How to introduce medical abortion in a country, the example of NZ
Margaret Sparrow; MD, New Zealand
In 1999 New Zealand abortion providers considered that New Zealand women should be
offered the choice of medical abortion. As no pharmaceutical firm was interested in
importing mifepristone, five doctors formed a not-for-profit company Istar Ltd. The name is
derived from Ishtar or Istar, an ancient Babylonian goddess of love, fertility and war.
In May 2000 Istar signed an agreement with the French manufacturer, Exelgyn and
applied to Medsafe, Ministry of Health for approval of a new prescription medicine.
On August 30 2001 Mifegyne 200mg was approved by the Minister of Health Hon Annette
King and gazetted for use in New Zealand for abortion only.
To comply with the law all abortions in New Zealand must be “performed” in a licensed
institution. For fear of prosecution most clinics except the one at Wellington Hospital,
chose not to use Mifegyne. Second trimester abortions in hospitals were not affected and
the first medical abortion using Mifegyne was carried out in Wellington Hospital in October
In April 2003 Mr Justice Durie in the High Court Wellington ruled that a woman must take
both sets of pills (Mifegyne, followed 48 hours later by prostaglandin) in a licensed
institution, but she does not need to stay on licensed premises between taking the pills,
nor does she need to stay on licensed premises until the abortion is complete. Clinics are
now able to perform early abortions within these limits.
Our experience demonstrates that with persistence, obstacles can be overcome.
Medical abortion in the private practice,
Specialist in OB/Gyne
Working in private practice
Head of the Family Planning Centre Berlin
This presentation gives you an overview and in depth analysis about induced medical abortion with the abortion pill Mifegyne© ( Mifepristone ) and the Prostaglandin Cytotec© ( Misoprostol) in practical experience as a practicing gynaecologist.
The description of the problems in Germany in terms of having to deal with the german federal law and the regulations about the specific distribution channels of the abortion pill is considered as well as the increased requirements in the fields of care and consulting service for the female patients.
The complexity in practice and the fact that in Germany the existence of prohibition for advertisment of induced abortions in general is another hurdle for the application of Mifegyne©. This is one section of the many reasons why last year 2003 only a percentage of 6,12 % of all induced abortions in Germany were done the non -surgical way.
Ivar Brod, Pan Am Pharmaceuticals, Inc., New York, USA
Christian Fiala MD, Gynmed Ambulatorium, Vienna, Austria
Misoprostol has been widely used in Ob/Gyn practice since the early days of its appearance on the market. However, Pfizer, the current manufacturer, so far has rejected continuous requests to add these indications. Moreover, in countries like Estonia and Latvia where registration expired, manufacturer refused to prolong it. We believe that the company’s reasons were financial only, since the price of Misoprostol is more than 10 times lower than the price of other prostaglandins, injectable or jelly, produced by this company. This reason overweighs the fact that other prostaglandins (E2 and F2a analogs) can cause heavy adverse effects, like myocardial infarction and bronchospasm, which is not the case for Misoprostol (E1 analog).
The use of Misoprostol in Ob/Gin in USA is based on FDA’s general recognition that off-label use of approved medicine is acceptable, if it’s based on published scientific evidence. Similar recommendations have been accepted by the European Community Pharmaceutical Directive as well as by British National Formulary. There are no such policies in countries of Eastern Europe - Russia and other post-communist countries. Data that is being analyzed is mainly from Russia, which is typical for all of these countries. Existing legislation there does not provide any positive information about the off-label use of medicine. Moreover, in case of Misoprostol, medical authorities periodically issue directions prohibiting the access to it, due to the lack of indication by the manufacturer. The first of such Directive Letters was issued in April 1999 by Russian Ministry of Health forbidding the use of prostaglandins for off-label indications. The last Directive Letter as of July 2003 forbids directly the Ob/Gyn use of Misoprostol. The breach of these directives can be assumed as a criminal case.
One of the biggest problems for countries like Russia, where 60% of pregnant women prefer abortion and 15% of women in reproductive age are sterile, is to conduct a gentle abortion procedure in order to avoid any harm to female’s reproductive system. Many experts acknowledge that medical termination of pregnancy, using mifepristone followed by Misoprostol, is the most merciful abortion method. Mifegyne (mifepristone), known as the most excellent medicine for medical termination of pregnancy, has been registered in Russia in 1999. Ban of Misoprostol use significantly deprived Russian women the right to choose this method of medical abortion.
There is one more serious aspect resulted from Misoprostol ban in obstetrics in Russia. Help to pregnant women during childbirth is particularly important in this country where more than 10% of deliveries present with high risk of complications for mother and a baby. More than 1/3 of those caused by failure to progress in labor. Russian Ob/Gyn specialists found direct correlation between using Mifegyne and Misoprostol and raising the Bishop range from 0-3 to 4-7. As a result, this method was patented and these indications were formulated in the instruction. Misoprostol ban in obstetrics makes it impossible to use this remarkable mode.
The literature supporting Misoprostol Ob/Gyn use is rather vast – more then 400 publications in leading medical journals. Among them there are publications of experts in Russia, Ukraine, Latvia, Lithuania, and others. Moreover, in Russia in 2004 is published a spacious monograph devoted to Ob/Gyn use of Misoprostol. However, most of all reported brilliant results were based on the use of Misoprostol in research institutions, not in general practice.
We have to stress, that the situation with Misoprostol is special because it is officially recommended to be used in Ob/Gyn by World Health Organization issuing in May 2003 the guidance “Safe Abortion: Technical and Policy Guidance for Health Systems”. We believe that these recommendations allow us to call upon medical authorities in countries of Eastern Europe to acknowledge that Misoprostol was proven to be a prominent drug in Ob/Gyn and to define the way of its appropriate use. Women should not be held hostage by the economic considerations of a private pharmaceutical company in the United States.
One-and two day mifepristone-misoprostol intervals are both effective in medical termination of second trimester pregnancy
Oskari Heikinheimo, Satu Suhonen and Maija Haukkamaa, Department of Ob&Gyn, Helsinki University Central Hospital, Finland
Termination of pregnancy because of fetal anomaly requires the utmost clinical sensitivity and individualized patient care. We compared the efficacy of a one-day mifepristone and misoprostol –interval in medical termination of second trimester pregnancy performed because of fetal anomaly with that of the standard two-day interval among the first 100 women in each group. A 200 mg dose of mifepristone was used; 0.4 mg of misoprostol was administered vaginally at three-hour intervals until abortion occurred.
When calculated from ingestion of mifepristone, the time to abortion was 28:25 h (23:10 – 50:40 h) (median (range)) and 52:43 h (45:55 – 83:15 h) (p<0.0001) in the one- and two-day MIFE-MISO groups, respectively. However, following initiation of misoprostol administration the time to abortion (7:25 h (1:00 – 23:15 h)) was longer (p<0.05) in the one-day interval group than in the two-day interval group (6:20 h (0:45 – 36:30 h); by 12 h 82 and 87% (n.s.), respectively, of the subjects had aborted. The proportions of cases undergoing surgical evacuation of the uterus were 64 and 45% (p<0.001), in the one- and two-day interval groups, respectively.
Thus both one- and two-day mifepristone-misoprostol intervals are both valuable in termination of second trimester pregnancy.
Therapieschema und Abläufe in der Klinik
Blanka Kothé (Germany)
Dieser Teil des Workshops richtet sich an alle Professionen, die mit medikamentösen Schwangeschaftsabbrüchen aus medizinischer Indikation zu tun haben: PränataldiagnostikerInnen, GynäkologInnen, HumangenetikerInnen, Hebammen, ArtzhelferInnen, Krankenschwestern/-pfleger, psychosoziale BeraterInnen etc.
Diese Professionen kommen mit Fragen der Indikationsstellung, der klinischen Umsetzung, den rechtlichen und institutionellen Rahmenbedingungen in Berührung. Darauf will der Workshop klärend eingehen.
Grundlagen der psychosozialen Beratung und Begleitung von betroffenen Frauen/Paaren in dieser besonderen Situation sollen dargestellt werden und die Möglichkeit gegeben werden, sich darüber auszutauschen.
Zusätzlich wird medizinisches Wissen u.a. aus langjähriger klinischer Erfahrung zum Einsatz von Mifegyne und Cytotec mit Besonderheiten der Anwendung im 2. Trimenon vermittelt und der Ablauf in der Klinik geschildert.
Themen wie Fetozid, psychiatrische Indikation, verdrängte Schwangerschaft und ein Exkurs zum aktuellen Stand der rechtlichen Situation können Raum haben.
Who should do the counselling: doctor – non doctor?
Karen Schlie , Family Planning, Hamburg - Germany
The first question arising in this connection is the question of what is at issue in the counselling. As a counsellor having graduated in pedagogic with additional therapeutic qualifications I have to focus on the client’s issues.
What are her needs and wishes concerning counselling prior to an abortion.
- Does she need support in taking her decision or rather an opportunity to reflect whether she has taken the right decision?
- Does she require information about abortion: medical information, the selection of the right method, the procedure, framework conditions or the steps to go – just to mention a few examples?
- Or does the client rather wish information about social/financial support in order to reconsider whether this would influence her decision?
- Are there any specific legal conditions concerning abortion to be observed in different countries?
- Are there any legal conditions for the physician such as her duty to inform about complications?
- Does the client wish any counselling at all?
This range of questions shows that different qualifications are required to provide adequate and professional help for the respective problem.
Therefore I would not ask who should do the counselling prior to an abortion but rather which qualifications the physician or other professional should have.
I work as a counsellor at the family planning centre in Hamburg/Germany. I have a university degree in pedagogics with additional qualifications in social work and psycho-therapy. These are qualifications from which I benefit in my pre-abortion counselling work.
As counselling prior to an abortion is compulsory in Germany, we often have to deal with resistance and fear. Frequently, our clients are insecure and don’t know what they have to expect from the counselling.
In our counselling work we distinguish between clients who have already taken their decision to have an abortion (which is the case for about 80 % of our clients) and those who rather seek support in their decision-taking process (some 20 %). The latter need a therapeutically trained counsellor.
Mostly, both types of clients wish to also receive medical information.
Therefore, medical knowledge about the performance of an abortion and any potential complications is required. In our team at the family planning centre, we have physicians and perform abortions ourselves. If the client has any questions I cannot answer, I can refer her to a physician or can acquire the relevant knowledge myself. Vice versa, the physicians can refer to me or one of my colleagues, if they become aware that the client has not yet taken her decision or is in a crisis due to an inner conflict.
Of course, these opportunities are not available at every institution or clinic; and therefore it is essential to try to establish a good network of cooperation and, if necessary, to take part in specific training.
Regardless of your profession, I think it is important to reflect your own inner processes as well as your practical work. Counselling competence, such as certain communication techniques, might also be of help in the medical context.
Thus, in supporting the client in her choice of the appropriate abortion method you should also talk about her personal situation taking into account her particular needs.
- Are there, for example, small children but nobody who could take care of them?
- Is she afraid of surgical abortion because of past bad experience with operations?
- Does she consider Mifegyne to be a more self-determined way which she would prefer while a surgical abortion might give her the feeling of being in someone’s hands (“there’s someone doing I don’t know what to me”) – possibly due to a history of sexual abuse?
- In case the pregnancy is too advanced for medical abortion so that she has to choose the surgical way, it may be important to reflect whether it is more appropriate for her to get local anaesthesia as she could then participate consciously in the entire process.
- Or would she rather prefer not to live consciously through the surgical abortion process because it might lead to retraumatization due to past experience with violence? Then general anaesthesia might be her choice.
For all these questions it is useful if I as a counsellor can reflect my own feelings while I inform the client about the various methods. Am I able to go with the client and her decision even if I would choose a different method in a similar situation? And by the way, what is my way of informing? Do I conduct the dialogue in a way ensuring that the client can take a self-determined decision about the method she considers most appropriate? Am I the one determining what is “self-determined” or am I rather able to put aside my own concepts of what might be best for the client.
Summarizing I come back to the one central question: What are the qualifications required by a counsellor to deal with abortion, no matter whether she is a physician or another health professional?
In my opinion we are not looking for an either-or solution but rather for an as-well-as solution. This means that physicians and other professionals should cooperate and support each other in order to participate from each other’s competence in striving for the greatest possible benefit for the client.