International Journal of Gynecology and Obstetrics- Global availability of misoprostol

Publication date: 2006

International Journal of Gynecology and Obstetrics (2006) 94 (Supplement 2), S151---S152 www.elsevier.com/locate/ijgo Global availability of misoprostol Martha Campbell a,*, Melodie Holden b,1 a School of Public Health, University of California, 506 Warren Hall, Berkeley, CA 94720-7360, USA b Venture Strategies for Health and Development, 1700 Shattuck Avenue #208; Berkeley, CA 94709, USA Misoprostol is registered as a gastric ulcer drug in many middle to high income countries; it is also used 'off label' in these same countries to prevent and control PPH. Its ease of administration and sta- bility in tropical climates make it an ideal drug for use in home births, as well as with Active Manage- ment of the Third Stage of Labor (AMTSL) in any busy hospital [2]. Until this year, however, misoprostol was not registered for any indication in most coun- tries in Sub-Saharan Africa, where maternal mortal- ities are among the highest in the world [3]. Since 2000, at the request of obstetricians from Nigeria, Kenya and Tanzania, the California-based nonprofit organization Venture Strategies for Health and Development (VSHD), has been working to se- cure the approval and distribution of misoprostol in low resource settings. VSHD is well positioned for such work because of its interest in making needed generic medicines available on a large scale at af- fordable prices. In addition, it is able to work with the private markets as well as with governments. For its scientific base, VSHD works in collaboration with the School of Public Health at the University of California, Berkeley. In January 2006, VSHD facilitated the registration of misoprostol in Nigeria, the most populous country in Africa. Not only did the government of Nigeria ap- prove the use of misoprostol, but it became the first * Corresponding author. Tel.: +1 510 524-4320. E-mail: campbell@berkeley.edu (M. Campbell). 1 Web address: www.venturestrategies.org 0020-7292/$ --- see front matter © 2006 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved. country in the world to register this drug for preven- tion and treatment of PPH. Because of the need for rapid access to misoprostol to save women' s lives, Nigeria' s drug regulatory authority fast-tracked the approval, and classified it as an 'orphan drug' . Four months later, Ethiopia approved the use of miso- prostol for controlling PPH, placing it on the coun- try' s Essential Drugs List. Tanzania took this impor- tant step in May 2006. In both countries, preparation for product registration is under way. Ethiopia' s Min- istry of Health is immediately launching availability of misoprostol through the government health sys- tem, while Nigeria has begun its distribution in pri- vate pharmacies as a prescription drug. This latter arrangement is reasonable, because research has shown that the lowest economic quintiles in low re- source countries are more likely to seek health care from the private sector than government hospitals for a variety of reasons [4]. Hence it is important that the misoprostol, backed by appropriate educa- tion and training, is made available in the private as well as the public sector. References [1] Prata N, Mbaruku G, Campbell M, Potts M, Vahidnia F. Con- trolling postpartum hemorrhage after home births in Tanza- nia. Int J Gynecol Obstet 2005;90:51---5. [2] Prata N, Hamza S, Gypson R, Nada K, Vahidnia F, Potts M. Misoprostol and active management of the third stage of labor. Int J Gynecol Obstet 2006;94(2):149---55. [3] UN Millennium Project. Public Choices, Private Decisions: S152 M. Campbell, M. Holden Sexual and Reproductive Health and the Millennium De- velopment Goals. United Nations Development Programme, 2006. [4] Prata N, Montagu D, Jeffreys E. Private sector, human re- sources and health franchising in Africa. Bull World Health Organ 2005;83(4):274---9.

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