Nicole M. Sifontis

Pregnancy outcomes in solid organ transplant recipients with exposure to mycophenolate mofetil or sirolimus

Background. Animal and limited human studies have raised concerns as to the safety of in utero exposure to mycophenolate mofetil (MMF) and sirolimus (SRL) in transplant recipients. This study examined the outcomes of pregnancies with exposure to MMF or SRL from 30 female transplant recipients (39 pregnancies) who have reported pregnancies to the National Transplantation Pregnancy Registry. Methods. Data were collected via questionnaires, phone interviews and medical records. Results. There were 18 kidney recipients reporting 26 pregnancies with exposure to MMF: 15 livebirths (LB), 11 spontaneous abortions (SA). Structural malformations were reported in four of the 15 children (26.7%) including: hypoplastic nails and shortened fifth fingers (one), microtia with cleft lip and palate (one), microtia alone (one), and neonatal death with multiple malformations (one). One kidney/pancreas (K/P) recipient reported one SA. Three liver recipients reported three pregnancies; two LB (no malformations), and one second trimester SA. Two heart recipients reported one LB (no malformations) and two SA. SRL exposures included seven recipients (four kidney, one K/P and two liver) reporting four LB (one infant whose mother was switched from MMF to SRL during late pregnancy had cleft lip and palate and microtia) and three SA. Conclusions. A higher incidence of structural malformations was seen with MMF exposures during pregnancy compared to the overall kidney transplant recipient offspring, while no structural defects have as yet been reported with early pregnancy sirolimus exposures. Centers are encouraged to report all pregnancy exposures in transplant recipients.

Update on the Teratogenicity of Maternal Mycophenolate Mofetil

Mycophenolic acid (MPA) products, namely mycophenolate mofetil and mycophenolate sodium, are immunosuppressive medications used to prevent rejection in solid organ transplant recipients and to treat various autoimmune disorders. Mycophenolate therapy is considered to be teratogenic based on observational studies of pregnancies exposed to MPA, which demonstrated an increased incidence of miscarriages in pregnancies exposed to MPA during their first trimester and a pattern of birth defects in the offspring of some pregnancies exposed to MPA. Herein, we have detailed case and series reports in a comprehensive literature review summarizing what is known to date regarding fetal exposure to MPA. Based on evidence from the literature, results of postmarketing surveillance, and information from registries such as the National Transplantation Pregnancy Registry in the United States, it is advised that pregnancy be avoided by women taking MPA. Preconception planning offers the opportunity to explore the alternatives to protect the mother, her transplanted organ, and minimize fetal risk. How to proceed in cases of unplanned pregnancies exposed to MPA in transplant recipients is a complex issue. Research involving large epidemiological studies is expected to be sparse as women heed the warnings about becoming pregnant on MPA. Published recommendations for managing MPA in women of childbearing potential include discontinuing the medication prior to conception, switching the MPA to another medication, or discontinuing the MPA when the pregnancy is discovered.

Pharmacy students' perspectives on a PharmD/MPH dual degree program at a large metropolitan school of pharmacy.

Objective To determine doctor of pharmacy (PharmD) students’ perceptions of a PharmD and master of public health (MPH) dual degree program. Methods A seven-item survey instrument was developed and distributed to students at a large metropolitan school of pharmacy during scheduled class time in April 2012. Results Among the 611 students enrolled in the PharmD program, 447 (73%) responded. Of those who responded, 72.3% were either “very likely” or “likely” to consider enrolling in such a PharmD/MPH dual degree program, and 77.4% believed that it would be attractive to future students. The most commonly identified potential limitations to pursuing the dual degree were time commitment (19.9%), increased workload and stress (11.2%), and tuition cost (10.3%). The most notable advantages documented were increased job opportunities for public health-related pharmacy positions (26.9%), increased ability to serve patients and the community (13.4%), and increased marketability for future jobs (8.7%). Conclusions PharmD student participants demonstrated overall positive attitudes and interest towards a PharmD/MPH dual degree program.

Drug–Nutrient Interactions in Transplantation

Although nutrient effects and nutritional status are specific to each type of organ transplant, there are some basic premises that apply to transplantation in general. Those guidelines can be explained in terms of the time period surrounding transplantation.