13 Aug, 14 | 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.
Class 2 Medicines Recall: Midazolam buccal liquid 10mg/mL (unauthorized)
The UK MHRA has issued a class 2 medicines recall (action within 48h) for specific batches of Midazolam buccal liquid 10mg/mL, 5mL (unauthorized product manufactured under a Specials Licence by Penn Pharma, distributed in Quantum Pharmaceutical livery). The screw caps on some units have not been correctly placed during manufacture, which may result in evaporation of the aqueous component of the product and thus an increase in the concentration of midazolam. For more information, click here.
Class 2 Medicines Recall: Buccolam (midazolam) oromucosal solutions
The UK MHRA has issued a class 2 medicines recall (action within 48h) for specific batches of Buccolam (midazolam) oromucosal solution 2.5mg, 5mg, 7.5mg and 10mg (ViroPharma SPRL). This is following a routine inspection of the company’s contract manufacturing site in the UK. The inspection identified the possibility for chemical contamination. No evidence of contamination has been identified within Buccolam oromucosal solution on the market. Replacement stocks of Buccolam are available. For full information, including affected batch numbers, click here.
New drug driving offence – Department for Transport guidance
The UK Government Department for Transport has produced guidance for health professionals on the new drug driving offence; driving in excess of specified levels of certain controlled drugs in the body. This offence, which is in addition to the existing rules on drug impaired driving and fitness to drive, is expected to come into force on 2 March 2015 (see our previous news items 07 January 2014 and 08 August 2013). For more information, click here.
The following Cochrane reviews have been published in full on-line:
- low molecular weight heparin versus unfractionated heparin for perioperative thromboprophylaxis in patients with cancer (CD009227)
- oxycodone for neuropathic pain and fibromyalgia in adults (CD010692).
BNF changes to haloperidol maximum dose
In May 2014, the BNF changed the PO dosing schedule of haloperidol for the treatment of schizophrenia, mania and psychoses, and reduced the maximum recommended PO dose to 20mg/day in divided doses. This was in line with changes in the Haldol SPC (Janssen) that were made in line with recent studies that used lower doses of antipyschotics due to the known risk of QT prolongation and other adverse effects. The BNF has now also reduced the maximum IM dose from 20mg/day to 12mg/day in divided doses, based on a PO haloperidol bio-availability of about 60%. The BNF notes that some of the generic SPCs for both the PO and IM formulations are yet to be amended and have highlighted this inconsistency to the MHRA. Thus, they have noted that BNF doses may differ from the product literature. For more information, click here.
New fentanyl sublingual tablet launched in UK
A fentanyl sublingual tablet (Recivit; Grunenthal) has been launched in the UK for the treatment of breakthrough pain in adults who are already receiving maintenance opioid therapy for chronic cancer pain. The sublingual tablets are available as 133, 267, 400 and 533 and 800microgram and are not interchangeable with other forms of transmucosal fentanyl, i.e. the dose must be individually titrated for each patient. Each sublingual tablet costs £4.50. For the SPC, click here.
Tapentadol oral solution launched in UK
Tapentadol oral solution 20mg/mL (Palexia: Grunenthal) has been launched in the UK for the treatment of moderate to severe acute pain in adults which can be managed only with opioid analgesics. It is available in 100mL and 200mL packs and the cost of a 50mg (2.5mL) dose = £0.45, which is equivalent to the tablet formulation. The dose can be taken undiluted or diluted in water or any non-alcoholic cold drink and is also suitable for administration via enteral feeding tubes. For the SPC, click here.
New oxycodone m/r tablet launched in UK
An oxycodone 12h m/r tablet (Dolocodon® PR: Zentiva) has been launched in the UK for the treatment of severe pain which can be adequately managed only with opioid analgesics. The m/r tablets are available in 5, 10, 20 and 40mg and the cost of 28 days @ 10mg, 20mg, and 40mg b.d. = £25, £50, and £100 respectively. For the SPC, click here.
New oxycodone immediate-release generic capsule launched in UK
An oxycodone immediate-release capsule (Lynlor: Actavis) has been launched in the UK for the treatment of severe pain which can be adequately managed only with opioid analgesics. The immediate-release generic oxycodone capsules are available in 5, 10, and 20mg. For the SPC, click here.
Switching between morphine and hydromorphone – What conversion ratio do you use?
Results from our survey (March 2014 – June 2014).
PCF updated monographs
The following monographs of the on-line Palliative Care Formulary (PCF) have been updated during July 2014 and supersede those in the publication of the 4th edition of the Palliative Care formulary (PCF4) and PCF4+2013 epdf. They can be accessed from the formulary section of the website:
Chapter 27: Anaphylaxis
For a full list of all the monographs updated since the publication of PCF4, click here. Follow us on twitter @palliativedrugs for the latest updates.
Prepared by Sarah Charlesworth and Andrew Wilcock