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Misoprostol for treatment of postpartum hemorrhage added to WHO Essential Medicines List

2015 May 15
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Shafia Rashid is senior program officer for Global Advocacy at Family Care International.

For more than five years, FCI has been working with Gynuity Health Projects and other partners to build the evidence base for expanded availability and use of misoprostol for the prevention and treatment of postpartum hemorrhage (PPH). PPH is the leading cause of maternal death, and misoprostol is a safe, effective medicine that is especially practical in low-resource settings, because it is available as a tablet and does not require refrigeration or injection.

This week marked an important milestone in global efforts to make misoprostol available to the women who need it, as the World Health Organization (WHO) approved its inclusion on the Model List of Essential Medicines (EML) for the treatment of PPH. Misoprostol was included on the EML for prevention of PPH in 2011, and the recent decision signifies WHO’s full endorsement of misoprostol as an essential maternal health medicine in settings where oxytocin — which requires cold storage and intravenous injection — is not available or cannot be used safely. The WHO Expert Committee for the Selection and Use of Essential Medicines, a panel that meets every two years to update the EML, recommended that misoprostol be listed for the additional indication of treating PPH[1] and retained on the list for prevention of PPH. read more…

Calling for an integrated approach to maternal and newborn health: Strategies toward Ending Preventable Maternal Mortality

2015 May 15
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Amy Boldosser-Boesch is Interim President and CEO of Family Care International. This post originally appeared on the Maternal Health Task Force blog.

Next week at the 68th World Health Assembly, the Ending Preventable Maternal Mortality (EPMM)Working Group — led by WHO in partnership with Family Care International (FCI), the Maternal Health Task Force, UNICEF, UNFPA, USAID, the Maternal Child Survival Program, and the White Ribbon Alliance — will launch its much-anticipated report, Strategies Toward Ending Preventable Maternal Mortality (EPMM). For FCI and our partners, this report presents an important opportunity to highlight the critical linkages between the health of a woman and that of her newborn baby. read more…

Maternal health takes the spotlight at the World Health Assembly

2015 May 12
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By Rima Jolivet, Maternal Health Consultant, MHTF

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

In an important development for the global maternal health community, the long-awaited Strategies toward Ending Preventable Maternal Mortality (EPMM) will be launched at the 68th World Health Assembly, at an event hosted by Cameroon and Malawi and co-sponsored by the contributors to the Every Newborn Action Plan.

This event marks the culmination of over two years of consensus work and collaboration with multiple stakeholders that began in January 2013. The EPMM Working Group—led by the WHO in partnership with MHTF, UNICEF, UNFPA, USAID, Family Care International, Maternal Child Survival Program (MCSP), and White Ribbon Alliance—has stewarded the process to gather key inputs and consult widely with a broad range of stakeholders to develop the ambitious yet feasible targets for ending preventable maternal deaths within a generation, and to identify the strategic priorities and actions necessary for achieving this vision. The strategies are presented in full in the EPMM report that has been recently published by the World Health Organization. The EPMM targets were included as part of the Every Newborn Action Plan resolution at last year’s World Health Assembly. read more…

The economic and social impacts of maternal death  

2015 May 5
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Guest post by Tezeta Tulloch, communications manager at the FXB Center for Health and Human Rights at Harvard University. This post originally appeared on the BMC Blog.

What happens when a mother dies? In the West, the most ready and obvious answer is grief – the harrowing emotional and psychological toll of losing a loved one. A mother’s death is largely viewed as a private tragedy that will grow more manageable in time.

But in many developing countries, a mother’s death is much more than an emotional crisis, often leading to long-term social and economic breakdown, both for her immediate family and the wider community. This topic is explored in new depth, in a special issue launched today in Reproductive Health (an open-access journal).

“The True Cost of Maternal Death: Individual Tragedy Impacts Family, Community and Nations” focuses exclusively on the immediate and longer-term effects of maternal death on surviving children, households, and communities. It features seven studies, with data drawn from four African countries – Ethiopia, Kenya, Malawi, and South Africa.

The research was conducted by two research groups, one led by Harvard’s FXB Center for Health and Human Rights, and the other a consortium made up of Family Care International, the International Center for Research on Women, and the Kenya Medical Research Institute (KEMRI)-CDC Research and Public Health Collaboration. The results provide hard evidence that a mother’s loss can devastate the livelihoods, quality of life, and survival chances of those she leaves behind.

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The supplement features seven studies, with data drawn from four African countries – Ethiopia, Kenya, Malawi, and South Africa. Photo via Pixabay

read more…

Supporting midwives for a better tomorrow

2015 May 4
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Martha Murdock is Vice President for Regional Programs at Family Care International.

Midwives save lives. It’s as simple as that. But the obstacles and barriers midwives face are anything but simple.

We all know that midwives have crucial clinical skills that help them care for women and their newborns everyday all over the world. If these lifesaving services were available and accessible to all the women and babies who need them, midwives could help avert two-thirds of the nearly 300,000 maternal deaths and half of the 3 million newborn deaths that occur every year. Midwives play an absolutely critical role in making progress on Millennium Development Goals 4 (reducing child mortality) and 5 (improving maternal health and achieving universal access to reproductive health). And without a well-supported, trained, and supplied midwifery cadre, we won’t be able to meet the maternal and child health targets that will be part of the post-2015 agenda. We’re delighted to join our colleagues at the International Confederation of Midwives (ICM) in celebrating the International Day of the Midwife today, 5 May. read more…

African youth amplify their voices at CPD

2015 April 21
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by Family Care International

By Kigen Korir, National Programme Coordinator, SRHR Alliance in Kenya; Hellen Owino, Advocacy Officer, Centre for the Study of Adolescents in Kenya; and Lara van Kouterik, Senior Programme Officer SRHR, Simavi in The Netherlands

We have the largest generation of young people ever.

The world must listen to young people’s voices. It must ensure that we have the opportunity to influence policies that affect us, especially in setting the new development agenda for the era beyond 2015. It must understand that young people know what they want and need, and are committed to safeguarding their sexual and reproductive health and rights (SRHR).

Too often, the voices of young people are drowned out by those of adult policymakers who think they know what young people need and assume young people are “too young” to articulate their issues effectively. For many years, these assumptions have limited the opportunities and constricted the space for young people to participate meaningfully in the creation of the development programs and policies that will have a direct impact on their lives.

At a recent side event during the Commission on Population and Development, young people voiced their concerns, shared best practices, and discussed key issues with other stakeholders. The event was hosted by Simavi (an NGO based in the Netherlands), the permanent mission of Ghana to the UN, and SRHR Alliances from Ghana, Kenya, Uganda, and Malawi, and was attended by representatives, including youth, from country delegations; SRHR advocates; policy makers; and young people.

Aisha Twalibu of YECE Malawi

Aisha Twalibu of YECE Malawi

“Involving young people in SRHR is a basic right enshrined in the laws of many countries, and it is therefore incumbent for countries to observe the same,” explained Edith Asamani, a youth representative from Curious Minds Ghana.

Aisha Twalibu, a youth representative from YECE in Malawi, explained to the group that young people are a diverse group with different needs, and that listening to their voices will help governments, CSOs and development agencies tailor SRHR programs to their needs.

Three other young Africans shared case studies on youth SRHR programs. First, Chris Kyewe from Family Life Education Programme described his peer education program in Uganda, in which youth peer educators (YPEs) are trained to give SRHR information and education to their peers and refer young people to local health centers where trained healthcare providers offer youth-friendly services. In addition to education, YPEs also provide their peers with condoms and oral contraceptive pills, together with instructions on how to use them. This example showed how young people are meaningfully engaged in the implementation of the program.

Then Hellen Owino from the Centre for the Study of Adolescents in Kenya shared that comprehensive sexuality education programs in Kenya empower young people to make informed choices about their health and sexuality. CSA and the Kenya SRHR Alliance have been engaged in advocacy to include comprehensive sexuality education in the national curriculum of Kenya. She also shared that CSE programs should be appealing and interactive, for example by using ICT and social media, to capture the attention of young people. Justine Saidi, the Principal Secretary for Youth in Malawi also called for the active involvement of parents in demanding that young people have access to sexuality information.

Charles Banda from YONECO shared the last case study that focused on preventing child marriage in Malawi. He shared his experience in working with youth-led organizations to build awareness on the negative impact of child marriages on girls and communities, creating a more enabling environment for young girls to exercise their rights. He also described how civil society organizations in Malawi have advocated successfully to raise the legal age of marriage to 18 years, which was recently made into law by the President of Malawi.

Highlighting lessons from the women’s movement, the side event concluded with a discussion of key strategies for youth advocates, including:

  • Mobilizing a critical mass of young people
  • Holding governments accountable for fulfilling their national and international commitments
  • Investing in ensuring that health data can be disaggregated by age group, especially for young people aged 10 to 14
  • Identifying champions at all levels to advance the youth and SRHR agenda

It is time that young people’s views and concerns are incorporated into the new development agenda. Without listening to young people, no country will be able to realize the potential of the demographic dividend that comes with this generation.

 

 

 

Managing postpartum hemorrhage at home deliveries in Chitral, Pakistan

2015 April 17
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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

2015 April 17
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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

2015 April 10
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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.

 

 

The myth of the meager maternal health market

2015 April 6
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By Deepti Tanuku, Program Director, USAID-Accelovate

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

pakistan mother maternal health quality care facility smile woman pakistani

Mother in Sindh, Pakistan receiving quality care. Photo: Jhpiego.

When I first entered this line of work, I often heard one thing: the maternal health market is way too small to be sustainable, much less lucrative. Naturally, one can only expect market failure for maternal health drugs and, by extension, a chronic situation of limited access to lifesaving medicines among those most in need.

However, I disagree.

The maternal health market is, of course, comparatively small when looking at the parallel markets for reproductive health, HIV, TB, malaria and even child health.

Take malaria for example. Prepared technical guidance provided by the President’s Malaria Initiative states that the unit cost for delivery of long-lasting insecticidal nets (LLINs) provided free of charge through antenatal clinics in four countries ranged from US $1.61 to $2.35 – which is roughly equivalent to the unit cost of US $1.50 for a delivery package of the three essential maternal health medicines: oxytocin, misoprostol and magnesium sulfate. However, in 2014 an estimated 214 million long-lasting insecticidal nets were delivered to malaria-endemic countries in Africa, while only 36 million women gave birth in the same region that same year. As any business school student can tell you, applying the formula of Price x Quantity = Revenue means that the maternal health market simply doesn’t compare in size.

This is the origin of the myth. For those of us committed to the goal of improved maternal health, we cannot confuse a small market with an unhealthy market – small can still mean healthy. Small can and should still mean a consistent and sustainable supply of high-quality and affordable maternal health drugs to all mothers in all settings.

There is a catch. The maternal health community cannot wait for market realities to drift toward our favor – we must actively and purposefully shape them. This begins with strong political will at both global and national levels. The creation of the UN Commission on Lifesaving Commodities for Women and Children is an excellent start, as is the inclusion of maternal health within the Reproductive Health Supplies Coalition (RHSC) agenda. These actions complement the ongoing efforts of other groups in this space, including the Maternal Health Task Force, itself.

The good news is that in the context of strong political will, there is plenty of research to shape evidence-based next steps. Together, we have built a clear understanding of market access barriers and we even know ways to incentivize around them. We also have market shaping strategies from other priority health areas, such as family planning, that serve as blueprints that we can adapt for our own purposes. As the maternal health community, it is up to us to use these tools to advocate for and help ourselves.

Finally, it’s good to revisit why this issue is critically important. Several studies and reports have demonstrated time and time again that healthy mothers strengthen families, societies and a nation’s economic development, which, in turn, strengthen a nation’s markets. Let’s say that again: Healthy mothers strengthen markets. It’s time markets returned the favor.

Resources used in the writing of this post:

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.

Changing incentives: Creating a market for high quality oxytocin

2015 March 31
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By Celina Schocken and Courtney Chang, Jhpiego

This post originally appeared on the Maternal Health Task Force Blog, as part of the 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.

 

Oxytocin is the first-line drug for the prevention and treatment of postpartum hemorrhage (PPH) and is widely available in developing countries. There is a large market for oxytocin and there are many manufacturers of the drug; however, there are growing concerns that products are not in good condition when they are injected, either because of poor manufacturing or degradation along the supply chain.

oxytocin

Issues with inconsistent oxytocin quality

In 2012, a study by US Pharmacopeia and the Ghanaian Food and Drug Authority found that only 8% of oxytocin samples in Ghana had market authorization. The majority (97.5%) of samples failed either assay or sterility testing and over 55% of samples failed their physio-chemical assay. Even when a product is properly manufactured, storage and labeling of the drug along the supply chain and in facilities varies: in fact, only 8% of oxytocin samples were stored in the proper temperature (2°-8° C). The study ultimately concluded that 65.5% of oxytocin sampled in country did not meet quality standards, severely impairing the ability to prevent and treat PPH.

In most countries, we lack clear information about the quality of oxytocin administered to postpartum women. More studies are underway, as it is critically important to ensure that quality oxytocin is administered.

Limited product choices for quality oxytocin

In order to regulate quality, the WHO prequalification process helps identify quality drugs for countries. Currently, there are no WHO-prequalified oxytocin products; the only regulated products currently in the market are approved by Stringent Regulatory Authorities (SRAs), which are national bodies like the US Food and Drug Administration. This less stringent regulation is present despite a high volume market for oxytocin; globally, 100 million doses per year are used for prevention and treatment of PPH. There are at least 300 different oxytocin products manufactured by at least 100 manufacturers, creating a market that is difficult to regulate.

Most oxytocin in developing countries is procured by national procurement agencies, and most do not require WHO prequalification of oxytocin. These agencies are very resource-constrained and tend to focus on procuring high volume for low cost.

Current market structure threatens quality

For manufacturers, the low price of oxytocin—ranging from about $0.15 to $0.20 per 10 international unit (IU) dose—paired with a large number of competitors, creates a highly price-sensitive market. Achieving prequalification requires a manufacturer to upgrade its factory or improve manufacturing processes, likely adding 5-12% to the cost of products: a cost that makes thriving in the current market too difficult.

In a market where procurers do not require regulatory approval, prequalified or SRA-approved drugs simply will not be competitive against non-quality assured drugs and manufacturers will have no incentive to go through WHO prequalification. Instead, in order to stay competitive in the market, manufacturers will compromise the quality of their products order to keep prices low, boost sales and sustain profits.

Promoting a market shaping strategy for improved oxytocin

As the market for oxytocin grows, national governments and international partners must work together to ensure that manufacturers are incentivized to produce quality oxytocin. National governments and international partners should rally around a market shaping strategy that involves the following components:

  1. International partners working with national procurement agencies to improve procurement guidelines and procedures to ensure that only quality drugs are accepted into countries
  2. International partners working with National Drug Regulatory Agencies and others to increase awareness about quality issues with oxytocin
  3. Stricter enforcement of national guidelines and routine quality audits of drugs

For more information on quality oxytocin, please read the Business Case: Investing in Production of High Quality Oxytocin for Low-Resource Settings

Photo: “DSC_0096″ © 2009 Colin, used under a Creative Commons Attribution license: http://creativecommons.org/licenses/by/2.0/

Improving Access to Maternal Health Commodities through a Systems Approach: Where are we now?

2015 March 27
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By Beth Yeager, Principal Technical Advisor, Management Sciences for Health & Chair, Maternal Health Supplies Caucus, Reproductive Health Supplies Coalition. This post originally appeared on the Maternal Health Task Force Blog.

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.

Nearly three years ago, I blogged about a systems approach to improving access for a Maternal Health Task Force (MHTF) series on maternal health commodities:

Increasing access to essential medicines and supplies for maternal health requires a systems approach that includes: improving governance of pharmaceutical systems, strengthening supply chain management, increasing the availability of information for decision-making, developing appropriate financing strategies and promoting rational use of medicines and supplies.

It was an exciting year for maternal health. The UN Commission on Life-Saving Commodities for Women and Children (UNCoLSC) had just released its report with 10 recommendations for improving access to 13 priority commodities that included 3 for maternal health: oxytocin, misoprostol and magnesium sulfate.  The UNCoLSC report also reflected the idea that a systems approach was necessary and included recommendations related to both upstream and downstream supply chain bottlenecks, information, financing and appropriate use. That same year, the Maternal Health Supplies Caucus of the Reproductive Health Supplies Coalition held its first membership meeting in October for the purpose of joining the maternal health and family planning communities to “draw on existing approaches to address the bottlenecks undermining commodity security across health systems.”

Since then, great progress has been made in identifying the bottlenecks to access, raising awareness of the complexity of addressing these challenges and increasing global commitment to ending preventable maternal deaths as part of the post-2015 development agenda.

Improving governance

With respect to governance, through the efforts of the UNCoLSC to promote coordinated national strategies for Reproductive, Maternal, Newborn and Child Health (RMNCH), the need for coordinated planning among all stakeholders, including measures of accountability, has come to the forefront.

Reviewing national policies — such as the essential medicines lists and standard treatment guidelines — and advocating for the inclusion of the three priority maternal health medicines in these policies has raised awareness of both the need to harmonize policies at the national level and the challenges to implementing these policies.

Recognition of the importance of the regulatory role governments play in ensuring the quality of products in circulation in the public and private sectors has also grown. In a recent study conducted by the USAID-funded Systems for Improved Access to Pharmaceuticals and Services program (SIAPS) in Bangladesh, we found that over 40% of the oxytocin in circulation at the district level was procured from local wholesalers.

Strengthening supply chain management

In terms of supply chain challenges, resources are now available to assist countries in more accurate forecasting for maternal health medicines. The Estimation of Unmet Medical Need for Essential Maternal Health Medicines developed by SIAPS (a project led by Management Sciences for Health with partners) presents an approach that allows national program managers and other key stakeholders to assess a country’s theoretical need for the three maternal health commodities and compare this with actual procurement data from past years in an effort to make more evidence-based decisions. The RMNCH quantification guidance developed by the Supply Chain Technical Resource Team of the UNCoLSC also includes the three maternal health medicines.

Information for decision making

Over the past three years, we have also learned how little information is readily available about these commodities and the conditions they are meant to treat at the country level. In many cases, logistic management information systems do not capture these three products (and many others necessary for maternal health). Likewise, health information systems do not necessarily capture the number of women who develop post-partum hemorrhage and are successfully treated. Efforts are currently underway in a number of countries to address this problem.

The global community has learned a lot these past three years and made great progress in further revealing the actions required to increase access to quality medicines and supplies for maternal health. With the current proposed target of ending preventable maternal deaths by 2030, global and national stakeholders need to continue their coordinated efforts to build stronger, more responsive systems.

Beth Yeager, MHS, is Principal Technical Advisor, SIAPS program, at Management Sciences for Health (MSH), Chair Maternal Health Supplies Caucus, Reproductive Health Supplies Coalition

Making connections: Ensuring access to reproductive and maternal health supplies

2015 March 24
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Shafia Rashid is Senior Program Officer for Global Advocacy at Family Care International. This post originally appeared on the Maternal Health Task Force blog.

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.

The past ten years have witnessed impressive gains in the availability and use of reproductive health supplies like condoms and oral contraceptives that allow men and women to safely and effectively prevent or space pregnancies. As a result of concerted efforts by many partners, contraceptive prevalence rates have risen over 60% in countries around the world.

These dramatic successes in improving access to reproductive health supplies can shed important lessons and guidance for those working to ensure that life-saving maternal health medicines — including, oxytocin, misoprostol and magnesium sulfate — are available to all women, when they need them and wherever they give birth. These medicines — which can save lives by preventing or treating the leading causes of maternal death — remain out of reach for many women, particularly for poor, rural, indigenous and other vulnerable women. Many countries lack clear, supportive policies and adequate budgets to make essential maternal health medicines widely available, or have weak supply chains and logistical systems. Inadequate regulatory capacity, poor quality of medicines and lack of information and guidance on correct use are other barriers to access.

In order to summarize lessons learned and provide concrete tools to improve access to maternal health supplies, the Reproductive Health Supplies Coalition tasked Family Care International to create seven policy briefs that show policy makers and program managers real-world examples of successful interventions. Importantly, there is a brief dedicated to each of the three most critical maternal health supplies: oxytocin, misoprostol and magnesium sulfate. Other briefs cover the cross-cutting issues of policy and financing, supply and demand generation.

Lessons learned from successful efforts to improve access to family planning commodities can help to effectively address the challenges related to maternal health medicines. Family planning advocates have, for example, tracked government expenditures on reproductive health supplies: in Indonesia, budget analysis and concerted advocacy led the mayors of five districts to increase their family planning budgets by as much as 80%. Similarly, many countries — including Bolivia, the Dominican Republic, El Salvador, Honduras, Nicaragua and Paraguay — have established contraceptive security committees that bring together multiple supply chain stakeholders to support coordination, address long-term product availability issues and reduce duplication and inefficiencies. These committees have advocated for increased financial support for contraceptives, improved inventory management, developed standard operating procedures, published reports and provided technical assistance. These efforts to increase budgets and ensure commodity security for contraceptives can be effectively adapted and expanded to improve financing and security for maternal health supplies as well.

A wide range of tools and resources can support countries in strengthening their forecasting, procurement and other supply chain functions. Tools originally developed with a sole focus on reproductive health supplies now include or can be adapted to apply to maternal health supplies as well and can be used by country managers working to improve the supply of maternal health medicines.

Finally, many countries are moving toward integrating their supply chains to include family planning commodities and other essential medicines, including medicines for maternal health. In Ethiopia, for instance, the government (with the support of in-country partners) integrated their supply chain to include all health commodities and to connect all levels of the supply chain with accurate and timely data for decision-making. In Nicaragua, where the supply chain was separated vertically by health issue and type of commodity until 2005, the health ministry has integrated the essential medicines system with the contraceptives’ supply chain and has now fully automated the system and expanded it to include all essential medicines.

There are many parallels and potential synergies between reproductive and maternal health supply chains and processes. The reproductive and maternal health communities must take the following actions to address the interrelated barriers that prevent access to and use of life-saving commodities:

  • Advocate for development and implementation of supportive policies at the national and sub-national levels,
  • Advocate for dedicated budget lines to enable monitoring and evaluation of policy implementation
  • Improve government systems and procedures for procuring high-quality medicines and maintaining their quality throughout the supply chain
  • Invest in a streamlined, coordinated supply chain across sectors and levels, reducing inefficiency and duplicative efforts
  • Strengthen the knowledge and skills of health providers so that they are aware of evidence-based policies and guidelines and can effectively administer these essential medicines

More information can be found in Essential Medicines for Maternal Health: Ensuring Equitable Access for All, a set of briefs that highlight challenges and strategies for increasing the availability of these maternal health medicines and identify linkages with reproductive health supplies. You can download the Essential Medicines for Maternal Health policy briefs in English, French and Spanish.

Three barriers to delivering maternal health supplies and the solution

2015 March 18
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By Katharine McCarthy and Saumya RamaRao

Katharine McCarthy is Research Coordinator and Saumya RamaRao is Senior Associate at Population Council. This article originally appeared on the Maternal Health Task Force blog.

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 Caucus and Family Care International, 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.

How can we use the lessons learned by the reproductive health community to advance the maternal health supplies issues?

Each year more than 180,000 women die during pregnancy or childbirth from hemorrhage or pre-eclampsia/eclampsia. Many of these deaths can be prevented with appropriate access to oxytocin, misoprostol and magnesium sulfate. A delivery package containing these medicines is estimated to cost less than US $1.50 per person, and is predicted to save 1.4 million lives over ten years, if available to all women. Current barriers in markets for maternal health drugs, however, cause these drugs to remain largely inaccessible for many women. As the maternal health field refocuses priorities for the SDGs, the importance of building healthy markets for essential medicines is evident.

What are the Major Barriers in Accessing Maternal Health Drugs?

In 2012 the UN Commission on Life Saving Commodities for Women and Children identified key barriers that limit access to lifesaving maternal health drugs:

  1. Market failures leading to an insufficient supply of quality drugs
  2. A weak regulatory environment leading to variability in drug formulation and quality
  3. Lack of provider and consumer awareness of drugs and/or their appropriate use

The interrelated nature of supply and demand challenges makes addressing them difficult. But, there may be a solution. As seen in other health commodity markets, market shaping strategies involving the “total market” may best address these challenges by capitalizing on the potential of all market players to achieve a coordinated approach.

The Solution: What is Market Shaping?

Like many markets, the maternal health drug market is made up of actors from different sectors, including the public (e.g., government), private commercial (e.g., manufacturers, distributors, midwives and oby-gyns), and private non-profit sectors (e.g., faith-based health care providers). Two main reasons for inefficiencies in markets are (1) lack of information and (2) an unbalanced sharing of risk.

Incomplete information or gaps in information flows can be a barrier to market entry. For example, manufacturers and suppliers of drugs may lack information on many aspects of the market such as volume of demand, timing of demand, prices and profitability. Such information gaps can be addressed by high quality demand forecasts, a schedule of when orders are likely to be place, and data on stock-outs, prices, and drug quality. With wider availability of information, new manufacturers and suppliers can be encouraged to enter the market, expanding the supply of available drugs.

To address unbalanced market risk, another strategy is volume guarantees. Unbalanced risk can occur in uncertain markets when a manufacturer or distributor bears the majority of upfront costs with an unforeseeable future profit. A volume guarantee, or an agreement by buyers to purchase of a certain quantity of a product, can offset the risk to suppliers and encourage drug production. Volume guarantees can also aid in negotiations to strengthen the quality and reduce the cost of drugs by achieving purchasing power not previously possible in fragmented developing country markets. Such leverage can also aid in identifying opportunities for innovations in product improvement and financing, further encouraging product purchase and use.

What Else Will it Take?

While capitalizing on market opportunities can facilitate access to drugs and save lives, these strategies alone are likely not sufficient. Complementary programmatic investments are needed to strengthen the supply chain and service delivery, as well as to generate demand by raising awareness on the need and appropriate use of maternal health drugs, and to advocate for the importance of women’s lives. As maternal health researchers, policy planners, advocates and program leaders, we all have our role to play in ensuring women have access to resources for a safe and healthy delivery. We must now turn to moving what we know can work to those in most need.

To learn more about how market shaping lessons from the HIV and reproductive health commodity markets can be applied to scale-up access to maternal health drugs, please see a recent commentary by McCarthy et al., published in Maternal and Child Health Journal.

Resources used in the writing of this post:

Call for posts: How to increase access to maternal and reproductive health supplies

2015 March 16
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By Milka Dinev, Beth Yeager, and Katie Millar

Milka Dinev is the Latin America and Caribbean Forum Regional Advisor for the Reproductive Health Supplies Coalition. Beth Yeager is the principal technical advisor for maternal, newborn and child health for Systems for Improved Access to Pharmaceuticals and Services (SIAPS) Program, led by Management Sciences for Health (MSH). Katie Millar is a technical writer for the Maternal Health Task Force (MHTF), where this article originally appeared

The Maternal Health Task Force (MHTF), the Reproductive Health Supplies Coalition (RHSC)/Maternal Health Supplies Caucus (MHS) and Family Care International (FCI) share the goal of increasing awareness of the key role that reliable access to quality maternal and reproductive health supplies plays in reducing maternal mortality. To this end, we’d like to invite you to contribute a post to our blog series, Increasing access to maternal and reproductive health supplies: Leveraging lessons learned in preventing maternal mortality.

women-mobile-clinicOur goal for this blog series is to create a platform for sharing innovative interventions, lessons-learned and opportunities for collaboration across various organizations and communities in terms of what can be done to ensure availability of quality maternal health supplies. The new global target of fewer than 70 maternal deaths per 100,000 births by 2030 makes timely access to quality maternal and reproductive health medicines and supplies for women even more critical.

Two of the major causes of maternal deaths are post-partum hemorrhage (PPH) and pre-eclampsia/eclampsia. Both conditions can be successfully managed with proven interventions that include administration of oxytocin and misoprostol in the case of PPH, and magnesium sulfate for pre-eclampsia and eclampsia.

Unfortunately, many health systems face challenges that limit access to these life-saving commodities. For example, in some cases there is insufficient funding for these medicines in national budgets, driving increased out-of-pocket spending. Likewise, regulatory agencies are sometimes unable to assure the quality of products circulating in the market due to funding and human resource constraints. Storage conditions remain inadequate for medicines with special storage requirements, like maintaining the cold chain. Lack of information systems that provide up-to-date, reliable data on supply availability further complicates the issue as managers are unable to make evidence-based decisions regarding supplies. Finally, demand side barriers exist as providers often lack appropriate guidance on the use of these life-saving supplies.

These challenges are not insurmountable. Indeed, many of these challenges have been successfully addressed in ensuring access to reproductive health commodities. The reproductive health community has worked for more than three decades to improve the quality of their supplies, strengthen the supply chains that deliver these supplies (mainly contraceptives) and create information systems that help managers make decisions regarding these supplies. Many of these lessons could well apply to increase accessibility and availability of quality maternal health supplies.

Questions and topics for potential guest posts:

  1. What are the barriers you face in ensuring mothers get the supplies they need? How has your work addressed the complicated interplay between contributing factors that attribute to a mother not receiving the life-saving medicine she needs?
  2. Are governments assuming responsibility for and taking the necessary actions to address maternal health supplies issues? What strategies have been successful to increase involvement of government in ensuring maternal health supplies?
  3. What have been successful strategies to reduce financial barriers to access maternal health supplies?
  4. What are lessons learned regarding supply chains for maternal health and information systems for their monitoring?
  5. How can we best prepare health providers to both use maternal health supplies correctly and advocate for their use?
  6. What strategies can be used to raise awareness of the importance of quality assurance among governments, health providers and women?
  7. How can we use the lessons learned by the reproductive health community to advance the maternal health supplies issues?

If your work involves other factors related to supplies, please feel free to propose an original topic.

General guidelines for guest blog posts:

  • Please include the author name, title, and photo
  • Goal: Guest posts should raise questions, discuss lessons learned, analyze programs, describe research, offer recommendations, share resources, or offer critical insight
  • Audience: The audience for this series is health and development professionals working in maternal and newborn health around the world, primarily in resource-constrained settings
  • Tone: Conversational. Does not need to meet professional publication standards
  • Feel free to choose your own style or approach. Q/A and lists (e.g. top ten lessons) can often be effective ways of organizing a blog post
  • Length: 400-600 words
  • No institutional promotion
  • Please include links to sources such as websites and/or publications
  • May also include photos and videos, please include a caption and a credit for the photo

To contribute a post to this series, please contact, Katie Millar, at kmillar@hsph.harvard.edu.

Submissions to this series will be reviewed and accepted on a rolling basis, but preference will be given to posts received by March 30th, 2014.

Posts in this series will be shared on the MHTF blog and may be cross-posted on other leading global health and development blogs.

Thank you for considering contributing to our series. We look forward to hearing from you soon!

Photo credit: Mobile Clinic Medical Day in Azbat Jarrad © 2010 Physicians for Human Rights – Israel, used under a Creative Commons Attribution license: https://creativecommons.org/licenses/by/2.0/