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Dear Colleague,

Welcome to the June 2014 BNF e-newsletter. In this month's newsletter we provide an update and clarification to the dosing schedule of Haloperidol. We also discuss changes to the legal classification of Tramadol, Lisdexamfetamine, Zaleplon and Zopiclone.

Kind regards,
BNF Team

BNF for Children 2014-2015 is available to pre-order now.
Significant changes More >
BNF on FormularyComplete - June update More >
Changes to Appendix 3 More >
Monthly price update reminder More >
How to purchase BNF More >
Drug Safety Update More >
Feedback on our e-newsletter More >
Significant changes
This month's changes to the clinical content of BNF publications are described in three parts:

• BNF & BNFC update should be read by all users of the BNF or BNFC
• BNF update should be read by all users of the BNF
• BNFC update should be read by all users of the BNF for Children

BNF 67
BNF & BNFC update

Changes in the legal classification of Tramadol, Lisdexamfetamine, Zaleplon, and Zopiclone
Tramadol will become a schedule 3 controlled drug (CD No Register POM). It will be exempt from Safe Custody Regulations. In BNF and BNFC, tramadol preparations are assigned a CD3 symbol.

Lisdexamfetamine will become a schedule 2 controlled drug (CD POM). In BNF and BNFC lisdexamfetamine preparations are assigned a CD2 symbol.

Zaleplon and zopiclone will become schedule 4 part 1 controlled drugs (CD Benz POM). In BNF, preparations of zaleplon and zopiclone are assigned a CD4-1 symbol.

These changes come into force on 10 June 2014. For more information, see Controlled Drugs and Drug Dependence and Prescribing Controlled Drugs.

BNF update

The BNF has received a number of queries about the new dosing schedule for haloperidol that was included in last month's newsletter. Some enquirers highlighted the fact that the maximum dose for oral and intramuscular (IM) routes for the treatment of acute schizophrenia, psychoses and mania in BNF was identical, and pointed out that generally it is accepted that bioavailability from the oral route is about 60% of that from the IM route. The IM haloperidol dose was the licensed dose taken from the Summary of Product Characteristics (SPC) for Haldol® Injection, which has now been discontinued by Janssen-Cilag. As the maximum oral dose for haloperidol has been reduced according to changes in the most recent SPC for Haldol 2mg/ml oral liquid (revised 3.12.13) due to concerns about adverse effects, it seems sensible to reduce the maximum IM dose accordingly. The BNF has therefore amended the dose for IM haloperidol. For further information, see Haloperidol.

The BNF is aware that the generic haloperidol SPCs have not been updated with the lower licensed oral doses and the SPC for generic Haloperidol BP Injection (Amdipharm, revised 20.1.14) retains a higher maximum dose than the BNF now recommends. We have highlighted this inconsistency to the MHRA who are investigating the matter. The BNF is also aware of the advice of the Royal College of Psychiatrists on doses of antipsychotic drugs above BNF upper limit, and the implications that amending the doses of haloperidol may have on clinical practice. It has been made clear that the IM haloperidol dose in the BNF differs from product literature.

We will review this issue again when we have received feedback from the MHRA and consulted further with our expert advisers.

Trastuzumab emtansine
Trastuzumab emtansine has been added to BNF section 8.1.5. Trastuzumab emtansine is an antibody-drug conjugate that combines trastuzumab with DM1, a cytotoxic microtubule inhibitor. It is licensed as monotherapy for the treatment of HER2-positive, unresectable, locally advanced breast cancer previously treated with trastuzumab and a taxane, or when there is disease recurrence during or following adjuvant therapy. For further information see Trastuzumab emtansine.

Brimonidine gel for rosacea
Brimonidine, a selective alpha2-adrenoceptor agonist, is licensed for the treatment of facial erythema in rosacea. For further information see Brimonidine.

Other changes
To review other changes in the BNF, click on changes.

BNFC update

To review changes in BNFC, click on changes.

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BNF on FormularyComplete - June update
BNF on FormularyCompleteThe June update of FormularyComplete - the customisable BNF product for creating local formularies - responds to clients' requests to obtain formulary reports in an immediately publishable format by adding HTML and PDF export options. It has also added the means to generate reports on the drugs in individual BNF chapters. Additionally, to clarify the various possible restrictions on prescribing, the number of definable formulary statuses has been increased to ten. We have made it easier to redefine them, in the event that a trust decides to revise its local classification system.

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Changes to Appendix 3: Cautionary and advisory labels
The following products from BNF and BNFC in the Appendix 3 list of products and their labels have been updated: :

Brimonidine gel - Mirvaso - Monopost

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Monthly price update reminder
Prices of all branded medicinal products in the BNF and BNFC are now updated monthly. Prices of generic preparations of medicinal products are updated every 2-4 months, to coincide with print editions of BNF and BNF for Children. The BNF team keep price information up-to-date using data sourced from the NHS dictionary of medicines and devices (dm+d).

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How to purchase BNF
Purchase a print copy Purchase print copies
To buy the March 2014 edition, visit the Pharmaceutical Press website.
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Outside the UK, content is available via a subscription to MedicinesComplete. For more information contact
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BNF is also available as an e-book on the iBookstore. Find out more here.
Drug Safety Update
Drug Safety UpdateDrug Safety Update is a monthly newsletter from the MHRA and Commission on Human Medicine. Review this month's Drug Safety Update.

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