Quality of drug label information on QT interval prolongation

TY - JOUR

T1 - Quality of drug label information on QT interval prolongation

AU - Warnier, Miriam J

AU - Holtkamp, Frank A

AU - Rutten, Frans H

AU - Hoes, Arno W

AU - de Boer, Anthonius

AU - Mol, Peter G M

AU - De Bruin, Marie L

PY - 2014

Y1 - 2014

N2 - BACKGROUND: Information regarding QT-prolongation in the drug label may vary between products. This could lead to suboptimal risk minimization strategies.OBJECTIVE: To systematically assess the variation in the extent and content of information on QT prolongation in the summary of product characteristics (SPC) of recently approved medicinal products.METHODS: Drug labels of products centrally approved in Europe between 2006 and 2012 were screened. Of drugs including the term 'QT' in the SPC, the message on QT-prolongation ('no prolongation'/'unclear drug-QT association'/'possibly QT-prolongation'/'QT-prolongation') and the advice on cautionary measures pertaining to QT-prolongation in the label were examined, as well as their association.RESULTS: Of the 175 screened products, 44 contained information on QT in the SPC ('no QT-prolongation': 23%, 'unclear drug-QT association': 43%, 'possibly QT-prolongation': 16%, 'QT-prolongation': 18%). 62% contained advices to act with caution in patients with additional risk factors for QT-prolongation. Products that more likely to have QT-prolonging properties according to the SPC provided more information on QT-prolongation in the SPC ('no prolongation': 10% and for the category 'QT-prolongation': 100%).CONCLUSIONS: The extent and content of information on QT-prolongation varies considerably between SPCs, and in almost half of the drugs a clear message on QT-prolongation was lacking in the SPC.

AB - BACKGROUND: Information regarding QT-prolongation in the drug label may vary between products. This could lead to suboptimal risk minimization strategies.OBJECTIVE: To systematically assess the variation in the extent and content of information on QT prolongation in the summary of product characteristics (SPC) of recently approved medicinal products.METHODS: Drug labels of products centrally approved in Europe between 2006 and 2012 were screened. Of drugs including the term 'QT' in the SPC, the message on QT-prolongation ('no prolongation'/'unclear drug-QT association'/'possibly QT-prolongation'/'QT-prolongation') and the advice on cautionary measures pertaining to QT-prolongation in the label were examined, as well as their association.RESULTS: Of the 175 screened products, 44 contained information on QT in the SPC ('no QT-prolongation': 23%, 'unclear drug-QT association': 43%, 'possibly QT-prolongation': 16%, 'QT-prolongation': 18%). 62% contained advices to act with caution in patients with additional risk factors for QT-prolongation. Products that more likely to have QT-prolonging properties according to the SPC provided more information on QT-prolongation in the SPC ('no prolongation': 10% and for the category 'QT-prolongation': 100%).CONCLUSIONS: The extent and content of information on QT-prolongation varies considerably between SPCs, and in almost half of the drugs a clear message on QT-prolongation was lacking in the SPC.

KW - Arrhythmias, Cardiac

KW - Drug Labeling

KW - Drug-Related Side Effects and Adverse Reactions

KW - Electrocardiography

KW - Europe

KW - Health Knowledge, Attitudes, Practice

KW - Heart Conduction System

KW - Humans

KW - Patient Education as Topic

KW - Risk Assessment

KW - Risk Factors

KW - Journal Article

KW - Research Support, Non-U.S. Gov't

U2 - 10.3233/jrs-140612

DO - 10.3233/jrs-140612

M3 - Journal article

C2 - 24902506

SN - 0924-6479

VL - 26

SP - 89

EP - 98

JO - International Journal of Risk and Safety in Medicine

JF - International Journal of Risk and Safety in Medicine

IS - 2

ER -