Perception of pregnant Japanese women regarding the teratogenic risk of medication exposure during pregnancy and the effect of counseling through the Japan drug information institute in pregnancy

Yakuwa, Naho; Nakajima, Ken; Koinuma, Sachi; Goto, Mikako; Suzuki, Tomo; Ito, Naoki; Watanabe, Omi; Murashima, Atsuko

doi:10.1016/j.reprotox.2018.05.009

Cited by 7 publications

(4 citation statements)

References 9 publications

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“…In addition, JDIIP provides educational lectures in response to invitations by academic associations, medical associations, and who are using drugs during pregnancy. This resulted in increased deliveries for women, who would otherwise hesitate to continue pregnancy due to excessive concern about drug risks (8).…”

Section: Education and Social Responsibility (How Does Jdiip Contribute To Society?)mentioning

confidence: 99%

The advances in dealing with the safety of medicated drugs in pregnancy

Murashima

Yakuwa²,

Koinuma³

et al. 2021

GHM

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The Japan Drug Information Institute in Pregnancy (JDIIP) was established with the aims of providing information on drug safety to women who are worried about drug use during pregnancy and creating evidence through epidemiological studies based on counseling cases. Since being established, JDIIP has made many contributions to the wellness of mothers and children by promoting the proper use of drugs during pregnancy. A network consisting of Core hospitals in 47 prefectures plays an important role in providing information for women living anywhere in Japan. Because cases of exposure to drugs whose safety we want to analyze are usually rare, networks of domestic and foreign teratology information services are necessary in order to produce high-quality evidence. JDIIP has been contributing to the education of pharmacists and doctors and to the creation of clinical practice guidelines in various medical societies by using keywords such as "pregnancy" and "medication". Future issues include creating an environment that is easily accessible for those seeking consultation, building a mechanism that makes it easy to create a basis for safety, and aiming for the continuing development of the organization.

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Section: Education and Social Responsibility (How Does Jdiip Contribute To Society?)mentioning

confidence: 99%

The advances in dealing with the safety of medicated drugs in pregnancy

Murashima

Yakuwa²,

Koinuma³

et al. 2021

GHM

Self Cite

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“…Few studies have investigated the outcomes of exposure counseling. One study found that knowledge increased and patients were able to more accurately appraise teratogenic risk after receiving exposure counseling with a TIS, and patients were more likely to continue medication after being accurately counseled on the risks (Yakuwa et al, 2018). Another study found a significant increase in knowledge about indications and prescribed medications, positive attitudes about where to seek information about medication in pregnancy, and higher rates of medication adherence in pregnancy following exposure counseling (Devkota et al, 2017).…”

Section: Introductionmentioning

confidence: 99%

Impact of perinatal exposure counseling on patient reported emotional outcomes and decisional empowerment

Müller,

Lake,

Krstić

et al. 2024

Birth Defects Research

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BackgroundExposures during pregnancy are common and most pregnant patients utilize at least one medication during pregnancy. The lack of reliable information on medication safety during pregnancy available to providers and patients is a stressor and obstacle to decision‐making about medication use in pregnancy. Previous studies showed that exposures in pregnancy are associated with guilt, worry, and decisional conflict. Although prior research has evaluated changes in patient knowledge after teratogen counseling, studies have not examined emotional outcomes or patients' decisional empowerment. This quasi‐experimental study measured changes in patients' feelings of guilt, anxiety, and decisional empowerment after receiving exposure counseling from trained teratogen information specialists.MethodsWe administered pre‐ and post‐counseling surveys to patients referred to a perinatal exposure clinic in Tampa, Florida. Validated scales were used to measure anxiety and guilt, and the ‘SURE’ measure was used to assess decisional empowerment. Paired samples t‐tests evaluated changes in anxiety and guilt and a McNemar test assessed for changes in empowered decision making.ResultsAmong the 34 participants who completed both surveys, anxiety, and guilt scores decreased significantly (p < .001). While only 21% felt informed and empowered to make a decision related to their exposure(s) before counseling, this increased to 85% (p < .001) on the post‐survey.ConclusionComprehensive counseling with a trained teratogen information specialist improves patient emotional outcomes as well as feelings of empowerment to make an informed decision regarding medication use in pregnancy. This study highlights that patient‐centered teratogen counseling goes beyond simple changes in patient knowledge.

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“…Indeed, it has been reported that providing information decreases pregnant women's perception of the risk of birth defects in her child due to medication exposure and increases her willingness to continue the pregnancy. 2 Thus, healthcare providers must accurately evaluate and provide information about the effects of medication on the fetus. 3 Although human data is required to assess the safety of medication use on the fetus, 4 human information rarely accumulates before marketing, because pregnant women are excluded from clinical trials due to ethical concerns.…”

Section: Introductionmentioning

confidence: 99%

“…Excessive concern about the effects of medication use during pregnancy on the fetus may result in unnecessary abortions, abstinence from having children, or the discontinuation of essential medicines. Indeed, it has been reported that providing information decreases pregnant women's perception of the risk of birth defects in her child due to medication exposure and increases her willingness to continue the pregnancy 2 . Thus, healthcare providers must accurately evaluate and provide information about the effects of medication on the fetus 3 .…”

Section: Introductionmentioning

confidence: 99%

Investigation on the accumulation of background and pregnancy outcome information on cases consulted by the Japan Drug Information Institute in Pregnancy

Yakuwa,

Murashima,

Miyazaki

2023

Congenital Anomalies

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Since pregnant women are excluded from clinical trials, it is essential to accumulate post‐marketing information to evaluate the effects on the fetus of medication use during pregnancy. The Japan Drug Information Institute in Pregnancy (JDIIP) was established at the National Center for Child Health and Development as a Ministry of Health, Labour, and Welfare project to provide patients with information and conduct follow‐up surveys. In this study, we investigated the status of the accumulation of JDIIP consultation cases to identify issues for enhancing clinical information appropriate for use during pregnancy and to examine how information should be collected and provided. In addition, the status of descriptions of Japanese package inserts, which are representative of those used by healthcare professionals as a source of information, was confirmed for medications used by JDIIP consultation cases. The characteristics of the JDIIP consultation cases information were that the contents that needed to be adjusted when evaluating the effects on the fetus of medication use during pregnancy were obtained. In addition, the follow‐up rate was 83.1%. However, although the number of consultation facilities has increased, the number of consultations has not, indicating the need to further increase the number. It was found that there is limited information on epidemiological studies of clinical use in Japanese package inserts. To improve clinical information on the appropriate use of medications during pregnancy, it is necessary to accumulate more information in the future, and it is considered necessary to consider new approaches utilizing the JDIIP system.

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Perception of pregnant Japanese women regarding the teratogenic risk of medication exposure during pregnancy and the effect of counseling through the Japan drug information institute in pregnancy

Cited by 7 publications

References 9 publications

The advances in dealing with the safety of medicated drugs in pregnancy

The advances in dealing with the safety of medicated drugs in pregnancy

Impact of perinatal exposure counseling on patient reported emotional outcomes and decisional empowerment

Investigation on the accumulation of background and pregnancy outcome information on cases consulted by the Japan Drug Information Institute in Pregnancy

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