OTC medications to the mother and foetus.AimsWe performed a systematic review and meta-analysis to determine the prevalence of OTC medication use in pregnancy.MethodsElectronic databases (Medline, Embase and Scopus) were systematically searched up to November 2023 to identify English-language articles with data on OTC medication use prevalence. Pooled prevalence (%) of OTC medication use with 95% confidence intervals (CI) were generated using a random-effects model. The quality of the studies was critically appraised using the Joanna Briggs Institute Critical Appraisal tool for use in systematic reviews for observational studies.ResultsOf the 20 studies included in the analyses, the majority (n = 13) were cross-sectional studies. The pooled prevalence of overall OTC medication use among pregnant women was 36% (95% CI 21%, 53%; n = 77,219). Pooled prevalence of overall analgesic use was 25% (95% CI 7%, 49%; n = 257,770). Highest individual OTC medications/medication classes were paracetamol use (32%; 95% CI 18%, 47%; n = 163,799) and antacid use (19%; 95% CI 8%, 32%; n = 1039). By trimesters, the pooled prevalence of OTC medication use was highest in the second trimester (30%; 95% CI 9%, 55%; n = 152,055), followed by the third trimester (25%; 95% CI 6%, 49%; n = 152,055), and the first trimester (19%; 95% CI 4%, 41%; n = 152,055).ConclusionsThe relatively high prevalence of OTC medication use among pregnant women is a cause for concern, but may be unavoidable. When known to healthcare providers, it is crucial to provide current, complete and accurate information about OTC medications to pregnant women. They should also be warned of the risks associated with OTC medications, and that if unsure, advice should be sought prior to use.