Preventing the preventable: role of transamine in total knee arthroplasty.

OBJECTIVE: To assess the efficacy and safety of perioperative intravenous Tranexamic Acid in reducing blood loss and transfusion requirements in patients undergoing Total Knee Arthroplasty. METHODS: The prospectivedouble-blind randomised control trial was conducted from March to July 2014 at the Combined Military Hospital, Rawalpindi, and comprised patients below 85 years of age undergoing unilateral or bilateral cemented Total Knee Arthroplasty. The patients were divided into control or Transaminegroups. Two doses of 15mg/kg of Transamine were given to the latter group. All patients were operated under spinal or combined spinal-epidural anaesthesiausing pneumatic tourniquet and similar cemented implant. Primary outcome was postoperative blood loss in drains. Secondary outcomes were the number of blood units transfused, change in haemoglobin level and adverse events. RESULTS: Of the 62 patients on the study, there were 34(55%) patents in the Transaminegroup with a mean age of 64±8.4 years, and28(45%)in the control group with a mean age of 60.8±10.3. The two groups were matched for demographic and blood indices.Mean blood loss via intra-articular drain in the control group was 619±243ml per knee, and 402±169ml per knee in the Transaminegroup. Blood transfusions were required by 14(50%)patients in the control groupand 6(17.6%)in the Transaminegroup. CONCLUSIONS: Perioperative intravenous transamine significantly reduced blood loss as well as blood transfusion requirements.

Cost of hospital-acquired infection.

The authors assessed the costs of hospital-acquired infections using rigorous econometric methods on publicly available data, controlling for the interdependency of length of stay and the incidence of hospital acquired infection, and estimated the cost shares of different payers. They developed a system of equations involving length of stay, incidence of infection, and the total hospital care cost to be estimated using simultaneous equations system. The main data came from the State of New Jersey UB 92 for 2004, complimented with data from the Annual Survey of Hospitals by the American Hospital Association and the Medicare Cost Report of 2004. The authors estimated that an incidence of hospital acquired infection increases the hospital care cost of a patient by $10,375 and it increases the length of stay by 3.30 days, and that a disproportionately higher portion of the cost is attributable to Medicare. They conclude that reliable cost estimates of hospital-acquired infections can be made using publicly available data. Their estimate shows a much larger aggregate cost of $16.6 billion as opposed to $5 billion reported by the Centers for Disease Control and Prevention but much less than $29 billion as reported elsewhere in the literature.

Cost differences between academic and nonacademic hospitals: a case study of surgical procedures.

Decreased public funding, a competitive healthcare market, and higher patient care costs have been blamed for the present financial challenges that confront academic health centers. The authors examined the costs associated with graduate medical education, particularly, indirect medical education expenses in the operating room. The results indicate that it is more costly for teaching hospitals to provide surgical care to patients in the operating room. The academic health center's indirect graduate medical expenses only covered a portion of the increased costs. If the missions of academic health centers are perceived as a public good, policy makers must design a system that more appropriately compensates academic health centers for the additional costs associated with surgical procedures in graduate medical education.

Drug Safety and the Cost of Monitoring: The Role of REMS in Risk Management.

BACKGROUND: The mission of the US Food and Drug Administration (FDA) can be viewed as a pendulum that swings between protecting public health and patient safety and promoting the public health through the drug review and approval process. Two decades of legislation have by and large provided the FDA with additional resources under the successive reauthorizations of the Prescription Drug User Fee Acts (PDUFA) to provide a necessary infusion of funds to hire medical experts, scientists, and epidemiologists, among other disciplines, to expedite review of new drug and biologic applications. However, a renewed attention to potential adverse drug experiences, culminating in the Vioxx withdrawal, has resulted in the passage of the Food and Drug Administration Amendments Act of 2007 (FDAAA). Under this act, the FDA was authorized to impose postapproval requirements on the biopharmaceutical industry through the imposition of risk evaluation and mitigation strategies (REMS) and postmarketing trial (PMT) requirements to improve drug safety. Despite the extensive dialogue between stakeholders and lawmakers in the development of the FDAAA, there remains some uncertainty as to the exact impact of REMS on not only operational costs for both industry and health care professionals but also product sales and prescribing habits in the 5 years since its implementation. METHODS: Recognizing that in the past 2 years, the use of REMS has shifted markedly, we sought to provide greater clarity on the duration of REMS requirements and impact of REMS on drug sales. RESULTS: While in absolute terms, the use of REMS may be declining, the REMS experience has provided an important, perhaps even critical, step in the development of current risk management strategies aimed at improving patient safety.