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Ishihara L, Lewis A, Kolli S, et al. European Survey of Prescriber Understanding of Risks Associated with Retigabine. Drugs Real World Outcomes. 2015;2(4):345-353doi: 10.1007/s40801-015-0044-3.
Ishihara, L., Lewis, A., Kolli, S., & Brickel, N. (2015). European Survey of Prescriber Understanding of Risks Associated with Retigabine. Drugs - real world outcomes, 2(4), 345-353. https://doi.org/10.1007/s40801-015-0044-3
Ishihara, Lianna, et al. "European Survey of Prescriber Understanding of Risks Associated with Retigabine." Drugs - real world outcomes vol. 2,4 (2015): 345-353. doi: https://doi.org/10.1007/s40801-015-0044-3
Ishihara L, Lewis A, Kolli S, Brickel N. European Survey of Prescriber Understanding of Risks Associated with Retigabine. Drugs Real World Outcomes. 2015;2(4):345-353. doi: 10.1007/s40801-015-0044-3. Epub 2015 Nov 16. PMID: 26688787; PMCID: PMC4674521.
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Drugs Real World Outcomes. 2015;2(4):345-353. doi: 10.1007/s40801-015-0044-3. Epub 2015 Nov 16.

European Survey of Prescriber Understanding of Risks Associated with Retigabine.

Drugs - real world outcomes

Lianna Ishihara, Anne Lewis, Sathish Kolli, Neil Brickel

Affiliations

  1. Department of Epidemiology, GlaxoSmithKline, Stockley Park, Middlesex UK ; Lundbeck SAS, 37-45 Quai du President Roosevelt, 92445 Issy-les-Moulineaux, France.
  2. United BioSource Corporation, Blue Bell, PA USA.
  3. Global Clinical Safety and Pharmacovigilance, GlaxoSmithKline, Uxbridge, Middlesex UK ; LEO Pharma, Horizon, Honey Lane, Hurley, Berkshire SL6 6RJ UK.
  4. Global Clinical Safety and Pharmacovigilance, GlaxoSmithKline, Uxbridge, Middlesex UK.

PMID: 26688787 PMCID: PMC4674521 DOI: 10.1007/s40801-015-0044-3

Abstract

BACKGROUND: We conducted a survey to assess physicians' knowledge and understanding of key risks associated with retigabine.

OBJECTIVE: The survey evaluated the effectiveness of the educational plan for retigabine, as specified in the GlaxoSmithKline (GSK) European Risk Management Plan.

METHODS: This was a cross-sectional survey of physicians across seven European countries (Denmark, Germany, Norway, Slovakia, Spain, Switzerland, and the UK) who had prescribed an antiepileptic drug at least once within the past 3 months, and to whom a letter containing the retigabine Physician's Guide was sent. The survey included multiple-choice and closed-ended questions. Primary outcome was the proportion of physicians correctly answering questions related to retigabine-associated risks. Point estimates for the proportion of correct responses and associated confidence intervals were calculated.

RESULTS: Overall, 294 prescribers completed the survey between November 2012 and October 2013. Generally, physicians had adequate knowledge of the retigabine indication (78-92 % correct responses). Specific dose-related knowledge (57-74 %) and management of individual risks (20-77 %) were recalled less well. Subgroup analyses showed that both the 189 physicians who read the retigabine education letter and the 144 who had prescribed retigabine had better recall of the risks associated with retigabine (20-78 %) than those who did not.

CONCLUSIONS: Overall, physicians were aware, to varying degrees, of the risks associated with retigabine. Subsequent to the conduct of this survey, GSK has made further changes to the product labeling for retigabine, sent an updated 'Dear Healthcare Professional' letter, and initiated another EU survey to assess how effectively specific risks associated with retigabine use are communicated.

Conflict of interest statement

Compliance with Ethical Standards Funding This study was sponsored and funded by GSK (ClinicalTrials.gov Identifier: NCT01721213; GSK study number WEUKBRE5744) and conducted by UBC. Although GSK funde

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