European Commission consultation paper on regulation of advanced therapy medicinal products
Source: MHRA
Area: News
The European Commission (EC) is seeking views from stakeholders on the application of the Regulation on advanced therapy medicinal products (Regulation 1394/2007). The Commission has invited comments by 31 March 2013. The MHRA will be responding to the Commission's consultation and would be interested in seeing any responses submitted by UK stakeholders to the Commission's consultation. UK respondents are encouraged to send copies of their responses to the Agency by 15 March 2013, to allow them to be taken into account in formulating its response. (Source: NeLM - News)
Source: NeLM - News - February 21, 2013 Category: Drugs & Pharmacology Source Type: news
NHS Commissioning Board authorises third wave of clinical commissioning groups,
Source: NHS Commissioning Board
Area: News
The NHS Commissioning Board has authorised 62 more clinical commissioning groups (CCGs) to commission healthcare services for their communities. The third wave of CCGs, which have all completed a rigorous assessment, will in total plan and commission hospital, community health and mental health services on behalf of more than 13 million people.
The first 34 CCGs were authorised in December 2012; with a further 67 CCGs authorised in January 2013. The 163 CCGs authorised so far will serve a total of around 42 million people. The remaining 48 CCGs are set for authorisati...
Source: NeLM - News - February 21, 2013 Category: Drugs & Pharmacology Source Type: news
National Pharmacy Association launches resources on Controlled Drugs
Source: NPA
Area: News
The National Pharmacy Association has produced resources to help members deal with Controlled Drugs (CDs) including 12 standard operating procedures (SOPs) for CDs which cover:
. Ordering pharmacy stock of CDs
. Receipt and storage of CDs
. Dispensing prescriptions for CDs
. Dispensing instalment prescriptions for CDs
. Delivery of CDs
. Disposal of patient-returned CDs
. Disposal of pharmacy stock of CDs
. Stock checks of CDs
. Record keeping for CDs
. Requests for CDs using a requisition
. Dealin...
Source: NeLM - News - February 21, 2013 Category: Drugs & Pharmacology Source Type: news
Review: Tuberculosis
This article in the New England Journal of Medicine on tuberculosis covers the following topics:
. Epidemiology
. Pathogenesis
. Clinical features
. Diagnosis
. Treatment: latent infection, drug-sensitive active TB, TB and HIV coinfection, multidrug-resistant TB, new drugs, BCG and new vaccines (Source: NeLM - News)
Source: NeLM - News - February 21, 2013 Category: Drugs & Pharmacology Source Type: news
Review: Non-heparin anticoagulants for heparin-induced thrombocytopenia
Source: N Engl J Med
Area: News
This review in the New England Journal of Medicine on non-heparin anticoagulants for heparin-induced thrombocytopenia begins with a case vignette followed by a discussion of the clinical problem, pathophysiology and effect of therapy, clinical use and clinical evidence (on parenteral direct thrombin inhibitors, danaparoid, fondaparinux, transition to a vitamin K antagonist), areas of uncertainty, guidelines; and ends with the authors' clinical recommendations on the management of the case in hand. (Source: NeLM - News)
Source: NeLM - News - February 21, 2013 Category: Drugs & Pharmacology Source Type: news
Applications submitted to extend marketing authorisation for certolizumab pegol (Cimzia®) to include treatment of active psoriatic arthritis and active axial spondyloarthritis
Source: PR Newswire
Area: News
UCB has announced new regulatory filings with the European Medicines Agency (EMA) and the FDA to extend the marketing authorisation for certolizumab pegol (Cimzia®) for the treatment of adult patients with active psoriatic arthritis (PsA) and for adult patients with active axial spondyloarthritis (axSpA).
Certolizumab pegol is a Fc-free, PEGylated anti-TNF. In the EU, it is currently licensed in combination with methotrexate (MTX) for the treatment of moderate to severe active rheumatoid arthritis in adult patients inadequately responsive to disease-modifying anti-rheumatic drug...
Source: NeLM - News - February 21, 2013 Category: Drugs & Pharmacology Source Type: news
MHRA warns of excessive heavy metal content of some unlicensed Chinese medicines purchased online
Source: MHRA
Area: News
The MHRA has warned people not to buy or use potentially dangerous unlicensed Chinese medicines sold online after some products were found to contain excessive levels of mercury or lead.
Health authorities in Hong Kong told the MHRA that various products are being recalled and they should not be used by people in the UK because of an increased toxic poisoning risk. The products are:
. Bak Foong Pills - used to relieve menstrual discomfort;
. Fung Shing Paij Tian-Ma Wan - used to relieve arthritis and headaches; and
. Shi Hu Ye Guang Wan and Nai Chang Min...
Source: NeLM - News - February 21, 2013 Category: Drugs & Pharmacology Source Type: news
FDA drug safety communication: Update of codeine use in children- new Boxed Warning and Contraindication on use after tonsillectomy and/or adenoidectomy
Source: FDA
Area: News
The FDA has notified the public about new actions being taken to address a known safety concern with codeine use in certain children after tonsillectomy and/or adenoidectomy
In August, it had issued an alert, following reports of children who developed serious adverse effects or died after taking codeine for pain relief after these procedures for obstructive sleep apnoea syndrome. These children (aged two to five) had evidence of an inherited ability to convert codeine into life-threatening or fatal amounts of morphine in the body. All children had received doses of codeine that were wit...
Source: NeLM - News - February 21, 2013 Category: Drugs & Pharmacology Source Type: news
NICE issues asthma quality standards
Source: NICE
Area: News
This quality standard from NICE covering the diagnosis and treatment of asthma in adults, young people and children aged 12 months and older, defines clinical best practice and provides specific, concise quality statements, measures and audience descriptors to provide the public, health and social care professionals, commissioners and service providers with definitions of high-quality care. (Source: NeLM - News)
Source: NeLM - News - February 21, 2013 Category: Drugs & Pharmacology Source Type: news
New national IV monograph on Sodium stibogluconate
Source: Medusa
Area: News
A new IV monograph on Sodium stibogluconate is now available from the NHS injectable medicines guide website (Medusa). Please see the link below for access (registration required).
(Source: NeLM - News)
Source: NeLM - News - February 20, 2013 Category: Drugs & Pharmacology Source Type: news
Updated national IV monograph on Amiodarone hydrochloride
Source: Medusa
Area: News
An updated IV monograph on Amiodarone hydrochloride is now available from the NHS injectable medicines guide website (Medusa). Please see the link below for access (registration required). (Source: NeLM - News)
Source: NeLM - News - February 20, 2013 Category: Drugs & Pharmacology Source Type: news
Updated national IV monograph on Desferrioxamine mesilate
Source: Medusa
Area: News
An updated IV monograph on Desferrioxamine mesilate is now available from the NHS injectable medicines guide website (Medusa). Please see the link below for access (registration required). (Source: NeLM - News)
Source: NeLM - News - February 20, 2013 Category: Drugs & Pharmacology Source Type: news
Updated national IV monograph on Sodium lactate intravenous infusion, compound
Source: Medusa
Area: News
An updated IV monograph on Sodium lactate intravenous infusion, compound is now available from the NHS injectable medicines guide website (Medusa). Please see the link below for access (registration required).
(Source: NeLM - News)
Source: NeLM - News - February 20, 2013 Category: Drugs & Pharmacology Source Type: news
Updated national IM monograph on Zuclopenthixol acetate - intermediate acting
Source: Medusa
Area: News
An updated IM monograph on Zuclopenthixol acetate - intermediate acting is now available from the NHS injectable medicines guide website (Medusa). Please see the link below for access (registration required). (Source: NeLM - News)
Source: NeLM - News - February 20, 2013 Category: Drugs & Pharmacology Source Type: news
Updated national IV monograph on Filgrastim (Zarzio)
Source: Medusa
Area: News
An updated IV monograph on Filgrastim (Zarzio) is now available from the NHS injectable medicines guide website (Medusa). Please see the link below for access (registration required). (Source: NeLM - News)
Source: NeLM - News - February 20, 2013 Category: Drugs & Pharmacology Source Type: news
