REMS Retigabine Study

REMS Prescriber and Pharmacist Understanding of the Risk of Urinary Retention With POTIGA™

As part of a post-marketing commitment, GSK will conduct a survey of prescribers' and pharmacists' understanding of the risk of urinary retention with retigabine products. This is to address the effectiveness of the Risk Evaluation and Mitigation Strategy (REMS) as outlined in the REMS approved by the FDA on 10th June 2011. The objectives of this survey are to assess prescribers' and pharmacists' understanding of the risk of urinary retention and the symptoms of acute urinary retention potentially associated with retigabine use as evaluated by a survey instrument.

This is a cross-sectional study of approximately 200 physicians (e.g. neurologists/epileptologists/neurosurgeons) who have prescribed retigabine at least once in the last 12 months, and 200 pharmacists who have dispensed an anti-epileptic drug (AED) at least once in the last 3 months. The primary outcome of the survey is the proportion of physicians and pharmacists providing correct responses to a series of questions concerning the risk of urinary retention and the symptoms of acute urinary retention that may be associated with retigabine. The risks captured will be those described in the retigabine Dear Healthcare Provider (DHCP) letters, specifically risks of urinary retention.

Study Overview

• Status: Completed
• Conditions: Epilepsy
• Intervention / Treatment: Other: Survey Responses

Detailed Description

POTIGA is a trademark of Valeant Pharmaceuticals North America, used by GlaxoSmithKline under license.

• Study Type: Observational
• Enrollment (Actual): 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

200 physicians (e.g. neurologists/epileptologists/neurosurgeons) who have prescribed retigabine at least once in the last 12 months, and 200 pharmacists who have dispensed an anti-epileptic drug (AED) at least once in the last 3 months.

Description

Inclusion Criteria:

• Able to read, speak, and understand English.
• Willing to take the online survey or have the survey administered via a telephone interview, including electronically signing a Confidentiality & Consent agreement and completing all study protocol-specified procedures.
• Prescribed retigabine within the past 12 months (prescribing physicians)
• Filled a prescription for at least one AED within the previous three months (pharmacists).

Exclusion Criteria:

• Physicians or pharmacists meeting any of the following criteria will not be eligible to take the survey:
• The physician or pharmacist is currently employed by, or is a representative of any of the following:
• A pharmaceutical company or manufacturer of medicines or healthcare products.
• Contributor/editor to published guideline committees for epilepsy or UR.
• The physician or pharmacist has a visual impairment that would prevent him or her from being able to read independently.
• The physician or pharmacist participated in the Pilot REMS study for retigabine.
• The physician or pharmacist is an employee of GSK or Concentrics Research.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Physicians; Retigabine Physicians (e.g. neurologists/epileptologists/neurosurgeons) who have prescribed retigabine at least once in the last 12 months.	Other: Survey Responses; Subject understanding of the risk of urinary retention and the symptoms of acute urinary retention associated with retigabine will be assessed using the survey instrument.
Pharmacists; Pharmacists who have dispensed an anti-epileptic drug (AED) at least once in the last 3 months.	Other: Survey Responses; Subject understanding of the risk of urinary retention and the symptoms of acute urinary retention associated with retigabine will be assessed using the survey instrument.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of physicians and pharmacists providing correct responses to a series of questions concerning the risk of urinary retention and the symptoms of acute urinary retention that may be associated with retigabine.	The outcome is a survey response by physicians and pharmacists so is not related to the drug exposure.	12 months

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: September 5, 2013
• First Submitted That Met QC Criteria: September 5, 2013
• First Posted (Estimate): September 10, 2013

Study Record Updates

• Last Update Posted (Estimate): October 1, 2014
• Last Update Submitted That Met QC Criteria: September 29, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy
• Other Study ID Numbers: 116490; WEUKBRE5993 (Other Identifier: GSK)