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”
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.
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 and retained on the list for prevention of PPH. Continue reading “Misoprostol for treatment of postpartum hemorrhage added to WHO Essential Medicines List”
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.
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—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 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:
 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.
 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.
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.
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.
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:
International partners working with national procurement agencies to improve procurement guidelines and procedures to ensure that only quality drugs are accepted into countries
International partners working with National Drug Regulatory Agencies and others to increase awareness about quality issues with oxytocin
Stricter enforcement of national guidelines and routine quality audits of drugs
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?
Market failures leading to an insufficient supply of quality drugs
A weak regulatory environment leading to variability in drug formulation and quality
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.
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.
Our 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:
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?
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?
What have been successful strategies to reduce financial barriers to access maternal health supplies?
What are lessons learned regarding supply chains for maternal health and information systems for their monitoring?
How can we best prepare health providers to both use maternal health supplies correctly and advocate for their use?
What strategies can be used to raise awareness of the importance of quality assurance among governments, health providers and women?
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.
Andrew Weeks is Professor of Women’s and Children’s Health at the University of Liverpool and the Principal Investigator of the MamaMiso study. Shafia Rashid is a senior program officer at Family Care International (FCI).Through research and advocacy,FCI works with Gynuity Health Projects and other partners to support increased access to and availability of misoprostol for prevention and treatment of postpartum hemorrhage.
Sarah Nerima was working on her banana plantation when she went into labor. Unable to reach a health center – the nearest was 6 miles away – Sarah gave birth in the fields, attended only by her mother-in-law. Already a mother of two, she had bled heavily in each of her previous deliveries, and she was afraid that a hemorrhage could take her life, leaving three motherless children.
For the 50% of women in rural Uganda who, like Sarah, give birth outside a health facility, a simple, safe and effective medicine, called misoprostol, can prevent or stop life-threatening bleeding. Misoprostol is a medicine that comes in tablet form, can be stored without refrigeration, and be administered without any specialized skills. The World Health Organization (WHO) recommends misoprostol for the prevention and treatment of postpartum hemorrhage (PPH) in settings where the standard of care, oxytocin – which requires cold storage and is administered by injection – is not available or cannot safely be used. WHO also recommends that misoprostol can be administered by community health workers for PPH prevention when skilled health providers are not present.
Some countries with high rates of non-facility births distribute misoprostol at antenatal care visits to women directly (a strategy called ‘advance distribution’), but WHO – citing unanswered questions about the safety and effectiveness of self-administered misoprostol in home births – has held off on recommending advance distribution, calling for additional research.
In Uganda, a research team from the University of Liverpool, Gynuity Health Projects, and Makerere University has tested the safety and feasibility of this community-based distribution model. MamaMiso, as this 2012 study was aptly called, provided misoprostol tablets to pregnant women for self-administration immediately after childbirth to prevent bleeding. Working in 200 villages in Mbale district, Eastern Uganda, the research team recruited women who came for antenatal care at Mbale Regional Referral Hospital or 3 large health centres (Busiu, Lwangoli and Siira) nearby.
Every pregnant woman at more than 34 weeks of gestation living in the recruitment villages was eligible to participate. Each participant was given a small purse, with a string that could be hung around the neck, containing 3 foil-packed tablets (600 micrograms misoprostol or placebo). Women were told to bring the purse home, to keep it with them, and to swallow the pills immediately after birth if they delivered at home. They were given an instruction sheet with written and pictorial instructions on how to take the tablets. Women were advised not to take the tablets if they went to a health facility for their delivery. Each participant was visited at 3 to 5 days after birth to check whether she had taken the medicine and to collect clinical outcomes.
MamaMiso’s results showed that self-administration of misoprostol is safe, and that advance distribution during antenatal care has the potential to increase the number of women who receive a medicine to prevent PPH. Of the women who enrolled in the research study, 57% gave birth at a facility and 43% delivered at home. Of those women who delivered at home, almost all (97%) took the study medicine after childbirth. Only 2 women (0.3%) took the medicine prior to delivery, and neither suffered adverse effects. Women who took misoprostol did experience fever and shivering, but they found these side effects to be acceptable.
These findings, together with results from other studies examining community-level use of misoprostol, have spurred national stakeholders to take action. The national Ugandan ob-gyn society has called for updating the national guidelines on PPH prevention to recommend community use of misoprostol, specifically enabling women to receive misoprostol as part of antenatal care. ‘We cannot continue to let women die when we have the solutions,’ said Dr. Charles Kiggundu, vice president of the Association of Obstetricians and Gynaecologists of Uganda. ‘The hindrance to using scientifically proven drugs is with health workers, not the women.”
Sarah Nerima was one of the women included in the MamaMiso study. After delivering her baby daughter among the banana trees, she opened her MamaMiso purse, and took the pills. “The bleeding was very, very little this time”, she said, “As you see, I am already very strong.”