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Committee Report (committee + report)
Selected AbstractsThe global burden of asthma: executive summary of the GINA Dissemination Committee ReportALLERGY, Issue 5 2004Matthew Masoli First page of article [source] Latest news and product developmentsPRESCRIBER, Issue 6 2008Article first published online: 24 APR 200 Government responds to NICE report The Government has published its response to the Health Select Committee's report into NICE, broadly arguing that the Committee's recommendations are either already being dealt with or are not appropriate. The Committee recommended appraisals for all new drugs, shorter, rapid appraisals to coincide with their launch, and improved mechanisms for setting drug prices. The Government says its negotiations on the PPRS preclude a detailed response but suggests a rapid system may not be transparent or legally robust. It is exploring how high-cost drugs can be brought within the payment-by-results tariff. While defending NICE's reliance on QALYs, the Government accepts the need to explore how wider economic factors can be considered. As for the threshold cost per QALY by which NICE defines cost effectiveness, it says this is being validated scientifically and NICE will continue to determine the threshold. More topically, the Committee criticised the quality of clinical trial data available to NICE. The Government sees no need to compel pharmaceutical companies to disclose information and says NICE is already becoming more involved with research programmes. All clinical trials must be registered (confidentially) with the EU and the Government believes mandatory registration in the UK would be ineffective and illegal. Prescription charge up again from April The Government has raised the prescription charge by 25p to £7.10 per item with effect from 1 April. Prescription prepayment certificates will cost £27.85 for three months and £102.50 for 12 months. The increase, below the annual rate of inflation for the 10th successive year, will be levied on the 12 per cent of prescriptions that are liable for the charge: 5 per cent via prepayment certificates and 7 per cent from other prescriptions. The charge will generate £435 million in England in 2008/09; this excludes money from prescriptions written by dispensing doctors, which is retained by the PCT. Following criticism of the charge by the Health Select Committee, the Government says it has reviewed the charge and is now consulting on ,cost-neutral' options. MHRA safety update The MHRA warns of possible dose errors associated with Boots Medisure Domiciliary Dosage System in its latest issue of Drug Safety Update (2008;1:issue 8). One case has been reported in which incomplete sealing allowed tablets to mix between compartments. No other cases are known and the MHRA says no harm was reported but the risk is serious. The system should be carefully sealed and inspected visually and physically. The MHRA reaffirms its plans to reclassify all pseudoephedrine and ephedrine products to prescription-only status in 2009 if the new restrictions on sales do not reduce misuse. Other topics in this month's Update include revised indications for oral ketoconazole (Nizoral), restricting its use to selected conditions unresponsive to topical therapy; reformulation of the injectable antibiotic Tazocin (piperacillin plus tazobactum); the risk of peripheral neuropathy associated with pegylated interferon and telbivudine (Sebivo) in the treatment of hepatitis B; and serious adverse events associated with modafinil (Provigil). First oral anticoagulant since warfarin In January this year the EMEA issued a positive opinion to recommend marketing authorisation of the oral, fixed-dose, direct thrombin inhibitor dabigatran etexilate (Pradaxa) for the primary prevention of venous thromboembolism (VTE) in adult patients that have undergone elective knee or hip replacement surgery. Marketing authorisation for the EU (including the UK) is expected from the European Commission in the next few weeks, making dabigatran the first oral anticoagulant since warfarin was introduced in 1954. Dabigatran etexilate has been shown to be as safe and effective as enoxaparin (Clexane) with a similar adverse event profile in the noninferiority phase III RENOVATE (Lancet 2007;370: 949-56) and RE-MODEL (J Throm Haemost 2007;5:217885) trials, which investigated the efficacy and safety of dabigatran compared to enoxaparin in reducing the risk of VTE after total hip and knee surgery respectively. Dabigatran has the practical advantage over low-molecular-weight heparin of oral postoperative administration and no risk of heparin-induced thrombocytopenia and, unlike warfarin, does not require monitoring or dose titration. Risk scale predicts anticholinergic effects US investigators have developed a scale for predicting the risk of anticholinergic side-effects from older patients' medicines (Arch Intern Med 2008;168: 508-13). The scale assigns a score from 1 (low) to 3 (high) for the risk of anticholinergic effects such as dry mouth, constipation and dizziness associated with commonly prescribed medicines. Checking the scale retrospectively in older patients in residential care, a higher score was associated with a 30 per cent increased risk of side-effects after adjustment for age and number of medicines. When this was repeated prospectively in a primary-care cohort, the increased risk was 90 per cent. HRT cancer risk persists The latest analysis of the Women's Health Initiative (WHI) trial of HRT shows that the small increase in the risk of cancer persists for up to three years after stopping treatment (J Am Med Assoc 2008;299:1036-45). WHI was stopped after 5.6 years' follow-up when it became clear the risks of HRT outweighed its benefits. This follow-up after a further three years (mean 2.4) involved 15 730 women. The annual risk of cardiovascular events was similar for HRT (1.97 per cent) and placebo (1.91 per cent). Cancers were more common among women who had taken HRT (1.56 vs 1.26 per cent), in particular breast cancer (0.42 vs 0.33 per cent). All-cause mortality was higher, but not statistically significantly so, with HRT (1.20 vs 1.06 per cent). Tight glycaemic control may increase falls Maintaining HbA1C at or below 6 per cent with insulin is associated with an increased risk of falls, a US study suggests (Diabetes Care 2008;31:391-6). The Health, Aging and Composition study involved 446 older people with type 2 diabetes (mean age 74) followed up for approximately five years. The incidence of falls ranged from 22 to 30 per cent annually. Comparing subgroups with HbA1C of ,6 per cent and >8 per cent, an increased risk of falls was associated with insulin use (odds ratio 4.4) but not oral hypoglycaemic drugs. Copyright © 2008 Wiley Interface Ltd [source] Executive Summary: The International Consultation on Incontinence 2008,Committee on: "Dynamic Testing"; for urinary incontinence and for fecal incontinence. part 1: Innovations in Urodynamic Techniques and Urodynamic Testing for signs and symptoms of urinary incontinence in female patients,,NEUROUROLOGY AND URODYNAMICS, Issue 1 2010Peter F.W.M. Rosier Abstract Aims The members of The International Consultation on Incontinence 2008 (Paris) Committee on Dynamic Testing' provide an executive summary of the chapter ,Dynamic Testing' that discusses (urodynamic) testing methods for patients with signs and or symptoms of urinary incontinence. Testing of patients with signs and or symptoms of faecal incontinence is also discussed. Methods Evidence based and consensus committee report. Results The chapter ,Dynamic Testing' is a continuation of previous Consultation-reports added with a new systematic literature search and expert discussion. Conclusions, based on the published evidence and recommendations, based on the integration of evidence with expert experience and discussion are provided separately, for transparency. Conclusion This first part of a series of three articles summarizes the committees recommendations about the innovations in urodynamic study techniques ,in general', about the test characteristics and normal values of urodynamic studies as well as the assessment of female with signs and or symptoms of incontinence and includes only the most recent and relevant literature references. Neurourol. Urodynam. 29: 140,145, 2010. © 2009 Wiley-Liss, Inc. [source] RESEARCH ON PRISONERS , A COMPARISON BETWEEN THE IOM COMMITTEE RECOMMENDATIONS (2006) AND EUROPEAN REGULATIONSBIOETHICS, Issue 1 2010BERNICE S. ELGER ABSTRACT The Institute of Medicine (IOM) Committee on Ethical Considerations for Revisions to DHHS Regulations for Protection of Prisoners Involved in Research published its report in 2006. It was charged with developing an ethical framework for the conduct of research with prisoners and identifying the safeguards and conditions necessary to ensure that research with prisoners is conducted ethically. The recommendations contained in the IOM report differ from current European regulations in several ways, some being more restrictive and some less so. For example, the IOM report suggests limiting the percentage of prisoners that should be involved in a biomedical study to 50%, a limit that does not exist in Europe. However, the report does not specifically advise against research without a direct benefit to an individual prisoner: the European regulations are more restrictive than the IOM committee recommendations in this respect. The definition of minimal risk varies, as well as the proposed role of the minimal risk requirement and of the principle of subsidiarity (research that can only be done effectively in prisons). The IOM report proposes a number of thoughtful suggestions, which it would be beneficial to implement everywhere, such as registers of research on prisoners. The European regulations offer pragmatic solutions to several thorny issues. In summary, the IOM committee report represents an admirable effort to tackle the present inconsistencies and deficiencies of federal regulations in the US on research on prisoners (45 CFR 46 Subpart C). Nonetheless, before acting on the recommendations, US regulators might consider revisiting international guidelines such as those published by the Council for International Organizations of Medical Science (CIOMS) and the Declaration of Helsinki. [source] When is an Individual an Individual Versus a Member of a Group?NUTRITION REVIEWS, Issue 5 2006An Issue in the Application of the Dietary Reference Intakes The Institute of Medicine (IOM) reports on Dietary Reference Intakes (DRIs) present a new paradigm for the description of nutrient requirements. Tradition and the DRI reports themselves have created an erroneous impression that the Recommended Dietary Allowance (RDA) is intended for use with individuals and the Estimated Average Requirement (EAR) is to be used with populations. Two recent IOM committee reports (one on nutrition labeling and one on Women, Infants and Children [WIC] food packages) challenge that interpretation, revealing the critical issues surrounding individuals versus groups or populations. The present paper examines the issues and concludes that the median requirement and Tolerable Upper Limit (UL) are the critical reference values for both individuals and populations. The RDA is both unneeded and lacking a sound scientific basis. [source] Software Use in Psychometric ResearchEDUCATIONAL MEASUREMENT: ISSUES AND PRACTICE, Issue 1 2004Gary Skaggs Research on psychometric methods is heavily dependent on software. The quality, availability, and documentation of such software are critical to the advancement of the field. In 2000, an ad hoc committee of NCME recommended that NCME adopt policies that promote greater availability and better documentation of software. This article follows the ad hoc committee's report by examining the use of software in four top-tiered journals in recent years. The results indicated that the most frequently cited programs were those written by the articles' authors. The documentation and availability for these programs are often not clear, particularly for software used for simulations. The use of proprietary software was not widespread in the four journals, but there is still room for concern in the future. This article recommends that NCME form a permanent committee to address software issues. [source] | ||||||||||