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Medicines Agency (medicine + agency)
Kinds of Medicines Agency Selected AbstractsHospitalizations for opioid poisoning: a nation-wide population-based study in Denmark, 1998,2004ADDICTION, Issue 1 2009Anne-Mette Bay Bjørn ABSTRACT Aims To assess hospitalization rates (HR) for poisoning with heroin, methadone or strong analgesics and relate them to quantities of prescribed methadone and strong analgesics in Denmark between 1998 and 2004. Design Population-based ecological study. Settings We extracted data on all emergency department visits and hospital admissions registered in the Danish National Patient Registry with a diagnosis of poisoning with heroin (n = 1688), methadone (n = 173) or strong analgesics (n = 384). To ascertain sale of prescribed medications we used data from the Danish Medicines Agency. Measurements Age- and gender-standardized HR and defined daily doses (DDD) per 1000 people per day. Findings HR for heroin poisoning was 4.4 [95% confidence interval (CI): 3.8,4.9] per 100 000 person-years (p-y) in 1998 and 4.6 (CI: 4.0,5.2) per 100 000 p-y in 2004. HR for methadone poisoning increased from 0.1 (CI: 0.0,0.2) per 100 000 p-y in 1998 to 1.1 (CI: 0.8,1.4) per 100 000 p-y in 2004. HR for poisoning with strong analgesics increased from 0.6 (CI: 0.4,0.9) per 100 000 p-y in 1998 to 2.1 (CI: 1.8,2.6) per 100 000 p-y in 2004. The sale of prescribed strong analgesics (5.0 DDD per 1000 people per day in 1998 to 5.9 DDD in 2004) and methadone (3.0 DDD per 1000 people per day in 1998 to 3.4 DDD in 2004) increased slightly between 1998 and 2004. Conclusion Increasing sale of prescribed methadone and strong analgesics coincided with increasing HRs of poisoning with these drugs, whereas HR of heroin poisoning varied. Further longitudinal studies are important for the guidance of future policy making. [source] Feasibility and challenges of independent research on drugs: the Italian Medicines Agency (AIFA) experienceEUROPEAN JOURNAL OF CLINICAL INVESTIGATION, Issue 1 2010Italian Medicines Agency (AIFA) Research & Development Working Group Eur J Clin Invest 2010; 40 (1): 69,86 Key points ,,National Health Service (NHS) is becoming increasingly aware of the need to support independent research to answer some important questions for patient care in areas of scant commercial interest. ,,This article reports the main features and strategies of the independent research programme on drugs launched by the Italian Medicines Agency (AIFA) in 2005. ,,In the three bids launched between 2005 and 2007, a total of 151 studies have been approved for funding for a total of about 78 million Euro. ,,In this article we describe the Italian legislative framework under which the programme was launched, the types of research funded and discuss how the supported studies could contribute, in an international framework, to the knowledge needed on drug efficacy, effectiveness and safety. [source] Agomelatine: a new treatment for depressionFUTURE PRESCRIBER, Issue 2 2009Professor Bill Deakin It is estimated that depression carries the greatest burden of disability in established economies. A range of treatments are available, and selective serotonin reuptake inhibitors (SSRIs) are currently the most commonly prescribed class of antidepressant. In this article, the author discusses agomelatine, a novel antidepressant recently licensed by the European Medicines Agency (EMEA), the evidence for its use, and its potential place in therapy. Copyright © 2009 John Wiley & Sons, Ltd. [source] Biosimilars: pharmacovigilance and risk management,PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 7 2010Leyre Zuñiga Ph.D. Abstract Biosimilars cannot be authorised based on the same requirements that apply to generic medicines. Despite the fact that the biosimilar and reference drug can show similar efficacy, the biosimilar may exhibit different safety profile in terms of nature, seriousness or incidence of adverse reactions. However, the data from pre-authorisation clinical studies normally are insufficient to identify all potential differences. Therefore, clinical safety of similar biological medicinal products must be monitored closely on an ongoing basis during the post-approval phase including continued risk,benefit assessment. The biosimilar applicant must provide the European Medicines Agency (EMEA) with a risk management plan (EU-RMP) and pharmacovigilance programme with its application, including a description of the potential safety issues associated with the similar biological medicinal product that may be a result of differences in the manufacturing process from the reference biologic. The most critical safety concern relating to biopharmaceuticals (including biosimilars) is immunogenicity. Risk management applies scientifically based methodologies to identify, assess, communicate and minimise risk throughout a drug's life cycle so as to establish and maintain a favourable benefit,risk profile in patients. The risk management plan for biosimilars should focus on heightens the pharmacovigilance measures, identify immunogenicity risk and implement special post-marketing surveillance. Although International Nonproprietary Names (INNs) served as a useful tool in worldwide pharmacovigilance, for biologicals they should not be relied upon as the only means of product identification. Biologicals should always be commercialised with a brand name or the INN plus the manufacturer's name. Copyright © 2010 John Wiley & Sons, Ltd. [source] Latest news and product developmentsPRESCRIBER, Issue 22 2007Article first published online: 28 DEC 200 Glitazones: benefits outweigh the risks Following a review of the safety of rosiglitazone and pioglitazone, the European Medicines Agency (EMEA) has concluded that their benefits outweigh their risks in the approved indications. The review was prompted by reports of an increased risk of fractures in women and, in patients taking rosiglitazone, ischaemic heart disease. The EMEA concluded that prescribing information for rosiglitazone should now include a warning that, in patients with ischaemic heart disease, it should only be used after careful evaluation of each patient's individual risk, and the combination of rosiglitazone and insulin should only be used in exceptional cases and under close supervision. No change was considered necessary to the prescribing information for pioglitazone. Modern dressings no better? A systematic review has found only weak evidence that modern dressings are better than saline gauze or paraffin gauze for healing acute and chronic wounds (Arch Dermatol 2007;143: 1297-304). The analysis, which included 99 studies, found that only hydrocolloids were demonstrably better than older dressings for healing chronic wounds, and alginates were superior to other modern dressings for debriding necrotic wounds. There was no evidence that modern dressings offered superior overall performance to the older alternatives. Hospital inflation twice primary care level The cost of drugs prescribed in secondary care but dispensed in the community increased by 6.4 per cent in 2006 - twice the rate of inflation in primary care - according to the latest statistics on hospital prescribing in England. The increase follows a reduction in costs in 2005 after the introduction of the new PPRS scheme. Data from The Information Centre (www.ic.nhs.uk) show that hospital medicines make up about 24 per cent of the NHS drugs budget. Secondary care has a consistently better record than primary care in prescribing lower-cost alternatives within therapeutic categories, eg simvastatin and pravastatin among the statins, omeprazole and lansoprazole among PPIs, and ACE inhibitors among drugs acting on the renin angiotensin system. The most expensive drug prescribed by hospital specialists and dispensed in the community is interferon beta. MHRA limits the use of fibrates The Medicines and Healthcare products Regulatory Agency (MHRA) has advised that fibrates should now be reserved for the treatment of isolated severe hypertriglyceridaemia. They should be considered for hypercholesterolaemia only when a statin or other treatment is contraindicated or not tolerated. In the latest Drug Safety Update, the MHRA says there is insufficient evidence of long-term benefits from fibrates, and first-line use is no longer justified because the evidence for the benefits of statins is robust. The MHRA also warns that some breastfeeding infants have increased susceptibility to the adverse effects of codeine taken by their mother, and that St John's wort may affect the hepatic metabolism of any anticonvulsant. Annual zoledronic acid infusion cuts mortality after hip fracture Once-yearly infusion of zoledronic acid (Aclasta) after hip fracture reduces deaths over a two-year period by 28 per cent compared with placebo, US investigators say (N Engl J Med 2007;357:1799-809). The HORIZON Recurrent Fracture Trial randomised 2127 men and women (mean age 75) within 90 days of surgery for hip fracture to zoledronic acid 5mg yearly or placebo. Mortality over 1.9 years of follow-up was 9.6 per cent with zoledronic acid and 13.3 per cent with placebo. Zoledronic acid also significantly reduced the rate of any new clinical fractures (by 35 per cent) and new clinical vertebral fractures(by 45 per cent),but the lower rate of hip fracture (2.0 vs 3.5 per cent with placebo) was not statistically significant. Rivastigmine patch for mild to moderate AD Rivastigmine (Exelon) is now available as a transdermal patch for the treatment of mild to moderate Alzheimer's disease. Applied once daily, the patch delivers 9.5mg per 24 hours and, says manufacturer Novartis, is associated with a lower incidence of nausea and vomiting than a comparable oral dose. The patch is available in two strengths: 4.6mg per 24hr is equivalent to oral doses of 3 or 6mg per day, and the 9.5mg per 24hr patch is equivalent to 9 or 12mg per day orally. The recommended dose of the patch is 9.5mg per day; both strengths cost £83.84 for 30 patches. Women more aspirin resistant than men? The cardioprotective effect of low-dose aspirin may be lower in women than men, say Canadian investigators (BMC Medicine 2007;5:29 doi: 10.1186/1741-70155-29). Their meta-analysis of 23 randomised trials involving a total of 113 494 participants found that aspirin significantly reduced the risk of nonfatal but not fatal myocardial infarction (MI). About one-quarter of the variation in its effects on nonfatal MI was accounted for by the sex mix of the trial population. Separating the results by sex showed the reduction in risk with aspirin use was statistically significant in men (relative risk, RR, 0.62) but not in women (RR 0.87). Look after physical health of mentally ill GPs and other primary care workers should take more responsibility for the physical health of their mentally ill patients, say advocacy groups. Mind and Body: Preventing and Improving Physical Health Problems in Patients With Schizophrenia points out that the mental health needs of patients with schizophrenia are met in secondary care, but their physical health needs should be met in primary care. In particular, the metabolic effects of antipsychotics may lead to obesity, diabetes and cardiovascular disease, and weight gain in particular is a frequent reason for nonadherence to treatment. The Mind and Body Manifesto was developed by SANE, The Mental Health Nurses Association, The National Obesity Forum and The Disability Rights Commission and sponsored by Bristol-Myers Squibb Pharmaceuticals Limited and Otsuka Pharmaceuticals (UK) Ltd. Copies are available from elizabeth.green@ ogilvyhealthworld.com. Health eCard costs Some costs quoted in our article on the Health eCard (The Health eCard: the way ahead for medical records?,5 October issue, pages 28-9) have been revised: the card and initial download will cost patients £39.50, and GPs will be entitled to charge patients £10 per annum for subsequent downloads. NICE appraisals of cytokine inhibitors in RA NICE has endorsed the use of the anti-TNF agents adalimumab (Humira), etanercept (Enbrel) and infliximab (Remicade), normally in conjunction with methotrexate, for the treatment of active RA when methotrexate and another DMARD have failed (also see New from NICE below). NICE has provisionally concluded, subject to consultation, that abatacept (Orencia) should not be recommended for the treatment of RA. Boots and BMJ launch health advice site www.askbootshealth.com is a new website providing information about health and medicines for the public produced by Boots using information provided by the BMJ Publishing Group. The website covers many of the topics already available from NHSDirect, with perhaps more information about available treatments. Diabetes care shows small improvement The third National Diabetes Audit in England and Wales has found that more people with diabetes were achieving the targets set by NICE for cholesterol levels, glycaemic control and blood pressure in 2005/06 - but younger patients were doing less well. Overall, the HbA1C target of ,7.5 per cent was achieved in 60 per cent of people with diabetes compared with 58 per cent in 2004/05. However, HbA1C was >9.5 per cent in 30 per cent of children and young people, of whom 9 per cent experienced at least one episode of ketoacidosis. More topics for NICE New topics referred to NICE include clinical guidelines on ovarian cancer, coeliac disease and stable angina, public health guidance on preventing cardiovascular disease, and technology appraisals on insulin detemir (Levemir) for type 1 diabetes, several treatments for cancer and hepatic and haematological disorders, and biological therapies for juvenile arthritis. New from NICE NICE appraisal on anti-TNFs for RA Since NICE published its first appraisal of agents acting against tumour necrosis factor-alpha (anti-TNFs) for the treatment of RA in 2002, the product licences for etanercept (Enbrel) and infliximab (Remicade) have changed and a new agent, adalimumab (Humira), has been introduced. The anti-TNFs act in different ways. Infliximab is a chimeric monoclonal antibody that binds to TNF-alpha, neutralising its activity. Etanercept, a recombinant human TNF-alpha receptor fusion protein, and adalimumab, a human-sequence antibody, both bind to TNF-alpha and block its interaction with cell surface receptors. Adalimumab also modulates some biological responses induced or regulated by TNF-alpha. These agents are recommended for adults with severe active RA (defined as a disease activity score - DAS28 - greater than 5.1) who have already tried two disease-modifying drugs, including methotrexate (if not contraindicated). Prior treatment should have been of at least six months' duration, including two months at the standard dose (unless limited by toxicity). Anti-TNFs should normally be prescribed with methotrexate; when this is not appropriate, etanercept and adalimumab may be prescribed as monotherapy. Treatment with an anti-TNF should be continued beyond six months only if there is an adequate response (defined as an improvement in DAS28 of at least 1.2). Data from the British Rheumatology Society Biologics register show that, after six months, 67 per cent of patients met NICE criteria for an adequate response; this declined to 55 per cent at 18 months. The basic annual cost of treatment is £9295 for adalimumab 40mg on alternate weeks or etanercept 25mg twice weekly; infliximab costs £3777 for a loading dose, then £7553-£8812 depending on dose. Assuming no progression of disability, the incremental costs per QALY (compared with sequential DMARDs) were £30 200 for adalimumab, £24 600 for etanercept and £39 400 for infliximab. There are no direct comparative trials of the anti-TNFs, and their clinical trial findings are not directly comparable. Unless other factors determine treatment choice, NICE therefore recommends the least expensive. If the first anti-TNF is withdrawn within six months due to an adverse event, a second may be tried. [source] The socio-economical burden of hypersomniaACTA NEUROLOGICA SCANDINAVICA, Issue 4 2010P. Jennum Jennum P, Kjellberg J. The socio-economical burden of hypersomnia. Acta Neurol Scand: 2010: 121: 265,270. © 2009 The Authors Journal compilation © 2009 Blackwell Munksgaard. Objectives,,, In the absence of socio-economical consequences of hypersomnia this study addresses the factual indirect and direct costs. Methods,,, Two thousand two hundred and eight patients with a hypersomnia diagnosis from 1998 to 2005 were identified in the Danish national patient registry (NPR), each compared with 4 age and gender adjusted, randomly chosen citizens selected from the Civil Registration System Statistics. The health cost was decomposed in direct and indirect yearly costs, including labor supply and social transfer payments. Direct costs included frequencies and costs of discharges and outpatient use by cost weights according to diagnosis related groups and specific outpatient prices based on data from The Danish Ministry of Health. The use of and costs of drugs was based on data from the Danish Medicines Agency. The frequencies and costs from primary sectors were based on data from The National Health Security. Indirect costs were based on income data from the coherent social statistics (CSS). Results,,, Patients with hypersomnia presented significant higher health related contact rate, expenses and medication use. No differences were identified in employment and income. The yearly sum of direct and indirect costs were yearly ,3402 vs. ,1212 in controls (P < 0.001), corresponding to a yearly excess costs ,2190. The patients presented higher transfer income, total ,889. Conclusion,,, Hypersomnia patient present higher health and medication uses, and social transfer income and thus represent a significant socio-economical burden. [source] European Committee on Antimicrobial Susceptibility Testing (EUCAST) Technical Notes on antimicrobial susceptibility testingCLINICAL MICROBIOLOGY AND INFECTION, Issue 6 2006G. Kahlmeter Abstract The main objectives of the European Committee on Antimicrobial Susceptibility Testing (EUCAST) are to harmonise breakpoints for antimicrobial agents in Europe, and to act as the breakpoint committee for the European Medicines Agency (EMEA) during the registration of new antimicrobial agents. Detailed EUCAST procedures for harmonising and setting breakpoints for antimicrobial agents are available on the EUCAST website. Beginning with the current issue, a series of EUCAST Technical Notes will be published in CMI, based on the rationale documents produced by EUCAST for each of the antimicrobial agents studied, with the aim of highlighting important background information underlying decisions on breakpoints made by EUCAST. [source] Evidence-based (S3) guideline for the treatment of psoriasis vulgaris , Update: "Therapeutic options" and "Efalizumab"JOURNAL DER DEUTSCHEN DERMATOLOGISCHEN GESELLSCHAFT, Issue 1 2010Alexander Nast Summary In February 2009, the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) had recommended the suspension of efalizumab's (Raptiva®) marketing authorization, because its benefits in the treatment of psoriasis were modest, while there was a risk of serious side effects in patients receiving the medicine, including the occurrence of progressive multifocal leukoencephalopathy (PML). The guideline group has changed the guideline accordingly. [source] | ||||||||||