11 Nov, 13 | by James Smallbone, Publishing Assistant
Selected items from the News and Latest Additions sections of www.palliativedrugs.com, the world’s leading palliative care website.
EMA confirms metoclopramide restrictions
The European Medicines Agency (EMA) has re-examined the recommended changes for metoclopramide in adults and children that it made in July 2013, following a request from one of the marketing authorization holders. It has concluded that the original advice for the use of medicines containing metoclopramide should be maintained. The following changes apply:
- metoclopramide is now only licensed for short-term use (up to 5 days). It is not licensed for use in chronic conditions such as gastroparesis, dyspepsia and gastro-oesophageal reflux disease, nor as an adjunct in surgical and radiological procedures
- in adults, metoclopramide remains licensed for prevention of post-operative nausea and vomiting (PONV), radiotherapy-induced nausea and vomiting and delayed (but not acute) chemotherapy-induced nausea and vomiting, and for symptomatic treatment of nausea and vomiting including that associated with acute migraine (where it may also be used to improve absorption of oral analgesics)
- in children, metoclopramide is only licensed as a second-line option for prevention of delayed chemotherapy-induced nausea and vomiting and treatment of established PONV. Use is contra-indicated in children under 1 year of age
- for adults and children the maximum dose is 0.5mg/kg/24h. In adults, the usual dose for all routes is 10mg up to 3 times daily. In children the recommended dose is 0.1 to 0.15mg/kg up to three times daily
- the following licensed products will be withdrawn from those countries where they are available; oral liquids containing more than 1mg/mL, intravenous formulations with concentrations above 5mg/mL and suppositories containing 20mg
- intravenous doses should be administered as a slow bolus over at least 3min to reduce the risk of adverse effects
- special care should be taken in patients likely to be at increased risk of cardiovascular undesirable effects, including the elderly, patients with cardiac conduction disturbances, uncorrected electrolyte imbalance or bradycardia, and those taking other drugs known to prolong QT interval.
Patients who are currently taking regular metoclopramide should have their treatment reviewed at a routine medical appointment. For more information, click here.
MHRA strengthened contra-indications for apixaban, and rivaroxaban
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has strengthened contra-indications for the new oral anticoagulants apixaban (Eliquis) and rivaroxaban (Xarelto) in line with those for dabigatran (Pradaxa) that were introduced in July 2012. All three new oral anticoagulants are now contra-indicated in patients with a lesion or condition that is considered a significant risk factor for major bleeding. Examples include; current or recent gastro-intestinal ulceration, cancer at high risk of bleeding, recent brain or spinal injury or surgery, recent ophthalmic surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformation, vascular aneurysms, or major intraspinal or intracerebral vascular abnormalities. They are also contra-indicated in combination with any other anticoagulants except when switching therapy or when unfractionated heparin is given at doses to maintain an open central arterial/venous catheter. Full details are available in the MHRA October 2013 Drug Safety Update. For more information, click here.
TD fentanyl Cochrane review
A Cochrane review on the use of transdermal fentanyl for cancer pain (CD010270.pub2) has been published.
CQC: safer use of controlled drugs guidance
The Care Quality Commission (CQC) has developed guidance in association with NHS England for health professionals handling controlled drugs. The guidance is published on the CQC website and is intended as supporting information to be read alongside the 2012 annual report on the safer management of controlled drugs which was published in August 2013. There are three sections; safer use of fentanyl and buprenorphine transdermal patches, safer use of oral oxycodone medicines and safer use of MS syringe drivers. All contain information on patient safety incidents reported and a checklist for safe use.
Clonazepam injection discontinued in UK
Roche has discontinued clonazepam 1mg/mL injection (Rivotril) in the UK due to on-going supply chain difficulties and low product demand, with immediate effect. Limited emergency stock may still be available via wholesalers. There is no other authorized (licensed) clonazepam injection in the UK. For more details, contact Roche medical information (0800 3281629).
We can confirm that discontinuation is just in the UK. The French and Swiss Rivotril are available via IDIS as an unauthorized (unlicensed) UK product. The price for a pack of 6 (6 x 1mL ampoule of solution and 6 x 1mL ampoule of solvent) is about £35, which is approximately 10 times the cost of the original UK product.
Buprenorphine 15microgram/h TD patch launched in US
A buprenorphine 15microgram/h transdermal patch (BuTrans, Purdue Pharma) is now available in the US. It is indicated for management of moderate to severe chronic pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. The transdermal patch is applied every 7 days and is an addition to the product range of 5, 10 and 20microgram/h transdermal patches already available. For more information, click here.
New suppository for chronic constipation launched in UK
A new type of laxative for chronic constipation has been launched in suppository form in the UK for adults and children. Lecicarbon A suppository (Aspire Pharma) contains (3-sn-Phosphatidyl)cholin = soybean oil, lecithines, as phosphatides. Small bubbles of carbon dioxide are formed when the suppository comes into contact with moisture in the rectum. Reflex bowel evacuation from the physical stimulation of the carbon dioxide occurs approximately 15–30min after insertion. It can also be used for bowel evacuation prior to surgical or diagnostic procedures. Use is contra-indicated in patients allergic to peanuts or soya. The NHS cost of a pack of 10 Lecicarbon A suppositories = £8.20. For more information, click here.
FDA approves a new oral diclofenac formulation
The US Food and Drug Administration (FDA) has approved a new oral diclofenac formulation (Zorvolex; Irko Pharmaceuticals) with altered absorption properties that allows patients to be treated with dosages 20% lower than currently available diclofenac oral formulations. The capsules are 18mg or 35mg and are recommended up to three times a day. They are not interchangeable with other formulations of diclofenac. Full prescribing information can be found on the FDA website.
Oxybutynin elixir re-introduced to UK
Oxybutynin elixir 2.5mg/5mL (Ditropan; Sanofi) has been re-introduced to the UK as a licensed product. The NHS cost of 150mL bottle is about £7, which is approximately the same price as before it was discontinued.
Note: oxybutynin oral solution 5mg/5mL (unlicensed product) will no longer be reimbursed under part VIIIb of the specials tariff unless the prescription specifically states “unlicensed special”. For more information, click here.
PCF updated monographs
The online Palliative Care Formulary (PCF) is being continually updated. The following monographs have been updated during October 2013 and supersede those in the publication of the 4th edition of the Palliative Care formulary (PCF4). They can be accessed from the formulary section of the website:
For a full list of all the monographs updated since the publication of PCF4, click here.
Prepared by Sarah Charlesworth and Andrew Wilcock