Overcoming silos in health care systems through meso-level organisations - a case study of health reforms in New South Wales, Australia.

Fragmented care delivery is a barrier to improving health system performance worldwide. Investment in meso-level organisations is a potential strategy to improve health system integration, however, its effectiveness remains unclear. In this paper, we provide an overview of key international and Australian integrated care policies. We then describe Collaborative Commissioning - a novel health reform policy to integrate primary and hospital care sectors in New South Wales (NSW), Australia and provide a case study of a model focussed on older person's care. The policy is theorised to achieve greater integration through improved governance (local stakeholders identifying as part of one health system), service delivery (communities perceive new services as preferable to status quo) and incentives (efficiency gains are reinvested locally with progressively higher value care achieved). If effectively implemented at scale, Collaborative Commissioning has potential to improve health system performance in Australia and will be of relevance to similar reform initiatives in other countries.

Co-designing a dashboard of predictive analytics and decision support to drive care quality and client outcomes in aged care: a mixed-method study protocol.

INTRODUCTION: There is a clear need for improved care quality and quality monitoring in aged care. Aged care providers collect an abundance of data, yet rarely are these data integrated and transformed in real-time into actionable information to support evidence-based care, nor are they shared with older people and informal caregivers. This protocol describes the co-design and testing of a dashboard in residential aged care facilities (nursing or care homes) and community-based aged care settings (formal care provided at home or in the community). The dashboard will comprise integrated data to provide an 'at-a-glance' overview of aged care clients, indicators to identify clients at risk of fall-related hospitalisations and poor quality of life, and evidence-based decision support to minimise these risks. Longer term plans for dashboard implementation and evaluation are also outlined. METHODS: This mixed-method study will involve (1) co-designing dashboard features with aged care staff, clients, informal caregivers and general practitioners (GPs), (2) integrating aged care data silos and developing risk models, and (3) testing dashboard prototypes with users. The dashboard features will be informed by direct observations of routine work, interviews, focus groups and co-design groups with users, and a community forum. Multivariable discrete time survival models will be used to develop risk indicators, using predictors from linked historical aged care and hospital data. Dashboard prototype testing will comprise interviews, focus groups and walk-through scenarios using a think-aloud approach with staff members, clients and informal caregivers, and a GP workshop. ETHICS AND DISSEMINATION: This study has received ethical approval from the New South Wales (NSW) Population & Health Services Research Ethics Committee and Macquarie University's Human Research Ethics Committee. The research findings will be presented to the aged care provider who will share results with staff members, clients, residents and informal caregivers. Findings will be disseminated as peer-reviewed journal articles, policy briefs and conference presentations.

Measuring the quality of maternal and care processes at the time of delivery in sub-Saharan Africa: development and validation of a short index.

BACKGROUND: There is a growing recognition that quality of care must improve in facility-based deliveries to achieve further global reductions in maternal and newborn mortality and morbidity. Better measurement of care quality is needed, but the unpredictable length of labor and delivery hinders the feasibility of observation, the gold standard in quality assessment. This study evaluated whether a measure restricted to actions at or immediately following delivery could provide a valid assessment of the quality of the process of intrapartum and immediate postpartum care (QoPIIPC), including essential newborn care. METHODS: The study used a comprehensive QoPIIPC index developed through a modified Delphi process and validated by delivery observation data as a starting point. A subset of items from this index assessed at or immediately following delivery was identified to create a "delivery-only" index. This delivery-only index was evaluated across content and criterion validation domains using delivery observation data from Kenya, Madagascar, and Tanzania, including Zanzibar. RESULTS: The delivery-only index included 13 items and performed well on most validation criteria, including correct classification of poorly and well-performed deliveries. Relative to the comprehensive QoPIIPC index, the delivery-only index had reduced content validity, representing fewer dimensions of QoPIIPC. The delivery-only index was also less strongly associated with overall quality performance in observed deliveries than the comprehensive QoPIIPC index. CONCLUSIONS: Where supervision resources are limited, a measure of the quality of labor and delivery care targeting the time of delivery may mitigate challenges in observation-based assessment. The delivery-only index may enable increased use of observation-based quality assessment within maternal and newborn care programs in low-resource settings.

Validation studies for population-based intervention coverage indicators: design, analysis, and interpretation.

BACKGROUND: Population-based intervention coverage indicators are widely used to track country and program progress in improving health and to evaluate health programs. Indicator validation studies that compare survey responses to a "gold standard" measure are useful to understand whether the indicator provides accurate information. The Improving Coverage Measurement (ICM) Core Group has developed and implemented a standard approach to validating coverage indicators measured in household surveys, described in this paper. METHODS: The general design of these studies includes measurement of true health status and intervention receipt (gold standard), followed by interviews with the individuals observed, and a comparison of the observations (gold standard) to the responses to survey questions. The gold standard should use a data source external to the respondent to document need for and receipt of an intervention. Most frequently, this is accomplished through direct observation of clinical care, and/or use of a study-trained clinician to obtain a gold standard diagnosis. Follow-up interviews with respondents should employ standard survey questions, where they exist, as well as alternative or additional questions that can be compared against the standard household survey questions. RESULTS: Indicator validation studies should report on participation at every stage, and provide data on reasons for non-participation. Metrics of individual validity (sensitivity, specificity, area under the receiver operating characteristic curve) and population-level validity (inflation factor) should be reported, as well as the percent of survey responses that are "don't know" or missing. Associations between interviewer and participant characteristics and measures of validity should be assessed and reported. CONCLUSIONS: These methods allow respondent-reported coverage measures to be validated against more objective measures of need for and receipt of an intervention, and should be considered together with cognitive interviewing, discriminative validity, or reliability testing to inform decisions about which indicators to include in household surveys. Public health researchers should assess the evidence for validity of existing and proposed household survey coverage indicators and consider validation studies to fill evidence gaps.

Improving coverage measurement for reproductive, maternal, neonatal and child health: gaps and opportunities.

BACKGROUND: Regular monitoring of coverage for reproductive, maternal, neonatal, and child health (RMNCH) is central to assessing progress toward health goals. The objectives of this review were to describe the current state of coverage measurement for RMNCH, assess the extent to which current approaches to coverage measurement cover the spectrum of RMNCH interventions, and prioritize interventions for a novel approach to coverage measurement linking household surveys with provider assessments. METHODS: We included 58 interventions along the RMNCH continuum of care for which there is evidence of effectiveness against cause-specific mortality and stillbirth. We reviewed household surveys and provider assessments used in low- and middle-income countries (LMICs) to determine whether these tools generate measures of intervention coverage, readiness, or quality. For facility-based interventions, we assessed the feasibility of linking provider assessments to household surveys to provide estimates of intervention coverage. RESULTS: Fewer than half (24 of 58) of included RMNCH interventions are measured in standard household surveys. The periconceptional, antenatal, and intrapartum periods were poorly represented. All but one of the interventions not measured in household surveys are facility-based, and 13 of these would be highly feasible to measure by linking provider assessments to household surveys. CONCLUSIONS: We found important gaps in coverage measurement for proven RMNCH interventions, particularly around the time of birth. Based on our findings, we propose three sets of actions to improve coverage measurement for RMNCH, focused on validation of coverage measures and development of new measurement approaches feasible for use at scale in LMICs.

Practice manager expectations of new graduate registered nurses in Australian general practice: a national survey.

Practice managers are often involved in the employment of practice nurses and are likely to have a significant role in future transition programs in general practice. Therefore, the aim of the study was to explore practice managers' expectations of new graduate registered nurses working in general practice. A nation-wide web-based electronic survey distributed by the Australian Association of Practice Management was used to collect demographic data and practice managers' expectations of new graduate nurses directly transitioning into general practice in their first year of practice. The sample was broadly representative of the Australian state and territory population numbers. Respondents were predominantly female with postgraduate qualifications. The findings of this study highlight that practice managers who currently work with practice nurses would be supportive of graduate registered nurses in general practice in their first year with preceptor support. The results of this study have important implications for nursing workforce development and it is recommended that such initiatives are widely introduced with appropriate financial support.

Development and Validation of an Index to Measure the Quality of Facility-Based Labor and Delivery Care Processes in Sub-Saharan Africa.

BACKGROUND: High quality care is crucial in ensuring that women and newborns receive interventions that may prevent and treat birth-related complications. As facility deliveries increase in developing countries, there are concerns about service quality. Observation is the gold standard for clinical quality assessment, but existing observation-based measures of obstetric quality of care are lengthy and difficult to administer. There is a lack of consensus on quality indicators for routine intrapartum and immediate postpartum care, including essential newborn care. This study identified key dimensions of the quality of the process of intrapartum and immediate postpartum care (QoPIIPC) in facility deliveries and developed a quality assessment measure representing these dimensions. METHODS AND FINDINGS: Global maternal and neonatal care experts identified key dimensions of QoPIIPC through a modified Delphi process. Experts also rated indicators of these dimensions from a comprehensive delivery observation checklist used in quality surveys in sub-Saharan African countries. Potential QoPIIPC indices were developed from combinations of highly-rated indicators. Face, content, and criterion validation of these indices was conducted using data from observations of 1,145 deliveries in Kenya, Madagascar, and Tanzania (including Zanzibar). A best-performing index was selected, composed of 20 indicators of intrapartum/immediate postpartum care, including essential newborn care. This index represented most dimensions of QoPIIPC and effectively discriminated between poorly and well-performed deliveries. CONCLUSIONS: As facility deliveries increase and the global community pays greater attention to the role of care quality in achieving further maternal and newborn mortality reduction, the QoPIIPC index may be a valuable measure. This index complements and addresses gaps in currently used quality assessment tools. Further evaluation of index usability and reliability is needed. The availability of a streamlined, comprehensive, and validated index may enable ongoing and efficient observation-based assessment of care quality during labor and delivery in sub-Saharan Africa, facilitating targeted quality improvement.

Accessibility and potency of uterotonic drugs purchased by simulated clients in four districts in India.

BACKGROUND: Surveillance of drug quality for antibiotics, antiretrovirals, antimalarials and vaccines is better established than surveillance for maternal health drugs in low-income countries, particularly uterotonic drugs for the prevention and treatment of postpartum hemorrhage. The objectives of this study are to: assess private sector accessibility of four drugs used for uterotonic purposes (oxytocin, methylergometrine, misoprostol, valethamate bromide); and to assess potency of oxytocin and methylergometrine ampoules purchased by simulated clients. METHODS: The study was conducted in Hassan and Bagalkot districts in Karnataka state and Agra and Gorakhpur districts in Uttar Pradesh state. A sample of 877 private pharmacies was selected (using a stratified, systematic sampling with random start), among which 847 were successfully visited. The target sample size for assessment of accessibility was 50 pharmacies per drug, per district. The target sample size for potency assessment was 100 purchases each of oxytocin and methylergometrine across all districts. Successful drug purchases varied by state. RESULTS: In Agra and Gorakhpur, 90%-100% of visits for each of the drugs resulted in a purchase. In Bagalkot and Hassan, only 29%-52% of visits for each drug resulted in a purchase. Regarding potency, the percent of active pharmaceutical ingredient was assessed using United States Pharmacopeia monograph #33 for both drugs; 193 and 188 ampoules of oxytocin and methylergometrine, respectively, were assessed. The percent of oxytocin ampoules outside manufacturer specification ranged from 33%-40% in Karnataka and from 22%-50% in Uttar Pradesh. In Bagalkot and Hassan, 96% and 100% of the methylergometrine ampoules were outside manufacturer specification, respectively. In Agra and Gorakhpur, 54% and 44% were outside manufacturer specification, respectively. CONCLUSION: Private sector accessibility of uterotonic drugs in study districts in Karnataka warrants attention. Most importantly, interventions to assure quality oxytocin and particularly methylergometrine are needed in study districts in both states.

Cumulative effects of heat exposure and storage conditions of Oxytocin-in-Uniject in rural Ghana: implications for scale up.

OBJECTIVE: Postpartum hemorrhage can be reduced substantially in home deliveries attended by community-based workers by using Oxytocin-in-Uniject (OIU) devices affixed with temperature-time indicators. We characterized the distribution of time to discard of these devices when stored under normal field conditions in Ghana. METHODS: Two drug storage simulation studies were conducted in rural Ghana in 2011 and 2012. Devices were transported under refrigeration from manufacture (Argentina) to storage at the study site. Twenty-three field workers each stored at home (unrefrigerated) 25 OIU devices and monitored them daily to record: (1) time to transition from usable to unusable, and (2) continuous digital ambient temperature to determine heat exposure over the simulation period. Time to discard was estimated and compared with mean kinetic temperature exposure of the devices during the shipment and storage phases and with characteristics of the storage locations using Weibull regression models. We used the time to discard distributions in a Monte Carlo simulation to estimate wastage rates in a hypothetical program setting. RESULTS: Time for shipment and transfer to long-term refrigerated storage and mean kinetic temperature during the shipment phase was 8.6 days/10.3°C and 13.4 days/12.1°C, for the first and second simulation studies, respectively. Median (range) time to discard when stored under field conditions (unrefrigerated) was 43 (6 to 59) days and 33 (14 to 50) days, respectively. Mean time to discard was 10.0 days shorter in the second simulation, during which mean kinetic temperature exposure was 3.9°C higher. Simulating a monthly distribution system and assuming typical usage, predicted wastage of product was less than 10%. CONCLUSION: The time to discard of devices was highly sensitive to small changes in temperature exposure. Under field conditions typical in rural Ghana, OIU packages will have a half-life of approximately 30 to 40 days based on the temperature monitor used during the study. Program managers will need to carefully consider variations in both ambient temperature and rate of use to allocate the appropriate supply level that will maximize coverage and minimize stock loss.

Direct observation of uterotonic drug use at public health facility-based deliveries in four districts in India.

OBJECTIVE: To describe intrapartum uterotonic drug use and related behaviors in public health facility-based deliveries and to describe drug storage conditions in associated pharmacies. METHODS: A descriptive study was conducted between August and November 2011 to document practices related to uterotonic administration and storage based on direct observation of deliveries at public health facilities in four Indian districts (n=97, n=89, n=91, and n=89) with contrasting maternal health and socioeconomic indicators. RESULTS: Uterotonic drug use before and after delivery was common among the 366 study participants. Labor augmentation rates ranged from 53.5%-93.0% of deliveries across districts, with many receiving multiple uterotonics and administration via intramuscular injection or intravenous push. Uterotonic use following delivery ranged from 78.6%-99.1% across districts, with correct use of uterotonics for postpartum hemorrhage prevention varying from 6.0%-8.8% in Uttar Pradesh and 41.2%-76.4% in Karnataka. Active management of the third stage of labor following Indian guidelines was less than 10% in all districts. Storage of uterotonics at room temperature was common. CONCLUSION: Given that labor augmentation is nearly routine and at odds with Indian guideline recommendations, rigorous research is needed to assess maternal and fetal outcomes of current versus guidelines-based practice. Active management of the third stage of labor as per Indian guidelines was minimal.

Community-based screening for obstetric fistula in Nigeria: a novel approach.

BACKGROUND: Obstetric fistula continues to have devastating effects on the physical, social, and economic lives of thousands of women in many low-resource settings. Governments require credible estimates of the backlog of existing cases requiring care to effectively plan for the treatment of fistula cases. Our study aims to quantify the backlog of obstetric fistula cases within two states via community-based screenings and to assess the questions in the Demographic Health Survey (DHS) fistula module. METHODS: The screening sites, all lower level health facilities, were selected based on their geographic coverage, prior relationships with the communities and availability of fistula surgery facilities in the state. This cross-sectional study included women who presented for fistula screenings at study facilities based on their perceived fistula-like symptoms. Research assistants administered the pre-screening questionnaire. Nurse-midwives then conducted a medical exam. Univariate and bivariate analyses are presented. RESULTS: A total of 268 women attended the screenings. Based on the pre-screening interview, the backlog of fistula cases reported was 75 (28% of women screened). The backlog identified after the medical exam was 26 fistula cases (29.5% of women screened) in Kebbi State sites and 12 cases in Cross River State sites (6.7%). Verification assessment showed that the DHS questionnaire had 92% sensitivity, 83% specificity with 47% positive predictive value and 98% negative predictive value for identifying women afflicted by fistula among women who came for the screenings. CONCLUSIONS: This methodology, involving effective, locally appropriate messaging and community outreach followed up with medical examination by nurse-midwives at lower level facilities, is challenging, but represents a promising approach to identify the backlog of women needing surgery and to link them with surgical facilities.

Effect on postpartum hemorrhage of prophylactic oxytocin (10 IU) by injection by community health officers in Ghana: a community-based, cluster-randomized trial.

BACKGROUND: Oxytocin (10 IU) is the drug of choice for prevention of postpartum hemorrhage (PPH). Its use has generally been restricted to medically trained staff in health facilities. We assessed the effectiveness, safety, and feasibility of PPH prevention using oxytocin injected by peripheral health care providers without midwifery skills at home births. METHODS AND FINDINGS: This community-based, cluster-randomized trial was conducted in four rural districts in Ghana. We randomly allocated 54 community health officers (stratified on district and catchment area distance to a health facility: ≥10 km versus <10 km) to intervention (one injection of oxytocin [10 IU] one minute after birth) and control (no provision of prophylactic oxytocin) arms. Births attended by a community health officer constituted a cluster. Our primary outcome was PPH, using multiple definitions; (PPH-1) blood loss ≥500 mL; (PPH-2) PPH-1 plus women who received early treatment for PPH; and (PPH-3) PPH-2 plus any other women referred to hospital for postpartum bleeding. Unsafe practice is defined as oxytocin use before delivery of the baby. We enrolled 689 and 897 women, respectively, into oxytocin and control arms of the trial from April 2011 to November 2012. In oxytocin and control arms, respectively, PPH-1 rates were 2.6% versus 5.5% (RR: 0.49; 95% CI: 0.27-0.88); PPH-2 rates were 3.8% versus 10.8% (RR: 0.35; 95% CI: 0.18-0.63), and PPH-3 rates were similar to those of PPH-2. Compared to women in control clusters, those in the intervention clusters lost 45.1 mL (17.7-72.6) less blood. There were no cases of oxytocin use before delivery of the baby and no major adverse events requiring notification of the institutional review boards. Limitations include an unblinded trial and imbalanced numbers of participants, favoring controls. CONCLUSION: Maternal health care planners can consider adapting this model to extend the use of oxytocin into peripheral settings including, in some contexts, home births. TRIAL REGISTRATION: ClinicalTrials.gov NCT01108289 Please see later in the article for the Editors' Summary.

Measuring coverage in MNCH: testing the validity of women's self-report of key maternal and newborn health interventions during the peripartum period in Mozambique.

BACKGROUND: As low-income countries strive to meet targets for Millennium Development Goals 4 and 5, there is growing need to track coverage and quality of high-impact peripartum interventions. At present, nationally representative household surveys conducted in low-income settings primarily measure contact with the health system, shedding little light on content or quality of care. The objective of this study is to validate the ability of women in Mozambique to report on facility-based care they and their newborns received during labor and one hour postpartum. METHODS AND FINDINGS: The study involved household interviews with women in Mozambique whose births were observed eight to ten months previously as part of a survey of the quality of maternal and newborn care at government health facilities. Of 487 women whose births were observed and who agreed to a follow-up interview, 304 were interviewed (62.4%). The validity of 34 indicators was tested using two measures: area under receiver operator characteristic curve (AUC) and inflation factor (IF); 27 indicators had sufficient numbers for robust analysis, of which four met acceptability criteria for both (AUC >0.6 and 0.75

Measuring coverage in MNCH: validating women's self-report of emergency cesarean sections in Ghana and the Dominican Republic.

BACKGROUND: Cesarean section is the only surgery for which we have nearly global population-based data. However, few surveys provide additional data related to cesarean sections. Given weaknesses in many health information systems, health planners in developing countries will likely rely on nationally representative surveys for the foreseeable future. The objective is to validate self-reported data on the emergency status of cesarean sections among women delivering in teaching hospitals in the capitals of two contrasting countries: Accra, Ghana and Santo Domingo, Dominican Republic (DR). METHODS AND FINDINGS: This study compares hospital-based data, considered the reference standard, against women's self-report for two definitions of emergency cesarean section based on the timing of the decision to operate and the timing of the cesarean section relative to onset of labor. Hospital data were abstracted from individual medical records, and hospital discharge interviews were conducted with women who had undergone cesarean section in two hospitals. The study assessed sensitivity, specificity, and positive predictive value of responses to questions regarding emergency versus non-emergency cesarean section and estimated the percent of emergency cesarean sections that would be obtained from a survey, given the observed prevalence, sensitivity, and specificity from this study. Hospital data were matched with exit interviews for 659 women delivered via cesarean section for Ghana and 1,531 for the Dominican Republic. In Ghana and the Dominican Republic, sensitivity and specificity for emergency cesarean section defined by decision time were 79% and 82%, and 50% and 80%, respectively. The validity of emergency cesarean defined by operation time showed less favorable results than decision time in Ghana and slightly more favorable results in the Dominican Republic. CONCLUSIONS: Questions used in this study to identify emergency cesarean section are promising but insufficient to promote for inclusion in international survey questionnaires. Additional studies which confirm the accuracy of key facility-based indicators in advance of data collection and which use a longer recall period are warranted.

Injections during labor and intrapartum-related hypoxic injury and mortality in rural southern Nepal.

OBJECTIVE: To estimate the association between unmonitored use of injections during labor and intrapartum-related neonatal mortality and morbidity among home births. METHODS: Recently delivered women in Sarlahi, Nepal, reported whether they had received injections during labor. Data on breathing and crying status at birth, time to first breath, respiratory rate, sucking ability, and lethargy were gathered. Neonatal respiratory depression (NRD) and encephalopathy (NE) were compared by injection receipt status using multivariate regression models. RESULTS: Injections during labor were frequently reported (7108 of 22352 [31.8%]) and were predominantly given by unqualified village "doctors." Multivariate analysis (excluding facility births and complicated deliveries) revealed associations with intrapartum-related NRD (relative risk [RR] 2.52; 95% CI, 2.29-2.78) and NE (RR 3.48; 95% CI, 2.46-4.93). The risks of neonatal death associated with intrapartum-related NRD (RR 3.78; 95% CI, 2.53-5.66) or NE (RR 4.47; 95% CI, 2.78-7.19) were also elevated. CONCLUSION: Injection during labor was widespread at the community level. This practice was associated with poor outcomes and possibly related to the inappropriate use of uterotonics by unqualified providers. Interventions are required to increase the safety of childbirth in the community and in peripheral health facilities. Parent trial registered at clinicaltrials.gov (NCT00 109616).

Traditional preparations used as uterotonics in Sub-Saharan Africa and their pharmacologic effects.

BACKGROUND: Little is known about the use of traditional preparations for uterotonic effects at or near delivery in Sub-Saharan Africa. OBJECTIVE: To describe (1) use of traditional preparations in Sub-Saharan Africa intended to have uterotonic effects at or near birth; and (2) results of pharmacologic investigations of the uterotonic properties of such preparations. SEARCH STRATEGY: Structured review of 13 databases. SELECTION CRITERIA: Articles describing use of traditional preparations in Sub-Saharan Africa with primary data, published in English between January 1, 1980 and June 30, 2010. DATA COLLECTION AND ANALYSIS: Full-text review using standard spreadsheet templates. MAIN RESULTS: Objective 1 analysis identified 208 plant species used for uterotonic effects at or near delivery. The most common use was labor induction/augmentation (n=185). Other uses were to expel the placenta, shorten the third stage of labor, manage retained placenta (n=61), and prevent/manage postpartum hemorrhage (n=20). Objective 2 analysis identified 82 species with uterotonic activity confirmed through pharmacologic evaluation. Studies also identified potentiating/inhibiting effects of extracts on pharmaceutical uterotonics. CONCLUSION: Numerous plants are used for uterotonic effects in Sub-Saharan Africa; uterotonic activity has been confirmed in many through pharmacologic evaluation. Such use may increase the risk of adverse outcomes. Further research is needed on the uterotonic efficacy of traditional preparations and on interventions to address use during labor.

Impact on postpartum hemorrhage of prophylactic administration of oxytocin 10 IU via Uniject™ by peripheral health care providers at home births: design of a community-based cluster-randomized trial.

BACKGROUND: Hemorrhage is the leading direct cause of maternal death globally. While oxytocin is the drug of choice for postpartum hemorrhage prevention, its use has generally been limited to health facilities. This trial assesses the effectiveness, safety, and feasibility of expanding the use of prophylactic intramuscular oxytocin to peripheral health care providers at home births in four predominantly rural districts in central Ghana. METHODS: This study is designed as a community-based cluster-randomized trial in which Community Health Officers are randomized to provide (or not provide) an injection of oxytocin 10 IU via the Uniject™ injection system within one minute of delivery of the baby to women who request their presence at home at the onset of labor. The primary aim is to determine if administration of prophylactic oxytocin via Uniject™ by this cadre will reduce the risk of postpartum hemorrhage by 50 % relative to deliveries which do not receive the prophylactic intervention. Postpartum hemorrhage is examined under three sequential definitions: 1) blood loss ≥500 ml (BL); 2) treatment for bleeding (TX) and/or BL; 3) hospital referral for bleeding and/or TX and/or BL. Secondary outcomes address safety and feasibility of the intervention and include adverse maternal and fetal outcomes and logistical concerns regarding assistance at home births and the storage and handling of oxytocin, respectively. DISCUSSION: Results from this trial will build evidence for the effectiveness of expanding the delivery of this established prophylactic intervention to peripheral settings. Complementary data on safety and logistical issues related to this intervention will assist policymakers in low-income countries in selecting both the best uterotonic and service delivery strategy for postpartum hemorrhage prevention. Results of this trial are expected in mid-2013. The trial is registered at ClinicalTrials.gov: NCT01108289.

Uterotonic drug quality: an assessment of the potency of injectable uterotonic drugs purchased by simulated clients in three districts in Ghana.

OBJECTIVES: Given use of uterotonics for postpartum haemorrhage and other obstetric indications, the importance of potent uterotonics is indisputable. This study evaluated access to and potency of injectable uterotonics in Ghana. DESIGN: Study design involved research assistants simulating clients to purchase oxytocin and ergometrine from different sources. Drug potency was measured via chemical assay by the Ghana Food and Drugs Board. SETTING: The study was conducted in three contrasting districts in Ghana. OUTCOME MEASURE: The per cent of active pharmaceutical ingredient was measured to assess the quality of oxytocin and ergometrine. RESULTS: 69 formal points of sale were visited, from which 55 ergometrine ampoules and 46 oxytocin ampoules were purchased. None of the ergometrine ampoules were within British Pharmacopoeia specification for active ingredient, none were expired and one showed 0% active ingredient, suggestive of a counterfeit drug. Among oxytocin ampoules purchased, only 11 (26%) were within British Pharmacopoeia specification for active ingredient and two (4%) were expired. The median percentages of active ingredients were 64% and 50% for oxytocin and ergometrine, respectively. CONCLUSIONS: The quality of injectable uterotonics in three contrasting districts in Ghana is a serious problem. Restrictions regarding the sale of unregistered drugs, and of registered drugs from unlicensed shops, are inadequately enforced. These problems likely exist elsewhere but are not assessed, as postmarketing drug quality surveillance is generally restricted to well-funded disease-specific programmes relying on antiretroviral, antimalarial and antibiotic drugs. Maternal health programmes must adopt and fund the same approach to drug quality as is standard in programmes addressing infectious disease.