A questionnaire survey of patients and carers of patients prescribed Sativex as an unlicensed medicine.
OBJECTIVE
To identify the areas of daily function most affected by the introduction of Sativex, a cannabis-based medicine, and the impact on caregivers and people with multiple sclerosis (MS).


BACKGROUND
Cannabinoid medicines have recently become available on prescription in several parts of the world, principally for the treatment of spasticity in people with MS. Their efficacy and safety have been demonstrated in the setting of randomised controlled clinical trials. Results of such studies may not always reflect the wider effectiveness that a medicine shows when used in clinical practice.


METHODS
A short questionnaire survey consisting mostly of multiple-choice questions, along with some free-text questions aimed at the patient and primary caregiver (ie, partner, mother, nurse or outside carer). The questionnaire was developed in consultation with a patient representative organisation, field tested, ethics approval gained, then distributed to prescribers in the United Kingdom, with the request that they in turn forward it to any patients who had received repeat prescriptions for Sativex within the previous 16 weeks. Patients were seen in both a primary care (general practice) and a secondary care (hospital) setting. There was no control group in this study. Most patients had MS, and the primary reasons for using Sativex were spasticity and pain.


RESULTS
The response rate was 57%, with 124 questionnaires returned. The majority of respondents and their caregivers reported improvements across a range of daily functional activities, alongside a reduction in the use of concomitant anti-spasticity medication and in the use of other healthcare resources.
Pain Research Unit, James Paget University Hospital, Great Yarmouth, Norfolk, UK. William.Notcutt@JPAGET.NHS.UK
William G
WG
Notcutt
D000203:Activities of Daily Living; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002185:Cannabidiol; D017028:Caregivers / Q000706:statistics & numerical data; D013759:Dronabinol; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009103:Multiple Sclerosis / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D009128:Muscle Spasticity / Q000188:drug therapy* / Q000209:etiology; D009437:Neuralgia / Q000188:drug therapy* / Q000209:etiology; D056687:Off-Label Use; D008517:Phytotherapy; D010936:Plant Extracts / Q000008:administration & dosage* / Q000627:therapeutic use; D010818:Practice Patterns, Physicians' / Q000706:statistics & numerical data; D012890:Sleep / Q000187:drug effects; D011795:Surveys and Questionnaires; D006113:United Kingdom
D004338:Drug Combinations; D010936:Plant Extracts; D002185:Cannabidiol; D013759:Dronabinol; C587251:nabiximols