Off-Label Use of Ondansetron in Pregnancy in Western Australia

Abstract

Aims. Nausea and vomiting of pregnancy is the most common medical condition in pregnancy. There is an increasing trend to prescribe ondansetron although its safety for use in pregnancy has not been established. Methods. Exposed pregnancies were all births in Western Australia, 2002–2005, where the mother was dispensed ondansetron under the Australian Pharmaceutical Benefits Scheme, compared with all other births during the same period. Outcomes investigated include maternal and child characteristics, birth defects, pregnancy, and delivery characteristics. Results. There were 96,968 births from 2002 to 2005. Ondansetron was dispensed to 251 pregnant women during this period. The women dispensed ondansetron were more likely to be privately insured (OR: 5.8; 95% CI: 4.3–7.9), to be Caucasian (3.3; 1.9–5.7), not to smoke during their pregnancy (2.9; 1.8–4.7), to have a multiple birth (2.7; 1.5–5.0), and to have used fertility treatment (1.8; 1.0–3.4). There was a small but not significantly increased risk of a major birth defect with first trimester exposure (1.2; 0.6–2.2). Conclusions. Our study did not detect any adverse outcomes from the use of ondansetron in pregnancy but could not conclude that ondansetron is safe to use in pregnancy.

Assessment of discharge treatment prescribed to women admitted to hospital for hyperemesis gravidarum

“…An Australian study reported that serotonin antagonists were more likely prescribed to non‐smoking women in agreement with our results . The same study also found they were used more for women in higher socioeconomic groups and Caucasian women, in contrast to our study . To the best of our knowledge, no study to date has assessed whether hospital prescribing for HG is compliant with national or local guidelines in England.…”

“…23 The same study also found they were used more for women in higher socioeconomic groups and Caucasian women, in contrast to our study. 32 To the best of our knowledge, no study to date has assessed whether hospital prescribing for HG is compliant with national or local guidelines in England.…”

Studies using Australia's Pharmaceutical Benefits Scheme data for pharmacoepidemiological research: a systematic review of the published literature (1987-2013)

“…1 The post-market setting provides the only opportunity to understand the benefits and risks of drug use in these populations. Compared to the elderly (represented primarily by DVA clients), we know little about medicines use in children [35][36][37][38] and pregnant women [39][40][41][42][43][44] and found no studies examining the outcomes of medicines use in Australian children. The studies of drug use and outcomes in pregnant women highlight Australia's capacity for pharmacoepidemiological research using linked routinely collected data in populations other than the elderly.…”

“…The studies of drug use and outcomes in pregnant women highlight Australia's capacity for pharmacoepidemiological research using linked routinely collected data in populations other than the elderly. [39][40][41][42][43][44][45] Australia is in a powerful position to conduct wholeof-population pharmacoepidemiological research due to its universal drug coverage for 23 million citizens and the more than 200 million prescriptions generated each year. 8 The significant investment in data linkage infrastructure through the Population Health Research Network has supported Australian states and territories to build a network enabling health data collected around the nation for health-related research purposes; 28 the recent establishment of Data Integrating Authorities will support the integration of Commonwealth data with state-based collections.…”

Quality use of an unlicensed medicine and off label use of a medicine

“…In fact, an UL and OL use of licensed medicines is not illegal and the outcomes should not be underestimated particularly when all other options of licensed medicines are unavailable, exhausted, not tolerated, ineffective or unsuitable for patient's healthcare needs. For these underlying reasons, in some instances an UL and OL medicine application may be the only choice or the best available access to therapy for vulnerable population such as obstetric (Colvin et al, 2013) pediatric ('tJong et al, 2001;Bavdekar and Gogtay, 2005;Bellis, et al, 2013;Silva et al, 2014), oncologic (Pool and Dooley, 2004;Soares, 2005), geriatric (Dautzenberg et al, 2009) and psychiatric (Chouinard, 2006;Hall et al, 2001) patients as well as patient on palliative care or with terminal disease condition (Pavis and Wilcock, 2001;Culshaw et al, 2013;). Indeed, OL prescribing is also common for so-called therapeutic orphan populations and/or rare diseases treatments and special condition (Hampton, 2007;Conroy et al 2000;Shah et al, 2007).…”