Product Brief: Caucus on New and Underused Reproductive Health Technologies- Medical Abortion

Publication date: 2011

PRODUC T BRIEF Caucus on New and Underused Reproductive Health Technologies Medical Abortion Description Medical abortion is a nonsurgical procedure in which drugs are used to induce abortion. !e most e"ective and safest medical abortion regimen requires the use of two medications, mifepristone and misoprostol. !e recommended regimen is 200 mg of mifepristone given orally, followed 24 to 48 hours later by 800 µg of misoprostol—given vaginally, sublingually, or buccally—up to 63 days since the last menstrual period.1 Misoprostol can be given orally at a dose of 400 µg, but due to the higher failure rate, it is recommended that oral misoprostol use at this dosage be limited to pregnancy under 50 days, and even then other routes of administration are preferred.2, 3, 4 Mifepristone blocks the action of progesterone to enhance the contractility of the uterus and prompt the detachment of the implanted embryo. It also acts to so$en and dilate the cervix. Misoprostol stimulates strong contractions of the uterus, expelling the products of conception. !is process is very similar to that of a spontaneous abortion or miscarriage.5 Repeated administration of misoprostol alone may lead to an abortion, but results in lower e"ectiveness rates and higher rates of side e"ects. However, misoprostol-only abortions may be an appropriate option in settings where mifepristone is not available.6 Quality abortion care should include counselling; con%rmation of pregnancy; estimation of length of gestation; and screening for ectopic pregnancy by the patient’s history, bimanual exam, or with ultrasound— although the latter is not required. Some settings o"er a second visit to con%rm the pregnancy is terminated. Contraceptive-options counselling should be provided at the time of the abortion or a$erwards. !e provision of safe abortion is an important component of reproductive health services. Medical abortion options have made abortion more available to women in a variety of health care settings. Efficacy Based on extensive research, mifepristone and misoprostol as a combined regimen have a success rate of complete abortion at 96 percent or higher and a rate of continued pregnancies at less than 1 percent.1 Cramping and vaginal bleeding are associated and expected e"ects of medical abortions. Under medical supervision, the use of mifepristone and misoprostol is very safe. Medical abortion has not been associated with long-term health impacts and is statistically less risky than continuation of pregnancy.7 Medical abortion may be preferable to surgical abortion for some women, and some providers, largely due to the avoidance of risks associated with such procedures (e.g., complications of anaesthesia), and also the fact that medical abortion is a less invasive and more private procedure. Current programme/sector use !ere are a number of political, logistical, cultural, religious, %nancial, and other barriers that limit universal access to medical abortion. Abortion is legally restricted in many countries. Where abortion is legal, challenges may arise in terms of health-system restrictions on where the services can be provided, procurement of the drugs (mifepristone products can be expensive, but lower cost products are becoming available), and provider training in order to properly inform and counsel patients about their options, the procedure, risks, and bene%ts. However, mifepristone and misoprostol are currently registered and being made available to women in numerous countries. !e level of use in countries such as the United States and those in Europe suggests that women appreciate having an alternative to surgical abortion. Women in Europe have been using mifepristone and misoprostol for more than 20 years. In the United States, more than 1.4 million women have used Mifeprex since it was registered in 2000.8 Manufacturer/supplier Mifepristone is branded as Mifegyne® by Exelgyn Laboratories and as Mifeprex® by Danco Laboratories. Misoprostol is most widely available as Cytotec®, which is manufactured and distributed by P%zer; it is only registered by P%zer for one indication—prevention and treatment of gastric ulcers secondary to chronic use of NSAIDs. Misoprostol products are registered for gynaecological indications in countries such as C A U C U S O N N EW A N D U N D ER U S ED R EP R O D U C TI V E H EA LT H T EC H N O LO G IE S P R O D U C T B R IE F For more information on the Caucus on New and Underused RH Technologies, please visit our web page at http://www.rhsupplies.org/working-groups/caucus-on-newunderused-rh-technologies.html. This publication forms part of a series of technical briefs, written by members of the Caucus on New and Underused Reproductive Health Technologies, a thematic group established under the auspices of the Reproductive Health Technologies Coalition. The Caucus’ aim is to broaden the discussion within the Coalition of reproductive health technologies that are not well integrated into the public or commercial health sectors. Responsibility for the selection and contents of the product briefs rests solely with the Caucus and does not imply endorsement by the Coalition or its wider membership. For additional information, please contact secretariat@rhsupplies.org. This brief was last updated January 2011. Brazil, France, Russia, and Egypt, and registered speci%cally for use with mifepristone for pregnancy termination in France (registered by HRA Pharma as Gymiso®) and Russia (registered by Pentcro$ Pharma as Misoprostol).!e Concept Foundation has developed a combination-pack mifepristone-misoprostol product (Medabon®) to be marketed in developing countries for medical abortion; it is currently registered for this indication in Cambodia, Ghana, India, Nepal, and Zambia. For more information, visit www.medabon.info. Other manufacturers are also marketing combi-packs of mifepristone and misoprostol in the developing world. !ese manufacturers include, but are not limited to, MTP, Cipla, Sun, Discovery Mankind, and INTAS. In addition, generic and nongeneric misoprostol products are available through additional suppliers (other than P%zer) in India, China, Egypt, Vietnam, Taiwan, Korea, Colombia, Brazil, and the United Kingdom.9 Registration status Mifepristone has been approved for use in 48 countries worldwide.10 Misoprostol has been approved for use in 85 countries for treatment and prevention of gastric ulcers and less frequently for treatment of gynaecologic conditions.11 Mifepristone and misoprostol are listed on the WHO essential medicines list for use as abortifacients where legal and acceptable.12 Public-sector price agreements !e Concept Foundation has negotiated a preferential price for the public-sector in developing countries for Medabon®. Other suppliers are also o"ering their product (including combi-packs) at preferential pricing to the developing world. !e number of suppliers is large and continuing to evolve. Pricing varies by manufacturer, is country-speci%c and is o$en dependent upon product demand. C A U C U S O N N EW A N D U N D ER U S ED R EP R O D U C TI V E H EA LT H T EC H N O LO G IE S P R O D U C T B R IE F References 1 World Health Organization (WHO). Frequently Asked Clinical Questions About Medical Abortion: Conclusions of an International Consensus Conference on Medical Abortion in Early First Trimester, Bellagio, Italy. Geneva: WHO; 2006. 2 Winiko" B, Dzuba IG, Creinin MD, et al. Two distinct oral routes of misoprostol in mifepristone medical abortion: a randomized controlled trial. Obstetrics and Gynecology. 2008;112(6):1303–1310. 3 Tang OS, Chan C, Ng E, Lee S, Ho P. A prospective, randomized, placebo-controlled trial on the use of mifepristone with sublingual or vaginal misoprostol for medical abortions of less than 9 weeks gestation. Human Reproduction. 2003;18(11):2315–2318. 4 von Hertzen H, Huong NTM, Piaggio G, et al., for the WHO Research Group on Postovulatory Methods of Fertility Regulation. Misoprostol dose and route a$er mifepristone for early medical abortion: a randomized controlled noninferiority trial. BJOG 2010; 117(10): 1186-96. 5 International Consortium for Medical Abortions (ICMA). !e ICMA Information Package on Medical Abortion: Information for Health Care Providers. London: ICMA; 2008. 6 Misoprostol Alone page. Medical Abortion website. Available at: www.medicationabortion.com/misoprostol/index.html. Accessed February 7, 2011. 7 Grimes DA. Estimation of pregnancy-related mortality risk by pregnancy outcome, United States, 1991 to 1999. American Journal of Obstetrics and Gynecology. 2006;194(1):92–94. 8 Mifeprex in the United States page. Mifeprex website. Available at: http://www.earlyoptionpill.com/section/health_professionals. Accessed February 7, 2011. 9 Fernandez MM, et al. Assessing the Global Availability of Misoprostol. International Journal of Gynecology and Obstetrics. 2009;105,180-186. 10 List of Mifepristone approval page. Gynuity website. Last updated June 2010. Available at: http://gynuity.org/resources/ info/list-of-mifepristone-approval/ Accessed February 7, 2011. 11 Map of Misoprostol Approval page. Gynuity website. Last updated March 2009. Available at: http://gynuity.org/resources/ info/map-of-misoprostol-approval/ Accessed February 7, 2011. 12 Mifepristone-Misoprostol page. WHO Essential Medicines Library website. Available at: http://apps.who.int/emlib/ MedicineDisplay.aspx?Language=EN&MedIDName=443%40mif epristone%20+%20misoprostol. Accessed February 7, 2011.

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