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Die Juli/August Ausgabe des APM Newsletter ist fertig

31st August 2012

The July/August issue of APM Newsletter for German-speaking users of is available.

Die Juli/August Ausgabe des APM Newsletter ist fertig. Über die aktuelle Ausgaben des Newsletters wird Sie das Bulletin Board informieren.

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FDA authorize tapentadol m/r for neuropathic pain

30th August 2012

US Food and Drug Administration (FDA) have authorized tapentadol m/r tablets (Nucynta ER; Janssen Pharmaceuticals) for the management of neuropathic pain associated with diabetic peripheral neuropathy in adults when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.

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NPSA Insulin Passport deadline

30th August 2012

NHS organisations should ensure that by 31 August 2012 the following actions outlined in the National Patient Safety Agency (NPSA) alert ‘The adult patient’s passport for safer use of insulin’ (NPSA/2011/PSA003) have been implemented:

  • adult patients on insulin therapy receive a patient information booklet and an Insulin Passport to help provide accurate identification of their current insulin products and provide essential information across healthcare sectors
  • health professionals and patients are informed how the Insulin Passport and associated patient information can be used to improve safety
  • when prescriptions of insulin are prescribed, dispensed or administered, health professionals cross-reference available information to confirm the correct identity of insulin products
  • systems are in place to enable hospital inpatients to self-administer insulin where feasible and safe.

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NICE final draft guidance for denosumab

21st August 2012

The UK National Institute for Health and Clinical Excellence (NICE) has published final draft guidance on the use of denosumab for the treatment of bone metastases from solid tumours and multiple myeloma. It makes the following recommendations:

  • denosumab is recommended as an option for preventing skeletal-related events in adults with bone metastases from breast cancer and from solid tumours (other than breast and prostate) if bisphosphonates would otherwise be prescribed and the manufacturer provides denosumab with the discount agreed in the patient access scheme
  • denosumab is not recommended for preventing skeletal-related events in adults with bone metastases from prostate cancer.


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Ondansetron new maximum IV single dose

9th August 2012

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has restricted the maximum single IV dose of ondansetron for the management of chemotherapy-induced nausea and vomiting in adults to 16mg (infused over at least 15min). This is in response to the results of a recent study which demonstrated a dose-dependent prolongation of the QT interval. There are no changes to the dosing for post-operative nausea and vomiting or for any indication in children or for any indication via the oral or rectal route. Ondansetron should be avoided in patients with congenital long QT syndrome and caution taken in patients with risk factors for QT interval prolongation or arrhythmias. Electrolyte disturbances should be corrected before drug administration. The FDA has also implemented the same restrictions.

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