Background: There is limited evidence on the safety of coronavirus disease 2019 (COVID-19) vaccination during pregnancy and lactation. Thus, we aimed to evaluate the association between COVID-19 vaccination during pregnancy and lactation and reporting risk of adverse pregnancy or lactation outcomes. Methods: Using VigiBase, we performed a disproportionality analysis with caseon case design. Cases were defined based on the Standardized MedDRA Queries (SMQs) of “pregnancy and neonatal topics” and non-cases were defined as all other adverse events. We included all reports with COVID-19 vaccines as the suspected cause. Using the full database as the comparators, reporting odds ratios (RORs) with 95% confidence intervals (CIs) were estimated by logistic regression while adjusting for maternal age. Infants’ age and sex were additionally adjusted in analyzing the risk of COVID-19 vaccination during lactation. Results: We identified 10,266 and 6,474 reports with the SMQ of “pregnancy and neonatal topics” associated with COVID-19 vaccines during pregnancy and lactation, respectively. No significant RORs of adverse pregnancy outcomes associated with COVID-19 vaccines during pregnancy were observed; however, “functional lactation disorders” showed significant disproportionality during lactation with adjusted ROR of 1.48 (95% CI, 1.21–1.79). Further analysis that analyzed “functional lactation disorders” at a preferred term level, showed higher ROR in mastitis (2.76 [95% CI, 1.45–5.27]). Conclusion Overall, we did not observe a positive association between COVID-19 vaccination during pregnancy and risk of reporting adverse pregnancy outcomes. However, we found a significant disproportionate reporting association between COVID-19 vaccination during lactation and “functional lactation disorders”, specifically mastitis. Continuous surveillance is warranted to confirm the safety of COVID-19 vaccine during pregnancy and lactation.

Objective: To explore the perception of drug utilization review (DUR) system and DUR modernization pilot project among healthcare professionals and patients. Methods: We conducted 8 times of focus group interviews (FGI) between August 1, 2019 to December 31, 2019. The healthcare professionals and patients who participated in the DUR modernization pilot project were included in the present study. Based on the type of project participation or medical institution, the participants were divided into the following four groups: group 1, hospital; group 2, clinic; group 3, pharmacy; and group 4, patient. Within each group, interviews were conducted under a pre-defined agenda to identify the implicit perceptions of the participants; the contents of the interviews were, then, categorized. Results: Healthcare professionals established a consensus on the positive aspects of the DUR system and DUR modernization pilot project. However, substantial concerns remain, such as additional workload associated with monitoring adverse events or acquiring consents from patients. Furthermore, a difference of opinion over the DUR convenience system was observed. Among 3 DUR convenience system, the personal medication history review service was highly utilized, but pop-up hold function and communication system was rarely used. Conclusion We observed that systematic intervention using the DUR system is effective for both healthcare providers and consumers. Adverse events caused by inappropriate drug use can be prevented by continuous patient monitoring. Therefore, the role of DUR system needs to be expanded to establish a safe drug management system.

Objective: To explore the perception of drug utilization review (DUR) system and DUR modernization pilot project among healthcare professionals and patients. Methods: We conducted 8 times of focus group interviews (FGI) between August 1, 2019 to December 31, 2019. The healthcare professionals and patients who participated in the DUR modernization pilot project were included in the present study. Based on the type of project participation or medical institution, the participants were divided into the following four groups: group 1, hospital; group 2, clinic; group 3, pharmacy; and group 4, patient. Within each group, interviews were conducted under a pre-defined agenda to identify the implicit perceptions of the participants; the contents of the interviews were, then, categorized. Results: Healthcare professionals established a consensus on the positive aspects of the DUR system and DUR modernization pilot project. However, substantial concerns remain, such as additional workload associated with monitoring adverse events or acquiring consents from patients. Furthermore, a difference of opinion over the DUR convenience system was observed. Among 3 DUR convenience system, the personal medication history review service was highly utilized, but pop-up hold function and communication system was rarely used. Conclusion We observed that systematic intervention using the DUR system is effective for both healthcare providers and consumers. Adverse events caused by inappropriate drug use can be prevented by continuous patient monitoring. Therefore, the role of DUR system needs to be expanded to establish a safe drug management system.

Background: Oral retinoids are used to treat various dermatological conditions, and their use is increasing in women of childbearing age. However, there is limited knowledge on the incidence of adverse outcomes after retinoid exposure during pregnancy. We aimed to evaluate the risk of adverse outcomes associated with oral retinoid exposure during pregnancy. Methods: We conducted a retrospective cohort study using the NHIS mother-child linked healthcare database in South Korea. We included all women who gave live birth from April 1, 2009 to December 31, 2020 and their children. The exposure was defined as having ≥ 1 prescription of isotretinoin, alitretinoin, and acitretin from one month before pregnancy to the delivery. The outcomes of interest were adverse child outcomes including major congenital malformations, low birth weight, and neurodevelopmental disorders (autism spectrum disorder and intellectual disorder), and adverse pregnancy outcomes including gestational diabetes mellitus, preeclampsia, and postpartum hemorrhage. Propensity score-based matching weights were used to control for various potential confounders. For congenital malformation, low birth weight, and adverse pregnancy outcomes, we calculated relative risk (RR) with 95% confidence interval (CI) using a generalized linear model and for neurodevelopmental disorders, we estimated hazard ratio (HR) with 95% CI using the Cox proportional hazard model. Results: Of 3,894,184 pregnancies, we identified 720 pregnancies (0.02%) as the oral retinoid-exposed group. The incidence of major congenital malformation was 400.6 per 10,000 births for oral retinoid-exposed group and 357.9 per 10,000 births for unexposed group and the weighted RR was 1.10 (95% CI, 0.65–1.85) in oral retinoid-exposed group compared with unexposed group. The neurodevelopmental disorder showed a potential increased risk, with the weighted HR of 1.63 (95% CI, 0.60–4.41) for autism spectrum disorder and 1.71 (95% CI, 0.60–4.93) for the intellectual disorder, although it did not reach statistical significance. For low birth weight and adverse pregnancy outcomes, no association was observed with oral retinoid exposure during pregnancy. Conclusion This study found no significantly increased risk of congenital malformations, autism spectrum disorders, and intellectual disability associated with oral retinoid exposure during pregnancy; however, given the limitations such as including only the live births and increased point estimate, potential risk cannot be fully excluded.

Background: Cancer patients have an increased risk of cardiovascular outcomes and are susceptible to coronavirus disease 2019 (COVID-19) infection. We aimed to assess the cardiovascular safety of COVID-19 vaccination for cancer patients in South Korea. Methods: We conducted a self-controlled case series study using the K-COV-N cohort (2018– 2021). Patients with cancer aged 12 years or older who experienced cardiovascular outcomes were identified. Cardiovascular outcomes were defined as myocardial infarction, stroke, venous thromboembolism (VTE), myocarditis, or pericarditis, and the risk period was 0–28 days after receiving each dose of COVID-19 vaccines. A conditional Poisson regression model was used to calculate the incidence rate ratio (IRR) with 95% confidence interval (CI). Results: Among 318,105 patients with cancer, 4,754 patients with cardiovascular outcomes were included. The overall cardiovascular risk was not increased (adjusted IRR, 0.99 [95% CI, 0.90–1.08]) during the whole risk period. The adjusted IRRs of total cardiovascular outcomes during the whole risk period according to the vaccine type were 1.07 (95% CI, 0.95–1.21) in the mRNA vaccine subgroup, 0.99 (95% CI, 0.83–1.19) in the ChAdOx1 nCoV-19 vaccine subgroup, and 0.86 (95% CI, 0.68–1.10) in the mix-matched vaccination subgroup. However, in the analysis of individual outcome, the adjusted IRR of myocarditis was increased to 11.71 (95% CI, 5.88–23.35) during the whole risk period. In contrast, no increased risk was observed for other outcomes, such as myocardial infarction, stroke, VTE, and pericarditis. Conclusion For cancer patients, COVID-19 vaccination demonstrated an overall safe profile in terms of cardiovascular outcomes. However, caution is required as an increased risk of myocarditis following COVID-19 vaccination was observed in this study.