Misoprostol For Postpartum Hemorrhage – A Life-Saving Technology for Maternal Health

Shafia Rashid is Senior Technical Advisor for the FCI Program of Management Sciences for Health.

Available since the 1980s, the medicine misoprostol was initially marketed to prevent stomach ulcers. Health professionals eventually discovered that misoprostol also stimulates contractions of the uterus, making it useful for a number of maternal and reproductive health conditions, including postpartum hemorrhage (PPH), induction of labor, treatment of miscarriage, and induced abortion (alone or in combination with mifepristone). Misoprostol is stable at room temperature, available in pill form, and inexpensive. Because of these advantages and misoprostol’s wide availability in many countries, health providers began using misoprostol off-label—in a way not specified on its registration—with differing regimens and routes of administration, and in the absence of evidence-based clinical guidelines. Continue reading “Misoprostol For Postpartum Hemorrhage – A Life-Saving Technology for Maternal Health”

New research calls for a different approach for misoprostol for postpartum hemorrhage

Shafia Rashid is senior program officer for the Global Advocacy program at Family Care International.

Postpartum hemorrhage (PPH)—excessive, uncontrolled bleeding during or after childbirth—is the leading cause of maternal death around the world.  Despite this, the condition is almost entirely preventable and treatable. In some parts of the world, women give birth at home or in health facilities lacking the essential supplies and equipment to manage PPH and other life-threatening complications.

Wherever a woman decides to give birth, she needs access to life-saving, uterus-contracting drugs, called uterotonics, for the prevention and treatment of PPH. The recommended uterotonic, injectable oxytocin, requires cold storage and technical skill to administer, making it difficult or impossible to use in many rural and low-resource areas. Misoprostol is a safe and effective uterotonic and a good alternative in community settings since it doesn’t require refrigeration or administration by a professional.

miso4pack

Continue reading “New research calls for a different approach for misoprostol for postpartum hemorrhage”

Managing postpartum hemorrhage at home deliveries in Chitral, Pakistan

By Meagan Byrne, Program Assistant, Gynuity Health Projects

This post originally appeared on the Maternal Health Task Force blog.

In Chitral district of Khyber-Pakhtunkhwa (KP) Province, Pakistan, a high rate of home births translates to inadequate or nonexistent treatment for life-threatening obstetric complications, like postpartum hemorrhage (PPH). According to the 2012-13 Pakistan DHS report, nearly two-thirds of women deliver at home in rural areas of KP province.

Customarily, home births are managed by a traditional birth attendant (TBA) and if a complication like PPH arises, the only care available is to transfer the woman to a higher level facility or have a skilled provider called to the woman’s home to administer oxytocin as treatment. In Chitral, many villages are located far from health centers and access to care is especially difficult due to poor infrastructure and limited transport. Faced with these barriers, women who develop PPH are rarely transferred to a facility, so having treatment options available at home is critical.

Misoprostol, a prostaglandin analog that reduces blood loss after delivery, is a useful drug in this setting because it requires neither cold storage nor a skilled attendant to administer it. A recent study—implemented in Chitral by Gynuity Health Projects and Aga Khan Health Service, Pakistan—explored the feasibility of providing misoprostol to traditional birth attendants and having them administer it to prevent and treat PPH in home deliveries.

In this study, women received misoprostol prophylaxis (a 3-tablet dose) and in the event of PPH, the TBA administered a treatment dose of misoprostol with referral to a higher level of care. Study trainings reiterated the importance of transfer if a woman experiences a delivery complication. Despite prophylaxis, there were women who were diagnosed with PPH and received study treatment. The study confirmed that TBAs are able to administer misoprostol correctly and safely for both prophylaxis and treatment.

There has been an increase in the number of facility-based deliveries worldwide; yet for many women, a facility delivery is not an option. Among women in our study who had planned to have a facility delivery, many delivered at home due to road blocks, unavailable transportation, or unavailability of a family member to accompany them to the facility.

There will always be women who will not be able to deliver at a facility, despite plan to do so. Among women who deliver at home and experience PPH, many will experience delays or will never be transferred to a health facility. For these women, it is imperative to have a treatment option available at the community level since the average time from onset of PPH to death is only two hours.

The following video showcases infrastructure barriers to safe delivery and expresses the thoughts of TBAs and other healthcare providers on access to obstetric services in Chitral and the use of misoprostol to manage PPH.

 

This post is part of the blog series “Increasing access to maternal and reproductive health supplies: Leveraging lessons learned in preventing maternal mortality,” hosted by the Maternal Health Task Force, Reproductive Health Supplies Coalition/Maternal Health Supplies CaucusFamily Care International and the USAID-Accelovate program at Jhpiego which discusses the importance and methods of reaching women with lifesaving reproductive and maternal health supplies in the context of the proposed new global target of fewer than 70 maternal deaths per 100,000 births by 2030. To contribute a post, contact Katie Millar.

Misoprostol for postpartum hemorrhage: translating promise into reality

By Melissa Wanda, Advocacy Officer, Family Care International – Kenya

This post originally appeared on the Maternal Health Taskforce blog.

In Kenya, where I work as an advocate for women’s health and rights, women continue to die during pregnancy and childbirth at alarming rates. Approximately 25% of these deaths are due to heavy bleeding following childbirth, also known as postpartum hemorrhage or PPH. More than half of women deliver at home; that proportion can be even higher in some counties with limited infrastructure and predominantly rural populations. Even in cases where a woman arrives to a health facility in time, she can still face significant barriers to receive the care she needs:

  • supplies needed for childbirth—such as a blood pressure cuff or clean gloves—may not be available;
  • essential medicines—such as oxytocin or misoprostol, which can prevent or treat postpartum bleeding—may be in short supply; and
  • a skilled health provider may not be present to provide the care a woman needs to have a safe delivery.

A key strategy for improving maternal health is to ensure that every woman has access to effective medicines to prevent and treat PPH during childbirth. Oxytocin and misoprostol are proven, lifesaving medicines for the prevention and treatment of PPH. Misoprostol offers a number of advantages for women living in remote, rural areas: misoprostol does not need refrigeration, is available in tablet form and can, therefore, be administered with no specialized equipment or skills. Misoprostol provides an effective option for preventing and treating PPH in settings such as homes and health facilities lacking electricity, refrigeration and IV equipment.

For these reasons, Kenya’s Ministry of Health established a national-level task force to provide a common forum for addressing policy-level issues related to the use of misoprostol for the prevention and treatment of PPH. While misoprostol is registered in Kenya for the management of PPH, and national guidelines govern its use, studies have shown that misoprostol’s procurement and availability in public health facilities is irregular and inconsistent.

This national, multi-stakeholder task force—composed of government, NGO, research, faith-based and health profession representatives[1]—was tasked with spearheading access to and use of misoprostol for PPH. Beginning in 2014, the Misoprostol Task Force, convened by the ministry of health, met regularly to identify the key policy gaps at the national level and to take concrete action. Key policy priorities identified by the Task Force:

  • Harmonize the national clinical guidelines:  Kenya has numerous clinical management guidelines advising health professionals on how to administer misoprostol for all its indications (PPH, induction of labor and post-abortion care): the 2009 Clinical Guidelines for Management and Referral of Common Conditions at Levels 4-6 and the 2012 National Guidelines for Quality Obstetric and Perinatal Care. While these guidelines recommend the use of misoprostol to prevent and treat PPH when oxytocin is unavailable, they do not reflect the latest evidence and were inconsistent with each other. The Task Force developed a handout that harmonizes these different guidelines and produced a job aid for health workers. Both documents are waiting approval by the ministry of health; once approved, they will be disseminated at the national and sub-national/county levels.
  • Revise the national essential medicine list: While the Kenya Essential Medicine List(KEML, 2010) classifies misoprostol as a complementary and core[2] oxytocic drug, no specification is made for its use in PPH prevention or treatment. The Task Force drafted a letter to the National Medicines and Therapeutics Committee, to call for the addition of misoprostol to the KEML for PPH prevention and treatment at all levels of the health system. This letter will likely be deliberated by the committee when it meets this year to update the KEML.

Continued advocacy is still needed to ensure these positive developments in the Kenyan national policy framework translate into actual improvements in the availability and use of misoprostol. The Task Force has served as a critical forum for bringing together key stakeholders, promoting national level discussion and supporting effective action.

For more information and tools for conducting effective advocacy:

Scaling up Misoprostol for Postpartum Hemorrhage: Moving from Evidence to Action

Advocacy, Approval, Access: Misoprostol for Postpartum Hemorrhage A Guide for Effective Advocacy

This post is part of the blog series “Increasing access to maternal and reproductive health supplies: Leveraging lessons learned in preventing maternal mortality,” hosted by the Maternal Health Task Force, Reproductive Health Supplies Coalition/Maternal Health Supplies CaucusFamily Care International and the USAID-Accelovate program at Jhpiego which discusses the importance and methods of reaching women with lifesaving reproductive and maternal health supplies in the context of the proposed new global target of fewer than 70 maternal deaths per 100,000 births by 2030. To contribute a post, contact Katie Millar.

[1] Membership includes representatives from the Ministry of Health-Reproductive Maternal Health Services Unit, Family Care International-Kenya, PATH, Management Sciences for Health, the Population Council, UNFPA, AMREF, Institute of Family Medicine (INFAMED), Christian Health Association of Kenya (CHAK), Jhpiego, the World Health Organization and professional organizations of gynecologists and nurses.

[2] The Core List represents the priority needs for the health care system. Medicines on the Core List are considered to be the most efficacious, safe and cost‐effective; are expected to be routinely available in health facilities; and should be affordable to the majority of the population.  Complimentary medicines are essential medicines needed for specialized diagnostic or monitoring facilities, and/or specialist medical care, and/or specialist training.

Let’s reward the use of maternal health supplies

By Milka Dinev, LAC Forum Regional Advisor, Reproductive Health Supplies Coalition 

This post originally appeared on the Maternal Health Task Force blog.

During a donor visit to Peru in the year 2000, a maternal health supporter and friend saw that rural women in Peru were suffering and dying because they lacked access to safe maternal health services during the critical hours of childbirth. This young donor had recently had her children, so she decided to reward the unsung heroes who made extraordinary efforts to save the lives of women during childbirth. It would be the “Oscar” of maternal health and survival.

The Sarah Faith Award was created to promote and reward the extraordinary efforts made by health providers and communities to save the lives of mothers and their children. For ten years, this award provided funding and technical assistance to the health teams and communities that had demonstrated teamwork and solidarity. Most cases were heroic efforts – transporting a mother to a rural health facility on the shoulders of four or five men using a stretcher made of wood and blankets (or in a boat along the Amazon River) or a doctor/nurse giving his or her own blood for a much-needed transfusion. The award honored deserving teams with US$25,000 to improve their health facilities or their community services. This award was an extraordinary tool to improve morale among health providers and health promoters. Each winning team received a beautiful statue that they prominently displayed in their facility.

Yet, it is worthwhile to observe that an important selection criterion for the Sarah Faith Award is how applicants improved access to maternal health services. So what happens to women who do not have access to such heroes as the ones the Sarah Faith prize rewards? I do believe this is where supplies come into play, carrying out a crucial, lifesaving role. How many lives could be saved if pregnant women had free access to misoprostol in order to prevent postpartum hemorrhage during their home delivery, or if the nurse in the health facility could administer magnesium sulfate to women with pre-eclampsia to control their blood pressure? How many lives could be saved if oxytocin supplies were adequately refrigerated?

Arguably, services — with their immediate human element — make for better story-telling a lot of the time. And good storytelling is a mainstay of the marketing and publicity that surround award mechanisms. And by comparison, supplies often carry rather sterile connotations of warehouses, supply chains, and transportation.

Working at the Reproductive Health Supplies Coalition, I am often struck by the challenge of even finding a photo that adequately tells the supplies story. And yes, there is a supplies story however, there is no “supplies award”. There is very little we do in promoting morale and engagement among those that work to make supplies available, accessible and  affordable within a framework of quality and equity!

As far as maternal health supplies go, it is easy for groups to forget the role of the three key life-saving commodities and therefore fail to prioritize their presence in health facilities 100% of the time. Much of the assistance provided through the Sarah Faith Award was directed to the direct provision of these commodities: a good fridge for the oxytocin (and vaccines of course) and a training package to update providers on the use, dosage and storage of these supplies.

The Family Planning Community has this saying “no product no program”. It is time to start using a similar phrase that includes maternal health supplies as part of a holistic approach to safe motherhood.

 

This post is part of the blog series “Increasing access to maternal and reproductive health supplies: Leveraging lessons learned in preventing maternal mortality,” hosted by the Maternal Health Task Force, Reproductive Health Supplies Coalition/Maternal Health Supplies CaucusFamily Care International and the USAID-Accelovate program at Jhpiego which discusses the importance and methods of reaching women with lifesaving reproductive and maternal health supplies in the context of the proposed new global target of fewer than 70 maternal deaths per 100,000 births by 2030. To contribute a post, contact Katie Millar.

 

 

Advocacy success story: Burkina Faso broadens access to misoprostol, an essential maternal health medicine

By Brahima Bassane, MD

[Version française ci-dessous]

Brahima Bassane, FCI’s national director in Burkina Faso, is a public health physician.

Postpartum hemorrhage (PPH) — excessive, uncontrolled bleeding after childbirth —remains the leading cause of maternal death worldwide.  In countries like Burkina Faso, where many births still occur at home, the drug misoprostol offers a number of advantages for preventing and treating PPH because (unlike oxytocin, considered the ‘gold standard’ medicine for PPH) it can be easily administered and does not require cold storage. In settings with limited infrastructure and lack of skilled birth attendants, misoprostol may be a woman’s only chance for surviving PPH.

Access to high-quality medicines is part of every citizen’s right to the highest attainable standard of health. But in spite of misoprostol’s proven safety and efficacy, decision-makers in some countries have been reluctant to authorize its widespread availability, or are unaware of the available evidence. Many governments have not included misoprostol in their national essential medicine list (EML), which is often used as the basis for importation, distribution, and marketing of medicines for the public health system.

FCI works to support wider understanding, acceptance, and use of misoprostol for PPH. This year in Burkina Faso, our efforts — with a range of advocacy partners — to persuade government officials to deem misoprostol for PPH an essential medicine were successful. This success story offers a potential model for effective, collaborative, focused advocacy in other countries where misoprostol’s lifesaving benefits are not yet broadly available.

Our advocacy began in earnest last September, when FCI convened a meeting  to share the latest research on misoprostol for PPH and to develop advocacy strategies that would convince the government to take action. These committed and motivated maternal health champions called for the widespread availability of misoprostol, stating that the inclusion of misoprostol in the national EML was an urgent national priority.

Following the meeting, a small advisory committee was assigned the task of reaching key government decision makers. The committee submitted a letter and technical note to the Director-General of Pharmacy, Medicines, and Laboratories (DGPML) requesting inclusion of misoprostol on the EML. A DGPML technical committee then reviewed the submitted application, gathering all available evidence on misoprostol. During this review period, FCI and our partners met again with the Director-General of the DGPML, who stated his support for misoprostol as a critical tool for reducing the burden of PPH in Burkina Faso. FCI and partners also met with the Secretary-General of the Ministry of Health, who affirmed the government’s responsibility for ensuring the availability of misoprostol for PPH at public health facilities. He also came out in support of misoprostol distribution at the community level, and recommended ongoing supervision and training to ensure its correct use.

In February of this year, all of these advocacy efforts paid off: the 2014 revision of the national EML (Liste Nationale Des Medicaments et Consommables Medicaux Essentials, Edition 2014) includes misoprostol both for prevention and for treatment of PPH.

While this is an important step in making misoprostol available in the government health system, FCI and our partners will continue advocating and working to ensure that all women have access to a uterotonic , like misoprostol or oxytocin, for effective prevention and treatment of postpartum hemorrhage. These efforts are critical for countries’ efforts to fulfill the promise of MDG 5 and put an end, once and for all, to preventable maternal death.

Learn more about FCI’s work on misoprostol for PPH here.

To join an online community on misoprostol for PPH, please click here.

 

Réussite exemplaire du plaidoyer : Le Burkina Faso élargit l’accès au misoprostol, un médicament essentiel de la santé maternelle

Par Brahima Bassane, MD– médecin en titre

Directeur national de FCI au Burkina Faso, Brahima Bassane est médecin de santé publique.

L’Hémorragie du post-partum (HPP) — des saignements excessifs, difficiles à arrêter survenant après l’accouchement — demeure la principale cause de décès maternels à travers le monde. Dans des pays tels que le Burkina Faso où un nombre important des accouchements surviennent encore à domicile, le médicament misoprostol fournit nombre d’avantages pour la prévention et le traitement de l’HPP dans la mesure où il peut être facilement administré et ne nécessite pas une conservation à dans un réfrigérateur (contrairement à l’ocytocine qui est considérée comme le médicament ‘de référence’ pour l’HPP).Le misoprostol peut représenter la seule chance de survie d’une femme en proie à l’HPP dans les milieux communautaires qui disposent d’un nombre insuffisant de centres de santé et d’accoucheuses qualifiées.

L’accès à des médicaments de haute qualité est un des droits de chaque citoyen pour lui permettre de jouir du meilleur état de santé possible. Toutefois, en dépit de l’innocuité et de l’efficacité reconnues du misoprostol, les décideurs ont été dans certains pays, réticents à autoriser sa mise à disposition généralisée ou ils ignorent les données disponibles. Plusieurs gouvernements n’ont pas inclus le misoprostol dans leur liste des médicaments essentiels (LME) qui est souvent utilisée comme critère pour l’importation, la distribution et la commercialisation de médicaments pour le système de santé publique.

FCI œuvre en vue de soutenir une meilleure compréhension, acceptation et utilisation du misoprostol pour l’HPP. Au Burkina Faso, nos initiatives —de concert avec un éventail de partenaires du plaidoyer —visant à convaincre cette année les responsables gouvernementaux de considérer le misoprostol pour l’HPP comme un médicament essentiel, ont été couronnées de succès. Cette réussite exemplaire fournit un modèle potentiel de plaidoyer efficace, mené en collaboration et bien ciblé dans d’autres pays où les avantages salvateurs du misoprostol ne sont pas encore largement disponibles.

Notre plaidoyer a véritablement débuté en septembre 2013 lorsque FCI a organisé une réunion en vue de partager les résultats des toutes dernières recherches sur le misoprostol pour l’HPP et de mettre au point des stratégies de plaidoyer qui convaincraient le gouvernement à prendre les bonnes décisions. Ces défenseurs engagés et motivés de la santé maternelle se sont prononcés pour la mise à disposition généralisée du misoprostol en indiquant que l’inclusion du misoprostol dans la Liste nationale des médicaments essentiels était une priorité nationale.

Suite à la réunion, la tâche de prendre contact avec les principaux décideurs gouvernementaux a été confiée à un petit comité consultatif. Le comité a présenté au Directeur Général de la Pharmacie, du Médicament et des Laboratoires (DGPML) une lettre et une note technique sollicitant l’inclusion du misoprostol dans la LME. Un comité technique de la DGPML a ensuite examiné la demande soumise en recueillant toutes les données disponibles relatives au misoprostol. Au cours de cette période d’examen, FCI et nos partenaires se sont réunis avec le Directeur Général de la GPML qui a exprimé son soutien pour le misoprostol comme outil crucial pour alléger le fardeau de l’HPP au Burkina Faso. Cette équipe restreinte de FCI et ses partenaires s’est également réunie avec le Secrétaire Général du Ministère de la Santé qui a affirmé la responsabilité du gouvernement à assurer la disponibilité du misoprostol pour l’HPP dans les établissements de santé. Il s’est également prononcé en faveur de la distribution du misoprostol jusqu’à l’échelle communautaire  tout en recommandant une supervision suivie et la formation afin de garantir son utilisation adéquate.

En février au cours de cette année 2014, toutes ces initiatives du plaidoyer ont porté leurs fruits : la révision en 2014 de la LNMCE (Liste Nationale Des Médicaments et Consommables Médicaux Essentiels, Édition 2014) comprend notamment le misoprostol pour la prévention ainsi que le traitement de l’HPP.

Bien que la mise à disposition du misoprostol dans le système public de santé constitue une étape importante, FCI et nos partenaires continueront à plaider et à œuvrer pour veiller à ce que toutes les femmes aient accès à un utérotonique tel que le misoprostol ou l’ocytocine pour une prévention et un traitement efficaces de l’hémorragie du post-partum. Ces initiatives sont cruciales pour les efforts des pays à tenir leur promesse pour l’OMD5 et à définitivement mettre un terme aux décès maternels évitables.

Trouvez de plus amples informations relatives aux travaux de FCI sur le misoprostol pour l’HPP.

Veuillez cliquer ici pour intégrer une communauté virtuelle sur le misoprostol pour l’HPP.

Building the momentum: Misoprostol for postpartum hemorrhage in Pakistan

By Imtiaz Kamal

Imtiaz Kamal is the president of the Midwifery Association of Pakistan. She has led a “one-woman crusade” to promote the midwifery profession for more than 50 years.

In June 2013, all four provinces of Pakistan—Punjab, Sindh, Khyber Pakhtunkhwa (KPK) and Balochistan—included misoprostol for the prevention and treatment of postpartum hemorrhage (PPH) on their respective Essential Medicines Lists (EMLs). EMLs indicate medicines that “satisfy the priority health care needs of the population” and should be affordable and available at all times within the context of a functioning health system. As advocates working towards improving reproductive and maternal health in Pakistan, we’ve come a long way in our mission to expand access to misoprostol. In this post, I share our advocacy strategy and the challenges we faced.

The sixth most populous country in the world, Pakistan has an alarmingly high maternal mortality ratio: 260 maternal deaths per 100,000 live births. Every year, almost 12,000 women in Pakistan die from pregnancy and childbirth related complications, accounting for almost 5% of the world’s maternal deaths, and PPH—excessive bleeding after childbirth—causes 27% of these deaths. About 57% of deliveries still take place without a skilled birth attendant present, and in these situations, women often do not have the means to address life-threatening complications when they arise. Fortunately, there is a safe and effective solution to treat and prevent PPH—misoprostol, a low-cost medicine that is practical for use in both facility and home births.

For many years, the National Committee for Maternal and Neonatal Health, the Midwifery Association of Pakistan (MAP), and the Association for Mothers and Newborns, with support from the Research & Advocacy Fund (RAF), championed the widespread availability of misoprostol in Pakistan.

One step for improving access to this essential medicine was to get provincial governments to include misoprostol on their respective EMLs. Then, the provincial governments can supply it to the public sector health facilities, which would provide this essential medicine at minimal or no cost to women wherever they live.

Usually, the Pakistani government follows the World Health Organization’s (WHO) EML, but due to misoprostol’s association as an “abortion drug,” we had to sell it to policymakers, highlighting misoprostol’s huge lifesaving potential and the urgency to expand access to women who need it. Misoprostol is an essential part of a package of strategies to improve maternal health, and we must ensure that its use for other indications does not lead to limitations on its availability for PPH.

We devised an advocacy strategy to share the evidence and stimulate supportive policy change through:

  • Public education and awareness: fact sheets and case studies in English and Urdu, press conferences, trainings with journalists, and air time on television;
  • Advocacy with decision-makers, including high-level Ministry of Health authorities, district health officers, OB/GYNs, and other health providers: face-to-face meetings  and dissemination seminars in Punjab, Sindh, and the federal capital, Islamabad, to share guidelines from WHO and the International Federation of Gynecology and Obstetrics (FIGO).
Advocates conducted seminars with health care providers to present evidence on the life-saving potential of misoprostol for PPH and post-abortion care (PAC). (Image: Midwifery Association of Pakistan)

Our advocacy strategy led to very specific, positive outcomes:

  • Endorsements from key champions: The Director General of Health in Sindh province became a close ally  and guided us on how to move forward in garnering support from  OB/GYNs and  district health officers;
  •  A widely distributed position paper on misoprostol for PPH and post-abortion care (PAC) was signed by six professional organisations working for maternal and neonatal health;
  • The National Assembly decided that the federal government should provide training to midwives and other health care providers on the administration of misoprostol to manage incomplete abortion and miscarriage and prevent PPH.  In Sindh, the Directorate of Nursing came to us for guidance, and the first misoprostol workshop for midwifery teachers is scheduled for late February 2014.
Midwives will receive training 0n the administration of misoprostol for PPH and PAC. (Image: Midwifery Association of Pakistan)

Our advocacy efforts weren’t without challenges, however. For example, many physicians were cautious or opposed to making misoprostol more widely available. The most senior OB/GYN (from a province with very high maternal mortality) raised a number of concerns after a presentation we held on misoprostol, commenting: “It is not candy. We cannot let it be available freely.”  We explained that, given the high prevalence of home births, we need to invest in solutions, such as misoprostol, that save lives now, until we can achieve the long-term goals of strengthening health systems and increasing rates of facility births. Distributing misoprostol doesn’t replace efforts to promote skilled care, but we need to recognize the reality that many women are not able to give birth in well-equipped health facilities with skilled staff. All women, wherever they decide to give birth, need access to effective medicines.

We faced similar comments and questions at every advocacy meeting. But this didn’t stop us; we continued to make our case. Eventually, that very same OB/GYN signed our position paper on misoprostol.

The movement to achieve national recognition of misoprostol for PPH has been challenging, but we are making progress, turning heads, and changing minds. Step by step, we push forward. Now that we have achieved Federal approval of misoprostol, we are working to advance community level distribution of misoprostol to women in their eighth month of pregnancy. As a global community, with partners such as FCI rallying behind the cause, we will succeed in making sure women no longer have to fear for their lives when giving birth.

For more information:

Mapping Misoprostol for Postpartum Hemorrhage Regional Perspectives on Challenges and Opportunities South Asia

Advocacy for PPH Prevention and PAC: PowerPoint Presentation at the Research and Advocacy Fund 2nd Annual Conference

The new frontier of community health care: Health huts in Senegal use misoprostol and oxytocin in Uniject to prevent postpartum hemorrhage

[Version française ci-dessous]

Shafia Rashid is a senior program officer for Global Advocacy at Family Care International.

While Senegal, a coastal West African country, has made considerable progress in decreasing maternal mortality since 1990, it still grapples with high rates of preventable maternal death. Postpartum hemorrhage (PPH)—excessive, uncontrolled bleeding—remains the leading cause of maternal death in Senegal and around the world.  In areas of Senegal where there is still a high prevalence of unattended deliveries, women may not have the means to manage PPH or other life-threatening complications.

Regardless of where they give birth, all women need access to uterus-contracting drugs, or uterotonics, for the prevention and treatment of PPH. The recommended uterotonic, injectable oxytocin, requires cold storage and technical skill to administer; oxytocin is also available as a Uniject® device—a pre-filled, single dose, non-reusable injection—which is easier to administer. Misoprostol is a safe and effective alternative in low-resources settings where oxytocin isn’t available or feasible; it doesn’t need refrigeration and is easy to use—particularly important in the absence of a skilled birth attendant.

Matrones, or volunteer birth attendants, received training on administration of their assigned intervention.

Between June 2012 and August 2013, Gynuity Health Projects, ChildFund Senegal, the USAID Community Health Program, and the Senegalese government’s Directorate of Reproductive and Child Health implemented a study to compare community-level administration of oral misoprostol and oxytocin in Uniject® to prevent PPH. One of the two interventions was assigned to each of 28 participating community health huts, one- or two-room concrete structures that bring basic healthcare closer to the communities. Project implementers trained matrones, volunteer birth attendants, to assist with deliveries and administer the designated intervention.

Communities played an integral part in encouraging the use of misoprostol and oxytocin. Community members assisted in identifying pregnant women for initial prenatal check-ups, and project staff recruited women by visiting them in their communities.

Since the launch of the project, over 1300 women received either 600 mg (3 tablets) of misoprostol or 10 IU oxytocin via Uniject® intramuscularly for PPH prevention. Both medicines were effective, and the matrones could manage all side effects, which included chills, tremors and fever. Among all the women who received prophylaxis, only one case of postpartum hemorrhage occurred.

“Before this study, we saw a lot of women with heavy bleeding, and it was always difficult to arrange transportation for referrals [to health facilities],” said Fatou Diouf, a matrone from the Koulouk Mbada hut. “Now, we do not see any hemorrhage after delivery.”

Chief nurse Amadou Gueye from the Ndiaganiao health post noted a similar outcome: “Since the start of the study, we have not seen a single case of PPH.”

As a result of the project, home births decreased from 10% to 1%, project leaders effectively maintained drug stocks, health providers demonstrated commitment and motivation, and the matrones administered medications and filled out data management tools successfully. Birth attendance at the community health huts improved because women sought delivery services in order to benefit from a PPH medication.

“When I came to deliver this morning, the matrone asked me if I wanted to take the three tablets. I said yes,” said Mariama Niang who had recently given birth at the Koulouk Mbada health hut. “I bled less than I did in previous deliveries when I bled a lot and had lots of dizziness. […] now, I am doing well.”

In Senegal where access to health facilities may be limited in remote areas, the community health hut system can play an important role in preventing and treating PPH. According to the study, both misoprostol and oxytocin in Uniject® proved to be equally effective and safe in preventing PPH, and matrones  posted at the health huts were capable of administering their assigned medicine. Whereas standard oxytocin injections require specialized skills, misoprostol and oxytocin in Uniject® are viable options at the community level. These health interventions can empower communities to protect women’s health and prevent unnecessary maternal death.

Through research and advocacy, Family Care International (FCI) is working with Gynuity Health Projects to support increased access to and availability of misoprostol for prevention and treatment of PPH. Learn more about FCI and Gynuity’s work to make misoprostol available to women around the globe.

 

Les nouveaux confins des soins de santé communautaire : Au Sénégal, les cases de santé utilisent le misoprostol et l’ocytocine par Uniject en vue de prévenir l’hémorragie du post-partum

Shafia Rashid est la Responsable du Programme Global Advocacy – « Plaidoyer mondial » auprès de Family Care International.

S’il est vrai que le Sénégal, pays côtier de l’Afrique de l’Ouest, a réalisé d’énormes progrès dans la baisse de la mortalité maternelle depuis 1990, il est toujours aux prises avec de forts taux de décès maternels évitables. L’Hémorragie du post-partum (HPP) – des saignements excessifs, difficiles à arrêter – demeure la principale cause de mortalité maternelle au Sénégal et à travers le monde. Dans des régions du Sénégal où il existe une forte prévalence d’accouchements en l’absence d’un personnel qualifié, il est possible que les femmes ne disposent pas de moyens pour le traitement de l’HPP ou d’autres complications potentiellement mortelles.

Quel que soit l’endroit où elles accouchent, toutes les femmes ont besoin d’avoir accès aux utérotoniques, les médicaments provoquant la contraction de l’utérus pour la prévention et le traitement de l’HPP. L’ocytocine injectable, l’utérotonique recommandé, nécessite la conservation à froid et des compétences techniques pour son administration ; l’ocytocine est également disponible en tant que dispositif Uniject® — une injection pré-remplie à dose unique et non réutilisable — qui est plus facile à administrer. Le misoprostol est une méthode alternative à l’ocytocine qui est sûre et efficace, particulièrement dans les milieux à faibles ressources où l’ocytocine n’est pas disponible ou faisable. Le misoprostol ne nécessite pas la réfrigération et est facile à utiliser — ce qui est notamment important en l’absence d’une accoucheuse qualifiée.

Entre juin 2012 et août 2013, Gynuity Health ProjectsChildFund SenegalProgramme de santé communautaire de l’USAID et la Direction de la Santé de la Reproduction et de la Survie de l’Enfant du gouvernement sénégalais ont mené une étude visant à comparer l’administration à l’échelle communautaire du misoprostol oral à celle de l’ocytocine par Uniject® en vue de prévenir l’HPP. Une des deux interventions était assignée à chacune des 28 cases de santé communautaires participantes, des structures en béton d’une à deux pièces, qui fournissent des soins de santé de base aux collectivités. Les exécutants du projet ont fourni une formation aux matrones, accoucheuses bénévoles, à apporter leur aide durant les accouchements et à administrer l’intervention désignée.

Matrones, or volunteer birth attendants, received training on administration of their assigned intervention.

Les collectivités ont assumé un rôle essentiel en encourageant l’utilisation du misoprostol et de l’ocytocine. Les membres de la collectivité ont aidé à identifier les femmes enceintes pour les consultations prénatales initiales et le personnel du projet a recruté les femmes en leur rendant visite au sein de leur communauté.

Depuis le lancement du projet plus de 1 300 femmes ont reçu soit 600 mcg (3 comprimés) de misoprostol ou 10 UI d’ocytocine par Uniject® par voie intramusculaire pour la prévention de l’HPP. Les deux médicaments étaient efficaces et les matrones ont pu traiter tous les effets secondaires qui comprenaient notamment les frissons, les tremblements et la fièvre. Seul un cas d’hémorragie du post-partum est survenu parmi les femmes ayant reçu le traitement préventif.

« Avant cette étude, un grand nombre de femmes présentaient des saignements profus et il était toujours difficile d’assurer le transport pour leur acheminement [aux établissements de santé], » dit Fatou Diouf, une matrone de la case Koulouk Mbada. « Désormais, nous n’observons plus d’hémorragie après l’accouchement. »

Amadou Gueye, Infirmier en chef du poste de santé de Ndiaganiao, a noté un résultat analogue : « Nous n’avons observé aucun cas d’HPP depuis le début de l’étude. »

En raison du projet, le nombre d’accouchements à domicile a baissé de 10 % à 1 %, les responsables du projet ont effectivement maintenu les stocks de médicaments, les prestataires de santé ont démontré leur engagement et leur motivation et les matrones ont administré les médicaments et rempli les formulaires de gestion des données de manière adéquate. La présence des accoucheuses dans les cases de santé communautaire s’est renforcée parce que les femmes ont sollicité des services d’accouchement afin de bénéficier des médicaments de l’HPP.

« Ce matin, lorsque je suis venue pour accoucher, la matrone m’a demandé si je voulais prendre les trois comprimés. J’ai répondu oui, » dit Mariama Niang qui a récemment accouché à la case de santé de Koulouk Mbada. « Mes saignements étaient plus légers que ceux de mes accouchements précédents où ils étaient abondants et accompagnés de vertiges. […] maintenant, je me sens bien. »

Les membres de la communauté jouent un rôle essentiel dans l’amélioration de la santé maternelle.

Au Sénégal où l’accès aux établissements de santé peut être limité dans les zones reculées, le système des cases de santé communautaire peut jouer un rôle important dans la prévention et le traitement de l’HPP. Selon l’étude, le misoprostol ainsi que l’ocytocine par Uniject® se sont tous les deux avérés tout aussi efficaces et sûrs dans la prévention de l’HPP et les matrones affectées aux cases de santé étaient en mesure d’administrer les médicaments qui leur étaient assignés. Alors que les injections standards d’ocytocine nécessitent des compétences particulières, le misoprostol et l’ocytocine par Uniject® constituent des options viables à l’échelle communautaire. Ces interventions médicales peuvent habiliter les collectivités à protéger la santé des femmes et à prévenir des décès maternels évitables.

Family care International (FCI) collabore avec Gynuity Health Projects au moyen de la recherche et du plaidoyer en vue de favoriser un accès accru au misoprostol et sa disponibilité pour la prévention et le traitement de l’HPP. Trouvez de plus amples informations relatives aux travaux de FCI et de Gynuity visant à mettre le misoprostol à la disposition des femmes à travers le monde.

Burkina Faso: Expanding Access to Misoprostol for Postpartum Hemorrhage

Catherine Lalonde is FCI’s senior program officer for Francophone Africa.

Each year in Burkina Faso, more than 2,000 women die from pregnancy-related complications. Many of these deaths are due to severe and uncontrolled bleeding (postpartum hemorrhage, or PPH) that occurs following childbirth. The vast majority of these deaths can be effectively prevented or treated if women have access to high-quality maternal health care. Essential medicines, such as oxytocin and misoprostol, are safe and effective for preventing and treating PPH; however for many women in Burkina Faso, and in countries around the world, these essential medicines are not available or easily accessible. Access to misoprostol, a safe and effective medicine for preventing and treating PPH, is particularly important in developing countries, and especially in rural areas, because (unlike oxytocin) it requires neither refrigeration nor injection: it can be used even in poorly-equipped health facilities and home births.

Home births are still very common in Burkina Faso
A third of all births in Burkina Faso still take place at home; in poor villages on the edge of the Sahara, this figure exceeds 60%

In early September, FCI convened a meeting in Burkina Faso with 40 high-level officials from the Ministry of Health, local and international NGOs, and national professional societies to share the latest evidence and research and identify strategies for making misoprostol more affordable and accessible for preventing and treating PPH. A room full of champions for improved maternal health in Burkina Faso, the participants called for widespread availability of misoprostol, particularly in regions where women may not be able to reach health facilities for delivery. At the same time, participants identified a number of challenges for making misoprostol more widely available; these included:

  • High cost of the drug: As it is now, women in Burkina Faso cannot purchase a single dose of misoprostol; only larger packages — 4 or 5 doses, depending on whether it will be used for prevention or treatment — are available, and they cost more than US$5, a considerable sum in Burkina Faso.
  • Use for other indications: Some meeting participants were also concerned about the possibility that, if it were made available for PPH, untrained or unskilled health workers could use misoprostol for abortion or to induce labor.
  • Conflicts with health facility deliveries: Participants raised the fear that making misoprostol available in community settings could discourage women from going to a health facility for delivery.
  • Need for more research/data: Meeting participants discussed whether more research in regions like the Sahel — remote, rural areas, where skilled care is unavailable or very far away and home birth is consequently very common — is needed.

Women in my district die from postpartum hemorrhage, so we can’t be against the use of misoprostol [for PPH] in rural areas. In the Sahel only 38% of births are attended by a skilled professional, and it’s not because women don’t want to deliver in a clinic. Here, travelling 2 kilometers takes as long as it would to travel 30 kilometers somewhere else.– Chief Medical Officer, Gorom-Gorom District, Sahel Region, Burkina Faso

Participants identified a number of agreements and strategies for moving forward. They agreed that:

  • The potential use of misoprostol for other indications, including abortion, is not a reason to restrict access to it for PPH. A safe and effective medicine should not be withheld from women who need it simply because it can also be used for other, more controversial indications. Further, evidence suggests that making misoprostol more widely available for PPH does not increase the rate of abortion. Women who want to have an abortion will have one, whether or not they have access to misoprostol.
  •  Misoprostol should be added to the national Essential Medicines List (EML) for use in peripheral health centers. A small group was established to work on a proposal for including misoprostol for PPH in the national EML.
  •  There is a need to lower the cost of the drug, either through government funding or social marketing.

FCI works at the global level and in select countries such as Burkina Faso and Kenya, in collaboration with our partners, to support wider understanding, acceptance, and use of misoprostol for PPH. FCI maps advocacy efforts, publishes case studies, articles, and information briefs, disseminates new information, and brings together experts through online events and conferences to discuss evidence and challenges related to misoprostol’s access and availability.

Action on the global stage: Life-saving reproductive health commodities getting much-needed attention

Ann Starrs is FCI’s president and co-founder.

During the third week of May, I was in Geneva — together with an impressive collection of global health leaders from governments, UN agencies, and civil society — for the 66th session of the World Health Assembly (WHA). I am in Geneva fairly often, for meetings with WHO, the Partnership for Maternal, Newborn & Child Health (PMNCH) and other partners, but the annual World Health Assembly meeting is unique. The WHA is the governing body of the World Health Organization, and so it is attended by high-level delegations – usually led by the Minister of Health – from WHO’s member states. That makes WHA a great opportunity for networking and strategizing: finding an available seat, much less a table, in the famous (but oddly named) Serpent Bar at the Palais de Nations is always a challenge, as many conference participants spend virtually all of their time huddled there in intense discussion.

WHA delegates at work in the Serpent Bar (WHO/Pierre Albouy)

Issues around reproductive, maternal, newborn, and child health featured strongly in this year’s agenda, which is why I was there. The MDGs, and development goals beyond 2015universal health coverage; life-saving commodities; and frameworks for holding countries and donors accountable for fulfilling their health commitments were all on the agenda, for formal discussion, side events, and hours of conversation at the Serpent Bar.

Perhaps most importantly, this year’s WHA considered, and ultimately passed, a resolution to implement the recommendations of the UN Commission on Life-Saving Commodities for Women and Children. The resolution commits countries to improving the quality, supply, and delivery of underutilized and essential commodities for RMNCH, and tasks WHO with reporting back to WHA each year through 2015 on progress in implementing the Commodity Commission recommendations as well as those of Commission on Information and Accountability for Women’s and Children’s Health. The WHA resolution is a clear, global endorsement of the Commodity Commission recommendations, and represents a commitment by the world’s nations to ensure that life-saving medicines and technologies get to the women and children who need them. It is a significant achievement for our community, and it provides an important mechanism for ongoing advocacy, and for holding governments and development partners accountable for keeping their promises.

Notably, the Commodity Commission’s list of 13 priority commodities includes two that are advocacy priorities for FCI: misoprostol, a drug that is highly effective for preventing and treating postpartum hemorrhage (PPH), the leading cause of maternal death; and emergency contraceptives, which help women prevent unintended pregnancy after unprotected sex. (FCI is host organization for the International Consortium for Emergency Contraception—ICEC.)  At a very well-attended side event during the WHA, hosted by the delegations from Nigeria, Norway, and the U.S., along with World Vision International and PATH, speakers focused on the importance of innovation in overcoming barriers to access to essential health commodities. Presentations highlighted the substantial achievements that have already been made, and the important step forward represented by the Commodity Commission’s recommendations. Representatives from various countries also noted the significant challenges that remain, including those related to health commodity distribution systems, manufacturing, and supply. Several countries expressed a preference for purchasing and distributing locally-manufactured commodities, although this approach can sometimes raise concerns about quality assurance; further study, and advocacy, will be needed to address this challenge.

Only a few days later, and half a world away, I was one of a dozen FCI staff members who attended Women Deliver 2013, in Kuala Lumpur, Malaysia. This week was even busier – in fact, much crazier – than the previous week in Geneva; there were meetings and events starting at 7 in the morning, and organized social events went until 8 or 9 pm every night. The conference was amazing, bringing together 4,500 leaders, clinicians, program managers, and advocates representing over 2,200 organizations and 149 countries. I could not take full advantage (or anywhere near it) of everything the conference had to offer; there was an endless variety of stimulating plenary and concurrent sessions (including six sessions presenting the latest findings from Countdown to 2015, in which FCI is a leading advocacy partner), as well as Speaker’s Corner (where FCI and WHO presented new tools for strengthening countries’ policies on adolescent sexual and reproductive health). There was a youth corner and a cinema corner, a busy and bustling exhibition hall, and many, many other activities going on at all times. The cumulative value of all the connections made, facts and ideas conveyed, materials disseminated, and plans and strategies developed was immeasurable but immense.

FCI country directors (Fatimata Kane, Mali; Angela Mutunga, Kenya; Brahima Bassane, Burkina Faso) meet at the FCI booth at Women Deliver 2013

Here, too, essential health commodities were on the agenda. On the Monday morning just before the conference officially started, FCI co-sponsored a side event called “In Our Hands: Successful Strategies to Prioritize Essential Maternal Health Supplies,” at which the Maternal Health Supplies Working Group and the Maternal Health Supplies Caucus of the Reproductive Health Supplies Coalition brought together global and national advocates and program implementers in an interactive forum – including advocacy case studies from Africa, Asia and Latin America – to network, strategize, and exchange ideas for elevating maternal health supplies onto global and national health agendas. At the same time, ICEC co-sponsored a session on “Emergency Contraception: New Research Findings, Programmatic Updates, and Advocacy Strategies,” at which advocates, researchers, pharmaceutical representatives, and other leaders in the field discussed efforts to ensure access to EC globally, with a focus on developing countries.

That afternoon, FIGO and Gynuity Health Projects (our partners in misoprostol advocacy) co-hosted a discussion of misoprostol for PPH: “New Evidence and the Way Forward.” Presenters offered the latest information on ways that the current evidence can help inform and develop effective policies and service delivery programs across varying levels of the health system, and on lessons learned from innovative programs in Afghanistan and Nepal. I concluded the session with a presentation on advocacy opportunities and challenges for “Making Misoprostol an Operational Reality.”

At these and related sessions the level of discussion, the enthusiastic participation by advocates and health workers, and the clear attention that these issues are getting from policy makers, made for an inspiring and energizing two weeks. “Making sure that women and children have the medicines and other supplies they need is critical for our push to achieve the MDGs,” said Secretary-General Ban Ki-moon when he launched the Commodities Commission 15 months ago. Progress is being made, and we, together with our advocacy partners, are working hard to make sure that essential commodities are available to all who need them.