EMEA approves denosumab for prevention of skeletal related events

30th August 2011

The European Medicines Agency (EMEA) has granted a marketing authorisation for denosumab (Xgeva, Amgen) for the prevention of skeletal related events in adults with bone metastases from solid tumours.

Xgeva is given once every four weeks as a single 120mg subcutaneous injection in the thigh, abdomen or upper arm.

Patients should take also take calcium 500mg and vitamin D 400 unit supplements.

Xgeva 120mg/1.7mL, 1 vial = £309.86 (reimbursement/discount arrangements available for certain hospitals).

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Extra Strength Tylenol maximum daily dosage reduced in US

30th August 2011

The maximum daily dosage of Extra Strength Tylenol (McNeil Consumer Health, US) which contains acetaminophen (paracetamol) 500mg/tablet, has been reduced to 3,000mg/day (6 tablets/day in divided doses). The product has not changed, the reduction has come in response to concerns about drug-induced liver injury.

The company plans to reduce the maximum daily dosage of regular strength Tylenol and other products containing acetaminophen (paracetamol) in 2012. It is unclear whether other US manufacturers of acetaminophen (paracetamol) will follow this same route of dosage reduction.

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MHRA patient level recall for all Nurofen Plus tablets

29th August 2011

MHRA have issued a Class 1 Patient Level Recall for all remaining unexpired stock of Nurofen Plus tablets in any pack size and any batch (Reckitt Benckiser 0500 455456). This follows the discovery of rogue blister strips of Seroquel XL 50mg tablets (AstraZeneca 0800 783 0033) and Neurontin 100mg capsules (Pfizer 01304 616161) within the Nurofen Plus cartons.

A Patient Level Recall means that wherever possible patients should be contacted and asked to return any Nurofen Plus tablets from where they were purchased or dispensed for a refund. More information and a copy of the MHRA alert are available from the link below.

Update 30-09-11

 Reckitt Benckiser has resumed production of Nurofen Plus, new packs can now be ordered from wholesalers.

The new packs (pack size 12, 16, 24, and 32) are individually wrapped in clear cellophane and have batch codes starting with 2 letters (NS) followed by 3 digits, e.g. NS123, so they can be easily distinguished from recalled stock.

The Class 1 Drug Alert recalling Nurofen Plus tablets containing rogue Seroquel XL 50mg tablets and Neurontin 100mg capsules issued on 26 August 2011  (see below) is still in place, and all remaining stock of unexpired Nurofen Plus should still be returned. Patients should be advised to bring back any old packs to the pharmacy.

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Consultation on the UK Misuse of Drugs Regulations

29th August 2011

The Home Office has issued a consultation document seeking views to consolidate and review specific provisions regarding controlled drugs under the Misuse of Drugs Regulations 2001. The suggested amendments are: 

• exempt designated bodies – hospices – and prisons from the requisition requirements under regulation 14
• include paramedics and operating department practitioners in the list of professions required to present a requisition in order to obtain controlled drugs under regulation 14(4)
• provide registered midwife ward managers with similar authorities to those currently applicable to senior registered nurses in charge of a ward
• make it mandatory for veterinary practitioners to include their Royal College of Veterinary Surgeon number on prescriptions for schedules 2 and 3 controlled drugs except temazepam
• remove the reference to the National Health Service (Scotland) Act 1978 from regulation 14(5)(b)
• clarify that regulation 15(3) – which enables a prescription for schedules 2 and 3 controlled drugs for the treatment of a patient in a hospital or care home to be written on the patient’s bed card – is not applicable to prisons
• extend the authorities currently applicable to senior registered nurses in charge of wards to senior registered nurses in charge of prison health centres.
• include prisons in the 2001 Regulations
• make midwife supply orders specific to a patient
• provide authority to enable ambulance trusts to possess and supply controlled drugs
• enable pharmacists to supply phenobarbital or phenobarbital sodium for the emergency treatment of epilepsy.

In addition:

• it is not proposed to introduce a legislative amendment making the use of a standardised requisition form by individual healthcare professionals mandatory at this time
• it is proposed not to make running balances for controlled drug registers a mandatory requirement at this time but to review the position in the light of further information.

The proposed changes to the Misuse of Drugs Regulations 2001 would have effect in England, Wales and Scotland. Northern Ireland has its own misuse of drugs regulations.

The closing date for responses is 28^th October 2011. Full details of the proposals and information about responding are available from the link below.

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FDA restrict citalopram maximum daily dose to 40mg

25th August 2011

The FDA has stated that the maximum daily dose of citalopram should be restricted to 40mg. This follows post-marketing reports of prolonged QT interval and an FDA evaluation of a QT study. The study showed dose-dependent QT interval prolongation with citalopram.

Patients with underlying heart conditions and those who are predisposed to low serum levels of potassium and magnesium are also at particular risk of QT interval prolongation. The FDA adds that studies have not shown a benefit in the treatment of depression at doses higher than 40mg per day, although the US drug label had stated that certain patients may require a dose of 60mg per day. In the UK the maximum daily dose is 60mg.

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FDA approves botulinum toxin A for urinary incontinence

25th August 2011

The FDA has approved botulinum toxin A injection (Botox) to treat urinary incontinence in people with neurological conditions such as spinal cord injury and multiple sclerosis who have an overactive bladder.

Botox is currently not approved for this indication in the UK.

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CQC annual report on safer management of controlled drugs

25th August 2011

The UK Care Quality Commission (CQC) has published its latest annual report into the safer management of controlled drugs, which includes recommendations on how chief executives and accountable officers could better aid the safer management of controlled drugs.

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NICE scope for opioids in palliative care published

25th August 2011

The UK National Institute for health and Clinical Excellence (NICE) has published the scope for the guideline it is to develop on the safe and effective prescribing of strong opioids for pain in palliative care of adults. The consultation process is due in early 2012, with guidance publication due May 2012.

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Guidance for pharmacists - safe custody of controlled drugs

22nd August 2011

The UK Royal Pharmaceutical Society has produced guidance on the safe custody of controlled drugs (CDs) aimed at pharmacists working in registered pharmacy premises. It explains which CDs require safe custody, exemptions when CDs do not require safe custody, structural requirements of safes, cabinets and rooms used for storing CDs, and guidance on key responsibilities, including a key log. To access the guidance click the link below. (RPS membership required).

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Nystatin oral suspension - anticipated stock shortage

18th August 2011

Bristol-Myers Squibb has advised on an anticipated shortage of Nystan Oral Suspension 100,000 units/mL (nystatin) in the UK. It is likely that supply will be limited and intermittent from July 2011 until December 2011. The issue is related to the supply of pipettes used to administer the product.

Generic equivalents are available. Please see link below for further information.

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DTB reviews prucalopride in constipation

10th August 2011

The August 2011 issue of the Drug and Therapeutics Bulletin (DTB), reviews the evidence for prucalopride (Resolor, Shire pharmaceuticals) and considers its place in the treatment of chronic constipation.

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FDA approve a tamper-resistant oxycodone formulation

1st August 2011

A novel formulation of oxycodone immediate-release tablets (Oxecta, Pfizer and Acura Pharmaceuticals) using a drug delivery system designed to reduce the incidence of abuse and tampering, has been approved by the FDA. The new technology discourages abuse by causing the active ingredient to gel or to irritate nasal passages, thereby hindering injection or inhalation.

Due to the nature of the new technology, the tablets cannot be crushed, chewed or dissolved and must not be administered by enteral feeding tubes as they will cause obstruction.

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