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Emergency Contraception

Mr. Andrew Turner: To ask the Secretary of State for Health (1) what advice the Government received in March 2000 from the Committee on Safety of Medicines on the need for medical supervision of the supply of the morning-after pill to girls under 16; whether that advice has been superseded; and what action is taken to ensure that its supply complies with that advice; [28207]

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Yvette Cooper: In March 2000, the advice of the Committee on Safety of Medicines (CSM) was sought on an application by Medimpex (in conjunction with Schering Health Care) to reclassify levonorgestrel (the morning after pill) 0.75 mg from prescription only to pharmacy availability for emergency hormonal contraception in women aged 16 and over. The CSM considered, on the evidence before it, that the criteria for prescription only status no longer applied to levonorgestrel 0.75 mg for this indication in this age group, and therefore advised that levonorgestrel 0.75 mg should only be supplied to those aged 16 and over without medical supervision. In giving its advice, CSM recognised that, although the efficacy and safety profile of levonorgestrel 0.75 mg for emergency hormonal contraception may not be expected to be different in the under 16s, provision to this age group posed special risk management issues. The CSM therefore advised that emergency contraception should only be supplied to those under 16 under medical supervision. That advice has not been superseded. The minutes of the CSM meeting of 23 March 2000 are available on their website csmhome.htm.

Medical supervision includes the supply by other health professionals (such as nurses and pharmacists) working to a patient group direction. Supply of the prescription product complies with the usual requirements for prescription only medicines.

The Royal Pharmaceutical Society of Great Britain has set professional standards and developed comprehensive guidance for pharmacists on the retail supply of emergency hormonal contraception (EHC). The guidance says that

No clinical trials of levonorgestrel use specific to girls under 16 have been conducted in the United Kingdom. The marketing authorisation granted in 1999 for levonorgestrel 0.75 mg tablets as a prescription only medicine was supported by evidence from two large randomised controlled studies, one conducted by the World Health Organisation, and published data from uncontrolled studies. Most women in the clinical trials were aged between 16 and 48, but a few girls aged 14 and 15 were included. There were no data available for girls between ages 11 and 14 years. Age analysis of efficacy and safety in randomised studies did not identify any population that responded differently to treatment.

General practitioners and other health professionals who supply levonorgestrel and paracetamol to girls under 16 are all professionally trained to provide advice and to

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follow procedures designed to ensure that these products are used safely. Health professionals operating under a patient group direction have to follow formal protocols which include measures to avoid unwanted interactions with other medicines. As an added safeguard, under European legislation, the patient information leaflet approved for all medicines must contain information about interactions with other medicines and measures that should be taken to avoid them.

Mr. Andrew Turner: To ask the Secretary of State for Health on how many occasions the morning-after pill was prescribed (a) in total and (b) to girls under 16 (i) in family planning clinics, (ii) by general practitioners, (iii) by hospital accident and emergency departments, (iv) by school nurses and (v) direct by pharmacists in each year since 1998; and what percentage (b) was of (a). [28206]

Yvette Cooper: Not all of the data requested are collected centrally. Information on emergency hormonal contraception supplied under a patient group direction, by school nurses and pharmacists is not available and only family planning clinics report data by age.

The tables show prescriptions for emergency hormonal contraception dispensed in family planning clinics and prescriptions dispensed in the community by community pharmacists and dispensing doctors in England.

Family planning clinics(32)
Total post-coital contraceptives prescribed 000s

Financial year All agesUnder 16sPercentage of prescriptions to under 16s

(32) Post-coital hormonal contraceptives which excludes IUDs

Prescriptions dispensed in the community(33)

Calendar year Number of prescription items

(33) This includes community pharmacists, appliance contractors, dispensing doctors and prescriptions submitted by prescribing doctors. A breakdown of age is not separately identifiable.

Dr. Richard Taylor: To ask the Secretary of State for Health if he will make a statement on the Government's policy on the provision of the morning after pill for 13 to 16-year-old girls. [29462]

Yvette Cooper: According to recent research, around a quarter of young people have sex before their sixteenth birthday. Under 16s are also less likely than older women to use contraception consistently. Our teenage pregnancy strategy recognises the importance of helping young people resist peer pressure to have early sex while seeking to ensure that those who are sexually active have easy access to high quality contraceptive advice. Emergency contraception is a safe and effective method of preventing unplanned pregnancy. It also brings young people into contact with a health professional where they can discuss

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their relationship, any on-going contraception needs and the importance of using condoms to protect against sexually transmitted infections.

Emergency contraception is considered to have a similar safety profile for under 16s as for older women and is supplied to under 16s under medical supervision, within the legal framework established in 1986.

Drug Safety (Roaccutane and Antidepressants

Paul Flynn: To ask the Secretary of State for Health what assessments she has made of the adequacy of the warning of the side effects of (a) roaccutane and (b) antidepressants; and what is his estimate of the effects of both. [28118]

Jacqui Smith: [holding answer 17 January 2002]:The safety of all medicines on the United Kingdom market is continuously monitored by the Medicines Control Agency and the independent advisory body, the Committee on Safety of Medicines (CSM). The product information includes the Summary of Product Characteristics for Prescribers and the Patient Information leaflet included in each pack of the medicine. These are also kept under continuous review to make sure that they provide the most up to date and relevant information to healthcare professionals and the public regarding the safe use of the medicine.

Roaccutane (isotretinoin) is licensed only for the treatment of very severe and disfiguring forms of acne. Roaccutane is a prescription only medicine and the terms of the marketing authorisation specify that it must be prescribed by, or under the supervision of, a consultant dermatologist. In addition, the supply of Roaccutane is restricted to hospitals or specified retail pharmacies.

The product information for Roaccutane was last updated in June 2001 with regard to warnings and possible side effects. One of the key previous amendments to the product information was the strengthening of the warning relating to depression and other psychiatric reactions including suicide, which was approved in March 1998.

Two major classes of antidepressant are the Selective Serotonin Re-uptake Inhibitors (SSRIs) and the Tricyclic Antidepressants. The safety profiles of SSRIs and TCAs are well-established and are reflected in the product information for prescribers and patients. MCA/CSM carried out a major review of the safety profile of SSRIs, which was completed in 2000 and resulted in product information being updated and an article being published in the drug safety bulletin "Current Problems in Pharmacovigilance".

Respiratory Consultants

Mr. Burns: To ask the Secretary of State for Health if the projected increase of 150 additional respiratory consultants by 2004 includes persons already in the process of specialising. [28809]

Mr. Hutton [holding answer 21 January 2002]: Current supply projections show that there will be an increase of around 150 trained specialists in respiratory medicine available to take up consultant posts in the specialty by 2004. The projections include specialist registrars currently in training in the specialty of

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respiratory medicine and take account of the long term effect of measures to increase consultant recruitment and deliver the NHS Plan target of 7,500 more consultants by 2004.

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