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News and updates from palliativedrugs.com
  1. Andrew Wilcock1 and
  2. Sarah Charlesworth2
  1. 1Department of Palliative Medicine, University of Nottingham, Nottingham, UK
  2. 2palliativedrugs.com, Hayward House Study Centre, Nottingham, UK
  1. Correspondence to Andrew Wilcock, Department of Palliative Medicine, University of Nottingham, Hayward House, Nottingham University Hospitals NHS Trust, Nottingham NG5 1PB, UK; andrew.wilcock{at}nottingham.ac.uk

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www.palliativedrugs.com has provided essential independent information about drugs used in palliative and hospice care for over a decade. It contains the online Palliative Care Formulary, and provides free access to a Bulletin Board to stimulate questions and share experiences, a Document Library containing 475 items of useful information and a Syringe Driver Survey Database containing details of over 2350 different drug combinations. Territory-specific book versions (the UK Palliative Care Formulary, fourth edition, Hospice and Palliative Care Formulary USA, second edition and Palliative Care Formulary Canadian edition) and an ebook PDF version of the Palliative Care Formulary (PCF) can also be purchased via the website. This feature provides a selection of items which have featured in the News and Latest Additions sections in recent months; for additional information please register for free on the website.

Safety updates

Carbamazepine, oxcarbazepine and eslicarbazepine risk of serious skin reactions

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has highlighted the risk of serious skin reactions, including Stevens-Johnson syndrome, with carbamazepine, oxcarbazepine and eslicarbazepine in patients with European descent or Japanese origin who have the HLA-A*3101 genetic marker. The risk of serious skin reactions with these drugs is already known to be associated with patients of Asian origin who have the genetic marker HLA-B*1502, and screening is recommended for patients of Han Chinese or Thai origin before treatment with these drugs.

There are currently insufficient data to support screening for the HLA-A*3101 genetic marker before treatment. Current advice is that patients of European descent or Japanese origin who are known to have the genetic marker HLA-A*3101 should only receive carbamazepine, oxcarbazepine or eslicarbazepine after careful consideration of the benefits and risks.

Routine hepatic monitoring recommended for lenalidomide

The UK MHRA now recommends routine monitoring of hepatic function at baseline, every week for the first 8 weeks and then monthly, for patients being treated with lenalidomide (Revlimid; Celgene, Uxbridge, UK). This follows reports of elevations of hepatic enzymes occurring in up to 10% of patients treated with lenalidomide for multiple myeloma in clinical trials. This is mostly without serious consequence and resolves when lenalidomide is stopped, at which point reintroduction of lenalidomide at a lower dose can be considered. However, in <1% of treated patients, acute hepatic failure, toxic hepatitis, hepatocellular hepatitis and cholestatic hepatitis have been reported.

Because lenalidomide is excreted predominantly renally, the dose should be adjusted in patients with renal impairment to avoid high plasma levels which may increase the risk of severe hepatotoxicity, as well as haematological undesirable effects.

Denosumab rare cases of atypical femoral fracture with long-term use

The UK MHRA have reported rare cases of atypical femoral fracture in patients receiving denosumab 60mg (Prolia; Amgen, Cambridge, UK) for postmenopausal osteoporosis for >2.5 years. They advise during denosumab treatment:

  • patients should report new or unusual thigh, hip or groin pain which should be evaluated for an incomplete femoral fracture; these may occur with little/no trauma in the subtrochanteric and diaphyseal regions of the femur

  • the contralateral femur should be examined carefully, as atypical femoral fractures are often bilateral

  • consider discontinuing treatment while the patient is evaluated; benefits and risks should be assessed on an individual basis.

Hot topics

Haloperidol for psychosis-induced aggression or agitation

A Cochrane review has been published on the use of haloperidol for rapid tranquilisation of psychosis-induced aggression or agitation. In summary, higher-grade evidence exists for the use of haloperidol together with the sedative antihistamine promethazine than for the use of haloperidol alone. Generally, there is insufficient ‘real world’ evidence regarding the use of alternative antipsychotics, to suggest that newer generation antipsychotics are any better than older drugs, or that adding a benzodiazepine to haloperidol is of benefit.

British National Formulary palliative care section updated

The online British National Formulary palliative care section has been updated. There have been changes in particular to the pain management with opioids section and the information on equivalent doses of opioid analgesics, including a new buprenorphine table and an updated fentanyl patch conversion table.

Guide on advance decisions to refuse treatment

The UK National Council for Palliative Care and the National Health Service (NHS) National End of Life Care Programme have produced a guide for health professionals on Advance Decisions to Refuse Treatment. This guide supersedes the 2008 version.

Updated Controlled Drugs Regulations (Supervision of Management and Use) from 1 April 2013

Controlled Drugs (Supervision of Management and Use) Regulations 2013 (SI2103/373) for England and Scotland come into force on 1 April 2013. These deal with governance arrangements, in particular the role and functions of Controlled Drugs Accountable Officers, and also reflect the new architecture for the NHS in England from April 2013. These regulations supersede the Controlled Drugs (Supervision of Management and Use) Regulations 2006 which came into force in 2007, and follow a consultation process by the Department of Health in September 2012. The Department of Health has published information about the 2013 Regulations, along with the official Regulations 2013 and the summary of consultation responses.

Drug updates

Glycopyrronium bromide inhaler launched in UK

A glycopyrronium bromide hard capsule powder inhaler (Seebri Breezhaler, Novartis, UK) has been launched as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease. The recommended dose is 50 μg once daily. The NHS cost of an inhaler plus 30 capsules is £28. The Scottish Medicines Consortium (SMC) has accepted Seebri Breezhaler for use within NHS Scotland. The National Institute for Health and Clinical Effectiveness (NICE) has produced a new medicine evidence summary for this product.

NICE evidence summary of oral magnesium glycerophosphate use

NICE has published its evidence summary (ESUOM4) for the use of unauthorised (unlicensed) oral magnesium glycerophosphate for preventing recurrent hypomagnesaemia.

Two strengths of insulin now available in UK

Insulin degludec (Tresiba; Novo Nordisk, UK) has been launched in two strengths as 100 units/ml and 200 units/ml. The 200 units/ml is higher than any other strength in the UK. Both are available as prefilled pen devices with distinct labelling to differentiate between the two strengths. Both devices have a dose counter window and deliver the dose in units, regardless of the strength, thus patients do not have to calculate the change in volume if swapping from one strength to another.

Oxymorphone new crush resistant strengths in USA

Oxymorphone modified release, crush resistant tablets (Opana ER; Endo pharmaceuticals, USA) are now available in 7.5 mg  and 15 mg strengths joining the rest of the strength range (5, 10, 20, 30 and 40 mg).

SMC accepts palonosetron capsules

The SMC has accepted palonosetron 500 μg soft capsules (Aloxi; Sinclair IS Pharma, UK) for use within NHS Scotland for the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy in adults. The soft capsule formulation has been shown to be clinically non-inferior to the intravenous formulation and is cost neutral. SMC has previously accepted palonosetron intravenous injection for the same indication.

Latest additions

PDF version of PCF4+

An ebook PDF version containing the latest content of the online PCF as of September 2012 (designated PCF4+) is available to purchase and download from the website. PCF4+ contains 17 updated monographs and 1 appendix, which supersede the printed PCF4 version. We anticipate publishing a PDF version annually, with the fifth edition of the book (PCF5) in 2014.

PCF monographs updated

The PCF is being continually updated online. The following monographs have been updated during December 2012 and January 2013 and the website versions supersede the printed PCF fourth edition book versions: Chapter 1: Proton pump inhibitors and H2-receptor antagonists; Chapter 5: Opioid antagonists and Naltrexone; Chapter 7: Desmopressin; Chapter 11: Mouthwashes. A full list of all the monographs updated since the publication of PCF4 can be found on the www.palliativedrugs.com website.

  • Received 20 March 2013.
  • Accepted 20 March 2013.
View Abstract

Footnotes

  • Competing interests None.

  • Provenance and peer review Not commissioned; internally peer reviewed.

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