A drug utilisation study in patients treated with EXELON® patch
Research type
Research Study
Full title
A drug utilisation study in patients treated with EXELON®/PROMETAX® (rivastigmine) transdermal patch
IRAS ID
186105
Contact name
Jane Watson
Contact email
Sponsor organisation
Novartis Pharma Services AG
Research summary
The research aim is to assess the extent of inappropriate use (defined as medication errors and misuse) of Exelon/Prometax (rivastigmine) patches, a cholinesterase inhibitor that is indicated to treat patients with mild to moderately severe Alzheimer’s dementia, among patients and their patient assistants following the introduction of a new risk minimisation tool, the Patient Reminder Card, comprised of the Instructions for Use and Medication Record Sheet.
Participating physician sites will recruit patients currently using or switching to an Exelon/Prometax patch during a regularly scheduled visit. Due to the nature of their condition (even among those with mild dementia) patients will be required to have an assistant who is willing to participate in the study as a condition of enrolment. The site personnel will administer an enrolment questionnaire to the patient assistant with input, as appropriate, by the patient. Then, the site personnel will provide the Medication Record Sheets (which are part of the patient reminder card and which will be used to record daily patch use for the study). Patients and/or patient assistants will be asked to complete the Medication Record Sheets each day for 28 days. After the 28-day observation period, the site personnel will conduct an interview by telephone to administer a follow-up questionnaire to the patient assistant. Furthermore, follow-up telephone interviews will be conducted every 2 months for 10 months while the patient continues using the Exelon/Prometax patch to assess inappropriate use as well as use of the Patient Reminder Card.
In addition to information collected from the patient and patient assistant, the physician will complete a case report form at enrolment, at the end of the 28-day observation period, and after the final follow-up interview, to record relevant medical history before, during, and at completion of the study based on the patient’s medical record.REC name
London - Harrow Research Ethics Committee
REC reference
15/LO/1263
Date of REC Opinion
12 Nov 2015
REC opinion
Further Information Favourable Opinion