From 10th April, Sativex will become a Schedule 4 Part I drug and its continued availability for use in healthcare will be enabled under the Misuse of Drugs Regulations 2001 (as amended) (the 2001 Regulations).
The Statutory Instrument, which applies to Great Britain, revokes the Home Office Open General Licence, which currently applies to Sativex, a prescription-only cannabinoid oromucosal mouth spray for use by patients with multiple sclerosis to alleviate symptoms such as neuropathic pain, spasticity or overactive bladder.
Specific regulatory requirements coming into force on 10th April 2013:
- Any person authorised by, or under the 2001 Regulations, to possess or destroy Sativex is required to keep records of the amounts of Sativex possessed or destroyed from 10th April 2013
- Records must be kept for a minimum of two years
- Patients, their representatives, and persons listed in Regulation 6(7) of the 2001 Regulations are specifically exempted from the requirement to keep records.
- The Misuse of Drugs (Safe Custody) Regulations 1973 do not apply to Sativex
- Regulation 15 which specifies how prescriptions for Schedules 2 and 3 CDs should be written does not apply to Sativex
- FP10PCD requirements do not apply when Sativex is prescribed privately
- The destruction of expired stocks of Sativex and patient returns by healthcare professionals do not need to be witnessed by an authorised witness
- The requirement to keep records does not extend to the use of a CD register. However, the Home Office strongly recommends the use of the CD register, as the most recognised UK CD record keeping document, for records relating to Sativex.
The SI implementing the changes is available here.
The ‘designation’ provisions which required possession, supply and production etc of Sativex to take place under a Home Office licence “for research or other special purpose” have also been removed.
By Ailsa Colquhoun