New generic buprenorphine sublingual tablets
23rd February 2012
A branded generic of buprenorphine 200microgram and 400microgram sublingual tablets (Tephine, Sandoz) has been launched in the UK. They are indicated as a strong analgesic for the relief of severe pain and are bioequivalent to Temgesic (RB Pharmaceuticals). The NHS cost of 50 tablets is £5 and £10 for the 200microgram and 400microgram strengths respectively.
Generic buprenorphine 400microgram, 2mg and 8mg sublingual tablets are already available but are indicated for substitution treatment for opioid dependence. Sandoz have also launched a branded generic in these strengths (Prefibin, Sandoz).
FDA approve a shared REMS for all transmucosal fentanyl products
20th February 2012
The US Food and Drug Administration (FDA) have approved a shared Risk Evaluation and Mitigation Strategy (REMS) for all Transmucosal Immediate Release Fentanyl (TIRF) products. This shared program has been designed to streamline the REMS process and will allow prescribers and pharmacists to enrol in one shared REMS system for all TIRF products. The branded fentanyl products currently included are; Abstral (sublingual tablet), Actiq (lozenge), Fentora (buccal tablet), Lazanda (nasal spray), Onsolis (buccal soluble film) and Subsys (sublingual spray), the website will be available in March 2012.
FDA approve a fentanyl sublingual spray
20th February 2012
The US Food and Drug Administration have approved a novel fentanyl single-dose sublingual spray (Subsys, Insys therapeutics, Phoenix, Arizona), indicated for treatment of breakthrough cancer pain in adult patients who are already receiving opioids for persistent cancer pain. The product is due to be launched shortly and will be available in individual, disposable spray units of 100microgram, 200microgram, 400microgram, 600microgram, and 800microgram strengths.
This product will come under the newly approved shared Risk Evaluation and Mitigation Strategy (REMS) for Transmucosal Immediate Release Fentanyl (TIRF) products (see our news item 20-02-12).
SMC accepts midazolam 5mg/mL oromucosal solution
16th February 2012
The Scottish Medicines Consortium (SMC) has accepted midazolam 5mg/mL oromucosal solution (Buccolam®, Viropharma) for use within NHS Scotland for the treatment of prolonged, acute, convulsive seizures in children (3months to <18years).
NPC reports on safe management of controlled drugs
16th February 2012
The UK National Prescribing Centre (NPC) has published three final reports regarding the safe management and use of controlled drugs in England; in prison, in the ambulance and paramedic services and private prescribing and requisitioning.
Epistatus liquid - temporary change to syringe size
14th February 2012
The oral syringe supplied with the unlicensed midazolam buccal liquid 10mg/mL, 5mL bottle (Epistatus) has temporarily changed in size from 1mL to 1.5mL. This modification was made in order to allow measurement of an adult dose of midazolam up to 15mg. However, in response to customer feedback the manufacturer (Special Products Ltd) has reverted back to the 1mL syringe size.
The new 1mL syringes will have a non-luer tip, in order to ensure full compliance with the National Patient Safety Agency (NPSA) 2007 guidelines "Promoting safer measurement and administration of liquid medicines via oral and other enteral routes".
Extra care should be taken when measuring and patients should be made aware that the syringe size supplied may vary.
10th February 2012
Leading organisations in the UK and around the world are supporting the morphine manifesto, which calls for an end to the unethical practice of promoting access to expensive opioid analgesics without also making low cost immediate release oral morphine available. The manifesto is appealing to governments, healthcare institutions, and the pharmaceutical industry to assure the accessibility of immediate release morphine to patients in need at a cost that the individual and community can afford. For more information and to sign the manifesto see below.
EAPC guidelines on the use of opioid analgesics for cancer pain
9th February 2012
An updated version of the guidelines of the European Association for Palliative Care (EAPC) on the use of opioids for the treatment of cancer pain has been published. The update was undertaken by the European Palliative Care Research Collaborative (EPCRC). The new guidelines were published in Lancet Oncology this month. The supporting evidence for the updated opioid guidelines consists of 17 systematic reviews that were published in a special issue of Palliative Medicine in July 2011. A patient friendly summary of the guidelines can be downloaded from the EPCRC website.
FDA safety communication on PPIs and clostridium difficile diarrhoea
9th February 2012
The US Food and Drug Administration has issued a safety communication stating that proton pump inhibitors (PPIs) may be associated with an increased risk of clostridium difficile associated diarrhoea.
Clonazepam oral solution - new licensed product
8th February 2012
Rosemont Pharmaceuticals (0800 919312) has launched Clonazepam 0.5mg/5mL and 2mg/5mL oral solutions in the UK. They are licensed for all clinical forms of epileptic disease and seizures in adults. The formulations are not indicated for paediatric use due to the presence of ethanol and should not be mixed with water. The NHS cost of 150mL bottle of 0.5mg/5mL and 2mg/5mL is £40 and £48 respectively.
MHRA consult on loperamide classification from P to GSL
7th February 2012
The UK Medicines and Healthcare products Regulation Agency (MHRA) are consulting on the reclassification of Imodium Instants (loperamide orodispersible tablets 2mg) 12 tablet pack from Pharmacy (P) to General Sales List (GSL) classification. Consultation closes 5 March 2012.
Revised patient guide on advance care planning
2nd February 2012
An updated version of the guide "Planning your future care" has been published by the National End of Life Care Programme, the University of Nottingham and the Dying Matters Coalition. This guide aims to explain advance care planning and the different options available to people when planning for their end of life care.
- Buprenorphine therapeutic review
- Cyclizine 50mg/mL injection supply problem in UK
- SIGN lung cancer guideline for consultation
- NICE evidence summary of oral desmopressin
- NICE changes its name
- Asilone discontinued in UK
- GMC publishes Good practice in prescribing and managing medicines and devices
- Aqueous cream may cause skin irritation
- Die Januar/Februar Ausgabe des APM Newsletter ist fertig
- Updated Controlled Drugs Regulations from 1st April 2013