Drugs and pregnancy. Maternal drug handling. Fetal drug exposure

Author(s):  
P. Defoort
2019 ◽  
Vol 25 (5) ◽  
pp. 496-504 ◽  
Author(s):  
Naïm Bouazza ◽  
Frantz Foissac ◽  
Déborah Hirt ◽  
Saïk Urien ◽  
Sihem Benaboud ◽  
...  

Background: Drug prescriptions are usual during pregnancy, however, women and their fetuses still remain an orphan population with regard to drugs efficacy and safety. Most xenobiotics diffuse through the placenta and some of them can alter fetus development resulting in structural abnormalities, growth or functional deficiencies. Methods: To summarize the different methodologies developed towards the prediction of fetal drug exposure. Results: Neonatal cord blood concentration is the most specific measurement of the transplacental drug transfer at the end of pregnancy. Using the cord blood and mother drug concentrations altogether, drug exchanges between the mother and fetus can be modeled and quantified via a population pharmacokinetic analysis. Thereafter, it is possible to estimate the fetus exposure and the fetus-to-mother exposure ratio. However, the prediction of placental transfer before any administration to pregnant women is desirable. Animal studies remain difficult to interpret due to structural and functional inter-species placenta differences. The ex-vivo perfusion of the human placental cotyledon is the method of reference to study the human placental transfer of drugs because it is thought to mimic the functional placental tissue. However, extrapolation of data to in vivo situation remains difficult. Some research groups have extensively worked on physiologically based models (PBPK) to predict fetal drug exposure and showed very encouraging results. Conclusion: PBPK models appeared to be a very promising tool in order to predict fetal drug exposure in-silico. However, these models mainly picture the end of pregnancy and knowledge regarding both, development of the placental permeability and transporters is strongly needed.


The Placenta ◽  
2011 ◽  
pp. 303-309
Author(s):  
Tatiana N. Nanovskaya ◽  
Gary D. V. Hankins ◽  
Mahmoud S. Ahmed

1990 ◽  
Vol 4 (4) ◽  
pp. 315-320
Author(s):  
Don C. Van Dyke ◽  
Lee Ann Grisolano ◽  
James Hulbert

Author(s):  
Carolyn E Wrzesniewski ◽  
Helen K Park

Abstract Disclaimer In an effort to expedite the publication of articles, AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. Purpose Producing compounded sterile preparations (CSP) of the highest quality and ensuring safe hazardous drug handling are well-established priorities for pharmacy departments. Maintaining compliance with United States Pharmacopeia general chapters 797 and 800 (USP <797> and <800>) must also be a priority for health-system leadership. This report describes how a pharmacy-driven multidisciplinary committee was created to provide USP <797> and <800> oversight within a multicampus Veterans Affairs health system and the facility and safety outcomes achieved. Summary The Veterans Health Administration required facilities to establish an oversight committee to ensure USP-compliant CSP procedures and the safe handling of hazardous drugs in all aspects of the medication-use process. Spearheaded by the pharmacy department, the VA Palo Alto Health Care System (VAPAHCS) chartered the CSP Advisory Committee to achieve this goal. The membership was composed of department heads in the areas of pharmacy, nursing, environmental management services, engineering, facility planning, safety, industrial hygiene, employee health, supply chain services, infection control, and quality management and the health system’s director’s office. The medication safety officer served as the executive secretary for the advisory committee and was responsible for agenda development, minutes, and coordinating timely follow-ups on action items; the VAPAHCS deputy director served as chair. Monthly meetings were conducted to receive updates on targeted sterile compounding and hazardous drug handling objectives: environmental controls and monitoring, compliance with regulatory requirements, staff competency, hazardous drug exposure event analyses, and development of well-defined health-system policy to guide practice. Conclusion Taking a multidisciplinary approach to USP <797> and <800> compliance facilitated communications, created engagement, and ensured completion of action plans.


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