Melissa Garcia is Senior Technical Officer for the International Consortium for Emergency Contraception and Sarah Rich is Senior Program Officer at Women’s Refugee Commission. This post originally appeared on the blog for the Sexual Violence Research Initiative.
Emergency contraception (EC) can reduce the risk of pregnancy after unprotected sex, including in cases of sexual violence. Global guidance is clear that EC should be offered to women and girls within 120 hours of sexual violence to prevent the traumatic consequences of pregnancy resulting from rape.
Yet women and girls who have experienced unprotected sex, including through sexual violence, do not routinely have access to EC. The global aid communities must work together to increase access to EC for sexual violence survivors around the world, including for women and girls who are the most marginalized, like those living in crisis-affected settings. A range of strategies can be implemented to improve access to EC. Further research is also needed to identify, evaluate, and invest in new and innovative solutions. Continue reading “Emergency contraception is a simple part of post-rape care: Why is it not routinely provided?”
Melissa Wanda Kirowo is Advocacy Project Officer with the FCI Program of Management Sciences for Health, based in Nairobi, Kenya. Melissa was nominated for the 120 Under 40 Project by family planning colleagues for her substantial contributions to reproductive health at the national level or local level. Learn more about Melissa’s work and vote here until July 10!
At Women Deliver 2016 last month, I had the opportunity to talk with one of a number of young midwives attending the conference. Clementina IIukol, a 22 year-old Ugandan midwife, represents the commitment of health care providers as they work, often under very difficult conditions, to provide essential services to women, newborns, children, and adolescents in the communities they serve. “I walk for miles before daybreak,” Clementina told me, “to fetch water for use at the clinic where I work.”
A week after Women Deliver, global health security was the top subject of discussion at the World Health Assembly, as member states recognize that sustainable development will be unattainable if resilient health systems cannot withstand epidemics like the Ebola, MERS, and Zika viruses. Ultimately, global health security requires individual health security; we must not only support rapid detection and response to cross-border infectious disease threats, but we must also guarantee that every individual has access to safe and effective health care. And what this requires, in turn, is an adequate, equitably distributed, skilled, and well-equipped health workforce. Healthcare workers, like Clementina, turn aspirations into actions. They constantly ‘innovate,’ building bridges to work failing health systems so that everyone facing a health emergency can get the treatment they need. Continue reading “Health workers: The unattended resource”
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”
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. Continue reading “Maternal health takes the spotlight at the World Health Assembly”
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
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.”
Shafia Rashid is a senior program officer for Global Advocacy at Family Care International.
For women around the world, compassionate and competent care from a midwife can mean the difference between life and death. We know that midwives provide life-saving care during pregnancy, childbirth, and in the postnatal period. Midwives, and other mid-level and community health providers, can administer essential medicines, such as oxytocin and misoprostol, which are safe and effective for preventing and treating life-threatening postpartum bleeding or hemorrhage (PPH), the leading cause of maternal death in most developing countries. Access to misoprostol is particularly important in developing countries, and especially in rural areas, because (unlike oxytocin) it requires neither refrigeration nor injection: it can be used in poorly equipped health facilities and even home births.
In order for midwives to provide life-saving maternal health care, they need the support of policies that enable them to provide a full range of medical interventions. In some countries, however, midwives are not legally authorized to administer oxytocin and/or misoprostol —despite evidence that administration by low and mid-level health providers is feasible and effective. But physicians sometimes resist or oppose expansion of midwives’ scope of practice, based on notions of “professional territoriality” and concerns about their capacity to correctly and safely administer these medications.
Most women in low-resource settings give birth in lower-level health facilities or at home, attended by a midwife or other mid-level health provider. So restrictive policies requiring that administration of medications be carried out only by physicians limits women’s access to essential medicines they need for safe pregnancy and childbirth. Placing misoprostol in the hands of non‐physician providers, for example, can expand access to timely PPH treatment. In remote and rural areas, where transfer for emergency obstetric treatment at a higher-level facility may be delayed, difficult, or impossible, misoprostol could be administered by a low-level provider as a “first aid” treatment to stop bleeding.
The global health community can play an important role in addressing and removing policy and regulatory barriers, and ultimately in improving women’s access to essential medicines. Making this happen will require that governments, in many countries, revise policies that allow administration of medications only by physicians. In 2012, WHO issued guidelines on task-shifting for maternal and newborn health. They called for a “more rational distribution of tasks and responsibilities among cadres of health workers …[to] significantly improve both access and cost-effectiveness – for example by training and enabling ‘mid-level’ and ‘lay’ health workers to perform specific interventions otherwise provided only by cadres with longer (and sometimes more specialized) training.” This makes excellent sense.
The leading global health professional associations focused on pregnancy and childbirth, the International Confederation of Midwives (ICM) and the International Federation of Gynecology and Obstetrics (FIGO), can work together to ensure that these international recommendations translate into changes in national norms and in clinical practice. Earlier this year, ICM and FIGO issued a joint statement, Misoprostol for the treatment of postpartum hemorrhage in low resource settings, which called on partners to:
Promote task-sharing approach
Ensure that skilled health providers (and not just doctors) can administer uterotonic drugs like misoprostol and oxytocin
Challenge regulatory and policy barriers that limit access to high quality maternal health care
Advocate for increasing the midwifery workforce
Implement innovative strategies to strengthen the role of midwives and non-physician providers in providing high-quality maternal health services
Health professionals, policy makers, and other partners must work together to ensure that every woman has access to the uterotonic medicines that can protect her from the suffering and potential death that can be caused by postpartum hemorrhage.
 Beverly Winikoff, Why misoprostol in the hands of non-physician providers matters, Presentation at the ICM Trienniel Congress, Prague, June 3, 2014.