REVIEW APPLICATION FOR INCLUSION OF MIFEPRISTONE AND MISOPROSTOL IN THE 14th WHO MODEL LIST OF ESSENTIAL MEDICINES

Background Unsafe abortion is a public health problem worldwide. One way of reducing the number of unsafe procedures is to increase safe choices for pregnancy termination. In developed countries, of the 28 million pregnancies occurring every year, 36% end in abortion. In developing countries, of the 182 million pregnancies occurring every year, 20% end in abortion. Almost 80% of all abortions are conducted in developing countries. Worldwide 3,6% of women aged 15-44 are estimated to have pregnancy terminations yearly which make a total of more than 46 million abortions per year. There is a great concern about the effectiveness and safety of surgical methods (vacuum aspiration or dilatation and curettage or hysterotomy) that may be less effective and may increase the risk of infection (sepsis), uterine perforation, cervical laceration, incomplete evacuation, hemorrhage, miscarriage, future sterility and death. Even though, in developing countries those unsafe methods are commonly used. According to WHO, 19 million women have an unsafe abortion worldwide each year and 18.5 million of these occur in developing countries. Mortality due to unsafe abortion is estimated about 68000 women each year. In a Cochrane systematic review of three clinical trials, vacuum aspiration versus dilatation and curettage, and flexible versus rigid vacuum aspiration cannula were compared. There was no indication of a preference of providers for one or the other method. There were no reports of maternal deaths and cases of uterine perforation in the trials identified. There were no statistically significant differences in negative outcomes, probably because the trials included are small and lack power to present meaningful differences among groups. Medical abortion became an alternative method of first trimester pregnancy termination. It has the potential to be easier to perform and be lower in cost compared to surgical methods. A Cochrane systematic review of five small studies evaluated medical methods in comparison to surgical method (vacuum aspiration) for first-trimester abortion. The efficacy rates were ranging between 76% and 97.2% for medical and between 94 and 100% for surgical abortions in the individual trials. The rate of incomplete abortions was statistically significantly higher in the prostaglandin used alone group (OR = 2.7, 95%CI: 1.1-6.8) in comparison to vacuum aspiration. There were no data on the most commonly