§ Baroness Masham of Iltonasked Her Majesty's Government:
What psychological or psychiatric problems may be caused to a woman following the handling and disposal of an unborn child aborted by the use of the abortion drug RU 486 and; [HL5227]
What advice is given to women about the disposal of the corpse of an unborn child following an abortion using abortion drug RU 486. [HL5228]
§ Lord Hunt of Kings HeathWomen seeking an abortion should be given clear information beforehand to help them prepare for the procedure and staff are on hand to give support. A study published in theBritish Journal of Obstetrics and Gynaecology1 found that two years after early medical and surgical abortion procedures there were no significant differences between women who had undergone medical abortion or surgical abortion in either general, reproductive or psychological health. Almost all women placed a high value on the provision of choice of method of termination. The Royal College of Obstetricians and Gynaecologists' evidence-based guideline The Care of Women Requesting Induced Abortion considered the mental health implications of termination and concluded "only a small minority of women experience any long term, adverse psychological sequelae after abortion" and stated that referral for further counselling should be available for these women.
145WAGuidance issued by the Department of Health in 1991 states that, for babies born dead before 24 weeks, the fetal tissue should be incinerated if the parents have not expressed any specific wishes about disposal. Terminations carried out after 24 weeks gestation (the legal age of viability) are registered as stillbirths and the law requires the body to be buried or cremated.
1Howle, F.L., Henshaw, R.C., Najl, S.A., Russell, I.T. & Templeton, A.A. (1997) Medical abortion or vacuum aspiration? Two year follow up of patient preference trial. British Journal of Obstetrics & Gynaecology 104, 829–833.
§ Baroness Masham of Iltonasked Her Majesty's Government:
What are the:
- (a) contra-indications; and
- (b) side effects; of the use of the abortion drug RU 486; and [HL5229]
What studies they have undertaken during each of the last 10 years into the safety of the abortion drug RU 486. [HL5258]
§ Lord Hunt of Kings HeathRU 486, now more commonly known as mifepristone (Mifegyne), is licensed for use in medical termination of pregnancy. Information on how to use mifepristone, as well as information on possible side effects, is provided in the product information for prescribers (summary of product characteristics (SPC)) and patients (patient information leaflet (PIL)).
Warnings and contraindications for the use of mifepristone which are included in the SPC and PIL are as follows: allergy to mifepristone or any component of the product, suspected ectopic pregnancy, pregnancy not confirmed by ultrasound scan or biological tests, chronic adrenal failure, severe asthma not controlled by therapy and presence of a inter-uterine device in situ. In addition, special care should be given to patients with haemostatic disorders with hypocoagulability or with anaemia, and patients on long-term therapy with corticosteroids since corticosteroid efficacy can be decreased by concomitant treatment with mifepristone. Mifepristone is not recommended for use in patients with hepatic or renal failure or in women over 35 years of age and who smoke more than 10 cigarettes a day.
As with all medicines, Mifepristone is not without side effects. Some of the side effects experienced by patients such as pain, uterine contractions, or cramping and vaginal bleeding result from the termination of pregnancy. Side effects of the medication which may occur in some women include nausea, vomiting, stomach cramping, hypersensitivity reactions such as skin rashes and urticaria, headaches, malaise, hot flushes, dizziness, chills and fever.
The Medicines Control Agency, with advice from the independent scientific advisory committee, the Committee on Safety of Medicines, is responsible for monitoring the safety of all marketed medicines.
The safety of mifepristone was evaluated at the time of granting a marketing authorisation and continues to be monitored using information from clinical trials, post-marketing studies and from spontaneous adverse reaction reports. There have been a large number of 146WA studies and reviews of the safety of mifepristone published in the scientific literature in the last 10 years.
Induced abortion is one of the most commonly performed gynaecological procedures in Great Britain. Abortion, both surgical and medical, is safer than carrying a pregnancy to term and complications are uncommon. All available evidence in terms of safety and efficacy of mifeprestone was reviewed by the Royal College of Obstetricians and. Gynaecologists when producing its evidence based clinical guideline The Care of Women Seeking Induced Abortion (2000) and is referenced. Medical abortion is one of the methods recommended in the guideline.
§ Baroness Masham of Iltonasked Her Majesty's Government:
What is the current rate of incomplete abortions following the use of the abortion drug RU 486. [HL5255]
§ Lord Hunt of Kings HeathAll methods of first trimester abortion carry a risk of failure to terminate the pregnancy, thus necessitating a further procedure. The evidence based clincal guidelineThe Care of Women Requesting Induced Abortion (2000) produced by the Royal College of Obstetricians and Gynaecologists states that the failure rate for medical abortions is around 6 per thousand.
§ Baroness Masham of Iltonasked Her Majesty's Government:
What counselling is available to a woman—
- (a) contemplating an abortion using the abortion drug RU 486;
- (b) during such an abortion; and
- (c) after such an abortion. [HL5256]
§ Lord Hunt of Kings HeathThe Royal College of Obstetricians and Gynaecologists' evidence-based guidelineThe Care of Women Requesting Induced Abortion (2000), which applies to both medical and surgical abortions, recognises the importance of women seeking abortion receiving accurate impartial information. Verbal advice must be supported by printed information which every woman considering abortion can understand and may take away and read before the procedure.
Clinicians caring for women requesting abortion should try to identify those patients who require more support in decision-making than can be provided in the routine clinic setting. Facilities for additional support, including access to social services, should be available. Appropriate information and support should be available for those who consider, but do not proceed to, abortion.
Professionals should be equipped to provide women with the information they need in order to give genuinely informed consent: that abortion is safer than continuing a pregnancy to term and that complications are uncommon; description of the abortion methods that are available; immediate complications; and complications in the early weeks 147WA following abortion. During the procedure, staff are on hand to give support to women.
The guideline also considers the mental health implications of termination and concludes: "Only a small minority of women experience any long-term, adverse psychological sequelae after abortion. Early distress, although common, is usually a continuation of symptoms present before the abortion. Conversely, long-lasting, negative effects on both mothers and their children are reported where abortion has been denied."
Referral for further counselling should be available for the small minority of women who experience long-term post abortion distress.
§ Baroness Masham of Iltonasked Her Majesty's Government:
Whether they are fully satisfied that the abortion drug RU 486 will be administered only in accordance with the Abortion Act 1967, as amended by Section 37 of the Human Fertilisation and Embryology Act 1990. [HL5260]
§ Lord Hunt of Kings HeathUnder Section 2(2) of the Abortion Act 1967, as amended, registered medical practitioners must notify the Chief Medical Officer of every completed termination of pregnancy they perform. The notification form contains detailed information relating to the procedure including the doctors who certified there were grounds under the Act, gestation, method used and place of termination. Every form is checked and monitored by Department of Health officials to ensure that the abortion was performed within the provisions of the Act.
§ Baroness Masham of Iltonasked Her Majesty's Government:
Whether they believe that the abortion drug RU 486 is safer than surgical abortion. [HL5257]
§ Lord Hunt of Kings HeathDepending on the gestation at which a woman presents for abortion and her individual circumstances, one or more different abortion methods may be appropriate. Both medical and surgical abortions are safe. Ideally, abortion services should offer women a choice of recommended methods for relevant gestation bands.
Abortion, both medical and surgical, is safer than continuing a pregnancy to term and complications are uncommon. The risk of complication is lowered the earlier in pregnancy an abortion is performed.
§ Baroness Masham of Iltonasked Her Majesty's Government:
What was the total cost to the National Health Service in each of the last five years to provide the abortion drug RU 486; and [HL5279]
What they estimate will be the savings during each of the next five years to the National Health Service of using the abortion drug RU 486 instead of surgical abortion. [HL5259]
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§ Lord Hunt of Kings HeathThe information available relates to all medical abortions, of which about 95 per cent are undertaken using RU 486.
The estimated cost to the National Health Service for NHS-funded medical abortions that took place on NHS premises in England is given in the table. This information is not available prior to 1998–99.
Inpatient and day case activity Outpatient attendances12 1998–99 £3.9 million Not available 1999–00 £4.4 million Not available 2000–01 £5.2 million £1.8 million Source: National Schedule of Refence Costs
1 A medical abortion, using RU 486, is a two-stage process. The first stage which is the administering of the drug RU 486, often takes place in an outpatient clinic.
2 The outpatient clinic component of the cost of medical abortions is not available prior to 2000–01.
The independent sector also undertakes some medical abortions, using RU 486, under NHS contract. Costs to the NHS for these abortions are not collected centrally.
It is important that women should be offered a choice of recommended methods for relevant gestation hands, in accordance with the Royal College of Obstetricians and Gynaecologists' evidence-based guideline The Care of Women Requesting Induced Abortion (2000). The Government have not set targets or made projections for the future uptake and costs of medical abortion. There is no significant difference in the overall costs between surgical and medical abortion.
§ Baroness Masham of Iltonasked Her Majesty's Government:
Whether they agree with the statements made on 17 May by Dr Richard Hausknecht, medical director of the RU 486 manufacturer Danco, that the use of the abortion drug RU 486:
- (a) "is not safer than a surgical abortion";
- (b) "is fraught with risk and problems";
- (c) "includes the taking of two or perhaps five hazardous drug combinations"; and
- (d) "too often has complications ranging from moderate bleeding to severe pain, and for some women blood transfusions; and [HL5224]
Whether they agree with the statements made in August 1990 by Edouardo Sakiz, the then chairman of the RU 486 abortion drug developer Roussel-Uclaf, that the abortion drug RU 486:
149WA
- (a) "is not at all easy to use";
- (b) is "more complex to use than the technique of vacuum extraction"; and
- (c) causes a woman "an appalling psychological ordeal". [HL5225]
§ Lord Hunt of Kings HeathWe have not seen the full text of Drs Hausknecht's and Sakiz's statements and cannot confirm whether the comments attributed to them are accurate. RU 486, now more commonly known as mifepristone, has been licensed for use in medical termination of pregnancy since 1991. The Medicines Control Agency in conjunction with its independent scientific advisory committee, the Committee on Safety of Medicines, is responsible for monitoring the safety of all marketed medicines to ensure that medicines meet acceptable standards of safety and efficacy.
Medical abortion is one of the methods recommended by the Royal College of Obstetricians and Gynaecologists in its evidence based clinical guideline The Care of Women Seeking Induced Abortion (2000).