NPSA Rapid Response Report on spinal connectors
29th December 2011
The UK National Patient Safety Agency (NPSA) have issued a Rapid Response Report on minimising risks of mismatching spinal, epidural and regional devices with incompatible connectors (NPSA/2011/RRR03). NPSA have quoted a recent patient safety incident, where a spinal needle with a neuraxial connector was supplied and used in error when a device with a Luer connector was required. The labelling and packaging of the two devices with Luer and neuraxial connectors, from the same manufacturer, looked very similar in their appearance.
Spinal, epidural and regional devices, with non-Luer compatible neuraxial connectors, that will not connect with intravenous equipment, are being placed on the market by industry in response to the NPSA Patient Safety Alert issued in 2009 (NPSA/2009/PSA004A) and updated in January 2011 (NPSA/2011/PSA001). Although the use of these devices will reduce the risks of wrong route errors, it is essential that effective controls are in place to minimise the risk of mis-selection and supply of devices with incompatible connectors that could cause delay in clinical procedures and harm patients.
The RRR provides additional guidance to the original patient safety alert, on minimising the risk of mis-selecting incompatible connectors, with a deadline for action complete of 31 March 2012.
Update: anti-epileptics monograph
29th December 2011
The anti-epileptics monograph has been updated and published in the Journal of Pain and Symptom Management (JPSM) as a therapeutic review.
Howard P et al (2011) Therapeutic Reviews: Anti-epileptic drugs. Journal of Pain and Symptom Management. 42: 788-804.
This is the 8th therapeutic review in a series in the JPSM. Previous featured monographs include octreotide (July 2010), propofol (September 2010), psychostimulants (November 2010), thalidomide (January 2011), ketamine (March 2011), antipsychotics (May 2011) and loperamide (August 2011). All of these articles are based on those featured in PCF4.
NPC review m/r oxycodone/naloxone
22nd December 2011
The NHS National Prescribing Centre (NPC) has published a MeReC rapid review of modified release oxycodone/naloxone in cancer pain discussing the results of a published 4 week clinical trial.
Prednisolone e/c blister packs recalled from Teva
16th December 2011
MHRA has issued a drug recall for all remaining stock in hospitals, clinics, pharmacies and wholesalers of prednisolone 2.5mg and 5mg e/c tablets in blister packs of the batches listed below from Teva UK.
Elevated levels of related substances have been detected early in the shelf-life during routine stability testing. Only blister packs are affected;
Prednisolone 2.5mg Batch 69894 Expiry Dec 2013.
Prednisolone 5mg Batch 80077 Expiry Jan 2014.
Prednisolone 5mg Batch 80057 Expiry Jan 2014.
Prednisolone 5mg Batch 69896 Expiry Feb 2014.
Citalopram and escitalopram maximum daily doses restricted
15th December 2011
Restrictions on the maximum daily doses of citalopram and escitalopram have been made following the evaluation of a QT study by the UK Medicines and Healthcare products Regulatory Agency (MHRA). The study showed dose-dependent QT interval prolongation with citalopram and escitalopram, and post-marketing reports of prolonged QT interval have also been received. A similar decision was taken by the US Food and Drug Administration last year (see our news item 25-08-11).
The maximum daily dose of citalopram should be restricted to 40mg (20mg in the elderly or those with hepatic impairment).
The maximum daily dose of escitalopram for adults <65 years remains 20mg daily, however in adults >65 years, the dose has been reduced to 10mg daily.
Citalopram and escitalopram are contra-indicated in patients with known QT interval prolongation or congenital long QT syndrome and in conjunction with other products known to prolong the QT interval. These include;
- class IA and III antiarrhythmics (eg, amiodarone, dronedarone, quinidine)
- antipsychotics (eg, fentiazine derviatives, pimozide, haloperidol)
- tricyclic antidepressants
- some antimicrobial agents (eg, sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, antimalaria treatment - particularly halofantrine)
- some antihistamines (astemizole, mizolastine)
- some antiretrovirals (eg, ritonavir, saquinavir, lopinavir).
Caution is advised in patients with underlying heart conditions and those who are predisposed to low serum levels of potassium and magnesium.
Doses of citalopram and escitalopram may also need to be reduced if used in conjunction with drugs that increase their plasma levels e.g. some antiretrovirals, omeprazole and cimetidine.
Extemporaneous thalidomide oral suspension stability study
15th December 2011
A stability study of thalidomide oral suspension 20mg/mL, using the contents of oral thalidomide capsules and a 1:1 mixture of Ora-Plus and Ora-Sweet, has been published. The HPLC method demonstrated stability for at least 35days when stored in amber plastic bottles under refrigeration.
Reminder about fentanyl patches and heat sources
12th December 2011
The Royal Pharmaceutical Society has issued a reminder about counselling patients regarding avoiding heat sources when using fentanyl patches. This follows reports in the press about the dangers of using them in the bath, with one reported fatality.
Patients using fentanyl patches should avoid heat sources such as hot water bottles, heat patches, electric blankets, heat lamps, hot whirlpool spa baths and prolonged hot baths, as an increase in temperature could increase the release-rate of fentanyl from the patch. This information is contained in the patient information leaflet.
This advice is echoed in our Quick Practice Guide: Use of transdermal fentanyl patches. PCF further advises that patients may shower but should not soak in a hot bath.
NICE consults on draft recommendations on the use of opioids in palliative care
8th December 2011
The UK National Institute for health and Clinical Excellence (NICE) is consulting on draft recommendations for the use of opioids in palliative care. Comments should be made using the standard proforma via registered stakeholders. The consultation period closes on 06-01-12. Full details, including the consultation document and a list of stakeholders are available below.
Draft specialist palliative care measures consultation
8th December 2011
A draft version of the specialist palliative care measures for inclusion in the Manual for Cancer Services has been issued by the UK Department of Health for a 12 week consultation period. It is aimed at interested stakeholders only and ends 27 February 2012.
- Die September/Oktober Ausgabe des APM Newsletter ist fertig
- Neuropathic pain guidelines published
- MHRA guidance on switching between different manufacturer’s products of anti-epileptic drugs
- Fentanyl buccal film launched in UK
- Oral ketoconazole tablets discontinued in UK
- SMC accepts orodispersible ondansetron
- Strong Opioid Identification Booklet now available!
- Diamorphine nasal spray launched in UK
- FDA approves first hydrocodone m/r capsule
- Consultation on end of life care guidance