§ Mr. McNamaraTo ask the Secretary of State for Health (1) what studies his Department has undertaken during each of the last 10 years into the safety of the abortion drug RU-486; and if he will make a statement; [70114]
(2) what the (a) contra-indications and (b) side effects are of the use of the abortion drug RU-486; and if he will make a statement. [70218]
§ Ms BlearsRU-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 in the summary of product characteristics (SPC) and for patients in the 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 1435W recommended for use in patients with hepatic or renal failure or in women over 35 years of age and who smoke more than ten 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 a 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 studies and reviews of the safety of mifepristone published in the scientific literature in the last ten 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 mifepristone 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.
§ Mr. McNamaraTo ask the Secretary of State for Health (1) what he estimates 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; and if he will make a statement; [70115]
(2) what was the total cost to the National Health Service in each of the last five years of providing the abortion drug RU-486. [70119]
§ Ms BlearsThe 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 is in the table below. This information is not available prior to 1998–99.
Inpatient and day case activity Outpatient attendances 1,2 1998–99 £3.9m Not available 1999–2000 £4.4m Not available 2000–01 £5.2m £1.8m 1A medical abortion, using RU486, is a two-stage process. The first stage, which is the administering of the drug RU486, often takes place in an outpatient clinic. 2The outpatient clinic component of the cost of medical abortions is not available prior to 2000–01. Source:
National Schedule of Reference Costs.
1436WThe independent sector also undertakes some medical abortions, using RU486, 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 has 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.
§ Mr. McNamaraTo ask the Secretary of State for Health what steps he is taking to ensure that the abortion drug RU-486 will be administered in accordance with the Abortion Act 1967, as amended by section 37 of the Human Fertilisation and Embryology Act 1990; and if he will make a statement. [70116]
§ Ms BlearsUnder 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 Departmental officials to ensure that the abortion was performed within the provisions of the Act.
§ Mr. McNamaraTo ask the Secretary of State for Health (1) how many abortions were carried out in each of the last 10 years using the abortion drug RU-486; [70117]
(2) what his proposed target levels in 2002–03 are for use of the abortion drug RU-486; and if he will make a statement. [70118]
§ Ms BlearsThe number of abortions carried out in the last ten years using the abortion drug RU-486 for residents of England and Wales are shown in the table.
Year England Wales England and Wales 1991 1022 42 1064 1992 1502 63 1565 1993 3719 224 3943 1994 5324 376 5700 1995 6983 685 7668 1996 8782 933 9715 1997 10345 956 11301 1998 12849 1064 13913 1999 14735 1284 16019 2000 17647 1844 19491 Source:
Statistics Division—Department of Health.
The Royal College of Obstetricians and Gynaecologists' evidence-based guideline The Care of Women Requesting Induced Abortion (2000) recommends that women should be offered a choice of recommended methods for relevant gestation bands. It is expected that as medical abortion becomes more widely available more women will choose this method. No targets have been set for the use of medical abortion.
1437W
§ Mr. McNamaraTo ask the Secretary of State for Health what the rate of incomplete abortions following the use of the abortion drug RU-486 is; and if he will make a statement. [70219]
§ Ms BlearsAll methods of first trimester abortion carry a risk of failure to terminate the pregnancy, thus necessitating a further procedure. The evidence based clinical 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 6.0 per thousand.
§ Mr. McNamaraTo ask the Secretary of State for Health what counselling is offered to a woman(a) contemplating, (b) during and (c) after an abortion using the abortion drug RU-486; and if he will make a statement.[70220]
§ Ms BlearsThe Royal College of Obstetricians and Gynaecologists's evidence-based guideline "The 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;complications in the early weeks 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 concluded: "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.