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FDA alert : US recall of Hydromorphone 2mg tablets (Ethex)

30th December 2008

A single lot of hydromorphone hydrochloride 2mg tablets (ETHEX Corporation, Lot 90219, Expiry 03/2010, NDC 58177-0620-04) have been recalled due to the potential for oversized tablets. The parent company of ETHEX Corporation, KV Pharmaceutical has advised the FDA that it is also voluntarily suspending shipments of all FDA-approved drug products in tablet form. This action is being taken as a precautionary measure, to allow KV to address manufacturing issues that have come to management's attention. Among the list of tablets affected are dextroamphetamine sulfate tablets, morphine sulfate extended release tablets, ondansetron orally disintegrating tablets, oxycodone hydrochloride tablets. The company is unable to determine when redistribution will resume. See the links below for more information.

FDA hydromorphone recall notice
FDA suspended shipments notice
FDA list of tablets affected

NPSA rapid response report: Reducing the risk of overdose with midazolam injection

11th December 2008

The NPSA has issued a rapid response report following 498 midazolam patient safety incidents between November 2004 and November 2008 where the dose prescribed or administered to the patient was inappropriate. Three of these incidents resulted in death.
The Report makes the following recommendations:
- storage and use of high strength midazolam (5mg/ml in 2ml and 10 ml ampoules; or 2mg/ml in 5ml ampoules) should be restricted to general anaesthesia, intensive care, palliative medicine and clinical areas/situations where its use has been formally risk assessed, for example, where syringe drivers are used
- in other clinical areas, storage and use of high strength midazolam should be replaced with low strength midazolam (1mg/ml in 2ml or 5ml ampoules)
- review therapeutic protocols to ensure that guidance on use of midazolam is clear and that the risks, particularly for the elderly or frail, are fully assessed
- ensure all healthcare practitioners involved directly or participating in sedation techniques have the necessary knowledge, skills and competences required
- ensure stocks of flumazenil are available where midazolam is used and the use of flumazenil is regularly audited as a marker of excessive dosing of midazolam
- ensure sedation is covered by organisational policy and that overall responsibility is assigned to a senior clinician which, in most cases, will be an anaesthetist.
The date for completion of actions is 09/06/09.

NPSA report on midazolam
NPSA report on midazolam, supporting evidence
NPSA website

MHRA consultation on mixing medicines in palliative care MLX 356

9th December 2008

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued a document (MLX 356) seeking views on its proposals to regularise the legal position of practitioners mixing and administering medicines in palliative care. This follows a position statement from the MHRA in September 2008 (see our news section 02-09-08).
The MHRA has reiterated it's previous guidance, both in the document and on it's website, stating that "whilst we secure a permanent legal basis for this long-standing practice, the Agency has issued a statement which makes clear that we would not consider enforcement action for breaches of medicines legislation by doctors, Nurse Independent Prescribers and Pharmacist Independent Prescribers prescribing and administering (and instructing others to administer) a mixture of licensed medication unless it would be in the public interest to do so. This also applies to those mixing in accordance with the directions of the prescriber."
The Royal Pharmaceutical Society of Great Britain (RPSGB) has issued a Law and Ethics Bulletin which takes the same view on this issue.
The MHRA have produced this document in conjuction with the Home Office as the practice of mixing medicines in palliative care involving controlled drugs is covered by both the Medicines Act 1968 and the Misuse of Drugs Regulations 2001.
We would encourage as many of you as possible to respond to this consultation, either on-line (via the link below) or in writing (address and details in the document). The deadline for response is 27 February 2009.

MHRA website link to MLX 356
MLX 356 document
RPSGB Law and Ethics Bulletin

Gabapentin (Neurontin) updated SPC

9th December 2008

The UK SPC for gabapentin (Neurontin, Pfizer 01304 616161) has been updated with a warning regarding suicidal ideation and behaviour in patients treated with antiepileptic medication. Also see our news report on MHRA advice on antiepileptics and suicidal thoughts 2008-08-04.

Neurontin SPC

Hospice and Palliative Care Formulary USA 2nd edition (HPCF2) now available

4th December 2008

HPCF2 is a comprehensive compendium which brings together a wealth of essential therapeutic information about drugs commonly used in hospice and palliative care, including drugs given for off-label indications or routes. Developed specifically for the USA, with the help of American pharmacists and an Editorial Advisory Panel.
HPCF2 costs $75 and can be ordered from Atlas books, or for members of the American Academy of Hospice and Palliative Medicine at the special price of $65. To claim this discount, go to the AAHPM website, log on and visit the Publisher Discount part of the members' only section.

Atlas books click here
AAHPM website click here

FDA questions and answers on erythropoiesis-stimulating agents medication guides

4th December 2008

The US Food and Drug Administration (FDA) has published a question and answer document regarding their patient medication guides on erythropoiesis-stimulating agents eg epoetin alfa (Procrit, Epogen) and darbepoetin alfa (Aranesp).

click here to view

EMEA review of conventional (typical) antipyschotics in elderly patients with dementia

4th December 2008

The European Medicines Agency (EMEA) has completed a review of the evidence on the safety of conventional (typical) antipyschotics in elderly patients with dementia and concluded that there is some evidence that these medicines can increase the risk of death in these patients.
The EMEA was unable to confirm whether the risk differs between individual conventional (typical) antipyschotics or whether the risk is greater with conventional (typical) antipyschotics than with atypical antipyschotics as suggested by some studies. The underlying mechanism is also unknown.
The EMEA has recommended that the product information (SPC) for all conventional (typical) antipyschotics be updated to include the increased risk of death in elderly patients with dementia in line with those for atypical antipyschotics.

EMEA review
EMEA Question and Answers