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Caucus on New and Underused Reproductive Health Technologies Misoprostol for maternal health oral misoprostol was associated with a significant reduction in the rate of postpartum hemorrhage Misoprostol can be used for a number of obstetric compared to women not using a uterotonic.3 A indications that address maternal health concerns. significant reduction in PPH was also observed with Misoprostol acts as a uterotonic by stimulating strong oral misoprostol when administered by traditional contractions of the uterus and also softens and dilates birth attendants during home deliveries in Pakistan.4 the cervix, similar to the natural process of labor. Its uses related to maternal health are many and The 2012 World Health Organization (WHO) include the prevention and treatment of postpartum recommendations for the prevention and treatment of hemorrhage, labor induction, treatment of incomplete postpartum hemorrhage and the 2012 WHO Priority abortion and miscarriage, induced abortion, treatment Life-saving Medicines for Women and Children of missed abortion, treatment of intrauterine fetal state that in settings where oxytocin is unavailable or death, and cervical ripening before delivery or cannot be safely used, the use of oral misoprostol (600 uterine instrumentation. μg) is recommended for prophylaxis.5,6 WHO's 17th Model List of Essential Medicines includes the use of Dosing regimens vary depending on the medical 600-μg oral misoprostol for prevention of PPH.7 indication. For labor induction and cervical ripening before delivery, the dose can be as low as For the treatment of PPH: In women who were
25 mg; however, other indications require a dose of given prophylactic oxytocin as part of the active between 400 and 800 mg. Recommended routes of management of the third stage of labor, misoprostol administration are oral, sublingual, rectal, or vaginal. and oxytocin were found to be clinical y equivalent In 2012, the International Federation of Gynecology when used to stop excessive postpartum bleeding.8 and Obstetrics (FIGO) revised dosage guidelines for In women not exposed to prophylactic oxytocin, all obstetric indications.
oxytocin was found to be more effective at controlling 1 Misoprostol is available in tablet form, and marketed products typical y have a bleeding within 20 minutes than misoprostol, but shelf life of 18 to 36 months when stored below 25°C researchers concluded that 800-mg sublingual to 30°C (77°F to 86°F) in a dry area. misoprostol might be a suitable first-line treatment in settings in which use of oxytocin is not feasible.9 WHO recommends the use of a prostaglandin drug (including sublingual misoprostol, 800 μg) for treatment of PPH if intravenous oxytocin is For the prevention of postpartum hemorrhage
unavailable, or if the bleeding does not respond (PPH): Misoprostol is an effective uterotonic
in situations where use of oxytocin or other injectable uterotonics that require refrigeration and For the treatment of incomplete abortion and
administration by a skilled provider is not feasible. miscarriage: The efficacy of misoprostol to treat
For these reasons, misoprostol can be especial y useful incomplete abortion and miscarriage is between 91 to in home deliveries. In a multicenter study conducted 99 percent, equivalent to the use of manual vacuum in hospitals, oxytocin performed marginal y better aspiration.* Medical management of incomplete than oral misoprostol in controlling blood loss.
abortion and miscarriage with misoprostol provides In a study of women delivering at home in India, a good opportunity to scale up post-abortion care * For a complete list of references and discussion, please refer to the Post-abortion care (PAC) Service Delivery Toolkit located at www.vsinnovations.org/ services.** WHO's 17th Model List of Essential deliveries) when the drug is distributed by community Medicines and its Priority Life-saving Medicines for health workers to women planning to deliver at Women and Children include the use of misoprostol home.16,17,18 Programs in Bangladesh, Ethiopia, Kenya, for this indication.6,7 Mozambique, Nigeria, Senegal, Tanzania, Uganda, and For induced abortion***: Effectiveness of
Zambia have shown that distribution at antenatal care visits and by community health workers is effective misoprostol-alone regimens for early-term medical abortion range from 76 to 96 percent. Technical and that misoprostol is used safely and correctly at home deliveries.19 Some countries are now taking steps and policy guidance for health systems, revised in 2012, recommends the use of misoprostol for to scale up the use of misoprostol for PPH prevention in national safe-motherhood programs. induced abortion when mifepristone is not available and provides dosage guidelines for pregnancies up Pilot PAC programs in Mozambique and Rwanda to 12 weeks gestational age, from 12 to 24 weeks, have shown that misoprostol can be safely used as a and beyond 24 weeks.10 Though not as effective as complementary method to manual vacuum aspiration the combination of mifepristone and misoprostol, (MVA) for treatment of incomplete abortion and misoprostol is more widely available than mifepristone miscarriage (evacuation of the uterus), particularly at and has been used safely and successful y for medical lower-level health facilities where the use of MVA may abortion around the world.11 not be feasible, or there may not be health workers For labor induction: Cochrane Reviews have
trained in its use.20 concluded that oral misoprostol is more effective In clinical settings global y, misoprostol is commonly than placebo and at least as effective as vaginal used off label for induction of labor and cervical dinoprostone for induction of labor with doses not ripening, and in combination with mifepristone for exceeding 50 μg; similarly, while vaginal misoprostol medical abortion, where legal y permissible.21 is more effective than other conventional methods, low-dose oral misoprostol is preferable.12,13 WHO and Manufacturer/supplier FIGO recommend the use of oral (25 μg, at two-hour intervals) or vaginal (25 μg, at six-hour intervals) More than 50 branded and non-branded generic misoprostol for the induction of labor.1,14 versions of 200-mg misoprostol tablets are manufactured by pharmaceutical companies in high-, middle-, and low-income countries including Current program/sector use Argentina, Bangladesh, Brazil, Chile, China, Egypt, In developing countries, programs to introduce or France, India, Mexico, Pakistan, Peru, Russia, expand the use of misoprostol into the health system South Korea, and the United States.22 Some of these for some obstetric indications are being implemented. manufacturers are making products for export to Misoprostol is included on the national essential low- and middle-income countries, but many only medicines lists in more than 20 countries. make products for their local markets. Cytotec® WHO recommends that misoprostol can be used by (manufactured by Pfizer) is the most widely available community health care workers and lay health workers misoprostol product. The few manufacturers of for PPH prevention when skilled birth attendants the 25-mg tablet include Cipla Pharmaceuticals are not present.
(India), Adwia Pharmaceuticals (Egypt), and Hebron 5 A similar recommendation for lay health workers is included in WHO's 2012 guidelines on optimizing health worker roles for maternal Misoprostol is eligible for the WHO's Prequalification and neonatal health, though advanced provision of of Medicines Programme, but no product is yet misoprostol to pregnant women is deemed a priority prequalified.23 As part of its Quality Assurance Policy for Reproductive Health Medicines, the For the prevention of PPH, studies in Afghanistan, United Nations Population Fund (UNFPA) has Bangladesh, and Nepal show that women can use set up an Expert Review Panel (ERP) to assess misoprostol consistently and safely (even for twin whether reproductive health products (including misoprostol) from manufacturers that apply for ** Further information on the treatment of incomplete abortion with misoprostol and service delivery guidelines for integrating misoprostol into PAC services can be found at http://vsinnovations.org/resources.html or http://www.ipas.org/ma/mpactoolkit and http://gynuity.org/resources/info/guidebook-on- *** For more information on misoprostol for induced medical abortion, please see the Caucus brief Mifepristone and Misoprostol for on Medical Abortion.
WHO prequalification could be recommended for Public-sector price agreements use before achieving prequalification.24 A product made by Exelgyn (France) has passed the ERP process, There are no global public-sector price agreements for but is only registered for use with mifepristone for misoprostol. Governments can purchase a misoprostol termination of pregnancy. Efforts are underway to product that is registered in their country and can negotiate the price with the distributor that holds the provide technical assistance to generic manufacturers of misoprostol products that can be registered for market approval. other obstetric indications, with the aim of building their capacity to pass the ERP process and achieve WHO prequalification.25 1. International Federation of Gynecology and Obstetrics Registration status (FIGO). Misoprostol Safe Dosage Guidelines. United Kingdom: FIGO; 2012. Available at: http://www.figo.org/ Registration, or market approval of a drug by a country's drug regulatory agency, grants permission for a product from a specific manufacturer to be 2. Gülmezoglu AM, Vil ar J, Ngoc NT, et al. WHO multicentre marketed in that country by a pharmaceutical randomised trial of misoprostol in the management of the third stage of labour. The Lancet, 2001;358(9283):689–95.
distributor for the medical indications for which 3. Derman RJ, Kodkany BS, Goudar SS, et al. Oral misoprostol the application was made. The registration status of in preventing postpartum haemorrhage in resource-poor misoprostol varies. Misoprostol is most commonly communities: a randomised controlled trial. The Lancet. registered for prevention and treatment of gastric ulcers; Cytotec® is registered in more than 80 4. Mobeen N, Durocher J, Zuberi N, et al. Administration of countries for these two indications. In many misoprostol by trained traditional birth attendants to prevent postpartum haemorrhage in homebirths in Pakistan: a countries, misoprostol may be legal y used off label randomised placebo-controlled trial. BJOG 2011;118(3):353– for obstetric indications. Misoprostol is increasingly being registered for 5. World Health Organization (WHO). WHO Recommendations obstetric indications. Exporting manufacturers that for the Prevention and Treatment of Postpartum Hemorrhage. Geneva: WHO; 2012. Available at: http://www.who.int/ have registered products for obstetric indications, mostly in sub-Saharan Africa and South Asia, include Acme Formulations (India), Cipla Pharmaceuticals 6. WHO. Priority Life-saving Medicines for Women and Children (India), Sigma Pharmaceuticals (Egypt), Square 2012. Geneva: WHO; 2012. Available at: http://www.who.int/ Pharmaceuticals (Bangladesh), Zizhu Pharmaceuticals (China), and Fourtts Laboratories (India), and there 7. WHO. Model List of Essential Medicines (17th Edition). Geneva: are likely to be others. WHO; 2011. Available at: http://whqlibdoc.who.int/hq/2011/ Products are registered for obstetric indications in 8. Blum J, Winikoff B, Raghavan S, et al. Treatment of post- more than 20 countries, including Bangladesh, Bolivia, partum haemorrhage with sublingual misoprostol versus Cambodia, Ethiopia, India, Kenya, Malawi, Mali, oxytocin in women receiving prophylactic oxytocin: a Mozambique, Myanmar, Nepal, Pakistan, Senegal, double-blind, randomised, non-inferiority trial. The Lancet. Somaliland, Sudan, Tanzania, Uganda, and Zambia. More registrations are expected in the coming years 9. Winikoff B, Dabash R, Durocher D, et al. Treatment of post- partum haemorrhage with sublingual misoprostol versus in response to increasing demand. The approved oxytocin in women not exposed to oxytocin during labour: a indications vary across countries; in some countries, double-blind, randomised, non-inferiority trial. The Lancet. products are only registered for PPH prevention and treatment, while in others they are registered 10. WHO. Safe Abortion: Technical and Policy Guidance for for multiple obstetric indications. The indications Health Systems (second edition). Geneva: WHO; 2012. for which the drug is granted approval usual y depend on the level of commitment and willingness 11. Faundes A, et al. Misoprostol for the termination of pregnancy of governments to integrate misoprostol into safe- up to 12 completed weeks of pregnancy. International Journal motherhood programs. More information on the of Gynecology & Obstetrics. 2007;99(2):S172–177.
global status of misoprostol registration can be found 12. Alfirevic Z, Weeks A. Oral misoprostol for induction of labour. Cochrane Database of Systematic Reviews. 2006;2:CD001338.
13. Hofmeyr GJ, Gülmezoglu AM, Pileggi C. Vaginal misoprostol 19. Prata N, Mbaruku G, Campbell M, Potts M, Vahidnia F. for cervical ripening and induction of labour. Cochrane Controlling postpartum hemorrhage after home births in Database of Systematic Reviews. 2010;10:CD000941.
Tanzania. International Journal of Gynecology & Obstetrics. 14. WHO. Recommendations for Induction of Labour. Geneva: WHO; 2011. Available at: http://whqlibdoc.who.int/ 20. Sahin-Hodoglugil N, Graves A and Prata N. The role of misoprostol in scaling up postabortion care. International 15. WHO. Optimizing Health Worker Roles to Improve Access Perspectives on Sexual and Reproductive Health. 2011;37(3):158.
to Key Maternal and Newborn Health Interventions Through 21. Weeks AD, Fiala C, Safar P. Misoprostol and the debate over Task Shifting. Geneva: OptimizeMNH, WHO; 2012. Available off-label drug use. BJOG. 2005;112(3):269–272.
at: http://www.optimizemnh.org/. 22. Fernandez MM, et al. Assessing the Global Availability 16. Sanghvi H, Ansari N, Prata JVN, Gibson H, Ehsan A, Smith of Misoprostol. International Journal of Gynecology and J. Prevention of postpartum hemorrhage at home birth in Afghanistan. International Journal of Gynecology and 23. WHO Prequalification of Medicines Programme website. Available at: http://apps.who.int/prequal. 17. Rajbhandari S, Hodgins S, Sanghvi H, et al. Expanding 24. United Nations Population Fund (UNFPA). Quality Assurance uterotonic protection following childbirth thought Policy for Reproductive Health Medicines. New York: UNFPA; community-based distribution of misoprostol: operations 2012. Available at: http://www.unfpa.org/public/home/ research in Nepal. International Journal of Gynecology and 25. Concept Foundation. Quality of Reproductive Health Medicines 18. Nasreen HE, Nahar S, Mamun M, Afsana K, Byass P. Oral Program. Available at: http://www.conceptfoundation.org/ misoprostol for preventing postpartum haemorrhage in home births in rural Bangladesh: how effective is it? Global Health 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 Supplies 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 May 2013

Source: http://www.rhsupplies.org/fileadmin/uploads/rhsc/Working_Groups/New_Underused_RH_Technologies_Caucus/Documents/Technical_Briefs/rhsc-brief-misoprostol_A4.pdf

Pii: s0196-0644(99)70419-

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