Demystifying buprenorphine misuse: Has fear of diversion gotten in the way of addressing the opioid crisis?

Buprenorphine is considered one of the most effective treatments for opioid use disorder and significantly reduces risk of overdose death. However, concerns about its diversion and misuse have often taken center stage in public discourse and in the design of practices and policies regarding its use. This has been to the detriment of many vulnerable patient populations, especially those involved in the criminal justice system. Policies that restrict access to buprenorphine in criminal justice and other settings due to concerns of diversion do not accurately reflect the relative risks and safety profile associated with it, creating unnecessary barriers that drive an illicit market of this much-needed medication. Although proper regulation of all controlled medications should be a priority, in most instances the benefits of buprenorphine highly outweigh its risks. In the midst of a national crisis, efforts should be focused on expanding, and not restricting, access to this lifesaving treatment.     

Deficiencies in the transfer and availability of clinical trials evidence: a review of existing systems and standards

ABSTRACT: BACKGROUND: Decisions concerning drug safety and efficacy are generally based on pivotal evidence provided by clinical trials. Unfortunately, finding the relevant clinical trials is difficult and their results are only available in text-based reports. Systematic reviews aim to provide a comprehensive overview of the evidence in a specific area, but may not provide the data required for decision making. METHODS: We review and analyze the existing information systems and standards for aggregate level clinical trials information from the perspective of systematic review and evidence-based decision making. RESULTS: The technology currently used has major shortcomings, which cause deficiencies in the transfer, traceability and availability of clinical trials information. Specifically, data available to decision makers is insufficiently structured, and consequently the decisions cannot be properly traced back to the underlying evidence. Regulatory submission, trial publication, trial registration, and systematic review produce unstructured datasets that are insufficient for supporting evidence-based decision making. CONCLUSIONS: The current situation is a hindrance to policy decision makers as it prevents fully transparent decision making and the development of more advanced decision support systems. Addressing the identified deficiencies would enable more efficient, informed, and transparent evidence-based medical decision making.     

The preterm gut microbiota: changes associated with necrotizing enterocolitis and infection

Aim: To describe gut colonization in preterm infants using standard culture and 16S gene rRNA profiling, exploring differences in healthy infants and those who developed NEC/late onset sepsis (LOS). Methods: Ninety‐nine stools from 38 infants of median 27‐week gestation were cultured; 44 stools from 27 infants had their microbial profiles determined by 16S. Ordination analyses explored effects of patient variables on gut communities. Results: Standard microbiological culture identified a mean of two organisms (range 0–7), DGGE 12 (range 3–18) per patient. Enterococcus faecalis and coagulase negative staphylococci (CONS) were most common by culture (40% and 39% of specimens). Meconium was not sterile. No fungi were cultured. Bacterial community structures in infants with NEC and LOS differed from healthy infants. Infants who developed NEC carried more CONS (45% vs 30%) and less Enterococcus faecalis (31% vs 57%). 16S identified Enterobacter and Staphylococcus presence associated with NEC/LOS, respectively. Conclusions: Important differences were found in the gut microbiota of preterm infants who develop NEC/LOS. The relationship of these changes to current practices in neonatal intensive care requires further exploration.