Of the 40 services offering chemoprevention for high-risk women, 15 (38%) did not prescribe but 31 (78%) recommended prescribing to primary care. Of the 31 services considering chemoprevention for moderate risk, eight (26%) did not prescribe with 26 (84%) recommended prescribing to primary care. Only three services reported having a shared protocol with primary care. Within 3 years of the guidelines, many services recognized the role of chemoprevention for both high and moderate risk with a key role for primary care to initiate prescribing. However, there is still room for improvement.Repeated doses of c-kit+ cardiac progenitor cells (CPCs) are superior to a single dose in improving LV function in rats with old myocardial infarction (MI). However, this concept needs testing in different species to determine whether it is generalizable. We used a new murine model of chronic ischemic cardiomyopathy whose unique feature is that cell therapy was started late (3 months) after MI. Mice received three echo-guided intraventricular infusions, 5 weeks apart, of vehicle, CPCs × 1, or CPCs × 3. Echocardiography demonstrated that the single-dose group exhibited improved LV ejection fraction (EF) after the 1st infusion (CPCs), but not after the 2nd and 3rd (vehicle). In contrast, in the multiple-dose group LVEF continued to improve, so that the final value was greater than in vehicle or single-dose groups (P  less then  0.05). Hemodynamic studies showed that compared with vehicle, both preload-dependent and preload-independent functional parameters were significantly increased in the multiple-dose groupionale for large animal studies. Graphical abstract.North America is experiencing an overdose crisis driven by fentanyl, related analogues, and fentanyl-adulterated drugs. In response, there have been increased calls for “safe supply” interventions based on the premise that providing a safer alternative (i.e., pharmaceutical drugs of known quality/quantity, non-adulterated, with user agency in consumption methods) to the street drug supply will limit people’s use of fentanyl-adulterated drugs and reduce overdose events. This study examined outcomes of a hydromorphone tablet distribution program intended to prevent overdose events among people who use drugs (PWUD) at high risk of fatal overdose. Semi-structured qualitative interviews were conducted with 42 people enrolled in the hydromorphone distribution program. Additionally, over 100 h of ethnographic observation were undertaken in and around the study site. Transcripts were coded using NVivo and based on categories extracted from the interview guides and those identified during initial interviews and ethnographic fieldwork. Analysis focused on narratives around experiences with the program, focusing on program-related outcomes. Our analysis identified the following positive outcomes of being enrolled in the hydromorphone tablet distribution program (1) reduced street drug use and overdose risk, (2) improvements to health and well-being, (3) improvements in co-management of pain, and (4) economic improvements. Our findings indicate that the hydromorphone distribution program not only is effective in responding to the current overdose crisis by reducing people’s use of illicit drugs but also addresses inequities stemming from the intersection of drug use and social inequality. Safe supply programs should be further implemented and evaluated in both urban and rural setting across North America as a strategy to reduce exposure to the toxic drug supply and fatal overdose.In this publication, the authors, having gained several decades of experience in Pharmacovigilance departments, both in pharmaceutical companies as well as in service providers companies, describe the reason why and the way how a guideline for outsourcing was created. While outsourcing in pharmacovigilance has become the rule rather than the exception in the last decade, a consensus guideline, based on best practice, appears to be missing. A group of committed professionals have given their time and knowledge to an iterative process of writing and reviewing drafts of such a guideline. One of the authors was closely involved with the writing as well as presenting the draft guidance at conferences. The other author was managing the process, including discussions, periodically reviewing the result, as well as responding to the reviewers’ comments. In this publication, a high-level overview of the guideline is provided. The key message is that outsourcing in PV requires both a detailed preparation, including risk assessments of the various elements, as well as close contact with the service provider.

Data sharing among stakeholders in the development, access, and use of drug therapies is critical but the current system and process are inefficient.

We take a Systems Engineering approach with a realistic use case to propose a scalable design for multi-stakeholder data sharing.

We make three major contributions to the drug development and healthcare communities first, a methodology for developing a multi-stakeholder data sharing system, with its focus on high-level requirements that influence the design of the system architecture and technology choice; second, the development of a realistic use case for long-term patient and therapy data tracking and sharing in the use of potentially curative and durable gene and cell therapies. Further, a bridge for the ‘awareness gap’ was found between the payer (Payer is organization which takes care of financial and operational aspects (which include insurance plans, provider network) of providing health care to US citizens. Or refer to health care insurers.) and the regulator communities by illustrating the common data tracking needs, which highlights the need for coordinated data activities; and third, a proposed system architecture for scalable, multi-stakeholder data sharing. Next steps are briefly discussed.

We present a system design for multiple stakeholders such as the payer, the regulator, the developer (drug manufacturer), and the healthcare provider to share data for their decision-making. The stakeholder community would benefit from collaboratively moving the system development proposal forward for efficient and cost-effective data sharing.

We present a system design for multiple stakeholders such as the payer, the regulator, the developer (drug manufacturer), and the healthcare provider to share data for their decision-making. TNG260 The stakeholder community would benefit from collaboratively moving the system development proposal forward for efficient and cost-effective data sharing.