European Survey of Prescriber Understanding of Risks Associated with Retigabine
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 w...
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| 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.
Clinical trials registration number
NCT01721213. |
|---|---|
| AbstractList | We conducted a survey to assess physicians' knowledge and understanding of key risks associated with retigabine.
The survey evaluated the effectiveness of the educational plan for retigabine, as specified in the GlaxoSmithKline (GSK) European Risk Management Plan.
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.
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.
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.
NCT01721213. BackgroundWe conducted a survey to assess physicians’ knowledge and understanding of key risks associated with retigabine.ObjectiveThe survey evaluated the effectiveness of the educational plan for retigabine, as specified in the GlaxoSmithKline (GSK) European Risk Management Plan.MethodsThis 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.ResultsOverall, 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.ConclusionsOverall, 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.Clinical trials registration number NCT01721213. 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. Clinical trials registration number NCT01721213. We conducted a survey to assess physicians' knowledge and understanding of key risks associated with retigabine.BACKGROUNDWe conducted a survey to assess physicians' knowledge and understanding of key risks associated with retigabine.The survey evaluated the effectiveness of the educational plan for retigabine, as specified in the GlaxoSmithKline (GSK) European Risk Management Plan.OBJECTIVEThe survey evaluated the effectiveness of the educational plan for retigabine, as specified in the GlaxoSmithKline (GSK) European Risk Management Plan.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.METHODSThis 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.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.RESULTSOverall, 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.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. Clinical trials registration number NCT01721213.CONCLUSIONSOverall, 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. Clinical trials registration number NCT01721213. |
| Author | Brickel, Neil Ishihara, Lianna Lewis, Anne Kolli, Sathish |
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| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/26688787$$D View this record in MEDLINE/PubMed |
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| References | GlaxoSmithKline. Trobalt Summary of Product Characteristics. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/001245/WC500104835.pdf. Accessed 23 Mar 2015. FrenchJAAbou-KhalilBWLeroyRFYacubianEMShinPHallSRandomized, double-blind, placebo-controlled trial of ezogabine (retigabine) in partial epilepsyNeurology.201176181555156310.1212/WNL.0b013e3182194bd31:CAS:528:DC%2BC3MXlsV2iur4%3D21451152 European Medicines Agency (EMA), European Network of Centres for Pharmacoepidemiology (ENCePP). Guide on methodological standard in pharmacoepidemiology June 2013. http://www.encepp.eu/standards_and_guidances. Accessed 4 Jun 2015. Head of Medicines Agencies, European Medicines Agency. Guideline on good pharmacovigilance practices (GVP): Module XVI Risk minimisation measures: selection of tools and effectiveness indicators http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/06/WC500144010.pdf. Accessed 4 Jun 2015. European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP). PRJ2250: survey of patient and prescriber understanding of risks associated with TROBALT. http://www.encepp.eu/encepp/viewResource.htm?id=6187. Accessed 23 Mar 2015. PorterRJBurdetteDEGil-NagelAHallSTWhiteRShaikhSRetigabine as adjunctive therapy in adults with partial-onset seizures: integrated analysis of three pivotal controlled trialsEpilepsy Res.20121011–210311210.1016/j.eplepsyres.2012.03.0101:CAS:528:DC%2BC38XlslSgur8%3D22512894 PrietoLSpoonerAHidalgo-SimonARubinoAKurzXArlettPEvaluation of the effectiveness of risk minimisation measuresPharmacoepidemiol Drug Saf.201221889689910.1002/pds.330522730332 PorterRJPartiotASachdeoRNohriaVAlvesWM205 Study GroupRandomized, multicenter, dose-ranging trial of retigabine for partial-onset seizuresNeurology.200768151197120410.1212/01.wnl.0000259034.45049.001:CAS:528:DC%2BD2sXjs12kurg%3D17420403 US National Institutes of Health. REMS retigabine study. https://clinicaltrials.gov/ct2/show/NCT01938560. Accessed 4 Jun 2015. GlaxoSmithKline. Physician’s guide: starting trobalt: points to discuss with patients. http://hcp.gsk.ie/content/dam/Health/en_IE/HCP_Home/content/Product/trobalt/documents/ie-trobalt-physicians-guide.pdf. Accessed 23 Mar 2015. US National Institutes of Health. Trobalt™ products risk survey. https://clinicaltrials.gov/ct2/show/NCT01721213. Accessed 4 Jun 2015. US Food and Drug Administation. Risk Evaluation and Mitigation Strategy (REMS) assessments: social science methodologies to assess goals related to knowledge: public workshop in June 2012. http://www.fda.gov/Drugs/NewsEvents/ucm292337.htm. Accessed 4 Jun 2015. European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP). WEUKBRE5744: European survey of patient and prescriber understanding of risks associated with TROBALT™. http://www.encepp.eu/encepp/viewResource.htm?id=9225. Accessed 4 Jun 2015. BrodieMJLercheHGil-NagelAElgerCHallSShinPEfficacy and safety of adjunctive ezogabine (retigabine) in refractory partial epilepsyNeurology.201075201817182410.1212/WNL.0b013e3181fd61701:CAS:528:DC%2BC3cXhsVans7jI20944074 BrickelNGandhiPVanLandinghamKEHammondJDeRossettSThe urinary safety profile and secondary renal effects of retigabine (ezogabine): A first-in-class antiepileptic drug that targets KCNQ (Kv7) potassium channelsEpilepsia.201253460661210.1111/j.1528-1167.2012.03441.x1:CAS:528:DC%2BC38XotFKgtro%3D22428574 US Food and Drug Administation. FDA Drug Safety Podcast: Anti-seizure drug Potiga (ezogabine) linked to retinal abnormalities and blue skin discoloration. http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm350120.htm. Accessed 4 Jun 2015. JA French (44_CR6) 2011; 76 MJ Brodie (44_CR3) 2010; 75 RJ Porter (44_CR5) 2012; 101 44_CR1 44_CR15 44_CR16 44_CR14 44_CR7 44_CR8 44_CR9 L Prieto (44_CR13) 2012; 21 RJ Porter (44_CR4) 2007; 68 N Brickel (44_CR2) 2012; 53 44_CR11 44_CR12 44_CR10 22730332 - Pharmacoepidemiol Drug Saf. 2012 Aug;21(8):896-9 20944074 - Neurology. 2010 Nov 16;75(20):1817-24 21451152 - Neurology. 2011 May 3;76(18):1555-63 17420403 - Neurology. 2007 Apr 10;68(15):1197-204 22428574 - Epilepsia. 2012 Apr;53(4):606-12 22512894 - Epilepsy Res. 2012 Aug;101(1-2):103-12 |
| References_xml | – reference: FrenchJAAbou-KhalilBWLeroyRFYacubianEMShinPHallSRandomized, double-blind, placebo-controlled trial of ezogabine (retigabine) in partial epilepsyNeurology.201176181555156310.1212/WNL.0b013e3182194bd31:CAS:528:DC%2BC3MXlsV2iur4%3D21451152 – reference: European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP). WEUKBRE5744: European survey of patient and prescriber understanding of risks associated with TROBALT™. http://www.encepp.eu/encepp/viewResource.htm?id=9225. Accessed 4 Jun 2015. – reference: US Food and Drug Administation. Risk Evaluation and Mitigation Strategy (REMS) assessments: social science methodologies to assess goals related to knowledge: public workshop in June 2012. http://www.fda.gov/Drugs/NewsEvents/ucm292337.htm. Accessed 4 Jun 2015. – reference: PrietoLSpoonerAHidalgo-SimonARubinoAKurzXArlettPEvaluation of the effectiveness of risk minimisation measuresPharmacoepidemiol Drug Saf.201221889689910.1002/pds.330522730332 – reference: US National Institutes of Health. REMS retigabine study. https://clinicaltrials.gov/ct2/show/NCT01938560. Accessed 4 Jun 2015. – reference: European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP). PRJ2250: survey of patient and prescriber understanding of risks associated with TROBALT. http://www.encepp.eu/encepp/viewResource.htm?id=6187. Accessed 23 Mar 2015. – reference: PorterRJPartiotASachdeoRNohriaVAlvesWM205 Study GroupRandomized, multicenter, dose-ranging trial of retigabine for partial-onset seizuresNeurology.200768151197120410.1212/01.wnl.0000259034.45049.001:CAS:528:DC%2BD2sXjs12kurg%3D17420403 – reference: PorterRJBurdetteDEGil-NagelAHallSTWhiteRShaikhSRetigabine as adjunctive therapy in adults with partial-onset seizures: integrated analysis of three pivotal controlled trialsEpilepsy Res.20121011–210311210.1016/j.eplepsyres.2012.03.0101:CAS:528:DC%2BC38XlslSgur8%3D22512894 – reference: Head of Medicines Agencies, European Medicines Agency. Guideline on good pharmacovigilance practices (GVP): Module XVI Risk minimisation measures: selection of tools and effectiveness indicators http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/06/WC500144010.pdf. Accessed 4 Jun 2015. – reference: US National Institutes of Health. Trobalt™ products risk survey. https://clinicaltrials.gov/ct2/show/NCT01721213. Accessed 4 Jun 2015. – reference: BrickelNGandhiPVanLandinghamKEHammondJDeRossettSThe urinary safety profile and secondary renal effects of retigabine (ezogabine): A first-in-class antiepileptic drug that targets KCNQ (Kv7) potassium channelsEpilepsia.201253460661210.1111/j.1528-1167.2012.03441.x1:CAS:528:DC%2BC38XotFKgtro%3D22428574 – reference: GlaxoSmithKline. Trobalt Summary of Product Characteristics. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/001245/WC500104835.pdf. Accessed 23 Mar 2015. – reference: BrodieMJLercheHGil-NagelAElgerCHallSShinPEfficacy and safety of adjunctive ezogabine (retigabine) in refractory partial epilepsyNeurology.201075201817182410.1212/WNL.0b013e3181fd61701:CAS:528:DC%2BC3cXhsVans7jI20944074 – reference: European Medicines Agency (EMA), European Network of Centres for Pharmacoepidemiology (ENCePP). 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We conducted a survey to assess physicians’ knowledge and understanding of key risks associated with retigabine.
Objective
The survey evaluated the... We conducted a survey to assess physicians' knowledge and understanding of key risks associated with retigabine. The survey evaluated the effectiveness of the... BackgroundWe conducted a survey to assess physicians’ knowledge and understanding of key risks associated with retigabine.ObjectiveThe survey evaluated the... We conducted a survey to assess physicians' knowledge and understanding of key risks associated with retigabine.BACKGROUNDWe conducted a survey to assess... |
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| SubjectTerms | Confidence intervals Convulsions & seizures Drug dosages Internal Medicine Medicine Medicine & Public Health Multiple choice Performance evaluation Pharmacology/Toxicology Pharmacotherapy Physicians Questionnaires Short Communication |
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| Title | European Survey of Prescriber Understanding of Risks Associated with Retigabine |
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