scholarly journals The Importance of Clinical Research in Pregnant Women to Inform Prescription Drug Labeling

2020 ◽  
Vol 60 (S2) ◽  
Author(s):  
Miriam Dinatale ◽  
Catherine Roca ◽  
Leyla Sahin ◽  
Tamara Johnson ◽  
Lily Yeruk Mulugeta ◽  
...  
Keyword(s):  
Clinical Research ◽  
Pregnant Women ◽  
Prescription Drug ◽  
Drug Labeling

Therapeutic Orphans

2019 ◽  
Vol 19 (1) ◽  
pp. 27-35
Author(s):  
Jennifer E. Miller ◽  
Marie-Catherine Letendre ◽  
Keyword(s):  
Public Health ◽  
Clinical Research ◽  
Pregnant Women ◽  
Insufficient Evidence ◽  
Health Concerns ◽  
Drug Labeling ◽  
Prescribed Medicines

Children and pregnant women are often excluded from clinical research. This has resulted in a paucity of evidence on how medicines work for fetuses, neonates, infants, and adolescents. It also raises bioethics, scientific, and public health concerns. For over half a century, doctors have prescribed medicines to children largely on the basis of how they work in adults, despite children’s varied physiologies and differences in how their bodies absorb and metabolize drugs. Regulations and legislation have led to an increase in the number of pediatric studies and to better drug labeling. However, children at all stages of their lives often remain “therapeutic orphans” owing to insufficient evidence about how medicines work for them.

Discrepancies in the Evidence and Recommendation Levels of Pregnancy Information in Prescription Drug Labeling in the United States, United Kingdom, Japan, and Korea

2018 ◽  
Vol 27 (9) ◽  
pp. 1086-1092 ◽  
Author(s):  
Yunha Noh ◽  
Dongwon Yoon ◽  
Inmyung Song ◽  
Han Eol Jeong ◽  
Ji Hwan Bae ◽  
...  
Keyword(s):  
United States ◽  
United Kingdom ◽  
Prescription Drug ◽  
The United States ◽  
Drug Labeling

Problems of Prescription Drug Labeling: On Conditions for Approval

2012 ◽  
Vol 43 (6) ◽  
pp. 381-386
Author(s):  
Chikako KUROSAWA ◽  
Chika UCHIYAMA ◽  
Tomoya SAKURADA ◽  
Eriko KOBAYASHI ◽  
Nobunori SATOH
Keyword(s):  
Prescription Drug ◽  
Drug Labeling

scholarly journals Study on Nutritional Supplements for Females in Dhaka City, Bangladesh

2020 ◽  
Vol 23 (1) ◽  
pp. 39-43
Author(s):  
Sadia Zahin Tasfia ◽  
Md Alamgir Kabir ◽  
Muhammad Rashedul Islam ◽  
Md Elias Al Mamun
Keyword(s):  
Pregnant Women ◽  
Prescription Drug ◽  
Daily Intake ◽  
Nutritional Supplements ◽  
Pharmaceutical Journal ◽  
Dhaka City ◽  
Iron Supplement ◽  
Female Population ◽  
Zinc Supplement ◽  
Face To Face

Physiological problems due to deficiency of minerals and vitamins level in Bangladeshi female population are on the rise. The primary goal of this study was to find out the intake of nutritional supplements among urban female population. A survey on nutritional supplements was designed for females in some selected area of Dhaka city. One hundred fifty females were recruited, segmented under two sections (non-pregnant / pregnant) and most of them were interviewed face-to-face systematically. 10.7% of the sample was pregnant women and the rest (89.3%) was the non-pregnant category. Participants were asked questions about their prescription drug patterns and intake of nutritional supplements. The study revealed that 53.0% of the female patients were not aware of the value of daily intake of nutritional foods. So, we also found that nutritional supplements were given to the patients continuously (34.48%), occasionally (18.39%) and at first (28.74%). Calcium supplement (36.90%), zinc supplement (14.10 %) and iron supplement (19.90 %) were prescribed most. Bangladesh Pharmaceutical Journal 23(1): 39-43, 2020

Clinical Research With Pregnant Women: Perspectives of Pregnant Women, Health Care Providers, and Researchers

2018 ◽  
Vol 28 (13) ◽  
pp. 2033-2047 ◽  
Author(s):  
Kyoko Wada ◽  
Marilyn K. Evans ◽  
Barbra de Vrijer ◽  
Jeff Nisker
Keyword(s):  
Health Care ◽  
Prenatal Care ◽  
Clinical Research ◽  
Pregnant Women ◽  
Health Care Providers ◽  
Research Participation ◽  
Well Being ◽  
Constructivist Grounded Theory ◽  
Care Providers ◽  
Women Health

Limited clinical research with pregnant women has resulted in insufficient data to promote evidence-informed prenatal care. Charmaz’s constructivist grounded theory methodology was used to explore how research with pregnant women would be determined ethically acceptable from the perspectives of pregnant women, health care providers, and researchers in reproductive sciences. Semistructured interviews were conducted with a purposive sample of 12 pregnant women, 10 health care providers, and nine reproductive science researchers. All three groups suggested the importance of informed consent and that permissible risk would be very limited and complex, being dependent on the personal benefits and risks of each particular study. Pregnant women, clinicians, and researchers shared concerns about the well-being of the woman and her fetus, and expressed a dilemma between promoting research for evidence-informed prenatal care while securing the safety in the course of research participation.

scholarly journals Reporting of Drug Benefit in FDA-Approved Prescription Drug Labeling

2019 ◽  
Vol 35 (1) ◽  
pp. 377-379
Author(s):  
Bansri Desai ◽  
Kyungwan Hong ◽  
John H. Powers ◽  
Peter Doshi
Keyword(s):  
Prescription Drug ◽  
Drug Benefit ◽  
Drug Labeling

International Prescription Drug Labeling

1983 ◽  
Vol 17 (4) ◽  
pp. 239-243
Author(s):  
P. J. Roylance ◽  
W. A. Buri
Keyword(s):  
Prescription Drug ◽  
Drug Labeling
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