Improving access to emergency contraceptionBMJ 2001; 322 doi: https://doi.org/10.1136/bmj.322.7280.186/a (Published 27 January 2001) Cite this as: BMJ 2001;322:186
Allowing pharmacy sales should help reduce unwanted pregnancies
- Mira Harrison-Woolrych, senior medical assessor,
- Andrea Duncan, contraceptive services manager, public health division,
- Jeannette Howe, deputy chief pharmacist,
- Conamore Smith (), director, clinical effectiveness unit
- Post-Licensing Division, Medicines Control Agency, London SW8 5NQ
- Department of Health, London SW1A 2NL
- Faculty of Family Planning and Reproductive Health Care, London NW1 4QP
From 1 January this year pharmacists in the United Kingdom have been able to supply progestogen-only emergency contraception without a prescription. Within the next few weeks a product containing levonorgestrel 750 μg (Levonelle) will be widely available for purchase by women aged 16 and over. Direct sale through pharmacies should make access to emergency contraception easier for many women, but current NHS routes of provision of emergency contraception will still exist and remain important.
Emergency contraception is intended for use after intercourse, but before blastocyst implantation. In the United Kingdom two hormonal regimens are licensed as prescription only medicines for use within 72 hours of unprotected intercourse. A combination of oestrogen and progestogen (Schering PC4, ethinylestradiol 100 μg plus levonorgestrel 500 μg repeated 12 hours later) has been available since 1984 and a progestogen-only regimen (Levonelle-2, levonorgestrel 750 μg repeated 12 hours later) since 1999. Although less effective than standard hormonal contraception used correctly, emergency contraception may be needed when routine methods have not been used or have failed.
Evidence from randomised controlled trials has shown that the progestogen-only regimen has higher efficacy and fewer side effects, such as nausea and vomiting, than the combined method.1 Both regimens are more effective when started within 24 hours of unprotected intercourse, efficacy decreasing with increasing time since intercourse.2
Measures to improve access to emergency contraception have been debated since the early 1990s.3 One mechanism proposed, and now adopted, was the legal reclassification of levonorgestrel 750 μg from a prescription only medicine to pharmacy status. A medicine must have prescription only status if there would be a danger to health if the substance were used without medical supervision; the product might be used incorrectly, so endangering health; and the active ingredient, or side effects it may cause, require further investigation.4 The Committee on Safety of Medicines advised that levonorgestrel as an emergency contraceptive did not meet these criteria and so could be safely supplied by a pharmacist without medical supervision. Not all countries have pharmacy status category as in the United Kingdom—in the United States, for example, medicines are either on prescription or on general sale. In France, Norway, and Portugal, however, hormonal emergency contraception is available from pharmacists without prescription.
The Royal Pharmaceutical Society of Great Britain and the Pharmaceutical Society of Northern Ireland have developed guidance for pharmacists on the supply of emergency contraception.5 As with all medicines, pharmacists must have sufficient knowledge of the product to supply it safely when requested. The key elements of the guidance include supply criteria; advice on dosing instructions and follow up; links with local contraceptive services; privacy and confidentiality; and criteria for referral to a doctor or family planning clinic. In particular, pharmacists should refer women aged under 16, those taking interacting medicines or with malabsorption syndromes (in whom efficacy may be decreased), women who have had unprotected sex more than 72 hours earlier, and women who are already pregnant. In addition pharmacists should refer any woman with known hypersensitivity to levonorgestrel or those with severe liver disease.
Pharmacists will receive a distance learning programme ahead of the product launch (http://cppe.man.ac.uk/ehc/index.htm) and can attend workshops. Although pharmacists are expected to deal with requests for emergency hormonal contraception personally, pharmacy staff will also receive training to ensure they respond appropriately to inquiries.
Women will still need to know how, when, and where they can obtain emergency contraception free of charge through established NHS routes of supply. This is particularly important for those under 16, other women whom pharmacists should refer to a doctor, and women who cannot afford the pharmacy product, which costs £19.99. Emergency contraception remains available free on prescription from general practitioners, family planning clinics, youth clinics, and walk in centres, and some genitourinary medicine and accident and emergency departments.
Clinical teams providing NHS contraceptive care have also recently been working to increase access to emergency hormonal contraception, by developing protocols for nurse supply of emergency contraception. New regulations, which came into effect last year,6 allow nurses, pharmacists, and other health workers to administer or supply medicines to whole groups of patients “who may not be individually identified before presentation for treatment” provided they meet the requirements of a protocol called a patient group direction. Patient group directions were used in pilot projects for the free supply of emergency contraception by pharmacists in areas with high unwanted pregnancy rates.7 Experience from these pilots informed the development of the materials to support pharmacists selling the pharmacy product.
All these developments are intended to improve access to emergency contraception as part of efforts to reduce the high number of unwanted pregnancies in the United Kingdom. However, no one initiative can succeed by itself. It will be necessary to coordinate and publicise the network of services—primary care, family planning clinics, out of hours services, and pharmacist provision—in each locality to ensure that women can find appropriate care when they need it.
CS has received fees for speaking at conferences jointly sponsored by Schering Pharmaceuticals.