NPSA rapid response report on syringe drivers

In response to over 160 error reports and 8 deaths in the past 5 years, the NPSA has issued a rapid response report on the safer use of ambulatory syringe drivers. Errors were more likely in older drivers with rate settings measured in terms of the length of syringe plunger travel. All organisations in the NHS and independent sector must develop an action plan to ensure that all ambulatory syringe drivers comply with specific safety features within a maximum of 5 years.

NPSA safer spinal (intrathecal), epidural and regional devices

This two-part patient safety alert update supersedes NPSA/2009/PSA004A issued in November 2009. In summary, part A requires that by April 2012 all spinal (intrathecal) bolus doses and lumbar puncture samples should be performed using syringes, needles and other devices with connectors that cannot also connect with intravenous equipment. Part B requires that by April 2013 all epidural, spinal (intrathecal) and regional anaesthesia infusions and bolus doses should be performed using devices with connectors that will not also connect with intravenous equipment.

NPSA publishes risk assessment guide for venous thromboembolism

This ‘How to’ guide is aimed at supporting the implementation of venous thromboembolism risk assessment for all patients admitted to hospital. It builds on existing resources already available and can be used to support the implementation of National Institute for Health and Clinical Excellence (NICE) Quality Standards Programme, Commissioning for Quality and Innovation requirements and NICE Guideline 92.

European Medicines Agency (EMEA) completes review of potential interaction between alcohol and opioid modified-release mechanisms

This review was undertaken following reports of the risk of alcohol dissolving the modified-release coating leading to a more rapid release of a drug than intended. The conclusions are that for the majority of modified-release products the risk is minor but that the summary of product characteristics (SPC) and patient information leaflet across the whole class should be updated with consistent warnings that the concomitant use of alcohol with opioids may enhance the pharmacodynamic effect and should be avoided.

However, for modified-release drugs that use a ‘polymethacrylate–triethylcitrate controlled release system’, the EMEA concluded that the marketing authorisations should be suspended until formulations that are more stable in alcohol are produced. The affected product appears to be Ethirfin (morphine sulphate, prolonged-release capsules, 20, 60, 120 and 200 mg), previously available in Denmark.

Lenalidomide: UK Medicines and Healthcare products Regulatory Agency safety warning

Lenalidomide (Revlimid; Celgene) is authorised in combination with dexamethasone for multiple myeloma in patients who have received at least one previous treatment. However, evidence from clinical trials and case reports suggest that lenalidomide further increases the already elevated risk of venous and arterial thromboembolism in these patients, including myocardial infarction and cerebrovascular accident. The SPC has been amended accordingly.

US Food and Drug Administration (FDA) limits the amount of acetaminophen (paracetamol) to 325 mg per dosage unit

The US FDA has asked manufacturers to reformulate prescription products containing acetaminophen (paracetamol) so that a single dosage unit contains a maximum of 325 mg acetaminophen. This includes combination products of acetaminophen and opioids. Dosage recommendations will not change and the maximum dose remains 4 g/day.

US FDA announces risk evaluation and mitigation strategy for modified-release opioids

The US FDA has published its risk evaluation and mitigation strategy for all modified-release opioid drugs, which aims to reduce their inappropriate prescribing, misuse and abuse. Manufacturers are required to develop an educational programme for prescribers and patients.

Clarifying dexamethasone prescribing

The British National Formulary now recommends prescribing of dexamethasone injection as dexamethasone base. This follows recent changes to the labelling of both UK dexamethasone injection products (Organon product, 2003, and Hospira product, June 2010) in line with guidance from the UK Medicines and Healthcare products Regulatory Agency and NPSA. In order to clarify the label changes and highlight the potential for confusion when swapping between products, www.palliativedrugs.com has produced a fact sheet that can be downloaded from the website.

UK national shortage of lorazepam 4 mg/ml injection

An unexpected manufacturing issue has left lorazepam injection 4 mg/ml (Ativan; Pfizer) in short supply in the UK, which is not expected to be resolved until late 2011.

Actiq SPC updated

The UK SPC for Actiq (oromucosal fentanyl lozenge; Flynn Pharma) has been amended to include additional information on measures to prevent a potential overdose and to further clarify the dosage during titration, maintenance therapy and dose readjustment.

Oramorph SPC updated

The UK SPC for Oramorph oral solution 10 mg/5 ml (morphine sulphate; Boehringer Ingelheim) has been updated to include a specific section for paediatric patients and new information for children 13–18 years old. Further information has also been added on excipients, including the amount of ethanol (alcohol; ie, 10 vol%).

EMEA grants a marketing authorisation for generic ibandronic acid

The EMEA has granted a marketing authorisation for generic ibandronic acid (Ibandronic Acid Teva) for the prevention of skeletal events in patients with breast cancer and bone metastases (50 mg tablets) and for the treatment of osteoporosis in postmenopausal women at risk of developing fractures (150 mg tablets). The EMEA has also granted a marketing authorisation for generic ibandronic acid (Lasibon) for the prevention of skeletal events in patients with breast cancer and bone metastases (tablets and infusion), and for the treatment of tumour-induced hypercalcaemia with or without metastases (infusion).

Rosiglitazone no longer available in UK

Further to the suspension of its licence, the two preparations containing rosiglitazone (Avandia and Avandamet; GSK) have been withdrawn from the UK.