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MHRA strengthened recommendations for IV iron

26th September 2013

The UK Medicines and Healthcare products Regulatory Agency (MHRA) have strengthened recommendations for the administration of IV iron in order to further manage and minimise the known risks of serious hypersensitivity reactions.

A Europe wide review has shown that serious hypersensitivity reactions can occur irrespective of whether a patient has received a test dose or previous treatment with the product. Therefore test doses are no longer recommended, due to the fact that they may confer false reassurance and will be removed from the product literature. Otherwise the product should be administered strictly as per the specific SPC (advice varies between products). In addition, caution is required with every dose of IV iron, with patients being monitored closely for signs of hypersensitivity during and for 30minutes after every dose. Resuscitation facilities and staff trained to use them must be available for every dose. Full details are available in the MHRA August 2013 Drug Safety Update (updated 9th September 2013).

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MHRA class 2 drug alert for Buprenorphine (Natzon) sublingual tablets

26th September 2013

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has  issued a class 2 medicine alert (action within 48h) for Natzon (buprenorphine) 0.4mg sublingual tablets (Morningside healthcare).

This is due to the inadvertent packaging of a small number of blister packs containing buprenorphine 8mg sublingual tablets into cartons labelled Natzon 0.4mg sublingual tablets.

Any Natzon 0.4mg sublingual tablet cartons with the batch numbers 13D22 and 13D24 (pack size 1 x 7; expiry April 2016) should be returned to the original supplier.

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EMA to re-examine metoclopramide restrictions

24th September 2013

The European Medicines Agency (EMA) is to re-examine the recommended changes for metoclopramide in adults and children that it made in July 2013 (see our article 8th August 2013), following a request from one of the marketing authorization holders, and will then issue a final opinion.

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FDA restrictions on m/r opioids

24th September 2013

The US Food and Drug Administration has announced proposed class-wide changes to the indications for all modified-release (m/r) opioids. Previously the products were indicated for ‘moderate to severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time’. The new indication will be, ‘for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate’.

New warnings on the risk of neonatal opioid withdrawal syndrome will be also added. Manufacturers will, in addition, be required to perform more studies and clinical trials to further assess the known risks of misuse, abuse, hyperalgesia, addiction, overdose, and death.

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NICE guidance urinary incontinence in women

24th September 2013

The UK National Institute for Health and Care Excellence (NICE) has published Clinical Guideline 171 Urinary incontinence in women. This supersedes the previous guideline CG40.

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NICE quality standards for lower urinary tract symptoms in men

24th September 2013

The UK National Institute for Health and Care Excellence (NICE) has published Quality Standard 45 Lower urinary tract symptoms in men.

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SIGN pain booklet for consultation

23rd September 2013

The Scottish Intercollegiate Guidelines Network (SIGN) has published a consultation draft of a book ‘Management of chronic pain: a booklet for patients and carers’.

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FDA request ink colour change for fentanyl transdermal patches

23rd September 2013

The US Food and Drug Administration (FDA) is requesting manufacturers of fentanyl transdermal patches print the name and strength of the drug on the patch in long-lasting ink, in a colour that is clearly visible. The current ink colour varies by strength and is not always easy to see. This is part of a safety use initiative and reminder of the dangers of accidental exposure.

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Lorazepam injection 4mg/mL now available

19th September 2013

Following extensive supply issues since 2010, lorazepam solution for injection 4mg/mL (Ativan; Pfizer) is now available again without restriction.

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BNF accreditation decision by NICE for consultation

17th September 2013

The National Institute for Health and Care Excellence (NICE) has opened a consultation on its draft decision not to give NICE accreditation to the processes used to produce the British National Formulary (BNF) and British National Formulary for Children (BNFc).

An independent advisory committee found that certain standard criteria, against which the BNF and BNFc were assessed, were not fully met. The full details of these can be found in appendix A of the full draft accreditation decision (see link below).

The consultation closes on the 4th October. Following a final decision, if accreditation is not granted, the BNF and BNFc will still be available on the NICE Evidence site but will not be identified by the accreditation mark graphic.

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BNF online pricing updated

11th September 2013

The prices in the on-line BNF and BNFc have now been updated and are consistent with the new print edition of the BNF66 (September 2013), which is now available.

BNF prices had been unchanged since BNF 62 (2011-2012) due to an overhaul of the system, which has now been completed.

Pricing data is obtained from the NHSBSA (formerly the PPD) and will be updated with each print edition (i.e. 6monthly).

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Tapentadol SPC updated

11th September 2013

The UK SPC for tapentadol has been updated to include palpitations and hypersensitivity, including angioedema as uncommon (≥1/1,000 to <1/100) undesirable effects.

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Anexate (flumazenil) discontinued

11th September 2013

Roche has discontinued flumazenil injection 100microgram/mL, 5mL ampoules (Anexate) due to low demand. However, there is an equivalent generic version available.

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Japanese translation of PCF over 3,000 copies sold since May 2013!

4th September 2013

We are delighted to report that following the launch of the Japanese translation of the Palliative Care Formulary (PCF) in May 2013 (see our new item 2013-05-21), over 3,000 copies have been sold and the book is already in its 3rd reprint!

It has been published by Igaku-Shoin and is available to purchase from the link below.

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