Oral contraceptives (OCs) represent one per cent of all pharmaceutical sales worldwide, worth two billion dollars per year. Sixty-three million women are using pills, including 38 million in developing countries. Why then is the safety of OCs still an issue? Why are there such a variety of standards for OC distribution and availability from country to country? Many of the restrictive regulations and contra-indications applied to OCs are based on outdated and sometimes incorrect medical information. Medical concerns about OCs in the past applied to pills containing 50 micrograms of oestrogen. With the newer 30 microgram pills, some absolute contra-indications -- such as hypertension -- have become reasons to monitor users more closely rather than not to use the method at all. Decisions about who can and cannot use OCs safely -- and which, if any, health workers should be able to distribute them to women without compromising safety -- require accurate medical data about the health impact of modern low dose OCs. When taken correctly, OCs have a high rate of effectiveness in preventing pregnancy. Concerns about the risks of the first OCs on the market led to extensive research on their safety and have made the Pill one of the most studied drugs of modern times. In this process, much has been learned, not only about the potential adverse effects but also the health benefits of OCs. In the current debates about how to make OCs more available to women who want to use them, those who oppose deregulation tend to express concerns about further reductions in already inadequate quality of care in service provision in many countries. They remind us that safety is dependent on quality of care and use and not just a technical assessment of the method itself. Some also question the assertion that OCs are very safe and point to uncertainties about breast and cervical cancer risks for some women. Those who support deregulation tend to emphasise the excellent safety record of OCs in actual use as well as the health benefits. They argue that the advantages of making OCs more available far outweigh the problems created by limiting women's access to this method. Major health benefits vs risks of OCs In addition to their major therapeutic use in prevention of pregnancy, OCs have many secondary health benefits. These include: significantly reduced menstrual loss, which can lead to higher serum iron levels and lower iron-deficiency anaemia; up to 50 per cent reduction in pelvic inflammatory disease, probably through the alteration in cervical mucus; significant protection against ectopic pregnancy; reduction in the incidence of ovarian cancer by 30-50 per cent; protection against endometrial cancer proportional to the duration of use and for up to 15 years after discontinuation; reduction in risk of benign breast disease; reduction in risk of fibroids and ovarian cysts; and relief from painful periods, pre-menstrual syndrome and endometriosis. In the 1960s and 70s, higher dose formulations of the Pill altered the lipid profile and blood clotting mechanisms and were associated with an increased risk of stroke, heart attack, and blood clot formation. The risk of stroke and heart attack with the lower dose OCs seems to be limited to women aged 35 and over who smoke. The risk of blood clot formation also appears to be lower.(1, 2, 3) Cancer is a common, serious and often fatal disease. Because some female genital cancers and breast cancer are hormone sensitive, any possible association with OC use has been important to determine. Sufficient information exists to be reassured about OCs and some cancers, but concerns continue to exist about the role of OCs with breast and cervical cancer. Whether women use OCs or not, the likelihood is that some women will develop breast cancer, mostly over the age of 50. Current evidence is contradictory on whether OCs may play a role in breast cancer development in young women who have used the pill for a long time and develop breast cancer early in life. With the exception of this group, no increased risk can be established. While women have good reason to fear breast cancer, the lack of association with OCs applies to the majority of women who might use the pill.(4) Cervical cancer is very common amongst women in developing countries. While certain studies suggest that use of OCs for more than five years may increase cervical cancer rates, a direct relationship is difficult to establish. Cervical cancer is now believed by many to be a sexually transmitted disease and to have multiple causes, all of which may contribute. While the oestrogen in OCs does affect the cervix, it may be that the lack of a barrier method that would help to protect the cervix is as relevant as the presence of oestrogen.(5) Safety vs medical barriers Contraceptives are very much subject to local folklore about their safety and side effects. Many factors influence local beliefs about methods. Women often discuss contraceptive side effects and negative experiences get translated into local medical fact. What constitutes an unacceptable side effect in one environment, such as weight gain, may be tolerated in another. Fears about the long-term damage from contraceptives also vary. While concerns about links between OCs and cancer may be paramount in one place, concerns about future fertility may be greater in another. OCs, like any other drug, are not and cannot be expected to be absolutely risk free. From a medical point of view, OCs have proven to be a safe and effective method of contraception for large numbers of women. Prevention of pregnancy will always be the primary reason why women would choose OC use, but the health benefits offer additional reasons why OCs may be a good choice for many women. In developed countries, where OCs have been available on prescription only, their safety record is extremely good because women whose health might be at risk from OCs are advised not to take them. Women who do opt for OCs have the opportunity to return to a doctor or clinic for follow-up, to discuss and try to deal with any problems they are experiencing, and to change brands until they find one that suits them or change methods as needed. In many countries, it has been found that there are unnecessary medical barriers when it comes to prescribing OCs. Incorrect and outdated medical information about the risks of OCs have led to over-frequent pelvic examinations and checks on weight and blood pressure. Inappropriate contra-indications are rigidly enforced, resulting in women with conditions such as diabetes being unnecessary refused OCs instead of being given them with special care. Legislation, either at national or local level, may restrict the category of provider allowed to dispense OCs. In addition, providers are at the interface between policy implementation and local myth. Because dissatisfied women present most often with problems, providers themselves may become biased against OCs because they are more familiar with the disadvantages. All these pressures influence national and local prescribing patterns. Whereas OCs are the most commonly used method in Zimbabwe, South Africa is completely different. Within South Africa there is a sharp contrast between the mostly black women who use mainly injectables, and the mostly white women who use mainly OCs. The shared myth between consumers and providers is that black women are not. Put another way, it is believed that women must have a certain of education before they can use the pill safely.(6) Proposed solutions Different strategies to overcome barriers have been introduced to make OCs more available to women, but OCs continue to be doctor-prescribed in countries like the USA and UK, where eight out of ten women take OCs at some time in their lives.(7) The real question in developed countries is what would happen to standards of care if a doctor's signature was no longer required to prescribe OCs. In many family planning clinics, nurses screen patients and doctors countersign their prescriptions. The doctor's signature often amounts to a rubber stamp as the real assessment has been done by the nurse. Allowing nurse prescribing in this situation is unlikely to diminish quality of care. Over-the-counter dispensing of OCs goes one step further than this. Women are presumably supposed to make decisions about pill usage on the basis of their intrinsic knowledge of the pill or with information obtained from leaflets. If South Africa is anything to go by, the majority of women -- be they urban sophisticated or rural -- have no idea about OC contra-indications, even if they are over 35 and smoke. With female illiteracy rates of 50 per cent, leaflet information has a limited value. Even for women who can read, the medical jargon currently used in pill leaflets makes the information inaccessible to all but health workers. If over-the-counter prescribing becomes the norm, where will women get their information from? Many women who presently get their pills from conventional outlets do not understand simple prescribing instructions, so it is likely that without supporting information they will take them incorrectly. Where will young and new users get their information from? Even in a country like the UK, with years of high OC prevalence, contraceptive users express a need for more information rather than less, and embarrassment and anxiety related to contraception are still high. Compliance has been shown to suffer when women do not have access to good counselling.(8) In an attempt to introduce stricter controls than over-the-counter dispensing allows for, some countries have introduced OC prescribing through pharmacies. South Africa, with a contraceptive prevalence rate of 50 per cent, introduced a pilot scheme in 1992 ostensibly to extend OC availability further. However, other forces seem also to have influenced this move. OC prescribing by pharmacists for a fee represents a large and potentially lucrative market. There is an ongoing feud within South Africa at present between pharmacists and private general practitioners about who controls drug dispensing in private primary care. Allowing pharmacists to prescribe OCs has allowed them to cut into the GPs' profit patch. This is an example of how market forces may start to influence OC prescribing. Women who can access other services. While pharmacies have the advantage of offering longer opening hours, this pilot scheme has not seriously considered quality of care issues. The proposed assessment of the scheme considers numbers of women reached with no attempt to evaluate how these women are being treated. In some developing countries, over-the-counter dispensing has meant no controls at all. Profit motives and the influence of local interest groups must always be considered when easier pill distribution schemes are suggested. However, the reality facing many developing countries is that they have a shortage not only of midwives, nurses and doctors but also of family planning clinics. Health professionals are overworked and under-resourced and are unable to give quality of care, partly because of large patient numbers. To solve this problem, community-based distributions (CBDs) have been trained to dispense OCs, condoms, and in some countries spermicidal pessaries. CBDs are selected from the communities they serve, and are trained providers and counsellors. CBDs are supposed to follow strict protocols for OC distribution under the supervision of clinic-appointed staff, and successful programmes build in ongoing support and training for them. Women are often started on OCs by the CBDs and referred to the local clinic within a specified time for examination. It is ironical that the very nature of CBD programmes may ensure more safeguards for women in developing countries than the over-the-counter approach being advocated in developed countries. Caution: justified concern or another barrier In the debate in the USA, the Boston Women's Health Book Collective, National Women's Health Network and National Black Women's Health Project have opposed over-the-counter sales of OCs on the grounds that the following benefits would be lost: preventative screening to detect factors which would make OC use risky; preventative screening for reproductive tract infections and other health problems requiring medical attention; face-to-face information, support and counselling, recognised as essential to quality of care; health promotion opportunities in areas such as sexuality and STD/HIV risk reduction.(9) The counter-argument is that these things are not happening anyway, especially in developing countries. To make OC availability subject to these conditions may continue to deny women the right to control their own fertility, as health services in developing countries are in crisis and simply do not have the capacity to expand services into new areas. In South Africa there have been longstanding concerns about quality of care and informed choice in family planning services. In addition, there is no national cervical screening programme, and neither HIV risk reduction efforts nor STD screening are a part of the family planning service.(10) In a large survey recently undertaken by the South Africa National Women's Coalition, women expressed concerns about both the accessibility and quality of care in existing family planning services.(11) Which of these problems should be prioritised? The answer being put forward in South Africa is that both should be prioritised. To increase the accessibility of OCs to all women, pilot CBD schemes based on a limited deregulation of the pill are now being proposed. At the same time, the structure and function of existing family planning services is being reviewed, and appropriate and affordable cervical screening programmes are being discussed. What is not being supported is over-the-counter distribution of OCs, as this would deny women who are already disadvantaged access to any cadre of health worker. At a time when the empowerment of women is high on the political agenda, over-the-counter prescribing is not seen as an option. Although the debate about OCs is not over, some things are not up for discussion. Conclusion A recent WHO survey showed that there are no international norms or consensus on the minimum elements of care required for OC prescribing. There is a need for standardised information about the side effects of OCs and standard guidelines on who can and cannot use OCs safely. Now that researchers are looking more closely at the acceptability of contraceptive methods, we are finding out just how many women have fears about the health risks of OCs, let alone other methods. It is rare for such research to trace the sources of these fears, which will doubtlessly vary from one setting to another, but such research is needed to find ways of replacing unwarranted fear with accurate information. There is agreement on the need to make OCs available to all women who can safely use them. The argument that over-the-counter distribution of OCs can be developed alongside attempts to improve the quality of care of health services is probably unrealistic. If this type of distribution became the norm, it would become very difficult to get health services to become more rigorous in their screening and counselling of women. Reliance on over-the-counter distribution means that market forces would become the dominant influence. With pill sales so valuable to the pharmaceutical industry, agendas other than women's health are likely to gain more rather than less influence. Thirdly, there is recognition that cadres of health workers other than doctors or nurses can be trained to distribute OCs safely, provided that sufficient safeguards are built into the system. In developed countries, professional jealousies that often prevent changes in health service norms should be re-examined. Nurses and/or midwives could well prescribe OCs without a doctor's countersignature. In developing countries with shortages of staff and resources, community-based distribution has proved to be a successful alternative, provided that there is ongoing support, training and infrastructure in place. The question is not whether some people are against quality health services for women. The real question is whether demands for such services will be heard if most standards for OC distribution are dropped. References 1. Lower dose pills. Population Reports. Series A, No 7, 1988. 2. Mehta, Suman. Oral contraception -- benefits and risks. Paper under publication by IPPF. 3. Grimes, D, 1990. The safety of oral contraceptives: epidemiologic insights from the first 30 years. American Journal of Obstetrics & Gynecology. 166(6/Suppl):1950-54. 4. Peterson, H, and Wingo, P, 1992. Oral contraceptives and breast cancer: any relationship? Contemporary Obstetrics and Gynaecology. 5. Brinton, L A, 1991. Oral contraceptives and cervical neoplasia. Contraception. 13:581-95. 6. Annual Report on Family Planning Statistics 1992/93. Department of National Health and Population Development, South Africa. 7. OCs o-t-c? [Editorial]. Lancet. 1993; 342(4 Sept):565-66. 8. Belfield, Toni, 1992. Problems of compliance in contraception. British Journal of Sexual Medicine. May/June:76-78. 9. Oral contraceptives over-the-counter? Not yet. Position paper of the Boston Women's Health Book Collective. May 1993. 10. Sai, Fred, Rees, Helen and McGarry, Steve, 1993. National Review of Reproductive Health and Family Planning. Commissioned for the European Community. 11. South African Women's National Coalition Interim Research Report: Campaign for Effective Equality. Rees, Helen, Acquiring the Pill: Safety Issues. , Reproductive Health Matters, 05-01-1994, pp 41-5.