Intensity and Variation of Health Navigator Support: Addressing Medical and Social Needs of Diabetes Patients in East Oakland.

BACKGROUND: Healthcare systems are increasingly screening and referring patients for unmet social needs (e.g., food insecurity). Little is known about the intensity of support necessary to address unmet needs, how this support may vary by circumstance or time (duration), or the factors that may contribute to this variation. OBJECTIVE: Describe health navigator services and the effort required to support patients with complex needs at a community health center in East Oakland, CA. DESIGN: Retrospective analysis of de-identified patient contact notes (e.g., progress notes). PARTICIPANTS: Convenience sample of patients (n = 27) enrolled in diabetes education and referred to health navigators. INTERVENTIONS: Navigators provide education on managing conditions (e.g., diabetes), initiate and track medical and social needs referrals, and navigate patients to medical and social care organizations. MAIN MEASURES: Descriptive statistics for prevalence, mean, median, and range values of patient contacts and navigation services. We described patterns and variation in navigation utilization (both contacts and navigation services) based on types of need. KEY RESULTS: We identified 811 unmet social and medical needs that occurred over 710 contacts with health navigators; 722 navigation services were used to address these needs. Patients were supported by navigators for a median of 9 months; approximately 25% of patients received support for > 1 year. We categorized patients into 3 different levels of social risk, accounting for patient complexity and resource needs. The top tertile (n = 9; 33%) accounted for the majority of resource utilization, based on health navigator contacts (68%) and navigation services (75%). CONCLUSIONS: The required intensity and support given to meet patients' medical and social needs is substantial and has significant variation. Meeting the needs of complex patients will require considerable investments in human capital, and a risk stratification system to help identify those most in need of services.

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.

Estimating demand for a new contraceptive method: projections for the introduction of Sayana Press.

OBJECTIVE: To describe a demand estimation exercise conducted in response to an initiative to introduce Sayana Press in Sub-Saharan Africa and South Asia. METHODS: Secondary data sources were used to develop estimates of the number of Sayana Press units needed for countrywide introductions in 12 countries. To estimate uptake, the number of women who had stated an intention to use injectables was calculated. Two sets of assumptions (one conservative, one more ambitious) were used to assess conversion to actual use. RESULTS: Even with the use of very conservative assumptions, and assuming no method switching, Sayana Press was estimated to have the potential to cumulatively reach 3-6million women by 2016. CONCLUSION: This projected uptake in a relatively short period and at the very beginning of an adoption curve suggests that Sayana Press has promise for countries looking to expand their list of contraceptive choices.

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.

Characterization of short-term temperature, exposure, and solubilization effects on library compound quality.

Many compound collections are stored under the same temperature conditions, which can limit flexibility by increasing the processing time required for high-demand compounds. In this study, the authors wanted to evaluate the impact of a hybrid-storage approach where high-demand compounds are stored for a shortened time period at room temperature to expedite processing operations. The use of a Covaris adaptive-focused acoustics platform was also characterized as a potential enhancement or alternative to storage at elevated temperatures. This study evaluated the impact of temperature, exposure, and solubilization on overall compound quality for short-term storage. A small library of 25 representative compounds was evaluated over an 18-week period to monitor the change in purity and concentration by high-performance liquid chromatography with ultraviolet detection. The authors concluded that temperature had a significant impact on compound concentration, and the effects due to exposure cycles were minimal. A storage time of 12 weeks at room temperature resulted in minimal compound loss, but storage times beyond this would be unacceptable because of a >20% decrease in concentration. Finally, the acoustic solubilization protocol also increased the number of compounds at the target concentration with no impact on overall purity, leading to a potential for increased storage times at frozen temperatures.