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CONTENTS

Executive Summary 3

Background 4Methodology 5

Organizational Goals, Strategies, and Activities 6

Compelling Needs, Passionate Responses 8

Perceived Barriers and Suggested Strategies 10

Summary and Recommendations 16

Conclusion 18

Appendixes 19

Appendix A: List of Organizations Contacted 20

Appendix B: List of Available Materials 21

Appendix C: Interview Guide 25

Appendix D: Activities by Organization 26

Appendix E: Map of Organizational Involvement 34

March 2011 Family Care International

Conducted by Francine Coeytaux and Elisa Wells

Photo credits: Joey OLoughlin, Sarah Nimeh


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Postpartum hemorrhage (PPH) is the single largestcause o maternal mortality worldwide, accountingor nearly one-quarter o maternal deaths. Preventingand treating PPH is especially difficult in places wheremost births occur in homes or local clinics and accessto emergency services, obstetric care, and surgery islimited. Evidence to date shows that misoprostol can

play an important, perhaps lie-saving, role in prevent-ing and treating PPH. It remains unclear, however, howmisoprostols clinical efficacy translates into programeffectiveness in different contexts, particularly at thecommunity level and or home births. In addition, therecontinues to be great variability in clinical practice andlack o clear, evidence-based policies and guidelines toenable policy makers to make sound decisions related tointroducing misoprostol at the national level.

o address these issues, Family Care International(FCI), working with Gynuity Health Projects, commis-sioned this survey to begin to map current activities andapproaches o the many organizations working globallyon misoprostol or PPH. Over 30 organizations wereasked to describe their organizational activities, sharetheir motivations or involvement, discuss the barriersthey have encountered in use o misoprostol, and sug-gest strategies or addressing these barriers. Tis report

details the findings o the survey and makes recommen-dations on how to move orward.

One o the clearest findings rom this exercise is that theuse o misoprostol or PPH is rapidly gaining traction

with organizations working to improve womens health.An impressive (and growing) number o organizationsare working in this area, and most o the respondentsmade the case or integrating the use o misoprostol intoreproductive health services programming worldwide.Tere is a belie among respondents that misoprostoloffers a real opportunity to make a difference in mater-nal mortalityone that is not dependent on waitingor health systems to be strengthenedand they wantto act on this opportunity as quickly as possible to save

womens lives.

1Since the interviews were conducted, WHO began the process of updating its guidelines for the prevention and treatment of PPH.

EXECUTIVE SUMMARY

Given the rapid orward momentum around miso-prostol, action is needed to address key barriers inseveral areas:

Consensus on evidence-based guidelines: Respon-dents noted the absence o a global consensus, andclear and updated evidence-based guidelines ormisoprostol use or PPH; they specifically highlightedthe lack o strength and clarity o the World HealthOrganization (WHO) guidelines (specifically relatedto the role o misoprostol in prevention o PPH andits use at the community level). Respondents calledor WHO to review available data and produce clearand updated guidelines as soon as possible.1

Te association of misoprostol with abortion:

Rather than hiding misoprostols abortion indicationto avoid controversy, this indication should be pre-sented as one o many ways misoprostol can potentiallysave womens lives.

Misoprostols role at the community level:Moreoperations research is needed to determine the easi-bility and desirability o distribution o misoprostolor PPH at the community and home level, includ-ing distribution through pharmacies and direct useby women.

Products:While several organizations are working toaddress the product-related issues associated withmisoprostolincluding appropriate dosages, labeling,and packagingmore needs to be done to address theact that the drug is already readily accessible. Inorma-tion about the proper use o misoprostol needs to begiven directly to women and the pharmacists, tradi-tional birth attendants, and others who serve them.

While the true extent to which misoprostol can benefitwomens health remains to be seen, it is clear that it isquickly being integrated into reproductive health pro-

gramming. Urgent action is needed to ensure that it ismade available to women in ways that best benefit themin terms o saety and effectiveness.

Mapping Misoprostol for Postpartum Hemorrhage: Organizational Activities, Challenges, and Opportunities


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Postpartum hemorrhage (PPH) is a serious medi-cal problem in need o urgent attention. PPH is thesingle largest cause o maternal mortality, accountingor nearly one-quarter o maternal deaths worldwide.Effectively preventing and treating PPH is especially di-ficult in areas where most births occur in homes or localclinics and access to emergency services, obstetric care,and surgery is limited.

Efforts to address PPH have ocused primarily on ac-tive management o the third stage o labor (AMSL),

with oxytocin as the preerred uterotonic drug. More

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BACKGROUND

recently, however, the availability, and in some casespromotion, o the drug misoprostol as an alternativewhen AMSL and oxytocin are not available has madethe discussion about how to best prevent and treat PPHmore complex.

Evidence to date shows that misoprostol, an oral tabletinitially designed to prevent gastric ulcers, can playan important role in preventing and treating PPH. Itremains unclear, however, how misoprostols clinicalefficacy translates into program effectiveness in differ-ent contexts, particularly at the community level andor home births. In addition, there continues to be great

variability in clinical practice, with health providers em-ploying differing regimens and routes o administration,

and lack o clear, evidence-based policies and guidelinesto enable policy makers to make sound decisions relatedto introducing misoprostol at the national level. Anadditional issue is that misoprostol can also be used toinduce abortion, raising concerns among some policymakers about its introduction or other indications.o address these issues, FCI is working with Gynu-ity Health Projects and other partners to develop anevidence-based policy and advocacy agenda or promot-ing misoprostol or PPH at the global, regional, andcountry levels. An important step in this process is to

map current activities and approaches o the many orga-nizations working globally on misoprostol or PPH. Te

primary objectives o the mapping exercise were to:

map key advocacy goals, messages, and strategies usedby organizations working on misoprostol or PPH;

identiy advocacy and policy priorities and challenges;and

assess opportunities or collaboration, and advocacyand policy change at the global, regional, andcountry levels.

Tis report details the findings and recommendationso the survey, including the methodology, organization-al motivations or involvement in misoprostol work,organizational activities, perceived barriers, and suggest-ed strategies or addressing barriers. Te report recom-mends key areas or moving orward.



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Te survey was conducted between April and September2010. As a starting point, a list o 17 individuals at 16 orga-nizations known to be working on the use o misoprostolor PPH was prepared, and each was sent a letter o invita-tion to participate. Phone interviews were conducted withthese individuals, with a 100% response rate.

As the interviews progressed, it became clear that addi-tional organizations needed to be included in the survey.Additional contacts were identified using a snowballsampling technique that relied on inormation rom theoriginal interviews as well as knowledge o organizationsand contacts working in reproductive health. Input rom14 additional organizations was included in the mappingsurvey; in total, 41 individuals representing 30 organiza-

tions participated. A ull list o the participating organiza-tions can be ound in Appendix A.

Interviews ollowed an open-ended questionnaire cover-ing topics such as: current organizational activities relatedto using misoprostol or PPH (advocacy, policy, research,program implementation, etc.); perceived barriers to usingmisoprostol or this indication; and possible strategies oraddressing the barriers. Respondents were asked to provideinormation about and links to publications and materialsproduced on the topic (Appendix B). A copy o the surveyquestionnaire can be ound in Appendix C.

Data were compiled or each survey question, and thenanalyzed or content to identiy both common themes andunique but important perspectives. For the responses tothe question, What are the main barriers to using miso-prostol or PPH? the number o organizations that men-tioned different types o barriers were tallied to get a roughsense o the relative perceived importance o the variousbarriers mentioned. When several interviewees rom thesame organization mentioned the same barrier, this wascounted as one mention. With the exception o Appendix

D, which lists activities by organization, all responses havebeen reported without attribution to protect the confiden-tiality o interviewees.

Te results are limited by several actors, including:

Sampling: Because a snowball sampling technique wasemployed, there is no way o knowing which or howmany organizations working on this topic might havebeen missed. However, given the interviewers knowledge

o the field and the act that most o the major U.S.-based international nongovernmental organizations(NGOs) are involved in reproductive health, the surveyis airly comprehensive. A more problematic limitation isrelying on the report o a single individual to represent anorganizations entire scope o work related to misopros-tol; while interviews were sometimes conducted withmultiple individuals at a single organization, in mostcases only a single individual was interviewed. As a result,important inormation and perspectives may havebeen missed.

Reporting bias:Te group o organizations working onthe use o misoprostol or PPH is a small one, in whicheveryone knows each other. While confidentiality was

ensured, given the politically charged nature o some othe questions, some respondents may have tempered orqualified their responses. Nevertheless, in general,respondents showed a remarkable openness to discussthe topic, and several shared inormation they identifiedas confidential.

Interviewer bias:While data were analyzed as objec-tively as possible, interviewers personal knowledge andattitudes may have biased the interpretation o the com-ments. Tis was controlled by independently tabulatingthe data and by checking one interviewers interpretation

against the others. ime:Limited time prevented a deeper investigation o

country-specific activities and approaches. Te scope owork also did not include an in-depth review o articlesand other print materials that interviewees provided.Many o these contain inormation about organizationalapproaches to advocacy and messaging about misopros-tol or PPH that could have helped inorm the recom-mendations. FCI will produce a separate report withthese findings.

On a positive note, none o the respondents hesitated toparticipate in the survey. On the contrary, all were verywilling to talk, and many expressed appreciation or theexercise, saying they looked orward to seeing the results.Te act that every person contacted took the time toparticipate in the survey was another indicator o just howcompelled everyone is to address the problem o PPH (seediscussion o results).

METHODOLOGY



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Respondents were asked about their organizational goalsand strategies relating to the use o misoprostol or PPH

prevention and treatment. Respondents overwhelminglyindicated that their primary goal was to reduce maternalmortality. Almost everyone spoke o the huge toll oPPH on womens health and lives and the urgent needto take action.

Within this broad goal, organizations reported usingmultiple strategies and implementing a wide range oactivities related to the use o misoprostol or PPH,including operations research, policy guidance, advo-cacy, product registration and quality assurance, and

program implementation (see Appendix D). Someorganizations were ocused in only one area, while oth-

ers were working in multiple areas. Examples o strate-gies employed by organizations are listed in able 1.

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ORGANIZATIONAL GOALS, STRATEGIES, AND ACTIVITIES

Te 30 organizations interviewed are working withmisoprostol in more than 35 countries (see AppendixE). An additional our organizations are working withmisoprostol but have no current activities related tomisoprostol or PPH.

It is worth noting that many o the organizations inter-viewed do not view themselves as specifically promot-ing misoprostol or PPH or even introducing misopros-tol or PPH. Rather, they describe themselves as workingto address PPH using whatever means is best suited tothe specific setting in which they are working; at timesthis means addressing the use o misoprostol. A ew othe organizations interviewed are working to improvematernal health by increasing access to sae abortion

services and/or postabortion care, and have begun toaddress the use o misoprostol or PPH aswell.



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Area of Work Strategies

Research Continue research on safety and eectiveness in particular, the safest dosethat can be used for prevention and treatment and translate that work into

policy and advocacy at the program level Undertake operations research to test the safety of advance distribution of

misoprostol or home use Conduct studies to document the cost eectiveness of using misoprostol to

treat PPH in particular, the cost eectiveness of widespread preventionversus targeted treatment approaches

Policy/Advocacy Ensure that recommendations or the use o misoprostol or PPH are based onsound scientific evidence

Make available evidence-based guidelines on using misoprostol to treat PPH

Disseminate evidence-based information for misoprostol use for various indica-tions, including PPH, by publishing research articles, review articles, and guidelines (such as the International Federation o Gynecology and Obstetrics [FIGO]guidelines) and posting materials on websites such as www.misoprostol.org

Drug Regulation/Drug uality Register and introduce misoprostol in countries where it is not yet registeredor PPH treatment and prevention indications

Assure that a quality misoprostol product is available at an aordable price forPPH indications

Identify poor-quality products and work toward a supply of better-qualityproduct

Program/Service Delivery Scale up PPH prevention activities started under the Prevention of Postpartum

Hemorrhage Initiative (POPPHI); the primary aim is to promote AMSL,but supplement with misoprostol where AMSL is not easible

Increase access to misoprostol to reduce maternal mortality, both through PPHindications and medical abortion

Introduce misoprostol as part of a package of interrelated interventions includ-ing amily planning and the use o magnesium sulate during delivery

Make misoprostol available through facilities, both community and hospital, asa backup or alternative to oxytocin

Make misoprostol available for prevention and treatment of PPH at the lowestlevels possible (as close to the community as possible) and where oxytocin isnot available by training midwives and traditional birth attendants in its use

Reduce maternal mortality by educating nonmedical local community leaders(such as village officials and key opinion leaders) and women themselves aboutusing misoprostol at home births or PPH prevention

TABLE 1. STRATEGIES USED BY ORGANIZATIONS WORKING

ON MISOPROSTOL FOR PPH



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Organizations were asked why it was worthwhile toinvest resources in misoprostol or PPH. Most o therespondents were passionate about the need or their

work in this area, reiterating the overall concern aboutreducing maternal mortality as well as raising othercompelling issues. Below are the key reasons identifiedby respondents or investing in misoprostol, along withdirect quotes rom interviewees. (Note: these are therespondents perceptions and may not always be sup-

ported by the available evidence.)

MISOPROSTOL CAN SAVE WOMENS LIVES.

We believe that anything that can have an impact onPPH, which is a major cause o maternal mortality, should

be addressed.PPH is still a leading cause o maternal mortality. Womendont have that many options or prevention/treatment. Areduction in risk o even 3050% is a good enough reasonto make it available.

We work on maternal health and mortality, and PPH isthe main cause [o mortality] misoprostol can make a

significant difference.

Misoprostol is a lie saver, especially at the community level.

MISOPROSTOL FILLS AN UNMET NEED INTHE CONTINUUM OF PPH CARE: WOMENDELIVERING AT HOME.

We see misoprostol as part o the continuum o care orPPH, which includes AMSL and/or misoprostol, [use oan] anti-shock garment or stabilization, and transport toa higher-level acility.

Misoprostol is currently the only way we have o helpingwomen without access to health services. In the long term,we hope that misoprostol will not be needed because womenwill have access to attended birth, oxytocin, etc.

Right now, misoprostol is the only tool that exists orunskilled people at the home and community level.

I there is something that saely prevents PPH or womendelivering at home, it would be a very important toolto promote.

We saw a big gap in countries where maternal mortality ishighestwomen deliver at home and there is nothing tohelp them. Misoprostol can help them.

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WOMEN DESERVE TO BE EMPOWERED TOHELP THEMSELVES HAVE SAFE BIRTHS.

Tere is one person who will always be present at birth: the

woman hersel. Tereore, she should be empowered to helphersel, even in the absence o skilled care.

Regardless o WHOs loy goals or skilled attendants atbirth, many women deliver at home. Tis is because

acilities are too crowded or women cant get there (ora variety o reasons). It may take us 25 to 30 years to getto the point that most births are attended, i we can evenreach that point. In the meantime, women are dying

fom preventable causes, and misoprostol needs to get intowomens hands.

MISOPROSTOL IS OUT THERE BEING USEDWE NEED TO PROMOTE SAFE USE.

Because misoprostol is available and being used, it isimportant to understand and promote evidence-based

practices or its sae use in reproductive health applications.For instance, we have heard anecdotal reports o ruptureduteri and high evers associated with misoprostol use(though not clear i this is associated with PPH use or orinduction). We need to know more in order to promote

sae guidelines.

Tough there is lots o talk about limiting circulation[in Nigeria], it is widely available to women throughother means.

In Asia, we see lots o products on the market, primarilymarketed or abortion.

MISOPROSTOL WILL HELP EXPANDUTEROTONIC COVERAGE.

Te only way to get universal uterotonic coerage is withan oral uterotonic.

Oxytocin is the first choice or effectiveness, but since itis still not available in many areas or its quality is com-promised, it is important to make an effective alternativeavailable.

We know that women give birth in low-resource settingswhere no oxytocin is available.

COMPELLING NEEDS, PASSIONATE RESPONSES



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Interviewees provided rich details about the numerousbarriers to and complexities o introducing misoprostolor PPH prevention and/or treatment. Barriers rangedrom practical issues, such as the lack o a globalconsensus, clear guidelines, and availability o a miso-

prostol product labeled or PPH use, to broader societalconcerns, such as a lack o willingness to empower wom-en to participate in their health care and the controversysurrounding the use o misoprostol or abortion.

Reported barriers are listed here in order o perceivedimportance (as roughly indicated by the number o or-ganizations that mentioned each barrier), with the mostrequently mentioned barriers listed first:

Lack o global consensus and clear, updated evidence-

based protocols and guidelines Association with abortion Concerns about saety and side effects Product issues Controversy over who can provide misoprostol at the

community level Fear o womens empowerment

More detailed descriptions o each barrier are below,ollowed by strategies suggested by respondents oraddressing them.

LACK OF GLOBAL CONSENSUS AND CLEAREVIDENCE-BASED PROTOCOLS

Te lack o global consensus and evidence-based proto-cols was the most requently mentioned barrier. Spe-cifically, respondents spoke o the lack o strength andclarity o the WHO guidelines or misoprostol use orPPH (particularly related to its role in prevention oPPH and use at the community level). Many intervie-

wees acknowledged the difficulties o sorting throughavailable research to determine the best protocol recom-

mendations (i.e., studies have used different approaches/doses/routes o administration, some are less rigorousthan others, etc.). Some respondents noted that WHOcan play an important role in ormulating a clear set oguidelines or inorming programming and policy; many

PERCEIVED BARRIERS AND SUGGESTED STRATEGIES

RESPONDENTS SUGGESTIONS FOR ADDRESS-

ING LACK OF CLEAR AND UPDATED GLOBAL

GUIDELINESUpdate WHO guidelines related to misoprostol for

PPH and add to Model Essential Medicines List (EML).

Over and over, respondents called for clear, evidence-

based guidelines on misoprostol use for PPH and to

add misoprostol to the EML for this indication. Sug-

gestions for accomplishing this included: organizations

joining together to exert more pressure on WHO to use

existing data to develop a recommendation in line with

the FIGO/ICM statement; holding another meeting with

WHO and NGO leaders to secure the WHOs commit-

ment to develop clearer guidelines.2

Use evidence-based advocacy.Many respondents

mentioned the success of and need for furtherevidence-based advocacy to help governments and

programmers understand the benets and risks of

using misoprostol in their programs. Some recommend-

ed urging countries to think independently of WHO

to make their own evidence-based decisions. Several

mentioned the strategy of gaining stakeholder

support using evidence-based advocacy, and then

piloting programs to demonstrate effectiveness in a

real-life setting.

A number of respondents urged that advocacy

focus not on misoprostol but rather on appropriate

strategies for prevention and treatment of PPH in dif-

ferent settings, which may include misoprostol and/or

other uterotonics.

Encourage NGO coordination and cooperation.One

respondent suggested that international NGOs work-

ing in a given country synchronize their agendas so

that messages about misoprostol are consistent and a

broad range of audiences (doctors, midwives, pharma-

cists, governments, womens groups, etc.) are reached

without duplication of effort.

Another respondent suggested that programs having

success with misoprostol for PPH could have an inu-

ence in convincing programs in neighboring countries

of their region to adopt a similar approach. Regionalbodies could also play a role. If, for example, the Afri-

can Union were to endorse misoprostol for PPH, one

could use this to encourage supportive policies at the

country level.


2Since the interviews were conducted, applications for the addition of misoprostol for prevention and treatment of PPH to the WHOs Essential Medicines Listwere submitted for consideration with the WHO Expert Committee during their meeting from March 2125 2011.


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One respondent pointed out that because misoprostolis widely available in many countries (through officialor unofficial channels), talk about limiting circulationdue to concerns that it might be used or abortion is not

productive:

Given the widespread availability o misoprostol, this con-cern shouldnt be used as an excuse not to make it available

or PPH.

CONCERNS ABOUT SAFETY AND SIDEEFFECTS

More than hal o the organizations mentioned concernsabout saety and side effects as barriers:

We need more evidence that it doesnt do more harmthan good.

Comments about saety ocused mainly on the con-cern that misoprostol can cause uterine rupture i usedimproperly or induction or augmentation o labor, ori given too early or PPH prevention (as in the case oan undelivered twin). About a third o the respondentsraised this issue:

People have big saety concernssuch as taking it at thewrong time during labor and possible ruptured uterus.

Misoprostol is a powerul drug.

Several people qualified their responses, saying that whilethis was something that is important to be aware o, it

should not be overstated:I am not saying that misoprostol is unsae, but there areearly signs that are worrisome and we need to tread verycareully.

Others suggested that the risks o misoprostol use needto be considered in conjunction with the benefits, statingthat the benefits ar outweigh concerns o overdosingor incorrect use:

Many people are more concerned about what might happenwith an intervention (i.e., side effects) than what might hap-

pen without an intervention (i.e., maternal death). In thiscase, women are more likely to be harmed by omission o theintervention than fom any danger posed by the interven-tion itsel.

Only a ew people mentioned concerns about sideeffects, stating that we need better inormation aboutoptimal dosing to reduce shivering and ever.

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RESPONDENTS SUGGESTIONS FOR ADDRESS-

ING THE ASSOCIATION WITH ABORTION

Focus messaging on value of misoprostol, lives saved.

To take the focus away from misoprostols potential usefor abortion, concentrate advocacy on the value of its

multiple uses and its potential for saving lives. Empha-size that there are multiple avenues to reduce maternalmortality and that misoprostol can play several rolesin abortion, postabortion care (treatment of incompleteabortion and miscarriage), PPH, etc. One respondentnoted that in Latin America, governments are chang-ing their opinions about the abortion issue due to adecrease in maternal mortality with greater availabilityof misoprostol.

Add misoprostol to safe delivery kits. Addingmisoprostol for PPH to safe delivery kits has been asuccessful approach in Pakistan because misoprostolis clearly part of postpartum care and the correctdosage is provided. Introducing misoprostol in thisway has not generated concerns about its potentialuse for abortion.

Control distribution of misoprostol to prevent

misuse.One suggestion to address the abortionconcern of some governments was to establish acentral depot for misoprostol at the community level(through community health workers, midwives, etc.)for controlled distribution to pregnant women of thecorrect dose for PPHalong the lines of a controlledsubstance registry.

Mount a legal challenge.One respondent recommend-ed mounting a legal challenge against a government

in a country (with high maternal mortality due to PPH)that restricted access to misoprostol. The suit would beon behalf of a woman who gave birth at home withoutmedical assistance, had a hemorrhage, and was unableto access misoprostol due to government restrictions.

Go under the radar.Introduce misoprostol for noncon-troversial uses, such as PPH, with the tacit understand-ing that it may also be used for abortion.

said that i this is not made clear up ront, the intro-

duction process could be derailed midstream by anti-abortion opponentsas occurred in Indonesia. Othersdisagree, as evidenced by these quotes:

We try to go under the radar to avoid controersy.

We eel there is tremendous promise or use o misoprostolor PPH, so we do not want to jeopardize that application

by highlighting the other indications.



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RESPONDENTS SUGGESTIONS FOR ADDRESSING

CONCERNS ABOUT SAFETY AND SIDE EFFECTS

Conduct additional, targeted research.Although abouthalf of respondents felt that research was sufcient to

move forward with using misoprostol for PPH, numer-ous respondents identied specic research needs to

strengthen the evidence base for decision making bypolicy makers and practitioners.

We need to do research and do it well. I have great

respect for my colleagues, but much of the research

that has been done is not quite good enough. We need

to have more concrete outcome measures.

We need to position misoprostol carefully and intro-

duce it well.

Based on frequency of mention, the rough order ofimportance of research needs is:

Distribute within the community for home use.The big-gest call was for operations research on the feasibility ofdistribution of misoprostol at the community and homelevel, including the benets and risks of distribution by

nonskilled workers, distribution through pharmacies,and direct use by women. An important question for theresearch to determine is whether providing misoprostoldiscourages women from accessing health facilities.

Determine the best dosage. A number of respondentsalso felt a need for more research on the lowest effectivedose for prevention of PPH, with the emphasis on ensur-ing effectiveness while decreasing side effects.

Scale up from pilot to wider introduction. Several

people suggested the need for careful design of studiesof scale up from pilot projects to larger-scale introduc-tion with emphasis on good training and monitoring. Thiswould include careful monitoring and evaluation of theadequacy of information given to women about how touse misoprostol, its safety, and its effectiveness.

Examine the costs and benets of use.A couple ofrespondents called for costing studies of communityinterventions in preventing PPH to make the case forgovernments to invest in large-scale national PPHprevention programs. An important cost consideration is

whether to focus on prevention at the community levelor just promote treatment when PPH occurs. Both ap-proaches are possible with misoprostol andhave cost implications for governments. Relatedto this is the question:

Are we overtreating by asking all women to take

misoprostol for prevention? We are asking all

women to take three pills upon delivery, yet not all

will need them. We need to test the alternative of

liberal treatmentwomen would be told to use

misoprostol only if she bleeds a certain amountfor

both effectiveness and cost.

Determine the best route of administration.A couple

of respondents also mentioned that differing practicesrelated to the route of administrationsublingual, oral,vaginal, and rectalneed to be sorted out.

Other research needs mentioned by single individualsincluded:

More research on the uses of misoprostol for

inducing and augmenting labor should be doneso that there can be clear guidelines on its usefor this indication, thus avoiding confusion withdosages used for PPH.

If product quality becomes an issue, research

should be conducted on the stability and shelflife of misoprostol at 25 or 30 degrees Celsius

and high humidity.

In some cases, country-specic operations

research may be needed to identify appropriateservice delivery mechanisms in a specic setting

and/or to satisfy government concerns.

Research on better mechanisms to monitor maternal

mortality is needed.



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PRODUCT ISSUES

About hal o the interviewees mentioned various prod-uct issues as barriers. Tese include:

Dosing and packaging for reproductive healthindications: wo doses o tablet are neededa 25 mcg

dose labeled or induction o labor as well as a 200 mcgtablet or all other indications. Te number o pills perpackage should be appropriate to the indication, andthe packaging should include instructions or repro-ductive health indications.

Registration for reproductive health indications:Registration can be difficult it can take up to ouryears, can be expensive, and can be difficult to negoti-ate. Registration or PPH indications is challengingbecause it is not registered or that indication in theUnited States or the United Kingdom, which many

countries look to as a basis or registration decisions.In addition, drug companies are unwilling to registertheir products or a drug with a potentially controver-sial indication.

Challenges of new drug introduction: Te introduc-tion process at the country level has a lot o stepsdrug registration or PPH indication, worker training,drug monitoring system, etc.

Supply chain problems:Tere are concerns aboutboth inadequacies in drug supply chains leading to

stock-out problems and leakage o unregisteredproduct rom other countries (product coming inacross borders, not labeled, taken out o packaging/blisters, no inormation on use and/or expiration, etc.).

Quality concerns:Te quality o misoprostol is ofenunknown, and this may be a barrier i there is a lot o

substandard product on the market. Misoprostolstored at 25 or 30 degrees Celsius and high humiditymight degrade. Is the emphasis on generic manuactur-ers and products at the expense o product quality?

CONTROVERSY OVER WHO CAN PROVIDE

MISOPROSTOL AT THE COMMUNITY LEVEL

Slightly less than hal o the interviewees mentionedthat concerns about who can provide misoprostol atthe community level were a barrier. Te concerns ellinto two categories. A ew o these respondents elt thatmisoprostol should be provided only by trained health

workers, citing concerns that use by less-skilled workersor in home settings would reduce the use o acilitiesor delivery. A greater number elt that appropriate useo misoprostol (i.e., in situations where women do not

have access to acilities/oxytocin) was being unnecessar-ily stymied by this concern. As one respondent put it:

We get pushback fom people who want to increase access toskilled proiders and who see our [community-based]approach as undermining this.

Several people specifically mentioned that the WHOstatement on misoprostol does not endorse its use incommunity-level distribution:

WHO/MPS [Making Pregnancy Saer] has chosen notto engage itsel with community interventions. While it isimportant to push skilled care at birth, it is still compatibleto push or interventions at the home level. Overall, there is

a lack o global interest in community-based interventions.WHO spent a lot o energy trying to promote BAs, then

abandoned that along with ocus on community-basedwork. We dont have evidence to show that bringing allbirths to acilities is the best way to go (skilled proiders at

acilities have little time, acilities are overcrowded, womenmay be better served at [the] community level with goodeducation/prevention inormation, etc.).

Others mentioned that ministries o health and drug

boards sometimes place restrictions on the level oprovider; denying prescriptive authority to midwivesis one example:

Midwives are the font-line workers in most countries withhigh maternal mortality, so they absolutely need access to

supplies and authority to use them.

Because we anticipated that the issue o qualifiedproviders might be a concern, we specifically askeda direct question about provision o misoprostol by

14

RESPONDENTS SUGGESTIONS FOR ADDRESSINGPRODUCT ISSUES

Register misoprostol products for PPH. There is a

need to have different packages/doses labeled forspecic indications, specically 600 mcg, 200 mcg,and 25 mcg packets, to reduce confusion about its use.

Make misoprostol available through the private sector.

The availability of misoprostol in the private sector (i.e.,pharmacies) may help encourage its use in public sectorprograms. Private sector distributors can help advocatefor product registration. The availability of genericdrugs may help get around the reluctance of themain misoprostol manufacturer to label it for utero-tonic indications.



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traditional birth attendants: Do you think misoprostolcan be saely provided by traditional birth attendants inhome-birth settings? No respondents answered noto this question, about two-thirds answered yes, andone-third declined to comment, stating either that there

was not yet evidence to support an answer one way or

the other, or that they were not qualified to make thatdetermination.

FEAR OF WOMENS EMPOWERMENT

A handul o respondents identified gender and the con-tinued low status o women as a significant barrier to theuse o misoprostol or PPH. Tey highlighted the desireto control women and the ear o giving women controlover their reproduction. One respondent summarized itlike this:

Tis is a gender issue. Misoprostol aces this unbelievablebarrier because it is a drug or women. On the issue o

HIV and circumcision, all o the WHO recommendations,guidelines, and materials were planned out completely in

advance o the study data by a working group conened toaddress this issue. WHO has had data on misoprostol or10 years yet has ailed to adopt lie-saving policies/guide-lines in this area.

Respondents also reported a perception that local medi-cal proessionals are unwilling to give women knowledgeabout and direct access to use o misoprostol because it

RESPONDENTS SUGGESTIONS FOR ADDRESSINGCONTROVERSY OVER WHO CAN PROVIDEMISOPROSTOL

Conduct research to answer concerns about safety

and effectiveness of this approach. See strategies toaddress concerns related to safety, above.

Focus on prevalence of home births.Advocacy shouldemphasize the prevalence of home births. One organiza-tion convinced a minister of health to allow traditionalbirth attendants to provide misoprostol for PPH by point-ing out that 80% of deliveries occur at home.

Engage professional organizations as advocates.

Professional organizations need to be involved in advo-cating for task shifting to ensure that lower-level cadresof staff are authorized to use uterotonics. Professionalgroups, such as country-level FIGO societies, can alsohelp disseminate evidence-based guidelines to providersworking at the community level in their countries.

will mean losing out on income. Tese proessionals siton boards and influence decision making about womensaccess to services. Tis medical bias also pertains to thelack o political will to involve traditional birth atten-dants in service delivery, even though traditional birthattendants are the reality or many women and are here

to stay.

OTHER BARRIERS

Barriers that were stated by only a ew people included:

Concerns about ecacy compared with oxytocin:Te results o clinical trials showing that misoprostol isless effective than oxytocin suggest that it should havea more limited role than some had hoped.

Lack of resources: Te lack o resources or PPHinterventions in general and or misoprostol, specific-

ally, raise questions about how the promotion oAMSL will continue as well as whether countrygovernments will have resources to pay or preventionstrategies, such as universal advance provision o miso

prostol at the community level.

Challenges of training:raining doctors and otherhealth workers at multiple levels about misoprostolmay be challenging because doctors are not amiliar

with its PPH indications and using it may be contraryto what is taught in medical schools (i.e., use ooxytocin).

RESPONDENTS SUGGESTIONS FOR ADDRESS-ING FEAR OF WOMENS EMPOWERMENT

Target women as providers of their own care. Sincewomen often do not have access to providers, we needto target women as the providers of their own care,including educating their family members, since theyare likely to be present at the birth.

Utilize womens organizations networks.Womensorganizations are key players for widely disseminatingthe information that misoprostol exists, is available,and can be used for PPH (and safe abortion).

Otherwise local women will not get this knowledge.

It has to get out of the medical circuit and reach

women directly. The work of non-medical activists is

crucial, there is no conicting agenda (as sometimes

it may be for medical professionals) and no legal

danger for the groups. Provision of scientic infor-

mation is a human right and protected by most

national constitutions.



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Tis mapping exercise makes it clear that the use omisoprostol or PPH is an issue that is rapidly gainingtraction with organizations working to improve womenshealth. Te willingness o respondents to participatein the exercise and the passion with which they madethe case or why they are working on misoprostol isan indication that misoprostol is here to stay and willincreasingly be integrated into reproductive health pro-gramming worldwide. People sense a real opportunity tomake a difference in maternal mortalityone that is notdependent on waiting or health systems to be strength-enedand want to act on it as quickly as possible tosave womens lives.

Growing organizational involvement.In the process o

conducting this mapping, it became clear that the origi-nal scope o work was too limited: the number o people

working on misoprostol or PPH had been significantlyunderestimated. By expanding our net, nearly twice asmany organizations with active involvement in miso-

prostol were identified. Tere are likely even more. It ispossible that in a ew years every organization workingon reproductive health will want to be involved at somelevel, similar to the rapid uptake o programming or

postabortion care.

Urgent need for updated evidence-based guidelines.Given this rapid diffusion o misoprostol or PPH, it isabsolutely critical that there be global consensus aroundevidence-based guidelines or this indication. Te actthat misoprostol is already available in many countriesand being used and promoted or PPH indicationsmakes it all the more urgent that key members o theinternational reproductive health community showleadership in identiying and promoting evidence-basedapproaches. Tis goal is not out o reach, particularlygiven that FIGO/ICM has already come up with clearevidence-based guidelines that are being well received inthe Latin American and Caribbean region.

Te survey ound that the biggest perceived barrier tomoving ahead is WHOs current position on the use omisoprostol or PPH (specifically related to misopros-tols use or PPH prevention and use at the communitylevel). As an alternative, the international reproductivehealth community could put its collective weight be-hind a jointly developed policy statement. Te Interna-tional Consortium or Emergency Contraception is one

example o a successul application o this approach.Alternatively, reproductive health groups could find

ways to bring more attention to an updated version othe FIGO/ICM statement and disseminate it morebroadly through regional and country-level agencies.Tere seems to be a sufficient consensus among a criticalmass o influential organizations to accomplish this.

If the gold standard is not achievable, groups willtry other options to save lives. Te current stalematesurrounding guidelines or the use o misoprostol orPPH appears to stem primarily rom concerns that thereare insufficient data to make a recommendation aboutits distribution and use at the community/home leveland that promoting misoprostol use at this level will

deter women rom seeking care at acilities and/or romtrained providers. While these may be valid concernsrom an intellectual perspective, they ignore the realitythat women ace in giving birth in low-resource settings.Te reality is that care in acilities (including accessto oxytocin) is still not available to a large number o

women despite being a long-standing goal.

Te mapping results show that organizations are notwilling to wait until the gold standard goal o havingall births assisted by skilled providers is achieved. Norare they willing to wait until every angle o research is

exhausted and the way orward is crystal clear. Tey seean opportunity to save lives that is good enough, andthey are moving orward with programs based on theirbest estimate o what works.

Groups will adjust their strategies or using misoprostolor PPH as research findings document the best andsaest approaches. Tereore, the aster the evidence andinormation about best practices can be made available,the aster the reproductive health community will movetoward consistency in use o evidence-based practices.

Addressing misoprostols association with abortion:embracing misoprostols multiple indications.Tesecond biggest barrier to using misoprostol or PPH

was that some o its multiple indications are viewed asbeing problematic and, in some cases, even too contro-

versial to mention. Given the passion that respondentsexpressed or addressing maternal mortality, it is ironicthat many o those working on this issue find themselvestrying to either ignore or hide the act that this drug hasmultiple promises or saving womens lives, including its

SUMMARY AND RECOMMENDATIONS

16 Mapping Misoprostol for Postpartum Hemorrhage: Organizational Activities, Challenges, and Opportunities


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use or abortion. While we acknowledge that local solu-tions to addressing the political implications o miso-

prostols abortion indication will have to be sought, thereneeds to be an international appreciation or the act thatthis is a multi-use drug and that part o the challenge ishaving very good inormation about how it is best used

or each indication labor induction, PPH prevention,PPH treatment, postabortion care,and abortion.

At the country level, a number o respondents men-tioned success with being more open about the multipleindications or misoprostol and that they serve the samegoal: to help save womens lives. In these examples, rankand open discussions with ministers o health and othersled to acceptance o misoprostol or PPH, despite con-cerns about its potential use or abortion. Tis was eventrue in examples rom Latin American countries, whereopposition to abortion is strong. Tis acceptance o and

transparency about misoprostols multiple indications iswhat will help make it available or womens health indi-cations in the long run. From the perspective o healthcare workers who deal with women on a comprehensivelevel, having an easily available drug that can help a

woman throughout the continuum o her reproductiveneeds should be seen as a boon rather than a hindrance.

Te recognition o and acceptance o multiple useso misoprostol also needs to extend to collaborationsbetween agencies working with misoprostol or any

indication. Building a firewall between these differentapplications or the organizations that work on them isdetrimental to progress. In conducting this mappingexercise, the organizations most experienced in work-ing with misoprostol are the ones using it or abortion.But, because o the controversy surrounding this use,the linkages between these groups and those working onmisoprostol or PPH are lacking. I there is going to bea consortium or ormal group o organizations workingon misoprostol or PPH, it should include organizationsthat are using misoprostol or abortion. Te knowledge

these organizations have about the intricacies o drugregistration and supply, as well as service delivery issues,related to misoprostol or abortion is directly relevantto its use or other indications, and these strategies andlessons learned should be shared.

Product is already available; information on use is key.In contrast to other reproductive health products, suchas microbicides, HIV vaccines, and emergency contra-ception, which have required significant investment inand coddling o manuacturers to produce a product,

we find ourselves in the welcome position o having aproduct that is already making its way to women throughexisting supply routes. As respondents indicated, thereclearly are some product-related issues associated withmisoprostolincluding quality, appropriate ormula-tions, labeling, and packagingand some groups are

working to address these by repackaging and registeringmisoprostol or PPH and other reproductive health indi-cations. Tese efforts will lend legitimacy to the productand help to ensure proper use over the long term, butthey will also take time and money.

While some investment in these efforts seems reasonable,it also makes sense to take advantage o misoprostols cur-rent widespread availability, low cost, and relative stabil-ity (compared with other uterotonics) and invest equalor even greater amounts in inorming women and service

providers, including pharmacists, about how to use it.

Because the biggest potential or misoprostol to savelives is at the community/home level, it makes sense toinvest in getting inormation directly to women and the

pharmacists, traditional birth attendants, and others whoserve them. Investment is also needed to add this inor-mation in all reproductive health organization trainingmaterials and medical, nursing, and pharmacy schoolcurricula. Tis off-label approach is consistent withcurrent medical practice in the United States and othercountries where pharmaceutical products are routinely

prescribed and/or used or off-label indications.

Common themes and messaging.Te mapping exerciserevealed a number o common themes and messages thatcan be used to position misoprostol with policy makersand providers. While these were not universally stated,they may serve as a starting point or developing an advo-cacy strategy :

Our goal is to help women survive. Misoprostol has thepotential to save lives.

Women do not have access to health services (andoxytocin) in many areas and likely will not have access

or many years to come. Tat is why misoprostol is socritical.

Misoprostol should be viewed as part o the largercontinuum o efforts to reduce maternal mortality andhas multiple roles within that continuum.

Tere is a continuum o care or PPH prevention andtreatment. Misoprostol fills a specific niche within thatcontinuum that supports and expands AMSL.

Women are capable o using misoprostol saely withaccess to appropriate inormation.



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Given the growing diffusion o misoprostol into mul-tiple acets o the reproductive health arena, this map-

ping exercise was extremely timely. Te organizationsthat participated in this survey are clearly the trailblazerson this issue, but they are soon to be joined by others asmisoprostol becomes part o mainstream reproductivehealth programming. Most were quick to acknowledgethe need or consensus building around misoprostol,and all expressed interest in receiving the results o thismapping exercise.

Te mapping revealed that there are areas o conver-gence, as well as disagreement, within the global policyand scientific communities. In addition, it is clear thatthere are misinormation and misconceptions that mayhave influenced respondents opinions and the strategies

proposed or addressing the key challenges. Building onthe findings o this mapping exercise, and in responseto the challenges outlined in this report, FCI will work

with the global scientific and policy communities toidentiy policy approaches on which consensus can beachieved, to harmonize messages regarding the use omisoprostol or PPH, and to influence policy change insupport o misoprostol at the national and global levels.

While more research is needed to monitor and evalu-

ate the various approaches and strategies being exploredand there are still issues to be worked outmost notablyachieving consensus about what constitutes evidence-based practicemisoprostol clearly shows promise ormeeting several reproductive health needs o women,including the prevention and treatment o postpartumhemorrhage. It is time to capitalize on the ready avail-ability, low cost, and convenience o misoprostol and getit to women in ways that will best benefit them. Many or-ganizations are ready, willing, and already moving ahead.

CONCLUSION

18Mapping Misoprostol for Postpartum Hemorrhage: Organizational Activities, Challenges, and Opportunities


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APPENDIXESAPPENDIX A: LIST OF ORGANIZATIONS CONTACTED

APPENDIX B: LIST OF AVAILABLE MATERIALS

APPENDIX C: INTERVIEW GUIDE

APPENDIX D: TYPES OF ACTIVITIES BY ORGANIZATION

APPENDIX E: MAP OF ORGANIZATIONAL INVOLVEMENT


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1. Aga Khan Health Services

2. BPAS

3. Christiana Care Health Service

4. Concept Foundation

5. DK International

6. Effective Care Research Unit, South Arica

7. EngenderHealth

8. Family Care International

9. Family Health International

10. FIGO/SOGC

11. Gynuity Health Projects

12. Ibis Reproductive Health13. International Conederation o Midwives

14. Ipas

15. Jhpiego

16. John Snow International

17. Latin American Federation o Obstetrics and

Gynecology Societies (FLASOG)

18. MacArthur Foundation

19. Management Sciences or Health

20. Marie Stopes International

21. Pathfinder

22. PAH/POPPHI

23. Population Council

24. Population Services International

25. University o Caliornia, San Francisco

26. University o Illinois, Chicago

27. University o Liverpool

28. USAID

29. Venture Strategies Innovations

30. Women on Waves/Women on Web

31. World Health Organization

APPENDIX A: LIST OF ORGANIZATIONS CONTACTED



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Misoprostol for the reatment of Postpartum Hemorrhage:Findings from Clinical Research rials. http://gynuity.org/downloads/res_sum_pph_treatment_card_en.pdf.

Postpartum Hemorrhage: A Challenge for Safe Mother-hood. http://www.familycareintl.org/UserFiles/File/pdfs/Misoprostol/misopph_challenge_en.pdf.

PPH Manual for Mid-Level Providers(in press).

FIGO/SOGC

Poster and a card outlining the various uses, dosages, and tim-ing of misoprostol use; http://www.figo.org/news/misopros-tol-safe-dosage-guidelines.

GYNUITY HEALTH PROJECTS

Instructions for Use: Misoprostol for Prevention of Post-partum Hemorrhage. http://www.pphprevention.org/files/IFU_PPH_Gynuity.pdf.

Misoprostol for the Prevention of Postpartum Hemorrhage:

Findings from Clinical Research rial in Chitral, Pakistan.http://gynuity.org/resources/info/misoprostol-for-the-preven-tion-of-postpartum-hemorrhage-findings-from-research.

Misoprostol for the reatment of Postpartum Hemorrhage:Findings from Clinical Research rials. http://gynuity.org/resources/info/misoprostol-for-the-treatment-of-postpartum-hemorrhage-findings-from-clinic/.

Postpartum Hemorrhage. Institutional program brief.http://gynuity.org/resources/info/postpartum-hemorrhage-program-brief/.

Postpartum Hemorrhage: A Challenge for Safe Mother-hood. http://www.familycareintl.org/UserFiles/File/pdfs/Misoprostol/misopph_challenge_en.pdf

Peer-reviewed publications

Alfirevic, Z., Blum, J., Walraven, G., Weeks, A., and Winikoff,B. reatment of Postpartum Hemorrhage with Misoprostol.International Journal of Gynaecology and Obstetrics99, Suppl. 2(2007): S2025.

Blum, J., Alfirevic, Z., Walraven, G., Weeks, A., and Winikoff,B. Prevention of Postpartum Hemorrhage with Misoprostol.International Journal of Gynaecology and Obstetrics99, Suppl. 2(2007): S19820.

Blum, J., Winikoff, B., Raghavan, R., Dabash, R., CherineRamadan, M., Dilbaz, B., Dao, B., Durocher, J., Yalvac,S., Diop, A., Dzuba, I. G., and Ngoc, N. . N. reatmentof Post-partum Haemorrhage with Sublingual MisoprostolVersus Oxytocin in Women Receiving Prophylactic Oxytocin:

A Double-Blind, Randomised, Non-inferiority rial. Lancet375, no. 9710 (2010): 21723.

Durocher, J., Bynum, J., Len, W., Barrera, G., and Win-ikoff, B. High Fever Following Postpartum Administrationof Sublingual Misoprostol. British Journal of Obstetrics andGynaecology117 (2010): 84552.

Hofmeyr, G. J., Fawole, B., Mugerwa, K., Godi, N. P., Blig-naut, Q., Mangesi, L., Singata, M., Brady, L., and Blum, J.Administration of 400 g of Misoprostol to AugmentRoutine Active Management of the Tird Stage of Labor.

International Journal of Gynaecology and Obstetrics112, no. 2(2011): 98102. doi:10.1016/j.ijgo.2010.08.019

Mobeen, N., Durocher, J., Zuberi, N. F., Jahan, N., Blum, J.,Wasim, S., Walraven, G., and Hatcher, J. Administration ofMisoprostol by rained raditional Birth Attendants to PreventPostpartum Haemorrhage in Homebirths in Pakistan: A Ran-domised Placebo-Controlled rial. British Journal of Obstetricsand Gynaecology, Epub December 2010. doi: 10.1111/j.1471-0528.2010.02807.x

Sloan, N., Durocher, J., Aldrich, ., Blum, J., and Winikoff,B. What Measured Blood Loss ells Us About PostpartumBleeding: A Systematic Review. British Journal of Obstetrics andGynaecology117 (2010): 788800.

Walraven, G., Blum, J., Dampha, Y., Sowe, M., Morison, L.,Winikoff, B., and Sloan, N. Misoprostol in the Managementof the Tird Stage of Labour in the Home Delivery Setting inRural Gambia: A Randomised Controlled rial. British Journalof Obstetrics and Gynaecology112, no. 9 (2005): 127783.

Widmer, M., Blum, J., Hofmeyr, G. J., Carroli, G., Abdel-Aleem, H., Lumbiganon, P., Ngoc, N. . N., Wojdyla, D.,Tinkhamrop, J., Singata, M., Mignini, L. E., Abdel-Aleem,M. A., Tach, . S., and Winikoff, B. Misoprostol as Adjunctreatment to Standard Uterotonics for reatment of Post-par-tum Haemorrhage: A Multicentre, Double-Blind Randomisedrial. Lancet375, no. 9728 (2010): 180813.

Winikoff, B., Dabash, R., Durocher, J., Darwish, E., Ngoc,N. . N., Len, W., Raghavan, S., Medhat, I., Chi, H. . K.,Barrera, G., and Blum, J. reatment of Post-partum Haemor-rhage with Sublingual Misoprostol Versus Oxytocin in WomenNot Exposed to Oxytocin During Labour: A Double-Blind,Randomised, Non-inferiority rial. Lancet375, no. 9710(2010): 21016.

Zuberi, N., Durocher, J., Sikander, R., Baber, N., Blum, J., andWalraven, G. Misoprostol in Addition to Routine reatmentof Postpartum Hemorrhage: A Hospital-Based RandomizedControlled-rial in Karachi, Pakistan. BMC Pregnancy Child-birth21, no. 8 (2008): 40.

JHPIEGO

Preventing Postpartum Hemorrhage: A Community-BasedApproach Proves Effective in Rural Indonesia. http://www.jhpiego.jhu.edu/resources/pubs/mnh/PPHpgmbrief.pdf.

Preventing PPH: Community Based Distribution of Miso-prostol. http://www.wilsoncenter.org/events/docs/5.%20Policy%20and%20Practice_Harshad%20Sanghvi.ppt.

Prevention of Post Partum Hemorrhage at Home Birth: AProgram Implementation Guide. http://www.accesstohealth.org/toolres/pdfs/PPH%20Implementation%20Guide_web.pdf



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PATHFINDER

PPH Continuum of Care tool kit including informationabout misoprostol for PPH. http://www.pathfind.org/site/PageServer?pagename=Pubs_PPH.

raining video includes information about misoprostol forPPH, and examples from Bangladesh, Nigeria, India, and Peru.

POPULATION SERVICES INTERNATIONAL

Misoprostol Prevents Excessive Bleeding After Childbirth.Poster (Zambia).

Como usar o MISO apos o parto para proteger a vida damae. Poster (Mozambique).

Use o MISO apos o parto para proteger a vida mae. Poster(Mozambique).

Use of Misoprostol for Prevention of Postpartum Haemor-rhage. Poster (Uganda Ministry of Health).

Decision Chart for Administration of Misoprostol for thePrevention of PPH.

Decision Chart for Administration of Misoprostol for thereatment of PPH.

ake Action Safe Delivery Card.

PREVENTION OF POST-PARTUM HEMORRHAGE

INITIATIVE (POPPHI)

All information and materials are available on the POPPHIwebsite, www.pphprevention.org.

Armbruster, D. Lessons Learned: Scale-up of Active Manage-ment of the Tird Stage of Labor and Challenges for Miso-prostol. PAH, 2009. http://gynuity.org/downloads/arm-bruster,_lessons_learned-_scale-up_of_active_management.pdf; accessed September 9, 2010.

UNIVERSITY OF CALIFORNIA, SAN FRANCISCO

Miller, S., et al. Randomized Double Masked rial ofZhiByed 11, a ibetan raditional Medicine, Versus Misopros-tol to Prevent Postpartum Hemorrhage in Lhasa, ibet. Jour-nal of Midwifery and Womens Health54, no. 2 (2009): 13341.

Sutherland, ., et al. Community-Based Distribution ofMisoprostol for reatment or Prevention of Postpartum

Hemorrhage: Cost-Effectiveness, Mortality, and MorbidityReduction Analysis.International Journal of Gynecology andObstetrics108, no. 3 (2010): 28994.

UNIVERSITY OF ILLINOIS, CHICAGO

http://gynuity.org/downloads/geller,_current_evidence_for_use_of_misoprostol_for_preventi.pdf

UNIVERSITY OF LIVERPOOL

www.misoprostol.org

http://www.figo.org/news/misoprostol-safe-dosage-guidelines

USAID

USAID materials are produced through collaborating agencies(see POPPHI and other cooperating agency websites).

VSIVENTURE STRATEGIES INNOVATIONS

Misoprostol Information, Education and Communication:Examples from the Field. http://www.vsinnovations.org/re-sources/VSI_Misoprostol_IEC_Field_Examples.pdf.

All misoprostol publications are accessible at http://www.vsinnovations.org/resources.html.Search by misoprostol todownload the following titles:

Community-Based Availability of Misoprostol: Is It Safe?

Community-Level Prevention of Postpartum Hemorrhage:Te Role of Misoprostol Evaluation in Brief

Cost-Effectiveness of Misoprostol to Control PostpartumHemorrhage in Low-Resource Settings. International Jour-nal of Gynaecology and Obstetrics97, no. 1 (2007): 5256.

Misoprostol Distribution at Antenatal Care: PreliminaryReport in Brief

Misoprostol for Postpartum Hemorrhage in Zanzibar:Evaluation and Policy Brief

Misoprostol Registration Map Global registration status of misoprostol for obstetric uses

Misoprostol: Strategies, Successes, and Challenges

Prevention of Postpartum Hemorrhage at Home Births inAghanistan: Averting Maternal Death and Disability

Prevention of Postpartum Hemorrhage: Options for HomeBirths in Rural Ethiopia

Saving Maternal Lives in Resource-Poor Settings:Facing Reality

WOMEN ON WAVES/ WOMEN ON WEB

Misoprostol hotline and user materials, Pakistan, June 2010.http://www.womenonwaves.org/set-2253-en.html.

Misoprostol Saves Womens Lives: Information for WomenAbout Misoprostol. http://www.womenonwaves.org/set-274-en.html.

Women on Waves. SuhaileMisoprostol HotlineLaunch in Pakistan [press release]. June 25, 2010.http://www.womenonwaves.org/article-2262-en.html.



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WORLD HEALTH ORGANIZATION

Report of the 17th Expert Committee on Selection and Useof Essential Medicines [unedited draft]. Geneva: World HealthOrganization, 2009. http://www.who.int/selection_medicines/committees/expert/17/WEBuneditedRS_2009.pdf;accessed on

June 11, 2009.

WHO Recommendations for the Management of PostpartumHaemorrhage and Retained Placenta. Geneva: World HealthOrganization, in press. http://whqlibdoc.who.int/publica-tions/2009/9789241598514_eng.pdf.

WHO Recommendations for the Prevention of PostpartumHaemorrhage. Geneva: World Health Organization, 2007(WHO/MPS/07.06).http://www.who.int/making_pregnancy_saf-er/publications/WHORecommendationsforPPHaemorrhage.pdf.

WHO Statement Regarding the Use of Misoprostol for Post-partum Haemorrhage Prevention and reatment, 2009. http://

whqlibdoc.who.int/hq/2009/WHO_RHR_09.22_eng.pdf.

OTHER SOURCESAbraham. C. Misoprostol: When Health and Moral Values Col-lide. June 25, 2010. http://www.theglobeandmail.com/news/

world/g8-g20/maternal/when-health-and-moral-values-collide/article1618325/; accessed September 8, 2010.

Fernandez, M., Coeytaux, F., Gomez Ponce de Leon, R., andHarrison, D. Assessing the Global Availability of Misoprostol.International Journal of Gynecology and Obstetrics105,no. 2 (2009): 18086.

Potts, M., Prata, N., and Sahin-Hodoglugil, N. Maternal Mor-tality: One Death Every 7 Min. Lancet 375, no. 9728 (2010):176263.http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(10)60750-7/fulltext - aff1#aff1.



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Background

As you know, Family Care International (FCI) is work-ing with Gynuity Health Projects and other partners to

develop an evidence-based policy and advocacy agendaor promoting misoprostol or PPH at the global,regional, and country levels. An important step in this

process is to map the current policy and advocacy strate-gies among the many organizations working globally onmisoprostol or PPH.

During this interview we will be asking you about:

your organizations goals and activities related topromoting misoprostol or PPH (both preventionand treatment), and

what you perceive as policy and advocacy prioritiesand challenges.

We will keep all responses confidential. FCI will sendyou a copy o the mapping report when it is done.

Section A: Organizational Goals and Strategies

1. What is your organizations main goal(s) in promot-ing misoprostol or PPH related to research, policy &advocacy, and/or project/program implementation

over the next 12 years?2.Whydoes your organization think it important to

investin or ocus on promoting misoprostol or itsPPH indications?

3. What are the main activitiesyour institution ispursuing to promote misoprostol or PPH over thenext 12 years?

4. Who are your main target audiencesor promotingmisoprostol or PPH?

a. At the globallevel?

b. At the regionallevel? c. At the countrylevel?

5. What materials(i.e., policy/advocacy, educationalmaterials) related to misoprostol and PPH have yourorganization produced/published in the past 2 years?Please share copies with FCI.

Section B: Overcoming Barriers, PromotingEffective Strategies

6. In your opinion, what are the main barriersto

promoting misoprostol or PPH: a. At the global levelrelated to research (clinical and

operations), policy/advocacy, and project/pro-gram implementation?

b. At the country levelrelated to research (clinicaland operations), policy/advocacy, and project/-

program implementation?

7. What specific actionsdo you think can be undertaken to overcome these barriers?

d. Bypolicy makers? e. By health providers?

. By international/UN agencies and partnerships?Probe or specifics.

g. Are there other key actors or players (such ascommunity/womens groups) who can play a rolein expanding access to misoprostol or PPH?

8. Do you think that the data currently available aresucientto convince policy makers to invest inmisoprostol or PPH? I not, what additional

research is needed?

9. In your view, what are the key areas of controversy/

debate related to promoting greater use o misopros-tol or PPH?

10. Do you think misoprostol can be safely provided bytraditional birth attendantsin home-birth settings?

Probe: How do you see the promotion o misopros-tol or PPH in remote settings fitting in with inter-national recommendations related to skilled attendance at birth?

11.Are there upcoming global eventsor other orumsthat would provide opportunities or influencing

policy change in support o misoprostol or PPH?

Tank you or your participation. Would you be will-ing to participate in a ollow-up interview or answeradditional questions?

APPENDIX C: INTERVIEW GUIDE



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Organization Activity Countries

EngenderHealth Works in the community to train tra-ditional birth attendants on the use omisoprostol or PPH.Conduct a pilot program or community-

based distribution o misoprostol orPPH prevention. Field workers distributemisoprostol (three-tablet packet with userinstructions) to pregnant women.Provides AMSL training or service

providers in maternity wards.

Nepal

Bangladesh

Bangladesh and Nepal

Family Care International In collaboration with Gynuity Health Proj-ects, publishedPostpartum Hemorrhage: AChallenge or Sae Motherhood, providinga act sheet and specific actions that policymakers and other stakeholders can under-

take to address the problem.ProducedPPH Manual or Mid-Level

Proidersin collaboration with AgaKhan Health Services, Pakistan in Urdu(in press).

With Gynuity Health Projects, publishedpocket cards outlining PPH preventionand treatment that highlight the mainfindings rom the Gates-unded researchtrials.Conducts ongoing advocacy and policy

work at the global, regional, and nationallevels to harmonize messages, buildconsensus, and promote supportive

policy change.

Global

Pakistan

Global

Global

Family Health International Works with misoprostol, but detailedinormation was not available in time orthis report.

Global

FIGO/SOGC Plans advocacy work on misoprostol ormember associations (with Gynuity HealthProjects).Publish guidelines or misoprostol use.Publish misoprostol study results in

journals, special issues, and commissionedarticles.

Global

GlobalGlobal



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Gynuity HealthProjects

Current activities:

Develops approaches to promote evidence-based policyand service delivery models or the prevention and treat-ment o PPH using misoprostol with a ocus on low-

resource environments and community-based services.Clinical and operations research objectives and activitiesinclude:Evaluation o the saety and efficacy o administeringmisoprostol both prophylactically and therapeutically.Comparison o the administration o oxytocin in

Uniject to oral misoprostol or PPH prevention atthe community level.

Comparison o the effect o oxytocin administeredintravenously and intramuscularly when given as a

primary component o AMSL.Identification o pathways or the sae and effective

use o misoprostol or PPH outside o tertiary-levelacilities, including at the community level.

Conducts additional advocacy and policy activities incollaboration with partner agencies (see descriptions orConcept Foundation, Family Care International, FIGO,PAH, Populations Services International [PSI], Uni-

versity o Caliornia, San Francisco [UCSF], Universityo Illinois, Chicago [UIC], University o Liverpool,

WHO).

Global; research to beconducted in Aghanistan,Bolivia, Burkina Faso, Ecuador,Egypt, Ethiopia, India, Kenya,

Mali, Nepal, Nigeria, Pakistan,Senegal, anzania, unisia,urkey, Uganda, and Vietnam

Previous activities:With Aga Khan University and Aga Khan Health Ser-vices, conducted community-based study to test whether600 mcg oral misoprostol reduces the incidence o PPH

when administered by traditional birth attendants dur-ing the third stage o labor ollowing home births.

With the Effective Care Research Unit, East London,South Arica, conducted research to determine the valueadded by using misoprostol in conjunction with oxyto-cin or PPH prevention.

With country partners, conducted large-scale,

multi-site, randomized controlled clinical trials onthe effectiveness o misoprostol or the treatment o

primary PPH (800 mcg sublingual misoprostol com-pared with 40 IU oxytocin [IV] or stopping hemor-rhage in tertiary care acilities).

With WHO, conducted clinical trial to evaluatewhether 600 mcg sublingual misoprostol plus standardinjectable uterotonic treatment o PPH has an addition-al benefit in reducing postpartum blood loss.

Pakistan

South Arica, Nigeria, andUganda

Burkina Faso, Ecuador, Egypt,

urkey, and Vietnam

Argentina, Egypt, SouthArica, Tailand, and Vietnam

28 Mapping Misoprostol for Postpartum Hemorrhage: Organizational Activities, Challenges, and Opportunities


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Management Sciencesor Health (MSH)

Trough partnership with other organizations, ispromoting best practices in sae motherhood andprioritizing the most effective interventionscontributing to prevention o maternal deaths.

Nepal, Bangladesh, and Malawi;South Sudan is in the planning stage

Marie Stopes Interna-tional (MSI)

Is working to register misoprostol in severalcountries or PPH (also or medical abortion and

postabortion care) either as a first-time registrationor re-registering it under the MSI brand name.In collaboration with Venture Strategies Innova-tion (VSI) and Ministry o Health, managed jointresearch study on the use o 200 mcg misoprostolor treatment o postabortion care and treatment/

prevention o PPH. Te study was intended to leadto misoprostol inclusion in the Essential MedicinesList or postabortion care and national protocol

or PPH. Te dossier has been submitted or drugregistration (or postabortion care only); a decisionis pending. Extensive training and supervision are

provided or public sector providers.

Additional inormation orthcoming

Madagascar

Pathfinder Is involved in introducing misoprostol in reugeecamps in northern anzania, with trained providersduring antenatal care. Women who are planning ahome birth are given misoprostol or use at home.Introduced misoprostol as part o more generalmaternal and child health (MCH) project.Provides training in misoprostol use at all levels(including traditional birth attendants at commu-nity level) as part o overall PPH training.Is planning a PPH project (with misoprostol oracility and community use as one component) as

part o an integrated amily health project.Conducts PPH work as part o a large maternaland child health project, including training tradi-tional birth attendants.rains all levels o providers in using misoprostolor prevention and treatment as part o overallmanagement o PPH.Is conducting a study on use o misoprostol ortreatment o PPH at the acility level.Distributes a misoprostol birth kit given to womenby community health agents, which includes threetablets o misoprostol and a blood collection matto measure blood loss. Provides counseling andtraining o staff at acilities that treat women with

pregnancy-related complications.

anzania

Burundi

Nigeria

Ethiopia

Mozambique

India

Peru

Bangladesh



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PAH/POPPHI Is working with Gynuity Health Projects onoperations research.Is studying use o oxytocin in Uniject.

Vietnam

Guatemala, Honduras, Indonesia,Ghana, India, and Mali; interest in

Argentina and NicaraguaPopulation Council Works with Ministry o Health and Venture

Strategies to distribute misoprostol throughyouth groups.Works with VSI and JSI to include misoprostoland instructions in sae delivery kits that aregiven to midwives (who also receive training).

With VSI, is developing plan to providemagnesium sulate or preeclampsia that willbe bundled with misoprostol.Is working with MSI on misoprostol or medi-

cal abortion and postabortion care.

Ethiopia

Pakistan

Northern Nigeria

Ghana and Bangladesh

Population ServicesInternational (PSI)

Is working with VSI to get drug registered incountry.Distributes misoprostol, including purchasingand importing the drug, vouching or qual-ity, overbranding (sometimes), detailing, anddistributing only to providers.Provides training or health care providers.Develops and distributes materials or detailers,

providers, and consumers.Conducts situation analysis, monitoring, andevaluation.In partnership with Gynuity, is designing aresearch study to gather more inormation onthe market and use o misoprostol in Uganda.


Zambia

Nigeria and IndiaAdditional inormation orthcoming


Uganda

University o Caliornia,San Francisco

Is conducting Millennium DevelopmentVillages research in Ghana in partnership

with University o Illinois (see above).Is acting as a consultant to Pathfinder on itsclinical and community actions project toaddress PPH.

Ghana

Nigeria and India



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University o Illinois,Chicago

Plans to implement a study o the cost effec-tiveness and saety o use comparing tworegimens 400 mcg for prevention versus600 mcg or treatment.Is working with Pathfinder on Continuumo Care or PPH project, which includes

community education, AMSL, provision oanti-shock garments, transport to higher levelacilities when needed, and provision o miso-

prostol in areas where oxytocin and ergometrinare not available.Is working with Earth Institutes MillenniumVillages Project doing operations research onmisoprostol provided to women who are deliv-ering at home. Te use o misoprostol duringhome births will be documented by externalobserversthe auxiliary birth midwives. Te

project includes up-ront policy work with thegovernment to get buy-in or replication/expan-sion i research shows easibility.Is working with Gynuity Health Projects on acomparison o universal prophylaxis with 600mcg oral misoprostol versus secondary preven-tion (women who bleed >350 ml postpartumreceive a dose o 800 mcg sublingual misopros-tol). Tis includes a cost-benefit analysis.

India

Nigeria and India

Ghana

India

University o Liverpool Is updating the FIGO guidelines based on newdata within next two years.

Is researching uterine contractility with miso-prostol doses o 200, 400, and 600 mcg, aswell as looking at genetic actors and how theyrelate to side effects o misoprostol. Results areexpected by 2012.

With Gynuity Health Projects, conducting arandomized controlled trial o 5,000 women

who receive either misoprostol or a placebo atantenatal care to be sel-administered. Te out-come measure is hemoglobin level. Te study

will be under way by spring/summer 2011.

Is involved in ongoing advocacy throughpublications and www.misoprostol.org.

Global

Uganda

Global



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USAID Helps countries to evaluate their need or community-based solutions or decreasing deaths rom PPH, and

where appropriate, supports countries to pilot-testcommunity-based distribution/use o misoprostol

with rigorous evaluation to provide data and lessonslearned to governments. Te data collected will assist

governments to make decisions about whether to scaleup the national program. I governments make thedecision to scale up, USAID will support this decision

with technical assistance. Te model is to give miso-prostol to women in their last trimester during a visitto antenatal care or to communities via communityhealth workers.Funded WHO to develop PPH prevention and treat-ment guidelines and also provided unding or WHOto make these guidelines more clear. USAID will holdanother Expert Committee meeting on this within

the next year. Provided support to get misoprostol onthe WHO Essential Medicine List (EML) or PPHprevention in 2009 (not successul). Will continue tosupport reapplication to EML or PPH prevention.

Pilots in Aghanistan and Nepal,possibly expanding to Malawi,Honduras, Senegal, and Ghana

Global

VSIVentureStrategiesInnovations

Conducts product registration o misoprostol or PPHprevention and treatment.

Is working with the Ministry o Health to gain accep-tance or misoprostol.Is working with manuacturers to establish distribution

strategies and pricing or misoprostol.rains providers and users o misoprostol.Conducts operations research to explore easibility ohome use o misoprostol.

Aghanistan, Bangladesh, Ethiopia,Ghana, Kenya, Madagascar, Malawi,Mozambique, Nepal, Pakistan, Nige-ria, anzania, Uganda, and ZambiaAdditional inormation orthcoming


Additional inormation orthcomingAdditional inormation orthcoming

Women onWaves/Womenon Web

rains womens organizations and nonmedical individ-uals in using misoprostol or PPH prevention and saeabortion in targeted countries in Arica and Asia.

anzania, the DRC, Kenya, Indone-sia, Sri Lanka, and Pakistan (trainingalso or Burundi)

World HealthOrganization

Is updating guidelines or PPH prevention and treat-ment in 2011 (Reproductive Health Division).Conducting research to evaluate misoprostol programimplementation (Reproductive Health Division).

Global

Global

3

ORGANIZATIONS WORKING WITH MISOPROSTOL BUT NOT FOR PPH INDICATION

AB Associates

BPAS

Ibis Reproductive Health

Ipas



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Documents

Mapping Final Sm