Data Briefing - The Liverpool care pathway: what do specialists think?
Source: BMJ Area: News The author of this article featured in the BMJ notes that the use of the Liverpool care pathway for end of life care has been heavily criticised in the media. The BMJ and Channel 4's Dispatches asked doctors for their views on the pathway, which are presented in the article. (Source: NeLM - News)
Source: NeLM - News - March 1, 2013 Category: Drugs & Pharmacology Source Type: news

The appeal of large simple trials
Source: BMJ Area: News Clinical trials have become complex, costly, and yet are often not big enough to answer questions necessary to optimise treatment for individual patients. The author of this article investigates whether having large simple trials in the future might be a solution. (Source: NeLM - News)
Source: NeLM - News - March 1, 2013 Category: Drugs & Pharmacology Source Type: news

Meta-analyses: how to read a funnel plot
Source: BMJ Area: News The author of this article uses an example of a funnel plot from a meta-analysis to explain what funnel plots are and how to interpret them. (Source: NeLM - News)
Source: NeLM - News - March 1, 2013 Category: Drugs & Pharmacology Source Type: news

Final 2012/13 staff flu vaccination figures released by the Department of Health
Source: Department of Health (DH) Area: News The Department of Health has released figures relating to the uptake of the flu vaccine among frontline healthcare workers in all trusts up to 31 January 2013. The figures reveal that more frontline healthcare workers have been vaccinated against flu this year than ever before. (Source: NeLM - News)
Source: NeLM - News - March 1, 2013 Category: Drugs & Pharmacology Source Type: news

Prospective cohort analysis: Pre-hospital lactated ringer's solution treatment and survival in out-of-hospital cardiac arrest
Source: PLoS Medicine Area: News The findings of this Japanese prospective, non-randomised observational study suggest that in Japanese patients experiencing out-of-hospital cardiac arrest (OHCA), the pre-hospital use of lactate Ringer's (LR) solution was independently associated with a decreased likelihood of a good functional outcome 1 month after the event, but with an increased likelihood of return of spontaneous circulation (ROSC) before hospital arrival. Pre-hospital use of LR solution was not associated with 1-month survival. Data for the study were obtained from national database and included a total of 531,854 pa...
Source: NeLM - News - March 1, 2013 Category: Drugs & Pharmacology Source Type: news

Review: Oncogenes in non-small-cell lung cancer: emerging connections and novel therapeutic dynamics
Source: Lancet Respiratory Medicine Area: News This review aims to provide an overview of the developments in the area of non-small cell lung cancer (NSCLC), focusing on the functional associations between key oncogenes involved in tumour formation. These mechanisms are crucial in NSCLC onset and progression and are emerging as clinically relevant diagnostic and therapeutically actionable targets. The following topics are discussed:   . Oncogene addiction: the EGFR paradigm . Molecular profiling as a guide to therapy . Molecular lesions in squamous-cell carcinomas . Tumour heterogeneity ...
Source: NeLM - News - March 1, 2013 Category: Drugs & Pharmacology Source Type: news

Care commissioning process is too laborious, report concludes
Source: BMJ, Nuffield Trust Area: News BMJ News features a story on a report by the Nuffield Trust which highlights the findings of an in-depth study of commissioning for people with long-term conditions. The study was funded by the National Institute for Health Research Health Services and Delivery Research (NIHR HS&DR) Programme. The Nuffield Trust carried out a 15 month (November 2010 to January 2012) study of commissioning practice in three high-performing primary care trust (PCT) areas (Calderdale, Somerset and the Wirral). The authors carried out detailed observation around what the trusts actually did around co...
Source: NeLM - News - March 1, 2013 Category: Drugs & Pharmacology Source Type: news

FDA approves long-acting injection formulation of aripiprazole
Source: PharmaTimes Area: News According to PharmaTimes approval has been granted in the United States for a long-acting, once monthly intramuscular injection formulation of aripiprazole (Abilify® Maintena®) for the treatment of schizophrenia. Approval was based on data from a 52-week Phase III maintenance trial of the drug in patients with schizophrenia, which showed that it significantly delayed time to relapse compared to placebo, and lowered the percentage of subjects experiencing relapse, the groups note. No further trial data are provided in the PharmaTimes story. (Source: NeLM - News)
Source: NeLM - News - March 1, 2013 Category: Drugs & Pharmacology Source Type: news

Horizon scanning: Drisapersen linked to serious side effects and hospitalisation according to safety data from trial investigating the drug in Duchenne muscular dystrophy
Source: BioSpace Area: News BioSpace reports that patients enrolled in an early stage trial investigating the use of drisapersen (GSK-2402968) in Duchenne muscular dystrophy (DMD) have been hospitalised due to kidney toxicity and low platelet counts. The report is based on data presented at a research meeting in Rome. GlaxSmithKline (GSK) has released some safety data from early stage clinical trials previously too and these mainly reported cases of proteinuria and decreased thrombocytes. According to the BioSpace report, four DMD) patients treated with drisapersen required hospitalisation due to thrombocytopenia and "se...
Source: NeLM - News - March 1, 2013 Category: Drugs & Pharmacology Source Type: news

Analysis: Will prescriptions for cultural change improve the NHS?
Source: BMJ Area: News This BMJ article focuses on the recent Francis report, which identified serious cultural deficiencies in the NHS and recommended fundamental cultural change (see previous NeLM news story). The authors examine what research tells us about the likelihood of success. The following key points are summarised in the article:   . Organisational cultures in healthcare are manifold, complex, and dynamic . Healthcare organisations are better seen as multiple co-existing subcultures than as uniform cultural monoliths . The national policy framework and top down strategic initiatives...
Source: NeLM - News - March 1, 2013 Category: Drugs & Pharmacology Source Type: news

HPA: Cases of whooping cough continue to decrease
Source: Health Protection Agency (HPA) Area: News Current figures published by the Health Protection Agency (HPA) show that confirmed cases of whooping cough in England and Wales have continued to decrease with 668 cases reported in January 2013, compared to 835 cases in December 2012. Although this will be the third month in a row that cases have decreased, the overall numbers remain unusually high following a sustained outbreak during 2012 which saw a record 9,741 cases (provisional number). The press release also notes that large numbers of cases continue to be reported in those aged 15 years and older with 579 cases r...
Source: NeLM - News - March 1, 2013 Category: Drugs & Pharmacology Source Type: news

FDA special feature: Don't take this with that - grapefruit interactions with medication
Source: FDA Area: News Special feature articles are timely and easy-to-read articles covering drug-related issues produced by the U.S. Food and Drug Administration (FDA), primarily for patients, carers and members of the public. The current article discusses interactions with grapefruit and notes that there are presently more than fifty prescription and over-the-counter drugs known to the FDA that can have negative interactions with grapefruit. (Source: NeLM - News)
Source: NeLM - News - March 1, 2013 Category: Drugs & Pharmacology Source Type: news

Systematic review and meta-analysis: Selected pregnancy and delivery outcomes after exposure to antidepressant medication
Source: JAMA Psychiatry Area: News The authors of this paper note that data on the potential risks of antidepressant use during pregnancy are conflicting. They carried out a meta-analysis to assess whether pre-natal antidepressant exposure is associated with risk for selected adverse pregnancy or delivery outcomes.   Data for the analysis were sourced through a search of various databases, including Medline, Embase and the Cochrane Library from the date the database started to 30th June 2010. Literature searches were independently carried out by 2 professional librarians with expertise in the areas of psychiatry...
Source: NeLM - News - March 1, 2013 Category: Drugs & Pharmacology Source Type: news

All Wales review & guidance for prescribing intervals (repeat prescribing)
Source: All Wales Medicines Strategy Group (AWMSG) Area: News The All Wales Medicines Strategy Group (AWMSG) has published a review into repeat prescribing intervals and made the following recommendations in Wales (direct from source):   . A 28-day repeat prescribing interval is broadly recommended; however, discretion should be used for individual patients or medicines. This should be coupled with a rigorous and effective medication review process.   . Repeat prescribing systems that promote synchronised, once per month requests for long-term medication should be developed.   . P...
Source: NeLM - News - March 1, 2013 Category: Drugs & Pharmacology Source Type: news

NHS charges from April 2013 announced - prescription charge to increase by 20p in England
Source: Department of Health (DH) Area: News The Department of Health has announced that the NHS prescription charge in England will increase by 20p from £7.65 to £7.85 for each quantity of a drug or appliance from 1st April 2013.   However, the cost of a prescription prepayment certificate (PPC) will remain at £29.10 for a 3 month certificate and the cost of the annual certificate will remain at £104. PPCs offer savings for those needing 4 or more items in 3 months or 14 or more items in one year.   The press release notes that in England, around 90 per cent of prescription items are dispensed free....
Source: NeLM - News - March 1, 2013 Category: Drugs & Pharmacology Source Type: news

All Wales guide to prescribing gluten-free products
Source: All Wales Medicines Strategy Group (AWMSG) Area: News The All Wales Medicines Strategy Group (AWMSG) has published a guide on prescribing gluten free products. The guide aims to support general practitioners and other healthcare professionals in Wales in the management of patients with coeliac disease, and aid the decision-making process in relation to prescribing Advisory Committee on Borderline Substances (ACBS)-approved gluten-free foods. (Source: NeLM - News)
Source: NeLM - News - March 1, 2013 Category: Drugs & Pharmacology Source Type: news

Draft NICE guidance supports the use of mirabegron for the treatment of symptoms associated with overactive bladder in certain patients
Source: NICE Area: News The National Institute for Health and Clinical Excellence (NICE) has issued draft guidance for consultation on the use of mirabegron for the treatment of symptoms associated with overactive bladder. The guidance makes the following preliminary recommendations:   1. Mirabegron is recommended as an option for treating the symptoms of overactive bladder only for people in whom antimuscarinic drugs are contraindicated or clinically ineffective, or have unacceptable side effects.   2. People currently receiving mirabegron whose condition does not meet the criteria above shoul...
Source: NeLM - News - March 1, 2013 Category: Drugs & Pharmacology Source Type: news

Confirmation of Payment by Results arrangements for 2013-14
Source: Department of Health (DH) Area: News Arrangements for Payment by Results (PbR) in 2013/14 have been confirmed following a road test exercise. The 2013-14 PbR guidance has been clarified and expanded in a number of areas, in response to feedback received from the road test exercise. A letter from the Deputy NHS Chief Executive notes that this is the final PbR package that the Department of Health (DH) will publish, though the DH PbR team will continue to have a role during 2013-14 in supporting organisations implement the tariff. Monitor and the NHS Commissioning Board will be responsible for tariff and currency de...
Source: NeLM - News - March 1, 2013 Category: Drugs & Pharmacology Source Type: news

CAS response monthly data published in 2013
Source: Department of Health (DH) Area: News The Department of Health publishes monthly snapshot data on responses received from all NHS Trusts to NPSA alerts going back to 2004. The data, in the form of a spreadsheet, indicates the current status of NPSA alerts within each trust as recorded on the Central Alerting System (CAS).  Data up to February 2013 can be accessed via the link below. (Source: NeLM - News)
Source: NeLM - News - February 28, 2013 Category: Drugs & Pharmacology Source Type: news

the month: issue 63, February 2013 now available
Source: Department of Health (DH) Area: News The February 2013 edition of the Department of Health newsletter "the month" is now available. In the current issue, Sir David Nicholson reflects on the Francis Report and looks towards 1 April 2013, the NHS Commissioning Board explains Sir Bruce Keogh's review of urgent and emergency care and there are updates from Public Health England, Health Education England and the NHS Trust Development Authority. (Source: NeLM - News)
Source: NeLM - News - February 28, 2013 Category: Drugs & Pharmacology Source Type: news

Anika Therapeutics S.r.l. withdraws its marketing authorisation application for Hyalograft C autograft
Source: EMA Area: News The European Medicines Agency (EMA) has been formally notified by Anika Therapeutics S.r.l. of its decision to withdraw its application for centralised marketing authorisation for Hyalograft C autograft (cultured autologous chondrocytes on hyaluronan based scaffold), 4 million cells seeded on scaffold, for implantation. It was intended to be used for the surgical repair of symptomatic cartilage defects of the femoral condyle (medial, lateral) or trochlea, caused by acute or repetitive trauma in adults.   Hyalograft C autograft has been used in a number of European Union (EU) countries since...
Source: NeLM - News - February 28, 2013 Category: Drugs & Pharmacology Source Type: news

Horizon scanning: Phase 2 trial investigates two dosing regimens of tosedostat in elderly patients with relapsed or refractory AML
Source: Lancet Oncology Area: News The results of this small randomised phase 2 open label study, investigating two doses of tosedostat, suggest that the drug has activity in older patients with relapsed or refractory acute myeloid leukaemia (AML) at either dose schedule. Tosedostat is being developed as an oral agent which inhibits aminopeptidases - thought to have a key role in the protein cell cycle. The study randomised (1:1 ratio) patients aged over 60 years with AML that had relapsed after a first complete remission lasting less than 12 months, or had achieved no previous complete remission to either first salvage t...
Source: NeLM - News - February 28, 2013 Category: Drugs & Pharmacology Source Type: news

PSNC highlights key changes for contractors in new pharmacy regulations
Source: PSNC Area: News The Pharmaceutical Services Negotiating Committee (PSNC) has produced a summary of key changes that contractors and Local Pharmaceutical Committees (LPCs) will need to be aware of within the newly laid National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013, which come into effect on 1st April 2013.   Please see links below for further details. (Source: NeLM - News)
Source: NeLM - News - February 28, 2013 Category: Drugs & Pharmacology Source Type: news

Cohort study: Ondansetron in pregnancy and risk of adverse foetal outcomes
Source: No information given Area: News The authors of this paper note that although ondansetron is often used to treat nausea and vomiting during pregnancy, its safety in pregnancy has not been studied in detail.   This Danish historic cohort study used data from registries in Denmark to investigate whether the use of ondansetron during pregnancy was associated with an increased risk of adverse foetal outcomes, (defined as spontaneous abortion, stillbirth, any major birth defect, preterm delivery, low birth weight, and small size for gestational age).   A historical cohort of 608,385 pregnancies was ide...
Source: NeLM - News - February 28, 2013 Category: Drugs & Pharmacology Source Type: news

SPC for Fostair® updated for new indication for maintenance and reliever therapy
Source: Personal communication Area: News Section 4.2 of the Summary of Product Characteristics (SPC) for Fostair (beclometasone dipropionate/formoterol) pressurised metered dose inhaler (pMDI) has been updated to include a new indication of Maintenance and Reliever Therapy. Under these circumstances, patients take their daily maintenance dose of Fostair and in addition take Fostair as needed in response to asthma symptoms. Patients using Fostair in this way should be advised to always have Fostair available for rescue use. (Source: NeLM - News)
Source: NeLM - News - February 28, 2013 Category: Drugs & Pharmacology Source Type: news

NHS Choices "Behind the Headlines Assessment": Swine flu jab narcolepsy risk is very small
Source: NHS Choices Area: News The Behind the Headlines service from NHS Choices has featured a quality assessment of a study published in the BMJ and reported widely in the media. The study (designed as a retrospective analysis) found an increased risk of narcolepsy after vaccination with ASO3 adjuvanted pandemic A/H1N1 2009 vaccine (Pandemrix vaccine), thus suggesting a causal association.   The NHS Choices assessment acknowledges that the media reports are underpinned by "a well-conducted, government-funded study that confirms findings of previous research from Finland". However, it also stresses that the risk...
Source: NeLM - News - February 28, 2013 Category: Drugs & Pharmacology Source Type: news

CADTH common drug review and formulary recommendation: Lurasidone (Latuda®) for schizophrenia
Source: Canadian Agency for Drugs and Technologies in Health (CADTH) Area: News The Canadian Drug Expert Committee (CDEC) has recommended that lurasidone not be listed for the acute treatment of schizophrenia. The Committee made this recommendation because there is insufficient evidence from randomised controlled trials (RCTs) to establish the comparative efficacy of lurasidone relative to other less costly antipsychotics for the acute treatment of schizophrenia.   Lurasidone is not currently licensed in the UK, although it has been filed for approval in the EU. A NICE evidence summary for new medicines for luras...
Source: NeLM - News - February 28, 2013 Category: Drugs & Pharmacology Source Type: news

NICE joins campaign for full disclosure of clinical trial data
Source: BMJ Area: News BMJ News reports that the National Institute for Health and Clinical Excellence (NICE) has given its support to a campaign to promote openness in reporting of clinical trials by signing the AllTrials campaign's petition.   The campaign was launched in January by the BMJ, leading medical bodies and charities. It calls on responsible bodies to ensure that all trials, past and present, for all treatments, are registered and that the full methods and full results are published. Campaigners believe that under-reporting in trials leads to overestimation of the benefits of drugs and underestimatio...
Source: NeLM - News - February 28, 2013 Category: Drugs & Pharmacology Source Type: news

RPS publishes Best Practice Standards for Managing Medicines Shortages in Secondary Care in England
Source: RPS Area: News The Royal Pharmaceutical Society has jointly published with the NHS Best Practice Standards for Managing Medicines Shortages in Secondary Care in England.  The short guide is available to members of the RPS. (Source: NeLM - News)
Source: NeLM - News - February 28, 2013 Category: Drugs & Pharmacology Source Type: news

Editorial: GLP-1 based agents and acute pancreatitis
Source: BMJ Area: News The author of this BMJ editorial discusses a recent study published in JAMA which found that the glucagon-like peptide (GLP)-1-based therapies sitagliptin and exenatide were associated with increased odds of hospitalisation for acute pancreatitis. According to the author, the FDA database carried a signal for acute pancreatitis with exenatide in 2006, a year before the agency alerted clinicians. He states, "Furthermore, all GLP-1 based agents that have been on the market for more than two years have also generated a signal for acute pancreatitis, suggesting a class effect." The regulatory procedures...
Source: NeLM - News - February 28, 2013 Category: Drugs & Pharmacology Source Type: news

NICE issues two new quality standards for epilepsy and updated commissioning guidance
Source: NICE Area: News The National Institute for Health and Clinical Excellence (NICE) has published two the quality standards for epilepsy - (i) Epilepsies in adults (aged 18 years and older) and (ii) Epilepsies in children and young people (aged up to 18 years). Each quality standard is made up of 9 quality statements which, when delivered collectively, should contribute to improving the effectiveness, quality, safety and experience of care for people with epilepsy.   NICE has also issued an updated guide to support the integrated commissioning of high-quality, evidence-based services for the referral and dia...
Source: NeLM - News - February 28, 2013 Category: Drugs & Pharmacology Source Type: news

Medicines information is changing - NeLM integration into NHS Evidence
Source: NICE Area: News In April 2013 the way you access and receive medicines information via the National electronic Library (NeLM) is changing.   From April 1 2013, evidence currently available through the National electronic Library for Medicines (NeLM) will only be accessible via NHS Evidence provided by NICE, and NeLM will cease to exist.    NICE is working with the UK Medicines Information service (UKMi) to bring medicines information together into one place, NHS Evidence, making it simpler for those with medicines and prescribing responsibilities to view, search and filter high quality evide...
Source: NeLM - News - February 28, 2013 Category: Drugs & Pharmacology Source Type: news

Mirabegron (BetmigaT) launched in the UK for overactive bladder
Source: Press release - Astellas Pharma Europe Area: News Mirabegron (BetmigaT) is now available in the UK for the symptomatic treatment of urgency, increased micturition frequency and/or urgency incontinence as may occur in adult patients with overactive bladder (OAB) syndrome. The recommended dose is 50mg once daily with or without food.   Mirabegron is available as 25mg and 50mg prolonged-release tablets (NHS list price for both strengths: £29 for 30 tabs).   Please see SPC for prescribing details. (Source: NeLM - News)
Source: NeLM - News - February 27, 2013 Category: Drugs & Pharmacology Source Type: news

Network meta-analysis: Comparative effectiveness and safety of oral phosphodiesterase type 5 inhibitors for erectile dysfunction
Source: European urology Area: News Phosphodiesterase type 5 inhibitors (PDE5-Is) including sildenafil, tadalafil, and vardenafil are currently the first-line therapy for erectile dysfunction (ED). However there are few comparative data investigating the effects of different classes of oral PDE5-Is.   To address this gap in knowledge a systematic search was performed in PubMed, Cochrane Library, and Embase to identify randomised controlled trials (RCTs) that compared different PDE5-Is (sildenafil, tadalafil, vardenafil, udenafil, mirodenafil, and avanafil) or PDE5-Is with a placebo for ED. The authors used networ...
Source: NeLM - News - February 27, 2013 Category: Drugs & Pharmacology Source Type: news

NICE costing template for its guidance on ranibizumab for diabetic macular oedema (TA 274)
Source: NICE Area: News NICE has published a costing statement to accompany its guidance on the use of ranibizumab for treating visual impairment due to diabetic macular oedema (TA 274).   The costing report calculates that: "the annual cost associated with implementing this recommendation is estimated as £41,000 for a population of 100,000 based on the standard assumptions in the model once a steady state is reached. There are also anticipated to be non-recurrent costs from treating the prevalent population on implementation of the guideline of around £341,000. It is assumed that people with eligible eyes will...
Source: NeLM - News - February 27, 2013 Category: Drugs & Pharmacology Source Type: news

Horizon scanning: Phase III Trial investigating cilengitide fails to meet primary endpoint of increasing overall survival in patients with newly diagnosed glioblastoma
Source: PharmaLive Area: News According to a report by PharmaLive, a phase III trial investigating cilengitide for newly diagnosed glioblastoma has failed to meet the primary endpoint, of increasing overall survival.   The phase III trial CENTRIC, was a randomised, controlled, multi-centre open-label trial which evaluated the safety and efficacy of cilengitide in combination with temozolomide and radiotherapy in more than 500 patients with newly diagnosed glioblastoma and methylated MGMT gene promoter status. (Source: NeLM - News)
Source: NeLM - News - February 26, 2013 Category: Drugs & Pharmacology Source Type: news

Clinical Commissioning Groups to get £186m for IT
Source: E-Health Insider Area: News The NHS Commissioning Board has announced that Clinical Commissioning Groups will get £186m a year to spend on GP IT. The money will need to be shared between England's 211 proposed CCGs, which will formally take over commissioning local NHS services on 1 April. (Source: NeLM - News)
Source: NeLM - News - February 26, 2013 Category: Drugs & Pharmacology Source Type: news

Review: Muscular dystrophies
Source: Lancet Area: News The Lancet has featured a review describing the management of patients with muscular dystrophies. Muscular dystrophies are characterised by progressive muscle weakness that affects limb, axial, and facial muscles to a variable degree.   The review discusses the following topics: . Classification of muscular dystrophies . Clinical manifestations . Management and prevention . Pathogenesis and associated treatment approaches (Source: NeLM - News)
Source: NeLM - News - February 26, 2013 Category: Drugs & Pharmacology Source Type: news

RCT: Safety and efficacy of colistimethate sodium dry powder for inhalation (Colobreathe DPI) in patients with cystic fibrosis
Source: Thorax Area: News According to a study published early online in Thorax, colistimethate sodium dry powder for inhalation (Colobreathe DPI) CDPI has demonstrated efficacy by virtue of non-inferiority to tobramycin inhaler solution, in lung function after 24 weeks of treatment in cystic fibrosis (CF) patients.   The phase III prospective, randomised open-label study involved 380 patients with stable CF aged ?6 years with chronic P aeruginosa lung infection. Patients were randomised to Colobreathe dry powder for inhalation (CDPI, one capsule containing colistimethate sodium 1 662 500 IU, twice daily, n=187) ...
Source: NeLM - News - February 26, 2013 Category: Drugs & Pharmacology Source Type: news

Horizon scanning: US FDA approves regorafenib for advanced gastrointestinal stromal tumors
Source: US FDA Area: News The U.S. Food and Drug Administration (FDA) has approved regorafenib (Stivarga) for the treatment of patients with advanced gastrointestinal stromal tumours (GIST) that cannot be surgically removed and no longer respond to other FDA-approved treatments for this disease - imatinib and sunitinib.   The approval is based on the results of the GRID trial, previously reported on the NeLM in November 2012 - please see link below details. (Source: NeLM - News)
Source: NeLM - News - February 26, 2013 Category: Drugs & Pharmacology Source Type: news

RCT: Melatonin does not improve appetite or other symptoms in patients with advanced cancer and cachexia
Source: JCO Area: News The Journal of Clinical Oncology has featured a study evaluating the safety and efficacy of melatonin for appetite improvement in patients with cancer cachexia.   The randomised, double-blind, placebo-controlled, 28-day trial involved patients with advanced lung or gastrointestinal cancer (GI) cancer, with appetite scores ? 4 on a 0 to 10 scale (10 = worst appetite), and a history of weight loss ? 5%. Assessments included weight, symptoms by the Edmonton Symptom Assessment Scale, and quality of life by the Functional Assessment of Anorexia/Cachexia Therapy (FAACT) questionnaire.   ...
Source: NeLM - News - February 26, 2013 Category: Drugs & Pharmacology Source Type: news

USPSTF recommends against calcium and vitamin D supplementation for the prevention of fractures in community-dwelling adults
Source: JAMA Area: News JAMA Internal Medicine has published the new US Preventive Services Task Force (USPSTF) recommendation statement on vitamin D and calcium supplementation to prevent fractures in adults.   The statement is based on 2 systematic evidence reviews and a meta-analysis on vitamin D supplementation with or without calcium to assess the effects of supplementation on bone health outcomes in community-dwelling adults, the association of vitamin D and calcium levels with bone health outcomes, and the adverse effects of supplementation.   The USPTF has made the following recommendations which...
Source: NeLM - News - February 26, 2013 Category: Drugs & Pharmacology Source Type: news

Sitagliptin and exenatide associated with an increased risk of acute pancreatitis
Source: JAMA Internal Medicine Area: News According to a study published in JAMA Internal Medicine, treatment of type 2 diabetes mellitus with the glucagon-like peptide (GLP)-1-based therapies sitagliptin and exenatide was associated with increased odds of hospitalisation for acute pancreatitis.   A large administrative database in the United States  was used to collect data for the  population-based case-control study - adults with type 2 diabetes mellitus aged 18 to 64 years were identified and 1269 hospitalised cases with acute pancreatitis using a validated algorithm and 1269 control subjects matche...
Source: NeLM - News - February 26, 2013 Category: Drugs & Pharmacology Source Type: news

Current use of oral glucocorticoids associated with an increased risk of acute pancreatitis
Source: JAMA Internal Medicine Area: News According to a study published in JAMA Internal Medicine, current oral glucocorticoid use is associated with an increased risk of acute pancreatitis.   Researchers conducted a nationwide population-based case-control study to investigate the potential association between oral glucocorticoid use and acute pancreatitis. Data from a Swedish registry were evaluated, where a total of 6161 cases with a first episode of acute pancreatitis and 61,637 controls were identified for the final analysis. Cases were all patients diagnosed as having a first episode of acute pancreatitis ...
Source: NeLM - News - February 26, 2013 Category: Drugs & Pharmacology Source Type: news

Department of Health publishes changes to the Controlled Drugs regulations
Source: Department of Health (DH) Area: News The Department of Health has announced that "The Controlled Drugs (Supervision of Management and Use) Regulations 2013" (SI (2013/373) have been laid in Parliament today and will come into force from 1st April 2013.   In support of the changes made to the Controlled Drugs Regulations, the Department of Health has also published additional supporting information "The Controlled Drugs (Supervision of Management and Use) Regulation 2013 - Information about the Regulations".   Additionally, following the Department of Health's Controlled Drugs Consultation, which ...
Source: NeLM - News - February 26, 2013 Category: Drugs & Pharmacology Source Type: news

Patient Access Scheme: guidance for companies considering a proposal in England
Source: Department of Health (DH) Area: News Guidance for companies considering a Patient Access Scheme (PAS) proposal in England has been published.  Please see the link below for further information. (Source: NeLM - News)
Source: NeLM - News - February 25, 2013 Category: Drugs & Pharmacology Source Type: news

Horizon scanning: Regulatory application filed in Japan for simeprevir for the treatment of genotype 1 hepatitis C
Source: BioSpace Area: News According to a BioSpace report, a regulatory application has been submitted to the Japanese Ministry of Health & Welfare authorities seeking approval for simeprevir, administered with pegylated interferon (Peg-IFN) and ribavirin (RBV) for the treatment of genotype 1 chronic hepatitis C patients who are treatment naïve, prior non responders or relapsed following treatment with Peg-IFN with or without RBV.   Simeprevir is an oral once-daily NS3/4A protease inhibitor in late Phase III clinical development. The application is supported by data from four Japanese phase III clinical st...
Source: NeLM - News - February 25, 2013 Category: Drugs & Pharmacology Source Type: news

Review: Muscular dystrophies
Source: Lancet Area: News This Seminar on muscular dystrophies discusses their clinical manifestations, molecular pathogenesis, diagnostic strategy, and therapeutic developments. (Source: NeLM - News)
Source: NeLM - News - February 25, 2013 Category: Drugs & Pharmacology Source Type: news

NHS Choices 'Behind the Headlines' assessment of press reports that a "new antiviral may help in flu fight"
Source: NHS Choices Area: News The 'Behind the Headlines' service from NHS Choices has featured a quality assessment of press reports that a 'flu drug shows promise in overcoming resistance' (BBC news and other; 22nd Feb 2013).   The reports are based on early stage laboratory and animal research, which examined the effectiveness of a possible new antiviral treatment for flu. It was found in the laboratory to be similarly or more effective than zanamivir at stopping the influenza virus from spreading between cells, including strains with demonstrated resistance to oseltamivir and zanamivir. The chemical was also ...
Source: NeLM - News - February 25, 2013 Category: Drugs & Pharmacology Source Type: news

Voluntary US recall of peginesatide injection due to postmarketing reports of serious hypersensitivity reactions
Source: FDA Area: News The US FDA is informing the public about a voluntary recall of all lots of peginesatide (Omontys®) injection. This action is being taken due to new postmarketing reports of serious hypersensitivity reactions, including anaphylaxis, that have occurred within 30 minutes after administration.   Peginesatide injection is licensed in the US for the treatment of anaemia due to chronic kidney disease in adult patients on dialysis. It is not currently licensed in the EU but a Marketing Authorisation Application is currently under review by the European Medicines Agency (see link below).   ...
Source: NeLM - News - February 25, 2013 Category: Drugs & Pharmacology Source Type: news