 A new offence of driving with certain specified controlled drugs in excess of specified levels is expected to come into force on 2nd March 2015. This offence is an addition to the existing rules on drug impaired driving and fitness to drive. The legislation also provides for a statutory ‘medical defence’ for this new offence, for patients taking their medicines in accordance with instructions.
In preparation for this, the Department of Transport has published guidance for healthcare professionals on drug driving. In line with current professional practice, pharmacists prescribing or supplying medicines take into account the risks of medicines (e.g. whether a patient’s driving may be impaired by their medicines) and advise accordingly. This practice has not changed, but pharmacists will need to be able to explain the new rules concerning this offence to patients. The guidance can be viewed on the Department for Transport website. Information on whether individual medicines are affected by the new legislation will be added to the Summary of Product Characteristics of the products which are available on the electronic Medicines Compendium.
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 The EMA has concluded its review of emergency contraceptives containing levonorgestrel or ulipristal acetate to assess whether the effectiveness of Levonelle (containing levonorgestrel) and ellaOne (containing ulipristal acetate) was reduced with increased body weight. They concluded that based on the data available the benefits of using these emergency contraceptives remains positive and it cannot be concluded that body weight has an impact on the effectiveness of these widely used medicines.
Click Here to see the MHRA Alert that has been sent to Pharmacies. Background You may already be aware that on 24th January 2014 the European Medicines Agency (EMA) launched a review of oral emergency hormonal contraception (EHC) to assess whether increased body weight/BMI reduces its efficacy in preventing an unintended pregnancy. More information on the work being undertaken by the EMA is available in their press notice. The review covers the two types of EHC available within the EU – and the UK – levonorgestrel and ulipristal acetate. It is being carried out under the provisions of Article 31 of the EU Medicines Directive (2001/83/EC) which covers referrals relating to the evaluation of data from pharmacovigilance (drug safety) activities of authorised medicinal products. The review was triggered in response to changes in the levonorgestrel (Norlevo) licence in a number of European countries based upon evidence indicating that a high bodyweight could impact the effectiveness of EHC. The EMA’s final decision may result in the need to make some changes to current practices within a short time frame, both for commissioners and service providers such as community pharmacies who provide EHC through a patient group direction or who sell EHC over the counter. The Faculty of Sexual and Reproductive Healthcare of the RCOG has recently published an update on this subject aimed at healthcare professionals; it outlines existing recommendations and arrangements for EHC provision in the UK. The document has been provided to clarify the current situation and to facilitate planning and rapid implementation of any changes to EHC availability that may result from the EMA review. A decision-making guide for community pharmacists is included as an appendix for quick reference. The guide will be easily amended to include weight criteria if this is indicated by the outcome of the EMA review and the FSRH will issue further guidance after the EMA report is published. The LPC would like to remind contractors that the Home Office is changing the regulations for tramadol .
We understand that the changes will come in force on Tuesday 10th June: The new legislation can be viewed by clicking here. The main changes that are likely to affect pharmacy contractors will be the following however the LPC recommend that contractors read the legislation changes.
The biggest impact is likely to be the change for tramadol and it means that all prescriptions for tramadol will have to comply with CD Schedule 3 requirements from 10th June 2014.  Despite assurances that there was sufficient stock of Jext autoinjectors, there is now a supply shortage. The alert below has been provided by the medicines optimisation team to deal with this short term problem. 
ALERT
November 2013 Jext® 300microgram Adrenaline Auto-injector Background: ALK-Abelló Ltd have made us aware aware of a shortage of Jext 300microgram adrenaline auto-injectors. The shortage may last until mid-December, but will hopefully be resolved sooner. The shortage has been caused by a much higher than expected prescription rate in the UK in September, coupled with the adoption of Jext in France, to replace Anapen. In order to maximise shelf-life of the devices in patients’ hands, ALK have minimised stockholding in the UK, so there is very little buffer stock in the supply chain. ALK have assured us that they are making every effort to resolve the issue, and understand the difficulty that this causes at a crucial stage in the roll-out of the change from Epipen to Jext. Action Required: GPs should prescribe Epipen in the equivalent dose on a temporary basis only until ALK confirm that stocks are again available. The patient will then keep the Epipen until expiry and will receive Jext (with training) at the next renewal. Community Pharmacies should request the patients GP prescribes Epipen in the equivalent dose if they are unable to obtain supplies of Jext. It is essential that whichever auto-injector is supplied, device-specific training should be provided. Further Information: Your practice pharmacist may be able to advise on action for individual patients Alternatively contact your locality Medicines Optimisation Pharmacist on 0191 217 2858 or Marie Thompkins NECS MO contact for this initiative[email protected] ALK customer services stock availability: 0118 903 7940. ALK locality contact Shona Hawkins : 07917 631740 |
Copies of our older Paper Based News Letters (The LPC News) can be found by clicking below.
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