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The National Institute for Health and Clinical Excellence (NICE) has issued draft guidance for consultation on the use of mirabegron for the treatment of symptoms associated with overactive bladder.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 sho...
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 sinc...
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 i...
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 ri...
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 lura...
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 underestimat...
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
