I’ll talk about miso and I hope some of you are specifically interested in integrating it or scaling it up in your programs, but many of the challenges and opportunities are applicable to improving access to ANY medicine or technology. How many of you are familiar with miso for PPH? For PAC? For MA? How many use or have used miso in your programs or materials? Anyone else considering it?...
First, for those of you who don’t know VSI, we are a nonprofit committed to improving women’s health in developing countries by creating access to effective and affordable technologies on a large scale. Our flagship program is around improving access to the generic drug misoprostol.
Misoprostol comes as a heat-stable tablet. Three misoprostol tablets, when taken immediately after childbirth, help stop bleeding. Excessive bleeding after childbirth, or postpartum hemorrhage, accounts for 25% of maternal deaths globally and up to 34% in sub-Saharan Africa. 99% of these deaths occur in developing countries, where women most often give birth at home, far from a health facility or skilled provider. Any woman can take misoprostol to prevent PPH. The tablets are taken orally and side effects are manageable at the household, making misoprostol an ideal public health intervention to take to scale.
VSI and partners have been conducting such investigation and findings are very promising. Program briefs are in folders and ops research reports are on our website. But today I’ll focus on the challenges to widespread implementation….
From our Presidents talk at Woodrow Wilson ctr last year: Apologies if any of you saw it then I will talk re each of these; but grouped the last 3 together as barriers to access at a local level This is not without challenges, but there are solutions. For example, with misoprostol, it is a highly sensitive product because of its alternative uses. We have found that local champions are the most effective advocates in their countries, and that policy meetings give a chance for scientific evidence to be analyzed and all voices to be heard. The need to institutionalize the intervention is about including it in the technical guidelines for each country. We have found that local policy makers are effective decision-makers when provided with scientific evidence. The lack of trained providers that is so predominant in any discussion of health care in developing countries can be addressed in cases like misoprostol with task shifting and sharing. The challenge of rural, remote environments is tackled my mapping local agencies and engaging public and private partnerships. And, finally, the challenge of high prices is addressed by breaking down all of the elements of cost to the end user and working to reduce each one through techniques like price competition with more than one product on the market, subsidization, and bulk purchasing.
Champions and professional associations are KEY to success ABORTION This has been the biggest challenge^The most successful route is to appeal to policy makers mandate to reduce MMR and provide evidence on how making miso avail for PPH AND PAC can do that: Another response that I like is the analogy that bicycle spokes can induce abortion too; but they are on the market PROMOTING HOME BIRTHS evidence shows that not the case: miso for PPH is a stopgap measure: but the gap is BIG only about 42% of the childbirths are assisted by a skilled attendant in the Africa region (WHO Afro) in many places the facilities nor human resources are currently insufficient to handle the caseload of all women delivered at facilities INFERIOR TO OXYTOCIN this is true; in WHO RCT; ,oxytocin performed slightly better than miso: however what happens out of controlled setting:::EG where oxy is not kept in cold chain or administered within 1 minute of birth of baby due to need for setting up injection::: Results from Egypt WORKING WITH TBAS if setting with high percentage of births attended by TBA; worth fighting for Med Director once said %Make no excuses for misoprostol% We fundamentally disagree with Gülmezoglu and colleagues’ interpretation of their findings. We think that the study, done largely in lessdeveloped countries, has been inappropriately interpreted from the perspective of the more-developed world. They show a difference in the incidence of major postpartum haemorrhage between misoprostol and oxytocin (4% vs 3%). The group’s interpretation is that misoprostol is not as good as oxytocin in hospital. Our interpretation, however, is that misoprostol is almost as effective as oxytocin. Given that misoprostol is cheap, safe, and stable, and, unlike oxytocin, is affordable to most less developed countries, we believe that this finding offers hope to the battle against maternal mortality due to haemorrhage. Even from the perspective of the moredeveloped world, Gülmezoglu and colleagues’ findings suggest that misoprostol is probably a useful addition to the therapeutic options for the prevention and management of postpartum haemorrhage. * Pat O’Brien, University College Hospital, London
FIGO&ICM endorse miso use in absence of oxy or where no skilled attendants in Call to Action (2006) WHO: In the absence of active management of the third stage of labour, a uterotonic drug (oxytocin or misoprostol) should be offered by a health worker trained in its use for prevention of PPH. (Strong recommendation, moderate quality evidence) – admit that it is still open for interpretation at program planning time, eg WHO has not defined what CBD of miso means; to be resolved? AND ON WHO EML FOR TIA (09)
Describe importance of each: NEML usually means automatic procurement and distribution in public sector
What challenges have you faced (or can you imagine facing) in integrating miso for PPH (or PAC) into your work?...
TASK SHIFTING Here again we face resistance to TBAs and other community workers: Evidence shows they can do it: Drug sellers often already carry miso and sell at exorbitant prices for MA; must be informed re other indications and have correct information No standard agreement between program implementers & WHO; but practical approach
Example of IEC material from Kenya pilot program for prevention of PPH at the community level, use if necessary
Example of IEC material from Kenya pilot program for prevention of PPH at the community level, use if necessary
BLOOD LOSS - Example Tanzania: Women bring old Kanga cloth to delivery as “pads” to put under the buttocks for soaking up blood 2 soaked Kangas = approx. 500 ml of blood COST - At three tablets, even including all of the elements of cost, the price of each birth protected from PPH is about 80 cents. MISO is as safe and effective as MVA for TIA and has a lot of important advantages, MISO ALONE is also safe and effective for MA; though slightly lower completion rates than mife and miso combined, as with other Tx for IA and MA there will be cases of incomplete following administration of miso; so a woman needs correct info re how to identify IA and when and where to seek further medical attention Doses for MISO for labor induction are very small and this is an important risk of ruptured uterus, assist registration of 25 mcg tab; educate providers
The work is complex and takes time, but it is worth it. The need is evident. These are quotes from our programs. … By looking holistically across an entire health care system, bringing in great interventions, leveraging existing infrastructure, and supporting local partners, we can have lasting impact.
In order to reach scale, success will be determined by how well we integrate this new intervention into the work of local agencies on the ground. One of our critical success factors has been the wonderful partnerships we’ve been able to develop with Ministries of Health, social marketers like PSI, MSI, and DKT, program implementers like Pathfinder, Jhipego, IPPF affiliates, Engender Health, commercial distributors, and a myriad of local NGOs, professional medical organizations, and community and women’s groups who are actively reaching out within their communities on a daily basis. We achieve far more together than we could ever dream of on our own. This slide shows examples of IEC materials that are developed specific to each country’s local context, and a training of trainers.
Note: Check Rwandan treatment guidelines for any other guidance about the use of misoprostol for any of the indications. Make sure that the regimens provided here parallel the treatment guidelines, if available. Please note that many other regimens for misoprostol use in obstetrics and gynecology are also available from other resources. These tables are compilation of information from many different references. Note/Reminder: Misoprostol tablets come in 200mcg, 100mcg and 25mcg
Implementing best practices postpartum hemorrhage_Alisha Graves_10.14.11
Misoprostol for PPH: Overcoming Challenges Alisha Graves, MPH Senior Programs Manager CORE Group Conference Washington, DC October 13-14, 2011
<ul><li>Hormone-like substance </li></ul><ul><li>Uterotonic: Contracts the uterus, ripens the cervix </li></ul><ul><li>Approved by the FDA in 1984 (Cytotec) for the prevention of peptic ulcer during NSAID treatment </li></ul>What is Misoprostol?
The case of misoprostol Misoprostol is capable of curbing maternal mortality due to postpartum hemorrhage & unsafe abortion <ul><li>Effective, evidence-based intervention </li></ul><ul><li>Heat-stable, low-cost, generic tablets </li></ul><ul><li>Simple to administer without skilled attendance </li></ul>Ideal in low-resource settings & supported by international health organizations
Improving community-based drug provision <ul><li>“ Interpretation Community provision of misoprostol and antibiotics to reduce maternal deaths from post-partum haemorrhage and sepsis could be a highly effective addition to health-facility strengthening in Africa. Investigation of such interventions is urgently needed to establish the risks, benefits, and challenges of widespread implementation.” </li></ul><ul><li>Source: Pagel et al. Estimation of potential effects of improved community-based drug provision, to augment health-facility strengthening, on maternal mortality due to post-partum haemorrhage and sepsis in sub-Saharan Africa: an equity-effectiveness model. The Lancet, 2009. </li></ul>
Challenges and solutions for large-scale implementation
Challenge #1: Political sensitivity <ul><li>Objections! </li></ul><ul><ul><li>Abortion </li></ul></ul><ul><ul><li>promoting home births </li></ul></ul><ul><ul><li>inferior to oxytocin </li></ul></ul><ul><ul><li>working with TBAs </li></ul></ul><ul><li>Identify and support local experts and advocates </li></ul><ul><li>scientific evidence & global policies support its use </li></ul><ul><li>www.vsinnovations.org offers resources to help you prepare an advocacy toolkit </li></ul>
Overcoming Political Sensitivities Global Policies and Scientific Evidence <ul><li>WHO added misoprostol to its Model Essential Medicines List for Treatment of Incomplete Abortion & PPH prevention ( WHO, 2009; 2011) </li></ul><ul><li>Misoprostol reduced PPH by half (RR=0.53), when compared to not using anything in community settings in India ( Derman et al.Lancet, 2006) </li></ul><ul><li>Community based distribution of misoprostol was found to be safe, effective and acceptable in both Afghanistan and Nepal ( Sanghvi et al. IJGO, 2010; Rajbhandari et al. IJGO, 2010) </li></ul><ul><li>A recent study from Bangladesh reported 81% protection against primary PPH when used in community settings (Hashima-E-Nasreen et al., Global Health Action 2011) </li></ul>
Challenge #2: Barriers to Access on a National Level <ul><li>Institutionalization </li></ul><ul><li>Registration </li></ul><ul><li>Addition to national essential medicines list </li></ul><ul><li>National guidelines and job aids </li></ul><ul><li>Public procurement and distribution </li></ul><ul><li>National curricula </li></ul>
Global Misoprostol Registration by Indication NEPAL INDIA TANZANIA & ZANZIBAR NIGERIA * Misoprostol may or may not be registered for gastric ulcers Registered for postpartum hemorrhage (PPH) & treatment of incomplete abortion* Registered for PPH and other ob/gyn indication* Registered for PPH* Registered for another ob/gyn indication, not PPH* Registered for gastric ulcers only BANGLADESH ZAMBIA UGANDA SUDAN GHANA KENYA Last updated: August 2011 SOMALILAND MOZAMBIQUE PAKISTAN SIERRA LEONE MALAWI ETHIOPIA
Challenge #3: Barriers to Access on a Local Level <ul><li>Lack of trained providers </li></ul><ul><ul><li>Antenatal care distribution </li></ul></ul><ul><ul><li>Community health workers </li></ul></ul><ul><ul><li>Traditional birth attendants </li></ul></ul><ul><li>Rural environments </li></ul><ul><ul><li>Public and private sectors, including pharmacists & drug sellers </li></ul></ul><ul><ul><li>Local implementers </li></ul></ul><ul><ul><li>Social marketing </li></ul></ul><ul><ul><li>Demand generation </li></ul></ul>
Community Awareness Campaign on Birth Preparedness and PPH Prevention <ul><li>Key messages: </li></ul><ul><li>Promote attendance at ANC throughout pregnancy </li></ul><ul><li>Importance of delivering in a health facility </li></ul><ul><li>Plan early for a safe delivery </li></ul><ul><li>PPH consequences & blood loss measurement </li></ul><ul><li>Misoprostol is available at ANC </li></ul>
Other challenges (perceived & real!) <ul><li>Programming for prevention vs treatment </li></ul><ul><li>Estimating blood loss </li></ul><ul><li>Cost </li></ul><ul><li>Safety, eg use for other indications </li></ul>
“ As men, we are the gravediggers in our communities. Since this project came, we have not dug any graves for our women.” - Safe Motherhood Action Group member, Kapiri Mposhi, Zambia “ I had nightmares while I was pregnant because I feared bleeding. I am grateful for misoprostol for protecting me.” - Mother with previous PPH, Hayin Ojo, Nigeria “ Thank you to those who have provided us with this drug. You have given us pride.” - Antenatal care provider, Masaiti, Zambia Thank You
Community mobilization involves the delivery of clear messages through local groups
Summary of Strategies for Community-based Distribution of Misoprostol <ul><li>Treatment </li></ul><ul><li>TBA recognition of PPH and treatment with misoprostol </li></ul><ul><li>Prevention </li></ul><ul><li>ANC distribution </li></ul><ul><li>HEWs trained in PPH management at health post and home births in collaboration with TBAs and other CHWs </li></ul><ul><li>TBA distribution of misoprostol at delivery for PPH prevention </li></ul><ul><li>Private sector </li></ul><ul><li>Hybrid Models: ANC + TBA </li></ul>
Regimens for Misoprostol Indications INDICATION REGIMEN Postpartum hemorrhage prevention 600 mcg, oral Postpartum hemorrhage treatment 1000 mcg, rectal 800 mcg ,sublingual Treatment of incomplete abortion & miscarriage 600 mcg, oral 400 mcg, sublingual Treatment of missed abortion 800 mcg, vaginal 600 mcg, sublingual Labor Induction (live fetus > 24 weeks) 25µg Vaginal (q 4 hrs, max 6 doses) , or 50µg Oral (q 4 hrs, max 6 doses) , or 20µg Oral solution* (q 2 hrs, max 12 doses) Intrauterine Fetal Death (13-17 weeks) (18-26 weeks) (27+ weeks) 200 mcg, vaginal (q 6 hours, max 4 doses) 100 mcg, vaginal (q 6 hours, max 4 doses) 25-50 mcg vaginal (q 4 hours, max 6 doses) Pregnancy termination (36-48 hours after 200 mg mifepristone) (<12 weeks) 800 mcg vaginal 400 mcg oral Pregnancy termination (alone) (<12 weeks) 800 mcg, vaginal (q 6,12 or 24 hours for 3 doses) 800 mcg, sublingual (q 3 hours for 3 doses)