Considerations in implementation of social risk factor screening and referral in maternal and infant care in Washington, DC: A qualitative study.

BACKGROUND: The District of Columbia (DC) has striking disparities in maternal and infant outcomes comparing Black to White women and babies. Social determinants of health (SDoH) are widely recognized as a significant contributor to these disparities in health outcomes. Screening for social risk factors and referral for appropriate services is a critical step in addressing social needs and reducing outcome disparities. METHODS: We conducted interviews among employees (n = 18) and patients (n = 9) across three diverse, urban clinics within a healthcare system and one community-based organization involved in a five-year initiative to reduce maternal and infant disparities in DC. Interviews were guided by the Consolidated Framework for Implementation Research to understand current processes and organizational factors that contributed to or impeded delivery of social risk factor screening and referral for indicated needs. RESULTS: We found that current processes for social risk factor screening and referral differed between and within clinics depending on the patient population. Key facilitators of successful screening included a supportive organizational culture and adaptability of more patient-centered screening processes. Key barriers to delivery included high patient volume and limited electronic health record capabilities to record results and track the status of internal and community referrals. Areas identified for improvement included additional social risk factor assessment training for new providers, patient-centered approaches to screening, improved tracking processes, and facilitation of connections to social services within clinical settings. CONCLUSION: Despite proliferation of social risk factor screeners and recognition of their importance within health care settings, few studies detail implementation processes for social risk factor screening and referrals. Future studies should test implementation strategies for screening and referral services to address identified barriers to implementation.

Science-based assessment of source materials for cell-based medicines: report of a stakeholders workshop.

Human pluripotent stem cells (hPSCs) have the potential to transform medicine. However, hurdles remain to ensure safety for such cellular products. Science-based understanding of the requirements for source materials is required as are appropriate materials. Leaders in hPSC biology, clinical translation, biomanufacturing and regulatory issues were brought together to define requirements for source materials for the production of hPSC-derived therapies and to identify other key issues for the safety of cell therapy products. While the focus of this meeting was on hPSC-derived cell therapies, many of the issues are generic to all cell-based medicines. The intent of this report is to summarize the key issues discussed and record the consensus reached on each of these by the expert delegates.

The European Medicines Agency review of eltrombopag (Revolade) for the treatment of adult chronic immune (idiopathic) thrombocytopenic purpura: summary of the scientific assessment of the Committee for Medicinal Products for Human Use.

On 11(th) March 2010, the European Commission issued a marketing authorization valid throughout the European Union for Revolade for the treatment of adult chronic immune (idiopathic) thrombocytopenic purpura. Revolade is an orphan medicinal product indicated for splenectomized patients with immune (idiopathic) thrombocytopenic purpura who are refractory to other treatments (e.g. corticosteroids, immunoglobulins) and as second-line treatment for non-splenectomized patients where surgery is contraindicated. The active substance of Revolade is eltrombopag (ATC code B02BX05). Eltrombopag increases platelet production through activation of the thrombopoietin receptor. The recommended oral dose is 50 mg once daily to achieve and maintain a platelet count of the 50×10(9)/L or more necessary to reduce or prevent the risk of bleeding. The benefit of Revolade is a durable response in maintaining platelet levels. The most common side effects include headache, nausea, hepatobiliary toxicity, diarrhea, fatigue, paresthesia, constipation, rash, pruritus, cataract, arthralgia and myalgia. The decision to grant the marketing authorization was based on the favorable recommendation of the Committee for Medicinal Products for Human Use of the European Medicines Agency. The objective of this paper is to describe the data submitted to the European Medicines Agency and to summarize the scientific review of the application. The detailed scientific assessment report and product information, including the summary of product characteristics, are available on the European Medicines Agency website (www.ema.europa.eu).