Selected items from the News and Latest Additions sections of www.palliativedrugs.com, the world’s leading palliative care website.
Safety updates
EMA restricts metoclopramide dose and duration of use
The European Medicines Agency (EMA) recommended changes to the dose and duration of use of metoclopramide in adults and children in July 2013, following a review. They recommend several changes to the authorized indications including restricting metoclopramide to short-term use (up to 5 days) with a maximum dose in adults of 10mg t.d.s. and significant restrictions for use in children. The full list of recommendations can be found from the link below. For more information, click here.
There has been discussion on our bulletin board about the impact of this decision on palliative care patients including a posting of a statement from the EMA regarding use in palliative care situations. In addition, the EMA announced in September 2013 that it will re-examine the recommendations following a request from a marketing authorisation holder and issue a final opinion. For more information, click here.
Oral ketoconazole contra-indicated for fungal infections
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has stated that oral ketoconazole-containing products should no longer be prescribed for fungal infections as the risk of liver injury outweighs the benefits. This follows reported cases of hepatitis, cirrhosis and liver failure at the recommended daily dose of 200mg occurring sometimes less than 1month after starting treatment.
Topical ketoconazole formulations (creams, ointments, and shampoos) have very low systemic absorption and may continue to be used as currently approved.
The European Commission is considering suspending all licenses for oral ketoconazole. However, arrangements are being put in place to ensure patients with Cushing’s syndrome using oral ketoconazole off-label will continue to have access to this product. For more information, click here.
FDA alert; risk of rare but serious skin reactions with paracetamol (acetaminophen)
Following a review of the FDA adverse event reporting system database and medical literature, the US Food and Drug Administration (FDA) has warned health professionals about the rare risk of severe skin reactions, e.g. Stevens Johnson Syndrome, toxic epidermal necrolysis and acute generalized exanthematous pustulosis, with paracetamol (acetaminophen). Warnings will also be added to the product label. For more information, click here.
Nitrofurantoin reminder of precautions for use in renal impairment
The UK MHRA is reminding health professionals that nitrofurantoin should not be used in patients with a renal creatinine clearance of <60mL/min, as treatment failure may occur due to insufficient drug being secreted into the urinary tract. The renal status of patients, particularly the elderly, should be checked before treatment. For more information, click here.
Hot topics
National alliance formed to respond the LCP review
A new Leadership Alliance for the Care of the Dying has been formed by NHS England in response to the independent review of the Liverpool Care Pathway (LCP). Many key organizations have already joined. The alliance will take forward the information from the LCP review and respond at a strategic and system-wide level. For more information, click here.
MHRA consultation on diclofenac as a Pharmacy medicine
The UK MHRA is consulting on the continued availability of diclofenac as a Pharmacy (P) medicine, as a result of the EU review on the cardiovascular risks of NSAIDs. The consultation closes on 28th October 2013.
CQC annual report: safer management of controlled drugs
The UK Care Quality Commission (CQC) has published their 2012 annual report on the safer management of controlled drugs.
Oral morphine Cochrane review
An updated version of the Cochrane review on oral morphine for cancer pain (CD003868.pub3), first published in 2003, is now available.
Drug updates
Etamsylate tablets discontinued in UK
Etamsylate 500mg tablets (Dicynene; Sanofi-Aventis) have been discontinued in the UK for commercial reasons, there is no alternative UK product available.
Etamyslate 500mg tablets are available via IDIS 01932 824000 (Dicynone; a French product) as an unauthorized UK product. They are considerably more expensive than the original UK tablets i.e. pack of 20 tablets = £23 approximately compared with the previous price of 100 tablets for £8.44.
Risperidone SPC updated
The Summary of Product Characteristics (SPC) for risperidone has been updated to include the warning of the risk of leukopenia, neutropenia and agranulocytosis which has been classified as occurring very rarely (<1/10,000 patients) following post-marketing surveillance. For more information see the SPC.
Granisetron transdermal patches launched in UK
Granisetron transdermal patches 3.1mg/24h (Sancuso; ProStrakan) have been launched in the UK. They are indicated for adults for the prevention of nausea and vomiting associated with moderately or highly emetogenic chemotherapy, for a planned duration of 3 to 5 consecutive days, where oral anti-emetic administration is complicated by factors making swallowing difficult. A single transdermal patch should be applied 24−48h before chemotherapy and removed a minimum of 24h after completion. The patch can be worn for up to 7 days depending on the duration of the chemotherapy regimen. For more information see the SPC.
Latest additions
PCF updated monographs
The online Palliative Care Formulary (PCF) is being continually updated. The following monographs have been updated during August 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:
Chapter 2: Antifibrinolytics and haemostatics
Chapter 5: NSAIDs
Chapter 5: Celecoxib
Chapter 5: Diclofenac
Chapter 5: Flurbiprofen
Chapter 5: Ibuprofen
Chapter 5: Ketorolac
Chapter 5: Naproxen
Chapter 5: Nabumetone
Chapter 7: Drugs for diabetes
In addition minor updates have been made to the following monographs:
Chapter 2: Anticoagulants new information, new box and references
Chapter 2: Etamsylate supply updated
Chapter 5: Codeine pharmacology updated and a new reference inserted.
For a full list of all the monographs updated since the publication of PCF4, click here.
Prepared by Sarah Charlesworth and Andrew Wilcock