Annual evidence update on chronic lung disease
26th November 2009
The UK NHS Evidence supportive and palliative care section (formerly National Library for Health) has produced an annual update of the evidence in chronic lung disease focusing on the treatment of cough and dyspnoea.
NPSA alert: safer use of spinal (intrathecal), epidural and regional devices
25th November 2009
The UK National Patient Safety Agency (NPSA) has produced guidance building on previous safe practice to minimise the risk of wrong route errors. All NHS healthcare organisations are asked to ensure that:
• from 1 April 2011 all spinal (intrathecal) bolus doses and lumbar puncture samples are performed using syringes, needles and other devices with connectors that will not also connect with intravenous Luer connectors (Part A)
• from 1 April 2013 all epidural, spinal (intrathecal) and regional infusions and boluses are performed with devices that use safer connectors that will not connect with intravenous Luer connectors or intravenous infusion spikes (Part B).
NHS organisations will need to review and update their purchasing policies, procedures and clinical protocols to include the use of devices with safer connectors. These devices with safer connectors are not currently available. By issuing this Alert the NPSA is expecting that the medical device and pharmaceutical industry will work collaboratively with the NHS to develop devices with safer connectors.
For further information see the link to the NPSA website below.
Palliativedrugs.com exceeds 10,000 members
19th November 2009
We are delighted to announce that www.palliativedrugs.com has exceeded 10,000 members since the relaunch of our website in August 2008.
There are 110 countries represented. Over half the members are from the UK with 851, 792, 553, 346 and 305 members from Australia, USA, Canada, Ireland and New Zealand respectively. Members consist mainly of doctors, nurses and pharmacists from palliative care, general medicine, oncology, general practice, medicines information and pain teams.
We would like to take this opportunity to thank you all for your support. We are particularly grateful for your contributions to the bulletin board, SDSD, surveys and donations of guidelines, protocols and patient/carer information leaflets. As always we encourage feedback please send your comments or suggestions to hq@palliativedrugs.com.
MHRA recalls multiple antacids
19th November 2009
The UK Medicines and Healthcare products Regulatory Agency (MHRA) have recently recalled the following products due to low level bacterial contamination detected in the products. The products affected are 500mL bottles of the following:
Gaviscon Advance Peppermint Flavour (Reckitt Benckiser); batch numbers 924471 and 925071
Boots Heartburn Relief Peppermint Flavour, batch number 41808
Peptac Peppermint Liquid (Ivax Pharmaceuticals UK), batch numbers 41808 and 41957
Peptac Liquid Aniseed Flavour (Ivax Pharmaceuticals UK), batch number 41757.
The recall is precautionary, the contamination could cause the medicine to spoil and change the smell from peppermint/aniseed to antiseptic. The microbial contamination is not likely to be harmful to normally healthy consumers. However, if these products are being used by patients with suppressed immune systems, the risk of infection and other adverse reactions cannot be ruled out.
For further details see the MHRA recall notices below.
MHRA recall notice for Reckitt Benckiser product
MHRA recall notice for Boots and Ivax products
FDA approves capsaicin patch
19th November 2009
The US Food and Drug Administration (FDA) has approved capsaicin 8% patch (Qutenza, NeurogesX Inc's), a medicated skin patch that relieves the pain of post-herpetic neuralgia (PHN). The dosage is a single application of up to 4 patches for a 60min period repeated no more frequently than every 3months. Pre-treatment with topical anaesthetic is required. See the product information below for further details.
FDA approves tranexamic acid tablets
19th November 2009
Tranexamic acid tablets are now available in the US. The Food and Drug Administration (FDA) has approved tranexamic acid tablets (Lysteda, Xanodyne pharmaceuticals) to treat menorrhagia.
Reducing the risk of errors when ePrescribing opioids
19th November 2009
The UK organisation NHS Connecting for Health has produced a document on reducing the risk of mis-selecting opioid preparations in electronic systems. It is likely to be of interest to individuals involved in the design and implementation of ePrescribing systems, and those who use them.
The document can be downloaded from below.
NICE consultation on delirium
19th November 2009
NICE is developing a clinical practice guideline on delirium. A draft version has been issued for consultation; registered stakeholders have until 6th January to comment on the provisional recommendations made. Please see the link below for details
RCGP launch end of life care strategy
19th November 2009
The UK Royal College of General Practitioners (RCGP) has published an end of life care strategy. Development of the strategy was led by Professor Keri Thomas. The aim of the strategy is to help develop good practice and promote excellence and identifies 10 recommended areas for further work.
Consensus guidelines for oral bowel cleansing agents
19th November 2009
The British Society of Gastroenterology, the British Society of Gastrointestinal and Abdominal Radiology, the Renal Association, the Royal College of Radiologists, and the Royal College of Surgeons have issued consensus guidelines for the prescription and administration of oral bowel-cleansing agents. These guidelines address the issue of clinical assessment and potential risks of harm through inappropriate use raised in the National Patient Safety Agency (NPSA) alert in February 2009 (see our news item 2009-03-24). Please see the link below for the full guidelines.
FAQ on non-medical prescribing
19th November 2009
The UK National Prescribing Centre (NPC) has put together a collection of Frequently Asked Questions (FAQs) on non-medical prescribing which have been developed as a result of queries received by the NPC. The answers have been reviewed by the NPC and the Department of Health. Please see link to the NPC website below.
FDA warnings of severe tissue injury with promethazine
19th November 2009
The US Food and Drug Administration has recently notified healthcare professionals that a boxed warning is being added to the prescribing information for promethazine hydrochloride products describing the risks of severe tissue injury, including gangrene requiring amputation, following intravenous administration of promethazine. The boxed warning will remind practitioners that due to the risks of intravenous injection, the preferred route of administration is deep intramuscular injection and that subcutaneous injection is contraindicated. For further information and guidance for healthcare professionals on the use of promethazine, see the FDA link below.
Intranasal fentanyl launched in the UK
17th November 2009
Intranasal Fentanyl (Instanyl, Nycomed 0800 633 5797) has been launched in the UK for the management of breakthrough pain in adults already receiving maintenance opioid therapy for chronic cancer pain. It is contra-indicated for opioid naive patients.
Breakthrough pain (BTP) is described as a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain.
Maintenance opioid therapy is described as those who are taking at least 60mg of oral morphine daily, 25microgram of transdermal Fentanyl/h, 30mg of oral oxycodone daily, 8mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.
The dose of Instanyl is independent of the daily opioid maintenance dose and must be individually titrated starting from 50microgram. The maximum daily dose is the treatment of four BTP episodes/day, each with no more than two doses separated by at least 10min, with at least 4h before treating another BTP episode.
See the SPC below for further details.
The nasal spray is available as 50microgram/dose, 100microgram/dose and 200microgram/dose of fentanyl and costs £59.50 per 1.8mL bottle (10 doses) or £119 per 2.9mL bottle (20 doses). The product has recently been approved by the Scottish medicines Consortium (SMC).
MHRA drug safety advice on mixing medicines in clinical practice
5th November 2009
The latest publication of Drug Safety Update from the UK Medicines and Healthcare products Regulatory Agency (MHRA) contains an update on mixing medicines in clinical practice.
The MHRA plan to implement the necessary legislative amendments that are needed to support the recommendations agreed with ministers earlier this year (see our article 2009-07-07) in November 2009.
The agreed recommendations were;
• Doctors and dentists (who can already mix medicines themselves) should be able to direct others to mix
• Non-medical prescribers should be able to mix medicines and be able to direct others to mix
• Nurse and pharmacist independent prescribers should be allowed to prescribe unlicensed medicines for their patients
• The MHRA should approach the Home Office and the Advisory Council for the Misuse of Drugs (ACMD) with CHM's recommendations that corresponding amendments are made to the Misuse of Drugs Regulations for controlled drugs
• Guidance should be developed for those involved in the mixing of medicines
• Research should be commissioned to develop authoritative national advice on mixing of medicines.
The full article can be downloaded from the MHRA website link below.
EMEA confirms previous recommendation of withdrawal of oral dextropropoxyphene medicines
5th November 2009
The European Medicines Agency has confirmed its previous recommendation to withdraw the marketing authorization for all non-parenteral formulations of dextropropoxyphene containing medicines because their risks, particularly the risk of potentially fatal overdose, are greater than their benefits. However, for the parenteral formulation, the committee concluded that the marketing authorizations should not be withdrawn but suspended until further clinical data are available which may support the re-introduction of this formulation onto the market. Further information is available from a Q&A link below.
NPSA rapid response report for oxygen safety
5th November 2009
The UK National Patient Safety Agency (NPSA) has produced a rapid response report for NHS organisations across England and Wales to minimise the risks of oxygen therapy in hospitals. Deadline for action complete is 2010-03-29.
MHRA drug safety advice on bisphosphonates and osteonecrosis of the jaw
4th November 2009
The latest publication of Drug Safety Update from the UK Medicines and Healthcare products Regulatory Agency (MHRA) contains information and guidance for healthcare professionals on bisphosphonates and osteonecrosis of the jaw.
They summarize that the risk of osteonecrosis of the jaw is greater for patients receiving intravenous bisphosphonates for cancer than for patients receiving oral bisphosphonates for osteoporosis or Paget's disease. All patients with cancer should have a dental check-up before bisphosphonate treatment. During treatment patients should be encouraged to maintain good oral hygiene, receive routine dental check-ups and report any oral symptoms.
The full article can be downloaded from the MHRA website link below.
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