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Mifepristone in south australia – the first 1343 tabletsprofessional
The first 1343 tablets
completed the steps required to obtain a licence Background
to market mifepristone in Australia. One avenue for medical practitioners to access Mifepristone has recently become available in Australia but its use is restricted.
an unlicensed drug is to gain the support of a Human Research Ethics Committee (constituted Objective
according to National Health and Medical To describe the use of mifepristone in South Australia in the period Research Council guidelines) and then to apply to 2009–2010 and to explore options that may become available to the TGA under the Authorised Prescriber scheme.4 A group of South Australian medical practitioners Discussion
sought authorisation to prescribe mifepristone for induction of first and second trimester medical Mifepristone has been added to regimens for early and second abortion and for cervical priming before first and trimester abortions – both medical and surgical abortions. It has been second trimester surgical abortion. Approval was most commonly used in early medical abortions. In this audit the granted in 2008 and supplies arrived in February complication rates of early medical abortion with mifepristone compared favourably to early surgical abortion. There are implications in service 2009. Details of regimens for mifepristone use in delivery of early medical abortion compared to early surgical abortion.
South Australia are shown in Table 1. Since then, mifepristone has been gradually introduced into Keywords: abortion, induced; mifepristone; misoprostol
The progesterone antagonist mifepristone Outcomes following medical and surgical abortions in five metropolitan public clinics and medical abortions conducted in two obstetric units were has expired. After extensive use in many reviewed following approval from three Human countries, including France (since 1988), Research Ethics Committees. Data sets comprised all women who had medical or surgical abortions (since 1991), the United States of America up to 9 weeks gestation in the largest clinic and all those who had first trimester medical or surgical 2001), there is now ample evidence of its abortions in four smaller clinics during the period safety and efficacy in inducing abortion.1 1 January 2009 to 31 December 2010. In addition, the records of all women who were prescribed mifepristone for second trimester medical abortion cervical ripening before surgical abortion, or cervical priming before second trimester surgical abortion in the same period were reviewed. regulation, postcoital contraception and Outcome data was gathered by interrogation of an electronic clinical data repository (OACIS) containing records generated by the The arrival of mifepristone in Australia was eight metropolitan public hospitals. Where an controversial.3 Use is regulated by the Therapeutic encounter with the public health system within Goods Administration (TGA), however it remains 28 days of abortion was recorded, the diagnosis, an unlicensed drug as no company has yet pathology and radiology reports and discharge 342 Reprinted from AUSTRAlIAN FAMIly PHySICIAN VOl. 40, NO. 5, MAy 2011
Mifepristone in South Australia – the first 869 tablets professional
summary were reviewed. In addition, paper bleeding and/or pelvic pain; 1 in 100 was admitted priming agent, 321 were also treated with records were reviewed in every case where for treatment of an abortion related problem (most mifepristone preoperatively. In the following 28 often retained products of conception) and some of days, five of these women (1.6%) presented to Nine hundred and forty-seven mifepristone these were treated with D&C surgery.
emergency departments with gynaecological tablets were prescribed for early medical abortion, The likelihood of being admitted for treatment symptoms. One was admitted for treatment of a 321 for preoperative preparation before early of complications and of having D&C surgery to surgical abortion (dilation and curettage of remove retained products of conception were uterus [D&C]), 49 for second trimester medical both significantly (p<0.001) higher following early mifepristone in addition to misoprostol and/or abortion and 26 for preoperative preparation medical abortion than they were following early osmotic dilation before second trimester surgical before second trimester surgical abortion (dilation abortion (D&E). There were four (15%) cervical and evacuation [D&E]) procedures in the first 24 Complications following first
Experience and complications
of second trimester medical
Table 3 shows the serious complications following abortion
There were 5823 early surgical and 947 early first trimester abortion including surgical injury, medical abortions conducted in the five centres significant blood loss (>1000 ml with or without Mifepristone was given before misoprostol for in 24 months. In addition, there were 26 second transfusion), treatment failure (continuing second trimester medical abortion in 49 cases. trimester surgical abortions using mifepristone pregnancy after abortion) and systemic sepsis (with The delay from induction to delivery varied from and 49 second trimester medical abortions admission for intravenous antibiotic treatment). 3 hours to over 55 hours. The mean time from These were all rare events within 28 days of first misoprostol (or other oxytocic) administration to trimester medical or surgical abortions. delivery was 17 hours and the median was 10 Adverse outcomes following first
Cervical preparation with
Two cases progressed to surgical D&E, one mifepristone before surgical
Table 2 shows the complications in the 28 days due to failure of the cervix to dilate and one abortion
following first trimester abortion. More than 1 in due to maternal distress. Ten cases required 50 women presented to an emergency department Among 5823 women who had first trimester manual removal of the placenta and prophylactic with gynaecological symptoms, most often surgical abortions with misoprostol as a cervical antibiotics. There were two postpartum haemorrhages. One required transfusion and Table 1. Regimens for mifepristone use
overnight intensive care admission. One woman had high vaginal culture which was positive for Early medical abortion up to 63 days gestation
Streptococcus pneumoniae, and was treated with Mifepristone 200 mg oral followed by misoprostol 800 µg per vagina, sublingual or buccal after intravenous and subsequently oral antibiotics. 0–72 hours. Further doses 200 µg misoprostol per vagina, sublingual or buccal three times per day on subsequent 2 days if cramping or heavy bleeding persist This was the only objectively proven infection in the series. Five others presented with symptoms Second trimester medical abortion
of retained products of conception. Four of Mifepristone 200 mg oral followed by admission for induction of labour 0–72 hours later with 800 µg misoprostol per vagina and up to four further doses of 400 µg every 3 hours these were treated surgically (D&C). These complications are shown in Table 4.
Cervical priming before surgical abortion
Mifepristone 200 mg oral, hours or days before admission for surgery Discussion
The rate of any adverse outcome following early
Table 2. Common complications of first trimester abortion
abortion is low. large numbers are required to Type of abortion
demonstrate any difference in the frequency department
of these infrequent events between different presentation
treatment groups. This audit only captured care provided in public hospitals and not complications treated by general practitioners. The power of this audit was not sufficient to demonstrate any significant advantage in adding preoperative mifepristone to standard cervical priming with misoprostol before early surgical abortion and little can be made of the likelihood of the most Reprinted from AUSTRAlIAN FAMIly PHySICIAN VOl. 40, NO. 5, MAy 2011 343
professional Mifepristone in South Australia – the first 869 tablets
other centres and are comparable to medical Table 3. Serious complications of first trimester abortion
terminations using only misoprostol.9 In addition, Type of abortion
mifepristone administered 24–48 hours before >1000 mL
misoprostol is known to reduce the rate of failed medical abortion,10 while use of a shorter interval between mifepristone and misoprostol doses may reduce time to delivery, as can other factors such as parity and lesser gestation.9 While the unplanned intervention rate in South Australia parallels other Australasian findings, the series was too small to be able to draw conclusions, in particular when commenting on induction times, Table 4. Complications of second trimester medical abortion
Adjustments on existing abortion
Adopting mifepristone has various impacts on • dilation and curettage for retained products of conception existing abortion services. Women are encouraged to present early for early medical abortion. • failed induction requiring dilation and evacuation They may present very early, with a pregnancy of unknown location. Transvaginal ultrasound and serial beta human chorionic gonadotrophin estimations are employed more frequently in clinics offering this option, as clinicians seek to Women selecting early medical abortion are Significant haemorrhage >1000 mL +/– transfusion expected to manage pain, bleeding and nausea serious adverse outcomes of early abortion except frequent than with first trimester abortion. at home with the support of another adult. More Cervical tears were prominent among later time is required to prepare these women, and to Comparison between the outcomes of early surgical abortions conducted with mifepristone as engage them in the care process than is the case medical and surgical abortion has been made, a cervical priming agent, while placental retention before surgical abortion; longer appointments are however, the groups differ in that early medical requiring manual removal was particular to later abortion was only offered to women at less than As women (and referring GPs) become more 9 weeks gestation while women who had surgery Following midtrimester medical abortion, familiar with early medical abortion, the number included those with gestation up to 12 weeks. of women selecting this option has risen from 276 Women self selected medical abortion and factors subsequent admission were frequent. Manual in 2009 to 539 in 2010. Doctors spend more time such as previous obstetric experience are probably removal of placenta and the high rate of talking to patients in the clinic and less time in associated with willingness to undertake this unplanned surgical intervention (rate of 32%) the operating theatre as more medical and fewer procedure. Despite these confounding factors, in these cases imposes additional costs as the findings that women were more likely to be well as placing demand on operating theatre admitted and to have D&C surgery after early resources. However, medical termination for mifepristone occasionally results in abortion while medical abortion than they were after early fetal abnormality may enable fetal examination awaiting surgery. While this is a safe outcome, surgical abortion are consistent with the results which could convey valuable information for it can cause anxiety. Surgery may need to be reported in one much larger5 and one more tightly ongoing care and counselling that primary surgical termination may not.8 The significant maternal Australian GPs and
Relatively few abortions are conducted in the and fetal risks of continuing a pregnancy where early medical abortion
second trimester. In South Australia only 7% of genetic termination is offered must be weighed abortions are performed after 14 weeks and less against the complications of termination.
Medical practitioners willing to undertake the than 2% after 20 weeks gestation.7 With small process required to gain access to mifepristone cohorts, it was difficult to assess the significance intervention in the South Australian cohort are have been obstetricians in tertiary referral of complication rates. Complications were more high, they are similar to the rates described in centres and GPs providing abortion in specialised 344 Reprinted from AUSTRAlIAN FAMIly PHySICIAN VOl. 40, NO. 5, MAy 2011
Mifepristone in South Australia – the first 869 tablets professional
clinics. General practitioners and specialists in private practice may have been precluded from Ashok P, Wagaarachchi P, Templeton A. The antiprogestogen mifepristone: a review. Curr using mifepristone by lack of access to an ethics committee or they may have been dissuaded by Petersen K. Early medical abortion: legal and medical developments in Australia. Med J Aust mifepristone in Australia, prescribing will da Costa C. Medical abortion for Australian women: it’s time. Med J Aust 2005;183:378–80.
become less difficult. General practitioners Niinimaki M, Pouta A, Bloigu A, et al. Immediate will continue to be restrained from providing complications after medical compared with surgi- early medical abortion in jurisdictions where cal termination of pregnancy. Obstet Gynecol legislation requires abortion to be provided in Kulier R, Gülmezoglu AM, Hofmeyr GJ, et al. hospitals (Northern Territory, South Australia Medical methods of first trimester abortion. Cochrane Database Syst Rev 2004;2:CD002855.
and the Australian Capital Territory). If access Chan A, Scott J, Nguyen A-M, et al. Pregnancy to mifepristone becomes more straightforward, outcome in South Australia 2008. Adelaide: GPs in Victoria, Queensland, New South Wales, Pregnancy Outcome Unit, SA Health, Government of South Australia, 2009. Available at www.
Western Australia and Tasmania will be able to health.sa.gov.au/pehs/publications/pregnancyout- consider providing early medical abortion. General come-operations-sahaelth-2008.pdf [Accessed 2 practitioners who already diagnose pregnancies Boyd P, Tondi F, Hicks N, et al. Autopsy after ter- mination for fetal anomaly: retrospective cohort pregnancy may then wish to include early medical abortion among the services they provide.
Dickinson JE, Brownell P, McGinnis K, et al. Mifepristone and second trimester pregnancy Important points
termination for fetal abnormality in Western Australia: worth the effort. Aust N Z J Obstet • Given a choice, some women prefer early 10. Chai J, Tang O, Hong Q, et al. A randomized con- medical abortion to a surgical procedure trolled trial to compare two dosage intervals of misoprostol following mifepristone administration in second trimester medical abortion. Hum Reprod • Gaining access to mifepristone is difficult for GPs, but it may become more straightforward in the future.
• Both surgical and medical abortion are safe and effective, however, retained products of conception treated with D&C are more likely after early medical abortion.
• Complications become more frequent for both medical and surgical abortion as pregnancy progresses into the second trimester.
Ea Mulligan BMBS, BMedSc, MHAdmin, PhD, FRACGP, FRACMA, FACHSE, is Research Associate, School of law, Flinders University of South Australia, Adelaide, South Australia. firstname.lastname@example.orgHayley Messenger MBBS, BSc, is a registrar, Department of Obstetrics and Gynaecology, Flinders Medical Centre, Adelaide, South Australia.
Conflict of interest: none declared.
Gynaecologists. The care of women request- ing induced abortion. london: Royal College of Reprinted from AUSTRAlIAN FAMIly PHySICIAN VOl. 40, NO. 5, MAy 2011 345
Prof Banie Boneschans CV- B BONESCHANS 1 PERSONAL PARTICULARS Boneschans, Barend 13 Krom Street, Potchefstroom, 2520, South Africa 1.1 Language skills Afrikaans 1.2 Computer skills Computer literate with excelent skills in the operation of the folowing software 1.3 Professional registration Registered as a Pharmacist with the South African Pharmacy Council w