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Bayer Healthcare, has announced that the UK Home Office, after advice from the Advisory Council on the Misuse of Drugs’ (ACMD), the independent expert body that advises the Home Office on drug-related issues, has rescheduled Sativex® Oromucosal Spray in the UK.(1)
Sativex®, the first cannabinoid medicine derived from whole plant extracts from the cannabis sativa plant containing both delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD), was approved by the MHRA in June 2010.(2) At this time, Sativex® remained in Schedule 1 under a specific Home Office general licence. The ACMD has recommended that Sativex® be rescheduled to a Schedule 4, Part 1 substance. This will come into effect on the 10th April 2013.(3)
Under the previous schedule, it was advised that Sativex® was stored in a lockable refrigerator or a refrigerator not visible to the general public. Although Sativex® still needs refrigeration it no longer needs to be locked away. Prescriptions had to be written in the same way as they are for Schedule 2 drugs with prescriptions including the dose, form, strength and total quantity of the preparation in both words and figures. These restrictions have now been lifted. The destruction of expired stocks of Sativex® and patient returns by healthcare professionals, does not need to be witnessed any longer, however, records are required to be kept on the amounts of Sativex® possessed or destroyed.(1,3)
Commenting on the rescheduling of Sativex®, Professor John Zajicek, Consultant Neurologist at Derriford Hospital, Plymouth said, “This is good news for healthcare professionals involved in the prescribing, supply and storage of Sativex®. There have been some questions about drug abuse and addiction with Sativex® that have now been answered through this rescheduling as the ACMD has recognised the low abuse potential and low diversion risk of Sativex®.”
Sativex® is indicated as treatment for symptom improvement in adult patients with moderate to severe spasticity due to multiple sclerosis (MS) who have not responded adequately to other anti-spasticity medication and who demonstrate clinically significant improvement in spasticity related symptoms during an initial trial of therapy.(2)
Sativex® is only available on prescription from a physician with experience in treating MS spasticity. It is sprayed into the mouth either onto the inside of the cheek or under the tongue.(2) The MS patient decides how many sprays they need in any one day with a typical patient taking four sprays a day (daily limit of up to 12 sprays).(2,4) The NHS price of Sativex® is £125 per 10ml vial however Bayer has a scheme to help with the cost of identifying those who respond to Sativex® by funding the first pack of treatment free of charge to the NHS.(5)
References
- ACMD Advice on Sativex®. February 2013. Available at: http://www.homeoffice.gov.uk/publications/agencies-public-bodies/acmd1/advice-sativex?view=Binary (Last accessed 28.03.13)
- Sativex® Summary of Product Characteristics. Available at: http://www.medicines.org.uk/EMC/medicine/23262/SPC/Sativex+Oromucosal+Spray/ (Last accessed 28.03.13)
- Royal Pharmaceutical Society. A Legislative changes to schedule Sativex®. Version 3.1. Available at: http://www.rpharms.com/support-pdfs/sativex—legislative-changes-alert—final.pdf?utm_medium=email&utm_source=Royal+Pharmaceutical+Society&utm_campaign=2306625_260313+-+Support+alert+-+Legislative+changes+to+schedule+Sativex&dm_i=EQ,1DFSX,4H7JBQ,4NMXU,1 (Last accessed 28.03.13)
- Bayer, Data on File 2011. SATDOF002.1
- MIMS. August 2012. pp278.
