Identification of off-Label Indications Drug for Pregnant Women in A Public Hospital in Yogyakarta Indonesia

BackgroundThe medicine of pregnant women practices to a targeted personalized approach, tailored to the specific characteristics and needs the implications of interdisciplinary work between healthcare stakeholders. Perinatal pharmacology comprises the impact of substances (drugs, medications and others) in pregnant women, nursing mothers, the unborn child, the premature, the newborn baby and the breastfed baby. Most of the drugs are off-label used. In this field grand challenge for Frontiers in Medicine emphasizes the importance of translational medicine.AimThe primary goal of SAPP has always been and remains the same: it is the link between medicine and pharmacy, between practice, clinic, research and health authorities, in order to increase the safety of medicines in the population of pregnant and breastfeeding women and their newborns.1MethodsOn December 6, 2007, an interdisciplinary team of 8 physicians and pharmacists founded the Swiss Association of Perinatal Pharmacology, SAPP. It collects and promotes new findings in the field of perinatal pharmacology.ResultsSpecialists from all areas of perinatal pharmacology work together in a scientific committee to develop and update evidence-based principles for work in everyday clinical practice (hospitals, doctor´s surgeries, pharmacies). Today, around 200 members benefit from this, who can orient themselves in regular further training courses and basic documents (monographs of active substances, therapy recommendations based on original literature). The SAPP thus closes the gap resulting from the predominant off-label use and the resulting lack of information on drugs in this population.ConclusionThe primary objective of SAPP has been achieved - it provides guidance for the practioners in the broad field of perinatal pharmacology and bridges the gap caused by the lack of drug approvals in this population. Long-term survival will be ensured by measures anchored in law.Referencewww.sappinfo.chDisclosure(s)Nothing to disclose

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Maternal, fetal, and neonatal pharmacokinetics

10.1093/med/9780198713333.003.0005 ◽

2016 ◽

Author(s):

Karel Allegaert ◽

Kristel Van Calsteren

Keyword(s):

Medical Treatment ◽

Pregnant Women ◽

Postpartum Period ◽

Drug Transport ◽

Scientific Evidence ◽

Healthcare Providers ◽

Off Label ◽

Dosing Regimens ◽

Peripartum Period ◽

Instructions For Use

Most drugs are not thoroughly evaluated for use during pregnancy, delivery, or postpartum (e.g. breastfeeding). The same holds true for early infancy, and results in extensive off-label, unlicensed pharmacotherapy in these specific subpopulations. At present, most drug labels do not contain any instructions for use during pregnancy, in infancy, or during breastfeeding, yet these are the main concerns of healthcare providers considering medical treatment. Anaesthetists commonly treat pregnant women with similar dosing regimens recommended for use in adults and subsequently titrate to effect. The (dis)continuation of breastfeeding in the postpartum period following anaesthesia is commonly based on opinions instead of scientific evidence. This chapter describes the alterations in pharmacokinetics (absorption, distribution, metabolism, elimination) in pregnant women with specific emphasis on placental drug transport, and in neonates, with additional emphasis on breastfeeding. Drugs commonly administered by anaesthetists to women in the peripartum period are discussed with particular reference to the changed pharmacodynamics in both mother and infant.

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Facts about Magnesium Sulfate: Time to Revise the Safety Concern in Obstetric Use

Journal of Enam Medical College ◽

10.3329/jemc.v4i3.20957 ◽

2014 ◽

Vol 4 (3) ◽

pp. 177-183

Author(s):

Zaida Rahman ◽

Asadul Mazid Helali

Keyword(s):

Pregnant Women ◽

Magnesium Sulfate ◽

Preterm Labor ◽

Safety Concern ◽

Safety Information ◽

Harmful Effect ◽

The United States ◽

Off Label Use ◽

Off Label ◽

Label Use

Magnesium sulfate (MgSO4) is the agent most commonly used for treatment of eclampsia and prevention of eclampsia in patients with severe pre-eclampsia. Another commonly practiced offlabel use of this drug is in preventing preterm labor in pregnant women where the duration of the treatment might be more than one week. It is usually given either by intramuscular or intravenous route. After administration, about 40% of plasma magnesium is bound with protein. The unbound magnesium ion diffuses into the extravascular extracellular space and then diffuses into bone. It also crosses the placenta and fetal membranes and then diffuses into the fetus and amniotic fluid. Magnesium is almost exclusively excreted in the urine; 90% of the dose is excreted during the first 24 hours after an intravenous infusion of MgSO4. The clinical effect and toxicity of MgSO4 can be linked to its concentration in plasma. A concentration of 1.83.0 mmol/L has been suggested for treatment of eclampsia. The actual magnesium dose and concentration needed for prophylaxis have never been estimated. Maternal toxicity is rare when MgSO4 is carefully administered and monitored. Deep tendon reflexes, respiratory rate, urine output and serum concentrations are the most common variables for monitoring the toxic effect. Currently the United States (US) Food and Drug Administration (FDA) is advising health care professionals against using MgSO4 injection for more than 57 days to stop preterm labor in pregnant women (off-label use). Administration of MgSO4 injection to pregnant women for more than 57 days may lead to low calcium levels and bone problems in the fetus, including osteopenia and fractures. The harmful effect in the fetus with the shortest duration is not established. In light of this new safety information, the drug label for MgSO4 injection, USP 50% has also been changed, including changing the pregnancy category to D from A and denoting the effect as New teratogenic effects. Similarly, the manufacturers of other MgSO4 injection products have made similar changes to their drug labels. In this review, the currently available knowledge of the pharmacokinetics of MgSO4 and its clinical usage for women with pre-eclampsia and eclampsia, its off-label use and safety concern regarding the warning announced by the FDA will be outlined. DOI: http://dx.doi.org/10.3329/jemc.v4i3.20957 J Enam Med Col 2014; 4(3): 177-183

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'He moved then?’: The management of worry-indicative information requests in moderate and high-risk fetal ultrasounds

Calidoscópio ◽

10.4013/cld.2021.192.02 ◽

2021 ◽

Vol 19 (2) ◽

pp. 174-192

Author(s):

Minéia Frezza ◽

Ana Cristina Ostermann

Keyword(s):

Phase Transition ◽

High Risk ◽

Pregnant Women ◽

Conversation Analysis ◽

Health Professionals ◽

Public Hospital ◽

Fetal Ultrasound ◽

Risk Pregnancy ◽

Information Requests ◽

Specific Phase

The present study analyzes video-recorded fetal ultrasound scans held in a moderate and high-risk pregnancy ward at a Brazilian public hospital. Informed by Multimodal Conversation Analysis (Mondada, 2018), it investigates the ethnomethods participants employ to manage worry-indicative concerns whose presentation is initiated by pregnant women in a medical exam that does not typically comprise a specific phase for that (Nishizaka, 2010, 2011b, 2014). The analysis shows that pregnant women orient to three environments to request worry-indicative information: (i) topic, (ii) image, (iii) phase transition, tailoring the design of their requests to each particular environment. The findings reveal that pregnant women are highly agentive in finding optimal opportunities to raise their concerns and to mobilize health professionals to respond to them. The physicians performing the scans respond to those requests while dealing with the contingencies inherent to the context of fetal ultrasounds and that have implications in attending to the requests. The results unveil the interplay between the pregnant women’s ethnomethods of raising concerns where ‘normality’ is constantly at stake and the health professionals’ ethnomethods in attending to those demands while orchestrating the distinct semiotic resources involved in the multiactivity setting of ultrasound scans.

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Hubungan Antropometri Ibu Hamil (Berat Badan, Lingkar Atas, Tinggi Fundus Uteri) dengan Reflek Fisiologi Bayi Baru Lahir Normal

AcTion Aceh Nutrition Journal ◽

10.30867/action.v1i2.16 ◽

2016 ◽

Vol 1 (2) ◽

pp. 88

Author(s):

Halimatussakdiah Halimatussakdiah ◽

Ampera Miko

Keyword(s):

Body Weight ◽

Pregnant Women ◽

Public Hospital ◽

Delivery Room ◽

P Value ◽

Upper Arm ◽

Cross Sectional ◽

Arm Circumference ◽

Mid Upper Arm Circumference ◽

Banda Aceh

Maternal Mortality is mostly caused by bleeding (32 %), hypertension during pregnancy (25 %). Infection (5 %), long parturition 5 %), and chronic energy deficiency (27.66 %). The objective of this research was to find out of correlation Between Maternal Anthropometry (Body Weight, Mid Upper Arm Circumference, Fundal Height) And Reflex physiology Of Normal Newborn Babies In delivery room of Regional Public Hospital Of Meuraxa Banda Aceh. The research was conducted from September 4 to September 22, 2016. The descriptive correlation design with cross sectional study approach was used in this research. There were thirty research sample that were chosen by using accidental sampling method. The result of this research indicated that were was no correlation between body Weight of pregnant woman with reflex physiology of their normal Newborn Babies In Delivery Room Of Regional Public Hospital of Meuraxa Banda Aceh (p Value 0.174). There was a correlation Between Mid Upper Arm Circumference (MUAC) of pregnant women with reflex physiology of their normal Newborn Babies (p Value 0.020). There was also a correlation between fundal height with reflex physiology of their normal Newborn Babies (p Value 0.000). Based on those result, it is suggest that the pregnant women should pay nurse attention to their health by doing regular check -ups during pregnancy in order to prevent any complication. It is also suggested that the health worker keep enhancing the medical service, such us the measurement of body weight, MUAC and fundal height. Keywords: Anthropometry, reflex physiology, normal newborn babies

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P3.043 Preterm Birth and Fetal Growth Restriction in HIV-Infected Pregnant Women at a Tertiary Public Hospital in Vitória, Brazil

Sexually Transmitted Infections ◽

10.1136/sextrans-2013-051184.0503 ◽

2013 ◽

Vol 89 (Suppl 1) ◽

pp. A161.3-A161

Author(s):

H B dos Reis ◽

K S Araujo ◽

L Ribeiro ◽

D R Rocha ◽

D P Rosato ◽

...

Keyword(s):

Preterm Birth ◽

Pregnant Women ◽

Fetal Growth ◽

Fetal Growth Restriction ◽

Public Hospital ◽

Growth Restriction

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Self-managed abortion in urban Haiti: a mixed-methods study

BMJ Sexual & Reproductive Health ◽

10.1136/bmjsrh-2017-200009 ◽

2018 ◽

Vol 44 (3) ◽

pp. 193-199 ◽

Cited By ~ 1

Author(s):

Erin Nicole Berry-Bibee ◽

Clotilde Josamine St Jean ◽

Nathan M Nickerson ◽

Lisa B Haddad ◽

Manuchca Marc Alcime ◽

...

Keyword(s):

Focus Groups ◽

Pregnant Women ◽

Public Hospital ◽

Perceived Barriers ◽

Health Providers ◽

Access Methods ◽

Illegal Abortion ◽

Abortion Access ◽

Few Data ◽

Induce Abortion

ObjectiveAlthough illegal abortion is believed to be widely practised in Haiti, few data exist on such practices. We aimed to learn about illegal abortion access, methods, and perceived barriers to abortion-related care. Additionally, we aimed to identify the proportion of unscheduled antepartum visits to a public hospital that were attributable to unsafe abortion in Cap Haitien, Haiti.Study designWe conducted eight focus groups with women (n=62) and 13 interviews with women’s health providers and subsequently administered a survey to pregnant or recently pregnant women (20 weeks of gestation or less) presenting to the hospital from May 2013 to January 2014 (n=255).ResultsAmong the focus groups, there was widespread knowledge of misoprostol self-managed abortion. Women described use of multiple agents in combination with misoprostol. Men played key roles in abortion decision-making and in accessing misoprostol.Among the 255 pregnant or recently pregnant women surveyed, 61.2% (n=150) reported the current pregnancy was unintended and 30% (n=78) reported attempting an induced abortion. The majority of women used misoprostol either alone or as a part of the medication/herb regimen for their self-managed abortion (85.1%, n=63).ConclusionsAwareness of methods to induce abortion is high among women in urban Haiti and appears widely practised; yet knowledge of the safest self-managed abortion options remains incomplete. Access to safer abortion services could improve maternal health in Haiti.

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