EMA to review cardiovascular safety of NSAIDs

21st October 2011

The European Medicines Agency (EMA) is to review the latest available data on the cardiovascular safety of non-selective non-steroidal anti-inflammatory drugs (NSAIDs) and update its opinion which was published in 2006.

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DH "Never Events"

20th October 2011

The UK Department of Health (DH) published it’s list of "Never Events" for 2011-2012 earlier this year, which has expanded to 25 from the original 8 published in previous years. "Never events" are very serious, largely preventable patient safety incidents that should not occur if the relevant preventative measures have been put in place.

1. Wrong site surgery (existing)
2. Wrong implant/prosthesis (new)
3. Retained foreign object post-operation (existing)
4. Wrongly prepared high-risk injectable medication (new)
5. Maladministration of potassium-containing solutions (modified)
6. Wrong route administration of chemotherapy (existing)
7. Wrong route administration of oral/enteral treatment (new)
8. Intravenous administration of epidural medication (new)
9. Maladministration of Insulin (new)
10. Overdose of midazolam during conscious sedation (new)
11. Opioid overdose of an opioid-naïve patient (new)
12. Inappropriate administration of daily oral methotrexate (new)
13. Suicide using non-collapsible rails (existing)
14. Escape of a transferred prisoner (existing)
15. Falls from unrestricted windows (new)
16. Entrapment in bedrails (new)
17. Transfusion of ABO-incompatible blood components (new)
18. Transplantation of ABO or HLA-incompatible Organs (new)
19. Misplaced naso- or oro-gastric tubes (modified)
20. Wrong gas administered (new)
21. Failure to monitor and respond to oxygen saturation (new)
22. Air embolism (new)
23. Misidentification of patients (new)
24. Severe scalding of patients (new)
25. Maternal death due to post partum haemorrhage after elective Caesarean  section (modified)

For more information see below

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NETAG does not recommend capsaicin cutaneous patch for neuropathic pain

14th October 2011

The NHS North East Treatment Advisory Group (NETAG) does not recommend the use of capsaicin cutaneous patch (Qutenza) for neuropathic pain, the group were concerned about the clinical efficacy of the treatment and considered that it did not represent a cost-effective treatment option.

NETAG capsaicin patch outcome
NETAG capsaicin patch appraisal

NETAG does not recommend tolvaptan for hyponatraemia due to SIADH

14th October 2011

The NHS North East Treatment Advisory Group (NETAG) does not recommend, following an appeal, the use of tolvaptan (Samsca) for hyponatraemia due to syndrome of inappropriate anti-diuretic hormone secretion (SIADH). The group concluded that tolvaptan is unlikely to be cost-effective compared with existing treatment options and was concerned about the potential for unrestricted long-term treatment. The group recognised that long-term treatment could be appropriate in certain circumstances according to a local protocol, see below for more details.

NETAG tolvaptan outcome
NETAG long term treatment protocol

Monitoring unwanted effects of antipsychotics

13th October 2011

A recent article in the Drug and Therapeutics Bulletin (DTB) discusses monitoring for unwanted effects of antipsychotics in adults, with a particular focus on second-generation antipsychotics. For more information see link below (subscription required for full text).

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MHRA: Avoid use of aqueous calamine cream before X-ray

13th October 2011

The UK Medicines and Healthcare Regulatory agency (MHRA) has issued a reminder that aqueous calamine cream should not be applied to the skin before an X-ray examination because it may affect the outcome of the radiograph. This preparation contains zinc oxide 3.0% w/w, and if used on the skin before an X-ray, the zinc oxide may mimic intramammary calcifications, which can be an important indicator of early breast cancer. The product label and leaflet have been updated to reflect this new advice.

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MHRA: Transferring patients to the new licensed buccal midazolam preparation

13th October 2011

The UK Medicines and Healthcare Regulatory Agency (MHRA) have highlighted that care is needed on transferring patients from unlicensed buccal midazolam preparations to the new licensed buccal midazolam preparation (Buccolam, ViroPharma).

Buccolam is oral midazolam 5mg/mL provided in age-specific, individual doses of 2.5mg, 5mg, 7.5mg or 10mg, in pre-filled syringes for buccal delivery (see our news item 14-09-2011). The NHS list price of 4 dose units is £82, £85.50, £89 and £91.50 respectively. It is licensed for patients diagnosed with epilepsy from age 3months to <18years.

Buccolam is half the strength of some of the unlicensed preparations that have been used and is also a different salt; it contains the hydrochloride salt, whereas some other preparations contain the maleate salt of midazolam. MHRA state that although there is some suggestion that the maleate salt may be better absorbed in the buccal cavity, there are adequate studies with midazolam hydrochloride to support the dosing schedule authorized for Buccolam in the SPC. It also references a publication of the experience of a hospital paediatric unit transferring its patients to licensed Buccolam.

MHRA safety update for Buccolam
SPC for Buccolam 2.5mg dose

World Hospice and Palliative Care Day - 8 October 2011

6th October 2011

The theme for 2011 is 'many diseases, many lives, many voices – palliative care for non-communicable conditions' and will focus on how people living with conditions which are not infectious (cardiovascular diseases, cancers, chronic respiratory conditions and diabetes) can benefit from palliative care. For more information and to register your event visit the new World Hospice and Palliative Care website www.worldday.org.

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Evidence for unlicensed and off-label medicines

4th October 2011

The UK Department of Health (DH) has announced that it will commission expert assessments of the evidence on the use of unlicensed or 'off-label' medicines, including in rare conditions. These assessments will be designed to inform doctors' decision-making and patients' choices, not to provide a yes or no recommendation. The work will be delivered by the National Institute for Health and Clinical Excellence (NICE), through its NHS Evidence arm, beginning in spring 2012.

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