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Application device for THC:CBD oromucosal spray in the management of resistant spasticity: pre-production testing.
Expert Rev Med Devices. 2019 Sep; 16(9):835-840.ER

Abstract

Background:

Patients with multiple sclerosis spasticity (MSS) and upper limb/hand impairment who are taking 9-delta-tetrahydrocannabinol:cannabidiol (THC:CBD) oromucosal spray (Sativex®) may have difficulty self-administering their medication, possibly limiting adherence and treatment effectiveness. A Class I EU device is available to support the administration of THC:CBD spray. Pre-production testing was undertaken in a patient sample.

Methods:

Current users of THC:CBD spray were recruited to review the instruction leaflet and test the device. Patients and observing health-care professionals (HCP) completed a purpose-designed questionnaire which captured user experience and HCP opinion.

Results:

Fifteen patients participated. Mean treatment time with THC:CBD spray was 4 (range: 0.1-6.1) years. 87% of participants 'always', 'often' or 'sometimes' had hand impairment, and 53% reported difficulty administering THC:CBD spray. Participants reported better application using the device (73%), with less strength required (54%). Most participants (93%) considered the instruction leaflet to be clear and many (66%) expressed interest in using the device. Most HCPs (93%) did not foresee any difficulties in use of the device.

Conclusion:

The proposed adherence device was useful to address self-application difficulties with THC:CBD spray in our sample. Providing the device to MSS patients with upper limb/hand spasticity impairment may restore autonomy and support adherence to THC:CBD spray.

Authors+Show Affiliations

Neurology Service, Hospital Clínico Universitario San Carlos , Madrid , Spain.R&D Department, Global Medical Affairs, Almirall S.A , Barcelona , Spain.

Pub Type(s)

Clinical Trial
Journal Article

Language

eng

PubMed ID

31393179

Citation

Montero-Escribano, Paloma, and Carlos Vila Silván. "Application Device for THC:CBD Oromucosal Spray in the Management of Resistant Spasticity: Pre-production Testing." Expert Review of Medical Devices, vol. 16, no. 9, 2019, pp. 835-840.
Montero-Escribano P, Vila Silván C. Application device for THC:CBD oromucosal spray in the management of resistant spasticity: pre-production testing. Expert Rev Med Devices. 2019;16(9):835-840.
Montero-Escribano, P., & Vila Silván, C. (2019). Application device for THC:CBD oromucosal spray in the management of resistant spasticity: pre-production testing. Expert Review of Medical Devices, 16(9), 835-840. https://doi.org/10.1080/17434440.2019.1653182
Montero-Escribano P, Vila Silván C. Application Device for THC:CBD Oromucosal Spray in the Management of Resistant Spasticity: Pre-production Testing. Expert Rev Med Devices. 2019;16(9):835-840. PubMed PMID: 31393179.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Application device for THC:CBD oromucosal spray in the management of resistant spasticity: pre-production testing. AU - Montero-Escribano,Paloma, AU - Vila Silván,Carlos, Y1 - 2019/08/19/ PY - 2019/8/9/pubmed PY - 2019/11/16/medline PY - 2019/8/9/entrez KW - Multiple sclerosis KW - THC:CBD oromucosal spray KW - medical device KW - upper limb/hand spasticity SP - 835 EP - 840 JF - Expert review of medical devices JO - Expert Rev Med Devices VL - 16 IS - 9 N2 - Background: Patients with multiple sclerosis spasticity (MSS) and upper limb/hand impairment who are taking 9-delta-tetrahydrocannabinol:cannabidiol (THC:CBD) oromucosal spray (Sativex®) may have difficulty self-administering their medication, possibly limiting adherence and treatment effectiveness. A Class I EU device is available to support the administration of THC:CBD spray. Pre-production testing was undertaken in a patient sample. Methods: Current users of THC:CBD spray were recruited to review the instruction leaflet and test the device. Patients and observing health-care professionals (HCP) completed a purpose-designed questionnaire which captured user experience and HCP opinion. Results: Fifteen patients participated. Mean treatment time with THC:CBD spray was 4 (range: 0.1-6.1) years. 87% of participants 'always', 'often' or 'sometimes' had hand impairment, and 53% reported difficulty administering THC:CBD spray. Participants reported better application using the device (73%), with less strength required (54%). Most participants (93%) considered the instruction leaflet to be clear and many (66%) expressed interest in using the device. Most HCPs (93%) did not foresee any difficulties in use of the device. Conclusion: The proposed adherence device was useful to address self-application difficulties with THC:CBD spray in our sample. Providing the device to MSS patients with upper limb/hand spasticity impairment may restore autonomy and support adherence to THC:CBD spray. SN - 1745-2422 UR - https://www.unboundmedicine.com/medline/citation/31393179/Application_device_for_THC:CBD_oromucosal_spray_in_the_management_of_resistant_spasticity:_pre_production_testing_ L2 - http://www.tandfonline.com/doi/full/10.1080/17434440.2019.1653182 DB - PRIME DP - Unbound Medicine ER -