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Asia Regional Meeting on Interventions for Impact in Essential Obstetric and Newborn Care: Prevention and Management of Postpartum Hemorrhage and Pre-eclampsia/Eclampsia and Special Care for Newborns Dhaka, Bangladesh, 4-6 May 2012
Peter Hall, Chief Executive Officer, Concept Foundation, Bangkok and Geneva
Study on quality of misoprostol products Factors influencing quality What is being done to address issues Implications for procurement
Prevention and Management of Postpartum Hemorrhage and Pre-eclampsia/Eclampsia. Dhaka, Bangladesh, 4-6 May 2012
Product availability
Searle (now part of Pfizer), registered misoprostol, as Cytotec, worldwide (except for most subSaharan African countries) for the prevention of gastric ulcers associated with NSAIDs. Misoprostol is widely available as generic formulations and, in many countries, cheaply. Has begun to be registered for obstetric indications in various countries. Included on WHO Model List of Essential Medicines for induction of labour; incomplete abortion; with mifepristone for early abortion; and for prevention of PPH.
Prevention and Management of Postpartum Hemorrhage and Pre-eclampsia/Eclampsia. Dhaka, Bangladesh, 4-6 May 2012
Product availability
In 2009, Ipas estimated are some 50 manufacturers of misoprostol worldwide. In India are some 30 brands of misoprostol and 10 brands of combination packs of mifepristone and misoprostol; are several contract manufacturers giving at least 16 FPP manufacturers; Are at least 20 brands in other lower and middle income countries, excluding China and S Korea. Because of proliferation of products, Gynuity Health Projects funded Concept Foundation to undertake a study on quality of misoprostol FPPs.
Prevention and Management of Postpartum Hemorrhage and Pre-eclampsia/Eclampsia. Dhaka, Bangladesh, 4-6 May 2012
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Prevention and Management of Postpartum Hemorrhage and Pre-eclampsia/Eclampsia. Dhaka, Bangladesh, 4-6 May 2012
Prevention and Management of Postpartum Hemorrhage and Pre-eclampsia/Eclampsia. Dhaka, Bangladesh, 4-6 May 2012
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In the absence of prequalified products, UNFPA has instituted an interim process for product review by a new Expert Review Panel for RH Medicines to be undertaken by WHO. Manufacturers must demonstrate adequate compliance with GMP and a commitment to continue to prequalification. Up to 5 products could complete this process in 2-6 months.
Prevention and Management of Postpartum Hemorrhage and Pre-eclampsia/Eclampsia. Dhaka, Bangladesh, 4-6 May 2012