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The UK's revolution in emergency contraception

Frances Perrow
Family Planning Writer

The past 12 months have seen a ­transformation in the world of postcoital or "emergency" contraception. The developments have been twofold. First, the drug company Schering Health Care released a progestogen-only pill, Levonelle-2, which is more effective and more user-friendly than its predecessor - PC4, the combined oestrogen/ progestogen emergency contraceptive pill. Second, the company applied and got a separate licence for the drug for use over the counter, in this instance known as Levonelle. This has enabled women who have had unprotected sex to walk into a chemist, answer the pharmacist's questions, buy it and take it.
The UK, faced with the highest teenage pregnancy rate in Western Europe of 63 conceptions per 1,000 women aged 13-19, needs any initiative that can improve these statistics. (For more information see www.statistics.gov.uk/ statbase) But critics claimed teenagers would use Levonelle instead of long-term contraceptive methods. So what should nurses know about emergency contraception?

Background

Postcoital contraception had remained unchanged for many years. Women had to go to their GP or family planning clinic and were offered either an intrauterine device, which could be inserted up to five days after unprotected sex, or the Schering Health Care drug PC4 (the "morning-after pill"), a combined oestrogen/ progestogen regimen, with two pills to be taken within 72 hours of unprotected sex followed by two further pills 12 hours later.
But this pill was not easy to take. Sheila Hancock, Manager of the Marie Stopes House clinic in central London, found that clients suffered severe nausea and vomiting. Despite recommendations to take the pill after food, or with an antisickness drug, many women who used PC4 once did not rush to take it again.
These anecdotes were endorsed by a World Health Organisation taskforce that found 50% of women treated with PC4 felt sick and one in five vomited.(1) By contrast, progestogen-only contraception is a far better tolerated method. Treatment consists of two tablets, each containing 750mg of levonorgestrel. One must be taken within 72 hours of unprotected sex, the next 12 hours later. Compared with PC4, the rates of nausea are halved, ­vomiting affects only one in 20 women and dizziness is reduced by one-third.
Progestogen-only contraception is also more effective. A trial involving nearly 2,000 women showed it prevented 85% of expected pregnancies, compared with 57% with PC4.(2)

Mode of action
Progestogen-only contraception works by suppressing ovulation, inhibiting fertilisation and preventing implantation. Levonelle has proved to be more effective than previous types of hormonal emergency contraception.(3) The earlier it is taken within the 72 hours, the more effective it is,(2) and overall it is still more effective than PC4. 
It has very few contraindications, which include pregnancy, breast cancer and sensitivity to progestogen-only contraceptives. Schering Health Care lists the possible side-effects as nausea and vomiting, breast tenderness, headaches, dizziness and fatigue, and a disturbance in menstrual patterns.

History
Levonelle-2 first got a licence as a prescription-only drug, but a number of pilots were set up where pharmacists were able to supply it using patient group directions (PGDs). 
The UK's Committee on the Safety of Medicines advised that the pills were "unlikely to present a direct or indirect danger to the health of women aged 16 and over when used without the supervision of a doctor", and Levonelle was licensed for sale over the counter from January 2001, at a cost of around £20. Levonelle-2 is available free on prescription from GPs, family planning clinics, some pharmacists (using PGDs) and walk-in centres.
Pharmacists have been issued with guidelines for dispensing Levonelle. The Medicines Control Agency has stipulated that they need to check the woman is 16 or over, is not already pregnant, and has not had unprotected sex in that cycle more than 72 hours previously. A few pilot schemes are now underway in parts of the UK to provide the prescription-only Levonelle-2 over the counter to girls under 16 using PGDs. 
Hands-on family planning nurses, such as Sheila Hancock of Marie Stopes International, are largely optimistic about the developments - but have a few reservations: "There is no doubt that [progestogen-only contraception] is a great improvement on the previous postcoital oral treatment, and I believe it is a fantastic step that it can be bought over the counter. [However,] our nurses can offer complete privacy, confidentiality and the time to talk. Women will not get this in a busy chemist's shop, and teenagers in particular might be frightened off in that environment."
She also commented that nurse practitioners had the experience to provide advice on long-term contraceptive methods and sexually transmitted infections. Nurses also take time to explain the changes in menstrual patterns which can result from taking Levonelle-2, and the possible need to return for a pregnancy test. For example, studies have shown that 57% of women started their period within three days of their expected date after taking Levonelle-2, but 15% were early, 15% were up to seven days late and 13% were more than seven days late.(2)
Marie Stopes clinics in the UK are able to offer Levonelle-2 using PGDs. The drug plus consultation costs £10 (Marie Stopes is a private provider so the product cost is £5), making it available to women at any time. Women can keep it with them in case they ever have a problem, such as contraceptive failure.
It had been expected that teenagers over the age of 16 would make use of over-the-counter Levonelle if they could afford it. However, Brook, an organisation that provides free confidential sex advice and contraceptives for young people, and Marie Stopes both believe that the price puts teenagers off. Under-16s are able to access Levonelle-2, with or without parental consent, if they can prove competency at their GP or family planning clinic. Schering Health Care has confirmed that 3% of Levonelle-2 users are under 16.
A Department of Health spokesperson said early results showed that women in their mid-20s were the biggest users of over-the-counter emergency contraception: "Although over-the-counter emergency oral contraception was seen as one of the government's solutions to teenage pregnancy, it wasn't intended to be. It's an extension of contraceptive choice for all women with easier access to services and advice. But we will be looking closely at the teenage pregnancy figures for the year 2000 to see what impact there is, if any."

Conclusion
Over-the-counter emergency contraception is still in its infancy, but this major reproductive health initiative has had a relatively smooth introduction. At this stage it is not possible to say whether there has been a drop in emergency contraception consultations at GP/family planning clinics/walk-in centres. However, Brook has reported an increase in the issue of emergency hormonal contraception, which they believe is due to increased awareness of its availability following the Levonelle launch. Critics have tried to highlight health risks and the dangers for underage girls of the increased availability of emergency contraception, but their argument will be completely lost if there is a decrease in abortion and teenage pregnancy rates for 2000.
The outstanding issues are the price in pharmacies and provision for under-16s. Family planning nurses will still play a vital dispensing role for the many women, including teenagers, who do not want to be seen­seeking a remedy in public for a sexual mistake.

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References

  1. Imogen Savage. EC comes of age. Community Pharm 2000;10:16-17.
  2. Schering Health Care. Emergency contraception in the 21st century. Press Release. 2 February 2000.
  3. World Health Organisation Task Force on Postovulatory Methods of Fertility Regulation. Randomised controlled trial of levonorgestrel versus the Yuzpe regimen of combined oral contraceptives for emergency contraception. Lancet 1998;352:428-33.

Resources
Department of Health
W:www.dh.gov.uk
Family Planning Association
W:www.fpa.org
Marie Stopes International
W:
www.mariestopes.org.uk
Brook
W:www.Brook.org.uk

Study days/conferences
2 November 2001
Teenage pregnancy in context Sheffield
Contact:
Janet Rodriguez Martinez
T:011 2229704
E:j.rodriguez@shef.ac.uk
W:www.snm.shef.ac.uk/news/events/events.htm