Death underfunded Improving access to emergency contraception

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Improving access to emergency contraception. Allowing pharmacy sales should help reduce unwanted pregnancies. From 1 January this year pharmacists in ...
Editorials

Death underfunded The mortuary service needs resources not resignations

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t can’t be much fun working in the pathology service in the United Kingdom as it lurches from one crisis to another with regular knocks from the government and the media. There have been mistakes, notably the practice of retaining organs without consent, and it will be some time before the public is reassured.1 Apportioning blame in the latest furore to blight the pathology service—bodies being stored outside mortuaries—is, however, not so clear cut. Last week the striking image of seven corpses stored in a hospital chapel, draped in sheets with the legs and face of one body visible, forced the resignation of Ken Williams, the chief executive of Bedford Hospital.2 A damaged door in an accessory morgue is said to have caused a shortage of suitable storage facilities. The hospital’s critics in the media and the department of health blame the management. Relatives are understandably distraught, although the resignation of Mr Williams, under pressure from the government, has not ended the controversy. Ironically, Bedford Hospital is in the top 20 of a much lauded league table of hospital performance, released this month.3 The Royal College of Pathologists has no data on the state of mortuaries nationally—this needs to be rectified by an audit—but consultant pathologists from all over England have readily confirmed to the BMJ that Bedford Hospital is not an isolated case. Bodies have been stored in unrefrigerated conditions for years, especially at times when the NHS is under greatest strain, such as the Christmas and New Year holidays. Storage facilities are then full to capacity and the outflow of bodies to undertakers is slow. The problem is not simply one of local mismanagement, which is what the department of health would have us believe, but one of chronic underinvestment in mortuary facilities. Since the Bedford incident, a second English hospital has reported storing bodies in a makeshift morgue, this time a boilerhouse.4 Indeed the government has documented a shortage in storage facilities for bodies,5 6 and funds for updating services are available. The pathology modernisation programme, responsible for allocating the government’s budget for modernisation, has been concerned by the underinvestment in the pathology service generally.7 In 1999-2000 bids from NHS trusts and health authorities oversubscribed by 10

times the programme’s budget of £10m. None the less, the government diverted half the allotment to other priorities, away from pathology. There has also been an increase in workload.8 For example, the number of histochemical stains prepared rose by about 28% from 1994-5 to 1999-2000, while the number of immunohistochemistry stains increased by 85%. Although staffing levels have gone up by around 25% in that period, there is still a shortfall of about one consultant per laboratory, if the Royal College of Pathologists’ recommendations are to be followed. And, contrary to popular perception, pathology is one of the most intensely scrutinised medical specialties. The clinical pathology accreditation scheme sets standards for medical laboratories, and peer review through external quality control is standard practice.9 The Royal College of Pathologists is also one of the pioneers of revalidation.10 Just as with organ retention, hospitals all over the country will be dreading the day a scandal breaks in their backyard. If health secretary Mr Alan Milburn genuinely wants to avoid distress among relatives then he must address the root cause of the mortuary crisis— which is that the service is outdated and underresourced. Dignity in death comes at a price that the government should pay. Kamran Abbasi assistant editor, BMJ 1

Abbasi K. Summit signals a change in the law on organ retention. BMJ 2001;322:125. 2 Laurence J. Milburn blames hospital’s managers for allowing corpses to be left on chapel floor. Independent 2001;17 Jan. 3 Kmietowicz Z. Hospital tables “should prompt authorities to investigate.” BMJ 2001;322:127. 4 Carvel J, Branigan T. Hospital admits storing 12 bodies in boilerhouse. Guardian 2001;19 Jan. 5 Department of Health. Emergency services action team report 1999. www.doh.gov.uk/esat99.htm (accessed 19 January 2001). 6 Department of Health. Millenium executive team report on winter 1999/2000. doh.gov.uk/pdfs/nhswinter992000.pdf (accessed 19 January 2001). 7 Pathology Modernisation Programme. Review of bids made for the modernisation fund 1999/2000. www.doh.gov.uk/pathologymodernisation/ review1999.htm (accessed 19 January 2001). 8 Wilson R, Shackleton R. Addressing workload and staffing issues in UK histopathology and cytology laboratories, September 2000. http://www.cpa-uk.co.uk (accessed 18 January 2001). 9 Clinical Pathology Accreditation (UK) Ltd. Standards for the medical laboratory.www.cpa-uk.co.uk (accessed 18 January 2001). 10 Du Boulay C. Revalidation for doctors in the United Kingdom: the end or the beginning? BMJ 2000;320:1490.

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Improving access to emergency contraception Allowing pharmacy sales should help reduce unwanted pregnancies

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rom 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 ìg (Levonelle) will be widely available for purchase by women aged 16 and over. Direct sale through pharmacies should make

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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 BMJ VOLUME 322

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Editorials as prescription only medicines for use within 72 hours of unprotected intercourse. A combination of oestrogen and progestogen (Schering PC4, ethinylestradiol 100 ìg plus levonorgestrel 500 ìg repeated 12 hours later) has been available since 1984 and a progestogenonly regimen (Levonelle-2, levonorgestrel 750 ìg 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 ìg 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 BMJ VOLUME 322

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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. Mira Harrison-Woolrych senior medical assessor Post-Licensing Division, Medicines Control Agency, London SW8 5NQ

Andrea Duncan contraceptive services manager, public health division Jeannette Howe deputy chief pharmacist Department of Health, London SW1A 2NL

Conamore Smith director, clinical effectiveness unit ([email protected]) Faculty of Family Planning and Reproductive Health Care, London NW1 4QP

CS has received fees for speaking at conferences jointly sponsored by Schering Pharmaceuticals.

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Cheng L, Gülmezoglu AM, Ezcurra E, Van Look PFA. Interventions for emergency contraception (Cochrane Review). In: Cochrane Library, Issue 4, 2000. Oxford: Update Software. Piaggio G, Von Hertzen H, Grimes DA, Van Look PF. Timing of emergency contraception with levonorgestrel or the Yuzpe regimen. Task Force on Postovulatory Methods of Fertility Regulation. Lancet 1999;353:721. Statement on emergency hormonal contraception. London: Joint Steering Group: Royal College of Obstetrics and Gynaecology/Faculty of Family Planning and Reproductive Health Care, 1995. Council Directive 92/26/EEC. Official Journal 1992;L113:5-7. Royal Pharmaceutical Society of Great Britain. Practice guidance on the supply of emergency hormonal contraception as a pharmacy medicine. Pharmaceut J 2000;265:890-2. Department of Health. Patient group directions. London: DoH, 2000 (HSC 2000/26). O’Brien K, Gray N. Supplying emergency hormonal contraception in Manchester under a group protocol. Pharmaceut J 2000;264:518-9.

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