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MHRA alert acetylcysteine injection

30th June 2010

Black particles have been found in a very small number of ampoules of acetlcysteine injection 200mg/mL (Aurum pharmaceuticals, Martindale livery, batch numbers 80455 and 90114).
The particles are carbonised material which forms if droplets of solution are present during sealing of the ampoules. Particles may be suspended in the solution, or may adhere to the inner wall of the ampoule neck.
In order to avoid stock shortages, these batches are not being recalled. The ampoules should be inspected as per normal parenteral practices and any affected ampoules should be discarded.

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DTB questions NICE neuropathic pain guidance for pregabalin

17th June 2010

The editorial in the latest Drug and Therapeutics Bulletin (DTB) questions the recommendation in the recent guideline on neuropathic pain from the UK National Institute for health and Clinical Excellence (NICE) that clinicians should offer oral amitriptyline or pregabalin as first-line treatment (see our news 2010-04-20).

DTB extract (full text requires subscription)
NICE neuropathic pain guidance

FDA approves ketorolac nasal spray

17th June 2010

U.S. Food and Drug Administration (FDA) has approved ketorolac tromethamine nasal spray (Sprix, Roxro Pharma), for the short-term (up to 5days) management of acute moderate to moderately severe pain that requires analgesia at the opioid level.

Sprix PI

Diclofenac gel availability OTC

16th June 2010

The maximum pack size of diclofenac ethylammonium 1.16% gel available over the counter (OTC) in the UK for the local symptomatic relief of pain and inflammation has been increased from 50G to 100G and the maximum treatment period (without medical advice) has been extended from 7days to 14days.

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Annual evidence update on homeopathy

15th June 2010

The UK NHS Evidence complementary and alternative medicine website (formerly a specialist section of National Library for Health) has produced the 2010 annual update of the evidence for homeopathy.

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DH guidance and NPC resource on mixing of medicines

9th June 2010

The UK Department of Health (DH) has published guidance on mixing of medicines prior to administration. This follows the changes in legislation in December 2009 to enable doctors and other prescribers to mix medicines themselves and to direct others to mix (see our news item 2010-01-07). The National Prescribing Centre (NPC) has published supporting guidance to help with practical questions, both documents can be downloaded from the links below.
Legislation changes to the Misuse of Drugs Regulations are still needed for mixing with controlled drugs. However, the guidance states that the original MHRA statement advising that it "would not consider taking enforcement action against those prescribing and administering mixtures of licensed medicines in clinical practice, unless it is in the public interest to do so," includes controlled drugs and that existing good practice arrangements on mixing before administration, which includes a controlled drug, should continue .

DH guidance on mixing of medicines
NPC supporting guidance

MHRA recall: Gabapentin PIL missing text

8th June 2010

All unused stock of a specific batch of Gabapentin 100mg capsules (Ranbaxy, batch number 2037862, pack size 100) are being recalled because the following text is missing from the patient information leaflet (PIL):
'A small number of people being treated with anti-epileptics such as Gabapentin have had thoughts of harming and killing themselves. If at any time you have these thoughts, immediately contact your doctor.'
Subsequent batches have been updated. Further information can be found from the link below and from Ranbaxy (UK) limited (02087425299).

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Instanyl recommendations within NHS Wales

8th June 2010

The All Wales Medicines Strategy Group (AWMSG) has made recommendations for the use of Fentanyl intranasal spray (Instanyl) within NHS Wales.
Fentanyl intranasal spray (Instanyl) is recommended as an option for use within NHS Wales for the management of breakthrough pain in adults already receiving maintenance opioid therapy for chronic cancer pain.
Fentanyl intranasal spray (Instanyl) should only be considered as an option for the management of breakthrough cancer pain when immediate release oral opioids (e.g. morphine, oxycodone) are either inadequate or unsuitable.
Fentanyl intranasal spray (Instanyl) may be suitable for shared care but should be initiated by, and remain under the supervision of a physician experienced in the management of opioid therapy in cancer patients.
Full details can be found in the AWMSG final appraisal report Fentanyl (Instanyl) - April 2010 which can be accessed from the link below.

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