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Clexane - Out of Stock on 40mg

Friday, November 3, 2017

Clexane 40mg  is going to be out of stock from next week until the end of this year. (There is a very small chance that the 20 mg strength will be affected, in which case the supply route is the same as below. No other strengths are affected.)

Hospitals will not be able to access the product during this time  - arrangements have been made for hospitals to access an alternative low molecular weight heparin product in the interim (switch to an alternative product).

Given the challenge of managing a switch of this product in primary care, Sanofi have agreed to protect a small amount of Clexane 40mg in line with historical demand for use in primary care. Our current understanding of the arrangement is that this stock has been ring fenced for community pharmacies in Phoenix. Given recent changes in prescribing practice, we estimate demand for this strength to be  low. The Boards with highest use of Clexane are GG&C, Lanarkshire and Forth Valley.  Not all community pharmacies have Phoenix accounts; if a pharmacy needs to access the stock and doesn’t have an account, they will need to source supply via another route, for example sourcing via a neighbouring pharmacy that has an account. It is hoped that this short-term arrangement will protect continuity of supply of Clexane 40mg to community pharmacies over the next few weeks.  

If a community pharmacy is unable to access Clexane, there is a biosimilar available (Inhixa). Decisions to switch need to be authorised by a prescriber (prescriptions should be issued by brand name) and arrangements made for the patient to be counselled on the change of device.  

We have attached some notes on biosimilars here for your information.

A biosimilar medicine is a biological medicine that is similar to another biological medicine which has already been granted a marketing authorisation. Although biosimilars and their reference biologic share a generic name, they are not presumed to be identical in the same way as generic non-biological medicines. To support pharmacovigilance and to ensure any switching between brands is authorised by the prescriber, the MHRA advise that biological medicine (including biosimilars) should be prescribed by brand name.

Currently a high proportion of prescriptions for enoxaparin in primary care are issued by generic name and do not specify a brand. Work is underway across Scotland to transition across to branded prescribing. In the interim, if a generic prescription for enoxaparin is received by pharmacies, pharmacists should confirm which brand the patient has been receiving, dispense this brand and endorse the prescription accordingly to ensure correct payment.

In the event that it is not possible to source Clexane from wholesalers,  the prescriber should be contacted. Due to differences in device design between the reference product and biosimilars, patients who self-inject that are switching from one device to the other will need to receive advice on the change.

More information about biosimilar medicines can be found in the Biosimilar Medicines: National Prescribing Framework which has been developed by Healthcare Improvement Scotland, in collaboration with NHS Boards and Area Drug and Therapeutics Committees.

The temporary interruption of supply is due to global demand requirements and is not related to any quality or safety issues. It is anticipated that full supply will return by the end of 2017.

If you need further information or support please contact us.