Influence of inventory management practices on the availability of emergency obstetric drugs in Rwandan public hospitals: a case of Rwanda Southern Province.

BACKGROUND: Stock-outs of some life-saving drugs, such as emergency obstetric drugs, are evident in many health facilities and have been reported to be the leading cause of maternal mortality and morbidity for women from low and middle income countries (LMICs). For many cases, this situation is associated with poor inventory management practices. The aim of this study was to investigate the influence of inventory management practices on the availability of emergency obstetric drugs in Rwandan public hospitals: case of the Rwanda Southern Province. Moreover, to gain a better grasp of the problem and to suggest possible areas for improvement. METHODS: An institutional-based cross-sectional study was carried out in all ten district hospitals (DHs) providing maternal health care and dispensing emergency obstetric drugs namely; Kigeme DH, Munini DH, Kabutare DH, Kibilizi DH, Gakoma DH, Nyanza DH, Ruhango DH, Gitwe DH, Kabgayi DH and Remera Rukoma DH. Both quantitative and qualitative data were collected and analyzed. Oxytocin injection, Misoprostol tablet and Magnesium sulphate injection as recommended emergency obstetric drugs by WHO, UNFPA and Rwanda Essential Medicines list were included in the study. RESULTS: The study revealed that keeping logistics management tools up to date is the backbone of inventory management practices in the availability of medicines and medical supplies. The results showed that hospitals with up-to-date logistics tools for their pharmaceutical management were 33.25 times more likely to have their emergency obstetric drugs in stock at all times compared to those that do not regularly update their logistics tools. The proper use of bin cards and electronic software (e-LMIS) contributed greatly to reducing the stock-out rate of emergency obstetric drugs by 89.9% and reduction of unusable to usable stock ratio by appropriate use of simple techniques such as the Min-Max inventory control model by 79%. Over an 18-month period, misoprostol tablet had the highest average days (32) of stock-outs (5.9%), followed by magnesium sulphate injection with an average of 31 days (5.7%), and oxytocin injection with an average of 13 days (2.4%). CONCLUSION: Proper use of pharmaceutical management tools within hospitals premises positively influence the availability of life-saving drugs, such as emergency obstetric drugs. Adequate supply chain staffing in health facilities is the most important key to improving inventory management practices and medicine availability.

Quality of care in prevention, detection and management of postpartum hemorrhage in hospitals in Afghanistan: an observational assessment.

BACKGROUND: Hemorrhage is the leading cause of maternal mortality worldwide and accounts for 56% of maternal deaths in Afghanistan. Postpartum hemorrhage (PPH) is commonly caused by uterine atony, genital tract trauma, retained placenta, and coagulation disorders. The purpose of this study is to examine the quality of prevention, detection and management of PPH in both public and private hospitals in Afghanistan in 2016, and compare the quality of care in district hospitals with care in provincial, regional, and specialty hospitals. METHODS: This study uses a subset of data from the 2016 Afghanistan National Maternal and Newborn Health Quality of Care Assessment. It covers a census of all accessible public hospitals, including 40 district hospitals, 27 provincial hospitals, five regional hospitals, and five specialty hospitals, as well as 10 purposively selected private hospitals. RESULTS: All public and private hospitals reported 24 h/7 days a week service provision. Oxytocin was available in 90.0% of district hospitals, 89.2% of provincial, regional and specialty hospitals and all 10 private hospitals; misoprostol was available in 52.5% of district hospitals, 56.8% of provincial, regional and specialty hospitals and in all 10 private hospitals. For prevention of PPH, 73.3% women in district hospitals, 71.2% women at provincial, regional and specialty hospitals and 72.7% women at private hospital received uterotonics. Placenta and membranes were checked for completeness in almost half of women in all hospitals. Manual removal of placenta was performed in 97.8% women with retained placenta. Monitoring blood loss during the immediate postpartum period was performed in 48.4% of women in district hospitals, 36.9% of women in provincial, regional and specialty hospitals, and 43.3% in private hospitals. The most commonly observed cause of PPH was retained placenta followed by genital tract trauma and uterine atony. CONCLUSION: Gaps in performance of skilled birth attendants are substantial across public and private hospitals. Improving and retaining skills of health workers through on-site, continuous capacity development approaches and encouraging a culture of audit, learning and quality improvement may address clinical gaps and improve quality of PPH prevention, detection and management.

Quality, availability and storage conditions of oxytocin and misoprostol in Malawi.

BACKGROUND: Postpartum haemorrhage (PPH) is the leading cause of maternal mortality in low- and middle-income countries (LMICs). Oxytocin and misoprostol are used for the prevention and treatment of PPH. However, both medicines are chemically unstable and sensitive to environmental conditions. Previous studies reported a high prevalence of substandard oxytocin and misoprostol preparations in LMICs. METHODS: In randomly selected health facilities of four districts of Malawi, the availability of oxytocin and misoprostol was determined, and the knowledge of health workers on storage requirements and use of oxytocics was assessed. Temperature loggers were used to record the storage temperature of oxytocics. Samples of oxytocin injections and misoprostol tablets were collected from the health facilities and from wholesalers. Oxytocin samples were analysed for identity, assay (= quantity of oxytocin) and for pH value according to United States Pharmacopeia 40. Misoprostol samples were analysed for identity, assay, dissolution and related substances according to the International Pharmacopeia 2017. RESULTS: All visited hospitals and health centers had oxytocin available. At non-refrigerated storage sites, the recorded mean kinetic temperature exceeded the oxytocic's storage temperature stated on the labels in 42% of the sites. At refrigerated storage sites, the required temperature of 2-8 °C was exceeded in 33% of the sites. Out of 65 oxytocin samples, 7 (11%) showed moderate deviations from specification, containing 82.2-86.8% of the declared amount of oxytocin. Out of 30 misoprostol samples, 5 (17%) showed extreme deviations, containing only 12.7-30.2% of the declared amount. The extremely substandard misoprostol was reported to the national authorities and to WHO, leading to an immediate recall of the respective brand in Malawi. The UK-based distributor of this brand closed its business shortly thereafter. CONCLUSION: Availability of oxytocin was excellent in Malawi, and its quality was better than reported in previous studies in other LMICs. However, storage conditions at the health facilities often did not meet the requirements. Extremely substandard misoprostol tablets were found, representing a serious risk to maternal health. This shows the need for continued efforts for quality assurance in medicine procurement and registration, as well as for post-marketing surveillance.

Quality of oxytocin ampoules available in health care facilities in the Democratic Republic of Congo: an exploratory study in five provinces.

BACKGROUND: Oxytocin injection is the first line therapy for the prevention and treatment of postpartum haemorrhage (PPH), the leading cause of maternal mortality. Currently access to high quality oxytocin in low and middle-income countries (LMICs) is compromised by variable manufacturing quality and the requirement for cold chain supply and storage to prevent product deterioration. Previous studies of oxytocin ampoules sampled from Africa, the region with highest maternal mortality rates, indicate that over half do not contain the specified amount of oxytocin. International efforts continue to further understand the issues relating to oxytocin quality in LMICs and this study is the first to assess oxytocin quality in the Democratic Republic of Congo (DRC), a country that bears one of the highest global rates of maternal mortality (693 maternal deaths per 100 000 live births). Importantly, the study methodology includes the use of investigative analytical techniques to understand the cause of quality deficiencies and inform remedial measures. METHODS: The study involved sampling of oxytocin injection ampoules from public and private health care facilities (n = 15) in urban and rural areas within five provinces of the DRC. Where available, each sample comprised 20 ampoules of oxytocin injection (10 IU/mL) with smaller numbers collected where supplies were limited. Sample collection used overt sampling and mystery shopper approaches, as appropriate. Analysis of ampoules for oxytocin content and known degradation products utilised validated HPLC and LCMS methods, respectively. Sterility testing was conducted in accordance with the United States Pharmacopeia monograph. RESULTS: Eighty percent of ampoules collected contained less than 90% of the specified content. Known degradation products of oxytocin were identified, indicating likely exposure to elevated temperatures post-manufacture. All samples contained an unknown impurity at a level of approximately 12.3% (8.0-20.5%) of the oxytocin main band peak. No samples failed sterility testing. CONCLUSIONS: There is evidence of a high prevalence of poor quality oxytocin ampoules in health facilities in the DRC likely resulting from both manufacturing quality issues and uncontrolled storage. A more comprehensive post-marketing surveillance study of oxytocin quality is warranted.

Modeling patient access to therapeutic oxytocin in Zanzibar, Tanzania.

BACKGROUND: Our objective is to estimate the effects of therapeutic oxytocin supply chain factors and social determinants of health on patient access to oxytocin in low-income settings using system dynamics modeling. Postpartum hemorrhage (PPH), a major cause of maternal mortality disproportionately affects women in low and middle income countries (LMICs). The World Health Organization recommends therapeutic oxytocin as the frontline uterotonic for PPH management and prevention. However, lack of access to quality therapeutic oxytocin in Tanzania, and throughout Sub-Saharan Africa, continues to result in a high number of preventable maternal deaths. METHODS: We used publicly available data from Zanzibar and Sub-Saharan Africa, literature review, oxytocin degradation kinetics and previously developed systems dynamics models to understand the barriers in patient access to quality therapeutic oxytocin. RESULTS: The model makes four basic predictions. First, there is a major gap between therapeutic oxytocin procurement and availability. Second, it predicts that at current population increase rates, oxytocin supply will have to be doubled in the next 30 years. Third, supply and storage temperature until 30 °C has minimal effect on oxytocin quality and finally distance of 5 km or less to birthing facility has a small effect on overall access to oxytocin. CONCLUSIONS: The model provides a systems level approach to therapeutic oxytocin access, incorporating supply and procurement, socio-economic factors, as well as storage conditions to understand how women's access to oxytocin over time can be sustained for better health outcomes.

Quality medicines in maternal health: results of oxytocin, misoprostol, magnesium sulfate and calcium gluconate quality audits.

BACKGROUND: The high level of maternal mortality and morbidity as a result of complications due to childbirth is unacceptable. The impact of quality medicines in the management of these complications cannot be overemphasized. Most of those medicines are sensitive to environmental conditions and must be handled properly. In this study, the quality of oxytocin injection, misoprostol tablets, magnesium sulfate, and calcium gluconate injections was assessed across the six geopolitical zones of Nigeria. METHOD: Simple, stratified random sampling of health facilities in each of the political zones of Nigeria. Analysis for identification and content of active pharmaceutical ingredient was performed using high-performance liquid chromatography procedures of 159 samples of oxytocin injection and 166 samples of misoprostol tablets. Titrimetric methods were used to analyze 164 samples of magnesium sulfate and 148 samples of calcium gluconate injection. Other tests included sterility, pH measurement, and fill volume. RESULTS: Samples of these commodities were procured mainly from wholesale and retail pharmacies, where these were readily available, while the federal medical centers reported low availability. Approximately, 74.2% of oxytocin injection samples failed the assay test, with the northeast and southeast zones registering the highest failure rates. Misoprostol tablets recorded a percentage failure of 33.7%. Magnesium sulfate and Calcium gluconate injection samples recorded a failure rate of 6.8% and 2.4%, respectively. CONCLUSION: The prevalence of particularly of oxytocin and misoprostol commodities was of substandard quality. Strengthening the supply chain of these important medicines is paramount to ensuring their effectiveness in reducing maternal deaths in Nigeria.

Postpartum hemorrhage prevention in Nepal: a program assessment.

BACKGROUND: In 2009, the Nepal Ministry of Health and Population launched a national program for prevention of postpartum hemorrhage (PPH) during home births that features advance distribution of misoprostol to pregnant women. In the years since, the government has scaled-up the program throughout much of the country. This paper presents findings from the first large-scale assessment of the effectiveness of the advance distribution program. METHODS: Data collection was carried out in nine districts and all three ecological zones. To assess knowledge, receipt and use of misoprostol, household interviews were conducted with 2070 women who had given birth within the past 12 months. To assess supply and provision of misoprostol, interviews were conducted with 270 Female Community Health Volunteers (FCHVs) and staff at 99 health facilities. RESULTS: Among recently delivered women, only 15% received information about misoprostol and 13% received misoprostol tablets in advance of delivery. Yet 87% who received advance misoprostol and delivered at home used it for PPH prevention. Among FCHVs, 96% were providing advance misoprostol for PPH prevention; however 81% had experienced at least one misoprostol stock out within the past year. About one-half of FCHVs were providing incomplete information about the use of misoprostol; in addition, many did not discuss side effects, how to recognize PPH or where to go if PPH occurs. Among health facilities, just one-half had sufficient misoprostol stock, while 95% had sufficient oxytocin stock, at the time of this assessment. CONCLUSIONS: In Nepal, women who receive advance misoprostol are both willing and able to use the medication for PPH prevention during home births. However the supply and personnel challenges identified raise questions about scalability and impact of the program over the long-term. Further assessment is needed.

La oxitocina en el tratamiento de los déficits sociales asociados a los trastornos del espectro autista / Oxytocin in the treatment of the social deficits associated to autism spectrum disorders

Introducción. La implicación de la oxitocina en la conducta social de animales y humanos ha llevado a estudiar los efectos de su administración en el comportamiento y cognición social de pacientes con trastornos del espectro autista (TEA). Objetivos. Revisar la investigación sobre el potencial terapéutico de la oxitocina en el tratamiento de los déficits sociales de la población con TEA y discutir las probables direcciones futuras de los estudios en este campo. Desarrollo. Diversos trabajos han relacionado la oxitocina con la fisiopatología de los TEA. La mayoría de los estudios que han administrado oxitocina, generalmente por vía intranasal (24 UI), ha observado mejoras significativas en el rendimiento social, sin detectar efectos secundarios destacables. No obstante, existen datos contradictorios debido a la heterogeneidad de las variables analizadas por los diferentes estudios, al uso de muestras heterogéneas y pequeñas o a la diferente duración de los tratamientos. Las limitaciones relacionadas con la falta de comprensión de los mecanismos de acción de la oxitocina y la diversidad sintomatológica de los TEA dificultan el establecimiento de este péptido como tratamiento de los pacientes autistas. Estudios recientes destacan la conveniencia de explorar el efecto de la combinación del tratamiento de oxitocina con programas conductuales de intervención en habilidades sociales, así como la potenciación de la secreción endógena de oxitocina. Conclusiones. Los efectos de la administración de oxitocina resultan prometedores en relación con el tratamiento de los déficits sociales en individuos con TEA. Estudios futuros deberían facilitar la comprensión de las vías de acción de la oxitocina y el establecimiento de pautas óptimas de tratamiento (AU)

Introduction. The recent involvement of oxytocin in social behavior of animals and humans has motivated the study of its effects on the social behavior of individuals with autism spectrum disorders (ASD). Aims. To review the current state of oxytocin studies concerning its therapeutic potential in treating social deficits of the ASD population, and to establish likely future directions to be taken by the studies in this field. Development. Some studies have linked oxytocin to the pathophysiology of autistic disorders. Most studies that have administered oxytocin (mainly with intranasal administration of 24 IU) to ASD subjects have shown significant improvements in their social performance with acceptable safety parameters. However, there is controversial data as the outcome measures are widely dispersed, the samples are reduced and heterogeneous, and the treatment durations are different. The limitations related to the lack of understanding of the oxytocin’s action mechanisms and the symptomatic heterogeneity of ASD are hampering progress towards the establishment of oxytocin as a treatment of ASD patients. Recent studies suggest the investigation of the combination of the oxytocin treatment with social skills training, and the enhancement of endogenous secretion of oxytocin. Conclusion. The effects of oxytocin are promising regarding the treatment of social deficits in ASD individuals. Future studies should aim to facilitate understanding of the oxytocin’s ways of action and to establish the optimal treatment regime (AU)

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.

Intrapartum oxytocin use for labor acceleration in rural India.

OBJECTIVE: To examine factors associated with the use of oxytocin for acceleration of labor in women delivered at home in rural India. METHOD: Quantitative data were collected from 527 women who were delivered at home and qualitative interviews were carried out with 21 mothers and 9 birth attendants. RESULTS: Oxytocin use was associated with higher education and socioeconomic status, primigravidity, and delivery by a traditional birth attendant. CONCLUSION: Labor acceleration with oxytocin occurs indiscriminately In India. Oxytocin use should be regulated, and training for birth attendants should be provided as well as health education for pregnant women.